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, 61055-61081 [2012-24434]
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Vol. 77
Friday,
No. 194
October 5, 2012
Part II
Department of Agriculture
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Animal and Plant Health Inspection Service
7 CFR Part 331
9 CFR Part 121
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; Final Rule
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Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules and Regulations
2, Riverdale, MD 20737–1231; (301)
851–3300, option 1.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
Executive Summary
7 CFR Part 331
9 CFR Part 121
[Docket No. APHIS–2009–0070]
RIN 0579–AD09
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: Final rule.
AGENCY:
In accordance with the
Agricultural Bioterrorism Protection Act
of 2002, we are amending and
republishing 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 implements the
findings of the third biennial review of
the list. In addition, we are reorganizing
the list of select agents and toxins based
on the relative potential of each select
agent or toxin to be misused to
adversely affect human, plant, or animal
health. Such tiering of the list allows for
the optimization of security measures
for those select agents or toxins that
present the greatest risk of deliberate
misuse with the most significant
potential for mass casualties or
devastating effects to the economy,
critical infrastructure, or public
confidence. We are also making a
number of amendments to the
regulations, including the addition of
definitions and clarification of language
concerning security, training, biosafety,
biocontainment, and incident response.
These changes will increase the
usability of the select agent regulations
as well as provide for enhanced program
oversight.
DATES: The amendments to 7 CFR 331.1
through 331.10, 331.13, and 331.16
through 331.20 and 9 CFR 121.1 through
121.10, 121.13, 121.16, 121.17, and
121.20 are effective December 4, 2012.
The remaining provisions of this final
rule are effective April 3, 2013.
FOR FURTHER INFORMATION CONTACT: Mr.
Charles L. Divan, Acting Director,
APHIS Agriculture Select Agent
Program, APHIS, 4700 River Road Unit
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SUMMARY:
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On July 29, 2010, we published in the
Federal Register (75 FR 44724–44725,
Docket No. APHIS–2009–0070) an
advance notice of proposed rulemaking
and request for comments (ANPR)1 and
On October 3, 2011, we published in the
Federal Register (76 FR 61228–61244,
Docket No. APHIS–2009–0070) a
proposal2 regarding our intent 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,
reorganize the list of select agents and
toxins based on the relative potential of
each select agent or toxin to be misused
to adversely affect human, plant, or
animal health, and amend the
regulations in order to add definitions
and clarify language concerning
security, training, biosafety,
biocontainment, and incident response.
Specifically, the ANPR solicited
comments regarding whether there are
other select agents or toxins that should
be added to the Plant Protection and
Quarantine (PPQ) and Veterinary
Services (VS) lists of select agents and
toxins, whether any of the select agents
or toxins on the PPQ or VS lists should
be removed, whether the PPQ and VS
lists of select agents and toxins should
be tiered based on the relative
bioterrorism risk presented by each
select agent or toxin, and whether the
security requirements for select agents
or toxins in the highest tier should be
stratified based on type of use or other
factors. Comments received as a result
of the ANPR were used in order to
inform our discussions on the content of
the select agent list and our
determination regarding reorganization
of the list in the proposed rule. We
solicited comments concerning our
proposal for 60 days ending December
2, 2011. We reopened and extended the
deadline for comments until January 17,
2012, in a document published in the
Federal Register on December 15, 2011
(76 FR 77914, Docket No. APHIS–2009–
0070). We received 30 comments by that
date. They were from researchers,
scientific organizations, laboratories,
and universities.
Changes to the current regulations
detailed in this final rule include:
1 To view the ANPR and the comments we
received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS–2009–0070.
2 To view the proposed rule and the comments
we received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS–2009–0070.
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1. Modification of the select agent and
toxin list:
• The following agents would no
longer be considered PPQ select agents
or toxins, or would be excluded from
compliance with the select agent
regulations: Any subspecies of Ralstonia
solanacearum except race 3, biovar 2
and all subspecies of Sclerophthora
rayssiae except var. zeae, and Xylella
fastidiosa, citrus variegated chlorosis
(CVC) strain.
• The following agents would no
longer be considered VS select agents or
toxins, or would be excluded from
compliance with the select agent
regulations: Any low pathogenic strains
of avian influenza virus, any strain of
Newcastle disease virus which does not
meet the criteria for virulent Newcastle
disease virus, 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), Akabane
virus; Bluetongue virus (exotic), Bovine
spongiform encephalopathy agent;
Camel pox virus; Ehrlichia ruminantium
(Heartwater); Japanese encephalitis
virus; Malignant catarrhal fever virus
(Alcelaphine herpesvirus type 1);
Menangle virus; and Vesicular
stomatitis virus (exotic): Indiana
subtypes VSV–IN2, VSV–IN3.
• The following agent would no
longer be considered a VS/Department
of Health and Human Services (HHS)
overlap select agent: Venezuelan Equine
Encephalitis Virus (subtypes ID and IE).
2. Tiering of the select agent and toxin
lists:
Tier 1 select agents and toxins:
• PPQ select agents and toxins: None.
• VS select agents and toxins: Footand-mouth disease virus and Rinderpest
virus.
• VS/HHS overlap select agents and
toxins: Bacillus anthracis, Burkholderia
mallei, and Burkholderia pseudomallei.
3. Establishing physical security
standards for entities possessing Tier 1
select agents and toxins, including the
requirement to conduct pre-access
assessments and ongoing monitoring of
personnel with access to Tier 1 agents
and toxins;
4. Miscellaneous revisions to the
regulations to clarify regulatory
language concerning security, training,
biosafety, and incident response.
Costs of the Rule: Entities affected by
the rule include research and diagnostic
facilities; Federal, State, and university
laboratories; and private commercial
and non-profit enterprises. The
regulations require registering the
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possession, use, and transfer of select
agents or toxins. In addition, the entity
is required to ensure that the facility
where the agent or toxin is housed has
adequate biosafety and containment
measures, that the physical security of
the premises is adequate, that all
individuals with access to select agents
or toxins have the appropriate
education, training, and/or experience
to handle such agents or toxins, and that
complete records concerning activities
related to the select agents or toxins are
maintained.
The rule will further reduce or
minimize the risk of misuse of select
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 and HHS recognize
that several of the required measures of
the regulations may impose certain
operational costs upon affected entities,
particularly entities that have the newly
designated Tier 1 select agents and
toxins. In many cases, however, the
affected entities already employ some or
all of the required measures.
Compliance costs actually incurred will
therefore vary from one entity to the
next.
While information on the specific
changes that would need to occur at
individual sites and the associated costs
was not readily available during
proposed rulemaking, some general
observations regarding the potential
costs were presented. These general cost
observations can be found in Table 2 of
the Regulatory Impact Analysis located
at: www.regulations.gov and at https://
www.selectagents.gov.
Benefits of the Rule: The objectives of
the final rule is to create a means of
ensuring enhanced oversight in the
transfer, storage, and use of select agents
and toxins; define the security
procedures and suitability assessments
for pre-access suitability and continual
monitoring of individuals with access to
Tier 1 select agents and toxins; and
require that entities in possession of
such agents and toxins develop and
implement effective means of biosafety,
information security, and physical
security. The overall benefit of the
amended provisions will be a reduced
likelihood of the accidental or
intentional release of a select agent or
toxin and the avoidance of costs
associated with such a release. The goal
of the amended regulations is to
enhance the protection of human,
animal, and plant health and safety.
Background
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (referred to below
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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
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
human and animal health or 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 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 amending and republishing the list
of select agents and toxins based on the
findings of our third 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 or disease
caused by the agent or toxin; and
• Any other criteria that the Secretary
considers appropriate to protect animal
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or plant health, or animal or plant
products.
We use the term ‘‘select agents and
toxins’’ throughout the preamble of this
final 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 agents and toxins listed in both
9 CFR 121.4 and 42 CFR 73.4).
On October 3, 2011, we published in
the Federal Register (76 FR 61228–
61244, Docket No. APHIS–2009–0070) a
proposal 3 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, reorganize the list of
select agents and toxins based on the
relative potential of each select agent or
toxin to be misused to adversely affect
human, plant, or animal health, and
amend the regulations in order to add
definitions and clarify language
concerning security, training, biosafety,
biocontainment, and incident response.
We solicited comments concerning
our proposal for 60 days ending
December 2, 2011. We reopened and
extended the deadline for comments
until January 17, 2012, in a document
published in the Federal Register on
December 15, 2011 (76 FR 77914,
Docket No. APHIS–2009–0070). We
received 30 comments by that date.
They were from researchers, scientific
organizations, laboratories, and
universities. They are discussed below
by topic.
Guidance Documents
In the proposed rule, we specifically
requested comment from the regulated
community and any other interested
persons on the need for and desirability
of guidance documents that would serve
to assist regulated entities in meeting
the requirements of regulations. We
were particularly interested in public
comment regarding Web sites, articles,
or other sources useful in developing
such guidance documents. We received
a number of comments on the issue of
guidance, which are discussed below.
Two commenters suggested the use of
specific documents in creating
guidance: The Laboratory Biorisk
Management Standard, which was
3 To view the proposed rule and the comments
we received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2009-0070.
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developed by the European Committee
for Standardization, and the report
‘‘Guidance for Enhancing Personnel
Reliability and Strengthening the
Culture of Responsibility,’’ which was
developed by the National Science
Advisory Board for Biosecurity.
We agree with the commenters and
have utilized both sources in developing
guidance.
One commenter stated that the select
agent program should develop a
standardized template that addresses
each item required by the regulations,
both for regulated entities and
inspectors. The commenter went on to
say that the templates should be posted
on the select agent Web site.
The National Select Agent Registry at
www.selectagents.gov includes
checklists, guidance documents, and
templates that we have developed to aid
entities in meeting the requirements of
the regulations. The select agent
program also conducts regular inspector
training in order to standardize
inspector understanding of the
regulations and inspection process. We
accept entity feedback regarding the
inspection process and incorporate it
into our training program as
appropriate.
Another commenter stated that the
involvement of regulated entities in the
development of guidance is crucial, as
it will ensure that the new regulations
may be implemented without
unsustainable increases in cost to those
entities.
The guidance documents developed
in conjunction with this rule are, in
part, a response to the questions and
issues raised by the commenters
regarding various aspects of the
proposed rule. We also consulted HHS
and USDA subject matter experts and
other sources including National
Science Advisory Board for Biosecurity,
the National Academies, the Department
of Defense Security Engineering
Facilities Planning Manual, and Director
of Central Intelligence Directive Number
6/9. Regarding the commenter’s cost
concerns, the guidance developed by
the select agent program does not set out
a prescriptive series of procedures that
must be followed by all regulated
entities; rather, it establishes examples
of ways in which an entity may choose
to meet the requirements of the
regulations. We have purposefully left
the regulations in their general state in
order to allow for the wide variety of
regulated entities to meet the regulatory
standard in a way that is most costeffective for each.
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PPQ Select Agents and Toxins
We proposed to amend the list of PPQ
select agents and toxins listed in 7 CFR
331.3 by removing Xylella fastidiosa,
citrus variegated chlorosis (CVC) strain,
from the list as it no longer meets the
criteria for use as an agroterrorism
agent.
One commenter stated that the
scientific basis for the removal of
Xylella fastidiosa from the list was
unclear and requested clarification
concerning our decision. The
commenter additionally stated that if
the review process for such removal
were to be transparent, with expert
opinion from the public and private
sector, including a sound scientific
analysis and an assessment of the
biosecurity risk of each agent, other
plant pathogens on the list of select
agents and toxins could potentially be
removed.
We are making no changes as a result
of this comment. Each agent on the
select agent and toxin list was
considered for retention or removal
based on a variety of factors, including,
but not limited to, the scientific
concerns cited by the commenter.
Further, the select agent program did
employ subject-matter experts as part of
the decision-making process as
recommended by the commenter in
addition to soliciting public comment.
Experts in the biology of these agents
and toxins evaluated their ‘‘potential for
mass casualties or devastating effects to
the economy, critical infrastructure, or
public confidence.’’ This evaluation
included assessments of morbidity and
mortality, communicability, low
infectious dose, availability of
countermeasures, and economic impact
of a potential attack. Each agent and
toxin was then assessed for its ‘‘risk of
deliberate misuse,’’ including its history
of weaponization and/or known interest
by State or non-State adversaries. These
evaluations, combined with input
received as a result of the publication of
an advance notice of proposed
rulemaking and request for comments
(ANPR) 4 in the Federal Register on July
29, 2010, and relevant findings in recent
government and non-government
reports, formed the basis for
deliberations concerning which agents
should constitute the list. It is important
to note that removal of pathogens from
the list of select agents and toxins does
not mean that they are not of potential
concern, but rather that the risk they
represent has been reevaluated using the
above criteria. Reduction of the list is
4 To view the ANPR and the comments we
received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2009-0070.
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meant to decrease the burden on
researchers and focus attention on
agents and toxins judged to be of
greatest biosecurity concern.
The list of PPQ select agents and
toxins includes an entry for
Xanthomonas oryzae. While we did not
propose any changes to the entry for
Xanthomonas oryzae, one commenter
stated that it should be removed from
the list of select agents and toxins and
offered a number of arguments, which
are discussed below.
The commenter proposed the removal
of Xanthomonas oryzae based on the
assertion that Xanthomonas oryzae
populations are adapted only to local
conditions and do not persist upon
introduction to new environments.
Given that the major natural host for
Xanthomonas oryzae is rice, the
commenter also compared cultivation
practices utilized in domestic
commercial rice production with those
utilized in Asian commercial rice
production. The commenter argued that
domestic commercial cultivation
practices eliminate transmission of the
pathogen since rice seeds are directly
planted whereas in Asia rice seedlings
are cultivated elsewhere and then
transplanted, and wounds created
during such handling and transplant are
important modes of transmission for the
pathogen to healthy seedlings. In
addition, the commenter said that
domestic weather patterns are not
conducive to dissemination and that
quarantines can prevent seed-borne
disease. The commenter claimed that
field-to-field spread of Xanthomonas
oryzae in Asia is largely dependent on
the strong winds and driving rains that
occur frequently during typhoon season.
We are making no changes to the
regulations as a result of this comment.
Natural spread or persistence of the
pathogen in a particular location is not
at issue; it is the risk of deliberate
misuse leading to the most significant
potential for mass casualties or
devastating effects to the economy,
critical infrastructure, or public
confidence. The issue of standard
commercial planting practices for rice in
a domestic versus Asian setting is not
relevant to the discussion of
Xanthomonas oryzae’s potential for use
as a biological weapon. APHIS analyzed
and assessed this pathogen using the
criteria discussed earlier in this
document. Based on that analysis and
assessment and the knowledge that
Xanthomonas oryzae has been modified
for use as a biological weapon in the
past, it has been retained on the list of
PPQ select agents and toxins.
The commenter also stated that
Xanthomonas oryzae should be
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removed from the list of select agents
and toxins because it is endemic in the
United States and any foreign strains
introduced in the future would prove
unlikely to establish and spread.
While we disagree with the
commenter’s assertion regarding
Xanthomonas oryzae’s pathogenicity,
these arguments are unrelated to the
work of the select agent program as a
whole as the select agent regulations do
not allow for the environmental release
of listed agents and toxins. Whether or
not a given select agent or toxin is
endemic in the United States is not the
only determining factor in the select
agent or toxin’s inclusion on the list.
The regulations govern use of listed
select agents and toxins in laboratory
settings only. In this regard, the case for
maintaining Xanthomonas oryzae on
the list of those select agents and toxins
whose deliberate misuse represents the
most significant potential for mass
casualties or devastating effects to the
economy, critical infrastructure, or
public confidence, is compelling as
work was done on Xanthomonas oryzae
in the 1970s which led to its
classification as a bioterrorism agent by
the security community.
The list of PPQ select agents and
toxins includes an entry for Ralstonia
solanacearum, race 3, biovar 2. While
we did not propose any changes to the
entry for Ralstonia solanacearum, race
3, biovar 2, five commenters stated that
it should be removed from the list of
select agents and toxins.
The commenters argued that, based
on the biological and historical climate
data for North America, Ralstonia
solanacearum, race 3, biovar 2 does not
have the potential to pose a severe
threat to plant health or plant products
in the context of U.S. agriculture. The
commenters stated that Ralstonia
solanacearum, race 3, biovar 2 is only
a serious problem in the developing
world in those areas of cool highland
tropics where annual temperature
profiles differ significantly from those
found in the major potato growing
regions in the United States (i.e.,
Colorado, Idaho, Maine, Minnesota,
North Dakota, and Wisconsin). The
commenters argued that, unlike the
northern States, the cool highland
tropics experience few hard freezes and
no long winters. Since, the commenters
claimed, epidemiological and laboratory
research data show that Ralstonia
solanacearum, race 3, biovar 2 is
intolerant of freezing and freeze-thaw
cycles and does not generally survive
winters in regions with sustained low
temperatures, the bacterium is unlikely
to become established in the northern
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U.S. where potatoes are commercially
grown.
We disagree with the commenters’
claim that Ralstonia solanacearum, race
3, biovar 2 is only a serious pathogen in
the developing world as the bacterium
has been shown to establish itself in
northern Europe by over-wintering in
weeds, thereby posing a severe threat to
Solanaceae species (e.g., potato,
eggplant, and tomato) in cool climates
such as those found both in northern
Europe and North America. In addition,
as discussed earlier in this document,
the evaluation process for select agents
includes broad criteria that not only
focus on the biological characteristics of
a given pathogen, but also that
pathogen’s ability to produce a
devastating effect on the economy and
the threat that pathogen represents if it
were to be used as a biological weapon.
We are making no changes as a result of
these comments.
The commenters also stated that
retaining Ralstonia solanacearum, race
3, biovar 2 on the list of select agents
and toxins would further constrain
research in the field of Ralstonia
research. The commenters attributed
such listing with registration time for
use, transfer, or possession of select
agents and toxins in excess of 18
months prior to the initiation of
research and difficulty in meeting the
registration requirements.
We are making no changes in
response to these comments. While
there are added requirements
concerning physical security, personnel
authorization, recordkeeping,
biocontainment, and site inspections,
we do not believe these requirements
will impede research as, in many cases
these regulations serve to codify systems
and procedures already in use by a
majority of regulated entities. Further,
entity registration for use, transfer, or
possession of select agents and toxins
does not take, nor has ever taken, 18
months. On average, new entity
registration takes 6 months from the
date the request is received by the select
agent program and the issuance of the
registration certificate. The security risk
assessment (SRA) takes less than 45
days and runs parallel to the entity
registration process. These timeframes
are all based on the assumption that the
entity registration submission and the
SRA submission are complete and
accurate for select agent program review
prior to the required on-site inspection.
Commenters additionally stated that
Ralstonia solanacearum, race 3, biovar
2 should be removed from the list for
the same reasons that were cited for the
proposed removal of Xylella fastidiosa,
CVC strain.
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We are making no changes as a result
of these comments. The decision to
remove the CVC strain from the list of
select agents and toxins was based on
the completion of extensive review and
analysis of the criteria for inclusion on
the list. In particular, the creation of
detection methods and the use of
geostatistical analysis with relation to
monitoring in order to facilitate a
response to any purposeful introduction
are both key components in our
decision to delist CVC. As discussed
earlier in this document, the evaluation
process for select agents includes a
broad number of criteria that not only
focus on the biological characteristics of
a given pathogen but also that
pathogen’s ability to produce a
devastating effect on the economy and
the threat that pathogen represents if it
were to be used as a biological weapon.
Based on that analysis and assessment
Ralstonia solanacearum, race 3, biovar
2 will remain on the list of select agents
and toxins.
Commenters said that eradicating
Ralstonia solanacearum, race 3, biovar
2 introduced into the United States
through infected geraniums cost
commercial greenhouses and importers
millions of dollars as a direct result of
its presence on the list of select agents
and toxins.
We are making no changes as a result
of these comments. The presence of
Ralstonia solanacearum, race 3, biovar
2 on the list of select agents and toxins
had no bearing on the eradication
program instituted by APHIS. The cost
of this eradication program to
commercial greenhouses and importers
was the same as the cost of eradicating
any other quarantine plant pathogen not
known to be present in the United
States.
Identification of Strains
The list of VS select agents and toxins
includes an entry for virulent Newcastle
disease virus. While we did not propose
any changes to the entry for virulent
Newcastle disease virus, one commenter
stated that, by not considering all forms
of Newcastle disease virus as select
agents, APHIS has created a period of
uncertainty prior to the completion of
the sequencing necessary to identify
whether a form of Newcastle disease
virus is virulent or not. The commenter
requested clarification as to whether
laboratories would be required to treat
uncharacterized Newcastle disease virus
as a select agent given this uncertainty.
We agree with the commenter’s point.
We have therefore revised the list of VS
only select agents and toxins in order to
list certain select agents and toxins not
by specific strains but by the generic
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taxonomic classifications for those
select agents. The specific VS only
select agents and toxins affected are:
Avian influenza virus (highly
pathogenic), mycoplasma capricolum
subspecies capripneumoniae
(contagious caprine pleuropneumonia),
mycoplasma mycoides subspecies
mycoides small colony (Mmm SC)
(contagious bovine pleuropneumonia),
and virulent Newcastle disease virus,
which we have altered to read avian
influenza virus, mycoplasma
capricolum, mycoplasma mycoides, and
Newcastle disease virus, respectively. In
order to capture the applicable strains,
subtypes, or pathogenicity levels we
have also added exemptions for those
strains, subtypes, or pathogenicity levels
of certain select agents and toxins which
are not considered to have the potential
to pose a severe threat to animal health
or animal products.
The list of overlap select agents and
toxins contains an entry for Venezuelan
equine encephalitis. One commenter
stated that, by not considering all
subtypes of Venezuelan equine
encephalitis as select agents, APHIS has
created a period of uncertainty prior to
the completion of the typing necessary
to identify whether a form of
Venezuelan equine encephalitis is
among the subtypes classified by APHIS
as select agents. The commenter
requested clarification as to whether
laboratories would be required to treat
untyped Venezuelan equine
encephalitis as a select agent given this
uncertainty.
We agree with the commenter’s point.
As stated previously, we have therefore
revised the list of overlap select agents
and toxins in order to list certain select
agents and toxins not by specific strains
but by the generic taxonomic
classifications for those select agents.
The specific overlap select agent is
Venezuelan equine encephalitis virus:
Epizootic Subtypes IAB, IC, which we
have altered to read Venezuelan equine
encephalitis virus. In order to capture
the applicable strains, subtypes, or
pathogenicity levels we have also added
exemptions for those strains, subtypes,
or pathogenicity levels of certain select
agents and toxins which are not
considered to have the potential to pose
a severe threat to animal or human
health or animal products. We do note
that we have specifically included
Bacillus anthracis (Pasteur strain) in the
list of overlap select agents and toxins.
This is necessary in order to distinguish
this strain, which we do not consider to
be a Tier 1 select agent, from all other
strains of Bacillus anthracis, which are
classified as Tier 1 select agents.
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Although we did not receive any
comments on this issue as it concerns
PPQ only select agents and toxins, in
order to strengthen the regulations as
discussed previously as well as to
maintain parity between the VS and
PPQ regulations, we are revising the list
of PPQ only select agents and toxins in
order to list certain select agents and
toxins not by specific strains but by the
generic taxonomic classifications for
those select agents. The specific PPQ
only select agents and toxins affected
are: Ralstonia solanacearum, race 3,
biovar 2 and Sclerophthora rayssiae var.
zeae which we have altered to read
Ralstonia solanacearum and
Sclerophthora rayssiae, respectively. In
order to capture the applicable strains,
subtypes, or pathogenicity levels we
have also added exemptions for those
strains, subtypes, or pathogenicity levels
of certain select agents and toxins which
are not considered to have the potential
to pose a severe threat to plant health
or plant products.
With the changes described above, we
clearly establish that when an agent or
toxin is initially identified to a
taxonomic level, in the case of an agent,
or by its toxicological properties, in the
case of a toxin, it is regulated under the
select agent regulations until further
testing is accomplished to exclude the
particular agent by strain, subtype,
pathogenicity levels, or a particular
toxin by properties. We believe it is
important that laboratories treat these
agents as select agents until further
testing can be conducted to verify
whether the agent is of a strain, subtype,
or pathogenicity level that presents a
higher level of danger to animal health
and safety. These changes will not have
any impact on the exemption for
diagnostic laboratories or alter the
process of receiving diagnostic samples
and forwarding any potentially
identified select agents for further
testing. They also do not change the
reporting criteria for those agents
confirmed to be select agents. Finally,
they do not change the current lists of
select agents and toxins but alters the
fashion in which select agents and
toxins are listed with specific
exemptions included to ensure that
appropriate verification of the agents by
strains, subtypes, or pathogenicity level
occurs.
VS Select Agents and Toxins
We proposed to remove nine VS
select agents and toxins from the list set
out in § 121.3(b). Specifically, we
proposed to remove the following:
Akabane virus; Bluetongue virus
(exotic), Bovine spongiform
encephalopathy agent; Camel pox virus;
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Ehrlichia ruminantium (Heartwater);
Japanese encephalitis virus; Malignant
catarrhal fever virus (Alcelaphine
herpesvirus type 1); Menangle virus;
and Vesicular stomatitis virus (exotic):
Indiana subtypes VSV–IN2, VSV–IN3.
One commenter recommended that
we exclude the Texas GB strain of
Newcastle disease virus from select
agent status. The commenter stated that
the exclusion is warranted since,
although Newcastle disease virus is
widespread in the environment, there is
little illness if a flock is exposed
because nearly all commercial poultry is
vaccinated against the disease. The
commenter observed that the Texas GB
strain of Newcastle disease virus is used
by vaccine manufacturers as the
challenge organism to verify the potency
of Newcastle disease virus vaccines and
this fact gives poultry producers a high
degree of assurance that their flocks are
protected against the Texas GB strain.
Given these factors, the commenter
concluded that the Texas GB strain is
not a biosecurity threat to the domestic
poultry industry, and the strain should
be excluded from APHIS’s definition of
virulent Newcastle disease virus.
We are making no change in this final
rule as a result of this comment. Texas
GB strain of Newcastle disease virus is
a highly virulent form of Newcastle
disease virus and, as such, is
appropriately included in the general
category of ‘‘virulent Newcastle disease
virus.’’ While vaccine manufacturers do
use the Texas GB strain of Newcastle
disease virus as a challenge organism for
Newcastle disease virus vaccines, this is
on account of its high level of virulence.
A vaccine effective against the Texas GB
strain of Newcastle disease virus can
therefore be assumed to be effective
against less virulent forms of Newcastle
disease virus.
The list of VS select agents and toxins
includes an entry for avian influenza
virus (highly pathogenic) (HPAI). While
we did not propose any changes to the
entry for HPAI, one commenter
proposed that we change the guidance
by which influenza strains are
categorized as HPAI. The commenter
argued that extensive evidence has been
obtained to support the conclusion that,
while the HA polybasic cleavage site is
the primary determinant for HPAI
strains, strains with removed HA
polybasic cleavage sites have been
created, tested, and ultimately excluded
from select agent status. The commenter
stated that, as a result of these
experiments and history, APHIS should
specify that avian influenza strains
without the HA polybasic cleavage site
are not HPAI viruses and, therefore, not
subject to the select agent regulations.
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The commenter further argued that
continuing to consider strains of avian
influenza with removed HA polybasic
cleavage sites as select agents until such
time as an exclusion is granted would
impede vaccine availability in the event
of an HPAI pandemic in either the
human or avian population. The
commenter stated that the lead
candidates for the seed viruses that
would be used to make vaccines against
HPAI viruses during such an event will
likely be attenuated strains with
mutated polybasic cleavage sites. The
commenter stated that the current
process by which avian influenza
strains that lack the polybasic cleavage
site are granted exclusions takes weeks
or months, an untenable timeline in the
event of an HPAI pandemic.
We are making no changes in
response to this comment. APHIS
standards are based on existing
internationally recognized requirements
established by the World Animal Health
Organization (OIE). In the event of a
future HPAI pandemic such as the one
described by the commenter, APHIS
would work in conjunction with HHS to
address any vaccine availability issues.
Finally, attenuated strains of select
agents officially approved for human
vaccination purposes by the Food and
Drug Administration (FDA) or other
recognized national or international
organizations continue to be exempt
from the select agent regulations as
specified by the regulations in § 121.5(c)
and (d).
Overlap Select Agents and Toxins
We proposed to modify the list of
overlap select agents and toxins by
removing certain subtypes of
Venezuelan equine encephalitis virus
from the list of overlap select agents and
toxins set out in 9 CFR 121.4(b), and to
clarify that only Venezuelan equine
encephalitis subtypes IAB and IC would
remain on the list. These subtypes
contain the only recognized strains of
Venezuelan equine encephalitis that can
suddenly affect a large number of
animals over a large area (i.e.,
epizootic). The remaining subtypes, ID
and IE, are strains prevalent among
existing animal populations (i.e.,
enzootic) and do not represent the same
type of risk. Other viruses within the
Venezuelan equine encephalitis
complex (subtypes IF and II through IV)
are separate viruses and are not
included in the list of overlap select
agents and toxins.
Another commenter recommended
that we remove Venezuelan equine
encephalitis strain 3014 from the list of
select agents and toxins. The commenter
argued that, although strain 3014 was
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derived from a 1AB isolate, this
molecularly cloned strain has properties
that render it incapable of causing
epizootic or epidemic transmission. The
commenter stated that mutations
selected after only a handful of passages
make the virus avirulent in adult mice
and dramatically increases its clearance
from the bloodstream of mice following
intravenous inoculation. Further, the
vanishingly low titers of strain 3014
consist of envelope glycoprotein gene
mutations, which allow the strain to
bind heparin sulfate; such binding is
also associated with the attenuated
phenotype of Venezuelan equine
encephalitis strain TC–83, which is also
derived from the 1AB Trinidad donkey
strain by passage in culture that has
already been excluded from select agent
status.
We are making no changes as a result
of this comment. Since Venezuelan
equine encephalitis strain 3014 is
derived from a listed overlap select
agent, the commenter’s proposal for its
removal is more appropriately
addressed via the exclusion process for
overlap select agents and toxins as
detailed in 9 CFR 121.6. We have
contacted the commenter and provided
guidance regarding how they may
initiate this process.
We proposed to designate Bacillus
anthracis as a Tier 1 select agent. A
number of commenters objected to such
a blanket designation, arguing instead
that the Bacillus anthracis Pasteur strain
should be exempted from consideration
both as a Tier 1 select agent and as a
select agent in general.
One commenter argued that given the
fact that Laboratory Response Network
(LRN) laboratories maintain live
cultures of non-pathogenic Bacillus
anthracis Pasteur strain for use in
quality control testing, designation of
Bacillus anthracis as a Tier 1 select
agent therefore has the potential to
impact the willingness or ability of LRN
laboratories to maintain inventories of
Bacillus anthracis Pasteur strain due to
the regulatory and financial burdens
associated with possession of Tier 1
select agents and toxins. The commenter
went on to state that this situation could
potentially impact national health and
safety given that the potential use of
Bacillus anthracis spores as a
bioweapon remains a viable threat and
increased burdens, particularly on small
laboratories, could lead to the overall
decrease in the number of laboratories
that would otherwise serve to ensure
that the LRN has sufficient capacity to
detect and respond to a deliberate
release of Bacillus anthracis.
Three commenters stated that the
Bacillus anthracis Pasteur strain is
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analogous to the Bacillus anthracis
Sterne strain, which is excluded since it
was determined not to pose a severe
threat to public health and safety,
animal health, or animal products. The
commenter argued that Bacillus
anthracis Pasteur strain should not be
considered as a select agent given that
the only way to create an agent that
poses a severe threat would be via
combination of the Pasteur strain with
a non-regulated strain. The commenter
pointed out that other agents that pose
little harm individually, but could be
modified genetically to become harmful
are not included on the select agent list
because of this potential threat.
Another commenter claimed that the
designation of Bacillus anthracis
Pasteur strain as a select agent would
not serve to prevent an authorized
person from intentionally or
accidentally facilitating the combination
of plasmids from Sterne and Pasteur
types of strains to create a wild type
phenotype. The commenter stated that
combination of these two strains can be
accomplished no matter what sort of
physical security may be employed to
prevent access, theft, loss, or release of
the agent. The commenter concluded
that more effective preventive measures
can be achieved through training and
educating microbiologists on how to
avoid accidentally combining these two
strains and by penalizing any
individuals who intentionally try to
combine them.
We agree with the commenters that
Bacillus anthracis Pasteur strain is
attenuated and poses a significantly
lower risk than wild type Bacillus
anthracis strains. We also agree that the
Pasteur strain is not likely to have the
potential for mass casualties or
devastating effects to the economy,
critical infrastructure, or public
confidence and therefore does not meet
the criteria used to apply the Tier 1
designation. In addition, we note that
the Pasteur strain has been used
successfully as a veterinary and human
vaccine, which further demonstrates the
attenuation of this strain. Therefore we
have determined that the Bacillus
anthracis Pasteur strain should not be
designated as a Tier 1 select agent.
While we agree that the Bacillus
anthracis Pasteur strain does not meet
the criteria for inclusion as a Tier 1
select agent, we do not agree with the
argument that regulating the Bacillus
anthracis Pasteur strain would not serve
to prevent the accidental (or intentional)
generation of a wild type Bacillus
anthracis strain by the combination of
the Bacillus anthracis Pasteur strain
with the Bacillus anthracis pXO1+/
pXO2- Sterne strain. Retaining the
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Bacillus anthracis Pasteur strain as a
select agent will allow for continued
oversight of laboratories in which the
accidental (or intentional) combination
of this strain with the Bacillus anthracis
Sterne strain could occur to produce the
wild type phenotype of Bacillus
anthracis de novo. Failure to retain the
Bacillus anthracis Pasteur strain as a
select agent could result in an
environment in which the probability of
creation of virulent wild type Bacillus
anthracis strains by the combination of
non-regulated strains would be
enhanced. Therefore, we have chosen
not to exclude the Bacillus anthracis
Pasteur strain from the list of select
agents in this rulemaking. We will
continue to evaluate exclusion requests
as additional information becomes
available in this area.
As explained above under the heading
‘‘VS Select Agents and Toxins,’’ avian
influenza virus (highly pathogenic) is
currently on the list of VS only select
agents and toxins. One commenter
recommended that, in light of recent
studies whereby researchers have
generated derivatives of influenza virus
A (H5N1) capable of efficient aerosol
transmission, we add ‘‘Replication
competent forms of influenza virus A
(H5N1) capable of efficient aerosol
transmission in ferrets or primates
containing any portion of the coding
regions of all eight gene segments
[influenza virus A (H5N1) capable of
efficient aerosol transmission in ferrets
or primates]’’ to the list of overlap select
agents and toxins. The commenter also
recommended that this type of avian
influenza virus be classified as a Tier 1
agent given the historical 50 percent
case-fatality rate of avian influenza virus
A (H5N1) in humans.
The select agent program is currently
in discussions regarding this issue and
may address it in future rulemaking.
Given the stage these discussions are in,
however, we are not making any
changes in this final rule based on this
comment.
Reorganization of the Current List of
Select Agents and Toxins
We proposed to establish a number of
select agents and toxins as ‘‘Tier 1’’
select agents and toxins within the lists
of VS and overlap select agents and
toxins. Specifically, we proposed to list
foot-and-mouth disease (FMD) virus and
rinderpest virus as Tier 1 VS select
agents and toxins and Bacillus
anthracis, Burkholderia mallei, and
Burkholderia pseudomallei as Tier 1
overlap select agents and toxins. We did
not include PPQ select agents and
toxins in this proposed reorganization
because none of the PPQ select agents
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and toxins met the minimum criteria for
inclusion on the proposed Tier 1 select
agents and toxins list. All other select
agents and toxins would continue to be
subject to the current requirements
concerning select agents and toxins.
One commenter argued that
Burkholderia mallei and Burkholderia
pseudomallei should not be classified as
Tier 1 select agents. The commenter
stated that these two select agents do
not represent the same level of concern
as the other select agents proposed for
inclusion in Tier 1 and should therefore
be assigned non-Tier 1 status.
Another commenter observed that
Bacillus anthracis is less virulent than
either Yersinia pestis or Francisella
tularensis, which are on the list of HHS
only select agents and toxins. The
commenter additionally stated that the
virulence of all three is far less than that
of the hemorrhagic fever viruses and the
encephalitis viruses that were not
proposed for inclusion on the list of Tier
1 select agents and toxins. The
commenter stated that significant
advances have been made in the
development of products for
environmental decontamination and
prophylaxis against inhalation of
Bacillus anthracis.
We are making no changes to the
regulations as a result of these
comments. The process by which we
determined which select agents and
toxins should be designated as Tier 1
was multi-faceted and we are confident
in the results of that process. Our
determinations were not based on one
aspect of each of the proposed select
agents or toxins only. In order to
determine which select agents and
toxins should be given Tier 1 status, a
two-part risk analysis was conducted on
each. First, experts in the biology of
these agents and toxins evaluated their
potential for mass casualties or
devastating effects to the economy,
critical infrastructure, or public
confidence. This process included
assessments of morbidity and mortality,
communicability, low infectious dose,
availability of countermeasures, and
economic impact of a potential attack.
Second, each select agent and toxin was
assessed for its risk of deliberate misuse,
including its history of weaponization
and/or known interest by State or nonState adversaries. These evaluations,
combined with input from public
comments received on our July 2010
ANPR and relevant findings in recent
government and non-government
reports, formed the basis for
deliberations on which agents should
constitute the Tier list. Agents that
scored highly on both the public health
and biothreat sets of criteria were
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judged to be those that were
appropriately given a Tier 1 designation.
Two commenters pointed out that the
categorization of select agents and
toxins has already been carefully
stratified into four biological safety
levels (BSL) as specified by the CDC,
with each BSL based on infectivity,
virulence, and ease of transmission of
the material in question. The
commenters further observed that the
Tier 1 designation implies the existence
of a Tier 2 category which would
require less attention to security. The
commenters concluded that the process
of tiering will only add confusion and
administrative and financial burden to
the current BSL grouping of select
agents and toxins.
Two additional commenters stated
that the proposed rule did not do
enough to reduce the regulatory burden
associated with non-Tier 1 agents. The
commenters said that reduced levels of
security requirements for personnel and
facilities should be considered for nonTier 1 agents.
In designating certain select agents
and toxins as ‘‘Tier 1,’’ the select agent
program considered and rejected the
idea of designating the remaining select
agents and toxins as ‘‘Tier 2.’’ The aim
of establishing the Tier 1 category is to
account for and respond to the
particular risks associated with the
agents and toxins in this category by
increasing their handling and security
requirements accordingly. The
establishment of the Tier 1 category is
in no way intended to imply that the
non-Tier 1 select agents and toxins pose
a lesser risk to public health and safety
than they have previously. In
accordance with that fact, we have not
decreased the handling and security
requirements for those non-Tier 1
agents. Biosafety levels describe the
required combination of lab practices
and techniques, safety equipment, and
lab facilities appropriate for the
operations being performed using
potentially harmful materials such as
select agents and toxins while the Tier
1 designation institutes security
measures applicable to the agents and
toxins themselves. For this reason there
is no conflict that exists between BSL
classifications and Tier 1 select agents
and toxins.
Two commenters expressed concern
regarding the proposal to list rinderpest
virus as a Tier 1 agent, given that there
are already special conditions in place
as contained in §§ 121.3(f)(3)(i),
121.5(a)(3)(i), and 121.9(c)(1)
concerning its handling and tracking.
The commenters suggested that an
alternative approach would be for
APHIS to designate rinderpest virus as
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a pathogen with very special handling
requirements that is not considered to
be part of either category of select
agents. The commenters argued that this
approach is justified due to the fact that
rinderpest has now been officially
eradicated worldwide.
We disagree with the commenters’
suggestion to classify rinderpest virus as
a separate type of agent apart from
either of the select agent categories of
designation. While it is true that
rinderpest was declared to be officially
eradicated by the OIE on May 25, 2011,
this development does not render the
disease any less of a concern as a select
agent with potential for misuse.
Enacting the suggestion that rinderpest
virus be treated as a pathogen with
‘‘very special handling requirements’’
and not as either a Tier 1 or non-Tier 1
select agent would only serve to create
a further level of required
administrative oversight for regulated
entities.
One commenter stated that the
proposed tiering system poses
significant questions as to the nature of
the risk assessment process.
Specifically, the commenter questioned
listing as Tier 1 agents bacterial diseases
that are treated with licensed
antibiotics, that are not commonly
spread person to person, and that are
present in the environment of the
United States, while viruses that have
no known therapy and that pose
extreme risk to Western populations are
absent. The commenter further stated
that the 20 criteria used for evaluation
of each select agent and toxin should be
made available to the regulated
community for review and assessment.
We are making no changes as a result
of this comment. The relative ease by
which exposure to a select agent or
toxin may be treated is only one aspect
considered by the select agent program
when determining the tier status of
each. The 20 criteria referenced by the
commenter are those employed by the
Federal Experts Security Advisory Panel
(FESAP) in providing recommendations
to the select agent program. The criteria
that the FESAP used in its risk
assessment process are:
1. The relative ease with which a
select agent or toxin might be acquired
from a laboratory or commercial source;
2. The relative ease of production of
a select agent or toxin;
3. The relative ease by which a select
agent or toxin might be modified in
order to enhance its pathogenicity,
transmissibility, or ability to evade
medical and non-medical
countermeasures;
4. The potential for easy deliberate
dissemination;
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5. The potential for creating disease or
illness;
6. The relative environmental stability
of a select agent or toxin by itself and
how well it survives in the environment
in which it is formulated or
disseminated;
7. The amount of select agent or toxin
necessary to induce illness;
8. The relative ease with which a
particular select agent or toxin might be
disseminated or transmitted from one
animal or person to another or into the
environment where it could produce a
deleterious effect upon animal, plant, or
human health;
9. Whether the target population has
innate immunity to the select agent or
toxin or whether immunity has been
acquired from a source such as vaccines;
10. The potential for the select agent
or toxin to create morbidity (i.e., any
non-fatal illness that renders partial
dysfunction to an animal or human
lasting weeks or months that will
eventually resolve with medical,
veterinary, and/or supportive care);
11. The burden placed on the human,
veterinary, or plant health system by the
deliberate release of the select agent or
toxin;
12. The ability to detect a release of
the select agent or toxin into the
environment, food, water, or soil;
13. The ability of the human and
agricultural health authorities to
accurately and rapidly diagnose and
treat the disease presented by a release
of the select agent or toxin;
14. The existence of countermeasures
to prevent, treat, or mitigate the
symptoms of a disease caused by the
release of a select agent or toxin and/or
its spread through a population;
15. The potential for high animal,
plant, or human mortality rates with
delivery of medical countermeasures;
16. The potential for high animal,
plant, or human mortality rates without
delivery of medical countermeasures;
17. The short-term economic impact
of a single outbreak of a disease or
release of a toxin;
18. The human, monetary, and other
resource costs of making an area,
building, industrial plant, farm, or field
safe for humans, animals or plants to
inhabit following the release of the
select agent or toxin;
19. The pathogen’s ability to persist in
the environment or to find a reservoir
that makes its recurrence more likely;
and
20. The long-term health or economic
consequences caused by a single release
of the select agent or toxin.
We believe that the process by which
determinations were made regarding the
Tier 1 or non-Tier 1 status of the select
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agents and toxins was responsive to
regulated community concerns received
during the comment period for the
advance notice of proposed rulemaking
as well as for the proposed rule.
One commenter asked why the
requirements for working with plant
pathogens had not been lessened. The
commenter stated that a transparent
process does not exist that is inclusive
of expert opinion from both the private
and public sectors to determine which
agents should be removed or added to
the list of select agents and toxins.
We are making no changes as a result
of this comment. In creating the Tier 1
class of agents, the Select Agent
Program considered and rejected the
idea of designating the remaining agents
as ‘‘Tier 2.’’ The aim of establishing the
Tier 1 category is to account for and
respond to the particular risks
associated with the agents and toxins in
this category by increasing their
handling and security requirements
accordingly. The establishment of the
Tier 1 category is in no way intended to
imply that the non-Tier 1 agents pose a
lesser risk to public health and safety
than they have previously. In
accordance with that fact, we have not
decreased the handling and security
requirements for those non-Tier 1
agents. Further, we determined that the
establishment of more varying levels of
risk would serve to create the need for
increased administrative oversight and
complication for regulated entities. We
believe that the process by which these
determinations were made was sensitive
to public and expert opinion via the
comment period on the initial advance
notice of proposed rulemaking as well
as on the proposed rule.
Security Measures for Tier 1 Select
Agents or Toxins
We also proposed additions to the VS
regulations that would allow for the
optimization of security measures for
those select agents or toxins that are
designated as Tier 1. These
requirements included:
• Additions regarding the assessment
of persons prior to their access to Tier
1 select agents and toxins that would be
made to the security plan currently
required to be developed by all entities
seeking approval for the possession, use,
and transfer of select agents and toxins;
ongoing oversight of those persons with
access to Tier 1 select agents and toxins;
and the role of the entity’s responsible
official in coordinating and assuring the
security of Tier 1 select agents and
toxins;
• Security enhancements that include
provisions for security barriers,
intrusion detection and monitoring,
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delay/response force, access control,
and information security;
• Additions to the biosafety plan
currently required to be developed by
all entities seeking approval for the
possession, use, and transfer of select
agents and toxins that would describe
implementation of an occupational
health program for individuals with
access to Tier 1 select agents and toxins;
• Development of security policies
and procedures describing the entity’s
response to a failure of an intrusion
detection or alarm system and
notification procedures for the Federal
Bureau of Investigation (FBI) in the
event of theft or suspicious activity that
may be criminal in nature involving a
Tier 1 select agent or toxin. These
policies and procedures would be
required as part of the entity’s incident
response plan; and
• Required annual insider threat
awareness briefings focused on how to
identify and report suspicious
behaviors.
We have made changes to some of
these proposed requirements, which are
discussed in detail below.
Many commenters had questions or
concerns regarding the additions to the
security plan for those entities
possessing a Tier 1 select agent or toxin
as proposed in 9 CFR 121.11(e). Specific
issues addressed by the commenters
included: Conduct of pre-access
suitability assessments, ongoing
suitability assessments, and self- and
peer-reporting of incidents or conditions
that could affect an individual’s ability
to safely have access to or work with
select agents and toxins. Commenters
generally fell into two categories in their
responses to the proposed additions:
Some felt that the requirements were too
vague to prove useful, creating
administrative burden without
improving the overall security of Tier 1
select agents and toxins, while others
felt that the requirements could or
would require entities to behave in a
manner contrary to local laws, privacy
laws, or union contracts.
For the most part, we anticipate that
these requirements are already being
met and that these regulations will
merely require those entities possessing
a Tier 1 select agent or toxin to codify
and document the systems and
processes currently in place. It should
be noted that many of the specific
concerns raised by commenters
regarding potential violation of laws or
union contracts arose as a result of the
commenters’ examination of those
recommendations given to the select
agent program by the FESAP. As a
matter of clarification, the select agent
program considered the FESAP
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recommendations, as well as
recommendations from other sources
(e.g., National Science Advisory Board
for Biosecurity), in developing the
proposed rule and suitability
assessment guidance documents;
however, we are not adopting all of the
specific recommendations found in
these studies. While we have created
specific guidance to aid in compliance
with this section of the revised
regulations, we are deliberately leaving
the regulatory text in its broadly-written
state in order to allow entities a measure
of flexibility in how they meet the
requirements. Given our experience
with the select agent and toxin
regulations and the wide variety of
regulated entities the regulations cover,
we have found this to be the most
effective approach. The guidance
document developed in conjunction
with this rule is, in part, a response to
the questions and issues raised by the
commenters. Issues addressed in this
document include, but are not limited
to:
• Understanding the risks and
reasons for suitability assessments;
• Delineating the roles and
responsibilities of individuals to ensure
optimal security;
• Requesting information about
individuals in a standardized manner
and assessing individuals in the context
of safety and security;
• Responding to reports in a
consistent, prompt, and confidential
manner; and
• Providing training for recognizing
and reporting suspicious behavior.
Full guidance on this and other issues
may be found on the National Select
Agent Registry at www.selectagents.gov.
In 9 CFR 121.11(e)(4)(i), we proposed
that regulated entities with Tier 1 select
agents and toxins prescribe and/or
implement ‘‘procedures that limit access
to registered space only to those
approved by the HHS Secretary or the
Administrator and meet the criteria of
the entity’s program that will ensure
individuals with access approval to
select agents and toxins are trustworthy
and behaving in a manner that upholds
public health and safety, the protection
of animal or plant health and animal or
plant products, security, and the
integrity of the scientific enterprise.’’
We are making a minor change to the
proposed language in 9 CFR 121.11(e)(4)
in order to stipulate that entities must
implement these security
enhancements, not merely prescribe
and/or implement them. The proposed
rule stated that ‘‘Entities with Tier 1
select agents and toxins must prescribe
and/or implement the following security
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enhancements.’’ We are removing the
words ‘‘prescribe and/or’’ for the
purposes of clarity. Our original intent
in creating that provision was to require
the use of the security enhancements in
question by those entities with Tier 1
select agents or toxins. By removing the
words ‘‘prescribe and/or’’ we are
eliminating a potential loophole by
which entities may have been able to
establish but not fulfill these
requirements while remaining in
compliance with the regulations.
Regarding the proposed language in 9
CFR 121.11(e)(4)(i), one commenter
stated that the use of the phrase
‘‘trustworthy and behaving in a manner
that upholds public health and safety,
the protection of animal or plant health
and animal or plant products, security,
and the integrity of the scientific
enterprise’’ would establish a regulatory
standard that would prove difficult or
impossible to enforce due to its
subjective nature.
We agree with the commenter’s
observation and have changed the
language to require that entities
possessing Tier 1 select agents or toxins
prescribe and implement ‘‘procedures
that will limit access to a Tier 1 select
agent or toxin to only those individuals
who are approved by the HHS Secretary
or Administrator, following a security
risk assessment by the Attorney General,
have had an entity-conducted pre-access
suitability assessment, and are subject to
the entity’s procedures for ongoing
suitability assessment.’’ We believe that
this establishes a more specific set of
requirements for regulated entities.
In 9 CFR 121.11(e)(4)(iv) we proposed
that regulated entities with Tier 1 select
agents and toxins establish a minimum
of three barriers where each subsequent
barrier is different and adds to the delay
in reaching secured areas where select
agents and toxins are used or stored.
Barriers would be required to be
monitored in such a way as to detect
and assess intentional and unintentional
circumventing of established access
control measures under all conditions
(day/night, severe weather, etc.) Two
commenters requested clarification
regarding what was meant by the term
‘‘barrier’’ and asked for examples of
what constitutes a barrier. The
commenters suggested that a definition
for ‘‘barrier’’ be added to the definitions
sections in 7 CFR 331.1 and 9 CFR
121.1.
We agree with the commenters and
we have added a definition for security
barrier to read as follows: ‘‘A physical
structure that is designed to prevent
entry by unauthorized persons, animals,
or materials.’’ In addition, we have
altered the language concerning security
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barriers in 9 CFR 121.11(f)(4)(iv) in
order to clearly indicate that the final
security barrier must limit access to the
select agent or toxin to personnel
approved by the HHS Secretary or
Administrator and following a security
risk assessment by the Attorney General.
In 9 CFR 121.11(e)(4)(v), we proposed
that all registered space and areas that
reasonably afford access to the
registered space must be protected by an
intrusion detection system (IDS) unless
physically occupied. One commenter
stated that the proposed requirement
contained a potential loophole by which
an entity could argue that the presence
of a janitor or similar personnel in
registered space outside of normal
working hours would allow that entity
to avoid installation of an IDS. The
commenter suggested that such a
situation could be avoided by adding a
stipulation that an IDS would need to be
used when the entity was not
‘‘physically occupied by the routine
contingent of working, approved
employees.’’
We disagree with the commenter’s
observation as it is unlikely that the
entity would be occupied at all hours,
thus creating the loophole that would
allow an entity to fail to install an IDS.
We are also not adopting the
commenter’s suggestion to add language
regarding the presence of approved
employees as we believe that would
create confusion concerning the number
of employees that could be described as
‘‘the routine contingent.’’ Further, the
IDS is one aspect of the security
measures required for regulated entities.
In the scenario proposed by the
commenter, the IDS would not be
engaged if a janitor or other personnel
were present in the entity outside of
normal working hours; however, the
other required physical security
measures would serve to protect the
entity at that time. Finally, the training
and employee suitability assessments
required for those employees with
access to select agents and toxins would
also serve to ensure that those
employees who work in registered areas
understand and can employ the
necessary security and safeguarding
measures to maintain the physical
security of the entity.
In 9 CFR 121.11(e)(4)(vii), we
proposed to require that entities provide
backup power and energy sources to
ensure that information security
networks and integrated access controls
and related systems will maintain
power during emergencies. While we
did not receive any comments on this
issue, in response to comments received
by CDC and in the interests of
maintaining parity between the APHIS
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and HHS regulations, we are amending
the text to stipulate that only those
entities with powered access control
systems will need to fulfill this
requirement. We have also reworded the
requirement to clarify that the aim is
maintenance of physical security
standards in the case of a power
disruption and that this maintenance
may, among the alternatives, take the
form of backup power.
In 9 CFR 121.11(e)(4)(viii) we
proposed that response time for security
forces or local police must not exceed
15 minutes from the time of an intrusion
alarm or report of a security incident for
any entity with Tier 1 select agents and
toxins. One commenter stated that such
a requirement would be burdensome,
unattainable, and cost-prohibitive
depending upon the number and nature
of the alarms. The commenter went on
to state that the security system at their
entity sounds an alarm when a door is
held open longer than a preset length of
time and that most alarms occur during
working hours, primarily as the result of
staff holding the door open too long.
The commenter explained that requiring
security respond to all these alarms is
unwarranted, excessive, and costly. The
commenter suggested that a better
alternative would be for a laboratory
supervisor or manager to be notified of
and investigate these incidents,
therefore allowing entities to respond in
a manner commensurate with the
severity of the incident that triggered
the alarm.
Our selection of the 15 minute
response time is based on Department of
Defense (DOD) and DHS standards for
high value assets and also on our
analysis of incident response plans
provided by the regulated community
since 2003. However, based on this
comment and others received by CDC,
we have modified the language in this
section. We have retained the 15 minute
response time goal for security forces or
local police, but we have also provided
additional flexibility for entities to
develop systems in line with the
optimal achievable response time in
their area. Entities may either
incorporate the 15 minute response time
into their security plans or determine an
alternate response time calculated in
conjunction with security forces or local
police. Response time can be
determined many ways. For example, an
entity can:
• Enter into a formal agreement with
local law enforcement.
• Discuss with local law enforcement.
• Discuss with the IDS service
provider.
• Conduct an exercise with the guard
force.
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61065
The issue of multiple false alarms and
the potential costs associated with such
a situation as raised by the commenter
is more appropriately addressed at the
entity level.
In 9 CFR 121.11(e)(4)(ix) we proposed
to require that entities conduct complete
inventory audits of all Tier 1 select
agents and toxins in long-term storage
upon the physical relocation of a
collection or inventory of select agents
or toxins for those Tier 1 select agents
or toxins in the collection or inventory,
upon the departure or arrival of a
principal investigator for those Tier 1
select agents or toxins under the control
of that principal investigator, or in the
event of a theft or loss of a Tier 1 select
agent or toxin.
We have reevaluated this provision in
light of comments received on the CDC
rule and, based on our experience with
the select agent program, we believe that
this requirement needs to be applied to
all select agents and toxins, and not
only Tier 1 select agents and toxins.
This change serves to codify our current
policy concerning inventory audits. We
have therefore revised the language to
address inventory verification for all
select agents and toxins.
In the case of those entities which
possess FMD and rinderpest virus, we
proposed to require four barriers,
including one barrier that is a perimeter
security fence or equivalent. These
requirements were listed in proposed 9
CFR 121.11(e)(5)(i). One commenter
inquired as to what the equivalent to a
perimeter security fence would be. The
commenter also wished to know if an
IDS would be considered a barrier.
One equivalent to a perimeter security
fence would be a perimeter wall
surrounding a specific building,
complex, compound, or campus, with
24 hour a day, 7 days a week
monitoring. Such a wall would serve a
purpose identical to a perimeter security
fence. We have developed guidance to
assist entities with the security barrier
requirement, which covers the issue of
perimeter fencing. Guidance documents
may be found on National Select Agent
Registry at www.selectagents.gov. As to
the commenter’s question regarding the
IDS: As stated above, a security barrier
would include only natural or manmade obstacles preventing or delaying
the movement of persons, animals, or
materials. While an IDS may alert
security or other personnel to potential
incidents, the IDS itself would not be
considered to be a security barrier since
it does not actively create an obstacle or
delay.
Another commenter asked whether
the proposed requirements would make
it illegal for U.S. veterinary diagnostic
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laboratories to perform diagnostic and/
or surveillance testing following an
FMD outbreak on U.S. soil if the
laboratories in question did not have a
fourth security barrier. The commenter
recommended that we revise the
paragraph in order to clarify our intent.
We are making no changes as a result
of this comment. The select agent
program recognizes the critical role of
diagnostic laboratories in the early
detection of and response to outbreaks
of select agent and toxin-related disease
in humans and agriculture. While all of
the Tier 1 regulatory requirements will
apply to entities that maintain
permanent stocks of Tier 1 select agents
and toxins, in the case of a public health
or agricultural emergency, a diagnostic
laboratory may request to retain the
select agent or toxin under the
provisions contained in 9 CFR 121.6(e).
Two commenters recommended that
the select agent program consult with
administrators and laboratory managers
from public and private research
institutions prior to the development of
any framework of suitability that can be
used to address security concerns.
We will engage subject matter experts
as necessary in the development of
guidance documents which may be
found on the National Select Agent
Registry at www.selectagents.gov. The
select agent program welcomes feedback
on the usability and usefulness of
existing guidance documents at any
time.
One commenter suggested that the
minimum security provisions for Tier 1
select agents and toxins should include
video monitoring of all select agents and
toxins work and storage areas, a twoperson rule for entry into select agents
and toxins work and storage areas, and
psychological assessment and
monitoring of those employees working
with select agents and toxins.
We are making no changes as a result
of this comment. The specific measures
the commenter suggested were
considered and rejected in favor of the
more general requirements listed. The
select agent program is highly conscious
of the need to balance biosecurity and
biocontainment concerns with allowing
entities the necessary flexibility so as to
not impede their research unduly. Since
there is variety in the type and size of
entities covered under the regulations,
we believe this approach is warranted.
We would note that the regulations do
not preclude any given entity from
adopting the approach suggested by the
commenter, among others.
One commenter stated that, while
many of the proposed security changes
are already in place, some are not and
it was unclear that additional costly or
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impractical security measures would
provide any additional benefit since
existing measures have proven adequate
to protect the security of these agents.
We are making no changes as a result
of this comment. It was our
determination, based on the information
available to us, that the additional
security requirements would not
constitute an economic burden on the
regulated entities. In many cases these
regulations serve to codify systems and
procedures already in use in these
regulated entities.
The regulations in 9 CFR 121.12
concern the development of a biosafety
plan that establishes measures sufficient
to contain the select agent or toxin (e.g.,
physical structure and features of the
entity, and operational and procedural
safeguards). We proposed to add a
paragraph that would stipulate that
entities registered to possess Tier 1
select agents or toxins establish an
occupational health program for
individuals with access to Tier 1 select
agents and toxins. One commenter
recommended that the occupational
health program requirements be
instituted for all select agents and
toxins, regardless of their categorization.
We are making no changes in
response to this comment. Due to the
greater level of concern associated with
Tier 1 select agents and toxins the select
agent program needs to ensure that
entity safety protocols are in place.
Further, after considering the issue and
in light of the fact that it caused
confusion amongst some commenters on
the CDC proposed rule, we are
eliminating the sentence that reads,
‘‘The occupational health program may
also be made available to individuals
without access to Tier 1 select agents
and toxins.’’ While we believe that
regulated entities should use their
discretion and judgment in considering
whether the creation of an occupational
health program applicable to those
employees working with non-Tier 1
select agents and toxins is needed, such
a suggestion is not appropriately
contained in the regulations. Guidance
on the development of an occupational
health program may be found on the
National Select Agent Registry at
www.selectagents.gov.
The regulations in 9 CFR 121.15
concern required mandatory training for
staff and visitors who work in or visit
areas where select agents or toxins are
handled or stored. In 9 CFR 121.15(b),
we proposed to add a requirement that
entities with Tier 1 select agents and
toxins must conduct annual insider
threat awareness briefings on how to
identify and report suspicious
behaviors. One commenter stated that
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this training should be required for all
registered entities possessing, storing, or
transferring select agents, not just those
with Tier 1 select agents or toxins.
We are making no changes in
response to this comment. Due to the
greater level of concern associated with
Tier 1 select agents and toxins the select
agent program needs to ensure that
entity safety protocols are in place.
Regulated entities should use their
discretion and judgment in considering
whether the creation of an annual
insider threat awareness training
program applicable to those employees
working with non-Tier 1 select agents
and toxins is needed. Guidance on the
development of annual insider threat
awareness training may be found on the
National Select Agent Registry at
www.selectagents.gov.
Another commenter asked for
clarification and guidance regarding the
requirement for annual insider threat
awareness briefings. The commenter
asked that the content of these threat
awareness briefings be made available to
public health laboratories so that it
could then be specifically customized
for various regions of the country.
While we have created specific
guidance regarding this section of the
revised regulations, that guidance does
not take the form of a prescriptive
program with content that may then be
adapted and distributed as the
commenter requests. Given our
experience with the select agent and
toxin regulations and the wide variety of
regulated entities those regulations
cover, we have found a broader
approach to be most effective. The
guidance documents developed in
conjunction with this rule are, in part,
a response to the questions and issues
raised by the commenters. The
documents will contain specific
examples of best practices that we
believe entities would be well served in
adopting including, but not limited to,
a designated person to manage the
assessment of laboratory personnel,
laboratorian involvement in threat
migration, and those behaviors of
concern which may indicate a possible
insider threat. Full guidance on this and
other issues may be found on the
National Select Agent Registry at
www.selectagents.gov.
Miscellaneous Changes
We proposed to make several smallerscale changes to the regulations,
including the addition of definitions
and clarification of language concerning
security, training, biosafety,
biocontainment, and incident response.
These changes are intended to increase
the usability of the select agent
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regulations as well as provide for
enhanced program oversight.
In 7 CFR 331.1 and 9 CFR 121.1, we
proposed to add definitions for
adjudicated as a mental defective, alien,
committed to any mental institution,
controlled substance, crime punishable
by imprisonment for a term exceeding 1
year, indictment, lawfully admitted for
permanent residence, mental
institution, and unlawful user of any
controlled substance. These definitions,
which described specific aspects of the
proposed definition of restricted person,
were intended to assist regulated
entities as well as those seeking
approval to access select agents and
toxins to better understand what status
or activities, past or present, might
prohibit such access.
Four commenters stated that these
definitions needed to be further
clarified. The commenters generally
characterized the proposed definitions
as either overly restrictive or vague.
After careful consideration we have
agreed with the commenters and have
decided not to include these definitions
or a definition for restricted person in
the final rule. We will look to develop
additional guidance in this area.
We proposed to add a definition for
recombinant and synthetic nucleic
acids. This addition was deemed
necessary, as the term ‘‘synthetic
nucleic acids’’ is employed in the
proposed changes to the select agent
regulations. We proposed to include
synthetic nucleic acids in the
regulations because, while synthetic
nucleic acids have the same potential
for harm as recombinant nucleic acids,
the process of production is different.
One commenter stated that the
proposed definition has implications in
all areas currently impacted by
synthetic biology technology, such as
industrial enzymes, renewable
chemicals for pharmaceutical and
industrial applications, bio-based
products, personal care products,
renewable specialty chemicals, biofuels,
and healthcare products. The
commenter argued that consequences of
adopting the proposed definition could
impede the growth of sustainable
products from emerging fields such as
synthetic biology technology. The
commenter therefore recommended that
we not adopt the new definition of
recombinant and synthetic nucleic acids
as stated in the proposed rule, arguing
that the existing language of the
regulation is sufficient to cover the
current uses of synthetic nucleic acids.
The commenter further stated that the
proposed definition utilizes language
that was proposed to, but rejected by,
the National Institutes of Health
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Recombinant DNA Advisory Committee
(NIH–RAC). The commenter suggested
that if the select agent program finds it
necessary to introduce a new definition
for recombinant and synthetic nucleic
acids, that we follow the leadership of
the NIH–RAC and establish a simpler
definition that is not focused on the
underlying mechanism of production of
the nucleic acids.
We disagree with the commenter’s
assertion regarding the broad impact of
the definitions used by the select agent
program. Our scope of oversight is
limited to the list of select agents and
toxins and therefore does not extend to
all synthetic biology. However, we do
agree that any definition adopted for use
in the regulations should be based on
the most current information available
from subject matter experts. Following
extensive consultation with the NIH, we
have updated the definition of
recombinant and synthetic nucleic acids
to reflect the most current thinking on
the subject. In addition, we have
separated the definition of recombinant
nucleic acids from the definition of
synthetic nucleic acids for purposes of
clarity.
We proposed to add a definition for
occupational exposure to the VS
regulations in 9 CFR 121.1 as it is used
in the regulations but not defined. This
definition was based on that used in the
Occupational Safety and Health
Administration regulations in 29 CFR
1910.1030. We did not propose to add
a corresponding definition to the PPQ
regulations in 7 CFR 331.1 since PPQ
select agents and toxins do not pose a
severe threat to human health and,
therefore, it is unnecessary to address
personnel safety and health. One
commenter suggested that we expand
the definition to specify that, due to
aerosol transmission, such exposure
incidents may impact other employees
working in the same area.
We agree with the commenter that the
proposed definition did not adequately
address the possibility of aerosol
transmission and have amended the
language accordingly.
Additionally, we are also removing
references to rickettsiae in the
definitions for biological agent and
toxin. This change is necessary because
there are no rickettsiae select agents or
toxins regulated by APHIS on the list of
select agents and toxins.
We proposed to amend 7 CFR
331.3(e), 9 CFR 121.3(e) and 9 CFR
121.4(e). These paragraphs specify that
attenuated strains of select agents or
toxins may be excluded from the
requirements of the select agent
regulations subject to an official request
and supporting scientific information.
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61067
We proposed to state that the ‘‘inactive
form of a select toxin’’ may be excluded
from regulation under each respective
part subject to the application
procedure. We also proposed to update
the Web site address in paragraph (e)(1)
of each section as all information
concerning the Select Agent Program is
now centralized on the National Select
Agent Registry at https://
www.selectagents.gov/. Finally, we
proposed to remove the language stating
that exclusions will be published in the
Federal Register. At the time the
regulations were initially created we
anticipated publication of exclusions
both in the Federal Register and on the
Internet; however, we have found that
publication on the National Select
Agent Registry Web site only has served
to provide the most up-to-date
information to the regulated
community.
One commenter suggested that, in
addition to publication of exclusions on
the National Select Agent Registry Web
site we should also develop and
maintain an email distribution list so
that registered facilities could be
notified when updates are added to the
Web site.
We currently engage in the type of
email updates that the commenter
suggests. Emails are sent to responsible
officials and alternate responsible
officials at all registered entities.
Dissemination of that information is at
the discretion of the responsible
officials and alternate responsible
officials. We plan on issuing guidance
and suggestions regarding information
dissemination, which we believe will
enable further information sharing
within regulated entities.
Another commenter asked that we
add a timeline to the regulations
indicating when the person requesting
the exclusion should expect to receive
a written response. The commenter
stated that, in the case of grant
applications, it may be difficult to meet
deadlines if the applicant has no idea
how long a response from the select
agent program will take.
We are making no changes as a result
of this comment. Due to the wide
variety of material submitted for
consideration for exclusions,
establishment of a timeline as the
commenter recommends is impractical.
The select agent program necessarily
examines each application on a case-bycase basis. We strive to make the
process as efficient as possible.
The regulations in 9 CFR 121.6 set out
guidelines for those instances where
overlap select agents and toxins may be
considered exempt from the regulations.
Specifically, § 121.6(e) concerns
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procedures by which an individual or
entity may be exempted from the
requirements of the regulations if
necessary in order to respond to a
domestic or foreign agricultural
emergency involving an overlap select
agent or toxin. Upon further
consideration, in order to eliminate an
unnecessary burden on such an
individual or entity, we have removed
the provision stating that the individual
or entity must complete APHIS/CDC
Form 5 in order to request such an
exemption. Guidance on requesting an
exemption for an individual or entity in
the case of a domestic or foreign
agricultural emergency involving an
overlap select agent or toxin may be
found on the National Select Agent
Registry at www.selectagents.gov.
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. We
proposed to explicitly require that all
designated responsible officials possess
the appropriate training or expertise to
execute their required duties. We also
proposed to clarify the role of alternate
responsible official in order to
definitively establish that the alternate
responsible official must have the
knowledge and authority to act for the
responsible official in his/her absence.
Finally, we proposed to add a
requirement that the responsible
official’s principal duty station be the
physical location of the registered
entity.
One commenter stated that the
language concerning responsible
officials is not clear and may cause
institutions to unnecessarily create new
administrative structures and positions
to meet this requirement. The
commenter urged the select agent
program to work with research
institutions in order to identify the most
appropriate level of administration for
the responsible official.
We are making no change in response
to this comment. The responsible
official should be an individual who can
perform all of the duties required for
that position. The regulations were
designed to place the responsibility for
ensuring entity compliance with the
regulations in one position. Given the
wide variety of entities covered by the
regulations, establishing more
prescriptive guidelines would decrease
the flexibility and usefulness of the
regulations to those entities. We neither
require nor prohibit the establishment of
a separate administrative position for
the responsible official as we leave it to
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the entity to decide how best to
designate a responsible official who
meets the requirements of the
regulations.
Another commenter said that the
absence of specific requirements
regarding responsible official
qualifications will establish an
inspection process that is subjective and
ineffectual. The commenter asked that
we add a section that explains and/or
defines what we consider the
‘‘appropriate training or expertise’’
necessary for an entity’s responsible
official.
We have established the regulations
regarding the training and expertise of
the responsible official in order that
they provide maximum flexibility to
regulated entities. The reasons for this
are twofold: First, given the quickly
developing and changing fields of
biosafety and biosecurity, any attempt
on our part to strictly define required
training and expertise within the
regulations would likely become
obsolete as the parameters continue to
evolve; second, given the wide variety
of entities covered by the regulations,
there is a need to maintain flexibility so
that they may remain applicable to all
of those entities. We have removed the
reference to ‘‘appropriate training or
expertise’’ and will continue to assess
the performance of the responsible
official based on his or her efficacy in
implementing the regulatory
requirements at his or her entity. With
an eye to the non-specificity of the
regulations, we have developed
guidance documents regarding this and
other aspects of entity compliance. They
are available on the National Select
Agent Registry at www.selectagents.gov.
Five commenters requested further
clarification regarding the proposed
requirement that the responsible
official’s principal duty station be the
physical location of the registered
entity. The commenters inquired
whether this requirement would mean
that the principal duty station should be
in the same building or only at the same
institution.
In response to these comments and
others received by the CDC, we are
modifying the language in 7 CFR 331.9
and 9 CFR 121.9 to stipulate that the
responsible official must have a
physical (as opposed to a telephonic or
audio-visual link) presence at the
registered entity to ensure that the entity
is in compliance with the regulations.
The responsible official will also be
more quickly able to respond to any onsite incidents involving select agents
and toxins if he or she is on-site.
Three commenters asked that the
definition of ‘‘entity’’ be clarified in
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relation to the requirement that the
responsible official’s principal duty
station be the physical location of the
registered entity and the impact of the
requirement assessed. The commenters’
request was based on their
understanding that an entity has to be
contiguous and that laboratories
separated on a campus constitute
separate entities. The commenters
concluded that having separate
responsible officials in this case would
be burdensome.
We realize that many entities are
located on a campus with several
registered laboratories in different
buildings. The intent of this
requirement is not to ensure that a
responsible official is assigned to each
physical laboratory but to ensure that
the responsible official is physically
located on the campus.
We proposed 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.
Specifically, we proposed to add new
provisions by which individuals may
have access to select agents at entities
other than the individual’s ‘‘home’’
entity. We also proposed to decrease the
maximum length of time for which a
security risk assessment will be valid
from 5 years to 3 years in order to more
expeditiously identify individuals who
may have fallen into one of the
prohibited or restricted categories.
One commenter asked whether,
during the time period in which an
individual has access to select agents at
entities other than the individual’s
‘‘home’’ entity, that individual would
have access to select agents at both
facilities, or if the access approval
would be transferred so that the
individual would only have access to
the select agents and toxins at the new
entity for the time specified. The
commenter stated that, from a biosafety
and biosecurity perspective, limiting
access to only one entity at the time
would be appropriate.
During this timeframe, the individual
will maintain access to select agents at
both facilities. We believe that such an
arrangement will serve to facilitate
collaboration between registered entities
as well as enabling various entities to
use their time and funds most efficiently
in order to continue ongoing research.
We do not agree with the commenter’s
assertion that this procedure would
threaten biosecurity or biosafety in any
way since all registered entities are
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required to undergo the same security
screening process as established by the
regulations.
Two commenters stated that
decreasing the maximum length of time
for which a security risk assessment will
be valid from 5 years to 3 years would
represent an undue burden on registered
entities. One commenter cited the
generally low rate of turnover at these
entities, while the other stated that the
existing policy, with renewal every 5
years, has proven to be both sufficient
and cost effective since the
establishment of the select agent
regulations. The first commenter
suggested that we allow for less frequent
risk assessments in the case of those
individuals working with non-Tier 1
select agents and toxins only. The
second commenter recommended
making no changes to the 5-year
interval.
The decision to begin processing
security risk assessments at 3-year
rather than 5-year intervals was made as
a result of the recommendations from a
working group comprised, in part, of
representatives from the DOD and the
HHS as well as various subject matter
experts. Based on input from the
working group as well as the FBI, we
have determined that conducting
security risk assessment approvals every
3 years is an effective method for
increasing the security of our entities.
Furthermore, the select agent program
has been processing security risk
assessments on a 3-year basis since June
1, 2011. Since that date, we have not
received any comments from the
regulated community regarding
additional financial or administrative
burden associated with the changed
practice. Regarding the first
commenter’s suggestion to process
security risk assessments differently for
those individuals working with nonTier 1 select agents and toxins only, the
establishment of the Tier 1 category is
in no way intended to imply that the
non-Tier 1 agents pose a lesser risk to
public health and safety than they have
previously. In accordance with that fact,
we have not decreased the handling and
security requirements for those non-Tier
1 agents.
We proposed to require that the
security plan described in 7 CFR 331.11
and 9 CFR 121.11 that must be
developed by all registered entities be
submitted for initial registration,
renewals of registration, and at any
other time upon request to replace the
existing requirement that they be
provided upon request only. We also
proposed that the security plan contain
provisions for the control of access to
select agents and toxins, including the
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safeguarding of animals or plants
intentionally or accidentally exposed to
or infected with a select agent, against
unauthorized access, theft, loss or
release. We also proposed to add a
requirement that the security plan
include procedures that require the
responsible official to immediately
notify the FBI in order to initiate a
threat assessment process in the event
that he or she becomes aware of
suspicious activity which is criminal in
nature, related to the facility, its
personnel, or select agents. We also
proposed to add provisions for
information security, including the need
for backup measures if the entity relies
on information systems for security. We
also proposed to codify current
practices for shipping, receiving, and
storage of select agents and toxins to
ensure that the entity has documented
processes for securing and monitoring
the shipment, receipt, and storage of
these items. Finally, we proposed to
amend paragraph (e) in 7 CFR 331.11
and 9 CFR 121.11, which previously
directed individuals creating a security
plan to guidance for developing such
documents contained in the ‘‘Morbidity
and Mortality Weekly Report’’ from
December 2002. We proposed that
applicants would instead be directed to
the ‘‘Security Information Document’’
and the ‘‘Security Plan Template’’ on
the National Select Agent Registry Web
site.
Two commenters requested
clarification concerning the proposed
requirement that entities address
procedures concerning animals or
plants accidentally or intentionally
exposed to or infected with a select
agent. Specifically, the commenters
requested clarification as to whether the
requirement would be limited to
experimental plants and animals that
are possessed and controlled by the
registered entity. One commenter
suggested two additions to the
requirements: One stipulating that the
incident response plan only cover those
animals or plants possessed and
controlled by the entity and the second
a certifying statement confirming that
the State animal health official (or plantassociated equivalent) has an incident
response plan in place to address
intentional or accidental exposure to
select agents for animals or plants
throughout the State, including those
plants or animals that are not possessed
or controlled by the entity but may be
located on the premises (e.g., wild
animals).
We are making no changes based on
these comments. It was always our
intent that the entity’s incident response
plan be limited to those exposed plants
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and animals that are possessed by and
controlled by the registered entity.
One commenter suggested that we
alter the wording from a requirement to
safeguard animals or plants
‘‘intentionally or accidentally exposed
to or infected with a select agent’’ to a
requirement to safeguard animals or
plants ‘‘intentionally exposed to, or
infected with, select agents.’’ The
commenter stated that the suggested
language would be clearer.
We are making no changes based on
this comment. We believe that animals
or plants accidentally exposed to or
infected with a select agent should be
handled as select agents and
safeguarded in the same manner as an
animal or plant intentionally exposed to
a select agent.
In the preamble to the proposed rule,
we stated that we were not proposing to
require the security plan to address
animals and plants exposed to select
toxins. This is because recovering the
toxin from within an animal or plant
subject is highly difficult and such
removal does not produce a reasonable
yield of recovery. In addition, there is
uncertainty as to whether or not the
toxin would remain active when
recovered from the animal or plant. For
these reasons it is highly unlikely that
once introduced into an animal or plant,
a sufficient amount of toxin could be
recovered to pose a significant hazard to
public health, agriculture, or agriculture
products. One commenter questioned
that rationale, stating that while toxins
are unlikely to be amplified or move
into multiple hosts outside a given
facility, there is still concern that
amplification of toxins could occur in
animals or insects during the course of
an experiment.
We disagree with the commenter’s
assertion. Select toxins do not amplify
the way select agents do. Toxins in an
animal or insect would prove deadly to
that organism before it could reach a
level at which extraction would become
possible.
One commenter stated that our
proposal to add a requirement that the
security plan include procedures for the
responsible official to notify the FBI of
suspicious activity that may be criminal
in nature and related to the entity, its
personnel, or its select agents or toxins
contradicts guidance contained in the
Nationwide Suspicious Activity
Reporting (SAR) Initiative (NSI)
established by the Department of
Justice, creates a conflict within those
entities that have their own recognized
law enforcement agencies, and
unnecessarily adds confusion due to the
potential for concurrent jurisdiction.
Two other commenters questioned the
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rationale for requiring FBI reporting
given that the select agent program is
jointly administered by APHIS and CDC
and, in the past, security concerns were
directed to those agencies.
We do not believe that there exists
any conflict between the security
requirements in 7 CFR 331.11 and 9
CFR 121.11 and the guidance offered by
the NSI. The intent of this requirement
is to facilitate the involvement of
antiterrorism resources which will
increase the security of select agents and
toxins. FBI field offices, which are
centrally located in major metropolitan
areas across the United States, can assist
entities by working closely with them
on crime threats. However, we agree
with the commenters that it may be
appropriate that notification of
suspicious activity first be given to local
law enforcement. We have therefore
changed the language in 7 CFR
331.11(c)(8) and 9 CFR 121.11(c)(8) to
read: ‘‘Describe procedures for how the
Responsible Official will be informed of
suspicious activity that may be criminal
in nature and related to the entity, its
personnel, or its select agents or toxins;
and describe procedures for how the
entity will notify the appropriate
Federal, State, or local law enforcement
agencies of such activity.’’
Another commenter suggested that we
require FBI notification for any
suspicious activity involving select
agents or toxins and not just activity
that may be criminal in nature. The
commenter argued that it is more
appropriate for the FBI to determine
whether or not the activity in question
is criminal in nature.
We are making no changes in
response to this comment. The intent of
this section of the regulations is to avoid
excessive reporting to the FBI. It is our
belief that a reasonable person would be
able to determine if the behavior in
question constitutes a potential criminal
act, which would therefore necessitate
FBI reporting.
One commenter requested that we
provide further details concerning the
proposed requirements for additions to
the security plan, specifically as it
relates to information security.
The purpose of the requirement in
question is to clarify the language in 7
CFR 331.11(c)(9)(i) and 9 CFR
121.11(c)(9)(i) of the regulations that
requires the entity to have procedures in
place for information systems control.
This is an overarching requirement that
covers electronic and non-electronic
information oversight by the regulated
community. Our intent is not to regulate
experimental data or the results of
studies involving select agents and
toxins but to regulate the select agents
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and toxins themselves. Therefore, we
have revised the language in order to
clearly indicate that the information
security provisions in question should
only be for access to the entity’s
registered space and records pertaining
to select agents and toxins, as identified
in sections 7 CFR 331.11, 9 CFR 121.11,
7 CFR 331.17, and 9 CFR 121.17.
Another commenter stated that the
information security requirement
represents an added regulatory burden,
and the impact of this requirement
should be evaluated.
For the most part, we anticipate that
these requirements are already being
met and will merely require entities to
codify and document the systems and
processes currently in place. The
guidance documents developed in
conjunction with this rule are, in part,
a response to the questions and issues
raised by the commenter. Issues
addressed in this document include, but
are not limited to: Information
technology security, network security,
computer security, peripheral devices
and data storage, physical security and
its application to information security,
risk management, and training. Full
guidance on information security may
be found on the National Select Agent
Registry at www.selectagents.gov.
Another commenter said that the
proposed requirement that authorized
and authenticated users only be granted
access to select agent and toxin related
information, files, equipment (e.g.,
servers or mass storage devices), and
applications as necessary to fulfill their
roles and responsibilities, and that their
access be modified when the user’s roles
and responsibilities change or when
their access to select agents and toxins
is suspended or revoked, would require
registration and security risk
assessments for all staff managing
records pertaining to select agent work.
The commenter argued that this
requirement would increase the burden
on manufacturers and institutions who
utilize administrative or information
technology staff for such document
management.
The security requirements referenced
by the commenter refer only to those
persons who have either physical access
to select agents and toxins or who have
the capability to alter security access to
select agents and toxins. Guidelines
concerning security requirements such
as these may be found on the National
Select Agent Registry at
www.selectagents.gov.
Another commenter stated that the
meaning of the phrases ‘‘network
connectivity monitoring’’ and ‘‘backup
security measures in the event that
access control systems and/or
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surveillance devices are rendered
inoperable’’ should be clarified.
Again, we note that, further details
regarding these and other aspects of the
information security requirements may
be found in the guidance documents
mentioned above, which may be found
on the National Select Agent Registry at
www.selectagents.gov.
We proposed to require that an
entity’s security plan contain provisions
and policies for shipping, receiving, and
storage of select agents and toxins,
including documented procedures for
receiving, monitoring, and shipping of
all select agents and toxins. These
provisions would provide that an entity
must properly secure containers on site
and have a written contingency plan for
unexpected shipments. One commenter
requested clarification regarding the
meaning of the term ‘‘unexpected
shipments.’’
We believe that the term ‘‘unexpected
shipments’’ is self-explanatory and
believe that the security plan should
contain procedures for these handling
unexpected shipments (e.g., when an
entity receives a shipment of a select
agent that it had neither requested nor
coordinated for, and therefore was not
expecting).
The regulations in 7 CFR 331.13 and
9 CFR 121.13 concern restricted
experiments, which are those
experiments that may not be performed
by regulated entities without the
approval of the Administrator. In
addition to the existing prohibition on
conducting restricted experiments, we
proposed to state that entities would not
be authorized to possess the products of
restricted experiments without the
approval of the Administrator.
We also proposed to expand the
restricted experiment approval
requirement to include all experiments
involving the creation of drug resistant
select agents that are not known to
acquire that resistance naturally, if such
acquisition could compromise the use of
the drug to control disease agents in
humans, veterinary medicine, or
agriculture, regardless of the method or
technology used to create the resistance.
Previously, the restricted experiment
language concerned only those
experiments involving recombinant
DNA. We proposed this change because,
while the introduction of a drug
resistance trait would normally
eliminate that drug as a therapeutic
option to control the disease, there may
be alternative drugs available to control
the disease.
In addition, we are adding a reference
to ‘‘chemical resistance traits,’’ to the
PPQ regulations in 7 CFR 331.13 in
order to capture the potential transfer of,
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or selection for, such traits that could
adversely affect plant and agricultural
health. Chemical resistant traits include,
but are not limited to herbicide
resistance, fungicide resistance, and
pesticide resistance. We did not propose
to add a corresponding definition to the
VS regulations in 9 CFR 121.13 since
chemical resistance traits are exclusive
to plant biology. It should be noted that
restricted experiments are not
prohibited experiments; an entity must
seek permission prior to the initiation of
a restricted experiment and receive
approval from the Administrator or HHS
Secretary. Approval for the performance
of a restricted experiment or the
possession of a product of a restricted
experiment may involve meeting
additional safety and/or security
requirements as prescribed by the select
agent program. Many experiments that
involve the deliberate transfer of a drug
resistant trait do not meet the definition
of a restricted experiment because the
drug is not used to control disease in
humans, veterinary medicine, or
agriculture. The select agent program
encourages anyone who intends to
conduct a select agent experiment
utilizing drug resistance markers to
submit that experiment for review so
that they may be advised regarding
whether the experiment would be
considered a restricted experiment and
therefore require approval prior to its
initiation.
Two commenters were concerned
about the proposed revisions classifying
those experiments that introduce drug
resistance to a select agent as restricted.
The commenters suggested aligning the
language concerning restricted
experiments with the recombinant DNA
guidelines issued by the NIH, which
restrict and require approval only for
those experiments with pathogens
involving drug resistance for
therapeutically useful agents against
that pathogen. The commenters stated
that the proposed language was too
broad.
We made no changes as a result of
these comments. Contrary to the
commenters’ assertion, we have not
expanded the definition of a restricted
experiment to include all experiments
utilizing select agents or toxins with
drug resistant traits, but only to those
utilizing select agents or toxins with
resistance to those drugs used to control
disease in humans, veterinary medicine,
or agriculture. The definition of a
restricted experiment contained in the
regulations is already aligned with the
NIH recombinant DNA guidelines.
One commenter argued that antibiotic
resistance not previously present could
emerge in one or more select agents at
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any time. The commenter wished to
know if the possession of such a
previously unknown antibiotic resistant
select agent would mean that all such
organisms would be required to be
destroyed. The commenter expressed
concern that such a requirement might
inadvertently prevent research in the
case of a select agent that suddenly
developed new antibiotic resistance
traits.
We are making no changes to the
regulations as a result of this comment.
Regardless of whether the select agent
develops a new trait, it is still
considered and treated as a select agent
from a biosafety or biocontainment
perspective. The aspect of the process
that makes a select agent the subject of
a restricted experiment is the purposeful
generation of antibiotic resistant
properties. If a select agent developed
new antibiotic resistance spontaneously,
then it would be included in the
category of select agents considered
‘‘known to acquire the resistance
naturally’’ as specified in 7 CFR
331.13(a)(1) and 9 CFR 121.13(b)(1).
Another commenter wanted to know
whether the use of the terms ‘‘the select
agent program’’ and ‘‘the
Administrator,’’ which refer to two
different entities, indicates that
restricted experiments would require
the approval of both the select agent
program and the Administrator.
Terms in this context are
interchangeable, as the APHIS
Administrator has delegated authority
for establishing and enforcing the
regulations to the select agent program.
Approval is therefore only needed from
the select agent program.
Another commenter stated that an
ombudsman, in the form of additional
working groups, should be included in
the approval process for restricted
experiments. The commenter said that
involvement of such groups in this
capacity would serve to engage those
regulated scientists while furthering
their understanding of the select agent
program.
We are making no changes as a result
of this comment. In reviewing
applications to conduct restricted
experiments, the select agent program
utilizes the expertise of the
Intragovernmental Select Agents and
Toxins Technical Advisory Committee
(ISATTAC), which is composed of
Federal scientists from the CDC, NIH,
FDA, APHIS, the Agricultural Research
Service (ARS), APHIS’ Center for
Veterinary Biologics (CVB), and DOD,
and its USDA counterpart, the
Agricultural ISATTAC, which is
composed of Federal scientists from
ARS, APHIS, and CVB. In the past,
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when appropriate, we have engaged the
advice of subject matter experts from
outside the government.
The regulations in 7 CFR 331.14 and
9 CFR 121.14 concern development of
an entity’s incident response plan. We
proposed to specify that each incident
response plan be based upon a sitespecific risk assessment. We also
proposed that the incident response
procedures contain stipulations
concerning animals and plants
accidentally or intentionally exposed to
or infected with a select agent.
One commenter argued that the
requirements in 7 CFR 331.14(a) and 9
CFR 121.14(a), which stipulate that
regulated entities must develop and
implement a written incident response
plan based on a site-specific risk
assessment, are misleading. The
commenter stated that, since there is no
standard methodology for conducting
such risk assessments, the addition of
specific issues that must be addressed
by a risk assessment should be included
in order to provide additional guidance
for the regulated community. The
commenter further observed that, in
general, the risk assessment
requirements for agricultural select
agents and toxins are somewhat
different from those for human select
agents and toxins. The commenter
concluded that a one size fits all
approach may be overly burdensome or
scientifically inaccurate.
We are making no changes based on
this comment. The site-specific risk
assessments required by the regulations
in 7 CFR 331.14(a) and 9 CFR 121.14(a)
are necessary in order to ensure the
physical security of regulated entities.
The risks cited by the commenter are
matters of the biological risk presented
by various select agents and toxins,
which is a separate issue from the
physical security of these select agents
and toxins. The regulations are intended
to prevent the theft, loss, or release of
select agents and toxins. We also
disagree with the commenter’s assertion
that there is no standard methodology
for conducting site-specific risk
assessments. We have developed
guidance on this subject that may be
found on the National Select Agent
Registry at www.selectagents.gov.
We proposed 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 proposed to require all registered
entities to provide security awareness
and incident response training. We also
proposed to establish that training for
escorted personnel would be based on
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the risk associated with accessing areas
where select agents and toxins are used
and/or stored. We further proposed to
require that refresher training, currently
required on an annual basis, also be
provided if a registered entity’s security,
incident response, biosafety, or
biocontainment plans are substantively
altered. Finally, we proposed to specify
that the responsible official ensure
maintenance of training records.
Currently there is no particular person
designated as the entity’s required
recordkeeper, only that a training record
must be kept.
One commenter suggested that 7 CFR
331.15(a) should specify that
information and training on both
biocontainment and biosafety be
provided, as only information and
training on biosafety had been specified
in the proposed rule.
We agree with the commenter and
have amended 7 CFR 331.15(a) in order
to reflect the proper terminology in
dealing with plant pathogens.
We proposed that the regulations in 7
CFR 331.15(a)(ii) concerning escorted
personnel stipulate that training for
such individuals must be based on the
risk associated with accessing areas
where select agents and toxins are used
and/or stored. One commenter inquired
what would represent an ‘‘appropriate
level of training.’’ The commenter
further wished to know how an entity
would determine the risk associated
with accessing such areas. Finally, the
commenter asserted that there should be
no need for non-approved individuals to
potentially access areas where select
agents and toxins are used and/or stored
given that unsecured select agents or
toxins could be moved elsewhere prior
to the arrival of any escorted personnel.
We disagree with the commenter’s
assertion that non-approved individuals
would never need to access areas where
select agents and toxins are used and/
or stored. For example, there may be a
need for the repair of a refrigeration unit
in a laboratory where employees are
utilizing select agents or toxins as a part
of concurrent research work. In
addition, inventories of select agents
and toxins may be large enough to make
moving them impractical and overly
time-consuming. It is therefore
necessary for any visitors to know and
understand the biological risks
associated with the select agents or
toxins used and/or stored in the area to
which they will have access. This
training would necessarily vary
depending upon the areas that the
escorted personnel would need to
access, which would be determined by
the entity. Visitors should ideally be
made aware of the safety and security
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procedures as defined by the entity in
question; however, we are leaving the
regulations in their broadly written state
in order to provide the greatest amount
of flexibility for the wide variety of
entities subject to the requirements.
We proposed to amend the
regulations in 7 CFR 331.16 and 9 CFR
121.16, which concern the transfer of
select agents and toxins from one
registered entity to another, in order to
codify practices for shipping, receiving,
and storage of select agents and toxins
to ensure that all registered entities have
documented processes for securing and
monitoring the shipment, receipt, and
storage of select agents and toxins that
make it extremely unlikely that such
materials would be made available to an
unauthorized individual.
Two commenters asserted that the
provisions concerning transfer are
unclear with regard to the subject of the
transfer of materials covered by the
exemptions for diagnostic or clinical
laboratories under 7 CFR 331.5, 9 CFR
121.5, and 9 CFR 121.6. The
commenters requested that we clearly
establish whether the new requirements
supersede the existing provisions for
transfer by exempt entities.
We are making no changes as a result
of this comment. Those materials which
qualify for exemption from the
regulations have always been
considered separately from the rest of
the listed select agents or toxins. This
may be a result of the exemptions
granted for diagnostic or clinical
laboratories, a result of a specific
exemption request, or for other reasons
which may be found in 7 CFR 331.5, 9
CFR 121.5, and 9 CFR 121.6. As a result,
these materials are not subject to the
regulations, including those portions of
the regulations concerning transfers,
apart from those sections pertaining to
exemptions.
However, given that some
commenters on the CDC proposed rule
expressed confusion associated with the
proposed provision, we have revised the
language in order to clarify our original
intent. Packaging of select agents and
toxins for transfer must be made by an
APHIS or CDC-approved individual.
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. We proposed to add
language to address synthetic select
agent organisms and animals and plants
inoculated with select agents. We also
proposed to add recordkeeping
requirements whereby regulated entities
maintain an accurate, current inventory
of any animals or plants intentionally or
accidentally exposed to or infected with
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a select agent (including number and
species, location, and appropriate
disposition). As previously stated, we
did not propose to require regulated
entities to keep records regarding
animals or plants exposed to select
toxins.
Four commenters argued that
counting individual vials of replicating
biological agents is costly, burdensome,
and a major source of frustration for
investigators. The commenters went on
to say that the requirement to measure
volumes within each vial is problematic
given both the ease with which volumes
can change through natural processes
and the difficulty in correctly assessing
them in the frozen state during
inventory verifications. The commenters
stated that both counting vials and
measuring volumes of individual vials
are not effective means of increasing
security.
We are making no changes to the
regulations based on these comments.
While we are aware of the burden
resulting from the requirement to
maintain an accurate and current
inventory of each select agent and toxin
held in long-term storage, we believe
this is an essential element in
establishing the security of select agents
or toxins. We recognize that it may still
be possible for an insider to steal a
sample of an agent either from working
stock or from an inventory without
being detected; however, if an entity has
a robust inventory management system,
such incidents have a better chance of
being detected. To assist registered
entities in meeting the requirements for
maintaining accurate inventories of
materials in long term storage, we have
developed guidance that may be found
on the National Select Agent Registry at
www.selectagents.gov. It should be
noted that, while the volume
measurements the commenter
references are required for inventories of
select toxins, they are not required in
the case of inventory of select agents
held in long-term storage due, in part,
to the points raised by the commenter.
However, we disagree with the
commenter’s assessment that measuring
volume in the case of select toxins and
counting vials in general as part of
required inventory tracking of both
select agents and toxins for registered
entities is not necessary.
Another commenter stated that there
is concern that the additional
requirements for inventory each time a
select agent is moved will adversely
impact the viability and quality of the
material in question.
We are making no changes as a result
of this comment. In the case of those
select agents and toxins in long-term
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storage, collections of vials of materials
can be recorded and grouped into
tamper-evident containers and audits
made of intact containers rather than
audits of individual vials. This practice
is stipulated in the current guidance
document regarding long term storage,
which is available on the National
Select Agent Registry at
www.selectagents.gov. Those select
agents and toxins that are part of an
entity’s working stock are already in
regular use and we therefore do not
anticipate adverse effects arising from
any required accounting.
Based on comments received on the
CDC rule, we now recognize that there
has been some confusion between those
animals (including arthropods) and
plants considered to be ‘‘working stock’’
and those considered to be ‘‘inventory.’’
To that end, we have developed
guidance that will enable entities to
better differentiate between these two
categories. This guidance is available at
www.selectagents.gov. It was not our
intent to require a formal inventory of
animals or plants intentionally or
accidentally exposed to or infected with
a select agent, but merely to state that
entities should keep some record of
such animals or plants. In order to
clarify our intent regarding ‘‘working
stock’’ and ‘‘inventory,’’ we are revising
7 CFR 331.17(a)(2) and 9 CFR
121.17(a)(2) to require an accurate,
current accounting of any animals or
plants intentionally or accidentally
exposed to or infected with a select
agent (including number and species,
location, and appropriate disposition)
instead of an accurate, current inventory
of those animals or plants.
Indirect and Economic Consequences
Eight commenters requested that we
consider the indirect consequences of
continuing to include agents and toxins
on the select agent list, the negative
effect of the proposed rule changes on
the potential workforce for select agent
research, and the possibility that
additional regulations concerning Tier 1
agents and toxins will mandate more
Federal oversight and institutional
compliance requirements, resulting in
increased costs to taxpayers both
directly and indirectly through reduced
research efficiency. Commenters
requested that the full economic and
scientific impact of these added
requirements be carefully assessed prior
to implementation, especially the
increased costs to academic institutions
with no associated funding, and the
increased burden on investigators
already having difficulty finding time
for research and experimentation. The
commenters also stated that the timeline
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for implementation of the new
requirements should be considered and
disclosed to affected entities.
A cornerstone of the select agent
program is to establish and enforce
safety and security measures to prevent
access to select agents and toxins for use
in domestic or international terrorism or
for any other criminal purpose. An
equally important function of the select
agent program is to ensure the
appropriate availability of biological
agents and toxins for research,
education, and other legitimate
purposes. To achieve both requires
balancing the need for continuing
biological research with requiring a
level of safety and security
commensurate with the risks posed by
these select agents and toxins. We
understand that safety and security
requirements cost money and that
money in the area of biological research
is often a scarce commodity. We are,
however, also aware that a lack of
adequate safety and security
requirements could result in damages
measured not only in dollars but in
human lives. It is our determination,
based on the information available to us,
that the additional requirements would,
in many cases, codify systems and
procedures already in use by a majority
of regulated entities.
We are also renumbering several
sections of the PPQ regulations so that
they will match the numbering of the
VS regulations, which we believe may
be useful for those entities housing both
PPQ select agents and toxins and VS
select agents and toxins. As proposed,
the section numbering did not match up
because we did not propose to classify
any PPQ select agents and toxins as Tier
1, so there were sections being added to
the VS regulations that were not
included in the PPQ regulations.
Effective Date
In response to comments received by
the CDC requesting guidance and a
timetable of when the proposed changes
would need to be addressed, we have
included a phase-in period for the
effective date for certain requirements of
the revised regulations, which should
allow entities to comply without
causing disruption or termination of
research or educational projects. As
noted in the ‘‘Dates’’ portion of this
document, 60 days from the publication
of the final rule, entities will be required
to be in compliance with 7 CFR 331.1
through 331.10, 331.13, and 331.16
through 331.20 and 9 CFR 121.1 through
121.10, 121.13, 121.16, 121.17, and
121.20. One hundred and eighty days
after the publication of the final rule,
entities will be required to be in
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compliance with 7 CFR 331.11, 331.12,
331.14, and 331.15 and 9 CFR 121.11,
121.12, 121.13, 121.14, and 121.15.
The staggered effective dates for the
provisions of the final rule are based on
the effective dates previously used for a
final rule published by the Select Agent
Program on March 18, 2005 (70 FR
13242–13292, Docket No. 02–088–4). If
the regulated community has concerns
about the established timeline, they can
contact the Federal select agent program
for technical assistance.
Therefore, for the reasons given in the
proposed rule and in this document, we
are adopting the proposed rule as a final
rule, with the changes discussed in this
document.
Executive Orders 12866 and 13563 and
Regulatory Flexibility Act
This final rule has been determined to
be significant/economically significant
for the purposes of Executive Order
12866 and, therefore, has been reviewed
by the Office of Management and
Budget.
We have prepared an economic
analysis for this rule. The economic
analysis provides a cost-benefit analysis,
as required by Executive Orders 12866
and 13563, which direct agencies to
assess all costs and benefits of available
regulatory alternatives and, if regulation
is necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, and equity). Executive Order
13563 emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. The
economic analysis also provides a final
regulatory flexibility analysis that
examines the potential economic effects
of this rule on small entities, as required
by the Regulatory Flexibility Act. The
economic analysis is summarized
below. Copies of the full analysis are
available on the Regulations.gov Web
site (see footnote 1 in this document for
a link to Regulations.gov) or by
contacting the person listed under FOR
FURTHER INFORMATION CONTACT.
Based on information obtained
through site-specific inspections, we
believe most registered entities already
have in place many of the information
security requirements set forth in the
final rule, and compliance costs of the
rules are therefore expected to be
minimal. Entities more likely to be
affected will be laboratories and other
institutions conducting research and
related activities that involve the use of
select agents and toxins categorized as
Tier 1. These entities will be required to
conduct a pre-access suitability
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assessment of individuals with access to
a Tier 1 select agent or toxin, as well as
enroll these individuals in an
occupational health program.
The rule would reduce the period that
FBI background checks are valid from
five to three years. This increased
frequency would effectively increase the
cost of background checks by 67
percent. Based on the current number of
individuals required to have the
background checks, we estimate that the
present value of these government-borne
costs over five years will increase by
$1.96 million across all registered
entities. The annual increase in costs
will total about $432,000.
While we expect few if any of the
registered entities to incur significant
compliance costs, required
documentation of measures already
regularly performed with respect to
biocontainment/biosafety, incident
response, information security, and
ongoing suitability assessment may
require additional time of personnel. We
estimate additional recurring costs
related to information security, such as
for software updates, could total about
$2 million per year, or about $5,500 per
entity, in the unlikely event that none
of the entities already uses equivalent
information security measures. As
noted, many of these costs are already
currently borne by entities in their
conduct of generally recognized best
practices.
For entities possessing a Tier 1 agent
or toxin, the costs of pre-access
suitability assessments and
occupational health programs are
estimated to total between $2.8 million
and $4.4 million, or between about
$9,600 and $15,100 per entity, on
average. Again, actual costs incurred are
unlikely to reach these maximum cost
ranges; we expect that many of the
entities with a Tier 1 agent or toxin
already conduct assessments and have
health programs similar or equivalent to
those required by the final rules.
The benefits of strengthened
safeguards against the unintentional or
deliberate release of a select agent or
toxin greatly exceed compliance costs of
the rules. As an example of losses that
can occur, the October 2001 anthrax
attacks caused 5 fatalities and 17
illnesses, disrupted business and
government activities (including $2
billion in lost revenues for the Postal
Service), and required more than $23
million to decontaminate one Senate
office building and $3 billion to
decontaminate postal facilities and
procure mail-sanitizing equipment.
Deliberate introduction greatly increases
the probability of a select agent
becoming established and causing wide-
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ranging and devastating impacts to the
economy, other disruptions to society,
and diminished confidence in public
and private institutions.
The amended regulations will
enhance the protection of human,
animal, and plant health and safety. The
final rules will reduce likelihood of the
accidental or intentional release of a
select agent or toxin. Benefits of the
rules will derive from the greater
probability that a release will be
prevented from occurring. While the
total cost of implementing the
regulations is estimated to range
between $2.8 million–$4.4 million
across all entities with a Tier 1 agent or
toxin and approximately $2.4 million in
annual cost across all registered entities
and the Federal Government, we believe
many of these costs are currently
incurred by affected entities as generally
recognized practices.
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 7 CFR part
3015, subpart V.)
Executive Order 12988
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts
all State and local laws and regulations
that are inconsistent with this rule; (2)
has no retroactive effect; and (3) does
not require administrative proceedings
before parties may file suit in court
challenging this rule.
Executive Order 13175
This rule has been reviewed in
accordance with the requirements of
Executive Order 13175, Consultation
and Coordination with Indian Tribal
Governments. The review reveals that
this regulation will not have substantial
and direct effects on Tribal governments
and will not have significant Tribal
implications.
Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection or recordkeeping
requirements included in this final rule
have been submitted for approval to the
Office of Management and Budget
(OMB). When OMB notifies us of its
decision, we will publish a document in
the Federal Register providing notice of
the assigned OMB control numbers or,
if approval is denied, providing notice
of what action we plan to take.
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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 rule, please contact Mrs. Celeste
Sickles, APHIS’ Information Collection
Coordinator, at (301) 851–2908.
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 are amending 7 CFR
part 331 and 9 CFR part 121 as follows:
Title 7
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 as
follows:
■ a. In the introductory text of the
definition of biological agent, by
removing the word ‘‘rickettsiae,’’;
■ b. By adding, in alphabetical order,
definitions of information security,
recombinant nucleic acids, security
barrier, and synthetic nucleic acids; and
■ c. In the introductory text of the
definition of toxin, by removing the
word ‘‘rickettsiae,’’.
The additions read as follows:
■
§ 331.1
Definitions.
*
*
*
*
*
Information security. Protecting
information and information systems
from unauthorized access, use,
disclosure, disruption, modification, or
destruction in order to provide:
(1) Integrity, which means guarding
against improper information
modification or destruction, and
includes ensuring information
authenticity;
(2) Confidentiality, which means
preserving authorized restrictions on
access and disclosure, including means
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for protecting personal privacy and
proprietary information; and
(3) Availability, which means
ensuring timely and reliable access to
and use of information.
*
*
*
*
*
Recombinant nucleic acids. (1)
Molecules that are constructed by
joining nucleic acid molecules and that
can replicate in a living cell (i.e.,
recombinant nucleic acids); or
(2) Molecules that result from the
replication of those described in
paragraph (1) of this definition.
*
*
*
*
*
Security barrier. A physical structure
that is designed to prevent entry by
unauthorized persons, animals, or
materials.
*
*
*
*
*
Synthetic nucleic acids. (1) Molecules
that are chemically or by other means
synthesized or amplified, including
those that are chemically or otherwise
modified but can base pair with
naturally occurring nucleic acid
molecules (i.e., synthetic nucleic acids);
or
(2) Molecules that result from the
replication of those described in
paragraph (1) of this definition.
*
*
*
*
*
■ 3. Section 331.3 is amended as
follows:
■ a. By revising paragraph (b);
■ b. In paragraph (c) introductory text,
by adding the words ‘‘and/or synthetic’’
after the word ‘‘recombinant’’ each time
it appears.
■ c. In paragraph (c)(2) introductory
text, by adding the words ‘‘and/or
synthetic’’ after the word
‘‘Recombinant’’.
■ d. By adding paragraph (d)(3); and
■ e. By revising paragraph (e)
The revisions and addition read as
follows:.
§ 331.3
PPQ select agents and toxins.
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*
*
*
*
*
(b) PPQ select agents and toxins:
Peronosclerospora philippinensis
(Peronosclerospora sacchari); Phoma
glycinicola (formerly Pyrenochaeta
glycines); Ralstonia solanacearum;
Rathayibacter toxicus; Sclerophthora
rayssiae; Synchytrium endobioticum;
Xanthomonas oryzae.
*
*
*
*
*
(d) * * *
(3) Any subspecies of Ralstonia
solanacearum except race 3, biovar 2
and all subspecies of Sclerophthora
rayssiae except var. zeae, provided that
the individual or entity can verify that
the agent is within the exclusion
category.
(e) An attenuated strain of a select
agent or an inactive form of a select
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toxin may be excluded from the
requirements of this part based upon a
determination by the Administrator that
the attenuated strain or inactivated
toxin does not pose a severe threat to
plant health or plant products.
(1) To apply for exclusion, an
individual or entity must submit a
written request and supporting
scientific information. A written
decision granting or denying the request
will be issued. An exclusion will be
effective upon notification to the
applicant. Exclusions will be listed on
the National Select Agent Registry Web
site at https://www.selectagents.gov/.
(2) If an excluded attenuated strain or
inactivated toxin is subjected to any
manipulation that restores or enhances
its virulence or toxic activity, the
resulting select agent or toxin will be
subject to the requirements of this part.
*
*
*
*
*
■ 4. Section 331.9 is amended as
follows:
■ a. In paragraph (a)(4), by removing the
word ‘‘and’’;
■ b. By redesignating paragraph (a)(5) as
paragraph (a)(6);
■ c. By adding a new paragraph (a)(5);
■ d. By revising the first sentence of
paragraph (b)
The addition and revision read as
follows:.
§ 331.9
Responsible official.
(a) * * *
(5) Have a physical (and not merely a
telephonic or audio/visual) presence at
the registered entity to ensure that the
entity is in compliance with the select
agent regulations and be able to respond
in a timely manner to onsite incidents
involving select agents and toxins in
accordance with the entity’s incident
response plan; and
*
*
*
*
*
(b) An entity may designate one or
more individuals to serve as an alternate
responsible official who acts for the
responsible official in his/her absence.
* * *
*
*
*
*
*
■ 5. Section 331.10 is amended as
follows:
■ a. By redesignating paragraphs (e)
through (i) as paragraphs (f) through (j)
respectively;
■ b. By adding a new paragraph (e); and
■ c. In newly redesignated paragraph (i),
by removing the number ‘‘5’’ and adding
the number ‘‘3’’ in its place.
The addition reads as follows:
§ 331.10 Restricting access to select
agents and toxins; security risk
assessments.
*
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*
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(e) 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 Administrator provide their
approved access status to another
registered individual or entity for a
specified period of time.
*
*
*
*
*
■ 6. Section 331.11 is amended as
follows:
■ a. By revising paragraph (b);
■ b. By revising paragraph (c)(2);
■ c. In paragraph (c)(6), by removing the
word ‘‘and’’;
■ d. In paragraph (c)(7), by removing the
period and adding a semicolon in its
place;
■ e. By adding new paragraphs (c)(8),
(9), and (10);
■ f. By redesignating paragraphs (e) and
(f) as paragraphs (g) and (h),
respectively;
■ g. By adding new paragraphs (e) and
reserved (f); and
■ h. By revising newly redesignated
paragraph (g).
The revisions and additions read as
follows:
§ 331.11
Security.
*
*
*
*
*
(b) The security plan must be
designed according to a site-specific risk
assessment and must provide graded
protection in accordance with the risk of
the select agent or toxin, given its
intended use. A current security plan
must be submitted for initial
registration, renewal of registration, or
when requested.
(c) * * *
(2) Contain provisions for the control
of access to select agents and toxins,
including the safeguarding of animals
(including arthropods) or plants
intentionally or accidentally exposed to
or infected with a select agent, against
unauthorized access, theft, loss or
release.
*
*
*
*
*
(8) Describe procedures for how the
Responsible Official will be informed of
suspicious activity that may be criminal
in nature and related to the entity, its
personnel, or its select agents or toxins;
and describe procedures for how the
entity will notify the appropriate
Federal, State, or local law enforcement
agencies of such activity.
(9) Contain provisions for information
security that:
(i) Ensure that all external
connections to systems which manage
security for the registered space are
isolated or have controls that permit
only authorized and authenticated
users;
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(ii) Ensure that authorized and
authenticated users are only granted
access to select agent and toxin related
information, files, equipment (e.g.,
servers or mass storage devices), and
applications as necessary to fulfill their
roles and responsibilities, and that
access is modified when the user’s roles
and responsibilities change or when
their access to select agents and toxins
is suspended or revoked;
(iii) Ensure that controls are in place
that are designed to prevent malicious
code (such as, but not limited to,
computer viruses, worms, spyware)
from compromising the confidentiality,
integrity, or availability of information
systems which manage access to spaces
registered under this part or records as
specified in § 331.17;
(iv) Establish a robust configuration
management practice for information
systems to include regular patching and
updates made to operating systems and
individual applications; and
(v) Establish procedures that provide
backup security measures in the event
that access control systems, surveillance
devices, and/or systems that manage the
requirements of § 331.17 are rendered
inoperable.
(10) Contain provisions and policies
for shipping, receiving, and storage of
select agents and toxins, including
documented procedures for receiving,
monitoring, and shipping of all select
agents and toxins. These provisions
must provide that an entity will
properly secure containers on site and
have a written contingency plan for
unexpected shipments.
*
*
*
*
*
(e) Entities must conduct complete
inventory audits of all affected select
agents and toxins in long-term storage
when any of the following occur:
(1) Upon the physical relocation of a
collection or inventory of select agents
or toxins for those select agents or
toxins in the collection or inventory;
(2) Upon the departure or arrival of a
principal investigator for those select
agents and toxins under the control of
that principal investigator; or
(3) In the event of a theft or loss of a
select agent or toxin, all select agents
and toxins under the control of that
principal investigator.
(f) [Reserved]
(g) In developing a security plan, an
individual or entity should consider the
documents entitled, ‘‘Security Guidance
for Select Agent or Toxin Facilities.’’
This document is available on the
National Select Agent Registry at
https://www.selectagents.gov/.
■ 7. Section 331.12 is amended as
follows:
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a. By revising paragraph (a);
■ b. By redesignating paragraph (d) as
paragraph (e); and
■ c. By adding reserved paragraph (d).
The revision reads as follows:
■
§ 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
containment procedures for the select
agent or toxin, including any animals or
plants intentionally or accidentally
exposed to or infected with a select
agent.
*
*
*
*
*
■ 8. Section 331.13 is amended by
removing footnote 5 and revising
paragraph (a) to read as follows:
§ 331.13
Restricted experiments.
(a) An individual or entity may not
conduct, or possess products resulting
from, the following experiments unless
approved by and conducted in
accordance with the conditions
prescribed by the Administrator:
(1) Experiments that involve the
deliberate transfer of, or selection for, a
drug or chemical resistance trait to
select agents that are not known to
acquire the trait naturally, if such
acquisition could compromise the
control of disease agents in humans,
veterinary medicine, or agriculture.
(2) Experiments involving the
deliberate formation of synthetic or
recombinant nucleic acids containing
genes for the biosynthesis of select
toxins lethal for vertebrates at an
LD[50]<100 ng/kg body weight.
*
*
*
*
*
■ 9. Section 331.14 is amended as
follows:
■ a. In the section heading, by
redesignating footnote 6 as footnote 5;
■ b. By revising the first sentence in
paragraph (a);
■ c. By redesignating footnote 7 as
footnote 6;
■ d. By revising paragraph (b);
■ e. By redesignating paragraphs (c) and
(d) as paragraphs (d) and (f),
respectively; and
■ f. By adding new paragraphs (c) and
reserved (e).
The revisions and additions read as
follows:
4 Technical assistance and guidance may be
obtained by contacting APHIS.
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§ 331.14
Incident response.5
(a) An individual or entity required to
register under this part must develop
and implement a written incident
response plan 6 based upon a site
specific risk assessment. * * *
(b) The incident response plan must
fully describe the entity’s response
procedures for the 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, and other natural and man-made
events.
(c) The response procedures must
account for hazards associated with the
select agent or toxin and appropriate
actions to contain such select agent or
toxin, including any animals (including
arthropods) or plants intentionally or
accidentally exposed to or infected with
a select agent.
*
*
*
*
*
■ 10. Section 331.15 is revised to read
as follows:
§ 331.15
Training.
(a) An individual or entity required to
register under this part must provide
information and training on
biocontainment, biosafety, security
(including security awareness), and
incident response to:
(1) Each individual with access
approval from the HHS Secretary or
Administrator before that individual has
such access to select agents and toxins.
The training must address the particular
needs of the individual, the work they
will do, and the risks posed by the
select agents or toxins; and
(2) Each individual not approved for
access to select agents and toxins by the
HHS Secretary or Administrator before
that individual enters areas where select
agents or toxins are handled or stored
(e.g., laboratories, growth chambers,
animal rooms, greenhouses, storage
areas, shipping/receiving areas,
production facilities, etc.). Training for
escorted personnel must be based on the
risk associated with accessing areas
where select agents and toxins are used
and/or stored.
(b) [Reserved]
(c) Refresher training must be
provided annually for individuals with
access approval from the HHS Secretary
or Administrator or at such time as the
5 Nothing in this section is meant to supersede or
preempt incident response requirements imposed
by other statutes or regulations.
6 Technical assistance and guidance may be
obtained by contacting APHIS.
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registered individual or entity
significantly amends its security,
incident response, or biocontainment
plans.
(d) The responsible official must
ensure a record of the training provided
to each individual with access to select
agents and toxins and each escorted
individual (e.g., laboratory workers,
visitors, etc.) is maintained. The record
must include the name of the
individual, the date of the training, a
description of the training provided,
and the means used to verify that the
employee understood the training.
■ 11. Section 331.16 is amended as
follows:
■ a. By redesignating footnote 8 as
footnote 7;
■ b. By redesignating paragraphs (e)
through (h) as paragraphs (h), (i), (j), and
(f) respectively;
■ c. By adding a new paragraph (e);
■ d. In newly redesignated paragraph
(f), by removing the words ‘‘packaging
and’’; and
■ e. By adding a new paragraph (g).
The additions read as follows:
synthetic nucleic acids, and organisms
containing recombinant and/or
synthetic nucleic acids) held in longterm storage (placement in a system
designed to ensure viability for future
use, such as in a freezer or lyophilized
materials), including:
*
*
*
*
*
(2) An accurate, current accounting of
any animals or plants intentionally or
accidentally exposed to or infected with
a select agent (including number and
species, location, and appropriate
disposition);
*
*
*
*
*
§ 331.19
§ 331.20
§ 331.16
Transfers.
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*
*
*
*
*
(e) After authorization is provided by
APHIS or CDC, the packaging of the
select agent(s) and toxin(s) is performed
by an individual approved by the HHS
Secretary or Administrator to have
access to select agents and toxins and is
in compliance with all applicable laws
concerning packaging.
*
*
*
*
*
(g) Transportation in commerce starts
when the select agent(s) or toxin(s) are
packaged for shipment and ready for
receipt by a courier transporting select
agent(s) or toxin(s) and ends when the
package is received by the intended
recipient who is an individual approved
by the HHS Secretary or Administrator
to have access to select agents and
toxins, following a security risk
assessment by the Attorney General.
*
*
*
*
*
■ 12. Section 331.17 is amended as
follows:
■ a. By revising paragraph (a)(1)
introductory text;
■ b. By redesignating paragraphs (a)(2)
through (6) as paragraphs (a)(3) through
(7), respectively; and
■ c. By adding a new paragraph (a)(2).
The revision and addition read as
follows:
§ 331.17
Records.
(a) * * *
(1) An accurate, current inventory for
each select agent (including viral
genetic elements, recombinant and/or
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[Amended]
13. Section 331.19 is amended as
follows:
■ a. By removing paragraph (b)(1)(iv);
and
■ b. By redesignating paragraphs
(b)(1)(v) through (b)(1)(viii) as
paragraphs (b)(1)(iv) through (b)(1)(vii),
respectively.
■ 14. Section 331.20 is revised to read
as follows:
■
Administrative review.
(a) An individual or entity may appeal
a denial, revocation, or suspension of
registration under this part. The appeal
must be in writing, state the factual
basis for the appeal, and be submitted
to the Administrator within 30 calendar
days of the decision.
(b) An individual may appeal a
denial, limitation, or revocation of
access approval under this part. The
appeal must be in writing, state the
factual basis for the appeal, and be
submitted to the Administrator within
180 calendar days of the decision.
(c) The Administrator’s decision
constitutes final agency action.
Title 9
PART 121—POSSESSION, USE, AND
TRANSFER OF SELECT AGENTS AND
TOXINS
15. 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.
16. Section 121.1 is amended as
follows:
■ a. In the introductory text of the
definition of biological agent, by
removing the word ‘‘rickettsiae,’’;
■ b. By adding, in alphabetical order,
definitions of information security,
occupational exposure, recombinant
nucleic acids, security barrier, and
synthetic nucleic acids; and
■ c. In the introductory text of the
definition of toxin, by removing the
word ‘‘rickettsiae,’’.
■
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The additions read as follows:
§ 121.1
Definitions.
*
*
*
*
*
Information security. Protecting
information and information systems
from unauthorized access, use,
disclosure, disruption, modification, or
destruction in order to provide:
(1) Integrity, which means guarding
against improper information
modification or destruction, and
includes ensuring information
authenticity;
(2) Confidentiality, which means
preserving authorized restrictions on
access and disclosure, including means
for protecting personal privacy and
proprietary information; and
(3) Availability, which means
ensuring timely and reliable access to
and use of information.
*
*
*
*
*
Occupational exposure. Any
reasonably anticipated skin, eye,
mucous membrane, parenteral contact,
or respiratory aerosol exposure to select
agents or toxins that may result from the
performance of an employee’s duties.
*
*
*
*
*
Recombinant nucleic acids. (1)
Molecules that are constructed by
joining nucleic acid molecules and that
can replicate in a living cell; or
(2) Molecules that result from the
replication of those described in
paragraph (1) of this definition.
*
*
*
*
*
Security barrier. A physical structure
that is designed to prevent entry by
unauthorized persons.
*
*
*
*
*
Synthetic nucleic acids. (1) Molecules
that are chemically or by other means
synthesized or amplified, including
those that are chemically or otherwise
modified but can base pair with
naturally occurring nucleic acid
molecules (i.e., synthetic nucleic acids);
or
(2) Molecules that result from the
replication of those described in
paragraph (1) of this definition.
*
*
*
*
*
■ 17. Section 121.3 is amended as
follows:
■ a. By adding a sentence at the end of
paragraph (a);
■ b. By revising paragraph (b);
■ c. In paragraph (c) introductory text,
by adding the words ‘‘and/or synthetic’’
after the word ‘‘recombinant’’ each time
it appears;
■ d. In paragraph (c)(2), by adding the
words ‘‘and/or synthetic’’ after the word
‘‘Recombinant’’;
■ e. By adding paragraph (d)(3);
■ f. By revising paragraph (e); and
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■ g. In paragraph (f)(3)(i), by removing
the words ‘‘Newcastle disease
virus‘‘(velogenic)’’ and adding the
words ‘‘virulent Newcastle disease
virus’’ in their place.
The revisions and additions read as
follows:
§ 121.3
VS select agents and toxins.
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(a) * * * The select agents and toxins
marked with an asterisk (*) are
designated as Tier 1 select agents and
toxins and are subject to additional
requirements as listed in this part.
(b) VS select agents and toxins:
African horse sickness virus; African
swine fever virus; Avian influenza
virus; Classical swine fever virus; *Footand-mouth disease virus; Goat pox
virus; Lumpy skin disease virus;
Mycoplasma capricolum; Mycoplasma
mycoides; Newcastle disease virus; 1
Peste des petits ruminants virus;
*Rinderpest virus; Sheep pox virus;
Swine vesicular disease virus.
*
*
*
*
*
(d) * * *
(3) Any low pathogenic strains of
avian influenza virus, any strain of
Newcastle disease virus which does not
meet the criteria for virulent Newcastle
disease virus, 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 verify
that the agent is within the exclusion
category.
(e) An attenuated strain of a select
agent or an inactive form of a select
toxin may be excluded from the
requirements of this part based upon a
determination by the Administrator that
the attenuated strain or inactivated
toxin does not pose a severe threat to
animal health or to animal products.
(1) To apply for exclusion, an
individual or entity must submit a
written request and supporting
scientific information. A written
decision granting or denying the request
will be issued. An exclusion will be
effective upon notification to the
applicant. Exclusions will be listed on
the National Select Agent Registry Web
site at https://www.selectagents.gov/.
1 A virulent Newcastle disease virus (avian
paramyxovirus serotype 1) 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.
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(2) If an excluded attenuated strain or
inactivated toxin is subjected to any
manipulation that restores or enhances
its virulence or toxic activity, the
resulting select agent or toxin will be
subject to the requirements of this part.
*
*
*
*
*
■ 18. Section 121.4 is amended as
follows:
■ a. By adding a sentence at the end of
paragraph (a);
■ b. By revising paragraph (b);
■ c. In paragraph (c) introductory text,
by adding the words ‘‘and/or synthetic’’
after the word ‘‘recombinant’’ each time
it appears;
■ d. In paragraph (c)(2) introductory
text, by adding the phrase ‘‘and/or
synthetic’’ after the word
‘‘Recombinant’’;
■ e. By adding paragraph (d)(3);
■ f. By revising paragraph (e); and
■ g. In paragraph (f)(3)(i), by removing
the words ‘‘Brucella melitensis, Hendra
virus, Nipah virus, Rift Valley fever
virus, and Venezuelan equine
encephalitis virus’’ and adding the
words ‘‘Burkholderia mallei, and
Burkholderia pseudomallei’’ in their
place.
The revisions and additions read as
follows:
§ 121.4
Overlap select agents and toxins.
(a) * * * The select agents and toxins
marked with an asterisk (*) are
designated as Tier 1 select agents and
toxins and are subject to additional
requirements as listed in this part.
(b) Overlap select agents and toxins:
*Bacillus anthracis; Bacillus anthracis
(Pasteur strain); Brucella abortus;
Brucella melitensis; Brucella suis;
*Burkholderia mallei; *Burkholderia
pseudomallei; Hendra virus; Nipah
virus; Rift Valley fever virus;
Venezuelan equine encephalitis virus.
*
*
*
*
*
(d) * * *
(3) Any subtypes of Venezuelan
equine encephalitis virus except for
Subtypes IAB or IC, provided that the
individual or entity can verify that the
agent is within the exclusion category.
(e) An attenuated strain of a select
agent or an inactive form of a select
toxin may be excluded from the
requirements of this part based upon a
determination by the HHS Secretary or
Administrator that the attenuated strain
or inactivated toxin does not pose a
severe threat to public health and safety,
to animal health or to animal products.
(1) To apply for exclusion, an
individual or entity must submit a
written request and supporting
scientific information. A written
decision granting or denying the request
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will be issued. An exclusion will be
effective upon notification to the
applicant. Exclusions will be listed on
the National Select Agent Registry Web
site at https://www.selectagents.gov/.
(2) If an excluded attenuated strain or
inactivated toxin is subjected to any
manipulation that restores or enhances
its virulence or toxic activity, the
resulting select agent or toxin will be
subject to the requirements of this part.
*
*
*
*
*
§ 121.5
[Amended]
19. In § 121.5, paragraph (a)(3)(i) is
amended by removing the words
‘‘bovine spongiform encephalopathy
agent,’’.
■ 20. Section 121.6 is amended as
follows:
■ a. In paragraph (a)(3)(i) by removing
the words ‘‘Brucella melitensis, Hendra
virus, Nipah virus, Rift Valley fever
virus, and Venezuelan equine
encephalitis virus’’ and adding the
words ‘‘Burkholderia mallei, and
Burkholderia pseudomallei’’ in their
place; and
■ b. By revising paragraph (e) to read as
follows:
■
§ 121.6 Exemptions for overlap select
agents and toxins.
*
*
*
*
*
(e) The Administrator may exempt an
individual or entity from the
requirements of this part for 30 calendar
days if it is necessary to respond to a
domestic or foreign agricultural
emergency involving an overlap select
agent or toxin. The Administrator may
extend the exemption once for an
additional 30 days.
*
*
*
*
*
■ 21. Section 121.9 is amended as
follows:
■ a. In paragraph (a)(4), by removing the
word ‘‘and’’;
■ b. By redesignating paragraph (a)(5) as
paragraph (a)(6);
■ c. By adding a new paragraph (a)(5);
■ d. By revising the first sentence of
paragraph (b); and
■ e. By revising the first sentence of
paragraph (c)(1).
The addition and revisions read as
follows:
§ 121.9
Responsible official.
(a) * * *
(5) Have a physical (and not merely a
telephonic or audio/visual) presence at
the registered entity to ensure that the
entity is in compliance with the select
agent regulations and be able to respond
in a timely manner to onsite incidents
involving select agents and toxins in
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accordance with the entity’s incident
response plan; and
*
*
*
*
*
(b) An entity may designate one or
more individuals to serve as an alternate
responsible official who acts for the
responsible official in his/her absence.
* * *
(c) * * *
(1) The identification of any of the
following select agents or toxins must be
immediately reported by telephone,
facsimile, or email: African horse
sickness virus, African swine fever
virus, avian influenza virus (highly
pathogenic), Bacillus anthracis,
Burkholderia mallei, Burkholderia
pseudomallei, classical swine fever
virus, foot-and-mouth disease virus,
virulent Newcastle disease virus,
rinderpest virus, and swine vesicular
disease virus. * * *
*
*
*
*
*
■ 22. Section 121.10 is amended as
follows:
■ a. By redesignating paragraphs (e)
through (j) as paragraphs (f) through (k),
respectively;
■ b. By adding a new paragraph (e); and
■ c. In newly redesignated paragraph (j),
by removing the number ‘‘5’’ and adding
the number ‘‘3’’ in its place.
The addition reads as follows:
§ 121.10 Restricting access to select
agents and toxins; security risk
assessments.
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*
*
*
*
*
(e) 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 Administrator provide their
approved access status to another
registered individual or entity for a
specified period of time.
*
*
*
*
*
■ 23. Section 121.11 is amended as
follows:
■ a. By revising paragraph (b);
■ b. By revising paragraph (c)(2);
■ c. In paragraph (c)(6), by removing the
word ‘‘and’’;
■ d. By adding new paragraphs (c)(8),
(9), and (10);
■ e. By redesignating paragraphs (e) and
(f) as paragraphs (g) and (h),
respectively;
■ f. By adding new paragraphs (e) and
(f); and
■ g. By revising newly redesignated
paragraph (g).
The revisions and additions read as
follows:
§ 121.11
*
*
Security.
*
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*
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(b) The security plan must be
designed according to a site-specific risk
assessment and must provide graded
protection in accordance with the risk of
the select agent or toxin, given its
intended use. A current security plan
must be submitted for initial
registration, renewal of registration, or
when requested.
(c) * * *
(2) Contain provisions for the control
of access to select agents and toxins,
including the safeguarding of animals or
plants intentionally or accidentally
exposed to or infected with a select
agent, against unauthorized access,
theft, loss or release.
*
*
*
*
*
(8) Describe procedures for how the
responsible official will be informed of
suspicious activity that may be criminal
in nature and related to the entity, its
personnel, or its select agents or toxins;
and describe procedures for how the
entity will notify the appropriate
Federal, State, or local law enforcement
agencies of such activity.
(9) Contain provisions for information
security that:
(i) Ensure that all external
connections to systems which manage
security for the registered space are
isolated or have controls that permit
only authorized and authenticated
users;
(ii) Ensure that authorized and
authenticated users are only granted
access to select agent and toxin related
information, files, equipment (e.g.,
servers or mass storage devices), and
applications as necessary to fulfill their
roles and responsibilities, and that
access is modified when the user’s roles
and responsibilities change or when
their access to select agents and toxins
is suspended or revoked;
(iii) Ensure that controls are in place
that are designed to prevent malicious
code (such as, but not limited to,
computer viruses, worms, spyware)
from compromising the confidentiality,
integrity, or availability of information
systems which manage access to spaces
registered under this part or records as
specified in § 121.17;
(iv) Establish a robust configuration
management practice for information
systems to include regular patching and
updates made to operating systems and
individual applications; and
(v) Establish procedures that provide
backup security measures in the event
that access control systems, surveillance
devices, and/or systems that manage the
requirements of § 121.17 are rendered
inoperable.
(10) Contain provisions and policies
for shipping, receiving, and storage of
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select agents and toxins, including
documented procedures for receiving,
monitoring, and shipping of all select
agents and toxins. These provisions
must provide that an entity will
properly secure containers on site and
have a written contingency plan for
unexpected shipments.
*
*
*
*
*
(e) Entities must conduct complete
inventory audits of all affected select
agents and toxins in long-term storage
when any of the following occur:
(1) Upon the physical relocation of a
collection or inventory of select agents
or toxins for those select agents or
toxins in the collection or inventory;
(2) Upon the departure or arrival of a
principal investigator for those select
agents and toxins under the control of
that principal investigator; or
(3) In the event of a theft or loss of a
select agent or toxin, all select agents
and toxins under the control of that
principal investigator.
(f) In addition to the requirements
contained in paragraphs (c) and (d) of
this section, the security plan for an
individual or entity possessing a Tier 1
select agent or toxin must also:
(1) Describe procedures for
conducting a pre-access suitability
assessment of persons who will have
access to a Tier 1 select agent or toxin;
(2) Describe procedures for how an
entity’s responsible official will
coordinate their efforts with the entity’s
safety and security professionals to
ensure security of Tier 1 select agents
and toxins and share, as appropriate,
relevant information; and
(3) Describe procedures for the
ongoing assessment of the suitability of
personnel with access to a Tier 1 select
agent or toxin. The procedures must
include:
(i) Self- and peer-reporting of
incidents or conditions that could affect
an individual’s ability to safely have
access to or work with select agents and
toxins, or to safeguard select agents and
toxins from theft, loss, or release;
(ii) The training of employees with
access to Tier 1 select agents and toxins
on entity policies and procedures for
reporting, evaluation, and corrective
actions concerning the assessment of
personnel suitability; and
(iii) The ongoing suitability
monitoring of individuals with access to
Tier 1 select agents and toxins.
(4) Entities with Tier 1 select agents
and toxins must prescribe the following
security enhancements:
(i) Procedures that will limit access to
a Tier 1 select agent or toxin to only
those individuals who are approved by
the HHS Secretary or Administrator
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following a security risk assessment by
the Attorney General, have had an
entity-conducted pre-access suitability
assessment, and are subject to the
entity’s procedures for ongoing
suitability assessment;
(ii) Procedures that limit access to
laboratory and storage facilities outside
of normal business hours to only those
specifically approved by the responsible
official or designee;
(iii) Procedures for allowing visitors,
their property, and vehicles at the entry
and exit points to the registered space,
or at other designated points of entry to
the building, facility, or compound that
are based on the entity’s site-specific
risk assessment;
(iv) A minimum of three security
barriers where each security barrier
adds to the delay in reaching secured
areas where select agents and toxins are
used or stored. One of the security
barriers must be monitored in such a
way as to detect intentional and
unintentional circumventing of
established access control measures
under all conditions (day/night, severe
weather, etc.) The final barrier must
limit access to the select agent or toxin
to personnel approved by the HHS
Secretary or Administrator, following a
security risk assessment by the Attorney
General.
(v) All registered space or areas that
reasonably afford access to the
registered space must be protected by an
intrusion detection system (IDS) unless
physically occupied;
(vi) Personnel monitoring the IDS
must be capable of evaluating and
interpreting the alarm and alerting the
designated security response force or
law enforcement;
(vii) For powered access control
systems, describe procedures to ensure
that security is maintained in the event
of the failure of access control systems
due to power disruption affecting
registered space;
(viii) The entity must:
(A) Determine that the response time
for security forces or local police will
not exceed 15 minutes where the
response time is measured from the time
of an intrusion alarm, or report of a
security incident, to the arrival of the
responders at the first security barrier
or;
(B) Provide security barriers that are
sufficient to delay unauthorized access
until the response force arrives in order
to safeguard the select agents and toxins
from theft, intentional release, or
unauthorized access. The response time
is measured from the time of an
intrusion alarm, or report of a security
incident, to the arrival of the responders
at the first security barrier.
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(5) Entities that possess foot-andmouth disease virus and rinderpest
virus must have the following
additional security requirements:
(i) A minimum of four barriers, one of
which must be a perimeter security
fence or equivalent which is monitored
24 hours a day, 7 days a week (24/7) to
detect the presence of unauthorized
persons, vehicles, materials, or
unauthorized activities;
(ii) Onsite 24/7 armed security
response force with roving patrol.
Response time must not exceed 5
minutes from the time of an intrusion
alarm or report of a security incident;
(iii) CCTV surveillance with 24/7
monitoring and recording; and
(iv) Transport vehicle with GPS
tracking designed to serve as a
containment vehicle.
(g) In developing a security plan, an
individual or entity should consider the
document entitled, ‘‘Security Guidance
for Select Agent or Toxin Facilities.’’
This document is available on the
Internet at
https://www.selectagents.gov/.
*
*
*
*
*
■ 24. Section 121.12 is amended as
follows:
■ a. By revising paragraph (a);
■ b. By revising paragraph (c)(1);
■ c. By adding a second sentence to
paragraph (c)(2);
■ d. In paragraph (c)(3), by removing the
address ‘‘https://www.aphis.usda.gov/
programs/ag_selectagent/ ’’
and adding in its place ‘‘https://
www.selectagents.gov/ ’’;
■ e. By redesignating paragraph (d) as
paragraph (e); and
■ f. By adding a new paragraph (d).
The revisions and addition 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.9 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.
*
*
*
*
*
(c) * * *
(1) The CDC/NIH publication,
‘‘Biosafety in Microbiological and
Biomedical Laboratories.’’ This
document is available on the National
9 Technical assistance and guidance may be
obtained by contacting APHIS.
PO 00000
Frm 00026
Fmt 4701
Sfmt 4700
Select Agent Registry at https://
www.selectagents.gov/.
(2) * * * This document is available
on the National Select Agent Registry at
https://www.selectagents.gov/.
*
*
*
*
*
(d) The biosafety plan must include
an occupational health program for
individuals with access to Tier 1 select
agents and toxins, and those individuals
must be enrolled in the occupational
health program.
*
*
*
*
*
25. Section 121.13 is amended by
removing footnote 10 and revising
paragraphs (a) and (b) to read as follows:
■
§ 121.13
Restricted experiments.
(a) An individual or entity may not
conduct, or possess products (i.e., select
agents that are not known to acquire a
drug resistance trait naturally, if such
acquisition could compromise the
control of disease agents in humans,
veterinary medicine, or agriculture, or
recombinant and/or synthetic nucleic
acids containing genes for the
biosynthesis of select toxins lethal for
vertebrates at an LD[50] < 100 ng/kg
body weight) resulting from, the
following experiments unless approved
by and conducted in accordance with
the conditions prescribed by the
Administrator:
(b) Restricted experiments: (1)
Experiments that involve the deliberate
transfer of, or selection for, a drug
resistance trait to select agents that are
not known to acquire the trait naturally,
if such acquisition could compromise
the control of disease agents in humans,
veterinary medicine, or agriculture.
(2) Experiments involving the
deliberate formation of synthetic or
recombinant nucleic acids containing
genes for the biosynthesis of select
toxins lethal for vertebrates at an
LD[50]<100 ng/kg body weight.
*
*
*
*
*
26. Section 121.14 is amended as
follows:
■ a. In the section heading, by
redesignating footnote 11 as footnote 10;
■ b. In paragraph (a), by redesignating
footnote 12 as footnote 11 and revising
the first sentence of paragraph (a);
■ c. By revising paragraph (b);
■ d. By redesignating paragraphs (c) and
(d) as paragraphs (d) and (f),
respectively; and
■ e. By adding new paragraphs (c) and
(e).
The revisions and additions read as
follows:
■
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Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules and Regulations
§ 121.14
Incident response.10
(a) An individual or entity required to
register under this part must develop
and implement a written incident
response plan 11 based upon a site
specific risk assessment. * * *
(b) The incident response plan must
fully describe the entity’s response
procedures for the 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, and other natural and man-made
events.
(c) The response procedures must
account for hazards associated with the
select agent or toxin and appropriate
actions to contain such select agent or
toxin, including any animals (including
arthropods) or plants intentionally or
accidentally exposed to or infected with
a select agent.
*
*
*
*
*
(e) Entities with Tier 1 select agents
and toxins must have the following
additional incident response policies or
procedures:
(1) The incident response plan must
fully describe the entity’s response
procedures for failure of intrusion
detection or alarm system; and
(2) The incident response plan must
describe procedures for how the entity
will notify the appropriate Federal,
State, or local law enforcement agencies
of suspicious activity that may be
criminal in nature and related to the
entity, its personnel, or its select agents
or toxins.
*
*
*
*
*
■ 27. Section 121.15 is revised to read
as follows:
pmangrum on DSK3VPTVN1PROD with RULES_2
§ 121.15
Training.
(a) An individual or entity required to
register under this part must provide
information and training on biosafety,
security (including security awareness),
and incident response to:
(1) Each individual with access
approval from the HHS Secretary or
Administrator before that individual has
such access to select agents and toxins.
The training must address the particular
needs of the individual, the work they
will do, and the risks posed by the
select agents or toxins; and
10 Nothing in this section is meant to supersede
or preempt incident response requirements
imposed by other statutes or regulations.
11 Technical assistance and guidance may be
obtained by contacting APHIS.
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15:27 Oct 04, 2012
Jkt 229001
(2) Each individual not approved for
access to select agents and toxins by the
HHS Secretary or Administrator before
that individual enters areas where select
agents or toxins are handled or stored
(e.g., laboratories, growth chambers,
animal rooms, greenhouses, storage
areas, shipping/receiving areas,
production facilities, etc.). Training for
escorted personnel must be based on the
risk associated with accessing areas
where select agents and toxins are used
and/or stored.
(b) Entities with Tier 1 select agents
and toxins must conduct annual insider
threat awareness briefings on how to
identify and report suspicious
behaviors.
(c) Refresher training must be
provided annually for individuals with
access approval from the HHS Secretary
or Administrator or at such time as the
registered individual or entity
significantly amends its security,
incident response, or biosafety plans.
(d) The responsible official must
ensure a record of the training provided
to each individual with access to select
agents and toxins and each escorted
individual (e.g., laboratory workers,
visitors, etc.) is maintained. The record
must include the name of the
individual, the date of the training, a
description of the training provided,
and the means used to verify that the
employee understood the training.
■ 28. Section 121.16 is amended as
follows:
■ a. By redesignating footnote 14 as
footnote 12;
■ b. By redesignating paragraphs (f)
through (i) as paragraphs (i), (j), (k), and
(g), respectively;
■ c. By adding a new paragraph (f);
■ d. In newly redesignated paragraph
(g), by removing the words ‘‘packaging
and’’; and
■ e. By adding a new paragraph (h).
The additions read as follows:
§ 121.16
Transfers.
*
*
*
*
*
(f) After authorization is provided by
APHIS or CDC, the packaging of the
select agent(s) and toxin(s) is performed
by an individual approved by the HHS
Secretary or Administrator to have
access to select agents and toxins and is
in compliance with all applicable laws
concerning packaging.
*
*
*
*
*
(h) Transportation in commerce starts
when the select agent(s) or toxin(s) are
packaged for shipment and ready for
receipt by a courier transporting select
agent(s) or toxin(s) and ends when the
package is received by the intended
PO 00000
Frm 00027
Fmt 4701
Sfmt 9990
61081
recipient who is an individual approved
by the HHS Secretary or Administrator
to have access to select agents and
toxins, following a security risk
assessment by the Attorney General.
*
*
*
*
*
■ 29. Section 121.17 is amended as
follows:
■ a. By revising paragraph (a)(1)
introductory text;
■ b. By redesignating paragraphs (a)(2)
through (6) as paragraphs (a)(3) through
(7), respectively; and
■ c. By adding a new paragraph (a)(2).
The revision and addition read as
follows:
§ 121.17
Records.
(a) * * *
(1) 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 (placement in a system
designed to ensure viability for future
use, such as in a freezer or lyophilized
materials), including:
*
*
*
*
*
(2) An accurate, current accounting of
any animals or plants intentionally or
accidentally exposed to or infected with
a select agent (including number and
species, location, and appropriate
disposition);
*
*
*
*
*
■ 30. Section 121.20 is revised to read
as follows:
§ 121.20
Administrative review.
(a) An individual or entity may appeal
a denial, revocation, or suspension of
registration under this part. The appeal
must be in writing, state the factual
basis for the appeal, and be submitted
to the Administrator within 30 calendar
days of the decision.
(b) An individual may appeal a
denial, limitation, or revocation of
access approval under this part. The
appeal must be in writing, state the
factual basis for the appeal, and be
submitted to the Administrator within
180 calendar days of the decision.
(c) The Administrator’s decision
constitutes final agency action.
Done in Washington, DC, this 28th day of
September 2012.
Edward Avalos,
Under Secretary for Marketing and Regulatory
Programs.
[FR Doc. 2012–24434 Filed 10–2–12; 11:15 am]
BILLING CODE 3410–34–P
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]]>Agencies
[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Rules and Regulations]
[Pages 61055-61081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24434]
[[Page 61055]]
Vol. 77
Friday,
No. 194
October 5, 2012
Part II
Department of Agriculture
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Animal and Plant Health Inspection Service
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7 CFR Part 331
9 CFR Part 121
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; Final Rule
Federal Register / Vol. 77 , No. 194 / Friday, October 5, 2012 /
Rules and Regulations
[[Page 61056]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 331
9 CFR Part 121
[Docket No. APHIS-2009-0070]
RIN 0579-AD09
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Agricultural Bioterrorism Protection
Act of 2002, we are amending and republishing 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
implements the findings of the third biennial review of the list. In
addition, we are reorganizing the list of select agents and toxins
based on the relative potential of each select agent or toxin to be
misused to adversely affect human, plant, or animal health. Such
tiering of the list allows for the optimization of security measures
for those select agents or toxins that present the greatest risk of
deliberate misuse with the most significant potential for mass
casualties or devastating effects to the economy, critical
infrastructure, or public confidence. We are also making a number of
amendments to the regulations, including the addition of definitions
and clarification of language concerning security, training, biosafety,
biocontainment, and incident response. These changes will increase the
usability of the select agent regulations as well as provide for
enhanced program oversight.
DATES: The amendments to 7 CFR 331.1 through 331.10, 331.13, and 331.16
through 331.20 and 9 CFR 121.1 through 121.10, 121.13, 121.16, 121.17,
and 121.20 are effective December 4, 2012. The remaining provisions of
this final rule are effective April 3, 2013.
FOR FURTHER INFORMATION CONTACT: Mr. Charles L. Divan, Acting Director,
APHIS Agriculture Select Agent Program, APHIS, 4700 River Road Unit 2,
Riverdale, MD 20737-1231; (301) 851-3300, option 1.
SUPPLEMENTARY INFORMATION:
Executive Summary
On July 29, 2010, we published in the Federal Register (75 FR
44724-44725, Docket No. APHIS-2009-0070) an advance notice of proposed
rulemaking and request for comments (ANPR)\1\ and On October 3, 2011,
we published in the Federal Register (76 FR 61228-61244, Docket No.
APHIS-2009-0070) a proposal\2\ regarding our intent 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, reorganize the list of select agents and toxins based
on the relative potential of each select agent or toxin to be misused
to adversely affect human, plant, or animal health, and amend the
regulations in order to add definitions and clarify language concerning
security, training, biosafety, biocontainment, and incident response.
---------------------------------------------------------------------------
\1\ To view the ANPR and the comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2009-0070.
\2\ To view the proposed rule and the comments we received, go
to https://www.regulations.gov/#!docketDetail;D=APHIS-2009-0070.
---------------------------------------------------------------------------
Specifically, the ANPR solicited comments regarding whether there
are other select agents or toxins that should be added to the Plant
Protection and Quarantine (PPQ) and Veterinary Services (VS) lists of
select agents and toxins, whether any of the select agents or toxins on
the PPQ or VS lists should be removed, whether the PPQ and VS lists of
select agents and toxins should be tiered based on the relative
bioterrorism risk presented by each select agent or toxin, and whether
the security requirements for select agents or toxins in the highest
tier should be stratified based on type of use or other factors.
Comments received as a result of the ANPR were used in order to inform
our discussions on the content of the select agent list and our
determination regarding reorganization of the list in the proposed
rule. We solicited comments concerning our proposal for 60 days ending
December 2, 2011. We reopened and extended the deadline for comments
until January 17, 2012, in a document published in the Federal Register
on December 15, 2011 (76 FR 77914, Docket No. APHIS-2009-0070). We
received 30 comments by that date. They were from researchers,
scientific organizations, laboratories, and universities.
Changes to the current regulations detailed in this final rule
include:
1. Modification of the select agent and toxin list:
The following agents would no longer be considered PPQ
select agents or toxins, or would be excluded from compliance with the
select agent regulations: Any subspecies of Ralstonia solanacearum
except race 3, biovar 2 and all subspecies of Sclerophthora rayssiae
except var. zeae, and Xylella fastidiosa, citrus variegated chlorosis
(CVC) strain.
The following agents would no longer be considered VS
select agents or toxins, or would be excluded from compliance with the
select agent regulations: Any low pathogenic strains of avian influenza
virus, any strain of Newcastle disease virus which does not meet the
criteria for virulent Newcastle disease virus, 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), Akabane virus; Bluetongue virus (exotic), Bovine
spongiform encephalopathy agent; Camel pox virus; Ehrlichia ruminantium
(Heartwater); Japanese encephalitis virus; Malignant catarrhal fever
virus (Alcelaphine herpesvirus type 1); Menangle virus; and Vesicular
stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3.
The following agent would no longer be considered a VS/
Department of Health and Human Services (HHS) overlap select agent:
Venezuelan Equine Encephalitis Virus (subtypes ID and IE).
2. Tiering of the select agent and toxin lists:
Tier 1 select agents and toxins:
PPQ select agents and toxins: None.
VS select agents and toxins: Foot-and-mouth disease virus
and Rinderpest virus.
VS/HHS overlap select agents and toxins: Bacillus
anthracis, Burkholderia mallei, and Burkholderia pseudomallei.
3. Establishing physical security standards for entities possessing
Tier 1 select agents and toxins, including the requirement to conduct
pre-access assessments and ongoing monitoring of personnel with access
to Tier 1 agents and toxins;
4. Miscellaneous revisions to the regulations to clarify regulatory
language concerning security, training, biosafety, and incident
response.
Costs of the Rule: Entities affected by the rule include research
and diagnostic facilities; Federal, State, and university laboratories;
and private commercial and non-profit enterprises. The regulations
require registering the
[[Page 61057]]
possession, use, and transfer of select agents or toxins. In addition,
the entity is required to ensure that the facility where the agent or
toxin is housed has adequate biosafety and containment measures, that
the physical security of the premises is adequate, that all individuals
with access to select agents or toxins have the appropriate education,
training, and/or experience to handle such agents or toxins, and that
complete records concerning activities related to the select agents or
toxins are maintained.
The rule will further reduce or minimize the risk of misuse of
select 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 and HHS recognize that several of the required measures
of the regulations may impose certain operational costs upon affected
entities, particularly entities that have the newly designated Tier 1
select agents and toxins. In many cases, however, the affected entities
already employ some or all of the required measures. Compliance costs
actually incurred will therefore vary from one entity to the next.
While information on the specific changes that would need to occur
at individual sites and the associated costs was not readily available
during proposed rulemaking, some general observations regarding the
potential costs were presented. These general cost observations can be
found in Table 2 of the Regulatory Impact Analysis located at:
www.regulations.gov and at https://www.selectagents.gov.
Benefits of the Rule: The objectives of the final rule is to create
a means of ensuring enhanced oversight in the transfer, storage, and
use of select agents and toxins; define the security procedures and
suitability assessments for pre-access suitability and continual
monitoring of individuals with access to Tier 1 select agents and
toxins; and require that entities in possession of such agents and
toxins develop and implement effective means of biosafety, information
security, and physical security. The overall benefit of the amended
provisions will be a reduced likelihood of the accidental or
intentional release of a select agent or toxin and the avoidance of
costs associated with such a release. The goal of the amended
regulations is to enhance the protection of human, animal, and plant
health and safety.
Background
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
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 human and animal health or
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 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 amending and republishing the list
of select agents and toxins based on the findings of our third 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 or disease 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 final 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 agents
and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4).
On October 3, 2011, we published in the Federal Register (76 FR
61228-61244, Docket No. APHIS-2009-0070) a proposal \3\ 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, reorganize the list of select agents and toxins based
on the relative potential of each select agent or toxin to be misused
to adversely affect human, plant, or animal health, and amend the
regulations in order to add definitions and clarify language concerning
security, training, biosafety, biocontainment, and incident response.
---------------------------------------------------------------------------
\3\ To view the proposed rule and the comments we received, go
to https://www.regulations.gov/#!docketDetail;D=APHIS-2009-0070.
---------------------------------------------------------------------------
We solicited comments concerning our proposal for 60 days ending
December 2, 2011. We reopened and extended the deadline for comments
until January 17, 2012, in a document published in the Federal Register
on December 15, 2011 (76 FR 77914, Docket No. APHIS-2009-0070). We
received 30 comments by that date. They were from researchers,
scientific organizations, laboratories, and universities. They are
discussed below by topic.
Guidance Documents
In the proposed rule, we specifically requested comment from the
regulated community and any other interested persons on the need for
and desirability of guidance documents that would serve to assist
regulated entities in meeting the requirements of regulations. We were
particularly interested in public comment regarding Web sites,
articles, or other sources useful in developing such guidance
documents. We received a number of comments on the issue of guidance,
which are discussed below.
Two commenters suggested the use of specific documents in creating
guidance: The Laboratory Biorisk Management Standard, which was
[[Page 61058]]
developed by the European Committee for Standardization, and the report
``Guidance for Enhancing Personnel Reliability and Strengthening the
Culture of Responsibility,'' which was developed by the National
Science Advisory Board for Biosecurity.
We agree with the commenters and have utilized both sources in
developing guidance.
One commenter stated that the select agent program should develop a
standardized template that addresses each item required by the
regulations, both for regulated entities and inspectors. The commenter
went on to say that the templates should be posted on the select agent
Web site.
The National Select Agent Registry at www.selectagents.gov includes
checklists, guidance documents, and templates that we have developed to
aid entities in meeting the requirements of the regulations. The select
agent program also conducts regular inspector training in order to
standardize inspector understanding of the regulations and inspection
process. We accept entity feedback regarding the inspection process and
incorporate it into our training program as appropriate.
Another commenter stated that the involvement of regulated entities
in the development of guidance is crucial, as it will ensure that the
new regulations may be implemented without unsustainable increases in
cost to those entities.
The guidance documents developed in conjunction with this rule are,
in part, a response to the questions and issues raised by the
commenters regarding various aspects of the proposed rule. We also
consulted HHS and USDA subject matter experts and other sources
including National Science Advisory Board for Biosecurity, the National
Academies, the Department of Defense Security Engineering Facilities
Planning Manual, and Director of Central Intelligence Directive Number
6/9. Regarding the commenter's cost concerns, the guidance developed by
the select agent program does not set out a prescriptive series of
procedures that must be followed by all regulated entities; rather, it
establishes examples of ways in which an entity may choose to meet the
requirements of the regulations. We have purposefully left the
regulations in their general state in order to allow for the wide
variety of regulated entities to meet the regulatory standard in a way
that is most cost-effective for each.
PPQ Select Agents and Toxins
We proposed to amend the list of PPQ select agents and toxins
listed in 7 CFR 331.3 by removing Xylella fastidiosa, citrus variegated
chlorosis (CVC) strain, from the list as it no longer meets the
criteria for use as an agroterrorism agent.
One commenter stated that the scientific basis for the removal of
Xylella fastidiosa from the list was unclear and requested
clarification concerning our decision. The commenter additionally
stated that if the review process for such removal were to be
transparent, with expert opinion from the public and private sector,
including a sound scientific analysis and an assessment of the
biosecurity risk of each agent, other plant pathogens on the list of
select agents and toxins could potentially be removed.
We are making no changes as a result of this comment. Each agent on
the select agent and toxin list was considered for retention or removal
based on a variety of factors, including, but not limited to, the
scientific concerns cited by the commenter. Further, the select agent
program did employ subject-matter experts as part of the decision-
making process as recommended by the commenter in addition to
soliciting public comment. Experts in the biology of these agents and
toxins evaluated their ``potential for mass casualties or devastating
effects to the economy, critical infrastructure, or public
confidence.'' This evaluation included assessments of morbidity and
mortality, communicability, low infectious dose, availability of
countermeasures, and economic impact of a potential attack. Each agent
and toxin was then assessed for its ``risk of deliberate misuse,''
including its history of weaponization and/or known interest by State
or non-State adversaries. These evaluations, combined with input
received as a result of the publication of an advance notice of
proposed rulemaking and request for comments (ANPR) \4\ in the Federal
Register on July 29, 2010, and relevant findings in recent government
and non-government reports, formed the basis for deliberations
concerning which agents should constitute the list. It is important to
note that removal of pathogens from the list of select agents and
toxins does not mean that they are not of potential concern, but rather
that the risk they represent has been reevaluated using the above
criteria. Reduction of the list is meant to decrease the burden on
researchers and focus attention on agents and toxins judged to be of
greatest biosecurity concern.
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\4\ To view the ANPR and the comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2009-0070.
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The list of PPQ select agents and toxins includes an entry for
Xanthomonas oryzae. While we did not propose any changes to the entry
for Xanthomonas oryzae, one commenter stated that it should be removed
from the list of select agents and toxins and offered a number of
arguments, which are discussed below.
The commenter proposed the removal of Xanthomonas oryzae based on
the assertion that Xanthomonas oryzae populations are adapted only to
local conditions and do not persist upon introduction to new
environments. Given that the major natural host for Xanthomonas oryzae
is rice, the commenter also compared cultivation practices utilized in
domestic commercial rice production with those utilized in Asian
commercial rice production. The commenter argued that domestic
commercial cultivation practices eliminate transmission of the pathogen
since rice seeds are directly planted whereas in Asia rice seedlings
are cultivated elsewhere and then transplanted, and wounds created
during such handling and transplant are important modes of transmission
for the pathogen to healthy seedlings. In addition, the commenter said
that domestic weather patterns are not conducive to dissemination and
that quarantines can prevent seed-borne disease. The commenter claimed
that field-to-field spread of Xanthomonas oryzae in Asia is largely
dependent on the strong winds and driving rains that occur frequently
during typhoon season.
We are making no changes to the regulations as a result of this
comment. Natural spread or persistence of the pathogen in a particular
location is not at issue; it is the risk of deliberate misuse leading
to the most significant potential for mass casualties or devastating
effects to the economy, critical infrastructure, or public confidence.
The issue of standard commercial planting practices for rice in a
domestic versus Asian setting is not relevant to the discussion of
Xanthomonas oryzae's potential for use as a biological weapon. APHIS
analyzed and assessed this pathogen using the criteria discussed
earlier in this document. Based on that analysis and assessment and the
knowledge that Xanthomonas oryzae has been modified for use as a
biological weapon in the past, it has been retained on the list of PPQ
select agents and toxins.
The commenter also stated that Xanthomonas oryzae should be
[[Page 61059]]
removed from the list of select agents and toxins because it is endemic
in the United States and any foreign strains introduced in the future
would prove unlikely to establish and spread.
While we disagree with the commenter's assertion regarding
Xanthomonas oryzae's pathogenicity, these arguments are unrelated to
the work of the select agent program as a whole as the select agent
regulations do not allow for the environmental release of listed agents
and toxins. Whether or not a given select agent or toxin is endemic in
the United States is not the only determining factor in the select
agent or toxin's inclusion on the list. The regulations govern use of
listed select agents and toxins in laboratory settings only. In this
regard, the case for maintaining Xanthomonas oryzae on the list of
those select agents and toxins whose deliberate misuse represents the
most significant potential for mass casualties or devastating effects
to the economy, critical infrastructure, or public confidence, is
compelling as work was done on Xanthomonas oryzae in the 1970s which
led to its classification as a bioterrorism agent by the security
community.
The list of PPQ select agents and toxins includes an entry for
Ralstonia solanacearum, race 3, biovar 2. While we did not propose any
changes to the entry for Ralstonia solanacearum, race 3, biovar 2, five
commenters stated that it should be removed from the list of select
agents and toxins.
The commenters argued that, based on the biological and historical
climate data for North America, Ralstonia solanacearum, race 3, biovar
2 does not have the potential to pose a severe threat to plant health
or plant products in the context of U.S. agriculture. The commenters
stated that Ralstonia solanacearum, race 3, biovar 2 is only a serious
problem in the developing world in those areas of cool highland tropics
where annual temperature profiles differ significantly from those found
in the major potato growing regions in the United States (i.e.,
Colorado, Idaho, Maine, Minnesota, North Dakota, and Wisconsin). The
commenters argued that, unlike the northern States, the cool highland
tropics experience few hard freezes and no long winters. Since, the
commenters claimed, epidemiological and laboratory research data show
that Ralstonia solanacearum, race 3, biovar 2 is intolerant of freezing
and freeze-thaw cycles and does not generally survive winters in
regions with sustained low temperatures, the bacterium is unlikely to
become established in the northern U.S. where potatoes are commercially
grown.
We disagree with the commenters' claim that Ralstonia solanacearum,
race 3, biovar 2 is only a serious pathogen in the developing world as
the bacterium has been shown to establish itself in northern Europe by
over-wintering in weeds, thereby posing a severe threat to Solanaceae
species (e.g., potato, eggplant, and tomato) in cool climates such as
those found both in northern Europe and North America. In addition, as
discussed earlier in this document, the evaluation process for select
agents includes broad criteria that not only focus on the biological
characteristics of a given pathogen, but also that pathogen's ability
to produce a devastating effect on the economy and the threat that
pathogen represents if it were to be used as a biological weapon. We
are making no changes as a result of these comments.
The commenters also stated that retaining Ralstonia solanacearum,
race 3, biovar 2 on the list of select agents and toxins would further
constrain research in the field of Ralstonia research. The commenters
attributed such listing with registration time for use, transfer, or
possession of select agents and toxins in excess of 18 months prior to
the initiation of research and difficulty in meeting the registration
requirements.
We are making no changes in response to these comments. While there
are added requirements concerning physical security, personnel
authorization, recordkeeping, biocontainment, and site inspections, we
do not believe these requirements will impede research as, in many
cases these regulations serve to codify systems and procedures already
in use by a majority of regulated entities. Further, entity
registration for use, transfer, or possession of select agents and
toxins does not take, nor has ever taken, 18 months. On average, new
entity registration takes 6 months from the date the request is
received by the select agent program and the issuance of the
registration certificate. The security risk assessment (SRA) takes less
than 45 days and runs parallel to the entity registration process.
These timeframes are all based on the assumption that the entity
registration submission and the SRA submission are complete and
accurate for select agent program review prior to the required on-site
inspection.
Commenters additionally stated that Ralstonia solanacearum, race 3,
biovar 2 should be removed from the list for the same reasons that were
cited for the proposed removal of Xylella fastidiosa, CVC strain.
We are making no changes as a result of these comments. The
decision to remove the CVC strain from the list of select agents and
toxins was based on the completion of extensive review and analysis of
the criteria for inclusion on the list. In particular, the creation of
detection methods and the use of geostatistical analysis with relation
to monitoring in order to facilitate a response to any purposeful
introduction are both key components in our decision to delist CVC. As
discussed earlier in this document, the evaluation process for select
agents includes a broad number of criteria that not only focus on the
biological characteristics of a given pathogen but also that pathogen's
ability to produce a devastating effect on the economy and the threat
that pathogen represents if it were to be used as a biological weapon.
Based on that analysis and assessment Ralstonia solanacearum, race 3,
biovar 2 will remain on the list of select agents and toxins.
Commenters said that eradicating Ralstonia solanacearum, race 3,
biovar 2 introduced into the United States through infected geraniums
cost commercial greenhouses and importers millions of dollars as a
direct result of its presence on the list of select agents and toxins.
We are making no changes as a result of these comments. The
presence of Ralstonia solanacearum, race 3, biovar 2 on the list of
select agents and toxins had no bearing on the eradication program
instituted by APHIS. The cost of this eradication program to commercial
greenhouses and importers was the same as the cost of eradicating any
other quarantine plant pathogen not known to be present in the United
States.
Identification of Strains
The list of VS select agents and toxins includes an entry for
virulent Newcastle disease virus. While we did not propose any changes
to the entry for virulent Newcastle disease virus, one commenter stated
that, by not considering all forms of Newcastle disease virus as select
agents, APHIS has created a period of uncertainty prior to the
completion of the sequencing necessary to identify whether a form of
Newcastle disease virus is virulent or not. The commenter requested
clarification as to whether laboratories would be required to treat
uncharacterized Newcastle disease virus as a select agent given this
uncertainty.
We agree with the commenter's point. We have therefore revised the
list of VS only select agents and toxins in order to list certain
select agents and toxins not by specific strains but by the generic
[[Page 61060]]
taxonomic classifications for those select agents. The specific VS only
select agents and toxins affected are: Avian influenza virus (highly
pathogenic), mycoplasma capricolum subspecies capripneumoniae
(contagious caprine pleuropneumonia), mycoplasma mycoides subspecies
mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia), and
virulent Newcastle disease virus, which we have altered to read avian
influenza virus, mycoplasma capricolum, mycoplasma mycoides, and
Newcastle disease virus, respectively. In order to capture the
applicable strains, subtypes, or pathogenicity levels we have also
added exemptions for those strains, subtypes, or pathogenicity levels
of certain select agents and toxins which are not considered to have
the potential to pose a severe threat to animal health or animal
products.
The list of overlap select agents and toxins contains an entry for
Venezuelan equine encephalitis. One commenter stated that, by not
considering all subtypes of Venezuelan equine encephalitis as select
agents, APHIS has created a period of uncertainty prior to the
completion of the typing necessary to identify whether a form of
Venezuelan equine encephalitis is among the subtypes classified by
APHIS as select agents. The commenter requested clarification as to
whether laboratories would be required to treat untyped Venezuelan
equine encephalitis as a select agent given this uncertainty.
We agree with the commenter's point. As stated previously, we have
therefore revised the list of overlap select agents and toxins in order
to list certain select agents and toxins not by specific strains but by
the generic taxonomic classifications for those select agents. The
specific overlap select agent is Venezuelan equine encephalitis virus:
Epizootic Subtypes IAB, IC, which we have altered to read Venezuelan
equine encephalitis virus. In order to capture the applicable strains,
subtypes, or pathogenicity levels we have also added exemptions for
those strains, subtypes, or pathogenicity levels of certain select
agents and toxins which are not considered to have the potential to
pose a severe threat to animal or human health or animal products. We
do note that we have specifically included Bacillus anthracis (Pasteur
strain) in the list of overlap select agents and toxins. This is
necessary in order to distinguish this strain, which we do not consider
to be a Tier 1 select agent, from all other strains of Bacillus
anthracis, which are classified as Tier 1 select agents.
Although we did not receive any comments on this issue as it
concerns PPQ only select agents and toxins, in order to strengthen the
regulations as discussed previously as well as to maintain parity
between the VS and PPQ regulations, we are revising the list of PPQ
only select agents and toxins in order to list certain select agents
and toxins not by specific strains but by the generic taxonomic
classifications for those select agents. The specific PPQ only select
agents and toxins affected are: Ralstonia solanacearum, race 3, biovar
2 and Sclerophthora rayssiae var. zeae which we have altered to read
Ralstonia solanacearum and Sclerophthora rayssiae, respectively. In
order to capture the applicable strains, subtypes, or pathogenicity
levels we have also added exemptions for those strains, subtypes, or
pathogenicity levels of certain select agents and toxins which are not
considered to have the potential to pose a severe threat to plant
health or plant products.
With the changes described above, we clearly establish that when an
agent or toxin is initially identified to a taxonomic level, in the
case of an agent, or by its toxicological properties, in the case of a
toxin, it is regulated under the select agent regulations until further
testing is accomplished to exclude the particular agent by strain,
subtype, pathogenicity levels, or a particular toxin by properties. We
believe it is important that laboratories treat these agents as select
agents until further testing can be conducted to verify whether the
agent is of a strain, subtype, or pathogenicity level that presents a
higher level of danger to animal health and safety. These changes will
not have any impact on the exemption for diagnostic laboratories or
alter the process of receiving diagnostic samples and forwarding any
potentially identified select agents for further testing. They also do
not change the reporting criteria for those agents confirmed to be
select agents. Finally, they do not change the current lists of select
agents and toxins but alters the fashion in which select agents and
toxins are listed with specific exemptions included to ensure that
appropriate verification of the agents by strains, subtypes, or
pathogenicity level occurs.
VS Select Agents and Toxins
We proposed to remove nine VS select agents and toxins from the
list set out in Sec. 121.3(b). Specifically, we proposed to remove the
following: Akabane virus; Bluetongue virus (exotic), Bovine spongiform
encephalopathy agent; Camel pox virus; Ehrlichia ruminantium
(Heartwater); Japanese encephalitis virus; Malignant catarrhal fever
virus (Alcelaphine herpesvirus type 1); Menangle virus; and Vesicular
stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3.
One commenter recommended that we exclude the Texas GB strain of
Newcastle disease virus from select agent status. The commenter stated
that the exclusion is warranted since, although Newcastle disease virus
is widespread in the environment, there is little illness if a flock is
exposed because nearly all commercial poultry is vaccinated against the
disease. The commenter observed that the Texas GB strain of Newcastle
disease virus is used by vaccine manufacturers as the challenge
organism to verify the potency of Newcastle disease virus vaccines and
this fact gives poultry producers a high degree of assurance that their
flocks are protected against the Texas GB strain. Given these factors,
the commenter concluded that the Texas GB strain is not a biosecurity
threat to the domestic poultry industry, and the strain should be
excluded from APHIS's definition of virulent Newcastle disease virus.
We are making no change in this final rule as a result of this
comment. Texas GB strain of Newcastle disease virus is a highly
virulent form of Newcastle disease virus and, as such, is appropriately
included in the general category of ``virulent Newcastle disease
virus.'' While vaccine manufacturers do use the Texas GB strain of
Newcastle disease virus as a challenge organism for Newcastle disease
virus vaccines, this is on account of its high level of virulence. A
vaccine effective against the Texas GB strain of Newcastle disease
virus can therefore be assumed to be effective against less virulent
forms of Newcastle disease virus.
The list of VS select agents and toxins includes an entry for avian
influenza virus (highly pathogenic) (HPAI). While we did not propose
any changes to the entry for HPAI, one commenter proposed that we
change the guidance by which influenza strains are categorized as HPAI.
The commenter argued that extensive evidence has been obtained to
support the conclusion that, while the HA polybasic cleavage site is
the primary determinant for HPAI strains, strains with removed HA
polybasic cleavage sites have been created, tested, and ultimately
excluded from select agent status. The commenter stated that, as a
result of these experiments and history, APHIS should specify that
avian influenza strains without the HA polybasic cleavage site are not
HPAI viruses and, therefore, not subject to the select agent
regulations.
[[Page 61061]]
The commenter further argued that continuing to consider strains of
avian influenza with removed HA polybasic cleavage sites as select
agents until such time as an exclusion is granted would impede vaccine
availability in the event of an HPAI pandemic in either the human or
avian population. The commenter stated that the lead candidates for the
seed viruses that would be used to make vaccines against HPAI viruses
during such an event will likely be attenuated strains with mutated
polybasic cleavage sites. The commenter stated that the current process
by which avian influenza strains that lack the polybasic cleavage site
are granted exclusions takes weeks or months, an untenable timeline in
the event of an HPAI pandemic.
We are making no changes in response to this comment. APHIS
standards are based on existing internationally recognized requirements
established by the World Animal Health Organization (OIE). In the event
of a future HPAI pandemic such as the one described by the commenter,
APHIS would work in conjunction with HHS to address any vaccine
availability issues. Finally, attenuated strains of select agents
officially approved for human vaccination purposes by the Food and Drug
Administration (FDA) or other recognized national or international
organizations continue to be exempt from the select agent regulations
as specified by the regulations in Sec. 121.5(c) and (d).
Overlap Select Agents and Toxins
We proposed to modify the list of overlap select agents and toxins
by removing certain subtypes of Venezuelan equine encephalitis virus
from the list of overlap select agents and toxins set out in 9 CFR
121.4(b), and to clarify that only Venezuelan equine encephalitis
subtypes IAB and IC would remain on the list. These subtypes contain
the only recognized strains of Venezuelan equine encephalitis that can
suddenly affect a large number of animals over a large area (i.e.,
epizootic). The remaining subtypes, ID and IE, are strains prevalent
among existing animal populations (i.e., enzootic) and do not represent
the same type of risk. Other viruses within the Venezuelan equine
encephalitis complex (subtypes IF and II through IV) are separate
viruses and are not included in the list of overlap select agents and
toxins.
Another commenter recommended that we remove Venezuelan equine
encephalitis strain 3014 from the list of select agents and toxins. The
commenter argued that, although strain 3014 was derived from a 1AB
isolate, this molecularly cloned strain has properties that render it
incapable of causing epizootic or epidemic transmission. The commenter
stated that mutations selected after only a handful of passages make
the virus avirulent in adult mice and dramatically increases its
clearance from the bloodstream of mice following intravenous
inoculation. Further, the vanishingly low titers of strain 3014 consist
of envelope glycoprotein gene mutations, which allow the strain to bind
heparin sulfate; such binding is also associated with the attenuated
phenotype of Venezuelan equine encephalitis strain TC-83, which is also
derived from the 1AB Trinidad donkey strain by passage in culture that
has already been excluded from select agent status.
We are making no changes as a result of this comment. Since
Venezuelan equine encephalitis strain 3014 is derived from a listed
overlap select agent, the commenter's proposal for its removal is more
appropriately addressed via the exclusion process for overlap select
agents and toxins as detailed in 9 CFR 121.6. We have contacted the
commenter and provided guidance regarding how they may initiate this
process.
We proposed to designate Bacillus anthracis as a Tier 1 select
agent. A number of commenters objected to such a blanket designation,
arguing instead that the Bacillus anthracis Pasteur strain should be
exempted from consideration both as a Tier 1 select agent and as a
select agent in general.
One commenter argued that given the fact that Laboratory Response
Network (LRN) laboratories maintain live cultures of non-pathogenic
Bacillus anthracis Pasteur strain for use in quality control testing,
designation of Bacillus anthracis as a Tier 1 select agent therefore
has the potential to impact the willingness or ability of LRN
laboratories to maintain inventories of Bacillus anthracis Pasteur
strain due to the regulatory and financial burdens associated with
possession of Tier 1 select agents and toxins. The commenter went on to
state that this situation could potentially impact national health and
safety given that the potential use of Bacillus anthracis spores as a
bioweapon remains a viable threat and increased burdens, particularly
on small laboratories, could lead to the overall decrease in the number
of laboratories that would otherwise serve to ensure that the LRN has
sufficient capacity to detect and respond to a deliberate release of
Bacillus anthracis.
Three commenters stated that the Bacillus anthracis Pasteur strain
is analogous to the Bacillus anthracis Sterne strain, which is excluded
since it was determined not to pose a severe threat to public health
and safety, animal health, or animal products. The commenter argued
that Bacillus anthracis Pasteur strain should not be considered as a
select agent given that the only way to create an agent that poses a
severe threat would be via combination of the Pasteur strain with a
non-regulated strain. The commenter pointed out that other agents that
pose little harm individually, but could be modified genetically to
become harmful are not included on the select agent list because of
this potential threat.
Another commenter claimed that the designation of Bacillus
anthracis Pasteur strain as a select agent would not serve to prevent
an authorized person from intentionally or accidentally facilitating
the combination of plasmids from Sterne and Pasteur types of strains to
create a wild type phenotype. The commenter stated that combination of
these two strains can be accomplished no matter what sort of physical
security may be employed to prevent access, theft, loss, or release of
the agent. The commenter concluded that more effective preventive
measures can be achieved through training and educating microbiologists
on how to avoid accidentally combining these two strains and by
penalizing any individuals who intentionally try to combine them.
We agree with the commenters that Bacillus anthracis Pasteur strain
is attenuated and poses a significantly lower risk than wild type
Bacillus anthracis strains. We also agree that the Pasteur strain is
not likely to have the potential for mass casualties or devastating
effects to the economy, critical infrastructure, or public confidence
and therefore does not meet the criteria used to apply the Tier 1
designation. In addition, we note that the Pasteur strain has been used
successfully as a veterinary and human vaccine, which further
demonstrates the attenuation of this strain. Therefore we have
determined that the Bacillus anthracis Pasteur strain should not be
designated as a Tier 1 select agent.
While we agree that the Bacillus anthracis Pasteur strain does not
meet the criteria for inclusion as a Tier 1 select agent, we do not
agree with the argument that regulating the Bacillus anthracis Pasteur
strain would not serve to prevent the accidental (or intentional)
generation of a wild type Bacillus anthracis strain by the combination
of the Bacillus anthracis Pasteur strain with the Bacillus anthracis
pXO1+/pXO2- Sterne strain. Retaining the
[[Page 61062]]
Bacillus anthracis Pasteur strain as a select agent will allow for
continued oversight of laboratories in which the accidental (or
intentional) combination of this strain with the Bacillus anthracis
Sterne strain could occur to produce the wild type phenotype of
Bacillus anthracis de novo. Failure to retain the Bacillus anthracis
Pasteur strain as a select agent could result in an environment in
which the probability of creation of virulent wild type Bacillus
anthracis strains by the combination of non-regulated strains would be
enhanced. Therefore, we have chosen not to exclude the Bacillus
anthracis Pasteur strain from the list of select agents in this
rulemaking. We will continue to evaluate exclusion requests as
additional information becomes available in this area.
As explained above under the heading ``VS Select Agents and
Toxins,'' avian influenza virus (highly pathogenic) is currently on the
list of VS only select agents and toxins. One commenter recommended
that, in light of recent studies whereby researchers have generated
derivatives of influenza virus A (H5N1) capable of efficient aerosol
transmission, we add ``Replication competent forms of influenza virus A
(H5N1) capable of efficient aerosol transmission in ferrets or primates
containing any portion of the coding regions of all eight gene segments
[influenza virus A (H5N1) capable of efficient aerosol transmission in
ferrets or primates]'' to the list of overlap select agents and toxins.
The commenter also recommended that this type of avian influenza virus
be classified as a Tier 1 agent given the historical 50 percent case-
fatality rate of avian influenza virus A (H5N1) in humans.
The select agent program is currently in discussions regarding this
issue and may address it in future rulemaking. Given the stage these
discussions are in, however, we are not making any changes in this
final rule based on this comment.
Reorganization of the Current List of Select Agents and Toxins
We proposed to establish a number of select agents and toxins as
``Tier 1'' select agents and toxins within the lists of VS and overlap
select agents and toxins. Specifically, we proposed to list foot-and-
mouth disease (FMD) virus and rinderpest virus as Tier 1 VS select
agents and toxins and Bacillus anthracis, Burkholderia mallei, and
Burkholderia pseudomallei as Tier 1 overlap select agents and toxins.
We did not include PPQ select agents and toxins in this proposed
reorganization because none of the PPQ select agents and toxins met the
minimum criteria for inclusion on the proposed Tier 1 select agents and
toxins list. All other select agents and toxins would continue to be
subject to the current requirements concerning select agents and
toxins.
One commenter argued that Burkholderia mallei and Burkholderia
pseudomallei should not be classified as Tier 1 select agents. The
commenter stated that these two select agents do not represent the same
level of concern as the other select agents proposed for inclusion in
Tier 1 and should therefore be assigned non-Tier 1 status.
Another commenter observed that Bacillus anthracis is less virulent
than either Yersinia pestis or Francisella tularensis, which are on the
list of HHS only select agents and toxins. The commenter additionally
stated that the virulence of all three is far less than that of the
hemorrhagic fever viruses and the encephalitis viruses that were not
proposed for inclusion on the list of Tier 1 select agents and toxins.
The commenter stated that significant advances have been made in the
development of products for environmental decontamination and
prophylaxis against inhalation of Bacillus anthracis.
We are making no changes to the regulations as a result of these
comments. The process by which we determined which select agents and
toxins should be designated as Tier 1 was multi-faceted and we are
confident in the results of that process. Our determinations were not
based on one aspect of each of the proposed select agents or toxins
only. In order to determine which select agents and toxins should be
given Tier 1 status, a two-part risk analysis was conducted on each.
First, experts in the biology of these agents and toxins evaluated
their potential for mass casualties or devastating effects to the
economy, critical infrastructure, or public confidence. This process
included assessments of morbidity and mortality, communicability, low
infectious dose, availability of countermeasures, and economic impact
of a potential attack. Second, each select agent and toxin was assessed
for its risk of deliberate misuse, including its history of
weaponization and/or known interest by State or non-State adversaries.
These evaluations, combined with input from public comments received on
our July 2010 ANPR and relevant findings in recent government and non-
government reports, formed the basis for deliberations on which agents
should constitute the Tier list. Agents that scored highly on both the
public health and biothreat sets of criteria were judged to be those
that were appropriately given a Tier 1 designation.
Two commenters pointed out that the categorization of select agents
and toxins has already been carefully stratified into four biological
safety levels (BSL) as specified by the CDC, with each BSL based on
infectivity, virulence, and ease of transmission of the material in
question. The commenters further observed that the Tier 1 designation
implies the existence of a Tier 2 category which would require less
attention to security. The commenters concluded that the process of
tiering will only add confusion and administrative and financial burden
to the current BSL grouping of select agents and toxins.
Two additional commenters stated that the proposed rule did not do
enough to reduce the regulatory burden associated with non-Tier 1
agents. The commenters said that reduced levels of security
requirements for personnel and facilities should be considered for non-
Tier 1 agents.
In designating certain select agents and toxins as ``Tier 1,'' the
select agent program considered and rejected the idea of designating
the remaining select agents and toxins as ``Tier 2.'' The aim of
establishing the Tier 1 category is to account for and respond to the
particular risks associated with the agents and toxins in this category
by increasing their handling and security requirements accordingly. The
establishment of the Tier 1 category is in no way intended to imply
that the non-Tier 1 select agents and toxins pose a lesser risk to
public health and safety than they have previously. In accordance with
that fact, we have not decreased the handling and security requirements
for those non-Tier 1 agents. Biosafety levels describe the required
combination of lab practices and techniques, safety equipment, and lab
facilities appropriate for the operations being performed using
potentially harmful materials such as select agents and toxins while
the Tier 1 designation institutes security measures applicable to the
agents and toxins themselves. For this reason there is no conflict that
exists between BSL classifications and Tier 1 select agents and toxins.
Two commenters expressed concern regarding the proposal to list
rinderpest virus as a Tier 1 agent, given that there are already
special conditions in place as contained in Sec. Sec. 121.3(f)(3)(i),
121.5(a)(3)(i), and 121.9(c)(1) concerning its handling and tracking.
The commenters suggested that an alternative approach would be for
APHIS to designate rinderpest virus as
[[Page 61063]]
a pathogen with very special handling requirements that is not
considered to be part of either category of select agents. The
commenters argued that this approach is justified due to the fact that
rinderpest has now been officially eradicated worldwide.
We disagree with the commenters' suggestion to classify rinderpest
virus as a separate type of agent apart from either of the select agent
categories of designation. While it is true that rinderpest was
declared to be officially eradicated by the OIE on May 25, 2011, this
development does not render the disease any less of a concern as a
select agent with potential for misuse. Enacting the suggestion that
rinderpest virus be treated as a pathogen with ``very special handling
requirements'' and not as either a Tier 1 or non-Tier 1 select agent
would only serve to create a further level of required administrative
oversight for regulated entities.
One commenter stated that the proposed tiering system poses
significant questions as to the nature of the risk assessment process.
Specifically, the commenter questioned listing as Tier 1 agents
bacterial diseases that are treated with licensed antibiotics, that are
not commonly spread person to person, and that are present in the
environment of the United States, while viruses that have no known
therapy and that pose extreme risk to Western populations are absent.
The commenter further stated that the 20 criteria used for evaluation
of each select agent and toxin should be made available to the
regulated community for review and assessment.
We are making no changes as a result of this comment. The relative
ease by which exposure to a select agent or toxin may be treated is
only one aspect considered by the select agent program when determining
the tier status of each. The 20 criteria referenced by the commenter
are those employed by the Federal Experts Security Advisory Panel
(FESAP) in providing recommendations to the select agent program. The
criteria that the FESAP used in its risk assessment process are:
1. The relative ease with which a select agent or toxin might be
acquired from a laboratory or commercial source;
2. The relative ease of production of a select agent or toxin;
3. The relative ease by which a select agent or toxin might be
modified in order to enhance its pathogenicity, transmissibility, or
ability to evade medical and non-medical countermeasures;
4. The potential for easy deliberate dissemination;
5. The potential for creating disease or illness;
6. The relative environmental stability of a select agent or toxin
by itself and how well it survives in the environment in which it is
formulated or disseminated;
7. The amount of select agent or toxin necessary to induce illness;
8. The relative ease with which a particular select agent or toxin
might be disseminated or transmitted from one animal or person to
another or into the environment where it could produce a deleterious
effect upon animal, plant, or human health;
9. Whether the target population has innate immunity to the select
agent or toxin or whether immunity has been acquired from a source such
as vaccines;
10. The potential for the select agent or toxin to create morbidity
(i.e., any non-fatal illness that renders partial dysfunction to an
animal or human lasting weeks or months that will eventually resolve
with medical, veterinary, and/or supportive care);
11. The burden placed on the human, veterinary, or plant health
system by the deliberate release of the select agent or toxin;
12. The ability to detect a release of the select agent or toxin
into the environment, food, water, or soil;
13. The ability of the human and agricultural health authorities to
accurately and rapidly diagnose and treat the disease presented by a
release of the select agent or toxin;
14. The existence of countermeasures to prevent, treat, or mitigate
the symptoms of a disease caused by the release of a select agent or
toxin and/or its spread through a population;
15. The potential for high animal, plant, or human mortality rates
with delivery of medical countermeasures;
16. The potential for high animal, plant, or human mortality rates
without delivery of medical countermeasures;
17. The short-term economic impact of a single outbreak of a
disease or release of a toxin;
18. The human, monetary, and other resource costs of making an
area, building, industrial plant, farm, or field safe for humans,
animals or plants to inhabit following the release of the select agent
or toxin;
19. The pathogen's ability to persist in the environment or to find
a reservoir that makes its recurrence more likely; and
20. The long-term health or economic consequences caused by a
single release of the select agent or toxin.
We believe that the process by which determinations were made
regarding the Tier 1 or non-Tier 1 status of the select agents and
toxins was responsive to regulated community concerns received during
the comment period for the advance notice of proposed rulemaking as
well as for the proposed rule.
One commenter asked why the requirements for working with plant
pathogens had not been lessened. The commenter stated that a
transparent process does not exist that is inclusive of expert opinion
from both the private and public sectors to determine which agents
should be removed or added to the list of select agents and toxins.
We are making no changes as a result of this comment. In creating
the Tier 1 class of agents, the Select Agent Program considered and
rejected the idea of designating the remaining agents as ``Tier 2.''
The aim of establishing the Tier 1 category is to account for and
respond to the particular risks associated with the agents and toxins
in this category by increasing their handling and security requirements
accordingly. The establishment of the Tier 1 category is in no way
intended to imply that the non-Tier 1 agents pose a lesser risk to
public health and safety than they have previously. In accordance with
that fact, we have not decreased the handling and security requirements
for those non-Tier 1 agents. Further, we determined that the
establishment of more varying levels of risk would serve to create the
need for increased administrative oversight and complication for
regulated entities. We believe that the process by which these
determinations were made was sensitive to public and expert opinion via
the comment period on the initial advance notice of proposed rulemaking
as well as on the proposed rule.
Security Measures for Tier 1 Select Agents or Toxins
We also proposed additions to the VS regulations that would allow
for the optimization of security measures for those select agents or
toxins that are designated as Tier 1. These requirements included:
Additions regarding the assessment of persons prior to
their access to Tier 1 select agents and toxins that would be made to
the security plan currently required to be developed by all entities
seeking approval for the possession, use, and transfer of select agents
and toxins; ongoing oversight of those persons with access to Tier 1
select agents and toxins; and the role of the entity's responsible
official in coordinating and assuring the security of Tier 1 select
agents and toxins;
Security enhancements that include provisions for security
barriers, intrusion detection and monitoring,
[[Page 61064]]
delay/response force, access control, and information security;
Additions to the biosafety plan currently required to be
developed by all entities seeking approval for the possession, use, and
transfer of select agents and toxins that would describe implementation
of an occupational health program for individuals with access to Tier 1
select agents and toxins;
Development of security policies and procedures describing
the entity's response to a failure of an intrusion detection or alarm
system and notification procedures for the Federal Bureau of
Investigation (FBI) in the event of theft or suspicious activity that
may be criminal in nature involving a Tier 1 select agent or toxin.
These policies and procedures would be required as part of the entity's
incident response plan; and
Required annual insider threat awareness briefings focused
on how to identify and report suspicious behaviors.
We have made changes to some of these proposed requirements, which
are discussed in detail below.
Many commenters had questions or concerns regarding the additions
to the security plan for those entities possessing a Tier 1 select
agent or toxin as proposed in 9 CFR 121.11(e). Specific issues
addressed by the commenters included: Conduct of pre-access suitability
assessments, ongoing suitability assessments, and self- and peer-
reporting of incidents or conditions that could affect an individual's
ability to safely have access to or work with select agents and toxins.
Commenters generally fell into two categories in their responses to the
proposed additions: Some felt that the requirements were too vague to
prove useful, creating administrative burden without improving the
overall security of Tier 1 select agents and toxins, while others felt
that the requirements could or would require entities to behave in a
manner contrary to local laws, privacy laws, or union contracts.
For the most part, we anticipate that these requirements are
already being met and that these regulations will merely require those
entities possessing a Tier 1 select agent or toxin to codify and
document the systems and processes currently in place. It should be
noted that many of the specific concerns raised by commenters regarding
potential violation of laws or union contracts arose as a result of the
commenters' examination of those recommendations given to the select
agent program by the FESAP. As a matter of clarification, the select
agent program considered the FESAP recommendations, as well as
recommendations from other sources (e.g., National Science Advisory
Board for Biosecurity), in developing the proposed rule and suitability
assessment guidance documents; however, we are not adopting all of the
specific recommendations found in these studies. While we have created
specific guidance to aid in compliance with this section of the revised
regulations, we are deliberately leaving the regulatory text in its
broadly-written state in order to allow entities a measure of
flexibility in how they meet the requirements. Given our experience
with the select agent and toxin regulations and the wide variety of
regulated entities the regulations cover, we have found this to be the
most effective approach. The guidance document developed in conjunction
with this rule is, in part, a response to the questions and issues
raised by the commenters. Issues addressed in this document include,
but are not limited to:
Understanding the risks and reasons for suitability
assessments;
Delineating the roles and responsibilities of individuals
to ensure optimal security;
Requesting information about individuals in a standardized
manner and assessing individuals in the context of safety and security;
Responding to reports in a consistent, prompt, and
confidential manner; and
Providing training for recognizing and reporting
suspicious behavior.
Full guidance on this and other issues may be found on the National
Select Agent Registry at www.selectagents.gov.
In 9 CFR 121.11(e)(4)(i), we proposed that regulated entities with
Tier 1 select agents and toxins prescribe and/or implement ``procedures
that limit access to registered space only to those approved by the HHS
Secretary or the Administrator and meet the criteria of the entity's
program that will ensure individuals with access approval to select
agents and toxins are trustworthy and behaving in a manner that upholds
public health and safety, the protection of animal or plant health and
animal or plant products, security, and the integrity of the scientific
enterprise.'' We are making a minor change to the proposed language in
9 CFR 121.11(e)(4) in order to stipulate that entities must implement
these security enhancements, not merely prescribe and/or implement
them. The proposed rule stated that ``Entities with Tier 1 select
agents and toxins must prescribe and/or implement the following
security enhancements.'' We are removing the words ``prescribe and/or''
for the purposes of clarity. Our original intent in creating that
provision was to require the use of the security enhancements in
question by those entities with Tier 1 select agents or toxins. By
removing the words ``prescribe and/or'' we are eliminating a potential
loophole by which entities may have been able to establish but not
fulfill these requirements while remaining in compliance with the
regulations.
Regarding the proposed language in 9 CFR 121.11(e)(4)(i), one
commenter stated that the use of the phrase ``trustworthy and behaving
in a manner that upholds public health and safety, the protection of
animal or plant health and animal or plant products, security, and the
integrity of the scientific enterprise'' would establish a regulatory
standard that would prove difficult or impossible to enforce due to its
subjective nature.
We agree with the commenter's observation and have changed the
language to require that entities possessing Tier 1 select agents or
toxins prescribe and implement ``procedures that will limit access to a
Tier 1 select agent or toxin to only those individuals who are approved
by the HHS Secretary or Administrator, following a security risk
assessment by the Attorney General, have had an entity-conducted pre-
access suitability assessment, and are subject to the entity's
procedures for ongoing suitability assessment.'' We believe that this
establishes a more specific set of requirements for regulated entities.
In 9 CFR 121.11(e)(4)(iv) we proposed that regulated entities with
Tier 1 select agents and toxins establish a minimum of three barriers
where each subsequent barrier is different and adds to the delay in
reaching secured areas where select agents and toxins are used or
stored. Barriers would be required to be monitored in such a way as to
detect and assess intentional and unintentional circumventing of
established access control measures under all conditions (day/night,
severe weather, etc.) Two commenters requested clarification regarding
what was meant by the term ``barrier'' and asked for examples of what
constitutes a barrier. The commenters suggested that a definition for
``barrier'' be added to the definitions sections in 7 CFR 331.1 and 9
CFR 121.1.
We agree with the commenters and we have added a definition for
security barrier to read as follows: ``A physical structure that is
designed to prevent entry by unauthorized persons, animals, or
materials.'' In addition, we have altered the language concerning
security
[[Page 61065]]
barriers in 9 CFR 121.11(f)(4)(iv) in order to clearly indicate that
the final security barrier must limit access to the select agent or
toxin to personnel approved by the HHS Secretary or Administrator and
following a security risk assessment by the Attorney General.
In 9 CFR 121.11(e)(4)(v), we proposed that all registered space and
areas that reasonably afford access to the registered space must be
protected by an intrusion detection system (IDS) unless physically
occupied. One commenter stated that the proposed requirement contained
a potential loophole by which an entity could argue that the presence
of a janitor or similar personnel in registered space outside of normal
working hours would allow that entity to avoid installation of an IDS.
The commenter suggested that such a situation could be avoided by
adding a stipulation that an IDS would need to be used when the entity
was not ``physically occupied by the routine contingent of working,
approved employees.''
We disagree with the commenter's observation as it is unlikely that
the entity would be occupied at all hours, thus creating the loophole
that would allow an entity to fail to install an IDS. We are also not
adopting the commenter's suggestion to add language regarding the
presence of approved employees as we believe that would create
confusion concerning the number of employees that could be described as
``the routine contingent.'' Further, the IDS is one aspect of the
security measures required for regulated entities. In the scenario
proposed by the commenter, the IDS would not be engaged if a janitor or
other personnel were present in the entity outside of normal working
hours; however, the other required physical security measures would
serve to protect the entity at that time. Finally, the training and
employee suitability assessments required for those employees with
access to select agents and toxins would also serve to ensure that
those employees who work in registered areas understand and can employ
the necessary security and safeguarding measures to maintain the
physical security of the entity.
In 9 CFR 121.11(e)(4)(vii), we proposed to require that entities
provide backup power and energy sources to ensure that information
security networks and integrated access controls and related systems
will maintain power during emergencies. While we did not receive any
comments on this issue, in response to comments received by CDC and in
the interests of maintaining parity between the APHIS and HHS
regulations, we are amending the text to stipulate that only those
entities with powered access control systems will need to fulfill this
requirement. We have also reworded the requirement to clarify that the
aim is maintenance of physical security standards in the case of a
power disruption and that this maintenance may, among the alternatives,
take the form of backup power.
In 9 CFR 121.11(e)(4)(viii) we proposed that response time for
security forces or local police must not exceed 15 minutes from the
time of an intrusion alarm or report of a security incident for any
entity with Tier 1 select agents and toxins. One commenter stated that
such a requirement would be burdensome, unattainable, and cost-
prohibitive depending upon the number and nature of the alarms. The
commenter went on to state that the security system at their entity
sounds an alarm when a door is held open longer than a preset length of
time and that most alarms occur during working hours, primarily as the
result of staff holding the door open too long. The commenter explained
that requiring security respond to all these alarms is unwarranted,
excessive, and costly. The commenter suggested that a better
alternative would be for a laboratory supervisor or manager to be
notified of and investigate these incidents, therefore allowing
entities to respond in a manner commensurate with the severity of the
incident that triggered the alarm.
Our selection of the 15 minute response time is based on Department
of Defense (DOD) and DHS standards for high value assets and also on
our analysis of incident response plans provided by the regulated
community since 2003. However, based on this comment and others
received by CDC, we have modified the language in this section. We have
retained the 15 minute response time goal for security forces or local
police, but we have also provided additional flexibility for entities
to develop systems in line with the optimal achievable response time in
their area. Entities may either incorporate the 15 minute response time
into their security plans or determine an alternate response time
calculated in conjunction with security forces or local police.
Response time can be determined many ways. For example, an entity can:
Enter into a formal agreement with local law enforcement.
Discuss with local law enforcement.
Discuss with the IDS service provider.
Conduct an exercise with the guard force.
The issue of multiple false alarms and the potential costs associated
with such a situation as raised by the commenter is more appropriately
addressed at the entity level.
In 9 CFR 121.11(e)(4)(ix) we proposed to require that entities
conduct complete inventory audits of all Tier 1 select agents and
toxins in long-term storage upon the physical relocation of a
collection or inventory of select agents or toxins for those Tier 1
select agents or toxins in the collection or inventory, upon the
departure or arrival of a principal investigator for those Tier 1
select agents or toxins under the control of that principal
investigator, or in the event of a theft or loss of a Tier 1 select
agent or toxin.
We have reevaluated this provision in light of comments received on
the CDC rule and, based on our experience with the select agent
program, we believe that this requirement needs to be applied to all
select agents and toxins, and not only Tier 1 select agents and toxins.
This change serves to codify our current policy concerning inventory
audits. We have therefore revised the language to address inventory
verification for all select agents and toxins.
In the case of those entities which possess FMD and rinderpest
virus, we proposed to require four barriers, including one barrier that
is a perimeter security fence or equivalent. These requirements were
listed in proposed 9 CFR 121.11(e)(5)(i). One commenter inquired as to
what the equivalent to a perimeter security fence would be. The
commenter also wished to know if an IDS would be considered a barrier.
One equivalent to a perimeter security fence would be a perimeter
wall surrounding a specific building, complex, compound, or campus,
with 24 hour a day, 7 days a week monitoring. Such a wall would serve a
purpose identical to a perimeter security fence. We have developed
guidance to assist entities with the security barrier requirement,
which covers the issue of perimeter fencing. Guidance documents may be
found on National Select Agent Registry at www.selectagents.gov. As to
the commenter's question regarding the IDS: As stated above, a security
barrier would include only natural or man-made obstacles preventing or
delaying the movement of persons, animals, or materials. While an IDS
may alert security or other personnel to potential incidents, the IDS
itself would not be considered to be a security barrier since it does
not actively create an obstacle or delay.
Another commenter asked whether the proposed requirements would
make it illegal for U.S. veterinary diagnostic
[[Page 61066]]
laboratories to perform diagnostic and/or surveillance testing
following an FMD outbreak on U.S. soil if the laboratories in question
did not have a fourth security barrier. The commenter recommended that
we revise the paragraph in order to clarify our intent.
We are making no changes as a result of this comment. The select
agent program recognizes the critical role of diagnostic laboratories
in the early detection of and response to outbreaks of select agent and
toxin-related disease in humans and agriculture. While all of the Tier
1 regulatory requirements will apply to entities that maintain
permanent stocks of Tier 1 select agents and toxins, in the case of a
public health or agricultural emergency, a diagnostic laboratory may
request to retain the select agent or toxin under the provisions
contained in 9 CFR 121.6(e).
Two commenters recommended that the select agent program consult
with administrators and laboratory managers from public and private
research institutions prior to the development of any framework of
suitability that can be used to address security concerns.
We will engage subject matter experts as necessary in the
development of guidance documents which may be found on the National
Select Agent Registry at www.selectagents.gov. The select agent program
welcomes feedback on the usability and usefulness of existing guidance
documents at any time.
One commenter suggested that the minimum security provisions for
Tier 1 select agents and toxins should include video monitoring of all
select agents and toxins work and storage areas, a two-person rule for
entry into select agents and toxins work and storage areas, and
psychological assessment and monitoring of those employees working with
select agents and toxins.
We are making no changes as a result of this comment. The specific
measures the commenter suggested were considered and rejected in favor
of the more general requirements listed. The select agent program is
highly conscious of the need to balance biosecurity and biocontainment
concerns with allowing entities the necessary flexibility so as to not
impede their research unduly. Since there is variety in the type and
size of entities covered under the regulations, we believe this
approach is warranted. We would note that the regulations do not
preclude any given entity from adopting the approach suggested by the
commenter, among others.
One commenter stated that, while many of the proposed security
changes are already in place, some are not and it was unclear that
additional costly or impractical security measures would provide any
additional benefit since existing measures have proven adequate to
protect the security of these agents.
We are making no changes as a result of this comment. It was our
determination, based on the information available to us, that the
additional security requirements would not constitute an economic
burden on the regulated entities. In many cases these regulations serve
to codify systems and procedures already in use in these regulated
entities.
The regulations in 9 CFR 121.12 concern the development of a
biosafety plan that establishes measures sufficient to contain the
select agent or toxin (e.g., physical structure and features of the
entity, and operational and procedural safeguards). We proposed to add
a paragraph that would stipulate that entities registered to possess
Tier 1 select agents or toxins establish an occupational health program
for individuals with access to Tier 1 select agents and toxins. One
commenter recommended that the occupational health program requirements
be instituted for all select agents and toxins, regardless of their
categorization.
We are making no changes in response to this comment. Due to the
greater level of concern associated with Tier 1 select agents and
toxins the select agent program needs to ensure that entity safety
protocols are in place. Further, after considering the issue and in
light of the fact that it caused confusion amongst some commenters on
the CDC proposed rule, we are eliminating the sentence that reads,
``The occupational health program may also be made available to
individuals without access to Tier 1 select agents and toxins.'' While
we believe that regulated entities should use their discretion and
judgment in considering whether the creation of an occupational health
program applicable to those employees working with non-Tier 1 select
agents and toxins is needed, such a suggestion is not appropriately
contained in the regulations. Guidance on the development of an
occupational health program may be found on the National Select Agent
Registry at www.selectagents.gov.
The regulations in 9 CFR 121.15 concern required mandatory training
for staff and visitors who work in or visit areas where select agents
or toxins are handled or stored. In 9 CFR 121.15(b), we proposed to add
a requirement that entities with Tier 1 select agents and toxins must
conduct annual insider threat awareness briefings on how to identify
and report suspicious behaviors. One commenter stated that this
training should be required for all registered entities possessing,
storing, or transferring select agents, not just those with Tier 1
select agents or toxins.
We are making no changes in response to this comment. Due to the
greater level of concern associated with Tier 1 select agents and
toxins the select agent program needs to ensure that entity safety
protocols are in place. Regulated entities should use their discretion
and judgment in considering whether the creation of an annual insider
threat awareness training program applicable to those employees working
with non-Tier 1 select agents and toxins is needed. Guidance on the
development of annual insider threat awareness training may be found on
the National Select Agent Registry at www.selectagents.gov.
Another commenter asked for clarification and guidance regarding
the requirement for annual insider threat awareness briefings. The
commenter asked that the content of these threat awareness briefings be
made available to public health laboratories so that it could then be
specifically customized for various regions of the country.
While we have created specific guidance regarding this section of
the revised regulations, that guidance does not take the form of a
prescriptive program with content that may then be adapted and
distributed as the commenter requests. Given our experience with the
select agent and toxin regulations and the wide variety of regulated
entities those regulations cover, we have found a broader approach to
be most effective. The guidance documents developed in conjunction with
this rule are, in part, a response to the questions and issues raised
by the commenters. The documents will contain specific examples of best
practices that we believe entities would be well served in adopting
including, but not limited to, a designated person to manage the
assessment of laboratory personnel, laboratorian involvement in threat
migration, and those behaviors of concern which may indicate a possible
insider threat. Full guidance on this and other issues may be found on
the National Select Agent Registry at www.selectagents.gov.
Miscellaneous Changes
We proposed to make several smaller-scale changes to the
regulations, including the addition of definitions and clarification of
language concerning security, training, biosafety, biocontainment, and
incident response. These changes are intended to increase the usability
of the select agent
[[Page 61067]]
regulations as well as provide for enhanced program oversight.
In 7 CFR 331.1 and 9 CFR 121.1, we proposed to add definitions for
adjudicated as a mental defective, alien, committed to any mental
institution, controlled substance, crime punishable by imprisonment for
a term exceeding 1 year, indictment, lawfully admitted for permanent
residence, mental institution, and unlawful user of any controlled
substance. These definitions, which described specific aspects of the
proposed definition of restricted person, were intended to assist
regulated entities as well as those seeking approval to access select
agents and toxins to better understand what status or activities, past
or present, might prohibit such access.
Four commenters stated that these definitions needed to be further
clarified. The commenters generally characterized the proposed
definitions as either overly restrictive or vague. After careful
consideration we have agreed with the commenters and have decided not
to include these definitions or a definition for restricted person in
the final rule. We will look to develop additional guidance in this
area.
We proposed to add a definition for recombinant and synthetic
nucleic acids. This addition was deemed necessary, as the term
``synthetic nucleic acids'' is employed in the proposed changes to the
select agent regulations. We proposed to include synthetic nucleic
acids in the regulations because, while synthetic nucleic acids have
the same potential for harm as recombinant nucleic acids, the process
of production is different.
One commenter stated that the proposed definition has implications
in all areas currently impacted by synthetic biology technology, such
as industrial enzymes, renewable chemicals for pharmaceutical and
industrial applications, bio-based products, personal care products,
renewable specialty chemicals, biofuels, and healthcare products. The
commenter argued that consequences of adopting the proposed definition
could impede the growth of sustainable products from emerging fields
such as synthetic biology technology. The commenter therefore
recommended that we not adopt the new definition of recombinant and
synthetic nucleic acids as stated in the proposed rule, arguing that
the existing language of the regulation is sufficient to cover the
current uses of synthetic nucleic acids. The commenter further stated
that the proposed definition utilizes language that was proposed to,
but rejected by, the National Institutes of Health Recombinant DNA
Advisory Committee (NIH-RAC). The commenter suggested that if the
select agent program finds it necessary to introduce a new definition
for recombinant and synthetic nucleic acids, that we follow the
leadership of the NIH-RAC and establish a simpler definition that is
not focused on the underlying mechanism of production of the nucleic
acids.
We disagree with the commenter's assertion regarding the broad
impact of the definitions used by the select agent program. Our scope
of oversight is limited to the list of select agents and toxins and
therefore does not extend to all synthetic biology. However, we do
agree that any definition adopted for use in the regulations should be
based on the most current information available from subject matter
experts. Following extensive consultation with the NIH, we have updated
the definition of recombinant and synthetic nucleic acids to reflect
the most current thinking on the subject. In addition, we have
separated the definition of recombinant nucleic acids from the
definition of synthetic nucleic acids for purposes of clarity.
We proposed to add a definition for occupational exposure to the VS
regulations in 9 CFR 121.1 as it is used in the regulations but not
defined. This definition was based on that used in the Occupational
Safety and Health Administration regulations in 29 CFR 1910.1030. We
did not propose to add a corresponding definition to the PPQ
regulations in 7 CFR 331.1 since PPQ select agents and toxins do not
pose a severe threat to human health and, therefore, it is unnecessary
to address personnel safety and health. One commenter suggested that we
expand the definition to specify that, due to aerosol transmission,
such exposure incidents may impact other employees working in the same
area.
We agree with the commenter that the proposed definition did not
adequately address the possibility of aerosol transmission and have
amended the language accordingly.
Additionally, we are also removing references to rickettsiae in the
definitions for biological agent and toxin. This change is necessary
because there are no rickettsiae select agents or toxins regulated by
APHIS on the list of select agents and toxins.
We proposed to amend 7 CFR 331.3(e), 9 CFR 121.3(e) and 9 CFR
121.4(e). These paragraphs specify that attenuated strains of select
agents or toxins may be excluded from the requirements of the select
agent regulations subject to an official request and supporting
scientific information. We proposed to state that the ``inactive form
of a select toxin'' may be excluded from regulation under each
respective part subject to the application procedure. We also proposed
to update the Web site address in paragraph (e)(1) of each section as
all information concerning the Select Agent Program is now centralized
on the National Select Agent Registry at https://www.selectagents.gov/.
Finally, we proposed to remove the language stating that exclusions
will be published in the Federal Register. At the time the regulations
were initially created we anticipated publication of exclusions both in
the Federal Register and on the Internet; however, we have found that
publication on the National Select Agent Registry Web site only has
served to provide the most up-to-date information to the regulated
community.
One commenter suggested that, in addition to publication of
exclusions on the National Select Agent Registry Web site we should
also develop and maintain an email distribution list so that registered
facilities could be notified when updates are added to the Web site.
We currently engage in the type of email updates that the commenter
suggests. Emails are sent to responsible officials and alternate
responsible officials at all registered entities. Dissemination of that
information is at the discretion of the responsible officials and
alternate responsible officials. We plan on issuing guidance and
suggestions regarding information dissemination, which we believe will
enable further information sharing within regulated entities.
Another commenter asked that we add a timeline to the regulations
indicating when the person requesting the exclusion should expect to
receive a written response. The commenter stated that, in the case of
grant applications, it may be difficult to meet deadlines if the
applicant has no idea how long a response from the select agent program
will take.
We are making no changes as a result of this comment. Due to the
wide variety of material submitted for consideration for exclusions,
establishment of a timeline as the commenter recommends is impractical.
The select agent program necessarily examines each application on a
case-by-case basis. We strive to make the process as efficient as
possible.
The regulations in 9 CFR 121.6 set out guidelines for those
instances where overlap select agents and toxins may be considered
exempt from the regulations. Specifically, Sec. 121.6(e) concerns
[[Page 61068]]
procedures by which an individual or entity may be exempted from the
requirements of the regulations if necessary in order to respond to a
domestic or foreign agricultural emergency involving an overlap select
agent or toxin. Upon further consideration, in order to eliminate an
unnecessary burden on such an individual or entity, we have removed the
provision stating that the individual or entity must complete APHIS/CDC
Form 5 in order to request such an exemption. Guidance on requesting an
exemption for an individual or entity in the case of a domestic or
foreign agricultural emergency involving an overlap select agent or
toxin may be found on the National Select Agent Registry at
www.selectagents.gov.
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. We proposed to explicitly
require that all designated responsible officials possess the
appropriate training or expertise to execute their required duties. We
also proposed to clarify the role of alternate responsible official in
order to definitively establish that the alternate responsible official
must have the knowledge and authority to act for the responsible
official in his/her absence. Finally, we proposed to add a requirement
that the responsible official's principal duty station be the physical
location of the registered entity.
One commenter stated that the language concerning responsible
officials is not clear and may cause institutions to unnecessarily
create new administrative structures and positions to meet this
requirement. The commenter urged the select agent program to work with
research institutions in order to identify the most appropriate level
of administration for the responsible official.
We are making no change in response to this comment. The
responsible official should be an individual who can perform all of the
duties required for that position. The regulations were designed to
place the responsibility for ensuring entity compliance with the
regulations in one position. Given the wide variety of entities covered
by the regulations, establishing more prescriptive guidelines would
decrease the flexibility and usefulness of the regulations to those
entities. We neither require nor prohibit the establishment of a
separate administrative position for the responsible official as we
leave it to the entity to decide how best to designate a responsible
official who meets the requirements of the regulations.
Another commenter said that the absence of specific requirements
regarding responsible official qualifications will establish an
inspection process that is subjective and ineffectual. The commenter
asked that we add a section that explains and/or defines what we
consider the ``appropriate training or expertise'' necessary for an
entity's responsible official.
We have established the regulations regarding the training and
expertise of the responsible official in order that they provide
maximum flexibility to regulated entities. The reasons for this are
twofold: First, given the quickly developing and changing fields of
biosafety and biosecurity, any attempt on our part to strictly define
required training and expertise within the regulations would likely
become obsolete as the parameters continue to evolve; second, given the
wide variety of entities covered by the regulations, there is a need to
maintain flexibility so that they may remain applicable to all of those
entities. We have removed the reference to ``appropriate training or
expertise'' and will continue to assess the performance of the
responsible official based on his or her efficacy in implementing the
regulatory requirements at his or her entity. With an eye to the non-
specificity of the regulations, we have developed guidance documents
regarding this and other aspects of entity compliance. They are
available on the National Select Agent Registry at
www.selectagents.gov.
Five commenters requested further clarification regarding the
proposed requirement that the responsible official's principal duty
station be the physical location of the registered entity. The
commenters inquired whether this requirement would mean that the
principal duty station should be in the same building or only at the
same institution.
In response to these comments and others received by the CDC, we
are modifying the language in 7 CFR 331.9 and 9 CFR 121.9 to stipulate
that the responsible official must have a physical (as opposed to a
telephonic or audio-visual link) presence at the registered entity to
ensure that the entity is in compliance with the regulations. The
responsible official will also be more quickly able to respond to any
on-site incidents involving select agents and toxins if he or she is
on-site.
Three commenters asked that the definition of ``entity'' be
clarified in relation to the requirement that the responsible
official's principal duty station be the physical location of the
registered entity and the impact of the requirement assessed. The
commenters' request was based on their understanding that an entity has
to be contiguous and that laboratories separated on a campus constitute
separate entities. The commenters concluded that having separate
responsible officials in this case would be burdensome.
We realize that many entities are located on a campus with several
registered laboratories in different buildings. The intent of this
requirement is not to ensure that a responsible official is assigned to
each physical laboratory but to ensure that the responsible official is
physically located on the campus.
We proposed 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. Specifically, we
proposed to add new provisions by which individuals may have access to
select agents at entities other than the individual's ``home'' entity.
We also proposed to decrease the maximum length of time for which a
security risk assessment will be valid from 5 years to 3 years in order
to more expeditiously identify individuals who may have fallen into one
of the prohibited or restricted categories.
One commenter asked whether, during the time period in which an
individual has access to select agents at entities other than the
individual's ``home'' entity, that individual would have access to
select agents at both facilities, or if the access approval would be
transferred so that the individual would only have access to the select
agents and toxins at the new entity for the time specified. The
commenter stated that, from a biosafety and biosecurity perspective,
limiting access to only one entity at the time would be appropriate.
During this timeframe, the individual will maintain access to
select agents at both facilities. We believe that such an arrangement
will serve to facilitate collaboration between registered entities as
well as enabling various entities to use their time and funds most
efficiently in order to continue ongoing research. We do not agree with
the commenter's assertion that this procedure would threaten
biosecurity or biosafety in any way since all registered entities are
[[Page 61069]]
required to undergo the same security screening process as established
by the regulations.
Two commenters stated that decreasing the maximum length of time
for which a security risk assessment will be valid from 5 years to 3
years would represent an undue burden on registered entities. One
commenter cited the generally low rate of turnover at these entities,
while the other stated that the existing policy, with renewal every 5
years, has proven to be both sufficient and cost effective since the
establishment of the select agent regulations. The first commenter
suggested that we allow for less frequent risk assessments in the case
of those individuals working with non-Tier 1 select agents and toxins
only. The second commenter recommended making no changes to the 5-year
interval.
The decision to begin processing security risk assessments at 3-
year rather than 5-year intervals was made as a result of the
recommendations from a working group comprised, in part, of
representatives from the DOD and the HHS as well as various subject
matter experts. Based on input from the working group as well as the
FBI, we have determined that conducting security risk assessment
approvals every 3 years is an effective method for increasing the
security of our entities. Furthermore, the select agent program has
been processing security risk assessments on a 3-year basis since June
1, 2011. Since that date, we have not received any comments from the
regulated community regarding additional financial or administrative
burden associated with the changed practice. Regarding the first
commenter's suggestion to process security risk assessments differently
for those individuals working with non-Tier 1 select agents and toxins
only, the establishment of the Tier 1 category is in no way intended to
imply that the non-Tier 1 agents pose a lesser risk to public health
and safety than they have previously. In accordance with that fact, we
have not decreased the handling and security requirements for those
non-Tier 1 agents.
We proposed to require that the security plan described in 7 CFR
331.11 and 9 CFR 121.11 that must be developed by all registered
entities be submitted for initial registration, renewals of
registration, and at any other time upon request to replace the
existing requirement that they be provided upon request only. We also
proposed that the security plan contain provisions for the control of
access to select agents and toxins, including the safeguarding of
animals or plants intentionally or accidentally exposed to or infected
with a select agent, against unauthorized access, theft, loss or
release. We also proposed to add a requirement that the security plan
include procedures that require the responsible official to immediately
notify the FBI in order to initiate a threat assessment process in the
event that he or she becomes aware of suspicious activity which is
criminal in nature, related to the facility, its personnel, or select
agents. We also proposed to add provisions for information security,
including the need for backup measures if the entity relies on
information systems for security. We also proposed to codify current
practices for shipping, receiving, and storage of select agents and
toxins to ensure that the entity has documented processes for securing
and monitoring the shipment, receipt, and storage of these items.
Finally, we proposed to amend paragraph (e) in 7 CFR 331.11 and 9 CFR
121.11, which previously directed individuals creating a security plan
to guidance for developing such documents contained in the ``Morbidity
and Mortality Weekly Report'' from December 2002. We proposed that
applicants would instead be directed to the ``Security Information
Document'' and the ``Security Plan Template'' on the National Select
Agent Registry Web site.
Two commenters requested clarification concerning the proposed
requirement that entities address procedures concerning animals or
plants accidentally or intentionally exposed to or infected with a
select agent. Specifically, the commenters requested clarification as
to whether the requirement would be limited to experimental plants and
animals that are possessed and controlled by the registered entity. One
commenter suggested two additions to the requirements: One stipulating
that the incident response plan only cover those animals or plants
possessed and controlled by the entity and the second a certifying
statement confirming that the State animal health official (or plant-
associated equivalent) has an incident response plan in place to
address intentional or accidental exposure to select agents for animals
or plants throughout the State, including those plants or animals that
are not possessed or controlled by the entity but may be located on the
premises (e.g., wild animals).
We are making no changes based on these comments. It was always our
intent that the entity's incident response plan be limited to those
exposed plants and animals that are possessed by and controlled by the
registered entity.
One commenter suggested that we alter the wording from a
requirement to safeguard animals or plants ``intentionally or
accidentally exposed to or infected with a select agent'' to a
requirement to safeguard animals or plants ``intentionally exposed to,
or infected with, select agents.'' The commenter stated that the
suggested language would be clearer.
We are making no changes based on this comment. We believe that
animals or plants accidentally exposed to or infected with a select
agent should be handled as select agents and safeguarded in the same
manner as an animal or plant intentionally exposed to a select agent.
In the preamble to the proposed rule, we stated that we were not
proposing to require the security plan to address animals and plants
exposed to select toxins. This is because recovering the toxin from
within an animal or plant subject is highly difficult and such removal
does not produce a reasonable yield of recovery. In addition, there is
uncertainty as to whether or not the toxin would remain active when
recovered from the animal or plant. For these reasons it is highly
unlikely that once introduced into an animal or plant, a sufficient
amount of toxin could be recovered to pose a significant hazard to
public health, agriculture, or agriculture products. One commenter
questioned that rationale, stating that while toxins are unlikely to be
amplified or move into multiple hosts outside a given facility, there
is still concern that amplification of toxins could occur in animals or
insects during the course of an experiment.
We disagree with the commenter's assertion. Select toxins do not
amplify the way select agents do. Toxins in an animal or insect would
prove deadly to that organism before it could reach a level at which
extraction would become possible.
One commenter stated that our proposal to add a requirement that
the security plan include procedures for the responsible official to
notify the FBI of suspicious activity that may be criminal in nature
and related to the entity, its personnel, or its select agents or
toxins contradicts guidance contained in the Nationwide Suspicious
Activity Reporting (SAR) Initiative (NSI) established by the Department
of Justice, creates a conflict within those entities that have their
own recognized law enforcement agencies, and unnecessarily adds
confusion due to the potential for concurrent jurisdiction. Two other
commenters questioned the
[[Page 61070]]
rationale for requiring FBI reporting given that the select agent
program is jointly administered by APHIS and CDC and, in the past,
security concerns were directed to those agencies.
We do not believe that there exists any conflict between the
security requirements in 7 CFR 331.11 and 9 CFR 121.11 and the guidance
offered by the NSI. The intent of this requirement is to facilitate the
involvement of antiterrorism resources which will increase the security
of select agents and toxins. FBI field offices, which are centrally
located in major metropolitan areas across the United States, can
assist entities by working closely with them on crime threats. However,
we agree with the commenters that it may be appropriate that
notification of suspicious activity first be given to local law
enforcement. We have therefore changed the language in 7 CFR
331.11(c)(8) and 9 CFR 121.11(c)(8) to read: ``Describe procedures for
how the Responsible Official will be informed of suspicious activity
that may be criminal in nature and related to the entity, its
personnel, or its select agents or toxins; and describe procedures for
how the entity will notify the appropriate Federal, State, or local law
enforcement agencies of such activity.''
Another commenter suggested that we require FBI notification for
any suspicious activity involving select agents or toxins and not just
activity that may be criminal in nature. The commenter argued that it
is more appropriate for the FBI to determine whether or not the
activity in question is criminal in nature.
We are making no changes in response to this comment. The intent of
this section of the regulations is to avoid excessive reporting to the
FBI. It is our belief that a reasonable person would be able to
determine if the behavior in question constitutes a potential criminal
act, which would therefore necessitate FBI reporting.
One commenter requested that we provide further details concerning
the proposed requirements for additions to the security plan,
specifically as it relates to information security.
The purpose of the requirement in question is to clarify the
language in 7 CFR 331.11(c)(9)(i) and 9 CFR 121.11(c)(9)(i) of the
regulations that requires the entity to have procedures in place for
information systems control. This is an overarching requirement that
covers electronic and non-electronic information oversight by the
regulated community. Our intent is not to regulate experimental data or
the results of studies involving select agents and toxins but to
regulate the select agents and toxins themselves. Therefore, we have
revised the language in order to clearly indicate that the information
security provisions in question should only be for access to the
entity's registered space and records pertaining to select agents and
toxins, as identified in sections 7 CFR 331.11, 9 CFR 121.11, 7 CFR
331.17, and 9 CFR 121.17.
Another commenter stated that the information security requirement
represents an added regulatory burden, and the impact of this
requirement should be evaluated.
For the most part, we anticipate that these requirements are
already being met and will merely require entities to codify and
document the systems and processes currently in place. The guidance
documents developed in conjunction with this rule are, in part, a
response to the questions and issues raised by the commenter. Issues
addressed in this document include, but are not limited to: Information
technology security, network security, computer security, peripheral
devices and data storage, physical security and its application to
information security, risk management, and training. Full guidance on
information security may be found on the National Select Agent Registry
at www.selectagents.gov.
Another commenter said that the proposed requirement that
authorized and authenticated users only be granted access to select
agent and toxin related information, files, equipment (e.g., servers or
mass storage devices), and applications as necessary to fulfill their
roles and responsibilities, and that their access be modified when the
user's roles and responsibilities change or when their access to select
agents and toxins is suspended or revoked, would require registration
and security risk assessments for all staff managing records pertaining
to select agent work. The commenter argued that this requirement would
increase the burden on manufacturers and institutions who utilize
administrative or information technology staff for such document
management.
The security requirements referenced by the commenter refer only to
those persons who have either physical access to select agents and
toxins or who have the capability to alter security access to select
agents and toxins. Guidelines concerning security requirements such as
these may be found on the National Select Agent Registry at
www.selectagents.gov.
Another commenter stated that the meaning of the phrases ``network
connectivity monitoring'' and ``backup security measures in the event
that access control systems and/or surveillance devices are rendered
inoperable'' should be clarified.
Again, we note that, further details regarding these and other
aspects of the information security requirements may be found in the
guidance documents mentioned above, which may be found on the National
Select Agent Registry at www.selectagents.gov.
We proposed to require that an entity's security plan contain
provisions and policies for shipping, receiving, and storage of select
agents and toxins, including documented procedures for receiving,
monitoring, and shipping of all select agents and toxins. These
provisions would provide that an entity must properly secure containers
on site and have a written contingency plan for unexpected shipments.
One commenter requested clarification regarding the meaning of the term
``unexpected shipments.''
We believe that the term ``unexpected shipments'' is self-
explanatory and believe that the security plan should contain
procedures for these handling unexpected shipments (e.g., when an
entity receives a shipment of a select agent that it had neither
requested nor coordinated for, and therefore was not expecting).
The regulations in 7 CFR 331.13 and 9 CFR 121.13 concern restricted
experiments, which are those experiments that may not be performed by
regulated entities without the approval of the Administrator. In
addition to the existing prohibition on conducting restricted
experiments, we proposed to state that entities would not be authorized
to possess the products of restricted experiments without the approval
of the Administrator.
We also proposed to expand the restricted experiment approval
requirement to include all experiments involving the creation of drug
resistant select agents that are not known to acquire that resistance
naturally, if such acquisition could compromise the use of the drug to
control disease agents in humans, veterinary medicine, or agriculture,
regardless of the method or technology used to create the resistance.
Previously, the restricted experiment language concerned only those
experiments involving recombinant DNA. We proposed this change because,
while the introduction of a drug resistance trait would normally
eliminate that drug as a therapeutic option to control the disease,
there may be alternative drugs available to control the disease.
In addition, we are adding a reference to ``chemical resistance
traits,'' to the PPQ regulations in 7 CFR 331.13 in order to capture
the potential transfer of,
[[Page 61071]]
or selection for, such traits that could adversely affect plant and
agricultural health. Chemical resistant traits include, but are not
limited to herbicide resistance, fungicide resistance, and pesticide
resistance. We did not propose to add a corresponding definition to the
VS regulations in 9 CFR 121.13 since chemical resistance traits are
exclusive to plant biology. It should be noted that restricted
experiments are not prohibited experiments; an entity must seek
permission prior to the initiation of a restricted experiment and
receive approval from the Administrator or HHS Secretary. Approval for
the performance of a restricted experiment or the possession of a
product of a restricted experiment may involve meeting additional
safety and/or security requirements as prescribed by the select agent
program. Many experiments that involve the deliberate transfer of a
drug resistant trait do not meet the definition of a restricted
experiment because the drug is not used to control disease in humans,
veterinary medicine, or agriculture. The select agent program
encourages anyone who intends to conduct a select agent experiment
utilizing drug resistance markers to submit that experiment for review
so that they may be advised regarding whether the experiment would be
considered a restricted experiment and therefore require approval prior
to its initiation.
Two commenters were concerned about the proposed revisions
classifying those experiments that introduce drug resistance to a
select agent as restricted. The commenters suggested aligning the
language concerning restricted experiments with the recombinant DNA
guidelines issued by the NIH, which restrict and require approval only
for those experiments with pathogens involving drug resistance for
therapeutically useful agents against that pathogen. The commenters
stated that the proposed language was too broad.
We made no changes as a result of these comments. Contrary to the
commenters' assertion, we have not expanded the definition of a
restricted experiment to include all experiments utilizing select
agents or toxins with drug resistant traits, but only to those
utilizing select agents or toxins with resistance to those drugs used
to control disease in humans, veterinary medicine, or agriculture. The
definition of a restricted experiment contained in the regulations is
already aligned with the NIH recombinant DNA guidelines.
One commenter argued that antibiotic resistance not previously
present could emerge in one or more select agents at any time. The
commenter wished to know if the possession of such a previously unknown
antibiotic resistant select agent would mean that all such organisms
would be required to be destroyed. The commenter expressed concern that
such a requirement might inadvertently prevent research in the case of
a select agent that suddenly developed new antibiotic resistance
traits.
We are making no changes to the regulations as a result of this
comment. Regardless of whether the select agent develops a new trait,
it is still considered and treated as a select agent from a biosafety
or biocontainment perspective. The aspect of the process that makes a
select agent the subject of a restricted experiment is the purposeful
generation of antibiotic resistant properties. If a select agent
developed new antibiotic resistance spontaneously, then it would be
included in the category of select agents considered ``known to acquire
the resistance naturally'' as specified in 7 CFR 331.13(a)(1) and 9 CFR
121.13(b)(1).
Another commenter wanted to know whether the use of the terms ``the
select agent program'' and ``the Administrator,'' which refer to two
different entities, indicates that restricted experiments would require
the approval of both the select agent program and the Administrator.
Terms in this context are interchangeable, as the APHIS
Administrator has delegated authority for establishing and enforcing
the regulations to the select agent program. Approval is therefore only
needed from the select agent program.
Another commenter stated that an ombudsman, in the form of
additional working groups, should be included in the approval process
for restricted experiments. The commenter said that involvement of such
groups in this capacity would serve to engage those regulated
scientists while furthering their understanding of the select agent
program.
We are making no changes as a result of this comment. In reviewing
applications to conduct restricted experiments, the select agent
program utilizes the expertise of the Intragovernmental Select Agents
and Toxins Technical Advisory Committee (ISATTAC), which is composed of
Federal scientists from the CDC, NIH, FDA, APHIS, the Agricultural
Research Service (ARS), APHIS' Center for Veterinary Biologics (CVB),
and DOD, and its USDA counterpart, the Agricultural ISATTAC, which is
composed of Federal scientists from ARS, APHIS, and CVB. In the past,
when appropriate, we have engaged the advice of subject matter experts
from outside the government.
The regulations in 7 CFR 331.14 and 9 CFR 121.14 concern
development of an entity's incident response plan. We proposed to
specify that each incident response plan be based upon a site-specific
risk assessment. We also proposed that the incident response procedures
contain stipulations concerning animals and plants accidentally or
intentionally exposed to or infected with a select agent.
One commenter argued that the requirements in 7 CFR 331.14(a) and 9
CFR 121.14(a), which stipulate that regulated entities must develop and
implement a written incident response plan based on a site-specific
risk assessment, are misleading. The commenter stated that, since there
is no standard methodology for conducting such risk assessments, the
addition of specific issues that must be addressed by a risk assessment
should be included in order to provide additional guidance for the
regulated community. The commenter further observed that, in general,
the risk assessment requirements for agricultural select agents and
toxins are somewhat different from those for human select agents and
toxins. The commenter concluded that a one size fits all approach may
be overly burdensome or scientifically inaccurate.
We are making no changes based on this comment. The site-specific
risk assessments required by the regulations in 7 CFR 331.14(a) and 9
CFR 121.14(a) are necessary in order to ensure the physical security of
regulated entities. The risks cited by the commenter are matters of the
biological risk presented by various select agents and toxins, which is
a separate issue from the physical security of these select agents and
toxins. The regulations are intended to prevent the theft, loss, or
release of select agents and toxins. We also disagree with the
commenter's assertion that there is no standard methodology for
conducting site-specific risk assessments. We have developed guidance
on this subject that may be found on the National Select Agent Registry
at www.selectagents.gov.
We proposed 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 proposed to require all registered entities to
provide security awareness and incident response training. We also
proposed to establish that training for escorted personnel would be
based on
[[Page 61072]]
the risk associated with accessing areas where select agents and toxins
are used and/or stored. We further proposed to require that refresher
training, currently required on an annual basis, also be provided if a
registered entity's security, incident response, biosafety, or
biocontainment plans are substantively altered. Finally, we proposed to
specify that the responsible official ensure maintenance of training
records. Currently there is no particular person designated as the
entity's required recordkeeper, only that a training record must be
kept.
One commenter suggested that 7 CFR 331.15(a) should specify that
information and training on both biocontainment and biosafety be
provided, as only information and training on biosafety had been
specified in the proposed rule.
We agree with the commenter and have amended 7 CFR 331.15(a) in
order to reflect the proper terminology in dealing with plant
pathogens.
We proposed that the regulations in 7 CFR 331.15(a)(ii) concerning
escorted personnel stipulate that training for such individuals must be
based on the risk associated with accessing areas where select agents
and toxins are used and/or stored. One commenter inquired what would
represent an ``appropriate level of training.'' The commenter further
wished to know how an entity would determine the risk associated with
accessing such areas. Finally, the commenter asserted that there should
be no need for non-approved individuals to potentially access areas
where select agents and toxins are used and/or stored given that
unsecured select agents or toxins could be moved elsewhere prior to the
arrival of any escorted personnel.
We disagree with the commenter's assertion that non-approved
individuals would never need to access areas where select agents and
toxins are used and/or stored. For example, there may be a need for the
repair of a refrigeration unit in a laboratory where employees are
utilizing select agents or toxins as a part of concurrent research
work. In addition, inventories of select agents and toxins may be large
enough to make moving them impractical and overly time-consuming. It is
therefore necessary for any visitors to know and understand the
biological risks associated with the select agents or toxins used and/
or stored in the area to which they will have access. This training
would necessarily vary depending upon the areas that the escorted
personnel would need to access, which would be determined by the
entity. Visitors should ideally be made aware of the safety and
security procedures as defined by the entity in question; however, we
are leaving the regulations in their broadly written state in order to
provide the greatest amount of flexibility for the wide variety of
entities subject to the requirements.
We proposed to amend the regulations in 7 CFR 331.16 and 9 CFR
121.16, which concern the transfer of select agents and toxins from one
registered entity to another, in order to codify practices for
shipping, receiving, and storage of select agents and toxins to ensure
that all registered entities have documented processes for securing and
monitoring the shipment, receipt, and storage of select agents and
toxins that make it extremely unlikely that such materials would be
made available to an unauthorized individual.
Two commenters asserted that the provisions concerning transfer are
unclear with regard to the subject of the transfer of materials covered
by the exemptions for diagnostic or clinical laboratories under 7 CFR
331.5, 9 CFR 121.5, and 9 CFR 121.6. The commenters requested that we
clearly establish whether the new requirements supersede the existing
provisions for transfer by exempt entities.
We are making no changes as a result of this comment. Those
materials which qualify for exemption from the regulations have always
been considered separately from the rest of the listed select agents or
toxins. This may be a result of the exemptions granted for diagnostic
or clinical laboratories, a result of a specific exemption request, or
for other reasons which may be found in 7 CFR 331.5, 9 CFR 121.5, and 9
CFR 121.6. As a result, these materials are not subject to the
regulations, including those portions of the regulations concerning
transfers, apart from those sections pertaining to exemptions.
However, given that some commenters on the CDC proposed rule
expressed confusion associated with the proposed provision, we have
revised the language in order to clarify our original intent. Packaging
of select agents and toxins for transfer must be made by an APHIS or
CDC-approved individual.
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. We proposed to add language to address
synthetic select agent organisms and animals and plants inoculated with
select agents. We also proposed to add recordkeeping requirements
whereby regulated entities maintain an accurate, current inventory of
any animals or plants intentionally or accidentally exposed to or
infected with a select agent (including number and species, location,
and appropriate disposition). As previously stated, we did not propose
to require regulated entities to keep records regarding animals or
plants exposed to select toxins.
Four commenters argued that counting individual vials of
replicating biological agents is costly, burdensome, and a major source
of frustration for investigators. The commenters went on to say that
the requirement to measure volumes within each vial is problematic
given both the ease with which volumes can change through natural
processes and the difficulty in correctly assessing them in the frozen
state during inventory verifications. The commenters stated that both
counting vials and measuring volumes of individual vials are not
effective means of increasing security.
We are making no changes to the regulations based on these
comments. While we are aware of the burden resulting from the
requirement to maintain an accurate and current inventory of each
select agent and toxin held in long-term storage, we believe this is an
essential element in establishing the security of select agents or
toxins. We recognize that it may still be possible for an insider to
steal a sample of an agent either from working stock or from an
inventory without being detected; however, if an entity has a robust
inventory management system, such incidents have a better chance of
being detected. To assist registered entities in meeting the
requirements for maintaining accurate inventories of materials in long
term storage, we have developed guidance that may be found on the
National Select Agent Registry at www.selectagents.gov. It should be
noted that, while the volume measurements the commenter references are
required for inventories of select toxins, they are not required in the
case of inventory of select agents held in long-term storage due, in
part, to the points raised by the commenter. However, we disagree with
the commenter's assessment that measuring volume in the case of select
toxins and counting vials in general as part of required inventory
tracking of both select agents and toxins for registered entities is
not necessary.
Another commenter stated that there is concern that the additional
requirements for inventory each time a select agent is moved will
adversely impact the viability and quality of the material in question.
We are making no changes as a result of this comment. In the case
of those select agents and toxins in long-term
[[Page 61073]]
storage, collections of vials of materials can be recorded and grouped
into tamper-evident containers and audits made of intact containers
rather than audits of individual vials. This practice is stipulated in
the current guidance document regarding long term storage, which is
available on the National Select Agent Registry at
www.selectagents.gov. Those select agents and toxins that are part of
an entity's working stock are already in regular use and we therefore
do not anticipate adverse effects arising from any required accounting.
Based on comments received on the CDC rule, we now recognize that
there has been some confusion between those animals (including
arthropods) and plants considered to be ``working stock'' and those
considered to be ``inventory.'' To that end, we have developed guidance
that will enable entities to better differentiate between these two
categories. This guidance is available at www.selectagents.gov. It was
not our intent to require a formal inventory of animals or plants
intentionally or accidentally exposed to or infected with a select
agent, but merely to state that entities should keep some record of
such animals or plants. In order to clarify our intent regarding
``working stock'' and ``inventory,'' we are revising 7 CFR 331.17(a)(2)
and 9 CFR 121.17(a)(2) to require an accurate, current accounting of
any animals or plants intentionally or accidentally exposed to or
infected with a select agent (including number and species, location,
and appropriate disposition) instead of an accurate, current inventory
of those animals or plants.
Indirect and Economic Consequences
Eight commenters requested that we consider the indirect
consequences of continuing to include agents and toxins on the select
agent list, the negative effect of the proposed rule changes on the
potential workforce for select agent research, and the possibility that
additional regulations concerning Tier 1 agents and toxins will mandate
more Federal oversight and institutional compliance requirements,
resulting in increased costs to taxpayers both directly and indirectly
through reduced research efficiency. Commenters requested that the full
economic and scientific impact of these added requirements be carefully
assessed prior to implementation, especially the increased costs to
academic institutions with no associated funding, and the increased
burden on investigators already having difficulty finding time for
research and experimentation. The commenters also stated that the
timeline for implementation of the new requirements should be
considered and disclosed to affected entities.
A cornerstone of the select agent program is to establish and
enforce safety and security measures to prevent access to select agents
and toxins for use in domestic or international terrorism or for any
other criminal purpose. An equally important function of the select
agent program is to ensure the appropriate availability of biological
agents and toxins for research, education, and other legitimate
purposes. To achieve both requires balancing the need for continuing
biological research with requiring a level of safety and security
commensurate with the risks posed by these select agents and toxins. We
understand that safety and security requirements cost money and that
money in the area of biological research is often a scarce commodity.
We are, however, also aware that a lack of adequate safety and security
requirements could result in damages measured not only in dollars but
in human lives. It is our determination, based on the information
available to us, that the additional requirements would, in many cases,
codify systems and procedures already in use by a majority of regulated
entities.
We are also renumbering several sections of the PPQ regulations so
that they will match the numbering of the VS regulations, which we
believe may be useful for those entities housing both PPQ select agents
and toxins and VS select agents and toxins. As proposed, the section
numbering did not match up because we did not propose to classify any
PPQ select agents and toxins as Tier 1, so there were sections being
added to the VS regulations that were not included in the PPQ
regulations.
Effective Date
In response to comments received by the CDC requesting guidance and
a timetable of when the proposed changes would need to be addressed, we
have included a phase-in period for the effective date for certain
requirements of the revised regulations, which should allow entities to
comply without causing disruption or termination of research or
educational projects. As noted in the ``Dates'' portion of this
document, 60 days from the publication of the final rule, entities will
be required to be in compliance with 7 CFR 331.1 through 331.10,
331.13, and 331.16 through 331.20 and 9 CFR 121.1 through 121.10,
121.13, 121.16, 121.17, and 121.20. One hundred and eighty days after
the publication of the final rule, entities will be required to be in
compliance with 7 CFR 331.11, 331.12, 331.14, and 331.15 and 9 CFR
121.11, 121.12, 121.13, 121.14, and 121.15.
The staggered effective dates for the provisions of the final rule
are based on the effective dates previously used for a final rule
published by the Select Agent Program on March 18, 2005 (70 FR 13242-
13292, Docket No. 02-088-4). If the regulated community has concerns
about the established timeline, they can contact the Federal select
agent program for technical assistance.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Orders 12866 and 13563 and Regulatory Flexibility Act
This final rule has been determined to be significant/economically
significant for the purposes of Executive Order 12866 and, therefore,
has been reviewed by the Office of Management and Budget.
We have prepared an economic analysis for this rule. The economic
analysis provides a cost-benefit analysis, as required by Executive
Orders 12866 and 13563, which direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, and equity). Executive Order 13563 emphasizes the importance
of quantifying both costs and benefits, of reducing costs, of
harmonizing rules, and of promoting flexibility. The economic analysis
also provides a final regulatory flexibility analysis that examines the
potential economic effects of this rule on small entities, as required
by the Regulatory Flexibility Act. The economic analysis is summarized
below. Copies of the full analysis are available on the Regulations.gov
Web site (see footnote 1 in this document for a link to
Regulations.gov) or by contacting the person listed under FOR FURTHER
INFORMATION CONTACT.
Based on information obtained through site-specific inspections, we
believe most registered entities already have in place many of the
information security requirements set forth in the final rule, and
compliance costs of the rules are therefore expected to be minimal.
Entities more likely to be affected will be laboratories and other
institutions conducting research and related activities that involve
the use of select agents and toxins categorized as Tier 1. These
entities will be required to conduct a pre-access suitability
[[Page 61074]]
assessment of individuals with access to a Tier 1 select agent or
toxin, as well as enroll these individuals in an occupational health
program.
The rule would reduce the period that FBI background checks are
valid from five to three years. This increased frequency would
effectively increase the cost of background checks by 67 percent. Based
on the current number of individuals required to have the background
checks, we estimate that the present value of these government-borne
costs over five years will increase by $1.96 million across all
registered entities. The annual increase in costs will total about
$432,000.
While we expect few if any of the registered entities to incur
significant compliance costs, required documentation of measures
already regularly performed with respect to biocontainment/biosafety,
incident response, information security, and ongoing suitability
assessment may require additional time of personnel. We estimate
additional recurring costs related to information security, such as for
software updates, could total about $2 million per year, or about
$5,500 per entity, in the unlikely event that none of the entities
already uses equivalent information security measures. As noted, many
of these costs are already currently borne by entities in their conduct
of generally recognized best practices.
For entities possessing a Tier 1 agent or toxin, the costs of pre-
access suitability assessments and occupational health programs are
estimated to total between $2.8 million and $4.4 million, or between
about $9,600 and $15,100 per entity, on average. Again, actual costs
incurred are unlikely to reach these maximum cost ranges; we expect
that many of the entities with a Tier 1 agent or toxin already conduct
assessments and have health programs similar or equivalent to those
required by the final rules.
The benefits of strengthened safeguards against the unintentional
or deliberate release of a select agent or toxin greatly exceed
compliance costs of the rules. As an example of losses that can occur,
the October 2001 anthrax attacks caused 5 fatalities and 17 illnesses,
disrupted business and government activities (including $2 billion in
lost revenues for the Postal Service), and required more than $23
million to decontaminate one Senate office building and $3 billion to
decontaminate postal facilities and procure mail-sanitizing equipment.
Deliberate introduction greatly increases the probability of a select
agent becoming established and causing wide-ranging and devastating
impacts to the economy, other disruptions to society, and diminished
confidence in public and private institutions.
The amended regulations will enhance the protection of human,
animal, and plant health and safety. The final rules will reduce
likelihood of the accidental or intentional release of a select agent
or toxin. Benefits of the rules will derive from the greater
probability that a release will be prevented from occurring. While the
total cost of implementing the regulations is estimated to range
between $2.8 million-$4.4 million across all entities with a Tier 1
agent or toxin and approximately $2.4 million in annual cost across all
registered entities and the Federal Government, we believe many of
these costs are currently incurred by affected entities as generally
recognized practices.
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 7 CFR part 3015, subpart V.)
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Executive Order 13175
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments. The review reveals that this regulation will not have
substantial and direct effects on Tribal governments and will not have
significant Tribal implications.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this final rule have been
submitted for approval to the Office of Management and Budget (OMB).
When OMB notifies us of its decision, we will publish a document in the
Federal Register providing notice of the assigned OMB control numbers
or, if approval is denied, providing notice of what action we plan to
take.
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 rule, please contact Mrs. Celeste Sickles,
APHIS' Information Collection Coordinator, at (301) 851-2908.
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 are amending 7 CFR part 331 and 9 CFR part 121 as
follows:
Title 7
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 as follows:
0
a. In the introductory text of the definition of biological agent, by
removing the word ``rickettsiae,'';
0
b. By adding, in alphabetical order, definitions of information
security, recombinant nucleic acids, security barrier, and synthetic
nucleic acids; and
0
c. In the introductory text of the definition of toxin, by removing the
word ``rickettsiae,''.
The additions read as follows:
Sec. 331.1 Definitions.
* * * * *
Information security. Protecting information and information
systems from unauthorized access, use, disclosure, disruption,
modification, or destruction in order to provide:
(1) Integrity, which means guarding against improper information
modification or destruction, and includes ensuring information
authenticity;
(2) Confidentiality, which means preserving authorized restrictions
on access and disclosure, including means
[[Page 61075]]
for protecting personal privacy and proprietary information; and
(3) Availability, which means ensuring timely and reliable access
to and use of information.
* * * * *
Recombinant nucleic acids. (1) Molecules that are constructed by
joining nucleic acid molecules and that can replicate in a living cell
(i.e., recombinant nucleic acids); or
(2) Molecules that result from the replication of those described
in paragraph (1) of this definition.
* * * * *
Security barrier. A physical structure that is designed to prevent
entry by unauthorized persons, animals, or materials.
* * * * *
Synthetic nucleic acids. (1) Molecules that are chemically or by
other means synthesized or amplified, including those that are
chemically or otherwise modified but can base pair with naturally
occurring nucleic acid molecules (i.e., synthetic nucleic acids); or
(2) Molecules that result from the replication of those described
in paragraph (1) of this definition.
* * * * *
0
3. Section 331.3 is amended as follows:
0
a. By revising paragraph (b);
0
b. In paragraph (c) introductory text, by adding the words ``and/or
synthetic'' after the word ``recombinant'' each time it appears.
0
c. In paragraph (c)(2) introductory text, by adding the words ``and/or
synthetic'' after the word ``Recombinant''.
0
d. By adding paragraph (d)(3); and
0
e. By revising paragraph (e)
The revisions and addition read as follows:.
Sec. 331.3 PPQ select agents and toxins.
* * * * *
(b) PPQ select agents and toxins: Peronosclerospora philippinensis
(Peronosclerospora sacchari); Phoma glycinicola (formerly Pyrenochaeta
glycines); Ralstonia solanacearum; Rathayibacter toxicus; Sclerophthora
rayssiae; Synchytrium endobioticum; Xanthomonas oryzae.
* * * * *
(d) * * *
(3) Any subspecies of Ralstonia solanacearum except race 3, biovar
2 and all subspecies of Sclerophthora rayssiae except var. zeae,
provided that the individual or entity can verify that the agent is
within the exclusion category.
(e) An attenuated strain of a select agent or an inactive form of a
select toxin may be excluded from the requirements of this part based
upon a determination by the Administrator that the attenuated strain or
inactivated toxin does not pose a severe threat to plant health or
plant products.
(1) To apply for exclusion, an individual or entity must submit a
written request and supporting scientific information. A written
decision granting or denying the request will be issued. An exclusion
will be effective upon notification to the applicant. Exclusions will
be listed on the National Select Agent Registry Web site at https://www.selectagents.gov/.
(2) If an excluded attenuated strain or inactivated toxin is
subjected to any manipulation that restores or enhances its virulence
or toxic activity, the resulting select agent or toxin will be subject
to the requirements of this part.
* * * * *
0
4. Section 331.9 is amended as follows:
0
a. In paragraph (a)(4), by removing the word ``and'';
0
b. By redesignating paragraph (a)(5) as paragraph (a)(6);
0
c. By adding a new paragraph (a)(5);
0
d. By revising the first sentence of paragraph (b)
The addition and revision read as follows:.
Sec. 331.9 Responsible official.
(a) * * *
(5) Have a physical (and not merely a telephonic or audio/visual)
presence at the registered entity to ensure that the entity is in
compliance with the select agent regulations and be able to respond in
a timely manner to onsite incidents involving select agents and toxins
in accordance with the entity's incident response plan; and
* * * * *
(b) An entity may designate one or more individuals to serve as an
alternate responsible official who acts for the responsible official in
his/her absence. * * *
* * * * *
0
5. Section 331.10 is amended as follows:
0
a. By redesignating paragraphs (e) through (i) as paragraphs (f)
through (j) respectively;
0
b. By adding a new paragraph (e); and
0
c. In newly redesignated paragraph (i), by removing the number ``5''
and adding the number ``3'' in its place.
The addition reads as follows:
Sec. 331.10 Restricting access to select agents and toxins; security
risk assessments.
* * * * *
(e) 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
Administrator provide their approved access status to another
registered individual or entity for a specified period of time.
* * * * *
0
6. Section 331.11 is amended as follows:
0
a. By revising paragraph (b);
0
b. By revising paragraph (c)(2);
0
c. In paragraph (c)(6), by removing the word ``and'';
0
d. In paragraph (c)(7), by removing the period and adding a semicolon
in its place;
0
e. By adding new paragraphs (c)(8), (9), and (10);
0
f. By redesignating paragraphs (e) and (f) as paragraphs (g) and (h),
respectively;
0
g. By adding new paragraphs (e) and reserved (f); and
0
h. By revising newly redesignated paragraph (g).
The revisions and additions read as follows:
Sec. 331.11 Security.
* * * * *
(b) The security plan must be designed according to a site-specific
risk assessment and must provide graded protection in accordance with
the risk of the select agent or toxin, given its intended use. A
current security plan must be submitted for initial registration,
renewal of registration, or when requested.
(c) * * *
(2) Contain provisions for the control of access to select agents
and toxins, including the safeguarding of animals (including
arthropods) or plants intentionally or accidentally exposed to or
infected with a select agent, against unauthorized access, theft, loss
or release.
* * * * *
(8) Describe procedures for how the Responsible Official will be
informed of suspicious activity that may be criminal in nature and
related to the entity, its personnel, or its select agents or toxins;
and describe procedures for how the entity will notify the appropriate
Federal, State, or local law enforcement agencies of such activity.
(9) Contain provisions for information security that:
(i) Ensure that all external connections to systems which manage
security for the registered space are isolated or have controls that
permit only authorized and authenticated users;
[[Page 61076]]
(ii) Ensure that authorized and authenticated users are only
granted access to select agent and toxin related information, files,
equipment (e.g., servers or mass storage devices), and applications as
necessary to fulfill their roles and responsibilities, and that access
is modified when the user's roles and responsibilities change or when
their access to select agents and toxins is suspended or revoked;
(iii) Ensure that controls are in place that are designed to
prevent malicious code (such as, but not limited to, computer viruses,
worms, spyware) from compromising the confidentiality, integrity, or
availability of information systems which manage access to spaces
registered under this part or records as specified in Sec. 331.17;
(iv) Establish a robust configuration management practice for
information systems to include regular patching and updates made to
operating systems and individual applications; and
(v) Establish procedures that provide backup security measures in
the event that access control systems, surveillance devices, and/or
systems that manage the requirements of Sec. 331.17 are rendered
inoperable.
(10) Contain provisions and policies for shipping, receiving, and
storage of select agents and toxins, including documented procedures
for receiving, monitoring, and shipping of all select agents and
toxins. These provisions must provide that an entity will properly
secure containers on site and have a written contingency plan for
unexpected shipments.
* * * * *
(e) Entities must conduct complete inventory audits of all affected
select agents and toxins in long-term storage when any of the following
occur:
(1) Upon the physical relocation of a collection or inventory of
select agents or toxins for those select agents or toxins in the
collection or inventory;
(2) Upon the departure or arrival of a principal investigator for
those select agents and toxins under the control of that principal
investigator; or
(3) In the event of a theft or loss of a select agent or toxin, all
select agents and toxins under the control of that principal
investigator.
(f) [Reserved]
(g) In developing a security plan, an individual or entity should
consider the documents entitled, ``Security Guidance for Select Agent
or Toxin Facilities.'' This document is available on the National
Select Agent Registry at https://www.selectagents.gov/.
0
7. Section 331.12 is amended as follows:
0
a. By revising paragraph (a);
0
b. By redesignating paragraph (d) as paragraph (e); and
0
c. By adding reserved paragraph (d).
The revision reads 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 containment procedures
for the select agent or toxin, including any animals or plants
intentionally or accidentally exposed to or infected with a select
agent.
---------------------------------------------------------------------------
\4\ Technical assistance and guidance may be obtained by
contacting APHIS.
---------------------------------------------------------------------------
* * * * *
0
8. Section 331.13 is amended by removing footnote 5 and revising
paragraph (a) to read as follows:
Sec. 331.13 Restricted experiments.
(a) An individual or entity may not conduct, or possess products
resulting from, the following experiments unless approved by and
conducted in accordance with the conditions prescribed by the
Administrator:
(1) Experiments that involve the deliberate transfer of, or
selection for, a drug or chemical resistance trait to select agents
that are not known to acquire the trait naturally, if such acquisition
could compromise the control of disease agents in humans, veterinary
medicine, or agriculture.
(2) Experiments involving the deliberate formation of synthetic or
recombinant nucleic acids containing genes for the biosynthesis of
select toxins lethal for vertebrates at an LD[50]<100 ng/kg body
weight.
* * * * *
0
9. Section 331.14 is amended as follows:
0
a. In the section heading, by redesignating footnote 6 as footnote 5;
0
b. By revising the first sentence in paragraph (a);
0
c. By redesignating footnote 7 as footnote 6;
0
d. By revising paragraph (b);
0
e. By redesignating paragraphs (c) and (d) as paragraphs (d) and (f),
respectively; and
0
f. By adding new paragraphs (c) and reserved (e).
The revisions and 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) An individual or entity required to register under this part
must develop and implement a written incident response plan \6\ based
upon a site specific risk assessment. * * *
---------------------------------------------------------------------------
\6\ Technical assistance and guidance may be obtained by
contacting APHIS.
---------------------------------------------------------------------------
(b) The incident response plan must fully describe the entity's
response procedures for the 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, and other
natural and man-made events.
(c) The response procedures must account for hazards associated
with the select agent or toxin and appropriate actions to contain such
select agent or toxin, including any animals (including arthropods) or
plants intentionally or accidentally exposed to or infected with a
select agent.
* * * * *
0
10. Section 331.15 is revised to 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, biosafety,
security (including security awareness), and incident response to:
(1) Each individual with access approval from the HHS Secretary or
Administrator before that individual has such access to select agents
and toxins. The training must address the particular needs of the
individual, the work they will do, and the risks posed by the select
agents or toxins; and
(2) Each individual not approved for access to select agents and
toxins by the HHS Secretary or Administrator before that individual
enters areas where select agents or toxins are handled or stored (e.g.,
laboratories, growth chambers, animal rooms, greenhouses, storage
areas, shipping/receiving areas, production facilities, etc.). Training
for escorted personnel must be based on the risk associated with
accessing areas where select agents and toxins are used and/or stored.
(b) [Reserved]
(c) Refresher training must be provided annually for individuals
with access approval from the HHS Secretary or Administrator or at such
time as the
[[Page 61077]]
registered individual or entity significantly amends its security,
incident response, or biocontainment plans.
(d) The responsible official must ensure a record of the training
provided to each individual with access to select agents and toxins and
each escorted individual (e.g., laboratory workers, visitors, etc.) is
maintained. The record must include the name of the individual, the
date of the training, a description of the training provided, and the
means used to verify that the employee understood the training.
0
11. Section 331.16 is amended as follows:
0
a. By redesignating footnote 8 as footnote 7;
0
b. By redesignating paragraphs (e) through (h) as paragraphs (h), (i),
(j), and (f) respectively;
0
c. By adding a new paragraph (e);
0
d. In newly redesignated paragraph (f), by removing the words
``packaging and''; and
0
e. By adding a new paragraph (g).
The additions read as follows:
Sec. 331.16 Transfers.
* * * * *
(e) After authorization is provided by APHIS or CDC, the packaging
of the select agent(s) and toxin(s) is performed by an individual
approved by the HHS Secretary or Administrator to have access to select
agents and toxins and is in compliance with all applicable laws
concerning packaging.
* * * * *
(g) Transportation in commerce starts when the select agent(s) or
toxin(s) are packaged for shipment and ready for receipt by a courier
transporting select agent(s) or toxin(s) and ends when the package is
received by the intended recipient who is an individual approved by the
HHS Secretary or Administrator to have access to select agents and
toxins, following a security risk assessment by the Attorney General.
* * * * *
0
12. Section 331.17 is amended as follows:
0
a. By revising paragraph (a)(1) introductory text;
0
b. By redesignating paragraphs (a)(2) through (6) as paragraphs (a)(3)
through (7), respectively; and
0
c. By adding a new paragraph (a)(2).
The revision and addition read as follows:
Sec. 331.17 Records.
(a) * * *
(1) 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 (placement in a system designed to ensure
viability for future use, such as in a freezer or lyophilized
materials), including:
* * * * *
(2) An accurate, current accounting of any animals or plants
intentionally or accidentally exposed to or infected with a select
agent (including number and species, location, and appropriate
disposition);
* * * * *
Sec. 331.19 [Amended]
0
13. Section 331.19 is amended as follows:
0
a. By removing paragraph (b)(1)(iv); and
0
b. By redesignating paragraphs (b)(1)(v) through (b)(1)(viii) as
paragraphs (b)(1)(iv) through (b)(1)(vii), respectively.
0
14. Section 331.20 is revised to read as follows:
Sec. 331.20 Administrative review.
(a) An individual or entity may appeal a denial, revocation, or
suspension of registration under this part. The appeal must be in
writing, state the factual basis for the appeal, and be submitted to
the Administrator within 30 calendar days of the decision.
(b) An individual may appeal a denial, limitation, or revocation of
access approval under this part. The appeal must be in writing, state
the factual basis for the appeal, and be submitted to the Administrator
within 180 calendar days of the decision.
(c) The Administrator's decision constitutes final agency action.
Title 9
PART 121--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
0
15. 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
16. Section 121.1 is amended as follows:
0
a. In the introductory text of the definition of biological agent, by
removing the word ``rickettsiae,'';
0
b. By adding, in alphabetical order, definitions of information
security, occupational exposure, recombinant nucleic acids, security
barrier, and synthetic nucleic acids; and
0
c. In the introductory text of the definition of toxin, by removing the
word ``rickettsiae,''.
The additions read as follows:
Sec. 121.1 Definitions.
* * * * *
Information security. Protecting information and information
systems from unauthorized access, use, disclosure, disruption,
modification, or destruction in order to provide:
(1) Integrity, which means guarding against improper information
modification or destruction, and includes ensuring information
authenticity;
(2) Confidentiality, which means preserving authorized restrictions
on access and disclosure, including means for protecting personal
privacy and proprietary information; and
(3) Availability, which means ensuring timely and reliable access
to and use of information.
* * * * *
Occupational exposure. Any reasonably anticipated skin, eye, mucous
membrane, parenteral contact, or respiratory aerosol exposure to select
agents or toxins that may result from the performance of an employee's
duties.
* * * * *
Recombinant nucleic acids. (1) Molecules that are constructed by
joining nucleic acid molecules and that can replicate in a living cell;
or
(2) Molecules that result from the replication of those described
in paragraph (1) of this definition.
* * * * *
Security barrier. A physical structure that is designed to prevent
entry by unauthorized persons.
* * * * *
Synthetic nucleic acids. (1) Molecules that are chemically or by
other means synthesized or amplified, including those that are
chemically or otherwise modified but can base pair with naturally
occurring nucleic acid molecules (i.e., synthetic nucleic acids); or
(2) Molecules that result from the replication of those described
in paragraph (1) of this definition.
* * * * *
0
17. Section 121.3 is amended as follows:
0
a. By adding a sentence at the end of paragraph (a);
0
b. By revising paragraph (b);
0
c. In paragraph (c) introductory text, by adding the words ``and/or
synthetic'' after the word ``recombinant'' each time it appears;
0
d. In paragraph (c)(2), by adding the words ``and/or synthetic'' after
the word ``Recombinant'';
0
e. By adding paragraph (d)(3);
0
f. By revising paragraph (e); and
[[Page 61078]]
0
g. In paragraph (f)(3)(i), by removing the words ``Newcastle disease
virus``(velogenic)'' and adding the words ``virulent Newcastle disease
virus'' in their place.
The revisions and additions read as follows:
Sec. 121.3 VS select agents and toxins.
(a) * * * The select agents and toxins marked with an asterisk (*)
are designated as Tier 1 select agents and toxins and are subject to
additional requirements as listed in this part.
(b) VS select agents and toxins: African horse sickness virus;
African swine fever virus; Avian influenza virus; Classical swine fever
virus; *Foot-and-mouth disease virus; Goat pox virus; Lumpy skin
disease virus; Mycoplasma capricolum; Mycoplasma mycoides; Newcastle
disease virus; \1\ Peste des petits ruminants virus; *Rinderpest virus;
Sheep pox virus; Swine vesicular disease virus.
---------------------------------------------------------------------------
\1\ A virulent Newcastle disease virus (avian paramyxovirus
serotype 1) 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.
---------------------------------------------------------------------------
* * * * *
(d) * * *
(3) Any low pathogenic strains of avian influenza virus, any strain
of Newcastle disease virus which does not meet the criteria for
virulent Newcastle disease virus, 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 verify that the agent is within the exclusion
category.
(e) An attenuated strain of a select agent or an inactive form of a
select toxin may be excluded from the requirements of this part based
upon a determination by the Administrator that the attenuated strain or
inactivated toxin does not pose a severe threat to animal health or to
animal products.
(1) To apply for exclusion, an individual or entity must submit a
written request and supporting scientific information. A written
decision granting or denying the request will be issued. An exclusion
will be effective upon notification to the applicant. Exclusions will
be listed on the National Select Agent Registry Web site at https://www.selectagents.gov/.
(2) If an excluded attenuated strain or inactivated toxin is
subjected to any manipulation that restores or enhances its virulence
or toxic activity, the resulting select agent or toxin will be subject
to the requirements of this part.
* * * * *
0
18. Section 121.4 is amended as follows:
0
a. By adding a sentence at the end of paragraph (a);
0
b. By revising paragraph (b);
0
c. In paragraph (c) introductory text, by adding the words ``and/or
synthetic'' after the word ``recombinant'' each time it appears;
0
d. In paragraph (c)(2) introductory text, by adding the phrase ``and/or
synthetic'' after the word ``Recombinant'';
0
e. By adding paragraph (d)(3);
0
f. By revising paragraph (e); and
0
g. In paragraph (f)(3)(i), by removing the words ``Brucella melitensis,
Hendra virus, Nipah virus, Rift Valley fever virus, and Venezuelan
equine encephalitis virus'' and adding the words ``Burkholderia mallei,
and Burkholderia pseudomallei'' in their place.
The revisions and additions read as follows:
Sec. 121.4 Overlap select agents and toxins.
(a) * * * The select agents and toxins marked with an asterisk (*)
are designated as Tier 1 select agents and toxins and are subject to
additional requirements as listed in this part.
(b) Overlap select agents and toxins: *Bacillus anthracis; Bacillus
anthracis (Pasteur strain); Brucella abortus; Brucella melitensis;
Brucella suis; *Burkholderia mallei; *Burkholderia pseudomallei; Hendra
virus; Nipah virus; Rift Valley fever virus; Venezuelan equine
encephalitis virus.
* * * * *
(d) * * *
(3) Any subtypes of Venezuelan equine encephalitis virus except for
Subtypes IAB or IC, provided that the individual or entity can verify
that the agent is within the exclusion category.
(e) An attenuated strain of a select agent or an inactive form of a
select toxin may be excluded from the requirements of this part based
upon a determination by the HHS Secretary or Administrator that the
attenuated strain or inactivated toxin does not pose a severe threat to
public health and safety, to animal health or to animal products.
(1) To apply for exclusion, an individual or entity must submit a
written request and supporting scientific information. A written
decision granting or denying the request will be issued. An exclusion
will be effective upon notification to the applicant. Exclusions will
be listed on the National Select Agent Registry Web site at https://www.selectagents.gov/.
(2) If an excluded attenuated strain or inactivated toxin is
subjected to any manipulation that restores or enhances its virulence
or toxic activity, the resulting select agent or toxin will be subject
to the requirements of this part.
* * * * *
Sec. 121.5 [Amended]
0
19. In Sec. 121.5, paragraph (a)(3)(i) is amended by removing the
words ``bovine spongiform encephalopathy agent,''.
0
20. Section 121.6 is amended as follows:
0
a. In paragraph (a)(3)(i) by removing the words ``Brucella melitensis,
Hendra virus, Nipah virus, Rift Valley fever virus, and Venezuelan
equine encephalitis virus'' and adding the words ``Burkholderia mallei,
and Burkholderia pseudomallei'' in their place; and
0
b. By revising paragraph (e) to read as follows:
Sec. 121.6 Exemptions for overlap select agents and toxins.
* * * * *
(e) The Administrator may exempt an individual or entity from the
requirements of this part for 30 calendar days if it is necessary to
respond to a domestic or foreign agricultural emergency involving an
overlap select agent or toxin. The Administrator may extend the
exemption once for an additional 30 days.
* * * * *
0
21. Section 121.9 is amended as follows:
0
a. In paragraph (a)(4), by removing the word ``and'';
0
b. By redesignating paragraph (a)(5) as paragraph (a)(6);
0
c. By adding a new paragraph (a)(5);
0
d. By revising the first sentence of paragraph (b); and
0
e. By revising the first sentence of paragraph (c)(1).
The addition and revisions read as follows:
Sec. 121.9 Responsible official.
(a) * * *
(5) Have a physical (and not merely a telephonic or audio/visual)
presence at the registered entity to ensure that the entity is in
compliance with the select agent regulations and be able to respond in
a timely manner to onsite incidents involving select agents and toxins
in
[[Page 61079]]
accordance with the entity's incident response plan; and
* * * * *
(b) An entity may designate one or more individuals to serve as an
alternate responsible official who acts for the responsible official in
his/her absence. * * *
(c) * * *
(1) The identification of any of the following select agents or
toxins must be immediately reported by telephone, facsimile, or email:
African horse sickness virus, African swine fever virus, avian
influenza virus (highly pathogenic), Bacillus anthracis, Burkholderia
mallei, Burkholderia pseudomallei, classical swine fever virus, foot-
and-mouth disease virus, virulent Newcastle disease virus, rinderpest
virus, and swine vesicular disease virus. * * *
* * * * *
0
22. Section 121.10 is amended as follows:
0
a. By redesignating paragraphs (e) through (j) as paragraphs (f)
through (k), respectively;
0
b. By adding a new paragraph (e); and
0
c. In newly redesignated paragraph (j), by removing the number ``5''
and adding the number ``3'' in its place.
The addition reads as follows:
Sec. 121.10 Restricting access to select agents and toxins; security
risk assessments.
* * * * *
(e) 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
Administrator provide their approved access status to another
registered individual or entity for a specified period of time.
* * * * *
0
23. Section 121.11 is amended as follows:
0
a. By revising paragraph (b);
0
b. By revising paragraph (c)(2);
0
c. In paragraph (c)(6), by removing the word ``and'';
0
d. By adding new paragraphs (c)(8), (9), and (10);
0
e. By redesignating paragraphs (e) and (f) as paragraphs (g) and (h),
respectively;
0
f. By adding new paragraphs (e) and (f); and
0
g. By revising newly redesignated paragraph (g).
The revisions and additions read as follows:
Sec. 121.11 Security.
* * * * *
(b) The security plan must be designed according to a site-specific
risk assessment and must provide graded protection in accordance with
the risk of the select agent or toxin, given its intended use. A
current security plan must be submitted for initial registration,
renewal of registration, or when requested.
(c) * * *
(2) Contain provisions for the control of access to select agents
and toxins, including the safeguarding of animals or plants
intentionally or accidentally exposed to or infected with a select
agent, against unauthorized access, theft, loss or release.
* * * * *
(8) Describe procedures for how the responsible official will be
informed of suspicious activity that may be criminal in nature and
related to the entity, its personnel, or its select agents or toxins;
and describe procedures for how the entity will notify the appropriate
Federal, State, or local law enforcement agencies of such activity.
(9) Contain provisions for information security that:
(i) Ensure that all external connections to systems which manage
security for the registered space are isolated or have controls that
permit only authorized and authenticated users;
(ii) Ensure that authorized and authenticated users are only
granted access to select agent and toxin related information, files,
equipment (e.g., servers or mass storage devices), and applications as
necessary to fulfill their roles and responsibilities, and that access
is modified when the user's roles and responsibilities change or when
their access to select agents and toxins is suspended or revoked;
(iii) Ensure that controls are in place that are designed to
prevent malicious code (such as, but not limited to, computer viruses,
worms, spyware) from compromising the confidentiality, integrity, or
availability of information systems which manage access to spaces
registered under this part or records as specified in Sec. 121.17;
(iv) Establish a robust configuration management practice for
information systems to include regular patching and updates made to
operating systems and individual applications; and
(v) Establish procedures that provide backup security measures in
the event that access control systems, surveillance devices, and/or
systems that manage the requirements of Sec. 121.17 are rendered
inoperable.
(10) Contain provisions and policies for shipping, receiving, and
storage of select agents and toxins, including documented procedures
for receiving, monitoring, and shipping of all select agents and
toxins. These provisions must provide that an entity will properly
secure containers on site and have a written contingency plan for
unexpected shipments.
* * * * *
(e) Entities must conduct complete inventory audits of all affected
select agents and toxins in long-term storage when any of the following
occur:
(1) Upon the physical relocation of a collection or inventory of
select agents or toxins for those select agents or toxins in the
collection or inventory;
(2) Upon the departure or arrival of a principal investigator for
those select agents and toxins under the control of that principal
investigator; or
(3) In the event of a theft or loss of a select agent or toxin, all
select agents and toxins under the control of that principal
investigator.
(f) In addition to the requirements contained in paragraphs (c) and
(d) of this section, the security plan for an individual or entity
possessing a Tier 1 select agent or toxin must also:
(1) Describe procedures for conducting a pre-access suitability
assessment of persons who will have access to a Tier 1 select agent or
toxin;
(2) Describe procedures for how an entity's responsible official
will coordinate their efforts with the entity's safety and security
professionals to ensure security of Tier 1 select agents and toxins and
share, as appropriate, relevant information; and
(3) Describe procedures for the ongoing assessment of the
suitability of personnel with access to a Tier 1 select agent or toxin.
The procedures must include:
(i) Self- and peer-reporting of incidents or conditions that could
affect an individual's ability to safely have access to or work with
select agents and toxins, or to safeguard select agents and toxins from
theft, loss, or release;
(ii) The training of employees with access to Tier 1 select agents
and toxins on entity policies and procedures for reporting, evaluation,
and corrective actions concerning the assessment of personnel
suitability; and
(iii) The ongoing suitability monitoring of individuals with access
to Tier 1 select agents and toxins.
(4) Entities with Tier 1 select agents and toxins must prescribe
the following security enhancements:
(i) Procedures that will limit access to a Tier 1 select agent or
toxin to only those individuals who are approved by the HHS Secretary
or Administrator
[[Page 61080]]
following a security risk assessment by the Attorney General, have had
an entity-conducted pre-access suitability assessment, and are subject
to the entity's procedures for ongoing suitability assessment;
(ii) Procedures that limit access to laboratory and storage
facilities outside of normal business hours to only those specifically
approved by the responsible official or designee;
(iii) Procedures for allowing visitors, their property, and
vehicles at the entry and exit points to the registered space, or at
other designated points of entry to the building, facility, or compound
that are based on the entity's site-specific risk assessment;
(iv) A minimum of three security barriers where each security
barrier adds to the delay in reaching secured areas where select agents
and toxins are used or stored. One of the security barriers must be
monitored in such a way as to detect intentional and unintentional
circumventing of established access control measures under all
conditions (day/night, severe weather, etc.) The final barrier must
limit access to the select agent or toxin to personnel approved by the
HHS Secretary or Administrator, following a security risk assessment by
the Attorney General.
(v) All registered space or areas that reasonably afford access to
the registered space must be protected by an intrusion detection system
(IDS) unless physically occupied;
(vi) Personnel monitoring the IDS must be capable of evaluating and
interpreting the alarm and alerting the designated security response
force or law enforcement;
(vii) For powered access control systems, describe procedures to
ensure that security is maintained in the event of the failure of
access control systems due to power disruption affecting registered
space;
(viii) The entity must:
(A) Determine that the response time for security forces or local
police will not exceed 15 minutes where the response time is measured
from the time of an intrusion alarm, or report of a security incident,
to the arrival of the responders at the first security barrier or;
(B) Provide security barriers that are sufficient to delay
unauthorized access until the response force arrives in order to
safeguard the select agents and toxins from theft, intentional release,
or unauthorized access. The response time is measured from the time of
an intrusion alarm, or report of a security incident, to the arrival of
the responders at the first security barrier.
(5) Entities that possess foot-and-mouth disease virus and
rinderpest virus must have the following additional security
requirements:
(i) A minimum of four barriers, one of which must be a perimeter
security fence or equivalent which is monitored 24 hours a day, 7 days
a week (24/7) to detect the presence of unauthorized persons, vehicles,
materials, or unauthorized activities;
(ii) Onsite 24/7 armed security response force with roving patrol.
Response time must not exceed 5 minutes from the time of an intrusion
alarm or report of a security incident;
(iii) CCTV surveillance with 24/7 monitoring and recording; and
(iv) Transport vehicle with GPS tracking designed to serve as a
containment vehicle.
(g) In developing a security plan, an individual or entity should
consider the document entitled, ``Security Guidance for Select Agent or
Toxin Facilities.'' This document is available on the Internet at
https://www.selectagents.gov/.
* * * * *
0
24. Section 121.12 is amended as follows:
0
a. By revising paragraph (a);
0
b. By revising paragraph (c)(1);
0
c. By adding a second sentence to paragraph (c)(2);
0
d. In paragraph (c)(3), by removing the address ``https://www.aphis.usda.gov/programs/ag_selectagent/ '' and adding in
its place ``https://www.selectagents.gov/ '';
0
e. By redesignating paragraph (d) as paragraph (e); and
0
f. By adding a new paragraph (d).
The revisions and addition 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.\9\ 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.
---------------------------------------------------------------------------
\9\ Technical assistance and guidance may be obtained by
contacting APHIS.
---------------------------------------------------------------------------
* * * * *
(c) * * *
(1) The CDC/NIH publication, ``Biosafety in Microbiological and
Biomedical Laboratories.'' This document is available on the National
Select Agent Registry at https://www.selectagents.gov/.
(2) * * * This document is available on the National Select Agent
Registry at https://www.selectagents.gov/.
* * * * *
(d) The biosafety plan must include an occupational health program
for individuals with access to Tier 1 select agents and toxins, and
those individuals must be enrolled in the occupational health program.
* * * * *
0
25. Section 121.13 is amended by removing footnote 10 and revising
paragraphs (a) and (b) to read as follows:
Sec. 121.13 Restricted experiments.
(a) An individual or entity may not conduct, or possess products
(i.e., select agents that are not known to acquire a drug resistance
trait naturally, if such acquisition could compromise the control of
disease agents in humans, veterinary medicine, or agriculture, or
recombinant and/or synthetic nucleic acids containing genes for the
biosynthesis of select toxins lethal for vertebrates at an LD[50] < 100
ng/kg body weight) resulting from, the following experiments unless
approved by and conducted in accordance with the conditions prescribed
by the Administrator:
(b) Restricted experiments: (1) Experiments that involve the
deliberate transfer of, or selection for, a drug resistance trait to
select agents that are not known to acquire the trait naturally, if
such acquisition could compromise the control of disease agents in
humans, veterinary medicine, or agriculture.
(2) Experiments involving the deliberate formation of synthetic or
recombinant nucleic acids containing genes for the biosynthesis of
select toxins lethal for vertebrates at an LD[50]<100 ng/kg body
weight.
* * * * *
0
26. Section 121.14 is amended as follows:
0
a. In the section heading, by redesignating footnote 11 as footnote 10;
0
b. In paragraph (a), by redesignating footnote 12 as footnote 11 and
revising the first sentence of paragraph (a);
0
c. By revising paragraph (b);
0
d. By redesignating paragraphs (c) and (d) as paragraphs (d) and (f),
respectively; and
0
e. By adding new paragraphs (c) and (e).
The revisions and additions read as follows:
[[Page 61081]]
Sec. 121.14 Incident response.\10\
---------------------------------------------------------------------------
\10\ Nothing in this section is meant to supersede or preempt
incident response requirements imposed by other statutes or
regulations.
---------------------------------------------------------------------------
(a) An individual or entity required to register under this part
must develop and implement a written incident response plan \11\ based
upon a site specific risk assessment. * * *
---------------------------------------------------------------------------
\11\ Technical assistance and guidance may be obtained by
contacting APHIS.
---------------------------------------------------------------------------
(b) The incident response plan must fully describe the entity's
response procedures for the 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, and other
natural and man-made events.
(c) The response procedures must account for hazards associated
with the select agent or toxin and appropriate actions to contain such
select agent or toxin, including any animals (including arthropods) or
plants intentionally or accidentally exposed to or infected with a
select agent.
* * * * *
(e) Entities with Tier 1 select agents and toxins must have the
following additional incident response policies or procedures:
(1) The incident response plan must fully describe the entity's
response procedures for failure of intrusion detection or alarm system;
and
(2) The incident response plan must describe procedures for how the
entity will notify the appropriate Federal, State, or local law
enforcement agencies of suspicious activity that may be criminal in
nature and related to the entity, its personnel, or its select agents
or toxins.
* * * * *
0
27. Section 121.15 is revised to read as follows:
Sec. 121.15 Training.
(a) An individual or entity required to register under this part
must provide information and training on biosafety, security (including
security awareness), and incident response to:
(1) Each individual with access approval from the HHS Secretary or
Administrator before that individual has such access to select agents
and toxins. The training must address the particular needs of the
individual, the work they will do, and the risks posed by the select
agents or toxins; and
(2) Each individual not approved for access to select agents and
toxins by the HHS Secretary or Administrator before that individual
enters areas where select agents or toxins are handled or stored (e.g.,
laboratories, growth chambers, animal rooms, greenhouses, storage
areas, shipping/receiving areas, production facilities, etc.). Training
for escorted personnel must be based on the risk associated with
accessing areas where select agents and toxins are used and/or stored.
(b) Entities with Tier 1 select agents and toxins must conduct
annual insider threat awareness briefings on how to identify and report
suspicious behaviors.
(c) Refresher training must be provided annually for individuals
with access approval from the HHS Secretary or Administrator or at such
time as the registered individual or entity significantly amends its
security, incident response, or biosafety plans.
(d) The responsible official must ensure a record of the training
provided to each individual with access to select agents and toxins and
each escorted individual (e.g., laboratory workers, visitors, etc.) is
maintained. The record must include the name of the individual, the
date of the training, a description of the training provided, and the
means used to verify that the employee understood the training.
0
28. Section 121.16 is amended as follows:
0
a. By redesignating footnote 14 as footnote 12;
0
b. By redesignating paragraphs (f) through (i) as paragraphs (i), (j),
(k), and (g), respectively;
0
c. By adding a new paragraph (f);
0
d. In newly redesignated paragraph (g), by removing the words
``packaging and''; and
0
e. By adding a new paragraph (h).
The additions read as follows:
Sec. 121.16 Transfers.
* * * * *
(f) After authorization is provided by APHIS or CDC, the packaging
of the select agent(s) and toxin(s) is performed by an individual
approved by the HHS Secretary or Administrator to have access to select
agents and toxins and is in compliance with all applicable laws
concerning packaging.
* * * * *
(h) Transportation in commerce starts when the select agent(s) or
toxin(s) are packaged for shipment and ready for receipt by a courier
transporting select agent(s) or toxin(s) and ends when the package is
received by the intended recipient who is an individual approved by the
HHS Secretary or Administrator to have access to select agents and
toxins, following a security risk assessment by the Attorney General.
* * * * *
0
29. Section 121.17 is amended as follows:
0
a. By revising paragraph (a)(1) introductory text;
0
b. By redesignating paragraphs (a)(2) through (6) as paragraphs (a)(3)
through (7), respectively; and
0
c. By adding a new paragraph (a)(2).
The revision and addition read as follows:
Sec. 121.17 Records.
(a) * * *
(1) 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 (placement in a system designed to ensure
viability for future use, such as in a freezer or lyophilized
materials), including:
* * * * *
(2) An accurate, current accounting of any animals or plants
intentionally or accidentally exposed to or infected with a select
agent (including number and species, location, and appropriate
disposition);
* * * * *
0
30. Section 121.20 is revised to read as follows:
Sec. 121.20 Administrative review.
(a) An individual or entity may appeal a denial, revocation, or
suspension of registration under this part. The appeal must be in
writing, state the factual basis for the appeal, and be submitted to
the Administrator within 30 calendar days of the decision.
(b) An individual may appeal a denial, limitation, or revocation of
access approval under this part. The appeal must be in writing, state
the factual basis for the appeal, and be submitted to the Administrator
within 180 calendar days of the decision.
(c) The Administrator's decision constitutes final agency action.
Done in Washington, DC, this 28th day of September 2012.
Edward Avalos,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2012-24434 Filed 10-2-12; 11:15 am]
BILLING CODE 3410-34-P
