Possession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus Cereus Biovar Anthracis to the HHS List of Select Agents and Toxins, 63138-63143 [2016-22049]
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63138
Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. GSA has determined that this
final rule is not a significant regulatory
action is not subject to review under
section 6(b) of Executive Order 12866.
GSA has further determined that this
final rule is not a major rule under 5
U.S.C. 804.
D. Regulatory Flexibility Act
This final rule will not have a
significant economic impact on a
substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq. This
final rule is also exempt from the
Administrative Procedure Act pursuant
to 5 U.S.C. 553(a)(2) because it applies
to agency management or personnel.
E. Paperwork Reduction Act
The Paperwork Reduction Act does
not apply because the changes to the
FTR do not impose recordkeeping or
information collection requirements, or
the collection of information from
offerors, contractors, or members of the
public that require the approval of the
Office of Management and Budget
(OMB) under 44 U.S.C. 3501, et seq.
F. Small Business Regulatory
Enforcement Fairness Act
This final rule is also exempt from
Congressional review prescribed under
5 U.S.C. 801. This final rule is not a
major rule under 5 U.S.C. 804.
List of Subjects in 41 CFR Parts 301–51
and 301–70
Government employees, Travel and
transportation expenses, Paying travel
expenses, Internal policy and procedure
requirements.
Dated: August 3, 2016.
Denise Turner Roth,
Administrator of General Services.
For the reasons set forth in the
preamble, pursuant to 5 U.S.C. 5701–
5711, GSA amends 41 CFR parts 301–
51 and 301–70 as set forth below:
asabaliauskas on DSK3SPTVN1PROD with RULES
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§§ 301–51.3 through 301–51.8
[Redesignated as §§ 301–51.4 through 301–
51.9]
4. Redesignate §§ 301–51.3 through
301–51.8 as §§ 301–51.4 through 301–
51.9, respectively.
■ 5. Add a new § 301–51.3 to read as
follows:
■
§ 301–51.3 What classes of employees are
exempt from mandatory use of the
Government contractor-issued travel
charge card?
The Administrator of General Services
exempts the following classes of
employees from mandatory use of the
Government contractor-issued travel
charge card:
(a) Any employee who has an
application pending for the Government
contractor-issued travel charge card;
(b) Any employee, when issuance of
the Government contractor-issued travel
charge card would adversely affect the
mission or put the employee at risk; and
(c) Any employee who is not eligible
to receive a Government contractorissued travel charge card.
[Amended]
PART 301–70—INTERNAL POLICY
AND PROCEDURE REQUIREMENTS
Authority: 5 U.S.C. 5707. Subpart A is
issued under the authority of Sec. 2, Pub. L.
105–264, 112 Stat. 2350 (5 U.S.C. 5701 note);
40 U.S.C. 121(c).
20:49 Sep 13, 2016
Expenses for which payment through
the Government contractor-issued travel
charge card is impractical (e.g., vendor
does not accept credit cards) or imposes
unreasonable burdens or costs (e.g., fees
are charged for using the card) are
exempt from use of the travel charge
card. Your agency may also exempt an
official travel expense when it is
necessary in the interest of the agency
(see § 301–51.4).
6. In the newly designated § 301–51.6,
after paragraph (c), revise the heading of
the note to read ‘‘Note to § 301–51.6’’.
1. The authority citation for 41 CFR
part 301–51 continues to read as
follows:
VerDate Sep<11>2014
§ 301–51.2 Are there any official travel
expenses that are exempt from the
mandatory use of the Government
contractor-issued travel charge card?
■
■
2. Revise § 301–51.1 to read as
follows:
You are required to activate the
Government contractor-issued travel
charge card once you receive it, and
then use it as the method of payment for
all official travel expenses unless
exempted under § 301–51.2.
■ 3. Revise § 301–51.2 to read as
follows:
§ 301–51.6
PART 301–51—PAYING TRAVEL
EXPENSES
■
§ 301–51.1 How must I use the
Government contractor-issued travel
charge card?
7. The authority citation for 41 CFR
part 301–70 continues to read as
follows:
■
Authority: 5 U.S.C. 5707; 40 U.S.C. 121(c);
Sec. 2, Pub. L. 105–264, 112 Stat. 2350 (5
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Fmt 4700
Sfmt 4700
U.S.C. 5701, note), OMB Circular No. A–126,
revised May 22, 1992, and OMB Circular No.
A–123, Appendix B, revised January 15,
2009.
§ 301–70.702
[Amended]
8. Amend § 301–70.702 by removing
‘‘MTT’’ and adding ‘‘MAE’’ in its place.
■ 9. Revise § 301–70.704 to read as
follows:
■
§ 301–70.704 What classes of employees
are exempt from mandatory use of the
Government contractor-issued travel
charge card?
The Administrator of General Services
exempts the following classes of
employees from mandatory use of the
Government contractor-issued travel
charge card:
(a) Any employee who has an
application pending for the Government
contractor-issued travel charge card;
(b) Any employee, when issuance of
the Government contractor-issued travel
charge card would adversely affect the
mission or put the employee at risk; and
(c) Any employee who is not eligible
to receive a Government contractorissued travel charge card.
■ 10. Revise § 301–70.708 to read as
follows:
§ 301–70.708 What actions may we take if
an employee fails to activate the
Government contractor-issued travel
charge card and/or misuses the travel
charge card?
Internal agency policies and
procedures should be established
defining what are considered to be
misuses of the Government contractorissued travel charge card. Appropriate
action may be taken pursuant to those
policies if an employee fails to activate
the Government contractor-issued travel
charge card within 60 days of receipt or
misuses the travel charge card.
[FR Doc. 2016–21987 Filed 9–13–16; 8:45 am]
BILLING CODE 6820–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 73
[CDC Docket No. CDC–2016–0045]
RIN 0920–AA64
Possession, Use, and Transfer of
Select Agents and Toxins—Addition of
Bacillus Cereus Biovar Anthracis to
the HHS List of Select Agents and
Toxins
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
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Interim final rule and request
for comments.
Dr.
Samuel Edwin, Director, Division of
Select Agents and Toxins, Centers for
SUMMARY: The Centers for Disease
Disease Control and Prevention, 1600
Control and Prevention (CDC) in the
Clifton Road NE., MS–A46, Atlanta,
Department of Health and Human
Georgia 30329. Telephone: (404) 718–
Services (HHS) is adding Bacillus cereus 2000.
Biovar anthracis to the list of HHS select
SUPPLEMENTARY INFORMATION: The
agents and toxins as a Tier 1 select
interim final rule is organized as
agent. We are taking this action to
follows:
regulate this agent that is similar to B.
anthracis to prevent its misuse, which
I. Public Participation
could cause a biological threat to public II. Background
A. Legal Authority
health and/or national security.
B. Historical Background to This
DATES:
Rulemaking
Effective date: The interim final rule
III. Rationale for Issuance of an Interim Final
is effective on October 14, 2016.
Rule
Public comment period: Written or
IV. Alternatives Considered
electronic comments must be submitted V. Required Regulatory Analyses
by November 14, 2016.
A. Executive Orders 12866 and 13563
Applicability dates: By October 14,
B. The Regulatory Flexibility Act
2016, any individual or entity that
C. Paperwork Reduction Act of 1995
D. EO 12988: Civil Justice Reform
possesses B. cereus Biovar anthracis
E. EO 13132: Federalism
must provide notice to the CDC’s DSAT
F. Plain Language Act of 2010
regarding their possession of this agent
VI. References
and must secure the agent against theft,
loss, release, or unauthorized access;
I. Public Participation
and by March 13, 2017, an individual or
Interested persons or organizations
entity that intends to continue to
are invited to participate in this
possess, use, or transfer this agent will
rulemaking by submitting written views,
be required to either register in
recommendations, and data. HHS/CDC
accordance with 42 CFR part 73 or
invites comments on the following
amend their current registration in
questions:
accordance with 42 CFR 73.7(h) and
(1) Are there other virulent (pBCXO1+ and
meet all of the requirements of select
pBCXO2+) strains of Bacillus species that
agent regulations (42 CFR part 73).
should also be regulated?
ADDRESSES: You may submit comments,
(2) What is the impact of designating B.
identified by Docket No. CDC–2016–
cereus Biovar anthracis as a Tier 1 select
0045 or RIN 0920–AA64 by any of the
agent?
following methods:
Comments received, including
• Federal eRulemaking Portal: https://
attachments and other supporting
www.regulations.gov. Follow the
materials, are part of the public record
instructions for submitting comments.
and subject to public disclosure. Do not
• Mail: Dr. Samuel Edwin, Director,
include any information in your
Division of Select Agents and Toxins,
comment or supporting materials that
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS– you consider confidential or
inappropriate for public disclosure.
A46, Atlanta, Georgia 30329, Attn:
HHS/CDC will consider comments that
Docket CDC–2016–0045
Instructions: All submissions received are received within 60 days of
publication of this rule in the Federal
must include the agency name and
Register. After the comment period
docket number or Regulatory
closes, we will publish another
Information Number (RIN) for this
document in the Federal Register. The
rulemaking. All relevant comments
document will include a discussion of
received will be posted without change
any comments we receive and any
to https://regulations.gov, including any
amendments that will be made to the
personal information provided. For
access to the docket to read background rule as a result of the comments.
documents or comments received, go to II. Background
https://www.regulations.gov.
A. Legal Authority
Comments will also be available for
public inspection from Monday through
HHS/CDC is promulgating this rule
Friday, except for legal holidays, from 9 under the authority of sections 201–204
a.m. to 5 p.m., Eastern Time, at 1600
and 221 of Title II of Public Law 107–
Clifton Road NE., Atlanta, Georgia
188, 116 Stat 637 (42 U.S.C. 262a).
30329. Please call ahead to (404) 718–
Subtitle A of Title II of the Public
2000 and ask for a representative from
Health Security and Bioterrorism
the Division of Select Agents and
Preparedness and Response Act of 2002,
Toxins to schedule your visit.
(42 U.S.C. 262a), requires HHS to
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ACTION:
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FOR FURTHER INFORMATION CONTACT:
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63139
regulate the possession, use, and
transfer of biological agents or toxins
that the HHS Secretary determines have
the potential to pose a severe threat to
public health and safety (select agents
and toxins). Subtitle B of Title II of the
Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
(which may be cited as the Agricultural
Bioterrorism Protection Act of 2002), (7
U.S.C. 8401), requires the United States
Department of Agriculture (USDA) to
regulate the possession, use, and
transfer of biological agents or toxins
that the USDA Secretary determines
have the potential to pose a severe
threat to animal or plant health, or
animal or plant products (select agents
and toxins). Accordingly, HHS and
USDA have promulgated regulations
requiring individuals or entities that
possess, use, or transfer select agents
and toxins to register with HHS/CDC or
USDA/Animal and Plant Health
Inspection Service (APHIS). See 42 CFR
part 73, 7 CFR part 331, and 9 CFR part
121 (the select agent regulations). The
Federal Select Agent Program, a
collaboration of HHS/CDC/Division of
Select Agents and Toxins and USDA/
APHIS/Agriculture Select Agent
Services, administers the select agent
regulations in a manner that minimizes
the administrative burden on persons
subject to the select agent regulations.
USDA/APHIS is currently considering
whether B. cereus Biovar anthracis
should also be listed as a USDA select
agent.
B. Historical Background to This
Rulemaking
Emerging B. cereus strains that cause
anthrax-like disease have been isolated
ˆ
in Cameroon (CA strain) and Cote
d’Ivoire (CI strain). We are currently
aware that geographic distribution of B.
cereus Biovar anthracis is limited to
some African countries, one registered
entity in the United States, and one
facility in Germany. The B. cereus strain
being added to the HHS list of select
agents is identified as B. cereus Biovar
anthracis and described in the
publication ‘‘Characterization of
Bacillus anthracis-like bacteria isolated
from wild great apes from Cote d’Ivoire
and Cameroon’’ (Ref. 3, see table below).
Recent research demonstrates that B.
cereus Biovar anthracis has all of the
virulence determinants and threat
potential of Bacillus anthracis, a Tier 1
select agent (Ref. 1). A biovar is a group
of microorganisms that are genetically
similar but differ from other members of
the species by biochemical or genetic
characteristics. B. cereus Biovar
anthracis was originally isolated about
a decade ago from gorillas and
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Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations
chimpanzees exhibiting anthrax-like
disease in Cameroon and Cote d’Ivoire
(Ref. 3–6). Genomic characterization
showed that these organisms belong to
the B. cereus species and harbor two
plasmids that are referred to as pBCXO1
and pBCXO2. The plasmid (pBCXO1) is
very similar to pXO1, which is found in
B. anthracis, and encodes active edema
and lethal toxins. The plasmid
(pBCXO2) is very similar to pXO2,
which is found in B. anthracis, and
encodes the enzymes that synthesize the
poly-D-glutamic acid capsule. Thus,
these organisms are genetically similar
and produce all of the primary virulence
factors (toxins and capsule) of B.
anthracis. In addition, pBCXO2 has a
functional hasACB operon that encodes
a second capsule composed of
hyaluronic acid (HA), which enhances
the neuro-invasiveness of these
organisms in laboratory models of
infection (Ref. 1). Accordingly, because
we believe that B. cereus Biovar
anthracis has the same potential to pose
a severe threat to public health as does
Bacillus anthracis, currently regulated
as a Tier 1 pathogen, we are adding
Bacillus cereus Biovar anthracis to HHS
select agent list by an interim final rule
because we believe that any delay in
bringing the possession, use, or transfer
into the United States of this pathogen
is contrary to the public interest. A
biological agent is designated as Tier 1
when it is determined that it presents
the greatest risk of deliberate misuse
with significant potential for mass
casualties or devastating effect to the
economy, critical infrastructure, or
public confidence, and poses a severe
threat to public health and safety. We
believe that Bacillus cereus Biovar
anthracis presents the same threat to
public health and national security as
does Bacillus anthracis.
In December 2015, the question of
whether B. cereus Biovar anthracis
should be regulated as a select agent
was considered by HHS/CDC’s
Intragovernmental Select Agents and
Toxins Technical Advisory Committee
(ISATTAC). The ISATTAC is comprised
of Federal government employees from
CDC, the Biomedical Advanced
Research and Development Authority
(BARDA) within the Office of the
Assistant Secretary for Preparedness
and Response (ASPR), the National
Institutes of Health (NIH), the Food and
Drug Administration (FDA), the
Department of Homeland Security
(DHS), the Department of Defense
(DOD), the USDA/Animal and Plant
Health Inspection Service (APHIS),
USDA/Agricultural Research Service
(ARS), and USDA Center for Veterinary
Biologics (CVB). Based on the criteria
outlined in the Public Health Security
and Bioterrorism Preparedness and
Response Act of 2002 (42 U.S.C. 262a),
the ISATTAC considered the following
in their review: The degree of
pathogenicity (ability of an organism to
cause disease), communicability (ability
to spread from infected to susceptible
hosts), ease of dissemination, route of
exposure, environmental stability, ease
of production in the laboratory, ability
to genetically manipulate or alter, longterm health effects, untreated acute
mortality, available therapeutics and
vaccines, status of immunity,
vulnerability of special populations, and
the burden or impact on the health care
system. The ISATTAC also considered
whether B. cereus Biovar anthracis
should be designated as a Tier 1 select
agent. Executive Order 13546,
‘‘Optimizing the Security of Biological
Select Agents and Toxins in the United
States,’’ defines as ‘‘Tier 1’’ those select
agents and 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 (Ref. 7). At this time,
HHS/CDC is not proposing to regulate
other strains of B. cereus that have B.
anthracis toxin genes as the data
available do not suggest those strains
pose a severe threat to public health
(Ref. 1 and Ref. 8).
The table below comes from
‘‘Bacteriological discrimination
characteristics of atypical B. anthracis
strains isolated from great apes, classic
B. anthracis strains, and other strains of
the B. cereus group’’ (Ref. 3).
Result a
B. anthracis CI
Microbiological characteristic
Primary
culture
Hemolysis .........................................................................................
Motility ...............................................................................................
Susceptibility to gamma phage ........................................................
Penicillin G ........................................................................................
Capsule .............................................................................................
a S,
¥
+
¥
S
+b
Sub
culture
+/¥
+
+/¥
S/R
+/¥
B. anthracis CA
Primary
culture
¥
+
¥
R
+
Sub
culture
+/¥
+
+/¥
R
+/¥
B. anthracis
¥
¥
+
S
+
B. cereus
+
+
¥
R
Absent in
vitro.c
sensitive; R, resistant; ¥, negative; +, positive; +/¥, some subclones positive, others negative.
production on bicarbonate agar under a CO2 atmosphere and on blood agar under an ambient atmosphere.
other Bacillus spp. can produce a polypeptide capsule but not under normal culture conditions.
b Capsule
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c Certain
After reviewing scientific publications
and consulting with subject matter
experts, ISATTAC recommended that B.
cereus Biovar anthracis should be listed
as a HHS select agent and regulated as
Tier 1 agent because:
• Genomic characterization showed
that B. cereus Biovar anthracis belongs
to the B. cereus species, but it harbors
virulence-associated plasmids that are
similar to B. anthracis, a Tier 1 select
agent (Ref. 1–2).
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• Fully virulent (pXO1+ pXO2+)
strains of B. anthracis are currently
regulated as Tier 1 select agent.
• To date, there have been no reports
of this biovar having been isolated from
humans. However, B. cereus Biovar
anthracis exhibited virulence,
comparable to B. anthracis in animal
models of subcutaneous and intranasal/
inhalational anthrax (Ref. 3). Thus, it is
reasonable to assume that B. cereus
Biovar anthracis can infect humans by
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the same routes as B. anthracis. In areas
(Cameroon and Cote d’Ivoire) where B.
cereus Biovar anthracis has been
isolated from gorillas and chimpanzees
(Ref. 4–6), it is possible that isolates
from human cases could be missed due
to the lack of laboratory capacity and to
the thorough characterization needed to
differentiate B. anthracis from B. cereus
Biovar anthracis.
• As with B. anthracis, the virulence
of this strain as a spore-forming
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bacterium may make it attractive to
those that wish to circumvent the select
agent regulations for nefarious purposes.
• PBCXO2—strains of B. cereus
Biovar anthracis (analogous to B.
anthracis veterinary vaccine Sterne
strain) produce a HA capsule from genes
present on pBCXO1. Studies have
shown such variants (pBCXO2¥) are
still as virulent as B. anthracis in animal
models (Ref. 1).
• There is no apparent difference
between this organism and B. anthracis
with respect to the criteria used to
designate B. anthracis as a Tier 1 agent.
In addition, the Federal Experts
Security Advisory Panel (FESAP)
provided policy and technical input for
the recommendation to list B. cereus
Biovar anthracis as an HHS select agent
and regulated as Tier 1 agent. The
mission of the FESAP is to make
technical and substantive
recommendations concerning the
appropriate safeguards and security
standards for persons possessing, using,
or transferring BSAT. The goal of the
FESAP is that their recommendations be
commensurate with the risk that such
agents or toxins pose to public health
and safety, including the risk of their
use in domestic or international
terrorism. The FESAP drew from the
expertise of its membership,
information from presentations by
several federal department and agency
subject matter experts, and technical
input from the Directors of the Federal
Select Agent Program (FSAP) to develop
its recommendation. The FESAP has
issued a draft report that recommended
listing B. cereus biovar anthracis as a
select agent (not Tier 1).
After consideration of all of the above,
HHS/CDC has determined that B. cereus
Biovar anthracis should be listed as a
Tier 1 HHS select agent given its
similarities to B. anthracis, which is
consistent with current regulatory
requirements for B. anthracis.
III. Rationale for Issuance of an Interim
Final Rule
Agency rulemaking is governed by
section 553 of the Administrative
Procedure Act (APA) (5 U.S.C. 553)
which, unless the rule falls within one
of the exemptions, requires that HHS/
CDC publish a notice of proposed
rulemaking in the Federal Register that
provides interested persons an
opportunity to submit written data,
views, or arguments. Section 553(b)(B)
of the APA authorizes a department or
agency to dispense with the prior notice
and opportunity for public comment
requirement for ‘‘good cause’’ if the
department or agency finds that it is
contrary to the public interest.
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B. cereus Biovar anthracis has all of
the virulence characteristics and threat
potential of Bacillus anthracis, which is
already regulated as a Tier 1 select
agent. Accordingly, for the reasons
stated above, we have determined that
B. cereus Biovar anthracis not only also
has the potential to pose a severe threat
to public health and safety; but that it
may present a great risk for deliberate
misuse with a significant potential for
mass casualties or devastating effects to
the economy, critical infrastructure; or
public confidence. We are taking this
action to place this agent under the
biosafety and security requirements of
the select agent regulations; and to
regulate its possession and transfer to
prevent an accidental release or its
misuse. We believe this interim final
rule is in the best interest of public
health and national security.
Pursuant to 5 U.S.C. 553(b)(3)(B), and
for the reasons stated above, we
therefore find that there is good cause to
dispense with prior public notice and
the opportunity to comment on this rule
before it becomes effective because any
delay in promulgating the rule would be
contrary to the public interest.
required by these Executive Orders and
has determined that it is consistent with
the principles set forth in the Executive
Orders and the Regulatory Flexibility
Act, as amended by the Small Business
Regulatory Enforcement Fairness Act
(SBREFA). We anticipate that the rule
will create minimal impact.
This regulatory impact section
presents the anticipated costs and
benefits that are quantified where
possible. Where quantification is not
possible, a qualitative discussion is
provided of the costs and/or benefits
that HHS/CDC anticipates from issuing
this regulation.
IV. Alternatives Considered
Regulatory Impact Analysis
In researching this addition to the
HHS select agents and toxins list, we
also considered whether B. cereus
Biovar anthracis should be designated
as a non-Tier 1 agent. We concluded
that B. cereus Biovar anthracis should
be regulated as a Tier 1 select agent for
the same reason that we currently
regulation B. anthracis as a Tier 1 select
agent.
Costs
V. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
HHS/CDC has examined the impacts
of this interim final rule (IFR) under
Executive Order 12866, Regulatory
Planning and Review (58 FR 51735,
October 4, 1993) and Executive Order
13563, Improving Regulation and
Regulatory Review, (76 FR 3821,
January 21, 2011). Both Executive
Orders direct agencies to evaluate any
rule prior to promulgation to determine
the regulatory impact in terms of costs
and benefits to United States
populations and businesses. Further,
together, the two Executive Orders set
the following requirements: Quantify
costs and benefits where the new
regulation creates a change in current
practice; define qualitative costs and
benefits; choose approaches that
maximize benefits; support regulations
that protect public health and safety;
and minimize the impact of regulation.
HHS/CDC has analyzed this IFR as
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Need for the Regulation
Bacillus cereus Biovar anthracis is a
recently recognized, emerging
pathogens that has all the virulence
characteristics and threat potential of
Bacillus anthracis, a Tier 1 select agent.
This organism is not currently on the
HHS List of Select Agents and Toxins;
we are proposing regulating this
organism as a Tier 1 select agent
because of its potential for misuse and
its threat to public health and safety.
Currently, the only entity in
possession of this agent is already
registered to possess Tier 1 select
agents. As a result, the burden
associated with this entity is minimal.
However, this rule will also affect
entities which plan to possess the agent
in the future. We believe that these
entities fall into three categories:
Entities not currently registered for a
select agent or toxin, and entities
already registered with the Federal
Select Agent Program (FSAP) but not for
a Tier 1 agent or toxin, and entities
already registered to possess a Tier 1
agent, such as the one already in
possession of the agent. Based on the
2012 Select Agent Final Rule, entities
already registered with the FSAP but
not for a Tier 1 agent or toxin will incur
costs of approximately $10,000–$15,000
in order to possess the agent, and
median annualized costs to entities not
currently registered to possess select
agent or toxin are estimated to be
approximately $37,000 in order to
possess the agent. As noted, for entities
already registered to possess a Tier 1
agent, costs are estimated to be minimal.
However, we lack data to forecast the
number of entities beyond the one entity
we are currently aware of that will
possess this agent in the future, and as
a result we do not estimate the total
associated costs.
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Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations
Benefits: The agents and toxins placed
on the HHS selects and toxins list have
the potential to pose severe threats to
public health and safety. The benefits of
the HHS/CDC interim final rule derive
from the strengthened prevention
against the accidental or intentional
release of B. cereus Biovar anthracis. We
based the following assumption on the
release of B. anthracis that occurred in
2001. The cost of such an event in
human life could be high. An outbreak
of B. cereus Biovar anthracis also would
require a complex and expensive
emergency response effort. This effort
would include extensive public health
measures, such as quarantine, isolation,
preventive treatment and health testing
for large numbers of potentially exposed
persons, and extensive
decontamination. Substantial costs
would likely be incurred by hospitals
and other medical facilities and
institutions of government at all levels.
An outbreak of B. cereus Biovar
anthracis, or widespread fear of one,
also would likely create significant
secondary effects to society including a
potentially rapid increase in health
anxiety among healthy individuals. This
may result in overcrowded healthcare
facilities and emergency rooms, and the
disruption of everyday business
operations, transportation, and other
normal behavior.
Impacts from the October 2001
anthrax attacks exemplify the costs that
the regulatory revisions will help to
prevent. The anthrax attacks caused five
fatalities and seventeen illnesses,
disrupted business and government
activities, closed substantial parts of the
U.S. Postal Service, and caused
widespread apprehension and changes
in behavior. Costs included more than
$23 million to decontaminate one
Senate office building, approximately $2
billion in revenues lost to the postal
service, and as much as $3 billion in
additional costs to the U.S. Postal
Service for cleanup of contamination
and procurement of mail-sanitizing
equipment (referenced from the
Regulatory Impact Analysis from the
2012 Select Agent Regulations Final
Rule). There were substantial costs due
to lost productivity throughout the
economy and investigations into the
incident (referenced from the Regulatory
Impact Analysis from the 2012 Select
Agent Regulations Final Rule).
A deliberate release of B. cereus
Biovar anthracis may cause wideranging impacts to the economy,
potential loss of market access for
consumer goods and services, other
disruptions to society, and diminished
confidence in public and private
institutions.
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Comparison of Costs and Benefits: In
our analysis, we determined that only
one entity that already possesses Tier 1
select agents in the United States is in
possession of B. cereus Biovar anthracis.
As noted above, the cost to the entity
would be minimal. Also noted above,
this rule will affect entities that plan to
possess the agent in the future. Based on
the 2012 Select Agent Final Rule,
entities already registered with the
FSAP but not for a Tier 1 agent or toxin
will incur costs of approximately
$10,000–$15,000 in order to possess the
agent, and median annualized costs to
entities not currently registered to
possess select agent or toxin are
estimated to be approximately $37,000
in order to possess the agent. For
entities already registered to possess a
Tier 1 agent, costs are estimated to be
minimal.
The benefit of regulating this
organism is the prevention of an
outbreak of disease due to this
organism. An analysis of the 2001
anthrax incident shows the impact of
the outbreak in terms of loss of life,
illness, decontamination costs, and loss
of productivity.
Based on this analysis, we believe the
benefit of this rulemaking outweighs the
costs.
B. The Regulatory Flexibility Act (RFA),
as Amended by the Small Business
Regulatory Enforcement Fairness Act
(SBREFA)
We have examined the impacts of the
interim final rule under the Regulatory
Flexibility Act (5 U.S.C. 601–612).
Unless we certify that the interim final
rule is not expected to have a significant
economic impact on a substantial
number of small entities, the Regulatory
Flexibility Act (RFA), as amended by
the Small Business Regulatory
Enforcement Fairness Act (SBREFA),
requires agencies to analyze regulatory
options that would minimize any
significant economic impact of a rule on
small entities. Based on our current
knowledge of who possesses B. cereus
Biovar anthracis, we certify that this
interim final rule will not have a
significant economic impact on a
substantial number of small entities
within the meaning of the RFA.
This regulatory action is not a major
rule as defined by Sec. 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996. This interim final
rule will not result in an annual effect
on the economy of $100,000,000 or
more; a major increase in cost or prices;
or significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
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companies to compete with foreignbased companies in domestic and
export markets.
C. Paperwork Reduction Act of 1995
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
rulemaking are currently approved by
the Office of Management and Budget
(OMB) under OMB control number
0920–0576, expiration date 12/31/2018.
This includes the burden on entities to
submitted amendments to their
registrations.
We expect that the entities who will
register for possession, use, or transfer
of B. cereus Biovar anthracis will
already be registered with the Federal
Select Agent Program. This rulemaking
will require such an entity to amend its
registration with the Federal Select
Agent Program using relevant portions
of APHIS/CDC Form 1 (Application for
Registration for Possessing, Use, and
Transfer of Select Agents and Toxins).
Estimated time to amend this form is
one hour for one select agent.
Additionally, any registered entity that
wishes to transfer B. cereus Biovar
anthracis will be required to submit
information using APHIS/CDC Form 2
(Request to Transfer of Select Agent and
Toxins). Estimated average time to
complete this form is one hour. Based
upon the limited publications on this
agent at this time, we estimate that only
one registered entity may add B. cereus
Biovar anthracis to their registration or
transfer B. cereus Biovar anthracis to
another registered entity. Therefore, we
calculate that there is no increase in the
number of respondents that need to
submit an application for registration,
we estimate the total number of
responses for entities to submit an
amendment to their registration may
increase by one, and the total burden
hours may increase to one hour.
D. E.O. 12988: Civil Justice Reform
This rule has been reviewed under
E.O. 12988, Civil Justice Reform. Once
the interim final rule is in effect, HHS/
CDC notes that: (1) All State and local
laws and regulations that are
inconsistent with this rule will be
preempted; (2) no retroactive effect will
be given to this rule; and (3)
administrative proceedings will not be
required before parties may file suit in
court challenging this rule.
E. E.O. 13132: Federalism
HHS/CDC has reviewed this interim
final rule in accordance with Executive
Order 13132 regarding Federalism, and
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Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations
has determined that it does not have
‘‘federalism implications.’’ The rule
does not ‘‘have substantial direct effects
on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’
In accordance with section 361(e) of
the PHSA [42 U.S.C. 264(e)], nothing in
this rule would supersede any
provisions of State or local law except
to the extent that such a provision
conflicts with this rule.
F. Plain Language Act of 2010
Under the Plain Language Act of 2010
(Pub. L. 111–274, October 13, 2010),
executive Departments and Agencies are
required to use plain language in
documents that explain to the public
how to comply with a requirement the
Federal Government administers or
enforces. HHS/CDC has attempted to
use plain language in promulgating this
rule consistent with the Federal Plain
Writing Act guidelines.
List of Subjects in 42 CFR Part 73
Biologics, Packaging and containers,
Penalties, Reporting and recordkeeping
requirements, Transportation.
For the reasons stated in the
preamble, we are amending 42 CFR part
73 as follows:
PART 73—SELECT AGENTS AND
TOXINS
1. The authority citation for part 73
continues to read as follows:
■
Authority: 42 U.S.C. 262a; sections 201–
204, 221 and 231 of Title II of Public Law
107–188, 116 Stat. 637 (42 U.S.C. 262a).
§ 73.3
[Amended]
2. Amend § 73.3(b) by adding the term
‘‘Bacillus cereus Biovar anthracis*’’ in
alphabetical order.
■
Dated: September 8, 2016.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2016–22049 Filed 9–13–16; 8:45 am]
BILLING CODE 4163–18–P
asabaliauskas on DSK3SPTVN1PROD with RULES
VI. References
1. Brezillon, C, Hauslant, M, Dupke, S, Corre,
JP, Lander, A, Franz, T, Monot, M,
Couture-Tosi, E, Jouvion, G, Leendertz,
FH, Grunow, R, Mock, ME, Klee, SR, and
Goossens, L. (2015) Capsules, toxins and
AtxA as virulence factors of emerging
Bacillus cereus Biovar anthracis. PLOS
Negl. Trop. Dis. 9(4):e0003455.
2. Helgason E, Tourasse NJ, Meisal R,
Caugant DA, Kolst< AB (2004)
Multilocus sequence typing scheme for
bacteria of the Bacillus cereus group.
Appl Environ Microbiol 70: 191–201.
3. Klee SR, Ozel M, Appel B, Boesch C,
Ellerbrok H, et al. (2006)
Characterization of Bacillus anthracislike bacteria isolated from wild great
apes from Cote d’Ivoire and Cameroon. J
Bacteriol 188: 5333–5344.
4. Leendertz FH, Ellerbrok H, Boesch C,
Couacy-Hymann E, Matz-Rensing K, et
al. (2004) Anthrax kills wild
chimpanzees in a tropical rainforest.
Nature 430: 451–452.
5. Leendertz FH, Yumlu S, Pauli G, Boesch
C, Couacy-Hymann E, et al. (2006) A new
Bacillus anthracis found in wild
chimpanzees and a gorilla from west and
central Africa. Plos Pathog 2: e8.
6. Leendertz FH, Lankester F, Guislain P,
´
Neel C, Drori O, et al. (2006) Anthrax in
Western and Central African great apes.
Am J Primatol 68: 928–933.
7. Report of the Working Group on
Strengthening the Biosecurity of the
United States, Executive Order 13486
Working Group (https://
edocket.access.gpo.gov/2009/pdf/E9818.pdf).
8. Avashia SB, et al. (2007) Fatal pneumonia
among metalworkers due to inhalation
exposure to Bacillus cereus containing
Bacillus anthracis toxin genes. Clin.
Infect. Dis. 44:414–416.
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NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
48 CFR Parts 1816, 1832, 1842, and
1852
63143
Submit comments
identified by NFS Case 2016–N025,
using any of the following methods:
Æ Regulations.gov: https://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
entering ‘‘NFS Case 2016–N025’’ under
the heading ‘‘Enter keyword or ID’’ and
selecting ‘‘Search.’’ Select the link
‘‘Submit a Comment’’ that corresponds
with ‘‘NFS Case 2016–N025.’’ Follow
the instructions provided at the ‘‘Submit
a Comment’’ screen. Please include your
name, company name (if any), and
‘‘NFS Case 2016–N025’’ on your
attached document.
Æ Email: John.J.Lopez@nasa.gov.
Include NFS Case 2016–N025 in the
subject line of the message.
Æ Fax: (202) 358–3082.
Æ Mail: National Aeronautics and
Space Administration, Headquarters,
Office of Procurement, Contract and
Grant Policy Division, Attn: John J.
Lopez, LP–011, 300 E Street SW.,
Washington, DC 20546–0001.
FOR FURTHER INFORMATION CONTACT: Mr.
John J. Lopez, NASA HQ, Office of
Procurement, Contract and Grant Policy
Division, LP–011, 300 E Street SW.,
Washington, DC 20456–0001.
Telephone 202–358–3740; facsimile
202–358–3082.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
RIN 2700–AE34
I. Background
NASA Federal Acquisition Regulation
Supplement: Revised Voucher
Submission & Payment Process (NFS
Case 2016–N025)
This interim rule revises the NFS to
implement revisions to the voucher
submittal and payment process. These
revisions are necessary due to section
893 of the National Defense
Authorization Act for Fiscal Year 2016
(Pub. L. 114–92) prohibiting DCAA from
performing audit work for non-Defense
Agencies. Section 893 prohibits DCAA
from performing audit work for nonDefense Agencies until DCAA’s backlog
of incurred cost audits is below 18
months. DCAA’s current backlog of cost
audits is greater than 18 months. NASA
had delegated to DCAA the task of
reviewing contractor requests for
payment under its cost-type contracts.
As a result of section 893, DCAA has
ceased cost voucher audit support to
NASA, in turn, jeopardizing timely
payment to contractors for work
performed. NASA has revised its cost
voucher submission and payment
process to ensure the continued prompt
payment to its suppliers. Accordingly,
the NFS needs to be immediately
revised to implement procedural
changes to minimize cost voucher
submission and payment delays to
NASA suppliers as well the potential
accrual of Government interest
payments to contractors.
National Aeronautics and
Space Administration.
ACTION: Interim rule.
AGENCY:
NASA is issuing an interim
rule amending the NASA Federal
Acquisition Regulation Supplement
(NFS) to implement revisions to the
voucher submittal and payment process.
These revisions are necessary due to
section 893 of the National Defense
Authorization Act for Fiscal Year 2016
prohibiting the Defense Contract Audit
Agency (DCAA) from performing audit
work for non-Defense Agencies. NASA
had delegated to DCAA the task of
reviewing contractor requests for
payment under NASA cost-type
contracts.
SUMMARY:
DATES:
Effective: September 14, 2016.
Comment date: Comments on the
interim rule should be submitted in
writing to the address shown below on
or before November 14, 2016, to be
considered in the formation of a final
rule.
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]]>Agencies
[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Rules and Regulations]
[Pages 63138-63143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22049]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
[CDC Docket No. CDC-2016-0045]
RIN 0920-AA64
Possession, Use, and Transfer of Select Agents and Toxins--
Addition of Bacillus Cereus Biovar Anthracis to the HHS List of Select
Agents and Toxins
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
[[Page 63139]]
ACTION: Interim final rule and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services (HHS) is adding Bacillus cereus
Biovar anthracis to the list of HHS select agents and toxins as a Tier
1 select agent. We are taking this action to regulate this agent that
is similar to B. anthracis to prevent its misuse, which could cause a
biological threat to public health and/or national security.
DATES:
Effective date: The interim final rule is effective on October 14,
2016.
Public comment period: Written or electronic comments must be
submitted by November 14, 2016.
Applicability dates: By October 14, 2016, any individual or entity
that possesses B. cereus Biovar anthracis must provide notice to the
CDC's DSAT regarding their possession of this agent and must secure the
agent against theft, loss, release, or unauthorized access; and by
March 13, 2017, an individual or entity that intends to continue to
possess, use, or transfer this agent will be required to either
register in accordance with 42 CFR part 73 or amend their current
registration in accordance with 42 CFR 73.7(h) and meet all of the
requirements of select agent regulations (42 CFR part 73).
ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0045 or RIN 0920-AA64 by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Dr. Samuel Edwin, Director, Division of Select
Agents and Toxins, Centers for Disease Control and Prevention, 1600
Clifton Road NE., MS-A46, Atlanta, Georgia 30329, Attn: Docket CDC-
2016-0045
Instructions: All submissions received must include the agency name
and docket number or Regulatory Information Number (RIN) for this
rulemaking. All relevant comments received will be posted without
change to https://regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to https://www.regulations.gov.
Comments will also be available for public inspection from Monday
through Friday, except for legal holidays, from 9 a.m. to 5 p.m.,
Eastern Time, at 1600 Clifton Road NE., Atlanta, Georgia 30329. Please
call ahead to (404) 718-2000 and ask for a representative from the
Division of Select Agents and Toxins to schedule your visit.
FOR FURTHER INFORMATION CONTACT: Dr. Samuel Edwin, Director, Division
of Select Agents and Toxins, Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS-A46, Atlanta, Georgia 30329.
Telephone: (404) 718-2000.
SUPPLEMENTARY INFORMATION: The interim final rule is organized as
follows:
I. Public Participation
II. Background
A. Legal Authority
B. Historical Background to This Rulemaking
III. Rationale for Issuance of an Interim Final Rule
IV. Alternatives Considered
V. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. The Regulatory Flexibility Act
C. Paperwork Reduction Act of 1995
D. EO 12988: Civil Justice Reform
E. EO 13132: Federalism
F. Plain Language Act of 2010
VI. References
I. Public Participation
Interested persons or organizations are invited to participate in
this rulemaking by submitting written views, recommendations, and data.
HHS/CDC invites comments on the following questions:
(1) Are there other virulent (pBCXO1+ and pBCXO2+) strains of
Bacillus species that should also be regulated?
(2) What is the impact of designating B. cereus Biovar anthracis
as a Tier 1 select agent?
Comments received, including attachments and other supporting
materials, are part of the public record and subject to public
disclosure. Do not include any information in your comment or
supporting materials that you consider confidential or inappropriate
for public disclosure. HHS/CDC will consider comments that are received
within 60 days of publication of this rule in the Federal Register.
After the comment period closes, we will publish another document in
the Federal Register. The document will include a discussion of any
comments we receive and any amendments that will be made to the rule as
a result of the comments.
II. Background
A. Legal Authority
HHS/CDC is promulgating this rule under the authority of sections
201-204 and 221 of Title II of Public Law 107-188, 116 Stat 637 (42
U.S.C. 262a).
Subtitle A of Title II of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, (42 U.S.C. 262a),
requires HHS to regulate the possession, use, and transfer of
biological agents or toxins that the HHS Secretary determines have the
potential to pose a severe threat to public health and safety (select
agents and toxins). Subtitle B of Title II of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (which
may be cited as the Agricultural Bioterrorism Protection Act of 2002),
(7 U.S.C. 8401), requires the United States Department of Agriculture
(USDA) to regulate the possession, use, and transfer of biological
agents or toxins that the USDA Secretary determines have the potential
to pose a severe threat to animal or plant health, or animal or plant
products (select agents and toxins). Accordingly, HHS and USDA have
promulgated regulations requiring individuals or entities that possess,
use, or transfer select agents and toxins to register with HHS/CDC or
USDA/Animal and Plant Health Inspection Service (APHIS). See 42 CFR
part 73, 7 CFR part 331, and 9 CFR part 121 (the select agent
regulations). The Federal Select Agent Program, a collaboration of HHS/
CDC/Division of Select Agents and Toxins and USDA/APHIS/Agriculture
Select Agent Services, administers the select agent regulations in a
manner that minimizes the administrative burden on persons subject to
the select agent regulations. USDA/APHIS is currently considering
whether B. cereus Biovar anthracis should also be listed as a USDA
select agent.
B. Historical Background to This Rulemaking
Emerging B. cereus strains that cause anthrax-like disease have
been isolated in Cameroon (CA strain) and C[ocirc]te d'Ivoire (CI
strain). We are currently aware that geographic distribution of B.
cereus Biovar anthracis is limited to some African countries, one
registered entity in the United States, and one facility in Germany.
The B. cereus strain being added to the HHS list of select agents is
identified as B. cereus Biovar anthracis and described in the
publication ``Characterization of Bacillus anthracis-like bacteria
isolated from wild great apes from Cote d'Ivoire and Cameroon'' (Ref.
3, see table below). Recent research demonstrates that B. cereus Biovar
anthracis has all of the virulence determinants and threat potential of
Bacillus anthracis, a Tier 1 select agent (Ref. 1). A biovar is a group
of microorganisms that are genetically similar but differ from other
members of the species by biochemical or genetic characteristics. B.
cereus Biovar anthracis was originally isolated about a decade ago from
gorillas and
[[Page 63140]]
chimpanzees exhibiting anthrax-like disease in Cameroon and Cote
d'Ivoire (Ref. 3-6). Genomic characterization showed that these
organisms belong to the B. cereus species and harbor two plasmids that
are referred to as pBCXO1 and pBCXO2. The plasmid (pBCXO1) is very
similar to pXO1, which is found in B. anthracis, and encodes active
edema and lethal toxins. The plasmid (pBCXO2) is very similar to pXO2,
which is found in B. anthracis, and encodes the enzymes that synthesize
the poly-D-glutamic acid capsule. Thus, these organisms are genetically
similar and produce all of the primary virulence factors (toxins and
capsule) of B. anthracis. In addition, pBCXO2 has a functional hasACB
operon that encodes a second capsule composed of hyaluronic acid (HA),
which enhances the neuro-invasiveness of these organisms in laboratory
models of infection (Ref. 1). Accordingly, because we believe that B.
cereus Biovar anthracis has the same potential to pose a severe threat
to public health as does Bacillus anthracis, currently regulated as a
Tier 1 pathogen, we are adding Bacillus cereus Biovar anthracis to HHS
select agent list by an interim final rule because we believe that any
delay in bringing the possession, use, or transfer into the United
States of this pathogen is contrary to the public interest. A
biological agent is designated as Tier 1 when it is determined that it
presents the greatest risk of deliberate misuse with significant
potential for mass casualties or devastating effect to the economy,
critical infrastructure, or public confidence, and poses a severe
threat to public health and safety. We believe that Bacillus cereus
Biovar anthracis presents the same threat to public health and national
security as does Bacillus anthracis.
In December 2015, the question of whether B. cereus Biovar
anthracis should be regulated as a select agent was considered by HHS/
CDC's Intragovernmental Select Agents and Toxins Technical Advisory
Committee (ISATTAC). The ISATTAC is comprised of Federal government
employees from CDC, the Biomedical Advanced Research and Development
Authority (BARDA) within the Office of the Assistant Secretary for
Preparedness and Response (ASPR), the National Institutes of Health
(NIH), the Food and Drug Administration (FDA), the Department of
Homeland Security (DHS), the Department of Defense (DOD), the USDA/
Animal and Plant Health Inspection Service (APHIS), USDA/Agricultural
Research Service (ARS), and USDA Center for Veterinary Biologics (CVB).
Based on the criteria outlined in the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 262a),
the ISATTAC considered the following in their review: The degree of
pathogenicity (ability of an organism to cause disease),
communicability (ability to spread from infected to susceptible hosts),
ease of dissemination, route of exposure, environmental stability, ease
of production in the laboratory, ability to genetically manipulate or
alter, long-term health effects, untreated acute mortality, available
therapeutics and vaccines, status of immunity, vulnerability of special
populations, and the burden or impact on the health care system. The
ISATTAC also considered whether B. cereus Biovar anthracis should be
designated as a Tier 1 select agent. Executive Order 13546,
``Optimizing the Security of Biological Select Agents and Toxins in the
United States,'' defines as ``Tier 1'' those select agents and 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 (Ref. 7). At
this time, HHS/CDC is not proposing to regulate other strains of B.
cereus that have B. anthracis toxin genes as the data available do not
suggest those strains pose a severe threat to public health (Ref. 1 and
Ref. 8).
The table below comes from ``Bacteriological discrimination
characteristics of atypical B. anthracis strains isolated from great
apes, classic B. anthracis strains, and other strains of the B. cereus
group'' (Ref. 3).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Result \a\
---------------------------------------------------------------------------------------------------------------------
Microbiological characteristic B. anthracis CI B. anthracis CA
------------------------------------------------------------------------- B. anthracis B. cereus
Primary culture Sub culture Primary culture Sub culture
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hemolysis......................... - +/- - +/- - +
Motility.......................... + + + + - +
Susceptibility to gamma phage..... - +/- - +/- + -
Penicillin G...................... S S/R R R S R
Capsule........................... + \b\ +/- + +/- + Absent in
vitro.\c\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ S, sensitive; R, resistant; -, negative; +, positive; +/-, some subclones positive, others negative.
\b\ Capsule production on bicarbonate agar under a CO2 atmosphere and on blood agar under an ambient atmosphere.
\c\ Certain other Bacillus spp. can produce a polypeptide capsule but not under normal culture conditions.
After reviewing scientific publications and consulting with subject
matter experts, ISATTAC recommended that B. cereus Biovar anthracis
should be listed as a HHS select agent and regulated as Tier 1 agent
because:
Genomic characterization showed that B. cereus Biovar
anthracis belongs to the B. cereus species, but it harbors virulence-
associated plasmids that are similar to B. anthracis, a Tier 1 select
agent (Ref. 1-2).
Fully virulent (pXO1+ pXO2+) strains of B. anthracis are
currently regulated as Tier 1 select agent.
To date, there have been no reports of this biovar having
been isolated from humans. However, B. cereus Biovar anthracis
exhibited virulence, comparable to B. anthracis in animal models of
subcutaneous and intranasal/inhalational anthrax (Ref. 3). Thus, it is
reasonable to assume that B. cereus Biovar anthracis can infect humans
by the same routes as B. anthracis. In areas (Cameroon and Cote
d'Ivoire) where B. cereus Biovar anthracis has been isolated from
gorillas and chimpanzees (Ref. 4-6), it is possible that isolates from
human cases could be missed due to the lack of laboratory capacity and
to the thorough characterization needed to differentiate B. anthracis
from B. cereus Biovar anthracis.
As with B. anthracis, the virulence of this strain as a
spore-forming
[[Page 63141]]
bacterium may make it attractive to those that wish to circumvent the
select agent regulations for nefarious purposes.
PBCXO2--strains of B. cereus Biovar anthracis (analogous
to B. anthracis veterinary vaccine Sterne strain) produce a HA capsule
from genes present on pBCXO1. Studies have shown such variants (pBCXO2-
) are still as virulent as B. anthracis in animal models (Ref. 1).
There is no apparent difference between this organism and
B. anthracis with respect to the criteria used to designate B.
anthracis as a Tier 1 agent.
In addition, the Federal Experts Security Advisory Panel (FESAP)
provided policy and technical input for the recommendation to list B.
cereus Biovar anthracis as an HHS select agent and regulated as Tier 1
agent. The mission of the FESAP is to make technical and substantive
recommendations concerning the appropriate safeguards and security
standards for persons possessing, using, or transferring BSAT. The goal
of the FESAP is that their recommendations be commensurate with the
risk that such agents or toxins pose to public health and safety,
including the risk of their use in domestic or international terrorism.
The FESAP drew from the expertise of its membership, information from
presentations by several federal department and agency subject matter
experts, and technical input from the Directors of the Federal Select
Agent Program (FSAP) to develop its recommendation. The FESAP has
issued a draft report that recommended listing B. cereus biovar
anthracis as a select agent (not Tier 1).
After consideration of all of the above, HHS/CDC has determined
that B. cereus Biovar anthracis should be listed as a Tier 1 HHS select
agent given its similarities to B. anthracis, which is consistent with
current regulatory requirements for B. anthracis.
III. Rationale for Issuance of an Interim Final Rule
Agency rulemaking is governed by section 553 of the Administrative
Procedure Act (APA) (5 U.S.C. 553) which, unless the rule falls within
one of the exemptions, requires that HHS/CDC publish a notice of
proposed rulemaking in the Federal Register that provides interested
persons an opportunity to submit written data, views, or arguments.
Section 553(b)(B) of the APA authorizes a department or agency to
dispense with the prior notice and opportunity for public comment
requirement for ``good cause'' if the department or agency finds that
it is contrary to the public interest.
B. cereus Biovar anthracis has all of the virulence characteristics
and threat potential of Bacillus anthracis, which is already regulated
as a Tier 1 select agent. Accordingly, for the reasons stated above, we
have determined that B. cereus Biovar anthracis not only also has the
potential to pose a severe threat to public health and safety; but that
it may present a great risk for deliberate misuse with a significant
potential for mass casualties or devastating effects to the economy,
critical infrastructure; or public confidence. We are taking this
action to place this agent under the biosafety and security
requirements of the select agent regulations; and to regulate its
possession and transfer to prevent an accidental release or its misuse.
We believe this interim final rule is in the best interest of public
health and national security.
Pursuant to 5 U.S.C. 553(b)(3)(B), and for the reasons stated
above, we therefore find that there is good cause to dispense with
prior public notice and the opportunity to comment on this rule before
it becomes effective because any delay in promulgating the rule would
be contrary to the public interest.
IV. Alternatives Considered
In researching this addition to the HHS select agents and toxins
list, we also considered whether B. cereus Biovar anthracis should be
designated as a non-Tier 1 agent. We concluded that B. cereus Biovar
anthracis should be regulated as a Tier 1 select agent for the same
reason that we currently regulation B. anthracis as a Tier 1 select
agent.
V. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
HHS/CDC has examined the impacts of this interim final rule (IFR)
under Executive Order 12866, Regulatory Planning and Review (58 FR
51735, October 4, 1993) and Executive Order 13563, Improving Regulation
and Regulatory Review, (76 FR 3821, January 21, 2011). Both Executive
Orders direct agencies to evaluate any rule prior to promulgation to
determine the regulatory impact in terms of costs and benefits to
United States populations and businesses. Further, together, the two
Executive Orders set the following requirements: Quantify costs and
benefits where the new regulation creates a change in current practice;
define qualitative costs and benefits; choose approaches that maximize
benefits; support regulations that protect public health and safety;
and minimize the impact of regulation. HHS/CDC has analyzed this IFR as
required by these Executive Orders and has determined that it is
consistent with the principles set forth in the Executive Orders and
the Regulatory Flexibility Act, as amended by the Small Business
Regulatory Enforcement Fairness Act (SBREFA). We anticipate that the
rule will create minimal impact.
This regulatory impact section presents the anticipated costs and
benefits that are quantified where possible. Where quantification is
not possible, a qualitative discussion is provided of the costs and/or
benefits that HHS/CDC anticipates from issuing this regulation.
Need for the Regulation
Bacillus cereus Biovar anthracis is a recently recognized, emerging
pathogens that has all the virulence characteristics and threat
potential of Bacillus anthracis, a Tier 1 select agent. This organism
is not currently on the HHS List of Select Agents and Toxins; we are
proposing regulating this organism as a Tier 1 select agent because of
its potential for misuse and its threat to public health and safety.
Regulatory Impact Analysis
Costs
Currently, the only entity in possession of this agent is already
registered to possess Tier 1 select agents. As a result, the burden
associated with this entity is minimal. However, this rule will also
affect entities which plan to possess the agent in the future. We
believe that these entities fall into three categories: Entities not
currently registered for a select agent or toxin, and entities already
registered with the Federal Select Agent Program (FSAP) but not for a
Tier 1 agent or toxin, and entities already registered to possess a
Tier 1 agent, such as the one already in possession of the agent. Based
on the 2012 Select Agent Final Rule, entities already registered with
the FSAP but not for a Tier 1 agent or toxin will incur costs of
approximately $10,000-$15,000 in order to possess the agent, and median
annualized costs to entities not currently registered to possess select
agent or toxin are estimated to be approximately $37,000 in order to
possess the agent. As noted, for entities already registered to possess
a Tier 1 agent, costs are estimated to be minimal. However, we lack
data to forecast the number of entities beyond the one entity we are
currently aware of that will possess this agent in the future, and as a
result we do not estimate the total associated costs.
[[Page 63142]]
Benefits: The agents and toxins placed on the HHS selects and
toxins list have the potential to pose severe threats to public health
and safety. The benefits of the HHS/CDC interim final rule derive from
the strengthened prevention against the accidental or intentional
release of B. cereus Biovar anthracis. We based the following
assumption on the release of B. anthracis that occurred in 2001. The
cost of such an event in human life could be high. An outbreak of B.
cereus Biovar anthracis also would require a complex and expensive
emergency response effort. This effort would include extensive public
health measures, such as quarantine, isolation, preventive treatment
and health testing for large numbers of potentially exposed persons,
and extensive decontamination. Substantial costs would likely be
incurred by hospitals and other medical facilities and institutions of
government at all levels.
An outbreak of B. cereus Biovar anthracis, or widespread fear of
one, also would likely create significant secondary effects to society
including a potentially rapid increase in health anxiety among healthy
individuals. This may result in overcrowded healthcare facilities and
emergency rooms, and the disruption of everyday business operations,
transportation, and other normal behavior.
Impacts from the October 2001 anthrax attacks exemplify the costs
that the regulatory revisions will help to prevent. The anthrax attacks
caused five fatalities and seventeen illnesses, disrupted business and
government activities, closed substantial parts of the U.S. Postal
Service, and caused widespread apprehension and changes in behavior.
Costs included more than $23 million to decontaminate one Senate office
building, approximately $2 billion in revenues lost to the postal
service, and as much as $3 billion in additional costs to the U.S.
Postal Service for cleanup of contamination and procurement of mail-
sanitizing equipment (referenced from the Regulatory Impact Analysis
from the 2012 Select Agent Regulations Final Rule). There were
substantial costs due to lost productivity throughout the economy and
investigations into the incident (referenced from the Regulatory Impact
Analysis from the 2012 Select Agent Regulations Final Rule).
A deliberate release of B. cereus Biovar anthracis may cause wide-
ranging impacts to the economy, potential loss of market access for
consumer goods and services, other disruptions to society, and
diminished confidence in public and private institutions.
Comparison of Costs and Benefits: In our analysis, we determined
that only one entity that already possesses Tier 1 select agents in the
United States is in possession of B. cereus Biovar anthracis. As noted
above, the cost to the entity would be minimal. Also noted above, this
rule will affect entities that plan to possess the agent in the future.
Based on the 2012 Select Agent Final Rule, entities already registered
with the FSAP but not for a Tier 1 agent or toxin will incur costs of
approximately $10,000-$15,000 in order to possess the agent, and median
annualized costs to entities not currently registered to possess select
agent or toxin are estimated to be approximately $37,000 in order to
possess the agent. For entities already registered to possess a Tier 1
agent, costs are estimated to be minimal.
The benefit of regulating this organism is the prevention of an
outbreak of disease due to this organism. An analysis of the 2001
anthrax incident shows the impact of the outbreak in terms of loss of
life, illness, decontamination costs, and loss of productivity.
Based on this analysis, we believe the benefit of this rulemaking
outweighs the costs.
B. The Regulatory Flexibility Act (RFA), as Amended by the Small
Business Regulatory Enforcement Fairness Act (SBREFA)
We have examined the impacts of the interim final rule under the
Regulatory Flexibility Act (5 U.S.C. 601-612). Unless we certify that
the interim final rule is not expected to have a significant economic
impact on a substantial number of small entities, the Regulatory
Flexibility Act (RFA), as amended by the Small Business Regulatory
Enforcement Fairness Act (SBREFA), requires agencies to analyze
regulatory options that would minimize any significant economic impact
of a rule on small entities. Based on our current knowledge of who
possesses B. cereus Biovar anthracis, we certify that this interim
final rule will not have a significant economic impact on a substantial
number of small entities within the meaning of the RFA.
This regulatory action is not a major rule as defined by Sec. 804
of the Small Business Regulatory Enforcement Fairness Act of 1996. This
interim final rule will not result in an annual effect on the economy
of $100,000,000 or more; a major increase in cost or prices; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
companies to compete with foreign-based companies in domestic and
export markets.
C. Paperwork Reduction Act of 1995
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 rulemaking are currently
approved by the Office of Management and Budget (OMB) under OMB control
number 0920-0576, expiration date 12/31/2018. This includes the burden
on entities to submitted amendments to their registrations.
We expect that the entities who will register for possession, use,
or transfer of B. cereus Biovar anthracis will already be registered
with the Federal Select Agent Program. This rulemaking will require
such an entity to amend its registration with the Federal Select Agent
Program using relevant portions of APHIS/CDC Form 1 (Application for
Registration for Possessing, Use, and Transfer of Select Agents and
Toxins). Estimated time to amend this form is one hour for one select
agent. Additionally, any registered entity that wishes to transfer B.
cereus Biovar anthracis will be required to submit information using
APHIS/CDC Form 2 (Request to Transfer of Select Agent and Toxins).
Estimated average time to complete this form is one hour. Based upon
the limited publications on this agent at this time, we estimate that
only one registered entity may add B. cereus Biovar anthracis to their
registration or transfer B. cereus Biovar anthracis to another
registered entity. Therefore, we calculate that there is no increase in
the number of respondents that need to submit an application for
registration, we estimate the total number of responses for entities to
submit an amendment to their registration may increase by one, and the
total burden hours may increase to one hour.
D. E.O. 12988: Civil Justice Reform
This rule has been reviewed under E.O. 12988, Civil Justice Reform.
Once the interim final rule is in effect, HHS/CDC notes that: (1) All
State and local laws and regulations that are inconsistent with this
rule will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
E. E.O. 13132: Federalism
HHS/CDC has reviewed this interim final rule in accordance with
Executive Order 13132 regarding Federalism, and
[[Page 63143]]
has determined that it does not have ``federalism implications.'' The
rule does not ``have substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.''
In accordance with section 361(e) of the PHSA [42 U.S.C. 264(e)],
nothing in this rule would supersede any provisions of State or local
law except to the extent that such a provision conflicts with this
rule.
F. Plain Language Act of 2010
Under the Plain Language Act of 2010 (Pub. L. 111-274, October 13,
2010), executive Departments and Agencies are required to use plain
language in documents that explain to the public how to comply with a
requirement the Federal Government administers or enforces. HHS/CDC has
attempted to use plain language in promulgating this rule consistent
with the Federal Plain Writing Act guidelines.
VI. References
1. Brezillon, C, Hauslant, M, Dupke, S, Corre, JP, Lander, A, Franz,
T, Monot, M, Couture-Tosi, E, Jouvion, G, Leendertz, FH, Grunow, R,
Mock, ME, Klee, SR, and Goossens, L. (2015) Capsules, toxins and
AtxA as virulence factors of emerging Bacillus cereus Biovar
anthracis. PLOS Negl. Trop. Dis. 9(4):e0003455.
2. Helgason E, Tourasse NJ, Meisal R, Caugant DA, Kolst[oslash] AB
(2004) Multilocus sequence typing scheme for bacteria of the
Bacillus cereus group. Appl Environ Microbiol 70: 191-201.
3. Klee SR, Ozel M, Appel B, Boesch C, Ellerbrok H, et al. (2006)
Characterization of Bacillus anthracis-like bacteria isolated from
wild great apes from Cote d'Ivoire and Cameroon. J Bacteriol 188:
5333-5344.
4. Leendertz FH, Ellerbrok H, Boesch C, Couacy-Hymann E, Matz-
Rensing K, et al. (2004) Anthrax kills wild chimpanzees in a
tropical rainforest. Nature 430: 451-452.
5. Leendertz FH, Yumlu S, Pauli G, Boesch C, Couacy-Hymann E, et al.
(2006) A new Bacillus anthracis found in wild chimpanzees and a
gorilla from west and central Africa. Plos Pathog 2: e8.
6. Leendertz FH, Lankester F, Guislain P, N[eacute]el C, Drori O, et
al. (2006) Anthrax in Western and Central African great apes. Am J
Primatol 68: 928-933.
7. Report of the Working Group on Strengthening the Biosecurity of
the United States, Executive Order 13486 Working Group (https://edocket.access.gpo.gov/2009/pdf/E9-818.pdf).
8. Avashia SB, et al. (2007) Fatal pneumonia among metalworkers due
to inhalation exposure to Bacillus cereus containing Bacillus
anthracis toxin genes. Clin. Infect. Dis. 44:414-416.
List of Subjects in 42 CFR Part 73
Biologics, Packaging and containers, Penalties, Reporting and
recordkeeping requirements, Transportation.
For the reasons stated in the preamble, we are amending 42 CFR part
73 as follows:
PART 73--SELECT AGENTS AND TOXINS
0
1. The authority citation for part 73 continues to read as follows:
Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of
Title II of Public Law 107-188, 116 Stat. 637 (42 U.S.C. 262a).
Sec. 73.3 [Amended]
0
2. Amend Sec. 73.3(b) by adding the term ``Bacillus cereus Biovar
anthracis*'' in alphabetical order.
Dated: September 8, 2016.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2016-22049 Filed 9-13-16; 8:45 am]
BILLING CODE 4163-18-P
