81 FR 63138 - Possession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus Cereus Biovar Anthracis to the HHS List of Select Agents and Toxins

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 178 (September 14, 2016)

Page Range		63138-63143
FR Document		2016-22049

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.

Federal Register, Volume 81 Issue 178 (Wednesday, September 14, 2016)

[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Rules and Regulations]
[Pages 63138-63143]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-22049]

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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.

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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: http://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 http://regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to http://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 (http://edocket.access.thefederalregister.org/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

63138 Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations

environmental, public health and safety § 301–51.1 How must I use the U.S.C. 5701, note), OMB Circular No. A–126,
effects, distributive impacts, and Government contractor-issued travel revised May 22, 1992, and OMB Circular No.
equity). E.O. 13563 emphasizes the charge card? A–123, Appendix B, revised January 15,
importance of quantifying both costs You are required to activate the 2009.
and benefits, of reducing costs, of Government contractor-issued travel § 301–70.702 [Amended]
harmonizing rules, and of promoting charge card once you receive it, and
flexibility. GSA has determined that this then use it as the method of payment for ■ 8. Amend § 301–70.702 by removing
final rule is not a significant regulatory all official travel expenses unless ‘‘MTT’’ and adding ‘‘MAE’’ in its place.
action is not subject to review under exempted under § 301–51.2. ■ 9. Revise § 301–70.704 to read as
section 6(b) of Executive Order 12866. ■ 3. Revise § 301–51.2 to read as follows:
GSA has further determined that this follows: § 301–70.704 What classes of employees
final rule is not a major rule under 5 are exempt from mandatory use of the
U.S.C. 804. § 301–51.2 Are there any official travel
expenses that are exempt from the Government contractor-issued travel
D. Regulatory Flexibility Act mandatory use of the Government charge card?
This final rule will not have a contractor-issued travel charge card? The Administrator of General Services
significant economic impact on a Expenses for which payment through exempts the following classes of
substantial number of small entities the Government contractor-issued travel employees from mandatory use of the
within the meaning of the Regulatory charge card is impractical (e.g., vendor Government contractor-issued travel
Flexibility Act, 5 U.S.C. 601, et seq. This does not accept credit cards) or imposes charge card:
final rule is also exempt from the unreasonable burdens or costs (e.g., fees (a) Any employee who has an
Administrative Procedure Act pursuant are charged for using the card) are application pending for the Government
to 5 U.S.C. 553(a)(2) because it applies exempt from use of the travel charge contractor-issued travel charge card;
to agency management or personnel. card. Your agency may also exempt an (b) Any employee, when issuance of
official travel expense when it is the Government contractor-issued travel
E. Paperwork Reduction Act necessary in the interest of the agency charge card would adversely affect the
The Paperwork Reduction Act does (see § 301–51.4). mission or put the employee at risk; and
not apply because the changes to the (c) Any employee who is not eligible
FTR do not impose recordkeeping or §§ 301–51.3 through 301–51.8 to receive a Government contractor-
[Redesignated as §§ 301–51.4 through 301–
information collection requirements, or issued travel charge card.
51.9]
the collection of information from ■ 10. Revise § 301–70.708 to read as
offerors, contractors, or members of the ■ 4. Redesignate §§ 301–51.3 through follows:
public that require the approval of the 301–51.8 as §§ 301–51.4 through 301–
Office of Management and Budget 51.9, respectively. § 301–70.708 What actions may we take if
(OMB) under 44 U.S.C. 3501, et seq. ■ 5. Add a new § 301–51.3 to read as an employee fails to activate the
follows: Government contractor-issued travel
F. Small Business Regulatory charge card and/or misuses the travel
Enforcement Fairness Act § 301–51.3 What classes of employees are charge card?
This final rule is also exempt from exempt from mandatory use of the Internal agency policies and
Government contractor-issued travel procedures should be established
Congressional review prescribed under
charge card? defining what are considered to be
5 U.S.C. 801. This final rule is not a
major rule under 5 U.S.C. 804. The Administrator of General Services misuses of the Government contractor-
exempts the following classes of issued travel charge card. Appropriate
List of Subjects in 41 CFR Parts 301–51 employees from mandatory use of the action may be taken pursuant to those
and 301–70 Government contractor-issued travel policies if an employee fails to activate
Government employees, Travel and charge card: the Government contractor-issued travel
transportation expenses, Paying travel (a) Any employee who has an charge card within 60 days of receipt or
expenses, Internal policy and procedure application pending for the Government misuses the travel charge card.
requirements. contractor-issued travel charge card;
[FR Doc. 2016–21987 Filed 9–13–16; 8:45 am]
(b) Any employee, when issuance of
Dated: August 3, 2016. the Government contractor-issued travel BILLING CODE 6820–14–P
Denise Turner Roth, charge card would adversely affect the
Administrator of General Services. mission or put the employee at risk; and
For the reasons set forth in the (c) Any employee who is not eligible DEPARTMENT OF HEALTH AND
preamble, pursuant to 5 U.S.C. 5701– to receive a Government contractor- HUMAN SERVICES
5711, GSA amends 41 CFR parts 301– issued travel charge card.
51 and 301–70 as set forth below: 42 CFR Part 73
§ 301–51.6 [Amended]
PART 301–51—PAYING TRAVEL ■ 6. In the newly designated § 301–51.6, [CDC Docket No. CDC–2016–0045]
EXPENSES after paragraph (c), revise the heading of RIN 0920–AA64
the note to read ‘‘Note to § 301–51.6’’.
■ 1. The authority citation for 41 CFR Possession, Use, and Transfer of
asabaliauskas on DSK3SPTVN1PROD with RULES

part 301–51 continues to read as PART 301–70—INTERNAL POLICY Select Agents and Toxins—Addition of
follows: AND PROCEDURE REQUIREMENTS Bacillus Cereus Biovar Anthracis to
Authority: 5 U.S.C. 5707. Subpart A is the HHS List of Select Agents and
issued under the authority of Sec. 2, Pub. L. ■ 7. The authority citation for 41 CFR
part 301–70 continues to read as Toxins
105–264, 112 Stat. 2350 (5 U.S.C. 5701 note);
40 U.S.C. 121(c). follows: AGENCY: Centers for Disease Control and
■ 2. Revise § 301–51.1 to read as Authority: 5 U.S.C. 5707; 40 U.S.C. 121(c); Prevention (CDC), Department of Health
follows: Sec. 2, Pub. L. 105–264, 112 Stat. 2350 (5 and Human Services (HHS).

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Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations 63139

ACTION:Interim final rule and request Dr.
FOR FURTHER INFORMATION CONTACT: regulate the possession, use, and
for comments. Samuel Edwin, Director, Division of transfer of biological agents or toxins
Select Agents and Toxins, Centers for that the HHS Secretary determines have
SUMMARY: The Centers for Disease the potential to pose a severe threat to
Disease Control and Prevention, 1600
Control and Prevention (CDC) in the Clifton Road NE., MS–A46, Atlanta, public health and safety (select agents
Department of Health and Human Georgia 30329. Telephone: (404) 718– and toxins). Subtitle B of Title II of the
Services (HHS) is adding Bacillus cereus 2000. Public Health Security and Bioterrorism
Biovar anthracis to the list of HHS select Preparedness and Response Act of 2002
agents and toxins as a Tier 1 select SUPPLEMENTARY INFORMATION: The
interim final rule is organized as (which may be cited as the Agricultural
agent. We are taking this action to Bioterrorism Protection Act of 2002), (7
regulate this agent that is similar to B. follows:
U.S.C. 8401), requires the United States
anthracis to prevent its misuse, which I. Public Participation Department of Agriculture (USDA) to
could cause a biological threat to public II. Background regulate the possession, use, and
health and/or national security. A. Legal Authority
B. Historical Background to This
transfer of biological agents or toxins
DATES: that the USDA Secretary determines
Effective date: The interim final rule Rulemaking
III. Rationale for Issuance of an Interim Final have the potential to pose a severe
is effective on October 14, 2016. Rule threat to animal or plant health, or
Public comment period: Written or IV. Alternatives Considered animal or plant products (select agents
electronic comments must be submitted V. Required Regulatory Analyses and toxins). Accordingly, HHS and
by November 14, 2016. A. Executive Orders 12866 and 13563 USDA have promulgated regulations
Applicability dates: By October 14, B. The Regulatory Flexibility Act requiring individuals or entities that
2016, any individual or entity that C. Paperwork Reduction Act of 1995 possess, use, or transfer select agents
possesses B. cereus Biovar anthracis D. EO 12988: Civil Justice Reform
E. EO 13132: Federalism
and toxins to register with HHS/CDC or
must provide notice to the CDC’s DSAT USDA/Animal and Plant Health
regarding their possession of this agent F. Plain Language Act of 2010
VI. References Inspection Service (APHIS). See 42 CFR
and must secure the agent against theft, part 73, 7 CFR part 331, and 9 CFR part
loss, release, or unauthorized access; I. Public Participation 121 (the select agent regulations). The
and by March 13, 2017, an individual or Interested persons or organizations Federal Select Agent Program, a
entity that intends to continue to are invited to participate in this collaboration of HHS/CDC/Division of
possess, use, or transfer this agent will rulemaking by submitting written views, Select Agents and Toxins and USDA/
be required to either register in recommendations, and data. HHS/CDC APHIS/Agriculture Select Agent
accordance with 42 CFR part 73 or invites comments on the following Services, administers the select agent
amend their current registration in questions: regulations in a manner that minimizes
accordance with 42 CFR 73.7(h) and the administrative burden on persons
meet all of the requirements of select (1) Are there other virulent (pBCXO1+ and
pBCXO2+) strains of Bacillus species that subject to the select agent regulations.
agent regulations (42 CFR part 73). USDA/APHIS is currently considering
should also be regulated?
ADDRESSES: You may submit comments, (2) What is the impact of designating B. whether B. cereus Biovar anthracis
identified by Docket No. CDC–2016– cereus Biovar anthracis as a Tier 1 select should also be listed as a USDA select
0045 or RIN 0920–AA64 by any of the agent? agent.
following methods: Comments received, including
• Federal eRulemaking Portal: http:// B. Historical Background to This
attachments and other supporting Rulemaking
www.regulations.gov. Follow the
materials, are part of the public record Emerging B. cereus strains that cause
instructions for submitting comments.
• Mail: Dr. Samuel Edwin, Director, and subject to public disclosure. Do not anthrax-like disease have been isolated
Division of Select Agents and Toxins, include any information in your in Cameroon (CA strain) and Côte
Centers for Disease Control and comment or supporting materials that d’Ivoire (CI strain). We are currently
Prevention, 1600 Clifton Road NE., MS– you consider confidential or aware that geographic distribution of B.
A46, Atlanta, Georgia 30329, Attn: inappropriate for public disclosure. cereus Biovar anthracis is limited to
Docket CDC–2016–0045 HHS/CDC will consider comments that some African countries, one registered
Instructions: All submissions received are received within 60 days of entity in the United States, and one
must include the agency name and publication of this rule in the Federal facility in Germany. The B. cereus strain
docket number or Regulatory Register. After the comment period being added to the HHS list of select
Information Number (RIN) for this closes, we will publish another agents is identified as B. cereus Biovar
rulemaking. All relevant comments document in the Federal Register. The anthracis and described in the
received will be posted without change document will include a discussion of publication ‘‘Characterization of
to http://regulations.gov, including any any comments we receive and any Bacillus anthracis-like bacteria isolated
personal information provided. For amendments that will be made to the from wild great apes from Cote d’Ivoire
access to the docket to read background rule as a result of the comments. and Cameroon’’ (Ref. 3, see table below).
documents or comments received, go to II. Background Recent research demonstrates that B.
http://www.regulations.gov. cereus Biovar anthracis has all of the
Comments will also be available for A. Legal Authority virulence determinants and threat
asabaliauskas on DSK3SPTVN1PROD with RULES

public inspection from Monday through HHS/CDC is promulgating this rule potential of Bacillus anthracis, a Tier 1
Friday, except for legal holidays, from 9 under the authority of sections 201–204 select agent (Ref. 1). A biovar is a group
a.m. to 5 p.m., Eastern Time, at 1600 and 221 of Title II of Public Law 107– of microorganisms that are genetically
Clifton Road NE., Atlanta, Georgia 188, 116 Stat 637 (42 U.S.C. 262a). similar but differ from other members of
30329. Please call ahead to (404) 718– Subtitle A of Title II of the Public the species by biochemical or genetic
2000 and ask for a representative from Health Security and Bioterrorism characteristics. B. cereus Biovar
the Division of Select Agents and Preparedness and Response Act of 2002, anthracis was originally isolated about
Toxins to schedule your visit. (42 U.S.C. 262a), requires HHS to a decade ago from gorillas and

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63140 Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations

chimpanzees exhibiting anthrax-like the greatest risk of deliberate misuse pathogenicity (ability of an organism to
disease in Cameroon and Cote d’Ivoire with significant potential for mass cause disease), communicability (ability
(Ref. 3–6). Genomic characterization casualties or devastating effect to the to spread from infected to susceptible
showed that these organisms belong to economy, critical infrastructure, or hosts), ease of dissemination, route of
the B. cereus species and harbor two public confidence, and poses a severe exposure, environmental stability, ease
plasmids that are referred to as pBCXO1 threat to public health and safety. We of production in the laboratory, ability
and pBCXO2. The plasmid (pBCXO1) is believe that Bacillus cereus Biovar to genetically manipulate or alter, long-
very similar to pXO1, which is found in anthracis presents the same threat to term health effects, untreated acute
B. anthracis, and encodes active edema public health and national security as mortality, available therapeutics and
and lethal toxins. The plasmid does Bacillus anthracis. vaccines, status of immunity,
(pBCXO2) is very similar to pXO2, In December 2015, the question of vulnerability of special populations, and
which is found in B. anthracis, and whether B. cereus Biovar anthracis the burden or impact on the health care
encodes the enzymes that synthesize the should be regulated as a select agent system. The ISATTAC also considered
poly-D-glutamic acid capsule. Thus, was considered by HHS/CDC’s whether B. cereus Biovar anthracis
these organisms are genetically similar Intragovernmental Select Agents and should be designated as a Tier 1 select
and produce all of the primary virulence Toxins Technical Advisory Committee agent. Executive Order 13546,
factors (toxins and capsule) of B. (ISATTAC). The ISATTAC is comprised ‘‘Optimizing the Security of Biological
anthracis. In addition, pBCXO2 has a of Federal government employees from Select Agents and Toxins in the United
functional hasACB operon that encodes CDC, the Biomedical Advanced States,’’ defines as ‘‘Tier 1’’ those select
a second capsule composed of Research and Development Authority agents and toxins that present the
hyaluronic acid (HA), which enhances (BARDA) within the Office of the greatest risk of deliberate misuse with
the neuro-invasiveness of these Assistant Secretary for Preparedness the most significant potential for mass
organisms in laboratory models of and Response (ASPR), the National casualties or devastating effects to the
infection (Ref. 1). Accordingly, because Institutes of Health (NIH), the Food and economy, critical infrastructure; or
we believe that B. cereus Biovar Drug Administration (FDA), the public confidence (Ref. 7). At this time,
anthracis has the same potential to pose Department of Homeland Security HHS/CDC is not proposing to regulate
a severe threat to public health as does (DHS), the Department of Defense other strains of B. cereus that have B.
Bacillus anthracis, currently regulated (DOD), the USDA/Animal and Plant anthracis toxin genes as the data
as a Tier 1 pathogen, we are adding Health Inspection Service (APHIS), available do not suggest those strains
Bacillus cereus Biovar anthracis to HHS USDA/Agricultural Research Service pose a severe threat to public health
select agent list by an interim final rule (ARS), and USDA Center for Veterinary (Ref. 1 and Ref. 8).
because we believe that any delay in Biologics (CVB). Based on the criteria The table below comes from
bringing the possession, use, or transfer outlined in the Public Health Security ‘‘Bacteriological discrimination
into the United States of this pathogen and Bioterrorism Preparedness and characteristics of atypical B. anthracis
is contrary to the public interest. A Response Act of 2002 (42 U.S.C. 262a), strains isolated from great apes, classic
biological agent is designated as Tier 1 the ISATTAC considered the following B. anthracis strains, and other strains of
when it is determined that it presents in their review: The degree of the B. cereus group’’ (Ref. 3).

Result a

B. anthracis CI B. anthracis CA
Microbiological characteristic
B. anthracis B. cereus
Primary Sub Primary Sub
culture culture culture 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 • Fully virulent (pXO1+ pXO2+) the same routes as B. anthracis. In areas
and consulting with subject matter strains of B. anthracis are currently (Cameroon and Cote d’Ivoire) where B.
experts, ISATTAC recommended that B. regulated as Tier 1 select agent. cereus Biovar anthracis has been
cereus Biovar anthracis should be listed • To date, there have been no reports isolated from gorillas and chimpanzees
as a HHS select agent and regulated as (Ref. 4–6), it is possible that isolates
asabaliauskas on DSK3SPTVN1PROD with RULES

of this biovar having been isolated from
Tier 1 agent because: humans. However, B. cereus Biovar from human cases could be missed due
• Genomic characterization showed anthracis exhibited virulence, to the lack of laboratory capacity and to
that B. cereus Biovar anthracis belongs comparable to B. anthracis in animal the thorough characterization needed to
to the B. cereus species, but it harbors models of subcutaneous and intranasal/ differentiate B. anthracis from B. cereus
virulence-associated plasmids that are inhalational anthrax (Ref. 3). Thus, it is Biovar anthracis.
similar to B. anthracis, a Tier 1 select reasonable to assume that B. cereus • As with B. anthracis, the virulence
agent (Ref. 1–2). Biovar anthracis can infect humans by of this strain as a spore-forming

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Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations 63141

bacterium may make it attractive to B. cereus Biovar anthracis has all of required by these Executive Orders and
those that wish to circumvent the select the virulence characteristics and threat has determined that it is consistent with
agent regulations for nefarious purposes. potential of Bacillus anthracis, which is the principles set forth in the Executive
• PBCXO2—strains of B. cereus already regulated as a Tier 1 select Orders and the Regulatory Flexibility
Biovar anthracis (analogous to B. agent. Accordingly, for the reasons Act, as amended by the Small Business
anthracis veterinary vaccine Sterne stated above, we have determined that Regulatory Enforcement Fairness Act
strain) produce a HA capsule from genes B. cereus Biovar anthracis not only also (SBREFA). We anticipate that the rule
present on pBCXO1. Studies have has the potential to pose a severe threat will create minimal impact.
shown such variants (pBCXO2¥) are to public health and safety; but that it This regulatory impact section
still as virulent as B. anthracis in animal may present a great risk for deliberate presents the anticipated costs and
models (Ref. 1). misuse with a significant potential for
• There is no apparent difference benefits that are quantified where
mass casualties or devastating effects to possible. Where quantification is not
between this organism and B. anthracis the economy, critical infrastructure; or
with respect to the criteria used to possible, a qualitative discussion is
public confidence. We are taking this provided of the costs and/or benefits
designate B. anthracis as a Tier 1 agent. action to place this agent under the
In addition, the Federal Experts that HHS/CDC anticipates from issuing
biosafety and security requirements of this regulation.
Security Advisory Panel (FESAP) the select agent regulations; and to
provided policy and technical input for regulate its possession and transfer to Need for the Regulation
the recommendation to list B. cereus prevent an accidental release or its
Biovar anthracis as an HHS select agent misuse. We believe this interim final Bacillus cereus Biovar anthracis is a
and regulated as Tier 1 agent. The rule is in the best interest of public recently recognized, emerging
mission of the FESAP is to make health and national security. pathogens that has all the virulence
technical and substantive Pursuant to 5 U.S.C. 553(b)(3)(B), and characteristics and threat potential of
recommendations concerning the for the reasons stated above, we Bacillus anthracis, a Tier 1 select agent.
appropriate safeguards and security therefore find that there is good cause to This organism is not currently on the
standards for persons possessing, using, dispense with prior public notice and HHS List of Select Agents and Toxins;
or transferring BSAT. The goal of the the opportunity to comment on this rule we are proposing regulating this
FESAP is that their recommendations be before it becomes effective because any organism as a Tier 1 select agent
commensurate with the risk that such delay in promulgating the rule would be because of its potential for misuse and
agents or toxins pose to public health its threat to public health and safety.
contrary to the public interest.
and safety, including the risk of their
use in domestic or international IV. Alternatives Considered Regulatory Impact Analysis
terrorism. The FESAP drew from the In researching this addition to the Costs
expertise of its membership, HHS select agents and toxins list, we
information from presentations by Currently, the only entity in
also considered whether B. cereus possession of this agent is already
several federal department and agency Biovar anthracis should be designated
subject matter experts, and technical registered to possess Tier 1 select
as a non-Tier 1 agent. We concluded agents. As a result, the burden
input from the Directors of the Federal that B. cereus Biovar anthracis should
Select Agent Program (FSAP) to develop associated with this entity is minimal.
be regulated as a Tier 1 select agent for However, this rule will also affect
its recommendation. The FESAP has the same reason that we currently
issued a draft report that recommended entities which plan to possess the agent
regulation B. anthracis as a Tier 1 select in the future. We believe that these
listing B. cereus biovar anthracis as a agent.
select agent (not Tier 1). entities fall into three categories:
After consideration of all of the above, V. Required Regulatory Analyses Entities not currently registered for a
HHS/CDC has determined that B. cereus select agent or toxin, and entities
A. Executive Orders 12866 and 13563 already registered with the Federal
Biovar anthracis should be listed as a
Tier 1 HHS select agent given its HHS/CDC has examined the impacts Select Agent Program (FSAP) but not for
similarities to B. anthracis, which is of this interim final rule (IFR) under a Tier 1 agent or toxin, and entities
consistent with current regulatory Executive Order 12866, Regulatory already registered to possess a Tier 1
requirements for B. anthracis. Planning and Review (58 FR 51735, agent, such as the one already in
October 4, 1993) and Executive Order possession of the agent. Based on the
III. Rationale for Issuance of an Interim 13563, Improving Regulation and 2012 Select Agent Final Rule, entities
Final Rule Regulatory Review, (76 FR 3821, already registered with the FSAP but
Agency rulemaking is governed by January 21, 2011). Both Executive not for a Tier 1 agent or toxin will incur
section 553 of the Administrative Orders direct agencies to evaluate any costs of approximately $10,000–$15,000
Procedure Act (APA) (5 U.S.C. 553) rule prior to promulgation to determine in order to possess the agent, and
which, unless the rule falls within one the regulatory impact in terms of costs median annualized costs to entities not
of the exemptions, requires that HHS/ and benefits to United States currently registered to possess select
CDC publish a notice of proposed populations and businesses. Further, agent or toxin are estimated to be
rulemaking in the Federal Register that together, the two Executive Orders set approximately $37,000 in order to
provides interested persons an the following requirements: Quantify possess the agent. As noted, for entities
asabaliauskas on DSK3SPTVN1PROD with RULES

opportunity to submit written data, costs and benefits where the new already registered to possess a Tier 1
views, or arguments. Section 553(b)(B) regulation creates a change in current agent, costs are estimated to be minimal.
of the APA authorizes a department or practice; define qualitative costs and However, we lack data to forecast the
agency to dispense with the prior notice benefits; choose approaches that number of entities beyond the one entity
and opportunity for public comment maximize benefits; support regulations we are currently aware of that will
requirement for ‘‘good cause’’ if the that protect public health and safety; possess this agent in the future, and as
department or agency finds that it is and minimize the impact of regulation. a result we do not estimate the total
contrary to the public interest. HHS/CDC has analyzed this IFR as associated costs.

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63142 Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations

Benefits: The agents and toxins placed Comparison of Costs and Benefits: In companies to compete with foreign-
on the HHS selects and toxins list have our analysis, we determined that only based companies in domestic and
the potential to pose severe threats to one entity that already possesses Tier 1 export markets.
public health and safety. The benefits of select agents in the United States is in
C. Paperwork Reduction Act of 1995
the HHS/CDC interim final rule derive possession of B. cereus Biovar anthracis.
from the strengthened prevention As noted above, the cost to the entity In accordance with section 3507(d) of
against the accidental or intentional would be minimal. Also noted above, the Paperwork Reduction Act of 1995
release of B. cereus Biovar anthracis. We this rule will affect entities that plan to (44 U.S.C. 3501 et seq.), the information
based the following assumption on the possess the agent in the future. Based on collection or recordkeeping
release of B. anthracis that occurred in the 2012 Select Agent Final Rule, requirements included in this
2001. The cost of such an event in entities already registered with the rulemaking are currently approved by
human life could be high. An outbreak FSAP but not for a Tier 1 agent or toxin the Office of Management and Budget
of B. cereus Biovar anthracis also would will incur costs of approximately (OMB) under OMB control number
require a complex and expensive $10,000–$15,000 in order to possess the 0920–0576, expiration date 12/31/2018.
emergency response effort. This effort agent, and median annualized costs to This includes the burden on entities to
would include extensive public health entities not currently registered to submitted amendments to their
measures, such as quarantine, isolation, possess select agent or toxin are registrations.
preventive treatment and health testing estimated to be approximately $37,000 We expect that the entities who will
for large numbers of potentially exposed in order to possess the agent. For register for possession, use, or transfer
persons, and extensive entities already registered to possess a of B. cereus Biovar anthracis will
decontamination. Substantial costs Tier 1 agent, costs are estimated to be already be registered with the Federal
would likely be incurred by hospitals minimal. Select Agent Program. This rulemaking
and other medical facilities and The benefit of regulating this will require such an entity to amend its
institutions of government at all levels. organism is the prevention of an registration with the Federal Select
An outbreak of B. cereus Biovar outbreak of disease due to this Agent Program using relevant portions
anthracis, or widespread fear of one, organism. An analysis of the 2001 of APHIS/CDC Form 1 (Application for
also would likely create significant anthrax incident shows the impact of Registration for Possessing, Use, and
secondary effects to society including a the outbreak in terms of loss of life, Transfer of Select Agents and Toxins).
potentially rapid increase in health illness, decontamination costs, and loss Estimated time to amend this form is
anxiety among healthy individuals. This of productivity. one hour for one select agent.
may result in overcrowded healthcare Based on this analysis, we believe the Additionally, any registered entity that
facilities and emergency rooms, and the benefit of this rulemaking outweighs the wishes to transfer B. cereus Biovar
disruption of everyday business costs. anthracis will be required to submit
operations, transportation, and other B. The Regulatory Flexibility Act (RFA), information using APHIS/CDC Form 2
normal behavior. as Amended by the Small Business (Request to Transfer of Select Agent and
Impacts from the October 2001 Toxins). Estimated average time to
Regulatory Enforcement Fairness Act
anthrax attacks exemplify the costs that complete this form is one hour. Based
(SBREFA)
the regulatory revisions will help to upon the limited publications on this
prevent. The anthrax attacks caused five We have examined the impacts of the agent at this time, we estimate that only
fatalities and seventeen illnesses, interim final rule under the Regulatory one registered entity may add B. cereus
disrupted business and government Flexibility Act (5 U.S.C. 601–612). Biovar anthracis to their registration or
activities, closed substantial parts of the Unless we certify that the interim final transfer B. cereus Biovar anthracis to
U.S. Postal Service, and caused rule is not expected to have a significant another registered entity. Therefore, we
widespread apprehension and changes economic impact on a substantial calculate that there is no increase in the
in behavior. Costs included more than number of small entities, the Regulatory number of respondents that need to
$23 million to decontaminate one Flexibility Act (RFA), as amended by submit an application for registration,
Senate office building, approximately $2 the Small Business Regulatory we estimate the total number of
billion in revenues lost to the postal Enforcement Fairness Act (SBREFA), responses for entities to submit an
service, and as much as $3 billion in requires agencies to analyze regulatory amendment to their registration may
additional costs to the U.S. Postal options that would minimize any increase by one, and the total burden
Service for cleanup of contamination significant economic impact of a rule on hours may increase to one hour.
and procurement of mail-sanitizing small entities. Based on our current
equipment (referenced from the knowledge of who possesses B. cereus D. E.O. 12988: Civil Justice Reform
Regulatory Impact Analysis from the Biovar anthracis, we certify that this This rule has been reviewed under
2012 Select Agent Regulations Final interim final rule will not have a E.O. 12988, Civil Justice Reform. Once
Rule). There were substantial costs due significant economic impact on a the interim final rule is in effect, HHS/
to lost productivity throughout the substantial number of small entities CDC notes that: (1) All State and local
economy and investigations into the within the meaning of the RFA. laws and regulations that are
incident (referenced from the Regulatory This regulatory action is not a major inconsistent with this rule will be
Impact Analysis from the 2012 Select rule as defined by Sec. 804 of the Small preempted; (2) no retroactive effect will
Agent Regulations Final Rule). Business Regulatory Enforcement be given to this rule; and (3)
asabaliauskas on DSK3SPTVN1PROD with RULES

A deliberate release of B. cereus Fairness Act of 1996. This interim final administrative proceedings will not be
Biovar anthracis may cause wide- rule will not result in an annual effect required before parties may file suit in
ranging impacts to the economy, on the economy of $100,000,000 or court challenging this rule.
potential loss of market access for more; a major increase in cost or prices;
consumer goods and services, other or significant adverse effects on E. E.O. 13132: Federalism
disruptions to society, and diminished competition, employment, investment, HHS/CDC has reviewed this interim
confidence in public and private productivity, innovation, or on the final rule in accordance with Executive
institutions. ability of United States-based Order 13132 regarding Federalism, and

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Interim final rule and request for comments.
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.
FR Citation		81 FR 63138
RIN Number		0920-AA64
CFR Associated		Biologics; Packaging and Containers; Penalties; Reporting and Recordkeeping Requirements and Transportation