[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]


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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.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]

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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