[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\
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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]
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