82_FR_17638 82 FR 17569 - Possession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus cereus Biovar anthracis to the HHS List of Select Agents and Toxins

82 FR 17569 - 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 82, Issue 69 (April 12, 2017)

Page Range17569-17570
FR Document2017-07210

On September 14, 2016, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) published in the Federal Register (81 FR 63138) an interim final rule and request for comments which added Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. CDC received two comments, both of which supported the rule change.

Federal Register, Volume 82 Issue 69 (Wednesday, April 12, 2017)
[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)]
[Rules and Regulations]
[Pages 17569-17570]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07210]


=======================================================================
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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).

ACTION: Interim rule; adoption as final and response to public 
comments.

-----------------------------------------------------------------------

SUMMARY: On September 14, 2016, the Centers for Disease Control and 
Prevention (CDC) in the Department of Health and Human Services (HHS) 
published in the Federal Register (81 FR 63138) an interim final rule 
and request for comments which added Bacillus cereus Biovar anthracis 
to the list of HHS select agents and toxins as a Tier 1 select agent. 
CDC received two comments, both of which supported the rule change.

DATES: Effective April 12, 2017.

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: Effective on October 14, 2016, Bacillus 
cereus Biovar anthracis was added to the list of HHS select agents and 
toxins as a Tier 1 select agent (81 FR 63138, September 14, 2016). In 
the interim final rule, HHS/CDC invited 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?
    The comment period ended November 14, 2016.
    We received two comments, both of which supported adding B. cereus 
Biovar anthracis to the list of HHS select agents and toxins. While 
both commenters supported the addition, one commented that the 
regulation of B. cereus Biovar anthracis will ``restrict the ability of 
future laboratories and organizations to test for and analyze possible 
pBXO1 and pBXO2 isolates.'' The commenter further argued that

[[Page 17570]]

``new laboratories seeking the ability to analyze this select agent 
will incur substantial costs and urged HHS/CDC reassess the impacts 
that a $37,000 buy-in for new laboratories might have on the ability to 
understand this deadly microbe.'' HHS/CDC made no changes based on this 
comment. 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. 2). HHS/CDC agrees that the regulations will impact new 
laboratories wishing to perform research with B. cereus Biovar 
anthracis. However, 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.
    HHS/CDC adopts the interim rule, which was effective October 14, 
2016 (81 FR 63138, September 14, 2016), as final without change. In 
accordance with the interim final rule, any individual or entity that 
possessed B. cereus Biovar anthracis on or after October 14, 2016, must 
provide notice to the CDC regarding their possession 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 is 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).

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. 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.

    Dated: April 4, 2017.
Thomas E. Price,
Secretary.
[FR Doc. 2017-07210 Filed 4-11-17; 8:45 am]
 BILLING CODE 4163-18-P



                                                              Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Rules and Regulations                                                       17569

                                             not subject to Executive Order 13211,                   section 408(n)(4). As such, the Agency                    other required information to the U.S.
                                             entitled ‘‘Actions Concerning                           has determined that this action will not                  Senate, the U.S. House of
                                             Regulations That Significantly Affect                   have a substantial direct effect on States                Representatives, and the Comptroller
                                             Energy Supply, Distribution, or Use’’ (66               or tribal governments, on the                             General of the United States prior to
                                             FR 28355, May 22, 2001) or Executive                    relationship between the national                         publication of the rule in the Federal
                                             Order 13045, entitled ‘‘Protection of                   government and the States or tribal                       Register. This action is not a ‘‘major
                                             Children from Environmental Health                      governments, or on the distribution of                    rule’’ as defined by 5 U.S.C. 804(2).
                                             Risks and Safety Risks’’ (62 FR 19885,                  power and responsibilities among the
                                             April 23, 1997). This action does not                                                                             List of Subjects in 40 CFR Part 180
                                                                                                     various levels of government or between
                                             contain any information collections                     the Federal Government and Indian                           Environmental protection,
                                             subject to OMB approval under the                       tribes. Thus, the Agency has determined                   Administrative practice and procedure,
                                             Paperwork Reduction Act (PRA) (44                       that Executive Order 13132, entitled                      Agricultural commodities, Pesticides
                                             U.S.C. 3501 et seq.), nor does it require               ‘‘Federalism’’ (64 FR 43255, August 10,                   and pests, Reporting and recordkeeping
                                             any special considerations under                        1999) and Executive Order 13175,                          requirements.
                                             Executive Order 12898, entitled                         entitled ‘‘Consultation and Coordination                    Dated: March 7, 2017.
                                             ‘‘Federal Actions to Address                            with Indian Tribal Governments’’ (65 FR
                                                                                                                                                               Michael Goodis,
                                             Environmental Justice in Minority                       67249, November 9, 2000) do not apply
                                             Populations and Low-Income                                                                                        Director, Registration Division, Office of
                                                                                                     to this action. In addition, this action
                                                                                                                                                               Pesticide Programs.
                                             Populations’’ (59 FR 7629, February 16,                 does not impose any enforceable duty or
                                             1994).                                                  contain any unfunded mandate as                             Therefore, 40 CFR chapter I is
                                                Since tolerances and exemptions that                 described under Title II of the Unfunded                  amended as follows:
                                             are established on the basis of a petition              Mandates Reform Act (UMRA) (2 U.S.C.
                                             under FFDCA section 408(d), such as                                                                               PART 180—[AMENDED]
                                                                                                     1501 et seq.).
                                             the exemption in this final rule, do not                   This action does not involve any
                                             require the issuance of a proposed rule,                technical standards that would require                    ■ 1. The authority citation for part 180
                                             the requirements of the Regulatory                      Agency consideration of voluntary                         continues to read as follows:
                                             Flexibility Act (RFA) (5 U.S.C. 601 et                  consensus standards pursuant to section                       Authority: 21 U.S.C. 321(q), 346a and 371.
                                             seq.), do not apply.                                    12(d) of the National Technology                          ■ 2. In § 180.910, add alphabetically the
                                                This action directly regulates growers,              Transfer and Advancement Act                              inert ingredient to the table to read as
                                             food processors, food handlers, and food                (NTTAA) (15 U.S.C. 272 note).                             follows:
                                             retailers, not States or tribes, nor does
                                             this action alter the relationships or                  VIII. Congressional Review Act                            § 180.910 Inert ingredients used pre- and
                                             distribution of power and                                 Pursuant to the Congressional Review                    post-harvest; exemptions from the
                                             responsibilities established by Congress                Act (5 U.S.C. 801 et seq.), EPA will                      requirement of a tolerance.
                                             in the preemption provisions of FFDCA                   submit a report containing this rule and                  *        *    *       *     *

                                                                   Inert ingredients                                                              Limits                                        Uses


                                                     *                 *                     *                              *                   *                     *                                *
                                             Monoethanolamine (CAS Reg. No. 141–43–5) ................          Not to exceed 3.35% by weight in pesticide formulation               Solvent.

                                                       *                       *                       *                          *                        *                     *                     *



                                             [FR Doc. 2017–07130 Filed 4–11–17; 8:45 am]             SUMMARY:   On September 14, 2016, the                     HHS select agents and toxins as a Tier
                                             BILLING CODE 6560–50–P                                  Centers for Disease Control and                           1 select agent (81 FR 63138, September
                                                                                                     Prevention (CDC) in the Department of                     14, 2016). In the interim final rule,
                                                                                                     Health and Human Services (HHS)                           HHS/CDC invited comments on the
                                                                                                     published in the Federal Register (81                     following questions:
                                             DEPARTMENT OF HEALTH AND
                                                                                                     FR 63138) an interim final rule and                         (1) Are there other virulent (pBCXO1+
                                             HUMAN SERVICES
                                                                                                     request for comments which added                          and pBCXO2+) strains of Bacillus
                                             42 CFR Part 73                                          Bacillus cereus Biovar anthracis to the                   species that should also be regulated?
                                                                                                     list of HHS select agents and toxins as                     (2) What is the impact of designating
                                             [CDC Docket No. CDC–2016–0045]                          a Tier 1 select agent. CDC received two                   B. cereus Biovar anthracis as a Tier 1
                                                                                                     comments, both of which supported the                     select agent?
                                             RIN 0920–AA64                                           rule change.                                                The comment period ended
                                                                                                     DATES: Effective April 12, 2017.                          November 14, 2016.
                                             Possession, Use, and Transfer of                                                                                    We received two comments, both of
                                             Select Agents and Toxins—Addition of                    FOR FURTHER INFORMATION CONTACT: Dr.
                                                                                                                                                               which supported adding B. cereus
                                             Bacillus cereus Biovar anthracis to                     Samuel Edwin, Director, Division of
                                                                                                                                                               Biovar anthracis to the list of HHS select
                                             the HHS List of Select Agents and                       Select Agents and Toxins, Centers for
                                                                                                                                                               agents and toxins. While both
pmangrum on DSK3GDR082PROD with RULES




                                             Toxins                                                  Disease Control and Prevention, 1600
                                                                                                                                                               commenters supported the addition, one
                                                                                                     Clifton Road NE., MS–A46, Atlanta,
                                             AGENCY:  Centers for Disease Control and                                                                          commented that the regulation of B.
                                                                                                     Georgia 30329. Telephone: (404) 718–
                                             Prevention (CDC), Department of Health                                                                            cereus Biovar anthracis will ‘‘restrict
                                                                                                     2000.
                                             and Human Services (HHS).                                                                                         the ability of future laboratories and
                                                                                                     SUPPLEMENTARY INFORMATION:    Effective                   organizations to test for and analyze
                                             ACTION: Interim rule; adoption as final
                                                                                                     on October 14, 2016, Bacillus cereus                      possible pBXO1 and pBXO2 isolates.’’
                                             and response to public comments.
                                                                                                     Biovar anthracis was added to the list of                 The commenter further argued that


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                                             17570            Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Rules and Regulations

                                             ‘‘new laboratories seeking the ability to               FEDERAL COMMUNICATIONS                                Bureau, and may also be contacted at
                                             analyze this select agent will incur                    COMMISSION                                            (202) 418–7233 (TTY).
                                             substantial costs and urged HHS/CDC                                                                           SUPPLEMENTARY INFORMATION: This is a
                                             reassess the impacts that a $37,000 buy-                47 CFR Part 22                                        summary of the Commission’s Second
                                             in for new laboratories might have on                   [WT Docket Nos. 12–40, 10–112; RM–11510,              Report and Order in the Cellular Reform
                                             the ability to understand this deadly                   RM–11660; FCC 17–27]                                  proceeding (Cellular Second R&O), WT
                                             microbe.’’ HHS/CDC made no changes                                                                            Docket No. 12–40, RM Nos. 11510 and
                                             based on this comment. HHS/CDC is not                   Cellular Service, Including Changes in                11660, and the Commission’s
                                             proposing to regulate other strains of B.               Licensing of Unserved Area                            companion Report and Order in the
                                             cereus that have B. anthracis toxin                                                                           Wireless Radio Services (WRS) Reform
                                                                                                     AGENCY:  Federal Communications                       proceeding (WRS R&O), WT Docket No.
                                             genes as the data available do not                      Commission.
                                             suggest those strains pose a severe threat                                                                    10–112, FCC 17–27, adopted March 23,
                                                                                                     ACTION: Final rule.                                   2017 and released March 24, 2017. The
                                             to public health (Ref. 1 and Ref. 2).
                                                                                                                                                           full text of the Cellular Second R&O and
                                             HHS/CDC agrees that the regulations                     SUMMARY:    In this document, the Federal             WRS R&O, including all Appendices, is
                                             will impact new laboratories wishing to                 Communications Commission                             available for inspection and copying
                                             perform research with B. cereus Biovar                  (Commission) adopts revised rules                     during normal business hours in the
                                             anthracis. However, we believe that B.                  governing the 800 MHz Cellular                        FCC Reference Center, 445 12th Street
                                             cereus Biovar anthracis has the same                    Radiotelephone (Cellular) Service. The                SW., Room CY–A157, Washington, DC
                                             potential to pose a severe threat to                    Commission revises the outdated                       20554, or by downloading the text from
                                             public health as does Bacillus anthracis,               Cellular radiated power rules and                     the Commission’s Web site at https://
                                             currently regulated as a Tier 1 pathogen.               related technical provisions, most                    apps.fcc.gov/edocs_public/attachmatch/
                                                                                                     notably allowing licensees the option to              FCC-17-27A1.pdf. Alternative formats
                                                HHS/CDC adopts the interim rule,
                                                                                                     comply with power spectral density                    are available for people with disabilities
                                             which was effective October 14, 2016                    (PSD) power limits, while also
                                             (81 FR 63138, September 14, 2016), as                                                                         (Braille, large print, electronic files,
                                                                                                     safeguarding systems that share the 800               audio format), by sending an email to
                                             final without change. In accordance                     MHz band, especially public safety
                                             with the interim final rule, any                                                                              FCC504@fcc.gov or calling the
                                                                                                     systems, from increased unacceptable                  Consumer and Government Affairs
                                             individual or entity that possessed B.                  interference. These updated rules will                Bureau at (202) 418–0530 (voice), (202)
                                             cereus Biovar anthracis on or after                     allow Cellular licensees to deploy                    418–0432 (TTY).
                                             October 14, 2016, must provide notice                   advanced mobile broadband services
                                             to the CDC regarding their possession                   such as long term evolution (LTE) more                Synopsis
                                             and must secure the agent against theft,                efficiently. The Cellular licensing rule              I. Second Report and Order (Cellular
                                             loss, release, or unauthorized access;                  revisions continue the transition to a                Reform Proceeding, WT Docket No. 12–
                                             and by March 13, 2017, an individual or                 geographic-based regime by eliminating                40)
                                             entity that intends to continue to                      certain filing requirements, and also
                                                                                                     eliminate the comparative hearing                     A. Background
                                             possess, use, or transfer this agent is
                                             required to either register in accordance               process for Cellular license renewals.                   1. In a Report and Order released on
                                             with 42 CFR part 73 or amend their                      Both the technical and licensing reforms              November 10, 2014 in the Cellular
                                             current registration in accordance with                 provide Cellular licensees with more                  Reform proceeding (WT Docket No. 12–
                                             42 CFR 73.7(h) and meet all of the                      flexibility, reduce administrative                    40) (2014 Cellular R&O), the
                                             requirements of select agent regulations                burdens, and enable Cellular licensees                Commission adopted new and revised
                                                                                                     to respond more quickly—and at lower                  rules to change to a geographic-based
                                             (42 CFR part 73).
                                                                                                     cost—to changing market conditions                    licensing regime. Specifically, it revised
                                             References                                              and consumer demand. They also                        the rules to establish geographic
                                                                                                     promote similar treatment across                      licenses based on cellular geographic
                                             1. Brezillon, C, Hauslant, M, Dupke, S, Corre,
                                                                                                     competing commercial wireless                         service area (CGSA) boundaries and
                                                  JP, Lander, A, Franz, T, Monot, M,
                                                                                                     spectrum bands.                                       provided licensees with significant new
                                                  Couture-Tosi, E, Jouvion, G, Leendertz,
                                                                                                     DATES: Effective May 12, 2017, except
                                                                                                                                                           flexibility to improve their systems
                                                  FH, Grunow, R, Mock, ME, Klee, SR, and
                                                                                                     for the amendments to 47 CFR 22.317,                  through modifications within those
                                                  Goossens, L. (2015) Capsules, toxins and
                                                                                                                                                           boundaries. It preserved the ability of
                                                  AtxA as virulence factors of emerging              22.911(a) through (c), 22.913(a), (c), and
                                                                                                                                                           licensees to expand their CGSAs into
                                                  Bacillus cereus Biovar anthracis. PLOS             (f), 22.947, and 22.953(c), which contain
                                                                                                                                                           Unserved Area if the area is at least 50
                                                  Negl. Trop. Dis. 9(4):e0003455.                    information collection requirements that
                                                                                                                                                           contiguous square miles, but
                                             2. Avashia SB, et al. (2007) Fatal pneumonia            have not yet been approved by the
                                                                                                                                                           dramatically reduced application filing
                                                  among metalworkers due to inhalation               Office of Management and Budget
                                                                                                                                                           burdens by permitting incumbents to
                                                  exposure to Bacillus cereus containing             (OMB) under the Paperwork Reduction
                                                  Bacillus anthracis toxin genes. Clin.
                                                                                                                                                           serve indefinitely, on a secondary basis,
                                                                                                     Act. The Commission will publish a
                                                  Infect. Dis. 44:414–416.
                                                                                                                                                           Unserved Area parcels smaller than 50
                                                                                                     document in the Federal Register
                                                                                                                                                           contiguous square miles. It eliminated
                                               Dated: April 4, 2017.                                 announcing the effective date of those
                                                                                                                                                           other filing requirements and
                                                                                                     amendments.
                                             Thomas E. Price,                                                                                              established a field strength limit rule
                                             Secretary.                                              FOR FURTHER INFORMATION CONTACT:                      tailored to reflect the continued ability
pmangrum on DSK3GDR082PROD with RULES




                                             [FR Doc. 2017–07210 Filed 4–11–17; 8:45 am]             Nina Shafran (Legal), (202) 418–2781, or              to expand Cellular service area
                                                                                                     Moslem Sawez (Technical), (202) 418–                  coverage. These reforms put Cellular
                                             BILLING CODE 4163–18–P
                                                                                                     8211, regarding the Cellular Second                   licensing more on par with the flexible
                                                                                                     R&O; and Kathy Harris, (202) 418–0609,                licensing schemes in other similar
                                                                                                     regarding the WRS R&O. All three                      mobile services, such as the Broadband
                                                                                                     contact persons are in the Mobility                   Personal Communications Service
                                                                                                     Division, Wireless Telecommunications                 (PCS), the commercial service in the 700


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Document Created: 2017-04-12 00:23:26
Document Modified: 2017-04-12 00:23:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionInterim rule; adoption as final and response to public comments.
DatesEffective April 12, 2017.
ContactDr. 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 Citation82 FR 17569 
RIN Number0920-AA64

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