Possession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus cereus, 17569-17570 [2017-07210]

Download as PDF 17569 Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Rules and Regulations not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: March 7, 2017. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.910, add alphabetically the inert ingredient to the table to read as follows: ■ § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * Inert ingredients Limits * * * Monoethanolamine (CAS Reg. No. 141–43–5) ................ * * * Not to exceed 3.35% by weight in pesticide formulation * * * BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 73 [CDC Docket No. CDC–2016–0045] RIN 0920–AA64 Possession, Use, and Transfer of Select Agents and Toxins—Addition of Bacillus cereus Biovar anthracis to the HHS List of Select Agents and Toxins Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Interim rule; adoption as final and response to public comments. AGENCY: VerDate Sep<11>2014 15:14 Apr 11, 2017 Jkt 241001 * Uses * 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. SUMMARY: [FR Doc. 2017–07130 Filed 4–11–17; 8:45 am] pmangrum on DSK3GDR082PROD with RULES * Effective on October 14, 2016, Bacillus cereus Biovar anthracis was added to the list of SUPPLEMENTARY INFORMATION: PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 * * Solvent. * 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 E:\FR\FM\12APR1.SGM 12APR1 17570 Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Rules and Regulations ‘‘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 buyin 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 pmangrum on DSK3GDR082PROD with RULES 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. BILLING CODE 4163–18–P 15:14 Apr 11, 2017 47 CFR Part 22 [WT Docket Nos. 12–40, 10–112; RM–11510, RM–11660; FCC 17–27] Cellular Service, Including Changes in Licensing of Unserved Area Federal Communications Commission. ACTION: Final rule. AGENCY: In this document, the Federal Communications Commission (Commission) adopts revised rules governing the 800 MHz Cellular Radiotelephone (Cellular) Service. The Commission revises the outdated Cellular radiated power rules and related technical provisions, most notably allowing licensees the option to comply with power spectral density (PSD) power limits, while also safeguarding systems that share the 800 MHz band, especially public safety systems, from increased unacceptable interference. These updated rules will allow Cellular licensees to deploy advanced mobile broadband services such as long term evolution (LTE) more efficiently. The Cellular licensing rule revisions continue the transition to a geographic-based regime by eliminating certain filing requirements, and also eliminate the comparative hearing process for Cellular license renewals. Both the technical and licensing reforms provide Cellular licensees with more flexibility, reduce administrative burdens, and enable Cellular licensees to respond more quickly—and at lower cost—to changing market conditions and consumer demand. They also promote similar treatment across competing commercial wireless spectrum bands. DATES: Effective May 12, 2017, except for the amendments to 47 CFR 22.317, 22.911(a) through (c), 22.913(a), (c), and (f), 22.947, and 22.953(c), which contain information collection requirements that have not yet been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. The Commission will publish a document in the Federal Register announcing the effective date of those amendments. SUMMARY: FOR FURTHER INFORMATION CONTACT: [FR Doc. 2017–07210 Filed 4–11–17; 8:45 am] VerDate Sep<11>2014 FEDERAL COMMUNICATIONS COMMISSION Jkt 241001 Nina Shafran (Legal), (202) 418–2781, or Moslem Sawez (Technical), (202) 418– 8211, regarding the Cellular Second R&O; and Kathy Harris, (202) 418–0609, regarding the WRS R&O. All three contact persons are in the Mobility Division, Wireless Telecommunications PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 Bureau, and may also be contacted at (202) 418–7233 (TTY). SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Second Report and Order in the Cellular Reform proceeding (Cellular Second R&O), WT Docket No. 12–40, RM Nos. 11510 and 11660, and the Commission’s companion Report and Order in the Wireless Radio Services (WRS) Reform proceeding (WRS R&O), WT Docket No. 10–112, FCC 17–27, adopted March 23, 2017 and released March 24, 2017. The full text of the Cellular Second R&O and WRS R&O, including all Appendices, is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street SW., Room CY–A157, Washington, DC 20554, or by downloading the text from the Commission’s Web site at https:// apps.fcc.gov/edocs_public/attachmatch/ FCC-17-27A1.pdf. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to FCC504@fcc.gov or calling the Consumer and Government Affairs Bureau at (202) 418–0530 (voice), (202) 418–0432 (TTY). Synopsis I. Second Report and Order (Cellular Reform Proceeding, WT Docket No. 12– 40) A. Background 1. In a Report and Order released on November 10, 2014 in the Cellular Reform proceeding (WT Docket No. 12– 40) (2014 Cellular R&O), the Commission adopted new and revised rules to change to a geographic-based licensing regime. Specifically, it revised the rules to establish geographic licenses based on cellular geographic service area (CGSA) boundaries and provided licensees with significant new flexibility to improve their systems through modifications within those boundaries. It preserved the ability of licensees to expand their CGSAs into Unserved Area if the area is at least 50 contiguous square miles, but dramatically reduced application filing burdens by permitting incumbents to serve indefinitely, on a secondary basis, Unserved Area parcels smaller than 50 contiguous square miles. It eliminated other filing requirements and established a field strength limit rule tailored to reflect the continued ability to expand Cellular service area coverage. These reforms put Cellular licensing more on par with the flexible licensing schemes in other similar mobile services, such as the Broadband Personal Communications Service (PCS), the commercial service in the 700 E:\FR\FM\12APR1.SGM 12APR1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)]
[Rules and Regulations]
[Pages 17569-17570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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