[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.

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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