80 FR 10656 - Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 39 (February 27, 2015)

In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A (Department of Health and Human Services) of Title II (Enhancing Controls on Dangerous Biological Agents and Toxins) of Public Law 107-188 (June 12, 2002) (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has initiated the review of the HHS list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. We are considering whether to propose amending the HHS list by removing six biological agents.

[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Proposed Rules]
[Pages 10656-10658]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-04169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 73

[Docket No. CDC-2015-0006]
RIN 0920-AA59


Possession, Use, and Transfer of Select Agents and Toxins; 
Biennial Review

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Advance notice of proposed rulemaking and request for comments.

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SUMMARY: In accordance with the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, Subtitle A (Department of Health 
and Human Services) of Title II (Enhancing Controls on Dangerous 
Biological Agents and Toxins) of Public Law 107-188 (June 12, 2002) 
(the Bioterrorism Response Act), the Centers for Disease Control and 
Prevention (CDC) located within the Department of Health and Human 
Services (HHS) has initiated the review of the HHS list of biological 
agents and toxins that have the potential to pose a severe threat to 
public health and safety. We are considering whether to propose 
amending the HHS list by removing six biological agents.

DATES: Comments should be received on or before April 28, 2015.

ADDRESSES: You may submit comments, identified by Regulation Identifier 
Number (RIN), 0920-AA59 or Docket Number CDC-2015-0006 in the heading 
of this document by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Centers for Disease Control and Prevention, Select 
Agent Program, 1600 Clifton Road NE., Mailstop A-46, Atlanta, Georgia 
30329, ATTN: RIN 0920-AAxx.
    Instructions: All submissions received must include the agency name 
and RIN for this rulemaking. All relevant comments received will be 
posted without change to http://www.regulations.gov, including any 
personal information provided.
    Docket Access: For access to the docket to read background 
documents or comments received or to download an electronic version of 
the ANPRM, go to http://www.regulations.gov. Comments will be available 
for public inspection Monday through Friday, except for legal holidays, 
from 9 a.m. until 5 p.m. at 1600 Clifton Road NE., Atlanta, GA 30329. 
Please call ahead to 1-866-694-4867 and ask for a representative in the 
Division of Select Agents and Toxins to schedule your visit. Please be 
aware that comments and other submissions from members of the public 
are made available for public viewing without changes.

FOR FURTHER INFORMATION CONTACT: Robbin Weyant, Director, Division of 
Select Agents and Toxins, Centers for Disease Control and Prevention, 
1600 Clifton Road NE., Mailstop A-46, Atlanta, Georgia 30329. 
Telephone: (404) 718-2000.

SUPPLEMENTARY INFORMATION: The Preamble to this notice of proposed 
rulemaking is organized as follows:

I. Public Participation
II. Background
III. Changes to 42 CFR Part 73, Modifications to the List of Select 
Agents and Toxins Being Considered
    A. Coxiella burnetii
    B. Rickettsia prowazekii
    C. Bacillus anthracis Pasteur strain
    D. Brucella abortus, B. melitensis, and B. suis
IV. References

I. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, recommendations, and data. 
Comments are invited on any topic related to this rulemaking.
    In addition, HHS/CDC invites comments specifically as to whether 
there are biological agents or toxins that should be added or removed 
from the HHS list of select agents and toxins based on the following 
criteria, or any other appropriate criteria:
    (1) The effect on human health of exposure to the agent or toxin;
    (2) The degree of contagiousness of the agent or toxin and the 
methods by which the agent or toxin is transferred to humans; and
    (3) The availability and effectiveness of pharmacotherapies and 
immunizations to treat and prevent any illness resulting from infection 
by the agent or exposure to the toxin.
    (4) The needs of children and other vulnerable populations.
    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 carefully consider all comments 
submitted in preparation of a proposed final rule.

II. Background

    The Bioterrorism Response Act requires the HHS Secretary to 
establish by regulation a list of biological agents and toxins that 
have the potential to pose a severe threat to public health and safety. 
In determining whether to include an agent or toxin on the list, the 
HHS Secretary considers criteria such as the effect on human health of 
exposure to an agent or toxin; the degree of contagiousness of the 
agent and the methods by which the agent or toxin is transferred to 
humans; the availability and effectiveness of pharmacotherapies and 
immunizations to treat and prevent illnesses resulting from an agent or 
toxin; and the needs of children and other vulnerable populations. The 
current list of HHS select agents and toxins can be found at 42 CFR 
73.3 (HHS select agents and toxins) and 42 CFR 73.4 (Overlap select 
agents and toxins). The list of HHS and Overlap

[[Page 10657]]

select agents and toxins is available at: http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html.
    The HHS Secretary last republished the list of HHS select agents 
and toxins in the Federal Register on October 5, 2012 (77 FR 61084). 
The list of HHS select agents and toxins is divided into two sections. 
The select agents and toxins listed in Sec.  73.3 (HHS select agents 
and toxins) are those regulated only by HHS under the authority of the 
Bioterrorism Response Act (42 U.S.C. 262a). The select agents and 
toxins listed in Sec.  73.4 (Overlap select agents and toxins) are 
those regulated by HHS under the authority of the Bioterrorism Response 
Act and regulated by the U.S. Department of Agriculture under the 
authority of the Agricultural Bioterrorism Protection Act of 2002 (7 
U.S.C. 8401).
    The Bioterrorism Response Act requires the HHS Secretary to review 
and republish the list of select agents and toxins on at least a 
biennial basis. Using government subject matter experts, HHS/CDC 
conducts the biennial review process in consultation with the HHS/CDC 
Intragovernmental Select Agents and Toxins Technical Advisory Committee 
(ISATTAC). The ISATTAC recommends changes to the list of HHS select 
agents and toxins. The ISATTAC is comprised of Federal government 
employees from CDC, Biomedical Advanced Research and Development 
Authority (BARDA) within the Office of the Assistant Secretary for 
Preparedness and Response, 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/CVB (Center for Veterinary Biologics). Based on the 
criteria outlined in the Bioterrorism Response Act, the ISATTAC used 
the following measures in its 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, ability 
to genetically manipulate or alter, long-term health effects, acute 
morbidity (illness), acute mortality (death), available treatment, 
status of host immunity, vulnerability of special populations, and the 
burden or impact on the health care system.

III. Proposed Changes to 42 CFR Part 73, Modifications to the List of 
Select Agents and Toxins Being Considered

    The purpose of this advanced notice of proposed rulemaking is to 
seek public comment on the appropriateness of the current list of HHS 
and Overlap select agents and toxins. Specifically, we are providing an 
opportunity for interested persons to submit comments, research data, 
and other information that will better inform us as to whether: (1) 
There are any other biological agents or toxins that should be added to 
the list because they have the potential to pose a severe threat to 
public health and safety; (2) there are any other biological agents or 
toxins currently on the list that should be removed because they no 
longer have the potential to pose a severe threat to public health and 
safety, and/or (3) the biological agents specifically listed in the 
following paragraphs should be removed or remain on the list.
    HHS/CDC is also seeking comments on the following considerations 
regarding the list of HHS and Overlap select agents:

A. Coxiella burnetii

    Coxiella burnetii causes a disease called Q fever. Q fever is an 
acute febrile rickettsial disease that varies in severity and duration. 
Should Coxiella burnetii be removed or retained as a HHS select agent? 
Are there other reasons or research data to support the removal besides 
the following reasons?
     It is not easily transmitted from person to person (1);
     It has a low mortality rate with antibiotic treatment (2); 
and
     There is an investigational new drug (IND) vaccine 
available for at-risk personnel (3).

B. Rickettsia prowazekii

    Rickettsia prowazekii causes epidemic typhus. Epidemic typhus is a 
potentially lethal, louse-borne, disease caused by R. prowazekii. 
Should Rickettsia prowazekii be removed or retained as a HHS select 
agent? Are there other reasons or research data to support the removal 
besides the following reasons?
     It is readily treatable with antibiotics (4);
     The risk of mass casualties is low because R. prowazekii 
can be treated with a single dose of doxycycline when symptoms are 
present (4); and
     Transmissibility from person to person is low due to the 
fact that R. prowazekii is usually transmitted via blood, although it 
can be spread through inhalation of louse feces.

C. Bacillus anthracis Pasteur Strain

    Bacillus anthracis is the bacterium that causes anthrax, an acute 
disease in animals and humans. However, different strains of B. 
anthracis have different abilities to cause disease. The Pasteur 
strain, for example, is unable to produce toxic factors and is not 
considered harmful to humans. Should B. anthracis Pasteur strain be 
removed or retained as an Overlap select agent? Are there other reasons 
or research data to support the removal besides the following reasons?
     B. anthracis Pasteur strain lacks the plasmid that encodes 
the toxin genes causing disease (6);
     B. anthracis Sterne strain, which lacks the plasmid that 
encodes for the capsule, was excluded from the requirements of the 
regulations effective on February 27, 2003 (7-8); and
     Historically, the B. anthracis Pasteur strain has been 
retained as a select agent to allow for continued oversight of 
laboratories in which the accidental (or intentional) combination of 
this strain with the Sterne strain could occur to produce de novo the 
wild type phenotype B. anthracis. However, a recent study indicates 
that bacterial transformation of B. subtilis with plasmid DNA (e.g. 
pXO1 into Bacillus anthracis Pasteur strain) is inefficient; indicating 
that transformation with bacteria such as B. anthracis would also be 
inefficient (9).

D. Brucella abortus, B. melitensis, and B. suis

    Brucella abortus, B. melitensis, and B. suis bacteria cause 
brucellosis, a disease that can spread from animals to humans. Should 
B. abortus, B. melitensis, and B. suis be removed or retained as select 
agents? Are there other reasons or research data to support the removal 
besides the following reasons?
     B. abortus has a low human mortality rate (10);
     B. abortus, B. melitensis, and B. suis are readily 
treatable with antibiotics (10); and
     Human-to-human transmission is extremely rare, and 
wildlife carriers in the United States often come into contact with 
humans without significant transmission (10).

IV. References

1. T.J. Marrie. Q fever. In: Marrie TJ, editor. Q fever. Vol. 1. 
Boca Raton, FL: CRC Press; 1990. (The disease).
2. M. Maurin and D. Raoult. Q fever. Clin Microbiol Rev. Oct. 
1999;12(4):518-53.
3. Biosafety in Microbiological and Biomedical Laboratories (BMBL) 
5th Edition, http://www.cdc.gov/biosafety/

[[Page 10658]]

publications/bmbl5/BMBL5_sect_VIII_d.pdf.
4. D. Raoult, J.B. Ndihokubwayo, H. Tissot-Dupont, V. Roux, B. 
Faugere, R. Abegbinni, and R.J. Birtles. Outbreak of epidemic typhus 
associated with trench fever in Burundi. The Lancet. Aug. 1998; 352 
(3125):353-358.
5. D. Raoult, T. Woodward, and J.S. Dumler. The history of epidemic 
typhus. Infect Dis Clin N Am. Mar. 2004; 18(1):127-140.
6. B.E. Ivins, J.W. Ezzell, J. Jemski, K.W. Hedlund, J.D. Ristroph, 
and S.H. Leppla. Immunization Studies with Attenuated Strains of 
Bacillus anthracis. Infection and Immunity. May 1986; 52(2):454-458.
7. Centers for Disease Control and Prevention, National Center for 
Emerging and Zoonotic Infectious Diseases ``Anthrax Sterne strain 
(34F2) of Bacillus anthracis,'' http://www.cdc.gov/nczved/divisions/dfbmd/diseases/anthrax_sterne/.
8. Federal Select Agent Program, ``Select Agents and Toxins 
Exclusions,'' http://www.selectagents.gov/SelectAgentsandToxinsExclusions.html.
9. C. Johnston, B. Martin, G. Fichant, P. Polard, and J.P. Claverys. 
Bacterial transformation: distribution, shared mechanisms and 
divergent control. Nature Rev. Microbiol. 2014; 12: 181-196.
10. Center for Food Security and Public Health, ``Brucellosis 
Technical fact sheet,'' http://www.cfsph.iastate.edu/Factsheets/pdfs/brucellosis.pdf.

    Dated: February 5, 2015.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2015-04169 Filed 2-26-15; 8:45 am]
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