[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Proposed Rules]
[Pages 10656-10658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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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