[Federal Register Volume 75, Number 238 (Monday, December 13, 2010)]
[Notices]
[Pages 77642-77644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31149]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number NIOSH-219]
Implementation of Section 2695 (42 U.S.C. 300ff-131) of Public
Law 111-87: Infectious Diseases and Circumstances Relevant to
Notification Requirements
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services.
ACTION: General Notice and Request for Comments.
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SUMMARY: The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub.
L. 111-87) addresses notification procedures for designated officers,
medical facilities, and State and community public health officers
regarding exposure of emergency response employees (EREs) to
potentially life-threatening infectious diseases. The Secretary of
Health and Human Services (Secretary) has delegated authority to the
Director of the Centers for Disease Control and Prevention (CDC) to
issue a list of potentially life-threatening infectious diseases,
including emerging infectious diseases, to which EREs may be exposed in
responding to emergencies (including a specification of those
infectious diseases that are routinely transmitted through airborne or
aerosolized means); guidelines describing circumstances in which
employees may be exposed to these diseases; and guidelines describing
the manner in which medical facilities should make determinations about
exposures. CDC is seeking comment on the list of diseases and
guidelines contained in this notice.
DATES: Comments must be received by February 11, 2011.
ADDRESSES: Comments on the content of this Notice should be in writing
and addressed to:
E-mail: NIOSH Docket Officer, [email protected]. Include
``Infectious Diseases'' and ``42 U.S.C. 300ff-131'' in the subject line
of the message.
Mail: NIOSH Docket Office, Robert A. Taft Laboratories,
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
Internet: Federal e-rulemaking portal, http://www.regulations.gov. Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name
and docket number for this Notice. All comments will be posted without
change to http://www.cdc.gov/niosh/docket/archive/docket219.html,
including any personal information provided. For detailed instructions
on submitting comments and additional information about this process,
see the ``Public Participation'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.cdc.gov/niosh/docket/archive/docket219.html.
FOR FURTHER INFORMATION CONTACT: Centers for Disease Control and
Prevention, Attention: James Spahr, Associate Director, Emergency
Preparedness & Response, Office of the Director, National Institute for
Occupational Safety and Health, Centers for Disease Control and
Prevention, 1600 Clifton Road, NE., Mailstop E20, Atlanta, GA 30333.
Telephone (404) 498-6185 (this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
Table of Contents
Public Participation
Introduction
Definitions
Part I. List of potentially life-threatening infectious diseases to
which emergency response employees may be exposed.
Part II. Guidelines describing the circumstances in which such
employees may be exposed to such diseases.
Part III. Guidelines describing the manner in which medical
facilities should make determinations for purposes of section
2695B(d) [42 U.S.C. 300ff-133(d)].
Addendum: References
Public Participation
Interested persons or organizations are invited to participate in
this request for public comments by submitting written views,
arguments, recommendations, and data. Comments are invited on any topic
related to this proposal. In particular, CDC invites comment on the
list of infectious diseases and both sets of guidelines discussed
herein.
Comments submitted by e-mail or mail should be titled ``Docket
219 Public Comments,'' addressed to the ``NIOSH Docket
Officer,'' and identify the author(s), return address, and a phone
number, in case clarification is needed. Comments can be submitted by
e-mail to [email protected] as e-mail text or as a Microsoft Word
file attachment. Printed comments can be sent to the NIOSH Docket
Office at the address above. All communications received on or before
the closing date for comments will be fully considered by CDC in
developing a final list of infectious diseases and guidelines which
will be published in the Federal Register.
Introduction
The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L.
111-87) amended the Public Health Service Act (PHS Act, 42 U.S.C. 201-
300ii), including the addition of a Part G to Title XXVI, which
addresses notification procedures and requirements for medical
facilities, State public health officers and their designated officers
regarding exposure of EREs to potentially life-threatening infectious
diseases. (See Title XXVI, Part G of the PHS Act, codified as amended
at 42 U.S.C. 300ff-131 to 300ff-140.)
For purposes of these notification requirements, Section 2695 [42
U.S.C. 300ff-131] requires the Secretary of Health and Human Services
(Secretary) to develop and disseminate:
(1) A list of potentially life-threatening infectious diseases,
[[Page 77643]]
including emerging infectious diseases, to which EREs may be exposed in
responding to emergencies (including a specification of those
infectious diseases on the list that are routinely transmitted through
airborne or aerosolized means);
(2) Guidelines describing the circumstances in which such employees
may be exposed to such diseases, taking into account the conditions
under which emergency response is provided; and
(3) Guidelines describing the manner in which medical facilities
should make determinations for purposes of section 2695B(d) [42 U.S.C.
300ff-133(d)].\1\
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\1\ Evaluation and Response Regarding Request to Medical
Facility.
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On July 7, 2010, the Secretary delegated authority for Section 2695
[42 U.S.C. 300ff-131] to the Director of the CDC (75 FR 40842). This
Notice includes the proposed list of diseases and guidelines developed
by CDC pursuant to this delegation and in accordance with Section 2695
[42 U.S.C. 300ff-131]. CDC invites comment on the list of infectious
diseases and both sets of guidelines.
Definitions
The following definitions are used in the list of diseases and
guidelines developed pursuant to Section 2695[42 U.S.C. 300ff-131]:
Aerosol means tiny particles or droplets suspended in air. These
range in diameter from about 0.001 to 100 [mu]m (Baron P, accessed
2010) (Baron PA and Willeke K, 2001; 1065).
Aerosolized transmission means person-to-person transmission of an
infectious agent through the air by an aerosol. See ``aerosolized
airborne transmission'' and ``aerosolized droplet transmission.''
Aerosolized airborne transmission means person-to-person
transmission of an infectious agent by an aerosol of small particles
able to remain airborne for long periods of time. These are able to
transmit diseases on air currents over long distances, to cause
prolonged airspace contamination, and to be inhaled into the trachea
and lung (Baron P, accessed 2010) (Seigel et al., 2007; 18).
Aerosolized droplet transmission means person-to-person
transmission of an infectious agent by large particles only able to
remain airborne for short periods of time. These generally transmit
diseases through the air over short distances (approximately 6 feet),
do not cause prolonged airspace contamination, and are too large to be
inhaled into the trachea and lung (Baron P, accessed 2010) (Seigel et
al., 2007; 17).
Contact or body fluid transmission means person-to-person
transmission of an infectious agent through direct or indirect contact
with an infected person's blood or other body fluids (Seigel et al.,
2007; 15).
Exposed means to be in circumstances in which there is recognized
risk for transmission of an infectious agent from a human source to an
ERE (Seigel et al., 2007; 14).
Potentially life-threatening infectious disease means an infectious
disease to which EREs may be exposed and that has reasonable potential
to cause death or fetal mortality in either healthy EREs or EREs who
are able to work but take medications or are living with conditions
that might impair host defense mechanisms.
Part I. List of Potentially Life-threatening Infectious Diseases to
Which Emergency Response Employees May Be Exposed
A. Potentially Life-threatening Infectious Diseases: Routinely
Transmitted by Contact or Body Fluid Exposures
Hepatitis B (HBV).
Hepatitis C (HCV).
Human immunodeficiency virus (HIV) infection.
Rabies (Rabies virus).
Vaccinia (Vaccinia virus).
B. Potentially Life-threatening Infectious Diseases: Routinely
Transmitted Through Aerosolized Airborne Means
These diseases are included within ``* * * those infectious
diseases on the list that are routinely transmitted through airborne or
aerosolized means.'' Section 2695(b) [42 U.S.C. 300ff-131(b)]
Measles (Rubeola virus).
Tuberculosis (Mycobacterium tuberculosis)--infectious
pulmonary or laryngeal disease; or extrapulmonary (draining lesion).
Varicella disease--chickenpox, disseminated zoster
(Varicella zoster virus).
C. Potentially Life-Threatening Infectious Diseases: Routinely
Transmitted Through Aerosolized Droplet Means
These diseases are included within ``* * * those infectious
diseases on the list that are routinely transmitted through airborne or
aerosolized means.'' Section 2695(b) [42 U.S.C. 300ff-131(b)]
Avian Influenza (Avian influenza A virus).
Diphtheria (Corynebacterium diphtheriae).
Meningococcal disease (Neisseria meningitidis).
Mumps (Mumps virus).
Plague, pneumonic (Yersinia pestis).
Rubella (German measles; Rubella virus).
SARS-CoV.
Smallpox (Variola virus).
Viral hemorrhagic fevers (Lassa, Marburg, Ebola, Crimean-
Congo, and other viruses yet to be identified).
CDC will continue to monitor the scientific literature on
infectious diseases. In the event that CDC determines that a newly
emerged infectious disease fits criteria for inclusion in the list of
potentially life-threatening infectious diseases required by the Ryan
White HIV/AIDS Treatment Extension Act of 2009, CDC will amend the list
and add the disease.
Part II. Guidelines Describing the Circumstances in Which Such
Employees May Be Exposed to Such Diseases
A. Exposure to Diseases Routinely Transmitted Through Contact or Body
Fluid Exposures
Contact transmission is divided into two subgroups: Direct and
indirect. Direct transmission occurs when microorganisms are
transferred from an infected person to another person without a
contaminated intermediate object or person. Indirect transmission
involves the transfer of an infectious agent through a contaminated
intermediate object or person.
Contact with blood and other body fluids may transmit the
bloodborne pathogens HIV, HBV, and HCV. When EREs have contact
circumstances in which differentiation between fluid types is
difficult, if not impossible, all body fluids are considered
potentially hazardous. In the Occupational Safety and Health
Administration (OSHA) Bloodborne Pathogens Standard, an exposure
incident is defined as a ``specific eye, mouth, other mucous membrane,
non-intact skin, or parenteral contact with blood or other potentially
infectious materials that results from the performance of an employee's
duties'' (29 CFR 1910.1030).
Occupational exposure to rabies would include exposure incidents
similar to those described for bloodborne pathogens, with special
concern for contact of mucous membranes (eyes, nose, mouth, etc.) or
non-intact skin to the saliva [rather than blood] of infected
individuals. Occupational exposures of concern to vaccinia would
include contact of mucous membranes (eyes, nose, mouth, etc.) or non-
intact skin with drainage from a vaccinia vaccination site.
[[Page 77644]]
B. Exposure to Diseases Routinely Transmitted Through Aerosolized
Airborne or Aerosolized Droplet Means
Occupational exposure to pathogens routinely transmitted through
aerosolized airborne transmission may occur when an ERE shares air
space with a contagious individual who has an infectious disease caused
by these pathogens. Such an individual can expel small droplets into
the air through activities such as coughing, sneezing and talking.
After water evaporates from the airborne droplets, the dried out
remnants can remain airborne as droplet nuclei. Occupational exposure
to pathogens routinely transmitted through aerosolized droplet
transmission may occur when an ERE comes within about 6 feet of a
contagious individual who has an infectious disease caused by these
pathogens and who creates large respiratory droplets through activities
such as sneezing, coughing, and talking.
Part III. Guidelines Describing the Manner in Which Medical Facilities
Should Make Determinations for Purposes of Section 2695B(d) [42 U.S.C.
300ff-133(d)]
Section 2695B(d) [42 U.S.C. 300ff-133(d)] specifies that medical
facilities must respond to appropriate requests by making
determinations about whether EREs have been exposed to infectious
diseases included on the list issued pursuant to Section 2695(a)(1) [42
U.S.C. 300ff-131(a)(1)].
A medical facility has access to two types of information related
to a potential exposure incident to use in making a determination.
First, the request submitted to the medical facility contains a
``statement of the facts collected'' about the ERE's potential exposure
incident. Section 2695B [42 U.S.C. 300ff-133]. Information about
infectious disease transmission provided in relevant CDC guidance
documents (such as Siegel et al., 2007) or in current medical
literature should be considered in assessing whether there is a
realistic possibility that the exposure incident described in the
``statement of the facts'' could potentially transmit an infectious
disease included on the list issued pursuant to Section 2695 (a)(1) [42
U.S.C. 300ff-131(a)(1)].
Second, the medical facility possesses medical information about
the victim of an emergency transported and/or treated by the ERE. This
is the medical information that the medical facility would normally
obtain according to its usual standards of care to diagnose or treat
the victim, since the Act does not require special testing in response
to a request for a determination. As stated in Section 2695G(b) [42
U.S.C. 300ff-138(b)], ``this part may not, with respect to victims of
emergencies, be construed to authorize or require a medical facility to
test any such victim for any infectious disease.''
Information about the potential exposure incident and medical
information about the victim should be used in the following manner to
make one of the four possible determinations as required by Section
2695B(d) [42 U.S.C. 300ff-133(d)].
(1) The ERE involved has been exposed to an infectious disease
included on the list issued pursuant to Section 2695(a)(1) [42 U.S.C.
300ff-131(a)(1)]:
--Facts provided in the request document a realistic possibility that
an exposure incident occurred with potential for transmitting a listed
infectious disease from the victim of an emergency to the involved ERE;
and
--The medical facility possesses sufficient medical information
allowing it to determine that the victim of an emergency treated and/or
transported by the involved ERE had a listed infectious disease that
was possibly contagious at the time of the potential exposure incident.
(2) The ERE involved has not been exposed to an infectious disease
included on the list issued pursuant to Section 2695(a)(1) [42 U.S.C.
300ff-131(a)(1)]:
--Facts provided in the request rule out a realistic possibility that
an exposure incident occurred with potential for transmitting a listed
infectious disease from the victim of an emergency to the involved ERE;
or
--The medical facility possesses sufficient medical information
allowing it to determine that the victim of an emergency treated and/or
transported by the involved ERE did not have a listed infectious
disease that was possibly contagious at the time of the potential
exposure incident.
(3) The medical facility possesses no information on whether the
victim involved has an infectious disease included on the list issued
pursuant to Section 2695(a)(1) [42 U.S.C. 300ff-131(a)(1)]:
--The medical facility lacks sufficient medical information allowing it
to determine whether the victim of an emergency treated and/or
transported by the involved ERE had, or did not have, a listed
infectious disease at the time of the potential exposure incident.
--If the medical facility subsequently acquires sufficient medical
information allowing it to determine that the victim of an emergency
treated and/or transported by the involved ERE had a listed infectious
disease that was possibly contagious at the time of the potential
exposure incident, then it should revise its determination to reflect
the new information.
(4) The facts submitted in the request are insufficient to make the
determination about whether the ERE was exposed to an infectious
disease included on the list issued pursuant to Section 2695(a)(1) [42
U.S.C. 300ff-131(a)(1)]:
--Facts provided in the request insufficiently document the exposure
incident, making it impossible to determine if there was a realistic
possibility that an exposure incident occurred with potential for
transmitting an infectious disease included on the list issued pursuant
to Section 2695(a)(1) [42 U.S.C. 300ff-131(a)(1)] from the victim of an
emergency to the involved ERE.
Addendum
References
Baron P. Generation and Behavior of Airborne Particles
(Aerosols). PowerPoint Presentation. U.S. Department of Health and
Human Services, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health, Division of Applied
Technology. http://www.cdc.gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf. Accessed September 23, 2010.
Baron PA, Willeke K, eds. Aerosol measurement: Principles,
Techniques, and Applications. Second edition. New York: John Wiley &
Sons, Inc. 2001.
OSHA Standards, Bloodborne Pathogens, 29 CFR 1910.1030 (2009).
Public Health Service Act, 42 U.S.C. 201 et seq. (2006).
Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L.
111-87, to be codified at 42 U.S.C. 300ff-131 et seq.).
Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
Healthcare Infection Control Practices Advisory Committee. 2007
Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 23, 2010.
Dated: December 2, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2010-31149 Filed 12-10-10; 8:45 am]
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