[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:
    <bullet> E-mail: NIOSH Docket Officer, <a href="/cdn-cgi/l/email-protection#89e7e0e6fae1ede6eae2ecfdc9eaedeaa7eee6ff"><span class="__cf_email__" data-cfemail="224c4b4d514a464d41494756624146410c454d54">[email protected]</span></a>. Include 
``Infectious Diseases'' and ``42 U.S.C. 300ff-131'' in the subject line 
of the message.
    <bullet> Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    <bullet> 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 
<greek-i>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 <a href="/cdn-cgi/l/email-protection#543a3d3b273c303b373f3120143730377a333b22"><span class="__cf_email__" data-cfemail="ff9196908c979b909c949a8bbf9c9b9cd1989089">[email protected]</span></a> 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

    <bullet> Hepatitis B (HBV).
    <bullet> Hepatitis C (HCV).
    <bullet> Human immunodeficiency virus (HIV) infection.
    <bullet> Rabies (Rabies virus).
    <bullet> 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)]
    <bullet> Measles (Rubeola virus).
    <bullet> Tuberculosis (Mycobacterium tuberculosis)--infectious 
pulmonary or laryngeal disease; or extrapulmonary (draining lesion).
    <bullet> 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)]
    <bullet> Avian Influenza (Avian influenza A virus).
    <bullet> Diphtheria (Corynebacterium diphtheriae).
    <bullet> Meningococcal disease (Neisseria meningitidis).
    <bullet> Mumps (Mumps virus).
    <bullet> Plague, pneumonic (Yersinia pestis).
    <bullet> Rubella (German measles; Rubella virus).
    <bullet> SARS-CoV.
    <bullet> Smallpox (Variola virus).
    <bullet> 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]
BILLING CODE 4163-19-P


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