[Federal Register Volume 59, Number 54 (Monday, March 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6492]


[[Page Unknown]]

[Federal Register: March 21, 1994]


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Part V





Department of Health and Human Services





_______________________________________________________________________



Centers for Disease Control and Prevention



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Ryan White Comprehensive AIDS Resources Emergency Act; Emergency 
Response Employees; Notice
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

 

Implementation of Provisions of the Ryan White Comprehensive AIDS 
Resources Emergency Act Regarding Emergency Response Employees

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

ACTION: Final notice.

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SUMMARY: The Ryan White Comprehensive AIDS Resources Emergency (CARE) 
Act (Pub. L. 101-381) includes provisions for emergency response 
employees (EREs) who may be exposed to potentially life-threatening 
diseases during the course of an emergency. This notice sets forth the 
final list of diseases to which these provisions apply; final 
guidelines describing circumstances under which exposure to listed 
diseases may occur; and final guidelines for determining whether an 
exposure to the listed diseases has occurred. The final list of 
diseases and guidelines incorporate comments received by CDC on a draft 
list and guidelines (57 FR 54794, November 20, 1992).

DATES: The list of diseases and guidelines in this notice are effective 
on March 21, 1994. All other applicable provisions of the Act 
pertaining to this notice are effective on April 20, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. Robert Mullan, Centers for Disease 
Control and Prevention, 1600 Clifton Road, NE., M/S F40, Atlanta, GA 
30333, telephone (404) 639-0983.

SUPPLEMENTARY INFORMATION:

Introduction

    The Ryan White CARE Act amended the Public Health Service Act to 
include provisions regarding emergency response employees (EREs). (See 
sections 2681-2690 of the PHS Act, 42 U.S.C. 300ff-81 to 300ff-90. 
References are to Title 42 of the U.S. Code.)
    Section 300ff-81 requires the development and publication of the 
following: (1) A list of potentially life-threatening infectious 
diseases to which EREs may be exposed in responding to emergencies; (2) 
guidelines describing circumstances in which EREs may be exposed to 
such diseases; and, (3) guidelines for medical facilities to determine 
whether such exposure occurred.
    Sections 300ff-82 through 300ff-83 specify that EREs must be 
notified of exposure to any of the airborne infectious diseases on the 
list and may request notification of exposure to other listed diseases. 
Sections 300ff-84 and 300ff-85 specify the procedures for notifying 
EREs when there has been an exposure to a listed disease. Under section 
300ff-86, every State public health officer must designate an official 
of every employer of EREs in the State who will be responsible for 
notifying EREs of exposure. This official is referred to as the 
Designated Officer. A medical facility that receives an infectious 
patient to which an ERE may have been exposed is responsible for 
notifying the Designated Officer that the ERE was exposed to a listed 
disease.
    Section 300ff-87 limits the time period for which medical 
facilities must maintain medical information on patients and respond to 
the request under section 300ff-83.
    Under section 300ff-88 these provisions may not be construed to 
authorize civil actions or penalties against a medical facility or 
Designated Officer; to require a medical facility to test patients for 
any infectious disease; to authorize or require the disclosure of 
identifying information; or, to authorize any ERE to fail to respond, 
or to deny services, to victims of emergencies.
    Section 300ff-89 requires the Secretary of Health and Human 
Services (the Secretary) to establish an administrative process through 
which the Department can be notified of alleged violations of the 
provisions and, as appropriate, investigate such alleged violations. 
The Secretary may seek injunctive relief for violations of these 
provisions.
    Under section 300ff-90, the provisions of the Act and the 
notification system do not apply in a State that has certified to the 
Secretary that its notification laws are in substantial compliance with 
the Act.
    The list of diseases and guidelines specified in section 300ff-81 
are effective on the date of publication. All other requirements of the 
notification process take effect 30 days after the publication of the 
list and guidelines.
    This notice includes definitions (Part I), the final list of 
potentially life-threatening diseases under section 300ff-81 (Part II), 
the final guidelines required under section 300ff-81 (Part III), and 
steps to implement sections 300ff-82-300ff-90 (Part IV). Three addenda 
are provided for background and informational purposes: A. The text of 
the Act; B. Excerpts concerning hepatitis B vaccination, and C. 
References.

Responses to Comments

    On November 20, 1992, CDC published in the Federal Register (57 FR 
54794) a request for comments, including a draft of the required list 
of infectious diseases and guidelines. CDC received comments from 101 
individuals and/or organizations. CDC solicited comments to the 
following questions:
     What procedural steps can be taken to protect the 
confidentiality of patient information subject to the provisions of the 
Act?
     Can the ERE notification process be carried out within 
existing State confidentiality laws?
     What will be the resource implications in carrying out 
this legislation?
     What are the likely benefits to be gained in implementing 
these requirements?
     Which States have notification laws that, under section 
300ff-90, could be viewed as being in substantial compliance with the 
Act?
    CDC received a total of 275 comments in response to these 
questions. In addition, there were 432 comments to other issues in the 
notification process. The comments to the five specific questions and 
the additional comments are addressed below.
    1. What procedural steps can be taken to protect the 
confidentiality of patient information subject to the provisions of the 
Act?
    According to section 300ff-88(c), this statute may not be construed 
to authorize or require any medical facility, any designated officer of 
emergency response employees, or any such employee, to disclose 
identifying information with respect to a victim of an emergency or 
with respect to an emergency response employee.''
    CDC received 74 comments to the question regarding this provision. 
Many of the comments expressed concern that the victim's 
confidentiality could be breached. However, commenters also 
acknowledged that EREs and medical facilities are already responsible 
for protecting patient confidentiality and that additional protection 
could be provided through training.
    Other commenters were concerned with the possible liability for 
medical facilities that provide patient information to Designated 
Officers. The statute addresses liability only from the perspective of 
failure to comply with duties established under the statute, not for 
breaches of confidentiality. As in other situations involving patient 
information, liability for breach of confidentiality is an issue of 
State law.
    Several commenters stated that informed consent must be obtained 
before information on a victim could be provided to a Designated 
Officer. The statute does not address informed consent and informed 
consent to sharing patient information. Therefore, medical facilities 
must look to State laws regarding informed consent and the sharing of 
patient information.
    The confidentiality provision (section 300ff-88[c]) must also be 
read in relation to section 300ff-84, procedures for notification of 
exposure. Under this later section, when a medical facility determines 
that a victim had an airborne infectious disease or that an ERE was 
exposed to an infectious disease on the list, the medical facility is 
required to provide (1) the name of the infectious disease involved; 
and (2) the date on which the victim of the emergency involved was 
transported by emergency response employees to the medical facility 
involved.'' These sections can be read together to mean that a medical 
facility that provides the required information under section 300ff-84 
is not disclosing identifying information under section 300ff-88(c).
    States should review their confidentiality statutes and resolve any 
conflict with this Federal legislation. Medical facilities must 
determine whether, under their State and local laws, providing the 
required information under section 300ff-84 violates State or local 
confidentiality laws.
    2. Can the ERE notification process be carried out within existing 
State confidentiality laws?
    CDC received responses to this question from 21 State health 
departments. Of these States, 11 thought the notification process could 
be implemented within the existing State confidentiality laws, 6 States 
did not think it could, and 4 States indicated that it could be carried 
out for some diseases, but not for other diseases, e.g., exposure to 
human immunodeficiency virus (i.e., acquired immunodeficiency syndrome, 
AIDS).
    3. What will be the resource implications in carrying out this 
legislation?
    CDC received 86 responses to this question. The vast majority (75) 
stated that the notification process would require an allocation of 
resources. Several commenters expressed a belief that the cost would be 
significant to medical facilities that are served by a large number of 
EREs requesting notification.
    4. What are the likely benefits to be gained in implementing these 
requirements?
    CDC received 41 comments to this question. Of these comments, 28 
expressed doubt that the notification process would be beneficial to 
EREs. According to the comments, the process was not projected to 
confer many benefits because EREs are already covered by the 
Occupational Health and Safety Administration's Bloodborne Pathogens 
Standard, and because EREs should be using universal precautions. The 
13 commenters who stated the process would be beneficial believed that 
it would increase uniformity in notification of EREs, reduce 
noncompliance among medical facilities in informing EREs of exposures, 
and provide additional protection to EREs.
    5. Which States have notification laws that, under section 300ff-
90, could be viewed as being in substantial compliance with the Act?
    Under section 300ff-90, the requirements under the Act do ``not 
apply in a State if the chief executive officer of the State certifies 
to the Secretary that the law of the State is in substantial compliance 
with'' the Act.
    A total of 30 commenters responded to this question. Of these, 14 
said that their State would be in substantial compliance with the law 
and 16 said that their State would not be in compliance with the law.
    Two commenters said that States should be allowed latitude in the 
determination whether they are in substantial compliance with the Act. 
Another commenter requested criteria that would be used to determine 
whether a State is in substantial compliance. However, the Act does not 
list any criteria for determining whether a State is in substantial 
compliance with the provisions of the Act. Therefore, CDC will accept 
the certification from the chief executive officer or designee of a 
State who certifies that the State is in substantial compliance with 
the Act. The certification must include the State statute(s) or 
regulation(s) upon which the certification is based. However, under 
section 300ff-89, the Secretary retains the authority to ``commence a 
civil action to obtain temporary or permanent injunctive relief with 
respect to any violation of'' the Act.
    6. List of diseases.
    Under section 300ff-81, the Secretary must develop ``a list of 
infectious disease to which emergency response employees may be exposed 
in responding to emergencies. The list * * * shall include a 
specification of those infectious diseases on the list that are 
routinely transmitted through airborne or aerosolized means.''
    CDC received 31 comments to the draft list.
    According to one commenter, ``uncommon or rare diseases'' should be 
deleted. However, the legislation calls for the list to include 
potentially life-threatening diseases regardless of their incidence. 
Therefore, the rarity of a disease should not determine whether it is 
included on the list.
    Other commenters suggested adding chicken pox, syphilis, childhood 
diseases, and meningitis to the list. These diseases are not 
appropriate for the list because chicken pox is not generally life-
threatening, syphilis does not pose a significant risk of transmission 
if an ERE is exposed to an infectious patient, and childhood diseases 
(i.e., measles and rubella) are not life-threatening to the ERE. 
Meningococcal disease is already on the list. Another commenter noted 
that meningococcal disease is not rare, and that it is transmitted 
through direct contact, and that the ERE is not likely to be aware of 
exposure. As noted in Part III, ``Under special circumstances, C. 
diphtheriae, N. meningitidis, and Y. pestis could be transmitted to 
EREs by direct contact with droplets from the respiratory tract of 
infected persons. However, such transmission is rare.'' Although one 
commenter recommended that diphtheria and meningococcal disease be 
classified as airborne diseases, they are transmitted by direct contact 
only. Likewise, another reviewer recommended that hemorrhagic fevers be 
classified as bloodborne diseases, rather than as uncommon or rare 
diseases. Although the hemorrhagic fevers have been reported to have 
been transmitted via inoculation with contaminated needles,\1\ it was 
decided to place the entire group under the uncommon or rare disease 
category to emphasize the decreased probability of exposure to these 
diseases.
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    \1\Benenson AS (ed). Control of communicable diseases in man. 
Washington, D.C.: The American Public Health Association, 15th 
edition, 1990.
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    It was also suggested that hepatitis C be deleted because of 
difficulty in interpretation of laboratory test, lack of routine test 
availability, and the lack of definitive treatment. Hepatitis C has 
been removed from the list at this time for the following reasons: 
Available laboratory tests do not distinguish between current or past 
infections, evidence of transmission in the health care setting is 
limited, and the withdrawal by the Immunization Practices Advisory 
Committee of its recommendations for prophylaxis with immune serum 
globulin following percutaneous exposure to hepatitis C. Moreover, 
there are no specific recommendations for following workers after an 
exposure incident involving hepatitis C. CDC will continue to monitor 
the scientific literature on hepatitis C, however, and if new 
information becomes available that suggests that hepatitis C should be 
returned to the list of diseases contained here, CDC will amend the 
list.
    A number of comments were received regarding tuberculosis. One 
commenter stated that tuberculosis is not life threatening, which 
should be noted in the regulation. However, tuberculosis, especially 
multiple drug-resistant tuberculosis (MDR-TB), can pose a threat to 
life; therefore it will remain in the list. Another commenter 
recommended that the list should specify tuberculosis disease as 
infectious ``pulmonary'' TB. This recommendation has been incorporated 
into the list.
    It was also recommended that tuberculosis should be deleted from 
the list since no emergency treatment is indicated and EREs are 
required to have annual skin tests. However, in the event of a 
recognized exposure to tuberculosis, employees should be skin tested 
six weeks thereafter for conversion. In the event of a conversion, a 
decision concerning chemoprophylaxis should be made as soon as 
feasible.
    One commenter suggested CDC reorganize the list of diseases into 
``mandatory reporting'' and ``exposure-triggered reporting.'' However, 
it was thought that the current organization made the most sense, since 
``exposure-triggered reporting'' is still ``mandatory,'' if an 
infectious disease exposure occurs that meets the criteria set forth in 
the Act. Some commenters thought the division of diseases into airborne 
and other modes of transmission was unnecessary. The diseases are 
distinguished by their mode of transmission because, under section 
300ff-81(b), the statute requires a ``specification of those infectious 
diseases on the list that are routinely transmitted through airborne or 
aerosolized means.''
    Many States commented that they already have a more comprehensive 
list of diseases requiring reporting. A more comprehensive list of 
diseases is not prohibited by the legislation; therefore, States may 
add diseases to the list, but no diseases on the list published herein 
may be removed by a State.
    7. Definitions.
    Under section 300ff-76, definitions for some of the terms applied 
in the statute can be found. Where it was necessary, additional 
definitions were added to the draft for clarification. A total of 32 
comments regarding the definitions used in the notification process 
were received.
    One commenter requested the definition of ``Secretary'' be added to 
the definitions to clarify that it is the Secretary of the Department 
of Health and Human Services who is responsible for injunctions under 
section 300ff-89. Therefore, the definition of ``Secretary'' has been 
added to the definitions.
    Many commenters requested a definition of medical facility. This 
term was not defined in the Act, therefore, a definition of medical 
facility has been added to the list of definitions. A medical facility, 
for purposes of this statute, is any facility that treats victims of 
emergencies.
    One commenter requested clarification whether the definition of an 
ERE included ``non-governmental EREs.'' The definition of EREs includes 
employees of non-governmental organizations. One commenter recommended 
that law enforcement personnel be included under the definition of 
EREs. Under the Act, the definition of EREs includes law enforcement 
officers.'' One commenter stated that it is unclear whether EREs who 
treat a victim but do not transport the victim are covered under the 
Act. Under section 300ff-82, when a medical facility makes a 
determination that a victim has an airborne infectious disease, the 
medical facility must notify only the Designated Officer of the EREs 
who transported the victim, not those who also treated the victim. 
However, under section 300ff-83, any ERE who ``attended, treated, 
assisted, or transported'' a victim may submit a request for a 
determination whether there was an exposure to an infectious disease. 
Therefore, under section 300ff-82, the medical facility is required to 
notify those EREs who transported a victim who has an airborne 
infectious disease, even when the ERE has not made a request for 
notification. For these EREs, section 300ff-82 does not require the 
medical facility to determine whether the ERE was exposed to the 
infectious disease. Under section 300ff-83, EREs who attended, treated, 
assisted, or transported a victim can request a determination from the 
medical facility of whether the ERE was exposed to an infectious 
disease from a victim. This determination would include a determination 
of whether an ERE was exposed to a victim of an airborne infectious 
disease.
    One commenter requested a definition of ``public health officer'' 
where, under section 300ff-83(g), a designated officer requests the 
assistance of the public health officer. Under that section, ``the 
public health officer for the community in which the medical facility 
is located shall evaluate'' a request from a designated officer to a 
medical facility where the medical facility finds that there is 
insufficient information to determine whether the ERE was exposed to a 
disease. Designated Officers must determine who the public health 
officer for the community is where the medical facility is located 
based on the jurisdiction where the medical facility is located, i.e., 
whether the community is a city or county.
    The majority of comments received on the definitions related to the 
definition of ``exposed'' as it is defined in the statute and applied 
in the notification process.
    The term ``exposed'' is found in two sections of the statute. Under 
section 300ff-81, the Secretary must develop the following: ``a list of 
potentially life-threatening infectious diseases to which emergency 
response employees may be exposed in responding to emergencies; 
guidelines describing the circumstances in which such employees may be 
exposed to such diseases * * *; [and] guidelines describing the manner 
in which medical facilities should make determinations for purposes of 
section 300ff-83(d).'' Under section 300ff-83(d), the medical facility 
must evaluate the facts submitted by a Designated Officer and make a 
determination whether, on the basis of the medical information 
possessed by the facility regarding the victim involved, the emergency 
response employee was exposed to an infectious disease included on the 
list, according to the guidelines issued by the Secretary.
    Under section 300ff-76(6), ``the term `exposed,' with respect to 
HIV disease, or any other infectious disease, means to be in 
circumstances in which there is a significant risk of becoming infected 
with the etiologic agent for the disease involved.'' Neither the 
statute nor the legislative history of the statute provide any 
additional information regarding the definition of significant risk. 
Therefore, without statutory or legislative elucidation as to the 
meaning of significant risk'', the term can be understood with 
reference to its use in other circumstances.
    Under the Supreme Court case School Board of Nassau County v. 
Arline, the Court listed the criteria by which it could be determined 
whether an individual poses a ``significant risk'' to others (480 
U.S.C. 273, 288). These criteria were recommended by the American 
Medical Association and included:
    A finding of facts, based on reasonable medical judgments given the 
state of medical knowledge, about
    (a) The nature of the risk (how the disease is transmitted),
    (b) The duration of the risk (how long is the carrier infectious),
    (c) The severity of the risk (what is the potential harm to 
others), and
    (d) The probabilities the disease will be transmitted and will 
cause varying degrees of harm.
    Subsequently, these criteria were incorporated into the definition 
of ``direct threat'' under the Americans With Disabilities Act. (See 
Senate Report No. 101-116, 101st Congress, 1st Session, 1989, page 40.) 
These criteria have been incorporated into the definition of 
``exposed'' and into the guidelines under section 300ff-81(a)(2).
    One commenter suggested that a system should be established that 
specifies the information required from a Designated Officer regarding 
exposure, thereby reducing the chance for confusion or insufficient 
information. Such a system is not required under the statute and has 
not been developed. The parties involved in this system must be given 
the latitude to develop procedures appropriate for their situation.
    Several commenters stated that the determination of exposure is 
complex and should be left to public health or occupational health 
officials and that the determination of exposure cannot be the 
responsibility of the medical facility. The responsibility for 
determining exposure is specified in the statute and rests with medical 
facilities. This process cannot be altered by CDC.
    Commenters also noted the need for more ``user-friendly'' exposure 
determination guidelines for Designated Officers with no medical 
background. The guidelines for Designated Officers describe the 
circumstances in which employees may be exposed to the diseases on the 
list. These guidelines are as succinct as possible within the 
specifications of the statute.
    It was noted that exposure to persons undergoing tuberculosis drug 
therapy and skin test converters, who are not infectious, should not be 
reported. CDC agrees with this comment and it is addressed under 
Comments on the Disease List. Another comment on tuberculosis stated 
that the section on airborne diseases is a problem because merely 
sharing air space is not sufficient to transmit tuberculosis and would 
not require treatment or followup. However, sharing air space is the 
main route of transmission for tuberculosis. EREs who transport 
patients with infectious TB are at risk of infection and should be 
medically evaluated.
    One individual asked whether States are ultimately responsible for 
determining which circumstances constitute exposure and whether State 
health officers or other professionals have input in this 
determination. Under the statute, in the case of airborne transmission, 
no determination of exposure must be made: if the medical facility 
determines that the victim has an airborne disease, the facility must 
notify the Designated Officer of the ERE who transported the victim. In 
the case of bloodborne exposures, it is the responsibility of 
Designated Officers and medical facilities to make these determinations 
based on the guidelines.
    One commenter stated that the duties of the medical facility should 
apply, as long as there is documentation that an ERE may have been 
exposed to one of the listed diseases. However, the period for which 
medical facilities must retain information on a victim is limited by 
section 300ff-87.
    As suggested by commenters, in section III.A.2 a recommendation has 
been added that when an exposure incident occurs or there is a breach 
of universal precautions, OSHA's Bloodborne Pathogens Standard 
protocols should be followed. Also, in defining occupational exposure 
to bloodborne pathogens, skin contact is limited to contact with non-
intact skin.
    One commenter suggested that ERE employers should provide, at no 
cost, counseling and medical evaluation, medical treatment, or 
prophylaxis whenever EREs are notified of occupational exposure. This 
suggestion is consistent with the OSHA Bloodborne Pathogens Standard. 
However, the Act does not require compliance with these provisions.
    One commenter stated that rural States with low prevalence of HIV 
and hepatitis B virus infection do not need a sophisticated 
notification system as specified under this legislation. However, the 
statute does not allow for distinguishing between States with high and 
low prevalences of the notifiable diseases.
    One commenter stated that the use of Control of Communicable 
Diseases in Man is not adequate to make exposure determinations. 
Control of Communicable Diseases in Man is intended to serve in 
conjunction with prior infection control training and experience of the 
Designated Officer in making exposure determinations.
    8. First responders.
    Several commenters stated that first responders should be covered 
under the notification system established by the Act, while one stated 
they should not be covered. First responders are individuals who have 
other responsibilities within an organization but who also, as part of 
their official responsibilities or as a volunteer, respond to 
emergencies that occur. Whether first responders are covered under the 
Act depends upon whether they fit within the definition of an ERE. The 
definition of ERE includes ``firefighters, law enforcement officer, 
paramedics, emergency medical technicians, and other individuals 
(including employees of legally organized and recognized volunteer 
organizations, without regard to whether such employees receive nominal 
compensation) who, in the course of professional duties, respond to 
emergencies in the geographic area involved.'' Therefore, for first 
responders to be covered by the Act, they must respond to emergencies 
as part of their professional duties.
    9. Patient testing.
    Twelve comments regarding the patient testing provision of the Act 
were received. Patient testing is addressed under 300ff-88(b). This 
section states that the Act ``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.''
    One commenter recommended that patient testing be mandatory and 
others suggested that this provision establishes an incentive to test 
patients. One other comment recommended routinely testing victims for 
tuberculosis. The Act does not authorize mandatory patient testing.
    Several commenters requested that the testing provision be 
incorporated into the guidelines for clarification. This has been done 
in a footnote to section III.C.3.
    Several comments addressed patient consent for testing. One 
commenter suggested that consent should be requested when knowledge of 
the patient's infected status is necessary in order to determine 
whether there has been an exposure. The Act does not prohibit seeking 
patient consent where consent is required in order to test the patient.
    Other commenters stated that, in their medical facility, patient 
consent is necessary before a patient can be tested. Whether consent is 
required in order to test a patient is a matter of State laws. Medical 
facilities should consult their State health department or other 
regulatory agency for State laws and regulation on patient consent.
    The patient testing provision must also be read in conjunction with 
the provisions of OSHA's Occupational Exposure to Bloodborne Pathogens 
Standard (29 CFR part 1910). Under OSHA's standard, following a report 
of an exposure incident, ``(A) [t]he source individual's blood shall be 
tested as soon as feasible and after consent is obtained in order to 
determine HBV and HIV infectivity. If consent is not obtained, the 
employer shall establish that legally required consent cannot be 
obtained. When the source individual's consent is not required by law, 
the source individual's blood, if available, shall be tested and the 
results documented'' (29 CFR Sec. 1910.1030(f)(3)(A)). Therefore, while 
the ERE notification system established under the Act does not 
authorize or require a medical facility to test a victim for any 
infectious disease, other laws or regulations may require or permit 
testing of victims. Also, other laws, particularly State laws, may 
address patient consent to testing. When there has been an exposure, 
employers should follow the OSHA Bloodborne Pathogens Standard and 
applicable State and local laws regarding patient testing and consent.
    10. 30-day implementation period.
    Under the Act, the provisions of the notification system take 
effect 30 days after publication of the list of diseases and guidelines 
under section 300ff-81. (42 U.S.C. 300ff-80 note.) Of the twenty 
comments received regarding this provision, nineteen stated that the 
30-day period was insufficient to implement the provisions of the Act. 
However, the 30-day implementation provision is statutorily defined, 
and CDC cannot alter it.
    11. 48-hour notification period.
    Under section 300ff-82(b), a medical facility must inform the 
Designated Officer as soon as is practicable, but not later than 48 
hours, when it determines that a victim has an airborne infectious 
disease, including when the victim dies before reaching the medical 
facility. The same time limitation applies, under section 300ff-83(e), 
when it determines that an ERE requesting notification was or was not 
exposed to an infectious disease.
    Of the comments received, fifteen stated that the statutory time 
frame for reporting was too short. In general these comments reflected 
the position that it would be difficult for medical facilities to 
comply with the time frame due to staff shortages, low weekend 
coverage, and occasions when appropriate medical personnel are 
unavailable. An additional nine comments stated that the time frame was 
too long. Several commenters stated that 48 hours was too long to wait 
for notification when the ERE has been exposed to meningococcal disease 
due to its incubation period. Another commenter stated that 48 hours is 
unacceptable for exposure to cases of plague, rabies, and hepatitis B.
    Since the time limits are established in the Act, they cannot be 
altered. However, it should be noted that, in the case of an airborne 
disease, notification is not required until a determination has been 
made that the victim has such a disease. The time limit begins after 
such a determination is made. For other diseases, if, after 48 hours, 
exposure cannot be determined without additional information, the 
medical facility must inform the designated officer that there are 
insufficient facts to make a determination or that the facility does 
not have the necessary information on a victim to determine whether the 
victim has a disease on the list of diseases.
    Both medical facilities and designated officers should be aware of 
the provisions of section 300ff-87 regarding time limits and 
information available on a victim. This section states that the duties 
of medical facilities under the Act
    (1) Shall apply only to medical information possessed by the 
facility during the period in which the facility is treating the victim 
for conditions arising from the emergency, or during the 60-day period 
beginning on the date on which the victim is transported by emergency 
response employees to the facility, whichever period expires first; and
    (2) Shall not apply to any extent after the expiration of the 30-
day period beginning on the expiration of the applicable period 
referred to in paragraph (1), except that such duties shall apply with 
respect to any request under section 300ff-83(c) received by a medical 
facility before the expiration of such 30-day period.
    One commenter requested clarification as to the meaning of this 
language. Subsection (1) establishes the time limit for which a medical 
facility must retain information on a victim of an emergency. The 
meaning of subsection (2) is somewhat ambiguous. Accordingly, the two 
subsections are interpreted and will be applied to mean that the duties 
of medical facilities terminate at the end of the period during which 
the facility provides medical care to the victim for conditions arising 
from the emergency, or at the end of the 60-day period beginning on the 
date on which the victim is transported by EREs to the facility, 
whichever period is shorter. However, the duties of the medical 
facility shall continue if, under section 300ff-83(c) a request is 
received within 30 days of the date of the applicable period under 
subsection (1) of section 300ff-87. In practice, if a victim is 
transported to a medical facility and released after two days, the 
facility must respond to a request submitted under section 300ff-83(c) 
if the request is received within 30 days of the date the victim was 
discharged from the facility. Also, if a victim of an emergency is 
transported to a medical facility and remains in the facility for more 
than 60 days, the facility must respond to a request under section 
300ff-83(c) when the request is received within 30 days from the 
expiration of the 60-day period.
    12. Designated Officers
    Under 42 U.S.C. 300ff-87:
    (a) For the purposes of receiving notifications and responses and 
making requests * * * on behalf of emergency response employees, the 
public health officer of each State shall designate 1 official or 
officer of each employer of emergency response employees in the State.
    (b) In making the designations required in section (a), a public 
health officer shall give preference to individuals who are trained in 
the provision of health care or in the control of infectious diseases.
    A total of 56 comments regarding these provisions were received. 
The majority of comments stated that it is impractical for State public 
health officers to make such designations due to the large number of 
employers of EREs in the State, the high turnover rate among some 
employees, and the lack of individuals trained in the control of 
infectious diseases among some employers of EREs. Other commenters 
stated that it would be more efficient for employers to designate the 
official or officer for their EREs. In order to address the concern 
that designating an official or officer for each employer of EREs is 
impractical or too burdensome on State public health officers, it would 
be permissible for States to allow employers to submit the name of an 
individual whom the employer would like for the State public health 
officer to designate as the designated officer for the employer.
    Many commenters recommended that the Designated Officer should be a 
physician or, in one comment, an epidemiologist or infection control 
practitioner. Many other commenters stated that it will be very 
difficult for employers to have a designated officer who is qualified 
to make the determinations required under the statute. Regarding the 
qualifications of the Designated Officer, the statute only requires 
that the State public health officer ``give preference to individuals 
who are trained in the provision of health care or in the control of 
infectious disease.'' While, under the statute, a State public health 
officer cannot require an employer to have a physician as the 
Designated Officer, employers can recommend to the State public health 
officer that a physician who is an employee be designated as the 
Designated Officer. In those cases where an employer does not consider 
any employee qualified to act as the Designated Officer, a qualified 
individual, such as a physician, could be retained by the employer to 
serve solely as the Designated Officer.
    A number of commenters suggested permitting the State public health 
officer to designate a regional Designated Officer, who could function 
in that capacity for several employers. This would be permitted under 
the statute only where the regional designated officer is also an 
employee of all the employers in the specified region.
    Two commenters stated that the duties of the Designated Officers 
may create liability for them. While the duties of the Designated 
Officer may create liability issues under State law for acts or 
omissions, the statutes provides that it * * * may not be construed to 
authorized any cause of action for damages or any civil penalty against 
any * * * designated officer, for failure to comply with the duties 
established. * * *''
    13. Comments on prevention.
    CDC received 44 comments regarding preventing disease in EREs. It 
was suggested that if EREs are using universal precautions, then there 
would not be a need for this regulation. However, universal precautions 
do not address airborne disease transmission. Moreover, universal 
precautions cannot protect entirely from inadvertent needlestick 
injury.
    It was also suggested that EREs may become lax regarding compliance 
with universal precautions if they know they can get patient 
information. Since exposure precedes notification, notification is not 
expected to deter EREs in the practice of universal precautions.
    One commenter thought that the concept of body substance isolation 
should be used instead of universal precautions. As noted under 
III.A.2, ``Under emergency circumstances in which differentiation 
between fluid types is difficult, if not impossible, all body fluids 
are considered potentially hazardous.'' This is essentially body 
substance isolation.
    One commenter suggested that, to avoid confusion and duplication, 
CDC should adopt language crafted by OSHA in their Bloodborne Pathogens 
Standard and tuberculosis compliance memorandum. This was agreed to; as 
noted above, several changes have been made to bring the two documents 
into closer alignment.
    One commenter suggested that purified protein derivative (PPD) 
testing should be given to EREs every 6 months. CDC recommends that 
tuberculin skin testing be performed every 6 months in areas where 
there is a high risk for tuberculosis transmission. For other, lower-
risk areas, annual tuberculin skin testing is recommended.
    One commenter stated that EREs need to be trained to recognize 
symptoms of active tuberculosis. CDC agrees with this.
    Another commenter noted that patients suspected of having active 
tuberculosis should be tested and isolated in a timely manner. CDC 
acknowledges that this is a key concept in tuberculosis control 
efforts.\2\,\3\
---------------------------------------------------------------------------

    \2\CDC. Guidelines for preventing the transmission of 
tuberculosis in health-care facilities, with special focus on HIV-
related issues. MMWR 1990;39(no. RR-17).
    \3\CDC. Draft Guidelines for Preventing the Transmission of 
Tuberculosis in Health-Care Facilities, Second Edition. Federal 
Register 1993:58 (no. 195):52810-52854, October 12.
---------------------------------------------------------------------------

    One commenter thought that CDC should explain if or how the 
proposed notification requirements will reduce transmission of airborne 
disease and how they will fit into the infection control strategy 
outlined in the 1990 CDC Guidelines for Preventing the Transmission of 
Tuberculosis in Health Care Settings. There is no conflict between 
these requirements and either the 1990 document\4\ or the 1993 draft 
Guidelines.\5\
---------------------------------------------------------------------------

    \4\See footnote 2.
    \5\See footnote 3.
---------------------------------------------------------------------------

    One commenter noted that tetanus/diphtheria boosters should be 
given every 10 years. This is current CDC policy.\6\
---------------------------------------------------------------------------

    \6\CDC. General recommendations on immunization. Recommendations 
of the Advisory Committee on Immunization Practices (ACIP) MMWR 
1994; 43(No. RR-1).
---------------------------------------------------------------------------

    One commenter thought that diphtheria vaccination virtually 
eliminates the possibility of occupational transmission. This is true; 
notification of exposure then provides an impetus for ensuring that 
diphtheria vaccination has been obtained recently enough to ensure that 
immunity has been maintained.
    It was also suggested that infection control education programs are 
needed for EREs. However, the legislation is not directed to this need. 
The OSHA Bloodborne Pathogens Standard has provisions for employee 
training programs for bloodborne pathogens.
    For plague and rabies, it was noted that education offers the best 
prevention against infection. Nonetheless, notification and follow-up 
are indicated upon potential exposure to either of these diseases.
    One commenter proposed that an ERE who sustains significant 
exposure should be assured counseling and testing, and that this is 
more important than inordinate efforts to determine patient HIV status. 
CDC believes that counseling and testing are key elements in follow-up 
of an employee exposure to a potentially life-threatening infectious 
disease. Additional language from the OSHA Bloodborne Pathogens 
Standard has therefore been appended in Addendum B for follow-up of a 
potential HIV exposure: ``Following a report of an exposure incident, 
the employer shall make immediately available to the exposed employee a 
confidential medical evaluation and follow-up including at least the 
following elements: * * * counseling.''
    One commenter stated that medical facilities should not be 
responsible for follow-up testing of EREs. There is no provision in the 
legislation that charges medical facilities with follow-up testing of 
EREs.
    One commenter suggested that regulation provides little incentive 
for ERE employers to adopt infection control plans. The threat of HIV 
infection should provide a powerful incentive for implementation of 
infection control plans. Moreover, there are Federal agencies and other 
organizations that require and recommend infection control procedures 
(e.g., OSHA and the National Fire Protection Administration).
    14. Airborne versus bloodborne.
    Ten comments were received regarding notification for airborne 
diseases versus notification for other diseases. It was suggested that 
EREs should be notified of all the listed diseases, not just airborne 
diseases, without making a request, and that the ERE request should be 
a ``back-up.'' This is not consistent with the legislation.
    One commenter suggested that in making a distinction between 
airborne and bloodborne exposures, the Act frustrates its intent, 
placing the burden on the ERE to request determinations of bloodborne 
exposures. The commenter thought that this would lead to more requests 
than if all diseases were treated alike. Again, this concept is not 
consistent with the legislation.
    15. Coordination with OSHA.
    Ten comments were received regarding this notification system and 
requirements of the OSHA Bloodborne Pathogens Standard.
    In one response, CDC was urged to cooperate with OSHA to develop a 
joint advisory notice on tuberculosis. However, OSHA has announced its 
intention to promulgate an occupational health standard addressing 
tuberculosis and other airborne pathogens. CDC will be assisting OSHA 
in this regulatory effort.
    Another commenter felt that CDC should require States without State 
plan OSHA programs to develop worker protection programs at least as 
effective as those in the already Federally approved States. States 
without State OSHA plans are already covered by Federal OSHA programs.
    One commenter thought it was unclear how the notification process 
interfaces with OSHA regulations and that there appeared to be 
duplication. Since a significant portion of EREs are not covered by 
OSHA regulations, some degree of overlap is inescapable.
    One reviewer stated that the draft notification process recommended 
that workers be immunized with hepatitis B virus vaccine,'' but noted 
that this is a requirement under the OSHA Bloodborne Pathogens 
Standard. The recommendation for immunization was added for those EREs 
not covered by the OSHA Bloodborne Pathogens Standard. The OSHA 
requirement is presented in Addendum B.
    Several commenters noted that the definition of bloodborne 
transmission is inconsistent with the OSHA Bloodborne Pathogens 
Standard's use of the term ``other potentially infectious material.'' 
Part III.2 has been expanded to comply with the OSHA definition.
    One commenter asked whether the Designated Officer represents the 
employer or the employee. According to the commenter, it would be 
inconsistent under the OSHA Bloodborne Pathogens Standard for the 
Designated Officer to represent the employee. In the ERE notification 
system, the Designated Officer is acting in the interest of the 
employee. This is not seen as inconsistent with OSHA regulations, 
however, since employers are still required to meet the notification 
provisions of the OSHA Bloodborne Pathogens Standard. In addition, many 
EREs are not covered by OSHA regulations.
    One commenter stated that his State has an approved occupational 
safety and health plan, and suggested that the notification process 
therefore is redundant. As noted in section 300ff-90, ``this [ERE 
portion of the Act] shall not apply in a State if the chief executive 
officer of the State certifies to the Secretary that the law of the 
State is in substantial compliance with this subpart.''
    One commenter suggested that all medical facilities are covered by 
OSHA regulations regarding exposure; therefore, Designated Officers 
should be aware of them and educate EREs. In fact, not all medical 
facilities are covered by OSHA (e.g., public hospitals in states 
without State OSHA plans). Moreover, EREs are not typically employees 
of the medical facility, thus necessitating another route of 
notification to that provided by the OSHA Bloodborne Pathogens 
Standard.
    16. Injunctive relief.
    Authority for injunctive relief is provided in section 300ff-89. 
This section states:
    (a) The Secretary may, in any court of competent jurisdiction, 
commence a civil action for the purpose of obtaining temporary or 
permanent injunctive relief with respect to any violation of [these 
provisions].
    (b) The Secretary shall establish an administrative process for 
encouraging emergency response employees to provide information to the 
Secretary regarding violations of [these provisions]. As appropriate, 
the Secretary shall investigate alleged such violations and seek 
appropriate injunctive relief.
    Regarding subsection (b) of these provisions, anyone alleging a 
violation of any of these provisions should contact CDC. Alleged 
violations of these provisions will be investigated. In any case that 
injunctive relief may be sought, the Department of Health and Human 
Services will coordinate its efforts with the Department of Justice.

Final Notice: Provisions of Section 411 of the Ryan White Comprehensive 
AIDS Resources Emergency Act Regarding Emergency Response Employees

    Section 411 of the Ryan White Comprehensive AIDS Resources 
Emergency (CARE) Act (Pub. L. 101-381), amends the Public Health 
Service Act to include provisions regarding emergency response 
employees (sections 2681-2690 of the PHS Act, 42 U.S.C. 300ff-81 to 
300ff-90). This notice sets forth the final list of diseases; final 
guidelines describing circumstances under which exposure to infectious 
diseases may occur; and final guidelines for determining whether an 
exposure to such a disease has occurred, as required under section 411 
of the Act. The final list of diseases and guidelines incorporate 
comments received by CDC to the draft list and guidelines (57 FR 54794, 
November 20, 1992). The list of diseases and guidelines are effective 
on March 21, 1994. All other provisions of section 411 of the Act are 
effective on April 20, 1994.
    CDC will continue to monitor the scientific literature on 
infectious diseases. If new information becomes available that suggests 
that additional infectious diseases should be added to the list of 
diseases contained here, CDC will amend the list.


    Dated: March 15, 1994.
Walter R. Dowdle,
Deputy Director, Centers for Disease Control and Prevention (CDC).

Contents

Part I. Definitions
Part II. List of Potentially Life-Threatening Infectious Diseases to 
Which Emergency Response Employees Can Be Exposed
Part III. Guidelines for Determining Exposure
Part IV. Implementation of the Law
Addendum A: Background--Text of Sections 2681-2690 of the PHS Act as 
amended by Pub. L. 101-381 (42 U.S.C. 300ff-81 to 300ff-90)
Addendum B: Excerpts Concerning Hepatitis B Vaccination
Addendum C: References
    Statutory citations within this notice are to the Title 42 of 
the U.S. Code.

Part I. Definitions

    Aerosol. Small particles of matter that float on air currents.
    Airborne transmission. Person-to-person transmission of an 
infectious agent by an aerosol.
    Bloodborne transmission. Person-to-person transmission of an 
infectious agent through contact with an infected person's blood.
    Designated Officer of Emergency Response Employees. An 
individual designated under 42 U.S.C. 300ff-86 by the public health 
officer of the State involved (42 U.S.C. 300ff-76).
    Emergency. An emergency involving injury or illness (42 U.S.C. 
300ff-76).
    Emergency response employees (EREs). Firefighters, law 
enforcement officers, paramedics, emergency medical technicians, and 
other persons (including employees of legally organized and 
recognized volunteer organizations, without regard to whether such 
employees receive nominal compensation) who, in the course of 
professional duties, respond to emergencies in the geographic area 
involved (42 U.S.C. 300ff-76).
    Employer of Emergency Response Employee. An organization that, 
in the course of professional duties, responds to emergencies in 
that geographic area involved (42 U.S.C. 300ff-76).
    Exposed. With respect to HIV disease or any other infectious 
disease, to be in circumstances in which there is a significant risk 
of becoming infected with the etiologic agent for the disease 
involved (42 U.S.C. 300ff-76).
    Medical Facility. Any facility that receives victims of 
emergencies who are transported to the facility by emergency 
response employees.
    Patient. A victim of an emergency who has been aided by an 
Emergency Response Employee and has been transported to a medical 
facility.
    Potentially life-threatening infectious disease. An infectious 
disease that can cause death in a healthy, susceptible host.
    Routinely transmitted by aerosol. A disease that is usually 
transmitted via the aerosol route.
    Secretary. The Secretary of the Department of Health and Human 
Services as this term is used in Title XXVI of the Public Health 
Service Act (42 U.S.C. 300ff-80 through 42 U.S.C. 300ff-90).
    Significant Risk. A finding of facts relating to a human 
exposure to an etiologic agent for a particular disease, based on 
reasonable medical judgments given the state of medical knowledge, 
about
    (a) The nature of the risk (how the disease is transmitted),
    (b) The duration of the risk (how long an infected person may be 
infectious),
    (c) The severity of the risk (what is the potential harm to 
others) and
    (d) The probabilities the disease will be transmitted and will 
cause varying degrees of harm.

Part II. List of Potentially Life-Threatening Infectious Diseases 
to Which Emergency Response Employees Can be Exposed

    In developing the list of infectious diseases to which EREs can 
be exposed, CDC used the following criteria:
    1. The disease is potentially life-threatening, i.e., it carries 
a significant risk of death if acquired by a healthy, susceptible 
host, and
    2. The disease can be transmitted from person to person.

A. Airborne Diseases

Infectious pulmonary tuberculosis (Mycobacterium tuberculosis)

B. Bloodborne Diseases

1. Hepatitis B
2. Human immunodeficiency virus infection (including acquired 
immunodeficiency syndrome [AIDS])

C. Uncommon or Rare Diseases

1. Diphtheria (Corynebacterium diphtheriae)
2. Meningococcal disease (Neisseria meningitidis)
3. Plague (Yersinia pestis)\7\
---------------------------------------------------------------------------

    \7\During the 1980s, a mean of 18 cases of plague was reported 
annually in persons exposed in enzootic areas of the southwestern 
United States. Thus, normally only EREs in this area face potential 
occupational exposure to plague.
---------------------------------------------------------------------------

4. Hemorrhagic fevers (Lassa, Marburg, Ebola, Crimean-Congo, and 
other viruses yet to be identified)
5. Rabies

Part III. Guidelines for Determining Exposure

A. Circumstances Under Which Exposure can Occur

1. Airborne Diseases

Infectious pulmonary tuberculosis (Mycobacterium tuberculosis)

    Occupational exposure to airborne pathogens may occur when an 
ERE shares air space with a patient who has an infectious disease 
caused by an airborne pathogen.

2. Bloodborne Diseases

Human immunodeficiency virus infection (including acquired 
immunodeficiency syndrome [AIDS])
Hepatitis B

    Occupational exposure to bloodborne pathogens may occur as the 
result of contact during the performance of normal job duties with 
blood or other body fluids to which universal precautions apply. 
When EREs have contact with body fluids under emergency 
circumstances in which differentiation between fluid types is 
difficult, if not impossible, all body fluids are considered 
potentially hazardous. Universal precautions, as outlined in 
Guidelines for Prevention of Transmission of Human Immunodeficiency 
Virus and Hepatitis B Virus to Health-Care and Public-Safety 
Workers, are recommended for all EREs to reduce the risk of exposure 
to bloodborne pathogens. In the Occupational Safety and Health 
Administrations 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.'' Bloodborne pathogens are defined therein as 
``pathogenic microorganisms that are present in human blood and can 
cause disease in humans. These pathogens include, but are not 
limited to, hepatitis B virus (HBV) and human immunodeficiency virus 
(HIV).''\8\
---------------------------------------------------------------------------

    \8\Occupational Safety and Health Administration. Occupational 
exposure to bloodborne pathogens: final rule. 29 CFR Part 1910.1030. 
Federal Register, December 6, 1991.
---------------------------------------------------------------------------

    These precautions, and other provisions of the Occupational 
Safety and Health Administration (OSHA) rule governing occupational 
exposure to bloodborne pathogens (29 CFR 1910.1030), may be 
mandatory for some EREs, depending upon whether they are employed in 
the public or private sector and whether the State in which they are 
employed has an approved occupational safety and health plan. 
Employers covered under the OSHA Bloodborne Pathogens Standard 
should comply with provisions contained in the standard when there 
is an exposure incident or a breach of universal precautions.
    Also, it is recommended that workers with occupational exposure 
to blood be vaccinated with hepatitis B vaccine (see Addendum B).

3. Uncommon or Rare Diseases

Diphtheria (Corynebacterium diphtheriae)
Meningococcal disease (Neisseria meningitidis)
Plague (Yersinia pestis)
Hemorrhagic fevers (Lassa, Marburg, Ebola, Crimean-Congo, and other 
viruses yet to be identified)
Rabies

    While person-to-person transmission of pathogens in this 
category is rare or theoretical, infection with any of these 
pathogens could be life-threatening. Under special circumstances, 
Corynebacterium diphtheriae, Neisseria meningitidis, and Yersinia 
pestis could be transmitted to EREs by direct contact with droplets 
from the respiratory tract of infected persons. However, such 
transmission is rare. Person-to-person transmission of plague, for 
example, has not been documented since 1924. Hemorrhagic fever 
viruses are primarily bloodborne pathogens, but none occur naturally 
in the U.S. Any suspected importation of these infectious agents are 
thoroughly investigated by the Public Health Service.

B. Guidelines for Determining Exposure to an Airborne Infectious 
Disease Listed in Part II

    Under section 300ff-82, if it is determined that a patient has 
an airborne infectious disease, the medical facility must notify the 
Designated Officer of the EREs who transported the patient as soon 
as practicable but not later than 48 hours after the determination 
has been made.

C. Guidelines for Determining Exposure to a Bloodborne or Other 
Infectious Disease Listed in Part II

    1. Under section 300ff-83(a), an ERE may submit a request for a 
determination whether he or she was exposed to an infectious 
disease.
    2. Upon receipt of such a request from an ERE, under section 
300ff-83 (b) and (c) the Designated Officer must:
    a. Collect facts relating to the circumstances under which the 
ERE may have been exposed to an infectious disease, and
    b. Evaluate the facts and determine if the ERE would have been 
exposed to an infectious disease (see Part III.A.).
    c. If the Designated Officer determines that the ERE may have 
been exposed to an infectious disease, he or she must send to the 
medical facility to which the patient was transported a signed 
written request, along with the facts collected, for a determination 
of whether the ERE was exposed to a listed disease.
    3. When a medical facility receives such a request, under 
section 300ff-83(d), it must:
    a. Determine if there is sufficient information in the request 
to identify the patient suspected of having an infectious disease 
(see Part III).\7\
---------------------------------------------------------------------------

    \7\Note however, that per section 300ff-88, ``this subpart 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.''
---------------------------------------------------------------------------

    b. If the medical facility can identify the patient in question, 
medical records should be reviewed for:
    (i) Results of tests diagnostic for any of the diseases listed 
in Part II.
    (ii) Signs or symptoms compatible with any of the diseases 
listed in Part II.
    c. If it is determined that the patient is infected with any of 
the diseases listed in Part II, the medical facility must review the 
information sent with the request to determine if the ERE was 
exposed.
    (i) In determining whether the ERE was exposed, the medical 
facility should consider whether, based on the facts, the ERE was in 
circumstances in which there is a significant risk of becoming 
infected with the etiologic agent for the disease with which the 
patient is infected;
    (ii) In determining whether there was a significant risk of the 
ERE becoming infected with the etiologic agent for the disease with 
which the patient is infected, the medical facility should consider:
    (a) The nature of the risk (how the disease is transmitted),
    (b) The duration of the risk (how long is the carrier 
infectious),
    (c) The severity of the risk (what is the potential harm to 
others), and
    (d) The probabilities the disease will be transmitted and will 
cause varying degrees of harm.
    (iii) Under section 300ff-83(e), if a determination of exposure 
is made, the medical facility must notify the Designated Officer in 
writing as soon as practicable, but not later than 48 hours after 
receiving the request, that the ERE was exposed to a listed disease.
    (iv) If the information provided by the Designated Officer is 
insufficient to make a determination, the medical facility must so 
notify the Designated Officer in writing as soon as practicable but 
not later than 48 hours after receiving the request.
    (v) Under section 300ff-83(g), if the Designated Officer 
receives notice of insufficient information, he or she may request 
the public health officer for the community in which the medical 
facility is located to evaluate the request and the medical 
facility's response. The public health officer must then evaluate 
the request and the medical facility's response and report his or 
her findings to the Designated Officer as soon as practicable but 
not later than 48 hours after receiving the request.
    (a) If the public health officer finds the information provided 
is sufficient to make a determination of exposure, he or she must 
submit the request to the medical facility.
    (b) If the public health officer finds the information provided 
was insufficient to make a determination of exposure, he or she must 
advise the Designated Officer about collecting more information. If 
sufficient facts are subsequently collected by the Designated 
Officer, the public health officer must resubmit the request to the 
medical facility.

D. References

    In making determinations or evaluations described in this Part, 
the Designated Officer, the medical facility, or the public health 
officer may use standard medical references or the latest edition of 
The Control of Communicable Diseases in Man. Additional references 
are listed in Addendum C.

Part IV. Implementation of the Law

    A. By April 20, 1994, State public health officers must have 
selected persons to serve as Designated Officers of EREs for each 
employer of EREs in their States. In the selection of Designated 
Officers, the State public health officer shall give preference to 
individuals who are trained in the provision of health care or the 
control of infectious diseases (section 300ff-86).
    B. By April 20, 1994, medical facilities must have in place 
procedures for:
    1. Notifying Designated Officers within 48 hours of any 
instances in which it is known that a patient who has been 
transported to the medical facility is infected with an airborne 
disease listed in Part II (section 300ff-82(a) and (b)).
    2. Responding within 48 hours to written requests from 
Designated Officers for determination of possible exposure to 
diseases listed in Part II (section 300ff-83(e)).
    C. By April 20, 1994, ERE employers must have in place 
procedures by which EREs can make requests of Designated Officers 
and procedures by which the Designated Officers would make 
appropriate disposition of such requests (section 300ff-83(a)).
    D. By April 20, 1994, local health agencies must have in place 
procedures for handling requests for evaluations from Designated 
Officers (section 300ff-83(g)).
    E. By April 20, 1994, the Secretary of Health and Human Services 
will:
    1. Send copies of the list of potentially life-threatening 
diseases and the exposure guidelines to State public health officers 
requesting appropriate distribution (section 300ff-81(c)(1)).
    2. Make copies of the list and guidelines available to the 
public (section 300ff-81(c)(2)).
    3. Have in place procedures for receiving and handling 
allegations of violations of the exposure notification process 
(section 300ff-89(b)).

Addendum A

Background--Text of Sections 2681-2690 of the PHS Act as amended by 
Pub. L. 101-381 (42 U.S.C. 300ff-81 to 300ff-90. References are to 
Title 42 U.S.C.). (Published for informational purposes only)

SUBPART II--Notifications of Possible Exposure to Infectious Diseases

    SEC. 300ff-81. Infectious Diseases and Circumstances Relevant to 
Notification Requirements.
    (a) In General.--Not later than 180 days after the date of the 
enactment of the Ryan White Comprehensive AIDS Resources Emergency 
Act of 1990, the Secretary shall complete the development of--
    (1) A list of potentially life-threatening infectious diseases 
to which emergency response employees may be exposed in responding 
to emergencies;
    (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 300ff-83(d).
    (b) Specification of Airborne Infectious Diseases.--The list 
developed by the Secretary under subsection (a)(1) shall include a 
specification of those infectious diseases on the list that are 
routinely transmitted through airborne or aerosolized means.
    (c) Dissemination.--The Secretary shall--
    (1) Transmit to the state public health officers copies of the 
list and guidelines developed by the Secretary under subsection (a) 
with the request that the officers disseminate such copies as 
appropriate throughout the states; and
    (2) Make such copies available to the public.
    Sec. 300ff-82. Routine Notifications With Respect to Airborne 
Infectious Diseases in Victims Assisted.
    (a) Routine Notification of Designated Officer.
    (1) Determination by Treating Facility.--If a victim of an 
emergency is transported by emergency response employees to a 
medical facility and the medical facility makes a determination that 
the victim has an airborne infectious disease, the medical facility 
shall notify the designated officer of the emergency response 
employees who transported the victim to the medical facility of the 
determination.
    (2) Determination by Facility Ascertaining Cause of Death.--If a 
victim of an emergency is transported by emergency response 
employees to a medical facility, the medical facility ascertaining 
the cause of death shall notify the designated officer of the 
emergency response employees who transported the victim to the 
initial medical facility of any determination by the medical 
facility that the victim had an airborne infectious disease.
    (b) Requirement of Prompt Notification.-- With respect to a 
determination described in paragraph (1) or (2), the notification 
required in each of such paragraphs shall be made as soon as is 
practicable, but not later than 48 hours after the determination is 
made.
    Sec. 300ff-83. Request for Notifications with Respect to Victims 
Assisted.
    (a) Initiation of Process by Employee.--If an emergency response 
employee believes that the employee may have been exposed to an 
infectious disease by a victim of an emergency who was transported 
to a medical facility as a result of the emergency, and if the 
employee attended, treated, assisted, or transported the victim 
pursuant to the emergency, then the designated officer of the 
employee shall, upon the request of the employee, carry out the 
duties described in subsection (b) regarding a determination of 
whether the employee may have been exposed to an infectious disease 
by the victim.
    (b) Initial Determination by Designated Officer.--The duties 
referred to in subsection (a) are that--
    (1) The designated officer involved collect the facts relating 
to the circumstances under which, for purposes of subsection (a), 
the employee involved may have been exposed to an infectious 
disease; and
    (2) the designated officer evaluate such facts and make a 
determination of whether, if the victim involved had any infectious 
disease included on the list issued under paragraph (1) of Section 
300ff-81(a), the employee would have been exposed to the disease 
under such facts, as indicated by the guidelines issued under 
paragraph (2) of such Section.
    (c) Submission of Request to Medical Facility.--
    (1) In General.--If a designated officer makes a determination 
under subsection (b)(2) that an emergency response employee may have 
been exposed to an infectious disease, the designated officer shall 
submit to the medical facility to which the victim involved was 
transported a request for a response under subsection (d) regarding 
the victim of the emergency involved.
    (2) Form of Request.--A request under paragraph (1) shall be in 
writing and be signed by the designated officer involved, and shall 
contain a statement of the facts collected pursuant to subsection 
(b)(1).
    (d) Evaluation and Response Regarding Request to Medical 
Facility.--
    (1) In General.--If a medical facility receives a request under 
subsection (c), the medical facility shall evaluate the facts 
submitted in the request and make a determination of whether, on the 
basis of the medical information possessed by the facility regarding 
the victim involved, the emergency response employee was exposed to 
an infectious disease included on the list issued under paragraph 
(1) of Section 300ff-81(a), as indicated by the guidelines issued 
under paragraph (2) of such Section.
    (2) Notification of Exposure.--If a medical facility makes a 
determination under paragraph (1) that the emergency response 
employee involved has been exposed to an infectious disease, the 
medical facility shall, in writing, notify the designated officer 
who submitted the request under subsection (c) of the determination.
    (3) Finding of no Exposure.--If a medical facility makes a 
determination under paragraph (1) that the emergency response 
employee involved has not been exposed to an infectious disease, the 
medical facility shall, in writing, inform the designated officer 
who submitted the request under subsection (c) of the determination.
    (4) Insufficient Information.--(A) If a medical facility finds 
in evaluating facts for purposes of paragraph (1) that the facts are 
insufficient to make the determination described in such paragraph, 
the medical facility shall, in writing, inform the designated 
officer who submitted the request under subsection (c) of the 
insufficiency of the facts.
    (B)(i) If a medical facility finds in making a determination 
under paragraph (1) that the facility possesses no information on 
whether the victim involved has an infectious disease included on 
the list under Section 2681(a), the medical facility shall, in 
writing, inform the designated officer who submitted the request 
under subsection (c) of the insufficiency of such medical 
information.
    (ii) If after making a response under clause (i) a medical 
facility determines that the victim involved has an infectious 
disease, the medical facility shall make the determination described 
in paragraph (1) and provide the applicable response specified in 
this subsection.
    (e) Time for Making Response.--After receiving a request under 
subsection (c) (including any such request resubmitted under 
subsection (g)(2)), a medical facility shall make the applicable 
response specified in subsection (d) as soon as is practicable, but 
not later that 48 hours after receiving the request.
    (f) Death of Victim of Emergency.--
    (1) Facility Ascertaining Cause of Death.--If a victim described 
in subsection (a) dies at or before reaching the medical facility 
involved, and the medical facility receives a request under 
subsection (c), the medical facility shall provide a copy of the 
request to the medical facility ascertaining the cause of death of 
the victim, if such facility is a different medical facility than 
the facility that received the original request.
    (2) Responsibility of Facility.--Upon the receipt of a copy of a 
request for purposes of paragraph (1), the duties otherwise 
established in this subpart regarding medical facilities shall apply 
to the medical facility ascertaining the cause of death of the 
victim in the same manner and to the same extent as such duties 
apply to the medical facility originally receiving the request.
    (g) Assistance of Public Health Officer.--
    (1) Evaluation of Response of Medical Facility Regarding 
Insufficient Facts.--
    (A) In the case of a request under subsection (c) to which a 
medical facility has made the response specified in subsection 
(d)(4)(A) regarding the insufficiency of facts, the public health 
officer for the community in which the medical facility is located 
shall evaluate the request and the response, if the designated 
officer involved submits such documents to the officer with the 
request that the officer make such an evaluation.
    (B) As soon as is practicable after a public health officer 
receives a request under paragraph (1), but not later than 48 hours 
after receipt of the request, the public health officer shall 
complete the evaluation required in such paragraph and inform the 
designated officer of the results of the evaluation.
    (2) Finding of Evaluation.--
    (A) If an evaluation under paragraph (1)(A) indicates that the 
facts provided to the medical facility pursuant to subsection (c) 
were sufficient for purposes of determinations under subsection 
(d)(1)--
    (i) The public health officer shall, on behalf of the designated 
officer involved, resubmit the request to the medical facility; and
    (ii) The medical facility shall provide to the designated 
officer the applicable response specified in subsection (d).
    (B) If an evaluation under paragraph (1)(A) indicates that the 
facts provided in the request to the medical facility were 
insufficient for purposes of determinations specified in subsection 
(c)--
    (i) The public health officer shall provide advice to the 
designated officer regarding the collection and description of 
appropriate facts; and
    (ii) If sufficient facts are obtained by the designated 
officer--
    (I) the public health officer shall, on behalf of the designated 
officer involved, resubmit the request to the medical facility; and
    (II) The medical facility shall provide to the designated 
officer the appropriate response under subsection (c).
    Sec. 300ff-84. Procedures for Notification of Exposure.
    (a) Contents of Notification to Officer.--In making a 
notification required under section 300ff-82 or section 300ff-
83(d)(2), a medical facility shall provide--
    (1) The name of the infectious disease involved; and
    (2) The date on which the victim of the emergency involved was 
transported by emergency response employees to the medical facility 
involved.
    (b) Manner of Notification.--If a notification under Section 
300ff-82 or Section 300ff-82(d)(2) [sic] is mailed or otherwise 
indirectly made--
    (1) The medical facility sending the notification shall, upon 
sending the notification, inform the designated officer to whom the 
notification is sent of the fact that the notification has been 
sent; and
    (2) Such designated officer shall, not later than 10 days after 
being informed by the medical facility that the notification has 
been sent, inform such medical facility whether the designated 
officer has received the notification.
    Sec. 300ff-85. Notification of Employee.
    (a) In General.--After receiving a notification for purposes of 
section 300ff-82 or 300ff-83(d)(2), a designated officer of 
emergency response employees shall, to the extent practicable, 
immediately notify each of such employees who--
    (1) Responded to the emergency involved; and
    (2) As indicated by guidelines developed by the Secretary, may 
have been exposed to an infectious disease.
    (b) Certain Contents of Notification to Employee.--A 
notification under this subsection to an emergency response employee 
shall inform the employee of--
    (1) The fact that the employee may have been exposed to an 
infectious disease and the name of the disease involved;
    (2) Any action by the employee that, as indicated by guidelines 
developed by the Secretary, is medically appropriate; and
    (3) If medically appropriate under such criteria, the date of 
such emergency.
    (c) Responses Other Than Notification of Exposure.--After 
receiving a response under paragraph (3) or (4) of subsection (d) of 
section 300ff-83, or a response under subsection (g)(1) of such 
section, the designated officer for the employee shall, to the 
extent practicable, immediately inform the employee of the response.
    Sec. 300ff-86. Selection of Designated Officers.
    (a) In General.--For the purposes of receiving notifications and 
responses and making requests under this subpart on behalf of 
emergency response employees, the public health officer of each 
state shall designate 1 official or officer of each employer of 
emergency response employees in the state.
    (b) Preference in Making Designations.--In making the 
designations required in subsection (a), a public health officer 
shall give preference to individuals who are trained in the 
provision of health care or in the control of infectious diseases.
    SEC. 300ff-87. Limitations With Respect to Duties of Medical 
Facilities.
    The duties established in this subpart for a medical facility--
    (1) Shall apply only to medical information possessed by the 
facility during the period in which the facility is treating the 
victim for conditions arising from the emergency, or during the 60-
day period beginning on the date on which the victim is transported 
by emergency response employees to the facility, whichever period 
expires first; and
    (2) Shall not apply to any extent after the expiration of the 
30-day period beginning on the expiration of the applicable period 
referred to in paragraph (1), except that such duties shall apply 
with respect to any request under section 300ff-83(c) received by a 
medical facility before the expiration of such 30-day period.
    Sec. 300ff-88. Rules of Construction.
    (a) Liability of Medical Facilities and Designated Officers.--
This subpart may not be construed to authorize any cause of action 
for damages or any civil penalty against any medical facility, or 
any designated officer, for failure to comply with the duties 
established in this subpart.
    (b) Testing.--This subpart 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.
    (c) Confidentiality.--This subpart may not be construed to 
authorize or require any medical facility, any designated officer of 
emergency response employees, or any such employee, to disclose 
identifying information with respect to a victim of an emergency or 
with respect to any emergency response employee.
    (d) Failure to Provide Emergency Services.--This subpart may not 
be construed to authorize any emergency response employee to fail to 
respond, or to deny services, to any victim of an emergency.
    Sec. 300ff-89. Injunctions Regarding Violation of Prohibition.
    (a) In General.--The Secretary may, in any court of competent 
jurisdiction, commence a civil action for the purpose of obtaining 
temporary or permanent injunctive relief with respect to any 
violation of this subpart.
    (b) Facilitation of Information on Violations.--The Secretary 
shall establish an administrative process for encouraging emergency 
response employees to provide information to the Secretary regarding 
violations of this subpart. As appropriate, the Secretary shall 
investigate alleged such violations and seek appropriate injunctive 
relief.
    Sec. 300ff-90. Applicability of Subpart.
    This subpart shall not apply in a state if the chief executive 
officer of the state certifies to the Secretary that the law of the 
state is in substantial compliance with this subpart.
    Effective Date.--Sections 300ff-80 and 300ff-81 of part E of 
title XXVI of the Public Health Service Act, as added by subsection 
(a) of this section, shall take effect upon the date of the 
enactment of this Act. Such part shall otherwise take effect upon 
the expiration of the 30-day period beginning on the date on which 
the Secretary issues guidelines under section 300ff-81(a).

(See 300ff-80 Note in Title 42 of the United States Code)

Addendum B

Excerpts Concerning Hepatitis B Vaccination

    Guidelines for Prevention of Transmission of Human 
Immunodeficiency Virus and Hepatitis B Virus to Health-Care and 
Public-Safety Workers. Morbidity and Mortality Weekly Report 1989; 
38 (supplement no. S-6).
    Emergency medical workers have an increased risk for hepatitis B 
infection . . . The degree of risk correlates with the frequency and 
extent of blood exposure during the conduct of work activities. A 
few studies are available concerning risk of HBV infection for other 
groups of public-safety workers (law-enforcement personnel and 
correctional-facility workers), but reports that have been published 
do not document any increased risk for HBV infection . . . 
Nevertheless, in occupational settings in which workers may be 
routinely exposed to blood or other body fluids as described below, 
an increased risk for occupational acquisition of HBV infection must 
be assumed to be present.
    Occupational Safety and Health Administration's Occupational 
Exposure to Bloodborne Pathogens Standard, 29 CFR Part 1910.1030.
    (f) Hepatitis B vaccination and post-exposure evaluation and 
follow-up--
    (1) General.
    (i) The employer shall make available the hepatitis B vaccine 
and vaccination series to all employees who have occupational 
exposure . . .
    (ii) The employer shall ensure that . . . the hepatitis B 
vaccine and vaccination series and post-exposure evaluation and 
follow-up, including prophylaxis, are:
    (A) Made available at no cost to the employee.
    (3) Post-exposure Evaluation and Followup. Following a report of 
an exposure incident, the employer shall make immediately available 
to the exposed employee a confidential medical evaluation and 
follow-up, including at least the following elements:
    (v) Counseling.

Addendum C

References

    General:
    Benenson AS (ed). Control of communicable diseases in man. 
Washington, D.C.: The American Public Health Association, 15th 
edition, 1990.
    For hepatitis B and human immunodeficiency virus:
    CDC. Guidelines for prevention of transmission of human 
immunodeficiency virus and hepatitis B virus to health-care and 
public-safety workers. MMWR 1989; 38 (supplement no. S-6).
    Occupational Safety and Health Administration. Occupational 
exposure to bloodborne pathogens: final rule. 29 CFR Part 1910.1030. 
Federal Register, December 6, 1991.
    For tuberculosis:
    American Thoracic Society/Centers for Disease Control. 
Diagnostic standards and classification of tuberculosis. Amer Rev 
Resp Dis 1009;142:725-35.
    American Thoracic Society/Centers for Disease Control. Control 
of tuberculosis. Amer Rev Resp Dis. 1983;128:336-342.

[FR Doc. 94-6492 Filed 3-18-94; 8:45 am]
BILLING CODE 4163-18-P