[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Proposed Rules]
[Pages 54160-54308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 97-27020]



[[Page 54159]]

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Part II





Department of Labor





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Occupational Safety and Health Administration



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29 CFR Part 1910



Occupational Exposure to Tuberculosis; Proposed Rule

Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / 
Proposed Rules

[[Page 54160]]


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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. H-371]
RIN 1218-AB46


Occupational Exposure to Tuberculosis

AGENCY: Occupational Safety and Health Administration (OSHA), Labor

ACTION: Proposed rule and notice of public hearing.

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SUMMARY: The Occupational Safety and Health Administration is proposing 
a health standard, to be promulgated under section 6(b) of the 
Occupational Safety and Health Act of 1970, 29 U.S.C. 655, to control 
occupational exposure to tuberculosis (TB). TB is a communicable, 
potentially lethal disease that afflicts the most vulnerable members of 
our society: the poor, the sick, the aged, and the homeless. As many as 
13 million U.S. adults are presently believed to be infected with TB; 
over time, more than 1 million of these individuals may develop active 
TB disease and transmit the infection to others. TB remains a major 
health problem with 22,813 active cases reported in the U.S. in 1995. A 
number of outbreaks of this disease have occurred among workers in 
health care settings, as well as other work settings, in recent years. 
To add to the seriousness of the problem, some of these outbreaks have 
involved the transmission of multidrug-resistant strains of 
Mycobacterium tuberculosis, which are often fatal. Although it is the 
responsibility of the U.S. Public Health Service to address the problem 
of tuberculosis in the general U.S. population, OSHA is solely 
responsible for protecting the health of workers exposed to TB as a 
result of their job.
    OSHA estimates that more than 5 million U.S. workers are exposed to 
TB in the course of their work: in hospitals, homeless shelters, 
nursing homes, and other work settings. Because active TB is endemic in 
many U.S. populations, including groups in both urban and rural areas, 
workers who come into contact with diseased individuals are at risk of 
contracting the disease themselves. The risk confronting these workers 
as a result of their contact with TB-infected individuals may be as 
high as 10 times the risk to the general population. Although the 
number of reported cases of active TB has slowly begun to decline after 
a resurgence between 1985-1992, 16 states reported an increase in the 
number of TB cases in 1995, compared with 1994. Based on a review of 
the data, OSHA has preliminarily concluded that workers in hospitals, 
nursing homes, hospices, correctional facilities, homeless shelters, 
and certain other work settings are at significant risk of incurring TB 
infection while caring for their patients and clients or performing 
certain procedures. To reduce this occupational risk, OSHA is proposing 
a standard that would require employers to protect TB-exposed employees 
by means of infection prevention and control measures that have been 
demonstrated to be highly effective in reducing or eliminating job-
related TB infections. These measures include the use of respirators 
when performing certain high hazard procedures on infectious 
individuals, procedures for the early identification and treatment of 
TB infection, isolation of individuals with infectious TB in rooms 
designed to protect those in the vicinity of the room from contact with 
the microorganisms causing TB, and medical follow-up for occupationally 
exposed workers who become infected. OSHA has preliminarily determined 
that the engineering, work practice, and administrative controls, 
respiratory protection, training, medical surveillance, and other 
provisions of the proposed standard are technologically and 
economically feasible for facilities in all affected industries.

DATES: Written comments on the proposed standard must be postmarked on 
or before December 16, 1997 and notices of intention to appear at the 
informal rulemaking hearings must be postmarked on or before December 
16, 1997.
    Parties requesting more than 10 minutes for their presentation at 
the hearings and parties submitting documentary evidence at the hearing 
must submit the full text of their testimony and all documentary 
evidence no later than December 31, 1997.
    The informal public hearings will begin at 10:00 a.m. on the first 
day of hearing and at 9:00 a.m. on each succeeding day. The informal 
public hearings will be held in Washington, D.C. and are scheduled to 
begin on February 3, 1998.

ADDRESSES: Hearings will be held in the Auditorium of the U.S. 
Department of Labor (Frances Perkins Building), 200 Constitution 
Avenue, NW, Washington, D.C. Subsequent additional informal public 
hearings will be held in other U.S. locations. A Federal Register 
notice will be issued upon determination of the locations and dates of 
these hearings.
    Comments on the proposed standard, Notices of Intention to Appear 
at the informal public hearings, testimony, and documentary evidence 
are to be submitted in quadruplicate to the Docket Officer, Docket No. 
H-371, Room N-2625, U.S. Department of Labor, 200 Constitution Ave., 
NW, Washington, DC 20210, telephone (202) 219-7894. Comments of 10 
pages or fewer may be transmitted by fax to (202) 219-5046, provided 
the original and three copies are sent to the Docket Officer 
thereafter. The hours of operation of the Docket Office are 10:00 a.m. 
until 4:00 p.m.
    Written comments, Notices of Intention to Appear at the informal 
rulemaking hearings, testimony, documentary evidence for the hearings, 
and all other material related to the development of this proposed 
standard will be available for inspection and copying in the Docket 
Office, Room N-2625, at the above address.

FOR FURTHER INFORMATION CONTACT: Bonnie Friedman, Office of Information 
and Consumer Affairs, Occupational Safety and Health Administration, 
Room N-3647, U.S. Department of Labor, 200 Constitution Ave., NW, 
Washington, DC 20210, Telephone (202) 219-8148, FAX (202) 219-5986.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. Pertinent Legal Authority
III. Events Leading to the Proposed Standard
IV. Health Effects
V. Preliminary Risk Assessment
VI. Significance of Risk
VII. Preliminary Economic and Regulatory Flexibility Analysis
VIII. Unfunded Mandates
IX. Environmental Impact
X. Summary and Explanation of the Proposed Standard
XI. Public Participation--Notice of Hearing
XII. Authority and Signature
XIII. The Proposed Standard

    References to the rulemaking record are in the text of the 
preamble. References are given as ``Ex.'' followed by a number to 
designate the reference in the docket. For example, ``Ex. 1'' means 
exhibit 1 in the Docket H-371. This document is a copy of the petition 
for a permanent standard filed by the Labor Coalition to Fight TB in 
the Workplace on August 25, 1993. A list of the exhibits and copies of 
the exhibits are available in the OSHA Docket Office.

[[Page 54161]]

I. Introduction

    The preamble to the Proposed Standard for Occupational Exposure to 
Tuberculosis discusses the events leading to the development of the 
proposed standard, the health effects of exposure to tuberculosis, and 
the degree and significance of the risk. An analysis of the 
technological and economic feasibility of the proposal and an 
explanation of the rationale supporting the specific provisions of the 
proposed standard are also included.
    Public comment on all matters discussed in this notice and all 
other relevant issues is requested for the purpose of assisting OSHA in 
the development of a new standard for occupational exposure to 
tuberculosis.

A. Issues

    OSHA requests comment on all relevant issues discussed in this 
preamble, including the health effects, risk assessment, significance 
of risk determination, technological and economic feasibility and 
requirements that should be included in the final standard. OSHA is 
especially interested in responses, supported by evidence and reasons, 
to the following questions. This list is provided to assist persons in 
formulating comments, but is not intended to be all inclusive or to 
indicate that participants need to respond to all issues or follow this 
format. Please give reasons for your answers and provide data when 
available.
    Specific issues of concern to OSHA are the following:
Health Effects
    1. What, if any, additional studies or case reports on TB should be 
included in the health effects analysis?
    2. Is there information that will provide data for estimating the 
rise in Multidrug-resistant TB (MDR-TB)? Is the rise in MDR-TB a 
serious threat?
Risk Assessment
    1. Are there alternative risk assessment methodologies available? 
What are they? Are there other studies available that would be useful 
for assessing risk?
    2. Are there factors other than or in addition to the ones OSHA has 
chosen that would be useful in estimating the background risk for TB?
Technological and Economic Feasibility
    1. Are OSHA's estimates of the numbers and types of workers 
currently exposed to M. tuberculosis reasonable? If not, please provide 
estimates of the number of workers currently at risk and the percentage 
of the total workforce these workers represent, by industry.
    2. Are OSHA's estimates of controlled access rates (i.e., the 
percentage of workers currently at risk who would remain at risk after 
employers minimize the number of workers exposed to individuals with 
suspected or confirmed infectious TB) reasonable? If the number of 
workers exposed to individuals with suspected or confirmed infectious 
TB is minimized, by what percentage could the number of workers at risk 
be reduced in each affected industry? In each industry, what are the 
job categories that would continue to be occupationally exposed?
    3. Are OSHA's estimates of the numbers of affected establishments 
reasonable? If not, please provide estimates of the number of affected 
establishments, by industry.
    4. Are OSHA's estimates of occupational and job turnover rates 
reasonable? If not, please provide estimates of turnover rates for each 
of the affected industries.
    5. Under what conditions would social work, social welfare 
services, teaching, law enforcement or legal services need to be 
provided to individuals identified as having suspected or confirmed 
infectious TB? What, if any, procedures could not be postponed until 
such individuals are determined to be noninfectious? How many workers 
in each of these categories may need to have contact with individuals 
with suspected or confirmed infectious TB under these conditions?
    6. Using the proposed definition of ``suspected infectious TB,'' 
how many individuals with suspected infectious TB are likely to be 
encountered for every confirmed infectious TB case in each of the 
covered industries?
    7. Are OSHA's estimates of the average number of suspected or 
confirmed infectious TB cases that would be transferred, per 
establishment in each industry, reasonable? If not, on average, how 
many TB cases per facility in each of the affected industries would be 
transferred?
    8. How are individuals with suspected infectious TB transferred to 
establishments with AFB isolation facilities? Who pays for the 
transport of such cases, particularly for individuals transferred from 
homeless shelters? OSHA solicits comment on the feasibility of 
temporary AFB isolation facilities in homeless shelters and on methods 
that could be used to temporarily isolate individuals with suspected or 
confirmed infectious TB in homeless shelters.
    9. Of the suspected infectious TB cases referred to hospitals from 
other facilities, how many are immediately ruled out without needing to 
be isolated?
    10. Are OSHA's estimates of the number of necessary AFB isolation 
rooms reasonable? Are existing AFB isolation rooms reasonably 
accessible to facilities that transfer individuals with suspected or 
confirmed infectious TB?
    11. What types of respirators are currently being used to protect 
workers against occupational exposure to M. tuberculosis?
    12. Which of the NIOSH-approved N95 respirators meet all of the 
proposed criteria, including fit testing and fit checking criteria?
    13. Are OSHA's estimates of respirator usage rates reasonable? For 
each of the covered industries, how often could respirators meeting the 
proposed requirements be reused and still maintain proper working 
condition? How often, on average, would respirators need to be 
replaced? Please specify the type of respirator.
    14. OSHA has assumed, in its Preliminary Economic Analysis, that 
hospitals will have licensed health care professionals on-site to 
perform the medical procedures that would be required by the proposed 
rule, and that in the other industries, employees will have to travel 
off-site to receive the medical procedures. Which of the other affected 
industries typically have licensed health care professionals on site 
who could perform the required medical procedures? If employers were 
allowed two weeks to provide the medical procedures, rather than being 
required to provide them prior to initial assignment to jobs with 
occupational exposure, will it be less likely that employees will have 
to travel off site to receive these tests/procedures? What would the 
costs be if employees travel off-site for these tests/procedures?
    15. Are OSHA's estimates of baseline compliance reasonable? If not, 
what types of controls are currently in place to protect workers 
against occupational exposure to M. tuberculosis, and what proportion 
of facilities in each of the affected industries currently are using 
such controls?
    16. For facilities that have implemented controls to protect 
workers against occupational exposure to M. tuberculosis, how effective 
have such controls been in reducing the transmission of TB?
    17. OSHA's Initial Regulatory Flexibility Analysis assesses the 
impacts of the proposed standard on small entities using the Small 
Business Administration's (SBA) size standards.

[[Page 54162]]

In addition, OSHA analyzed the impacts of the proposed standard on 
entities employing fewer than 20 workers. Are these definitions 
appropriate for the covered industries? If not, how should small 
entities be defined for each industry?
    18. The SBA defines small government jurisdictions as ``governments 
of cities, counties, towns, townships, villages, school districts, or 
special districts with populations of less than 50,000.'' OSHA requests 
comment on the number of such small government jurisdictions.
    19. Some parties have suggested that OSHA should allow the use of 
the CDC guidelines as an alternative to the proposed rule. However, 
OSHA believes that the CDC guidelines are not written in a regulatory 
format that would allow OSHA's Compliance Safety and Health Officers 
(CSHOs) to determine whether or not an employer is in compliance with 
the Guidelines. Others have suggested that OSHA could judge compliance 
with the guidelines by determining the number or rate of skin test 
conversions at the employer's facility. OSHA does not believe that 
smaller facilities have an adequate population for trends in test 
conversions to have any statistical validity. OSHA welcomes suggestions 
on any methods of making the CDC guidelines an enforceable alternative 
to an OSHA regulation or methods of measuring performance that could be 
applied across all types and sizes of facilities.
    20. Because of the limited availability of data, OSHA characterized 
the risk in many sectors as similar to that in hospitals, and less than 
that documented in nursing homes and home health care. OSHA welcomes 
industry-specific data on test conversion rates or active case rates.
    21. OSHA is unable to determine the effectiveness of specific 
elements of an effective infection control program in hospitals. OSHA 
welcomes any evidence on the relative effectiveness of individual 
elements in such programs, such as the identification and isolation of 
suspect cases, the use of engineering controls, the use of respirators, 
and employee training.
    22. OSHA based its estimate of the effectiveness of infection 
control programs in other sectors on studies of the effectiveness of 
such programs in hospitals. OSHA welcomes any data concerning the 
effectiveness of OSHA's proposed infection prevention measures, or of 
other alternative infection control measures, in sectors other than 
hospitals.
    23. SBREFA Panel members suggested a number of alternative 
approaches to the regulation. OSHA believes that it has at least 
partially adopted a number of these approaches. OSHA welcomes comments 
and suggestions on these approaches and the extent to which OSHA should 
further adopt them:
      Cooperative initiatives, such as expanding OSHA's current 
cooperative initiative with JCAHO;
      A federal-state government public health partnership to 
develop guidelines in various industry sectors;
      Performance standards developed with the assistance of 
federal, state, and local government, and labor and industry 
stakeholders;
      Separate approaches for the health and non-health 
industries (the approach for the health industries could be keyed to 
existing industry standards and that for non-health industries to 
guidelines);
      Different levels of compliance requirements for different 
industries, depending on their expertise, resources, and risk;
      Less stringent trigger mechanisms for the more burdensome 
portions of the standard; and
      Separate standards for each affected industry.
    24. OSHA is proposing to include homeless shelters in the Scope of 
the standard. During the informal public hearings, OSHA intends to 
schedule a special session for participants to present additional 
information on homeless shelters. Also, OSHA is conducting a special 
study of the homeless shelter sector. The information gathered in the 
study will be placed in the docket for public comment. OSHA welcomes 
comment on any of the topics this study will cover including:
      Percentage of homeless persons that would meet OSHA's 
definition of a suspected infectious TB case (A breakdown of which 
symptoms are particularly common will help OSHA construct the best 
definition);
      Turnover among the homeless who use shelters;
      Employee turnover in homeless shelters;
      Trends in the number of homeless persons served in 
shelters.
      Criteria currently used by some homeless shelters to 
identify suspected infectious TB cases;
      Current practices used in homeless shelters to address TB 
hazards so that baseline compliance with the proposed standard can be 
determined. Of particular concern to OSHA are:

--Methods of isolation; and
--How suspected TB cases are handled.

      Feasibility of hospitals providing cards to the homeless 
indicating TB skin test status;
      Number of TB skin test conversions and active cases among 
the homeless and homeless shelter employees;
      Types of benefits offered to homeless shelter employees 
(e.g., health insurance);
      Economic feasibility:

--Costs of running a shelter;
--Revenue sources;
--How costs are accommodated as the number of homeless persons served 
increases; and
--Opportunities for cost pass-through;

      Number, location and types (e.g., family-oriented, walk-
in, all-male) of homeless shelters;
      Number or proportion of homeless shelter workers who are 
unpaid volunteers; and
      The OSH Act applies to employees, not bona fide 
volunteers. However, OSHA understands that some states may, as a matter 
of law, require facilities to provide volunteers with protections 
established by OSHA standards. OSHA is seeking information on:

--Economic impacts in such states of covering volunteers (e.g., how 
costs would be handled, cost pass-through); and
--Protections currently offered to volunteers.

    25. In what states, if any, do employers provide volunteers in the 
sectors affected by this proposed standard with the same protections as 
they provide to employees? How many volunteers might be affected by 
such requirements?
    26. OSHA is concerned that medical removal protection and medical 
treatment of active cases of TB may have significant economic impacts 
on small firms that have an employee with an active case of TB. Is 
there any form of insurance available for covering the costs of medical 
removal protection or medical treatments required by the OSHA standard? 
Should OSHA consider phasing-in these provisions of the standard?
    27. OSHA believes that substance abuse treatment centers, 
particularly in-patient treatment centers, normally have entry 
procedures that may include medical examinations. OSHA solicits 
comments on entry procedures for substance abuse treatment programs, 
the extent to which these entry procedures now include medical 
examinations, and the extent to which these examinations now include 
and examination for TB symptoms.
    28. OSHA requests comment on the effects of extended compliance 
phase-in dates for the proposed requirements,

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particularly for respirators, for small businesses and facilities 
relying on charitable and/or Medicare and Medicaid funding.
    29. OSHA requests comment on all assumptions and estimates used in 
developing the Preliminary Economic Analysis. Please provide reasons 
and data to support suggested changes to the assumptions and estimates.
    30. The World Health Organization (WHO) has launched an initiative 
to reduce active TB through the use of multi-drug therapy and using 
directly observed therapy. OSHA solicits comment on whether it should 
revise its risk assessment or any of its benefits estimates as a result 
of this initiative.
    31. OSHA requests comment on the number of affected facilities that 
are tribally-operated, by industry.
General
    1. A number of provisions in the proposed standard are triggered by 
the identification of an individual as having either ``suspected 
infectious tuberculosis'' or ``confirmed infectious tuberculosis.'' Of 
these provisions, are there some that should be triggered only once an 
individual has been identified as having ``confirmed infectious 
tuberculosis?'' If so, which provisions and why?
    2. A number of the proposed standard's provisions require 
compliance or performance on an annual basis, e.g., reviews of the 
exposure control plan, the biosafety manual for laboratories, and the 
respiratory protection program; certification of biological safety 
cabinets; fit testing or a determination of the need for fit testing of 
respirators; medical histories, TB skin tests; and training. In 
addition, certain requirements must be performed on a semi-annual 
basis, e.g., inspection and performance monitoring of engineering 
controls, verification of air flow direction in laboratories, and, in 
some instances, TB skin testing. How can OSHA reduce the aggregate 
burden of these requirements, particularly in small entities, while 
still providing equal protection to employees? Of these annual and 
semi-annual provisions, which, if any, should be performed less 
frequently? Why and at what frequency? Which of these provisions, if 
any, should be performed more frequently? Why and at what frequency?
Scope
    1. Is there information demonstrating risk of TB transmission for 
employees in work settings other than those included in the scope? 
Should OSHA, for example, expand the scope of this standard to cover 
all or some offices of general practitioners or dentists and if so, 
how? Should OSHA expand the scope to cover all teachers?
    2. Are there provisions of the standard with which emergency 
medical services, home health care, and home-based hospice care 
employers cannot comply because their employees are at temporary work 
settings over which the employer has little or no control? If so, what 
are those provisions and why would an employer be unable to comply with 
them?
    3. In covering only long-term care facilities for the elderly, is 
OSHA excluding similar facilities where there is increased risk of 
transmission of TB? If so, what are these facilities? Should OSHA 
include long-term care populations in addition to the elderly, such as 
long-term psychiatric care facilities? If so, what are these 
populations?
    4. OSHA is proposing that employers provide medical management and 
follow-up for their employees who work in covered work settings, but 
who are not occupationally exposed, when they have an exposure incident 
resulting from an engineering control failure or similar workplace 
exposure. Is this the best way of assuring such employees receive 
medical management and follow-up?
    5. OSHA is covering employees who have occupational exposure in 
covered work settings yet are not employees of the work setting (e.g., 
physician employed by another employer with hospital privileges, who is 
caring for a TB patient in the hospital). Can this be made more clear?
    6. OSHA has proposed that facilities offering treatment for drug 
abuse be covered in the scope of the standard. Is coverage of such 
facilities appropriate? What factors unique to facilities that offer 
treatment for drug abuse would make compliance with the provisions of 
this proposed standard infeasible (e.g., would complying with certain 
provisions of the standard compromise the provision of services at 
facilities that offer treatment for drug abuse)?
Application
    1. OSHA has proposed that an employer covered under the standard 
(other than an operator of a laboratory) may claim reduced 
responsibilities if he or she can demonstrate that his or her facility 
or work setting: (1) Does not admit or provide medical services to 
individuals with suspected or confirmed infectious TB; (2) has had no 
case of confirmed infectious TB in the past 12 months; and (3) is 
located in a county that, in the past 2 years, has had 0 cases of 
confirmed infectious TB reported in one year and fewer than 6 cases of 
confirmed infectious TB reported in the other year. Are there 
alternative methods that can be used to assure protection of employees 
in areas where infectious TB has not recently been encountered?
Exposure Control Plan
    1. OSHA has proposed that the employer's exposure control plan 
contain certain policies and procedures. What, if any, policies and 
procedures should be added to the plan?
    2. The proposed standard requires exposure incidents and skin 
conversions to be investigated, but does not require aggregate data 
regarding employee conversions to be collected and analyzed. Would the 
collection and analysis of aggregate data provide benefits beyond those 
provided by investigating each individual exposure incident or 
conversion? Why or why not? If aggregate data collection and analysis 
were required, what type of analysis should be required, at what 
analytical endpoint should employer action be required, and what should 
that action be?
    3. OSHA has set forth the extent of responsibility for transfer of 
individuals based upon the type of work setting where such individuals 
are encountered. What are current practices regarding transfer of 
individuals with suspected or confirmed infectious TB in the work 
settings covered by the proposal?
Work Practices and Engineering Controls
    1. Is OSHA's time limit of 5 hours following identification for 
transferring an individual with suspected or confirmed infectious TB to 
another facility or placing the individual into AFB isolation 
appropriate? If not, what is the maximum amount of time that an 
individual should be permitted to await transfer or isolation in a 
facility before the employer must implement the other provisions of the 
proposed standard?
    2. OSHA has considered requiring facilities that encounter 6 or 
more individuals with confirmed infectious TB within the past 12 months 
to provide engineering controls in intake areas where early 
identification procedures are performed (e.g., emergency departments, 
admitting areas). Should this be a requirement? Are there types of 
controls, engineering or otherwise, that would be effective in 
controlling transmission in intake areas? Would the trigger of 6 
individuals with confirmed infectious TB be appropriate?

[[Page 54164]]

    3. Are there methods other than smoke trail testing and continuous 
monitors that would be effective for verifying negative pressure in AFB 
isolation rooms or areas?
    4. OSHA is requiring engineering controls to be inspected and 
performance monitored every 6 months. Is this frequency appropriate?
    5. OSHA is allowing exhaust air from AFB isolation rooms or areas 
where M. tuberculosis may be aerosolized that cannot feasibly be 
discharged directly outside to be HEPA-filtered and recirculated back 
into general ventilation. Is permitting such recirculation appropriate? 
If used, should there be any requirements to detect system failure?
    6. OSHA is permitting stand-alone HEPA filter units to be used as a 
primary control measure. Is this appropriate? What, if any, methods 
other than ventilation and filtration can provide consistent 
protection?
    7. Should ambulances that have carried an individual with suspected 
or confirmed infectious TB be required to be ventilated for a specific 
period of time or in a particular way before allowing employees to 
enter without a respirator? What engineering controls are available for 
ambulances?
Laboratories
    1. The standard does not require labeling of laboratory specimens. 
Should OSHA require that laboratory specimens be labeled within the 
facility or when specimens are being shipped? If so, what should the 
label contain? Are there other agencies that require these specimens be 
labeled? What are these agencies and what is required?
    2. OSHA has attempted to incorporate the CDC/NIH recommendations 
given in ``Biosafety in Microbiological and Biomedical Laboratories'' 
into the standard. Do any provisions need to be added in order for 
employees in clinical and research laboratories to be fully protected 
against exposures to M. tuberculosis?
Respirators
    1. OSHA is requiring employees who are transporting an unmasked 
individual with suspected or confirmed infectious TB within a facility 
to wear a respirator. Is this appropriate? How often would an 
individual with suspected or confirmed infectious TB be transported 
unmasked through a facility? Under what circumstances would it be 
infeasible to mask such an individual? What other precautions should be 
taken when transporting such an individual who is not masked?
    2. OSHA is requiring that maintenance personnel use respiratory 
protection during maintenance of air systems or equipment that may 
reasonably be anticipated to contain aerosolized M. tuberculosis. When 
would it be necessary to access such an air system at the time it was 
carrying air that may contain aerosolized M. tuberculosis? Should OSHA 
require that such air systems be purged and shut down whenever these 
systems are accessed for maintenance or other procedures?
    3. OSHA has received information that the use of certain kinds of 
respirators in helicopters providing emergency medical services may 
hamper pilot communication. Have other air ambulance services 
encountered this problem? Does this problem exist when the employee is 
using a type N95 respirator or other types of respiratory protection 
such as powered air purifying respirators? What other infection control 
or industrial hygiene practices could be implemented to minimize 
employee exposure in these circumstances?
    4. The CDC states that there may be selected settings and 
circumstances (e.g., bronchoscopy on an individual with suspected or 
confirmed infectious TB or an autopsy on a deceased individual 
suspected of having had active TB at the time of death) where the risk 
of transmission may be such that increased respiratory protection such 
as that provided by a more protective negative-pressure respirator or a 
powered air purifying respirator may be necessary. Are there 
circumstances where OSHA should require use of a respirator that is 
more protective than a type N95 respirator? If so, what are the 
circumstances and what type of respiratory protection should be 
required?
    5. OSHA is proposing that respirators be fit-tested annually, which 
is consistent with general industrial hygiene practice, or, in lieu of 
an annual fit test, that employees have their need to receive the 
annual fit test be evaluated by the physician or other licensed health 
care professional, as appropriate. For the circumstances and conditions 
regulated by this standard, will the evaluation provide enough ongoing 
information about the fit of a respirator to be an adequate substitute 
for fit testing? Should OSHA require that an actual fit test be 
performed periodically? If so, at what frequency?
    6. OSHA has not included any provisions regarding the use of 
supplied air respirators. Are there circumstances in which supplied air 
respirators would be used to protect against M. tuberculosis? Should 
OSHA include provisions addressing supplied air respirators in the 
standard?
    7. OSHA is permitting the reuse of disposable respirators provided 
the respirator does not exhibit excessive resistance, physical damage, 
or any other condition that renders it unsuitable for use. Will the 
respirators continue to protect employees throughout the reuse period?
    8. In the proposed standard for TB, OSHA has included separate 
provisions for all aspects of a respiratory protection program for 
tuberculosis. What other elements might need to be included? Which 
respiratory protection provisions, if any, are not appropriate for 
protection against TB? Please provide reasons and data to support 
inclusion or exclusion of particular provisions.
Medical Surveillance
    1. Should any provisions be added to the Medical Surveillance 
program?
    2. OSHA has not required that physical exams be included as part of 
the baseline evaluation. Is there information that is essential to 
medical surveillance for TB that can only be learned from a baseline 
physical exam?
    3. OSHA is specifying tuberculin skin testing frequencies for 
employees with negative skin tests. Should tuberculin skin testing be 
administered more or less frequently? Are there other ways to determine 
the frequency of tuberculin skin testing?
    4. OSHA is proposing that employees entering AFB isolation rooms or 
areas be skin tested every 6 months. However, employees providing home 
health care, home care, and home-based hospice care are to be skin 
tested annually. Employees entering the home of an individual who has 
suspected or confirmed infectious TB may have the same potential for 
exposure to aerosolized M. tuberculosis as employees who enter an 
isolation room. In light of this, should employees providing care to 
individuals with suspected or confirmed infectious TB in private homes 
be skin tested every 6 months?
    5. OSHA is requiring that all tuberculin skin testing be 
administered, read, and interpreted by or under the supervision of a 
physician or other licensed health care professional, as appropriate, 
according to current CDC recommendations. Should OSHA require specific 
training for individuals who are administering, reading, and 
interpreting tuberculin skin tests? If so, what type of training should 
be required?

[[Page 54165]]

    6. Should OSHA require a declination form for employees who do not 
wish to undergo tuberculin skin testing?
    7. OSHA is including Medical Removal Protection (MRP) provisions 
for employees who are unable to wear respiratory protection or who 
contract infectious tuberculosis. Are there additional provisions that 
need to be included? What remedies are available to employees in states 
where worker compensation system do not consider occupational TB a 
compensable disease? What benefits are provided to workers who are 
unable to wear a respirator?
    8. OSHA is requiring that employees who must wear a respirator be 
provided a face-to-face determination of their ability to wear the 
respirator. Does this determination need to be made through a medical 
evaluation or would the use of an appropriately designed questionnaire 
be adequate? What would be the advantages and disadvantages of relying 
on a questionnaire to make this determination? Are there sample 
questionnaires that have proven to be effective for determining an 
employee's ability to wear a respirator?
    9. OSHA has drafted Medical Surveillance, paragraph (g), to explain 
first who must be provided with the protections listed in the paragraph 
and how the surveillance is to be administered and secondly, in 
paragraphs (g)(2), Explanation of Terms, and (g)(3), Application, how 
the general medical terms are to be construed to meet the standard and 
in what instances the medical examinations or tests are to be offered. 
The Agency realizes that there is some repetition in these paragraphs 
and seeks comment on whether there might be a better way to list the 
requirements.
Communication of Hazards and Training
    1. OSHA is requiring that signs for isolation rooms and areas bear 
a ``STOP'' Sign and the legend ``No Admittance Without Wearing A Type 
N95 or More Protective Respirator.'' Is there another sign that would 
assure patient confidentiality while providing adequate notification of 
the hazard and the necessary steps to minimize the hazard for employees 
who may be inadvertently exposed?
    2. OSHA is requiring that ducts be labeled ``Contaminated Air--
Respiratory Protection Required.'' Should OSHA require that duct labels 
also include the ``STOP'' sign?
    3. Is the labeling of ducts carrying air that may contain 
aerosolized M. tuberculosis (e.g., from isolation rooms and areas, 
labs) at all access points feasible? What, if any, equally protective 
alternative exists to permanent labeling in situations where an exhaust 
duct from a room may or may not be carrying air containing aerosolized 
M. tuberculosis (e.g., the exhaust duct would only be carrying 
aerosolized M. tuberculosis when an individual with infectious TB is 
being isolated in the room)?
Dates
    1. OSHA has proposed that very small businesses with fewer than 20 
employees be given an additional 3 months to comply with the standard's 
engineering control provisions (i.e., the start-up date for engineering 
controls for small businesses would be 270 days from the Effective Date 
of the standard). Are there other requirements of the proposed standard 
(e.g., respiratory protection) for which very small businesses should 
be given additional time to come into compliance? If so, for which 
provisions would they need additional time and why? Are 20 employees an 
appropriate cut-off for this purpose? Are there other employers that 
may need extended time to achieve compliance?
Definitions
    1. A number of provisions in the standard are triggered by the 
identification of an individual as having ``suspected infectious 
tuberculosis.'' Under the definition of ``suspected infectious 
tuberculosis'', OSHA has proposed criteria that the Agency believes are 
the minimum indicators that, when satisfied by an individual, require 
an employer to consider that the individual may have infectious 
tuberculosis. Are there other criteria that should be included in this 
definition?
    2. Coverage of an employee under the standard is based upon the 
definition of ``occupational exposure.'' Similar to OSHA's Bloodborne 
Pathogens standard, occupational exposure is dependent upon reasonable 
anticipation of contact with an individual with suspected or confirmed 
infectious tuberculosis or with air that may contain aerosolized M. 
tuberculosis. Are there additions that could be made to this definition 
that would help employers determine which of their employees are 
occupationally exposed?
    3. OSHA has proposed requirements for research laboratories that 
differ from those of clinical laboratories. The standard includes 
definitions of ``research laboratory'' and ``clinical laboratory'' to 
assist the employer in differentiating between these two types of 
laboratory. Do the definitions clearly differentiate between these two 
types of laboratories? Should such a distinction be made? Are there any 
modifications that should be made to these definitions?

B. Information Collection Requirements

    This proposed Tuberculosis standard contains collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA'95), 44 
U.S.C. 3501 et seq. and the regulation at 5 CFR Sec. 1320. PRA'95 
defines collection of information to mean, ``the obtaining, causing to 
be obtained, soliciting, or requiring the disclosure to third parties 
or the public of facts or opinions by or for an agency regardless of 
form or format.'' [44 U.S.C. Sec. 3502(3)(A)].
    The title, description of the need for and proposed use of the 
information, summary of the collections of information, description of 
the respondents, and frequency of response of the information 
collection are described below with an estimate of the annual cost and 
reporting burden, as required by 5 CFR Sec. 1320.5(a)(1)(iv) and 
Sec. 1320.8(d)(2). Included in the estimate is the time for reviewing 
instructions, gathering and maintaining the data needed, and completing 
and reviewing the collection of information.
    OSHA invites comments on whether the proposed collection of 
information:
    (1) Ensures that the collection of information is necessary for the 
proper performance of the functions of the agency, including whether 
the information will have practical utility;
    (2) Estimates the projected burden accurately, including whether 
the methodology and assumptions used are valid;
    (3) Enhances the quality, utility, and clarity of the information 
to be collected; and
    (4) Minimizes the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    Title: Tuberculosis 29 CFR 1910.1035.
    Description: The proposed Tuberculosis (TB) Standard is an 
occupational safety and health standard that will prevent or minimize 
occupational exposure to TB. The standard's information collection 
requirements are essential components that will protect employees from 
occupational exposure. The information will be used by employers and 
employees to implement the protection

[[Page 54166]]

required by the standard. OSHA compliance officers will use some of the 
information in their enforcement of the standard.
    Respondents: The respondents are employers whose employees may have 
occupational exposure in the following settings: hospitals; long-term 
care facilities for the elderly; correctional facilities and other 
facilities that house inmates or detainees; hospices; shelters for the 
homeless; facilities that offer treatment for drug abuse; facilities 
where high hazard procedures are performed; and laboratories that 
handle specimens that may contain M. tuberculosis or process or 
maintain the resulting cultures, or perform related activity that may 
result in the aerosolization of M. tuberculosis.
    Also, occupational exposure occurring during the provision of 
social work, social welfare services, teaching, law enforcement or 
legal services would be covered if the services are provided in the 
work settings previously mentioned, or in residences, to individuals 
who are in AFB isolation or are segregated or otherwise confined due to 
having suspected or confirmed infectious TB. Respondents also include 
employers whose employees are occupationally exposed during the 
provision of emergency medical services, home health care and home-
based hospice care. Approximately 101,875 employers will be responding 
to the standard.
    Total Estimated Cost: First year $62,972,210; Recurring years 
$53,691,915.

                                    Summary of the Collection of Information                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                        Total   
      Information collection        Number of     Frequency of response        Average time per         burden  
           requirement              responses                                     response\1\          (hours)  
----------------------------------------------------------------------------------------------------------------
Exposure Control Plan:                                                                                          
    (c)(2)(i)....................      101,875  All Affected Employers to   24 hours per         906,980
                                                 Develop Plan.              Hospital.                           
                                                                            8 hours per                 
                                                                            Facility for all Other              
                                                                            Industries                          
    (c)(2)(vii)(B)...............      101,875  Annual Reviews and          8 hours per          238,243
                                                 Updates for All Affected   Hospital.                           
                                                 Employers.                 2 hours per                 
                                                                            Facility for all Other              
                                                                            Industries                          
Respiratory Protection:                                                                                         
    (f)(2).......................       82,138  All Employers not           8 hours per          335,323
                                                 Qualified for Appendix A   Hospital.                           
                                                 Program to Develop         4 hours per                 
                                                 Program.                   Facility for all Other              
                                                                            Industries                          
    (f)(5), Appendix B...........    2,207,580  Initially, for all          30 minutes per       551,962
                                                 employees assigned         employee.                           
                                                 respirators.                                                   
                                        22,078  Annual refit tests for 1%   30 minutes per         5,520
                                                 of population assigned     employee.                           
                                                 respirators.                                                   
    (f)(8).......................       82,138  Annual Evaluation of        2 hours per           83,831
                                                 Program for All Affected   Hospital.                           
                                                 Employers not Qualified    1 hour per                  
                                                 for Appendix A Program.    Facility for all Other              
                                                                            Industries                          
Medical Surveillance:                                                                                           
     Medical History         1,831,724  Initially for All           1 hour per         1,831,724
     (g)(3)(i)(A).                               Affected Employees.        Hospital Employee (inc.             
                                                                            LHCP time).                         
                                                                            1 hour per                  
                                                                            Employee in all Other               
                                                                            Industries (inc. travel             
                                                                            time)                               
                                     1,595,432  Annually for All Affected   1 hour per         1,595,432
                                                 Employees in Facilities    Hospital Employee (inc.             
                                                 not Qualified for          LHCP time).                         
                                                 Appendix A.                1 hour per                  
                                                                            Employee in all Other               
                                                                            Industries (inc. travel             
                                                                            time)                               
                                        47,953  Initially, for New          1 hour per            47,953
                                                 Employees.                 Hospital Employee (inc.             
                                                                            LHCP time).                         
                                                                            1 hour per                  
                                                                            Employee in all Other               
                                                                            Industries (inc. travel             
                                                                            time)                               
     Medical Examination        47,863  Annually, 3% of             2 hours per           72,518
     (inc. History and Physical)                 Controlled Population at   Hospital Employee in                
     (g)(3)(i) (B)-(D).                          Risk estimated to          Facilities not                      
                                                 request exam as a result   Qualified for Appendix              
                                                 of having signs or         A (inc. LHCP time).                 
                                                 symptoms of TB; have a     1\1/2\ hour per             
                                                 TST conversion; or         Employee in All Other               
                                                 indicated as a result of   Industries (inc. travel             
                                                 an exposure incident.      time)                               
     Tuberculin Skin                                                                                    
     Tests                                                                                                      
        Initial 2-Step TST             474,627  Initially, for Entire       1\1/2\ hours       1,026,377
         (g)(3)(i)(A).                           Controlled Population at   per Hospital Employee               
                                                 Risk.                      (inc. LHCP time).                   
                                                                            2\1/4\ hour per             
                                                                            Employee in All Other               
                                                                            Industries (inc. travel             
                                                                            time)                               
        Exposure Incident                8,268  Annually, 2% of             1\1/2\ hours          17,879
         (g)(3)(i)(C).                           Controlled Population at   per Hospital Employee               
                                                 Risk in Facilities         (inc. LHCP time).                   
                                                 Qualified for Appendix A.  2\1/4\ hour per             
                                                                            Employee in All Other               
                                                                            Industries (inc. travel             
                                                                            time)                               
        Pre-Exit (g)(3)(i)(E)....       76,257  Annually for Employment     1 hour for each      110,504
                                                 Turnover.                  Hospital Employee (inc.             
                                                                            LHCP time).                         
                                                                            1\1/2\ hour per             
                                                                            Employee in All Other               
                                                                            Industries (inc. travel             
                                                                            time)                               
        Prior to Initial                76,257  All New Employees with      1\1/2\ hour per      165,756
         Assignment.                             Occupational Exposure.     Hospital Employee (inc.             
                                                                            LHCP time).                         

[[Page 54167]]

                                                                                                                
        Annual (g)(3)(ii)(A).....      413,400  All employees in            \1/2\ hour per       297,991
                                                 facilities not qualified   Hospital Employee (inc.             
                                                 for Appendix A.            LHCP time).                         
                                                                            45 minutes per              
                                                                            Employee in all Other               
                                                                            Industries (inc. travel             
                                                                            time)                               
        Additional 6-month TST         131,367  All employees who:          1 hour per           171,314
         (g)(3)(iii).                            Enter an AFB       Hospital Employee (inc.             
                                                 isolation room or area     LHCP time).                         
                                                 Perform or are     1\1/2\ hour for             
                                                 present during the         each Employee in All                
                                                 performance of high-       Other Industries (inc.              
                                                 hazard procedures          travel time)                        
                                                 Transport or are                                       
                                                 present during the                                             
                                                 transport of an                                                
                                                 individual with                                                
                                                 suspected or confirmed                                         
                                                 infectious TB in an                                            
                                                 enclosed vehicle                                               
                                                 Work in an                                             
                                                 intake area in                                                 
                                                 facilities where 6 or                                          
                                                 more confirmed TB cases                                        
                                                 have been encountered in                                       
                                                 the past 12 mos                                                
     Information Provided    1,965,967  Information for each        10 minutes per       327,661
     to Licenced Health Care                     affected establishment     employee.                           
     Professional (LHCP)                         to provide a copy of the                                       
     (g)(6)(I).                                  rule, and for                                                  
                                                 information on each                                            
                                                 employee with a                                                
                                                 respirator.                                                    
                                       558,549  Information for each new    10 minutes per        93,091
                                                 employee assigned a        employee.                           
                                                 respirator.                                                    
                                        64,692  Information surrounding     10 minutes per        10,782
                                                 exposure incidents (2%     employee.                           
                                                 of controlled population                                       
                                                 at risk).                                                      
     LHCP Written Opinion    2,745,188  Initially, for each         5 minutes per        228,766
     (g)(7).                                     medical procedure          written opinion.                    
                                                 performed.                                                     
                                     2,034,269  Annually, for each          5 minutes per        169,522
                                                 medical procedure          written opinion.                    
                                                 performed.                                                     
Training:                                                                                                       
    (h)(3)(ii)(B)................      202,066  Number of training          2 hours for          237,829
                                                 sessions in first year.    employees required to               
                                                                            wear respirators.                   
                                                                            1 hour for                  
                                                                            employees with                      
                                                                            occupational exposure               
                                                                            who are not assigned                
                                                                            respirators                         
                                                                            Assumes 20                  
                                                                            employees per session               
    (h)(3)(ii)(A)................      106,258  Number of training          For new               50,193
                                                 sessions for new           employees:.                         
                                                 employees entering        2 hours for employees                
                                                 affected occupations for   required to wear                    
                                                 the first time + number    respirators                         
                                                 of training sessions for  1 hour for employees                 
                                                 employees staying in       with occupational                   
                                                 affected occupations,      exposure who are not                
                                                 but starting new jobs.     assigned respirators                
                                                                           \1/2\ hours for                      
                                                                            employees required to               
                                                                            wear respirators                    
                                                                           15 minutes for employees             
                                                                            with occupational                   
                                                                            exposure who are not                
                                                                            assigned respirators                
    (h)(3)(ii)(C)................      154,966  Recurring number of         For 25% of            57,313
                                                 training sessions.         exposed employees                   
                                                                            unable to demonstrate               
                                                                            competence:.                        
                                                                           1 hour for employees                 
                                                                            required to wear                    
                                                                            respirators                         
                                                                           \1/2\ hour for employees             
                                                                            with occupational                   
                                                                            exposure who are not                
                                                                            assigned respirators                
                                                                            For 75% of                  
                                                                            exposed employees able              
                                                                            to demonstrate                      
                                                                            competence                          
                                                                            Assumes 20                  
                                                                            employees per session               
Recordkeeping:                                                                                                  
    Medical (I)(1)(I)............    3,713,645  Initially, to create a      10 minutes to        631,320
                                                 medical record for each    set up each record.                 
                                                 affected employee.                                             
                                     1,358,800  Create medical records      10 minutes to        230,996
                                                 for each new employee      set up each record.                 
                                                 with occupational                                              
                                                 exposure.                                                      
                                     2,447,669  Annually, for each          5 minutes to         195,814
                                                 medical procedure          update each record.                 
                                                 performed.                                                     

[[Page 54168]]

                                                                                                                
    Training (I)(3)(I)...........      264,451  Initially, to create        10 minutes to         44,957
                                                 records for each           create each training                
                                                 training session.          record.                             
                                       217,351  Annually, to reflect        10 minutes to         36,950
                                                 recurring training         create each training                
                                                 sessions and initial       record.                             
                                                 training for new                                               
                                                 employees.                                                     
    Engineering controls                24,761  Annually, for each          5 minutes per          3,962
     (I)(4)(I).                                  engineering control.       record.                             
    Availability (I)(5)..........        2,037  Annually, for 2% of         5 minutes per            163
                                                 affected employers.        employer.                           
    Transfer to NIOSH............            1  Annually, for estimated 1   1 hour per                 1
                                                 employer per year to       employer.                           
                                                 transfer records.                                              
                                  -------------                                                     ------------
        Totals...................                                                                               
             First-Year..  ...........  .........................  ........................    7,098,011
             Recurring...  ...........  .........................  ........................   3,655,728 
----------------------------------------------------------------------------------------------------------------
\1\ Estimates represent average burden hours per response. The actual burden hours per response will vary       
  depending on factors such as the size of the facility, current practices at the facility, and whether the     
  facility transfers or admits individuals with suspected or confirmed infectious TB.                           
Note: Estimates take into account baseline compliance with the proposed requirements.                           

    The Agency has submitted a copy of the information collection 
request to OMB for its review and approval. Interested parties are 
requested to send comments regarding this information collection to the 
Office of Information and Regulatory Affairs, Attn. OSHA Desk Officer, 
OMB New Executive Office Building, 725 17th Street NW, Room 10235, 
Washington DC 20503.
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
approval of the final information collection request: they will also 
become a matter of public record.
    Copies of the referenced information collection request are 
available for inspection and copying in the OSHA Docket Office and will 
be mailed immediately to any person who request copies by telephoning 
Todd Owen at (202) 219-7075. For electronic copies of the Tuberculosis 
information collection request, contact the Labor News Bulletin Board 
(202) 219-4784, or OSHA web page on the Internet at http://
www.osha.gov/. Copies of the information collection requests are also 
available at the OMB docket office.

C. Federalism

    This standard has been reviewed in accordance with Executive Order 
12612, 52 FR 41685 (October 30, 1987), regarding Federalism. This Order 
requires that agencies, to the extent possible, refrain from limiting 
State policy options, consult with States prior to taking any actions 
that would restrict State policy options, and take such actions only 
when there is clear constitutional authority and the presence of a 
problem of national scope. The Order provides for preemption of State 
law only if there is a clear Congressional intent for the Agency to do 
so. Any such preemption is to be limited to the extent possible.
    Throughout the development of this proposed standard, OSHA has 
sought and received assistance from state representatives. 
Representatives of state departments of health and labor and industries 
have helped direct OSHA to pertinent information and studies on TB and 
have submitted drafts of state standards relevant to TB. In addition, 
representatives of state occupational safety and health departments 
participated in the review of the draft standard by OSHA field offices 
and in OSHA's TB Stakeholder meetings, where the requirements of the 
proposed standard were presented and information was collected from 
employers, employees, and their representatives on what was being done 
to prevent occupational exposure to TB in the various worksites and how 
an OSHA standard for TB could further reduce the exposures.
    Section 18 of the Occupational Safety and Health Act (OSH Act), 
expresses Congress' clear intent to preempt State laws with respect to 
which Federal OSHA has promulgated occupational safety or health 
standards. Under the OSH Act a State can avoid preemption only if it 
submits, and obtains Federal approval of, a plan for the development of 
such standards and their enforcement. Occupational safety and health 
standards developed by such State-Plan states must, among other things, 
be at least as effective in providing safe and healthful employment and 
places of employment as the Federal standards.
    The proposed tuberculosis standard is drafted so that employees in 
every State will be protected by general, performance-oriented 
standards. To the extent that there are State or regional 
peculiarities, States with occupational safety and health plans 
approved under Section 18 of the OSH Act would be able to develop their 
own State standards to deal with any special problems. Moreover, the 
performance nature of this standard, of and by itself, allows for 
flexibility by States and employers to provide as much safety as 
possible using varying methods consonant with conditions in each State.
    There is a clear national problem related to occupational safety 
and health for employees exposed to M. tuberculosis. Approximately 6.5% 
of the U.S. adult population is infected (i.e., carrying the 
tuberculosis bacillus, not manifesting active disease), and although 
the prevalence of TB infection and disease varies throughout the 
country, TB disease has been reported in every state. Political and 
geographic boundaries do not contain infection and disease spread. The 
U.S. population is mobile, moving freely from place to place for 
business and pleasure. Immigrants, a group whose members are known to 
have a high prevalence of TB, settle throughout the country. While 
there are counties that do not report cases in a given year, the 
counties change from year to year along with the number of cases 
reported. In addition, reports do not always reflect all the locations 
where exposure incidents can occur; infectious TB cases are often 
transferred from their site of diagnosis to a distant location for 
treatment and reported as a TB case only in the county

[[Page 54169]]

where treatment is administered. Finally, underreporting may occur 
because some individuals with infectious TB, in particular the homeless 
and clients of drug abuse facilities, do not avail themselves of 
further diagnosis and treatment. TB infection and disease is truly 
national in scope.
    Those States which have elected to participate under Section 18 of 
the OSH Act would not be preempted by this regulation and would be able 
to deal with special, local conditions within the framework provided by 
this performance-oriented standard while ensuring that their standards 
are at least as effective as the Federal standard.

D. State Plans

    The 23 States and 2 territories with their own OSHA-approved 
occupational safety and health plans must adopt a comparable standard 
within 6 months after the publication of a final standard for 
occupational exposure to tuberculosis or amend their existing standard 
if it is not ``at least as effective'' as the final Federal standard. 
OSHA anticipates that this standard will have a substantial impact on 
state and local employees. The states and territories with occupational 
safety and health state plans are: Alaska, Arizona, California, 
Connecticut, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, 
Minnesota, Nevada, New Mexico, New York, North Carolina, Oregon, Puerto 
Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, the Virgin 
Islands, Washington, and Wyoming. (In Connecticut and New York, the 
plan covers only State and local government employees). Until such time 
as a State standard is promulgated, Federal OSHA will provide interim 
enforcement assistance, as appropriate.

II. Pertinent Legal Authority

    The purpose of the Occupational Safety and Health Act, 29 U.S.C. 
651 et seq. (``the Act'') is ``to assure so far as possible every 
working man and woman in the nation safe and healthful working 
conditions and to preserve our human resources.'' 29 U.S.C. 
Sec. 651(b). To achieve this goal Congress authorized the Secretary of 
Labor to promulgate and enforce occupational safety and health 
standards. 29 U.S.C. Secs. 655(a) (authorizing summary adoption of 
existing consensus and federal standards within two years of Act's 
enactment), 655(b) (authorizing promulgation of standards pursuant to 
notice and comment), 654(b) (requiring employers to comply with OSHA 
standards).
    A safety or health standard is a standard ``which requires 
conditions, or the adoption or use of one or more practices, means, 
methods, operations, or processes, reasonably necessary or appropriate 
to provide safe or healthful employment or places of employment.'' 29 
U.S.C. Sec. 652(8).
    A standard is reasonably necessary or appropriate within the 
meaning of Section 652(8) if it substantially reduces or eliminates 
significant risk, and is economically feasible, technologically 
feasible, cost effective, consistent with prior Agency action or 
supported by a reasoned justification for departing from prior Agency 
actions, supported by substantial evidence, and is better able to 
effectuate the Act's purposes than any national consensus standard it 
supersedes. See 58 Fed. Reg. 16612--16616 (March 30, 1993).
    OSHA has generally considered, at a minimum, a fatality risk of 1/
1000 over a 45-year working lifetime to be a significant health risk. 
See the Benzene standard, Industrial Union Dep't v. American Petroleum 
Institute, 448 U.S. 607, 646 (1980); the Asbestos standard, 
International Union, UAW v. Pendergrass, 878 F.2d 389, 393 (D.C. Cir. 
1989).
    A standard is technologically feasible if the protective measures 
it requires already exist, can be brought into existence with available 
technology, or can be created with technology that can reasonably be 
expected to be developed. American Textile Mfrs. Institute v. OSHA, 452 
U.S. 490, 513 (1981) (``ATMI''), American Iron and Steel Institute v. 
OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991)(``AISI'').
    A standard is economically feasible if industry can absorb or pass 
on the costs of compliance without threatening its long-term 
profitability or competitive structure. See ATMI, 452 U.S. at 530 n. 
55; AISI, 939 F.2d at 980.
    A standard is cost effective if the protective measures it requires 
are the least costly of the available alternatives that achieve the 
same level of protection. ATMI, 453 U.S. at 514 n. 32; International 
Union, UAW v. OSHA, 37 F.3d 665, 668 (D.C. Cir. 1994) (``LOTO III'').
    All standards must be highly protective. See 58 FR 16614--16615; 
LOTO III, 37 F.3d at 669. However, health standards must also meet the 
``feasibility mandate'' of Section 6(b)(7) of the Act, 29 U.S.C. 
Sec. 655(b)(5). Section 6(b)(5) requires OSHA to select ``the most 
protective standard consistent with feasibility'' that is needed to 
reduce significant risk when regulating health hazards. ATMI, 452 U.S. 
at 509.
    Section 6(b)(5) also directs OSHA to base health standards on ``the 
best available evidence,'' including research, demonstrations, and 
experiments. 29 U.S.C. Sec. 655(b)(5). OSHA shall consider ``in 
addition to the attainment of the highest degree of health and safety 
protection * * * the latest scientific data * * * feasibility and 
experience gained under this and other health and safety laws.'' Id.
    Section 6(b)(7) authorizes OSHA to include among a standard's 
requirements labeling, monitoring, medical testing and other 
information gathering and transmittal provisions. 29 U.S.C. 
Sec. 655(b)(7).
    Finally, whenever practical, standards shall ``be expressed in 
terms of objective criteria and of the performance desired.'' Id.

III. Events Leading to the Proposed Standard

    Tuberculosis (TB) is a contagious disease caused by the bacterium 
Mycobacterium tuberculosis (M. tuberculosis). Infection is usually 
acquired by the inhalation of airborne particles carrying the 
bacterium. These airborne particles, called droplet nuclei, can be 
generated when persons with infectious pulmonary or laryngeal TB cough, 
sneeze, or speak. TB has long been considered an occupational hazard in 
the health care setting. However, it is inhalation exposure to 
aerosolized M. tuberculosis and not some other factor unique to the 
health care setting that places workers at risk of infection. Thus, any 
work setting where employees can reasonably be anticipated to encounter 
individuals with infectious TB also contains the occupational hazard of 
TB infection.
    On December 21, 1992, the Labor Coalition to Fight TB in the 
Workplace (the Coalition) requested the Agency to issue nationwide 
enforcement guidelines to protect workers against exposure to TB in 
health care, criminal justice, and other high risk settings and to 
issue a Joint Advisory Notice on TB in conjunction with the Centers for 
Disease Control and Prevention (CDC) (Ex. 2). This petition was signed 
by the presidents of the Service Employees International Union (SEIU), 
the American Federation of State, County, and Municipal Employees 
(AFSCME), and the American Federation of Teachers (AFT), and was 
endorsed by 9 other unions. The petition included a list of provisions 
that the petitioners felt should be included in the guidelines, ranging 
from a written control plan and medical surveillance to anti-
discrimination language and medical removal protection.

[[Page 54170]]

    Eight months later, on August 25, 1993, the Coalition petitioned 
OSHA to initiate rulemaking for a permanent standard issued under 
Sec. 655(b) of the Act to protect workers from occupational 
transmission of TB (Ex. 1). Citing the recent resurgence of TB and the 
emergence and increasing rate of new cases of multidrug-resistant TB 
(MDR-TB), the petitioners stressed the need for a substance-specific 
standard to address the hazards associated with occupational exposures 
to TB. The petitioners contended that the non-mandatory CDC TB 
Guidelines do not provide adequate protection because they are not 
fully or rigorously implemented in most workplaces. They also stated 
that in every outbreak of TB investigated by CDC, noncompliance with 
the Guidelines was evident.
    In addition to a permanent standard, the petitioners also requested 
that OSHA immediately issue the nationwide enforcement guidelines that 
the Coalition had previously requested, and that OSHA promulgate an 
Emergency Temporary Standard (ETS) as an interim measure. The Coalition 
requested that the standard be applicable to all work settings where 
employees can reasonably anticipate contact with infectious TB. The 
petition included a discussion on occupational risk that included both 
the traditional high-risk occupations and other occupations such as 
sheet metal workers, postal workers, airline employees, teachers, and 
office workers.
    Like the request for nationwide enforcement guidelines, the 
petition contained provisions that the petitioners requested be 
included in the standard. Examples include a facility hazard assessment 
and written exposure control plan, engineering and work practice 
controls, respiratory protection, medical surveillance (e.g., 
tuberculin skin testing) and counseling, post-exposure management, 
outbreak management, training, and recordkeeping.
    On October 8, 1993, OSHA issued nationwide enforcement procedures 
for occupational exposure to TB. The compliance document contained the 
enforcement procedures that the Agency could and would use in certain 
work settings for protecting workers with occupational exposure to TB. 
In the compliance procedures, the Agency noted that although OSHA has 
no standard designed specifically to reduce occupational exposure to 
TB, the Agency has existing standards that apply to this hazard. For 
example, 29 CFR 1910.134 requires employers to provide respiratory 
protection equipment and 29 CFR 1910.145(f) requires accident 
prevention tags to warn of biological hazards. In addition, section 
5(a)(1), the General Duty Clause of the Act, requires that each 
employer:

     * * * furnish to each of his employees employment and a place 
of employment which are free from recognized hazards that are 
causing or are likely to cause death or serious physical harm to his 
employees.

    On January 26, 1994, in response to their August 25 petition, 
Secretary of Labor Robert B. Reich informed the petitioners that OSHA 
was initiating rulemaking on a permanent standard to be issued under 
Section 6(b)(5) of the Act for occupational exposure to TB (Ex. 1B). At 
the same time, the petitioner's request for an ETS was denied. The 
Agency had determined that the available data did not meet the criteria 
for an ETS as set forth in Section 6(c) of the Act. However, OSHA 
committed to enforcing existing regulations and Section 5(a)(1) of the 
Act in certain work settings while preparing this standard.
    On October 28, 1994 the CDC issued revised guidelines for 
preventing the transmission of tuberculosis in health care facilities 
(Ex. 4B). In addition, in June of 1995, the National Institute for 
Occupational Safety and Health (NIOSH) published revised certification 
procedures for non-powered air purifying particulate respirators (Ex. 
7-261). As a result of changes in these two documents, OSHA issued 
revised enforcement policies and procedures relative to TB in February 
of 1996 (Ex. 7-260).
    In October and November of 1995, OSHA held a series of meetings 
with stakeholder groups representing labor unions, professional 
organizations, trade associations, state and federal government, 
representatives of employers, as well as frontline workers from the 
various sectors anticipated to be covered by the proposed standard. 
During these meetings, participants provided input relative to the 
concepts and approaches OSHA was considering for the proposed 
tuberculosis standard.
    In September of 1996, in accordance with the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA), a Small Business 
Advocacy Review Panel was convened to consider the impact of OSHA's 
draft proposed tuberculosis standard on affected small entities. The 
panel, comprised of members from the Office of Advocacy of the Small 
Business Administration (SBA), the Office of Management and Budget 
(OMB), and OSHA, prepared a report based on the Panel's findings and 
recommendations with regard to comments on the standard received from 
small business employers. This report was submitted to the Assistant 
Secretary for OSHA for its consideration during the development of the 
standard (Ex. 12). OSHA's proposed standard reflects input generated 
during both the stakeholder meetings and the SBREFA review process.

Comparison of OSHA's Proposed Standard and CDC's Revised Guidelines

    In preparing its proposed standard for TB, OSHA has relied heavily 
on the expertise of CDC. The Agency has consulted with CDC and has 
incorporated the basic elements of CDC's revised guidelines for 
preventing the transmission of M. tuberculosis in health care 
facilities in this proposed standard. Both CDC and OSHA rely on 
minimizing exposures and consequent transmission by identifying 
suspected infectious TB individuals and isolating them. The OSHA 
proposed standard includes the following CDC components: written 
exposure control plans, procedures for early identification of 
individuals with suspected or confirmed infectious TB, procedures for 
initiating isolation of individuals with suspected or confirmed 
infectious TB or for referring those individuals to facilities with 
appropriate isolation capabilities, procedures for investigating 
employee skin test conversions, and education and training for 
employees. In addition, OSHA has incorporated CDC recommendations for 
engineering control measures such as the use of negative pressure for 
AFB isolation rooms or areas, daily monitoring of negative pressure 
while AFB isolation rooms are in use for TB, HEPA filtration of 
recirculated air from AFB isolation rooms, and periodic maintenance and 
monitoring of engineering controls. With regard to respiratory 
protection, OSHA has adopted CDC's standard performance criteria for 
the selection of respiratory protection devices appropriate for use 
against M. tuberculosis. And finally, where appropriate, OSHA has 
attempted to assure that where certain practices are required by OSHA's 
proposed standard, e.g., tuberculin skin testing and medical management 
and follow-up of employees who acquire TB infections or active disease, 
these practices are conducted according to the current recommendations 
of the CDC. Therefore, OSHA's proposed standard for occupational 
exposure to TB closely follows CDC's recommended elements for a TB 
infection control program.
    However, there are some minor differences between OSHA's proposed 
standard and CDC's guidelines that go

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beyond the obvious enforcement distinction between a guideline and a 
standard. These differences are found primarily in the areas of risk 
assessment, medical surveillance and respiratory protection. Even so, 
OSHA believes that despite these differences the vast majority of the 
provisions included in this proposed standard closely track the 
recommendations of the CDC. The following discussion identifies where 
these differences occur and describes the extent of these differences 
and the degree to which they impact on employers' responsibilities 
under the proposed standard.

Risk Assessment

    As a part of its guidelines, CDC recommends that a risk assessment 
be conducted in all facilities to assess the risk of transmission of M. 
tuberculosis in each facility. This risk assessment is to be conducted 
using information such as the profile of TB in the community, the 
number of suspected and confirmed cases of TB among patients and health 
care workers, results of health care worker tuberculin skin testing 
(i.e., conversion rates), and observation of TB infection control 
practices. Using the results of this risk assessment, appropriate 
infection control interventions can then be selected based on the 
actual risk in the facility. CDC includes a protocol for conducting 
this risk assessment in which there are 5 categories of risk: 
``minimal'', ``very-low'', ``low'', ``intermediate'', and ``high''. 
Each category from ``minimal'' to ``high'' has an increasing number of 
infection control interventions that are recommended for each 
particular level of risk.
    OSHA, however, has chosen a simpler approach and is not requiring 
employers to conduct such a risk assessment. Consistent with other 
standards, OSHA has determined that employees in the work settings and 
employees providing services set forth in the scope section are at risk 
of occupational exposure to TB. Their employers are required to conduct 
an exposure assessment to determine which employees have occupational 
exposure, i.e., reasonably anticipated contact with an individual with 
suspected or confirmed infectious TB or air that may contain 
aerosolized M. tuberculosis. The standard then specifies the provisions 
applicable for the employees whom the employer has identified as having 
occupational exposure. In addition, consistent with its approach in 
other standards, OSHA does not require that individual risk assessments 
be conducted by each work setting covered under the standard, as they 
may be too difficult and burdensome for employers to prepare. Also, 
many work settings will have too few occupationally exposed employees 
to do an accurate risk assessment. Finally, conducting the risk 
assessments in order to determine applicable duties may require a level 
of expertise some facilities lack, making enforcement burdensome for 
the Agency.
    OSHA realizes, however, that in many work settings, very few 
individuals with suspected or confirmed infectious TB may be seen and 
that in many of those work settings, individuals with suspected or 
confirmed infectious TB will be transferred to other facilities that 
are better equipped to provide services and care using appropriate TB 
isolation precautions. Because there is likely to be less risk of 
transmission of M. tuberculosis in those situations, OSHA believes that 
it is possible to make the standard less burdensome for the employers 
with these types of work settings while still maintaining worker 
protection.
    For example, an employer who can demonstrate that his or her 
facility or work setting: (1) Does not admit or provide medical 
services to individuals stwith suspected or confirmed infectious TB, 
(2) has not had any individuals with confirmed infectious TB within the 
work setting within the last 12 months, and (3) is located in a county 
that, in the past 2 years, has had 0 cases of confirmed infectious TB 
reported in one year and fewer than 6 cases of confirmed infectious TB 
reported in the other year, does not have to comply with all provisions 
of the standard. Such employers would only be responsible for 
compliance with certain provisions, e.g., a written exposure control 
plan, a baseline skin test and medical history, medical management and 
follow-up after exposure incidents, medical removal protection where 
necessary, employee training, and recordkeeping. These provisions are 
very similar to the recommendations of the CDC for facilities 
classified as having ``minimal risk,'' i.e., no TB in the community or 
in the facility. The only major difference is that CDC does not 
recommend baseline skin testing. However, CDC does state that baseline 
skin testing would be advisable so that if an unexpected exposure does 
occur, conversion could be distinguished from positive skin test 
results caused by previous exposures.

Medical Surveillance

    In the area of medical surveillance, the main differences between 
OSHA and CDC are related to tuberculin skin testing. OSHA requires 
baseline skin testing for all employees whom the employer identifies as 
having occupational exposure. CDC recommends baseline skin testing for 
all employees with potential exposure except those who work in 
facilities that fall into CDC's ``minimal risk'' category. However, CDC 
notes that even for employees in ``minimal risk'' facilities, it may be 
advisable to perform baseline skin testing so that if unexpected 
exposures do occur, conversions can be distinguished from positive skin 
test results caused by previous exposures. Thus, there is little 
difference between OSHA requirements and CDC recommendations with 
regard to baseline skin testing.
    Relative to periodic skin testing, OSHA requires periodic re-
testing for all employees identified as having occupational exposure 
who have negative skin tests except for the employees of those 
employers who have no TB in the community and who have not encountered 
any individuals with confirmed infectious TB in their work settings 
within the past year. CDC recommends re-testing for employees in the 
``low'', ``intermediate'', and ``high'' risk categories. According to 
the CDC guidelines, periodic re-testing is not necessary for employees 
in the ``minimal'' risk category or the ``very-low'' risk categories. 
CDC's periodic skin test recommendations for the ``minimal'' risk 
category are similar to OSHA's limited program for employers who do not 
admit or provide medical services to individuals with suspected or 
confirmed infectious TB, have not encountered any confirmed infectious 
TB in their work setting, and are located in a county that, in the past 
2 years, has reported 0 cases of confirmed infectious TB in one year 
and fewer than 6 cases in the other year. OSHA is different from the 
CDC in that employees in a ``very-low risk category'' are required to 
be periodically retested. However, CDC notes that even in the ``very-
low'' risk category, employees who are involved in the initial 
assessment of individuals in emergency departments and admitting areas 
may have potential exposure and thus may need periodic re-testing.
    Another difference between CDC and OSHA is the frequency of the re-
testing. This is primarily due to the fact that OSHA's required 
frequencies are based on the type of work that employees do that result 
in exposures whereas CDC's recommendations are based more on evidence 
of conversions. For example, OSHA requires re-testing every six months 
for all employees who (1) enter AFB isolation rooms or areas, (2) 
perform high-hazard procedures, (3)

[[Page 54172]]

transport individuals with suspected or confirmed infectious TB in an 
enclosed vehicle, or (4) work in intake areas where early 
identification procedures are performed (e.g., emergency departments, 
admitting areas) in facilities where 6 or more individuals with 
confirmed infectious TB have been encountered in the past 12 months. 
For all other employees with occupational exposure, re-testing is 
required every 12 months. In comparison, CDC recommends re-testing 
every year for employees in ``low'' risk categories, every 6-12 months 
for employees in ``intermediate'' risk categories, and every 3 months 
for employees in ``high'' risk categories. Under CDC recommendations, 
employees in ``low'' risk categories who enter AFB isolation rooms or 
areas or employees who transport individuals with suspected or 
confirmed infectious TB in an enclosed vehicle would be re-tested every 
12 months. However, under OSHA requirements, those same employees would 
be required to be re-tested every six months. Thus, OSHA is more 
protective than CDC in this case.
    OSHA also would require that employees who perform high-hazard 
procedures or who work in intake areas where early identification 
procedures are performed in facilities that encounter 6 or more 
individuals with confirmed infectious TB be re-tested every six months. 
Under CDC's Guidelines employees in areas in which cough-inducing 
procedures are performed on individuals who may have active TB are 
recommended to follow an intermediate risk protocol. Similarly, CDC 
recommends that an intermediate risk protocol be followed in areas 
where more than six individuals who may have active TB receive initial 
assessment and diagnostic evaluation (e.g., ambulatory care, emergency 
departments, admitting areas). CDC recommends re-testing every 6-12 
months for employees in intermediate risk categories. OSHA would 
require re-testing every 6 months for the two situations above, which 
is very similar to CDC's recommendation of re-testing every 6-12 
months.
    CDC is more protective in its recommendations for employees in the 
``high'' risk category. These employees are recommended to be re-tested 
every 3 months. OSHA does not have a requirement for re-testing 
employees every 3 months. However, after an exposure incident, OSHA 
requires that a skin test be administered as soon as feasible and again 
3 months after the exposure incident, if the first skin test is 
negative. Since it is possible that an exposure incident(s) could be 
the type of event that would cause an employee(s) to be included in the 
``high'' risk category as defined by CDC, OSHA requirements, to some 
extent, track the CDC recommendations for a higher frequency of 
periodic skin testing.
    With regard to two-step testing, both OSHA and CDC require or 
recommend two-step testing at the time baseline skin testing is 
administered. Also, both OSHA and CDC add that two-step testing is not 
necessary if the employee has had a documented negative skin test 
within the last 12 months. CDC is different from OSHA in that its 
Guidelines imply that two-step testing can be discontinued if there is 
evidence of a low frequency of boosting in the facility. OSHA's 
proposed standard does not allow such an exemption, i.e., for each 
employee who must have a baseline skin test at the time of the initial 
medical examination, the skin test must include a two-step test unless 
the employee has a documented negative test within the last 12 months, 
regardless of the frequency of boosting in the facility. The value of 
two-step skin testing is that it enables one to distinguish true 
conversions from boosted reactions. OSHA believes that this is 
important to know for each employee because if the employee is 
incorrectly identified as having converted, he or she may needlessly be 
subjected to preventive therapy that may have toxic side effects of its 
own. Since it is important to know the true skin test status for each 
employee, OSHA has preliminarily concluded that it is inappropriate to 
allow the overall frequency of boosting among employees in a facility 
to dictate whether any one employee receives two-step testing at the 
time of his or her baseline testing.

Respiratory Protection

    OSHA requirements and CDC recommendations for respiratory 
protection are very similar. A respirator is a personal protective 
equipment device worn over the nose and mouth of the employee that 
filters certain airborne contaminants from the inhaled air. OSHA has 
adopted CDC's performance criteria for respirators appropriate for use 
for TB. Also, both OSHA and CDC have similar requirements or 
recommendations that respirators be worn when entering an isolation 
room, when performing cough-inducing procedures or aerosol-generating 
procedures on an individual with suspected or confirmed infectious TB, 
when repairing or maintaining air systems that may contain aerosolized 
M. tuberculosis, when transporting an individual with suspected or 
confirmed infectious TB in an enclosed vehicle and when working in a 
residence where an individual with suspected or confirmed infectious TB 
is known to be present. However, OSHA also requires that respirators be 
worn when employees are transporting individuals with suspected or 
confirmed infectious TB within the facility if those individuals are 
not masked (e.g., a surgical mask or a valveless respirator). CDC does 
not have a similar recommendation for respiratory protection while 
transporting individuals within the facility, but CDC does recommend, 
and assumes to some extent, that individuals with suspected or 
confirmed infectious TB are masked whenever they are outside an 
isolation room. In addition, OSHA requires that respirators be worn 
when employees work in an area where an unmasked individual with 
suspected or confirmed infectious TB has been segregated or otherwise 
confined. For example, this provision would cover employees such as 
those who work in admitting areas and must attend to unmasked 
individuals with suspected or confirmed infectious TB while those 
individuals are awaiting transfer. These types of employees are likely 
to be found in facilities that would meet CDC's definition of 
``minimal'' risk. CDC states that respiratory protection is not 
necessary for employees in the ``minimal'' risk category. However, 
again, CDC recommends that if an individual with suspected or confirmed 
infectious TB is identified in a ``minimal'' risk facility, the 
individual should be masked while he or she is awaiting transfer to 
another facility, thus obviating the need for respiratory protection. 
OSHA, on the other hand, cannot require employers to mask clients or 
patients in a facility, and the Agency must therefore include 
provisions for respirator use to protect potentially exposed employees. 
However, consistent with CDC, OSHA proposes not to require respirators 
where the employer elects, as a part of his or her own administrative 
policies, to mask individuals with suspected or confirmed infectious 
TB. Thus, when individuals with suspected or confirmed infectious TB 
are masked while they are awaiting transfer to another facility or 
while they are being transported within the facility, employees would 
not be required by the standard to wear a respirator.
    In some instances, the CDC may be more protective than OSHA with 
regard to respiratory protection. The CDC states that the facility's 
risk assessment may identify selected settings where the

[[Page 54173]]

estimated risk of transmission of M. tuberculosis may be such that a 
level of respiratory protection exceeding the standard performance 
criteria is appropriate (e.g., more protective negative pressure 
respirators, powered air purifying respirators). The examples given of 
such selected settings are a bronchoscopy performed on an individual 
suspected of having TB and an autopsy performed on a deceased person 
suspected of having had active TB at the time of death. OSHA does not 
have a similar requirement for more protective respiratory protection. 
Respirators meeting the minimal performance criteria laid out by the 
standard would be required by OSHA for employees performing all high-
hazard procedures, including bronchoscopies and aerosol-generating 
autopsy procedures.

IV. Health Effects

Introduction

    For centuries Tuberculosis (TB) has been responsible for the death 
of millions of people throughout the world. It was not until 1882, 
however, that Robert Koch identified a species of bacteria, 
Mycobacterium tuberculosis (M. tuberculosis), as the cause of TB.
    TB is a communicable disease that usually affects the lungs. The 
airborne route is the predominant mode of transmission, a situation 
created when individuals with infectious TB discharge the bacilli from 
the lungs when coughing, sneezing, speaking or singing. Some 
individuals who breathe contaminated air become infected with TB. Most 
often, the immune system responds to fight the infection. Within a few 
weeks, the infected lesions become inactive and there is no residual 
change except for possible lymph node calcifications. These individuals 
will have a positive skin test result. They will harbor the infection 
for life. At some time in the future, the infection can progress and 
can become an active disease, with pulmonary infiltration, cavitation, 
and fibrosis, possibly causing permanent lung damage and even death. 
With some exceptions, however, TB is treatable with antimicrobial 
drugs. If the active TB is treated early, there will be minimal 
residual lung damage. For this reason, individuals who have a TB 
exposure incident and develop a TB infection are treated to prevent 
progression to active TB disease.
    With the introduction of antimicrobial drug treatment in the 1940s 
and the creation of programs in the United States such as the U.S. 
Public Health Service's Tuberculosis Program, there began a decline in 
the incidence of active TB cases in the U.S. From 1953, when active 
cases began to be reported in the U.S., until 1984, the number of 
annual reported cases declined 74%, from 84,304 (53 per 100,000) to 
22,255 (9.4 per 100,000) (Ex. 7-50). However, this steady decline in TB 
cases did not continue. Instead, from 1985 through 1992, the number of 
reported TB cases increased 20.1% from 22,201 to 26,673 (10.5 cases per 
100,000) (Ex. 6-13).
    This resurgence in TB brought to attention a number of problems in 
the existing TB control programs. The direction of resources to areas 
with the highest increase in active cases has caused this increase to 
decline. The number of cases reported for 1995 indicates that the rate 
of active TB has returned to its 1985 levels. In 1995, a total of 
22,813 cases of TB (8.7 per 100,000) was reported to CDC (Ex. 6-34). 
While this represents a decline in active TB, the 1995 rate is still 
two and one half times greater than the target case rate of 3.5 per 
100,000 for the year 2000 and approximately 87 times the goal of less 
than one case per million population by the year 2010 proposed by the 
Advisory Committee on the Elimination of Tuberculosis (Ex. 6-19).
    TB continues to be a national problem. Each year, cases of active 
disease are reported in every state in the Nation and in a substantial 
majority of counties nationwide. CDC estimated in 1990 that 
approximately 10 million people were infected with the tuberculosis 
bacterium and that approximately 90% of the new cases of active disease 
that arise in the United States come from this already infected group 
(Ex. 7-52). Given the recent resurgence of TB, it is likely that a new 
population of individuals has been infected as well. Of great concern 
are strains of M. tuberculosis that have emerged that are resistant to 
several of the first-line anti-TB drugs normally used to treat TB 
infection and disease (e.g., isoniazid and rifampin). This drug-
resistant form of the disease, referred to as multidrug-resistant TB or 
MDR-TB, is more often a fatal form of TB due to the difficulty in 
finding antimicrobial drugs to stop the bacteria's growth and 
progressive tissue destruction. In addition, individuals with MDR-TB 
often remain infectious for longer periods of time due to delays in 
diagnosing resistance patterns and initiating appropriate treatment. 
This, in turn, increases the risk that infectious individuals will 
transmit the organism to other persons coming in contact with them.
    Most of the decreases in reported cases of TB since 1992 have 
occurred in areas such as New York City, where resources have been 
invested to improve or initiate TB control provisions, such as those 
outlined in OSHA's proposed standard. However, the 1995 statistics show 
that over the course of four years there is substantial variability in 
the increases and decreases of cases reported by each state for any 
given year (Ex. 6-34). In 1995, 15 states reported an increase in the 
number of TB cases compared with 1994. In addition, a recent study has 
shown that MDR-TB has spread to patients in Florida and Nevada, and to 
health care workers in Atlanta, Georgia and Miami, Florida. Moreover, 
one individual with MDR-TB infected or caused disease in at least 12 
people in a nursing home in Denver, Colorado (Ex. 7-259). This study 
shows very clearly the ability of TB to be spread to different areas of 
the country. This is to be expected given the mobile nature of today's 
society and the frequency with which people travel. Immigration also 
contributes to the incidence of the disease. For example, while the 
number of active TB cases has decreased among U.S. born persons, the 
number of foreign born persons reported with TB has increased 63% since 
1986, with a 5.4% increase in 1995 (i.e., from 7,627 cases in 1994 to 
8,042 cases in 1995). Thirty to fifty percent of these cases were 
diagnosed 1 to 5 years after the individual enters the U.S. (Ex. 6-34). 
Thus, tuberculosis continues to be a public health problem throughout 
the United States.
    The following discussion will briefly describe the basic concepts 
and terminology associated with TB as well as common factors that 
facilitate its transmission from one individual to another. This 
discussion will also include a review of studies relating to the 
occupational transmission of TB.

Background

    TB is a contagious disease caused by the bacterium M. tuberculosis. 
Infection is generally acquired by the inhalation of airborne particles 
carrying the bacterium. These airborne particles, called droplet 
nuclei, can be generated when persons with pulmonary or laryngeal 
tuberculosis in the infectious state of the disease cough, sneeze, 
speak or sing.
    In some individuals exposed to droplet nuclei, tuberculosis bacilli 
enter the lung and establish an infection (Ex. 7-52). Once in the 
alveoli, the tuberculosis bacilli are taken up by alveolar macrophages 
and spread throughout the body by the lymphatic system, until the 
immune response limits further growth (usually a period of two to ten 
weeks). In most cases the tuberculosis bacilli are contained by the

[[Page 54174]]

immune response. Macrophage cells engulf the bacteria, which limits the 
spread of the bacilli. Initial lesions from infection heal; however, 
small calcifications called tubercles are formed and may remain a 
potential site of later reactivation.
    Individuals in this state are infected with TB. They will show a 
positive skin test and they are at risk of developing active TB, a risk 
they carry throughout their lifetime. In many cases, as described 
below, preventive therapy is initiated with anti-TB drugs to prevent 
the progression to active TB disease. These drugs are toxic and may 
cause adverse effects such as hepatitis. Severe preventive therapy-
associated hepatitis cases have necessitated liver transplants and in 
some cases have resulted in death (Ex. 6-10).
    When the bacilli are not contained by the immune system, they 
continue to grow and invade the tissue, leading to the progressive 
destruction of the organ involved, which in most cases is the lung, 
i.e., pulmonary tuberculosis. The inflammatory response caused by the 
disease produces weakness, fever, chest pain, cough, and, when blood 
vessels are eroded, bloody sputum. Also, many individuals have 
drenching night sweats over the upper half of the body several times a 
week (Ex. 5-80). The extent of disease varies from minimal symptoms of 
disease to massive involvement with extensive cavitation and 
debilitating constitutional and respiratory symptoms. Since 
tuberculosis bacilli are spread throughout the body after the initial 
infection, other organs may also be infected and disease may occur at 
sites outside the lung, i.e., extrapulmonary tuberculosis.
    There are two general stages of TB, tuberculosis infection and 
active tuberculosis disease. Individuals with tuberculosis infection 
and no active disease are not infectious. These tuberculosis infections 
are asymptomatic or subclinical and are only detected by a positive 
response to a tuberculin skin test. However, there are some individuals 
whose immune system is impaired and cannot mount a sufficient response 
to skin test antigens, i.e., they are anergic. Such individuals may be 
infected, although they do not show a positive response to the skin 
test. Individuals with tuberculosis infection and no disease would have 
negative bacteriologic studies and no clinical or radiographic evidence 
of tuberculosis disease. However, these individuals are infected for 
life and are at risk of developing active TB in the future.
    Anti-tuberculosis drugs may be used for individuals with TB 
infection but who do not have active disease. In these cases, the 
antimicrobials are used as preventive therapy to prevent the onset of 
active disease. Because of the toxicity associated with the 
antimicrobials, preventive therapy may not be appropriate for all 
infected individuals. Various factors are considered to determine 
whether an infected individual is an appropriate candidate for 
preventive therapy (e.g., age, immune status, how recently the 
infection occurred, and other high-risk factors associated with TB) 
(Ex. 7-52, pg. 17). Isoniazid is currently the only drug that has been 
well tested in humans for its efficacy as preventive therapy (Ex. 7-50, 
pg. 61). However, serious side effects may result from isoniazid. A 
study in New York for the years 1991 to 1993 examined cases of 
hepatitis induced by isoniazid preventive therapy. In this study, 10 
patients undergoing preventive therapy for TB were identified at a 
transplant center. Eight of these patients had developed hepatitis from 
isoniazid. Five received a liver transplant; the other three died while 
awaiting a liver donor. In addition, one of the transplant patients 
died after transplantation. Thus, preventive therapy may carry 
considerable risks for infected individuals.
    In those cases where isoniazid cannot be tolerated by the patient 
or where it is suspected that infection resulted from exposure to 
isoniazid-resistant strains of M. tuberculosis, rifampin may be 
recommended for preventive therapy. Considerations for such alternative 
drug therapies are made on a case-by-case basis by the health care 
provider based on the medical and case history of the infected patient. 
Rifampin has adverse side effects as well. However, preventive therapy 
using rifampin has not been followed as well as that involving 
isoniazid and therefore, its side effects are less well characterized.
    Individuals with active TB have clinical and/or radiographic 
evidence of disease. The initial laboratory method for diagnosing TB is 
the Acid Fast Bacilli (AFB) smear. This is a quick and easy technique 
in which body fluids, typically sputum samples, from individuals with 
suspected TB are examined for mycobacteria. However, this type of test 
only permits a presumptive diagnosis of TB since the test cannot 
distinguish between tuberculosis mycobacteria and other non-
tuberculosis mycobacteria. Chest X-rays may also be used to diagnose 
active TB; however, some individuals with TB may have X-ray findings 
that are atypical of those usually associated with TB (e.g., HIV 
infected individuals). The diagnosis of clinically active TB is most 
definitively established by the isolation of M. tuberculosis in 
culture. However, it may take three to six weeks or longer from 
obtaining a culture to getting a result.
    Individuals with active TB disease may be infectious, especially if 
they are untreated or inadequately treated and if the disease is in the 
lungs. The clinical symptoms of pulmonary TB include loss of appetite, 
weight loss, fatigue, fever, night sweats, malaise, cough with 
productive sputum and/or blood, and chest pain. The extent of the 
disease varies from very minimal symptoms to extensive debilitating 
constitutional and respiratory symptoms. If untreated, the pulmonary TB 
follows a chronic and progressive course in which the tissue is 
progressively destroyed. It has been estimated that approximately 40 to 
60% of untreated cases result in death (Exs. 5-80, 7-50, and 7-66). 
However, even among cured cases of TB, long-term damage can result, 
including impaired breathing due to lung damage (Ex. 7-50, pg. 31).
    Approximately 90% of immunocompetent adults who are infected do not 
develop active TB disease. However, for 10% of infected immunocompetent 
adults, either directly after infection or after a latency period of 
months, years or even decades, the initial infection progresses to 
clinical illness, that is, active TB (Ex. 4B). The risk of developing 
active TB is increased for individuals whose immune system is impaired 
(i.e., immunocompromised). Such individuals include persons undergoing 
treatment with corticosteroid or immunosuppressive drugs (e.g., persons 
with organ transplants or persons undergoing chemotherapy for cancer), 
persons suffering from malnutrition or chronic conditions such as 
asthma and emphysema, and persons infected with the human 
immunodeficiency virus (HIV).
    The main first-line drugs currently used to treat active TB are 
isoniazid, rifampin, pyrazinamide, ethambutol and streptomycin. 
Combinations of these antimicrobials are used to attack the 
tuberculosis bacilli in the body. Recommended treatment regimens 
include two or more drugs to which the bacilli are susceptible, because 
the use of a single drug can lead to the development of bacilli 
resistant to that drug (Ex. 5-85). Treatment with these first-line 
drugs involves a two-phase process: an initial bactericidal phase for 
the quick elimination of the bulk of bacilli from most body sites and a 
longer-term sterilizing phase for eliminating the remaining bacilli.

[[Page 54175]]

Different regimes of drug treatment (i.e., the types of drugs and 
frequency of administration) are recommended depending on the medical 
history of the patient involved and the results of drug susceptibility 
testing. The U.S. Public Health Service has recommended options for the 
initial therapy and dosage schedules for the treatment of drug-
susceptible TB (Ex. 4B). While these antimicrobials are effective in 
the treatment of active TB, some of these drugs also have toxic 
potential. Adverse side effects of these drugs include hepatitis, 
peripheral neuropathy, optic neuritis, ototoxicity and renal toxicity 
(Ex. 7-93). Thus, patients undergoing TB therapy must also be monitored 
for drug toxicity that may occur from anti-tuberculosis drugs.
    Individuals with active disease who are infectious may need to be 
hospitalized in order to provide isolation so that they will not infect 
other individuals. After the initiation of treatment for active TB, 
improvement of the disease can be measured through clinical 
observations such as loss of fever, reduction in coughing, increased 
appetite and weight gain. A reduction in the number of bacilli in 
sputum smears also indicates improvement. Three consecutive negative 
sputum smears generally indicate that the individual is no longer 
infectious. However, decisions about infectiousness are usually 
determined on a case-by-case basis after taking a number of factors 
into consideration, such as the presence of cough, the positivity of 
sputum smears, and the status or response to chemotherapy. Although no 
longer infectious to other individuals, the individual undergoing 
treatment still has tuberculosis disease and must continue treatment. 
Discontinuing or erratically adhering to the treatment regime can allow 
some of the bacilli to survive such that the individual will be at risk 
of becoming ill and infectious again (Ex. 7-52, p. 25).
    Not all strains of the tuberculosis bacilli are susceptible to all 
of the antimicrobials used to treat TB. In some instances, drug-
resistant forms of M. tuberculosis may emerge. Drug resistance may 
emerge by 1 of 3 mechanisms (Exs. 5-85; 7-50, pp. 44-47). Drug-
resistant TB may occur naturally from random mutation processes, i.e., 
primary resistance. In addition, drug-resistant TB may result due to 
inadequate or erratic treatment, i.e., acquired resistance. In these 
cases, erratic or inadequate treatment allows the tuberculosis bacilli 
to become resistant to one or several of the drugs being used. Finally, 
drug-resistant TB may result due to the active transmission of drug-
resistant TB from an individual already infected with drug-resistant 
strains of the tuberculosis bacteria, i.e., transmitted resistance. In 
recent years, drug-resistant forms of TB have emerged that are 
resistant to two or more of the first-line drugs used to treat TB, such 
as isoniazid and rifampin, two of the most effective anti-TB drugs. 
These drug-resistant forms of the disease are referred to as multidrug-
resistant TB or MDR-TB. MDR-TB represents a significant form of drug-
resistant TB from a public health standpoint, since its resistance to 
the first-line drugs used for therapy complicates finding adequate 
therapy regimens that will control the bacilli's growth.
    Treatment of drug-resistant TB is determined on a case-by-case 
basis, using information from the patient's medical history and drug 
susceptibility testing. The recommended course of treatment will vary 
depending on the drugs to which the bacilli are susceptible. Compared 
to conventional TB drug therapy, MDR-TB, in general, requires more 
complex interventions, longer hospitalization and more extensive 
laboratory monitoring. The risk of death from such infections is 
markedly increased. For example, from January 1990 through September 
1992, the CDC investigated eight outbreaks of MDR-TB. In these 
outbreaks, 253 patients were infected, of whom approximately 75% died 
(Ex. 3-38-A). Many of these were immunocompromised due to infection 
with HIV. The interval from the time of TB diagnosis to the time of 
death ranged from 4 to 16 weeks, with a median time of 8 weeks.

Factors Affecting Transmission

    A number of factors can influence the likelihood of acquiring a 
tuberculosis infection: (1) The probability of coming into contact with 
an individual with infectious TB, (2) the closeness of the contact, (3) 
the duration of the contact, (4) the number of tuberculosis bacilli in 
the air, and (5) the susceptibility of the uninfected individual. 
Several environmental conditions can influence the likelihood of 
infection. For example, the volume of shared air space, the amount of 
ventilation, the presence or absence of sunlight, the humidity and the 
crowded nature of the living quarters. These types of factors will 
affect the probability of acquiring a tuberculosis infection after 
being exposed to an individual with infectious TB. MDR-TB is not more 
contagious than drug-susceptible forms of the disease. However, due to 
time delays in diagnosing resistance patterns and initiating adequate 
treatment, individuals with active MDR-TB may remain infectious for 
longer periods of time. Consequently, the likelihood that they will 
infect other noninfected individuals is increased.
    Once infection occurs, other factors may influence the probability 
of progressing to the active form of disease. As previously discussed, 
10% of immunocompetent adults infected with TB develop active TB. Three 
to five percent of untreated immunocompetent adults develop active TB 
within the first year after infection (Ex. 7-50, pg. 30; 7-52). Thus, 
recently infected individuals have the highest risk of developing 
active TB. This risk is increased for individuals whose immune system 
is impaired (e.g., persons being treated with immunosuppressive or 
glucocorticoid drugs, persons with chronic conditions such as asthma or 
emphysema or persons infected with the HIV). The probability of 
developing active disease can also be influenced by other conditions 
that may alter immune function such as overall decreased general health 
status, malnutrition, and increasing age.
    The resurgence of TB in the United States from 1985 to 1992 has 
been attributed to a number of interacting factors: (1) The inadequate 
control of disease in high prevalence areas; (2) the increase in 
poverty, substance abuse, poor health status and crowded substandard 
living conditions; and (3) the growing number of inmates, residents of 
homeless shelters, elderly persons in long-term care facilities, 
persons with HIV infection and immigrants from countries with a high 
prevalence of TB infection (Ex. 7-50). This increase has begun to 
decline, with the 1995 case levels approaching the 1985 levels. 
However, a main reason for this decrease is the implementation of TB 
control measures, like those proposed in this standard, in selected 
areas of the country such as New York City. OSHA believes that 
implementation of such measures is necessary to prevent a resurgent 
peak such as that observed from 1985 to 1992 and to realize the goal 
set out by the National Advisory Committee for the Elimination of 
Tuberculosis. The following discussion describes some of the health 
effects data related to occupational exposure to TB and illustrates how 
the presence of TB control measures influences TB infection and 
disease.

Occupational Exposure

    Exposure to TB in the health care setting has long been considered 
an occupational hazard. With the steady

[[Page 54176]]

decline in reported TB cases from 1953 to 1985, some of the concern for 
occupational exposure and transmission also declined. However, from 
1985 to 1992 the number of reported cases of TB increased. In addition, 
in recent years, several outbreaks of TB among both patients and staff 
in hospital settings have been reported to the CDC. These outbreaks 
have been attributed to several factors: (1) Delayed recognition of 
active TB cases, (2) delayed drug susceptibility testing, (3) 
inadequate isolation of individuals with active TB (e.g., lack of 
negative pressure ventilation in isolation rooms, recirculation of 
unfiltered air, and allowing infectious patients to freely move in and 
out of isolation rooms), and (4) performance of high-risk procedures on 
infectious individuals under uncontrolled conditions (Ex. 7-50). In 
addition to hospitals, outbreaks of TB have also been reported among 
the patients, clients, residents and staff of correctional facilities, 
drug treatment centers, homeless shelters and long-term health care 
facilities for the elderly. The factors contributing to the outbreaks 
in these other occupational settings are very similar to those factors 
contributing to the outbreaks in hospital settings (i.e., delayed 
recognition of TB cases and poor/inadequate ventilation for isolation 
areas).
    The following is a discussion of some of the studies that have 
examined occupational transmission of TB. A large proportion of the 
available information comes from exposures occurring in hospitals, in 
part because this occupational setting has been recognized for many 
years as an area of concern with regards to the transmission of TB. 
However, in more recent years this concern has spread to other 
occupational settings which share factors identified in the hospital 
setting as contributing to the transmission of disease. The following 
sections will include a discussion of some of the historical data from 
the hospital setting, as well as the more recent data that have been 
developed in hospitals and other occupational settings where the 
transmission of TB has occurred as a result of the recent resurgences 
in the number of active TB cases.

Hospitals--Prior to 1985

    Even prior to the recent resurgence of TB in the general 
population, studies have shown an increased risk of transmission of TB 
to health care workers exposed to individuals with infectious TB. These 
studies clearly demonstrate that in the absence of appropriate TB 
control measures (e.g., lack of early identification procedures, lack 
of appropriate engineering controls), employees exposed to individuals 
with infectious TB have become infected and in some cases have 
developed active disease.
    In 1979, Barrett-Connor (Ex. 5-11) examined the incidence of TB 
among currently practicing physicians who graduated from California 
medical schools from approximately 1950 to 1979. Through mailed 
questionnaires, physicians were asked to provide information that 
included their year of graduation from medical school, BCG vaccination 
history, history of active TB, results of their tuberculin skin 
testing, and the number of patients they were exposed to with active TB 
within the past year. They were also asked to classify themselves as 
tuberculin positive or negative and to indicate the year of the last 
negative and first positive tuberculin test.
    Of the 6425 questionnaires mailed out, 4140 responses were received 
from currently practicing physicians. Twelve percent of the physicians 
had received the BCG vaccine. Sixty-one percent of the unimmunized 
physicians, who also had no history of active tuberculosis, considered 
themselves to be tuberculin negative. A total of 1542 (42%) reported 
themselves as having a positive response to the tuberculin skin test, 
with approximately 44 percent of those tuberculosis infections 
occurring before entering medical school. Of those infections occurring 
before entering medical school, approximately eight percent were 
reported as having been a result of contact following work experience 
in the hospital prior to entering medical school. For those physicians 
infected either during or after medical school, the sources of 
infection were reported as occurring as a result of a known patient 
contact (45.1%), an unknown contact (41.5%) and a non-patient contact 
(13.4%). In some cases, the nonpatient contact was reported as another 
physician or another hospital employee. Approximately one in ten of the 
physicians infected after entry into medical school developed active TB 
disease.
    The authors also examined the incidence of infection, measured as 
the conversion rates in those remaining negative at the end of 
different time intervals (e.g., the last three years of medical school 
and five to 10 years after graduation). This examination indicated that 
from 1950 to 1975, there was a 78% decrease in tuberculin conversion 
rates despite the expanding pool of susceptible medical students (i.e., 
an increasing number of medical students who were tuberculin negative). 
Yet despite this overall decrease in infection rates over a 25 year 
period, tuberculin conversion rates among recent graduates exceeded 1% 
per year and age-specific infection rates among all the physicians 
studied were more than twice that of the U.S. population at comparable 
ages. The authors did not obtain information from the physicians on 
what type of infection control measures were being used in the 
facilities where they acquired their infections.
    A similar analysis by Geisleler et al. (Ex. 7-46) evaluated the 
occurrence of active tuberculosis among physicians graduating from the 
University of Illinois medical school between the years 1938 and 1981. 
This study, also conducted by questionnaire, reported that among 4575 
physicians questioned, there were 66 cases of active TB, of which 23% 
occurred after 1970. Sixty-six percent of the cases occurred within 6 
years of graduation. In addition, the authors reported that in most 
years the incidence of TB was greater among these physicians than the 
general population.
    Weiss (Ex. 7-45) examined tuberculosis among student health nurses 
in a Philadelphia hospital. From 1935 to 1939, before the introduction 
of anti-TB drugs and the beginning of the general decline of TB in the 
United States, 100% conversion rates were observed among those students 
who were initially tuberculin negative. For example, of 643 students 
admitted, 43% were tuberculin negative. At the end of only 4 months, 
48% were tuberculin positive. At the end of 1 year, 85.9% were 
tuberculin positive and by the end of the third year 100% were 
positive. Of those students who converted during their student nursing 
tenure, approximately 5 percent developed active TB disease.
    A decline in the rate of infection was observed over the next 36 
years among student nurses at this hospital. The rates of infection 
were followed for ten classes of student nurses from 1962 to 1971. The 
students had little contact with patients during their first year but 
spent 4 weeks of their second year of training on the tuberculosis 
wards. Among those students initially tuberculin negative, the average 
conversion rate was 4.2% over the nine year period, ranging from 0 to 
10.2%. Of the students who converted, 0.6% developed active TB disease. 
The authors attributed the decreases in conversion rates to not only 
the general decrease in TB disease in the community, but also to the 
increased efficiency of surveillance of patients entering the hospital 
for the early identification of potential cases of TB and the increased 
efficiency of isolation

[[Page 54177]]

for TB patients. Despite the dramatic decreases in conversion rates 
among these student nurses, conversion rates were observed at levels as 
high as 10% for a given year, indicating that while the infection rates 
had decreased substantially since 1939, there still remained a 
significant amount of occupational transmission of TB in 1971. 
Moreover, this study shows that short term exposure, i.e., 4 weeks, is 
capable of infecting hospital employees.
    Similar rates of conversion among hospital employees initially 
tuberculin negative were observed in a 1977 study by Ruben et al. (Ex. 
7-43) which analyzed the results of a tuberculin skin testing program 
31 months after its inception at a university hospital in Pittsburgh. 
Of 626 employees who were tested twice with the tuberculin skin test, 
28 (4.5%) converted from negative to positive. The employees were 
classified as either having a ``presumed high degree of patient 
exposure'' or a ``presumed low degree of patient exposure''. Employees 
presumed to have high patient exposure included nurses, X-ray and 
isotope laboratory personnel and central escort workers. Employees 
presumed to have low exposure included secretaries, persons in 
housekeeping and dietary work, and business office, laundry and central 
supply personnel. The rates of conversion for employees with presumed 
high exposure (6%) and for employees with presumed low exposure (8%) 
were not significantly different. However, this study excluded 
physicians and medical and nursing students. These groups of employees 
would also presumably have had high exposure to patients since they are 
often the hospital staff most directly involved in administering 
patient care. Had these employees been included the number of 
conversions among employees with presumably high exposure may have been 
significantly increased.
    The study was not designed to determine the source of exposure for 
any of the employees who converted. However, the authors suggested that 
the high level of conversions among those employees with presumed low 
exposure to patients may have resulted from exposures at home. A 
majority of this group was comprised of housekeeping staff who were of 
low socio-economic status. The authors also suggested that unrecognized 
cases of tuberculosis may be playing an important role in the 
occupational transmission of TB in the hospital.
    Unrecognized cases of TB have been shown to play a significant role 
in the outbreak of TB in a general hospital. In 1972, Ehrenkranz and 
Kicklighter (Ex. 5-15) reported a case study in which 23 employees 
converted after exposure to a patient with an undetected case of 
tuberculosis bronchopneumonia. In this study, the source case was an 
individual who was admitted to the emergency room with pulmonary edema. 
Upper lobe changes of the lung were noted in the chest X-ray, and TB 
was mentioned as a possible cause. However, no sputum cytology was 
conducted. The patient spent 3 hours in the emergency room, 57 hours in 
a private room and another 67 hours in intensive care until his death. 
Treatment of the patient included intubation with an endotracheal tube 
and vigorous nasotracheal suctioning. It was only upon microscopic 
examination of tissue samples of the lung and lymph nodes after the 
autopsy of the patient that tuberculosis mycobacteria were detected.
    Employees who worked in the emergency room, the intensive care unit 
and on the floor of the private room (NW 3) and who were also 
tuberculin negative before the admission of the patient, were retested 
to detect possible conversion. In addition, 21 initially tuberculin 
negative employees on an adjacent floor (NW 2) were also retested. Of 
the 121 employees tested, 24 were identified as having converted to 
positive status (21 working on NW 3, 2 working in the intensive care 
unit and 1 working on NW 2). No conversions were observed among those 
working in the emergency room.
    The employees who were retested were classified as either having 
close contact (e.g., providing direct care), little contact (e.g., more 
distant contact), unknown contact (e.g., no record or recollection of 
contact) or indirect contact (e.g., in the same room a day or two after 
the patient's stay). Conversions occurred in 50% (13 of 26) of those 
employees with close contact, 18.5% (6 of 33) of those with little 
contact, 21.4% (3 of 14) of those with unknown contact and 3.7% (1 of 
29) of those with indirect contact.
    While the majority of conversions seems to have occurred in those 
employees on NW 3 who had close or little contact, there also were 
employees with more distant contact who were infected. An analysis of 
the ventilation of NW 3 indicated that the central air conditioning 
recycled 70% of the air with no high efficiency filter and no record of 
balancing the air conditioning system, thus allowing the air from the 
patients' rooms to mix with and return to the central corridor air. In 
addition, smoke tube tests detected direct air flow from the patients' 
rooms to the hall corridor. Perhaps the more important factor was that 
the patient was not diagnosed with infectious TB until after his death, 
by which time he had already infected 24 employees.
    These earlier studies illustrate that despite the decrease in TB 
morbidity since the advent of anti-tuberculosis drugs in the 1940's, 
occupational transmission of TB continues to be a problem. In addition, 
while many improvements have been made in infection control procedures 
for TB in hospitals, evidence of occupational transmission of TB 
continues to be reported.

Hospitals--1985 to Present

    As discussed above, the transmission of TB has been well 
established as an occupational hazard in the hospital setting. Many 
improvements were made in infection control practices. However, the 
resurgence in TB from 1985 to 1992 has brought to attention the fact 
that many TB control measures have not been implemented or have been 
inadequately applied. These studies demonstrate that TB continues to be 
an occupational hazard in the hospital setting. In addition, similar to 
the earlier studies, the more recent data show that the lack of early 
identification procedures and the lack of appropriate ventilation, 
performance of high-hazard procedures under uncontrolled conditions and 
the lack of appropriate respiratory protection have resulted in the 
infection of employees and in some cases the development of active 
disease. The more current outbreaks are even more troubling due to the 
emergence of multidrug-resistant forms of TB disease, which in some 
cases have resulted in fatality rates approaching 75%.
    In a 1985 study, Chan and Tabak (Ex. 7-3) investigated the risk of 
TB infection among physicians in training at a Miami hospital. In this 
study a survey was conducted among 665 physicians in training who were 
in their first four years of postgraduate training. Only 404 responded 
to the survey, of which 13 were illegible. Another 72 were excluded 
because they had received the BCG vaccination. Of the remaining 319 
physicians, 55 were tuberculin positive.
    Of the 279 who were tuberculin negative at the beginning of their 
post graduate training, 15 were excluded because they had more than 
four years of training and 43 were excluded because they had not had 
repeat skin tests. Of the 221 remaining available for evaluation, 15 
converted to positive tuberculin status, of which two developed active 
disease.
    The overall conversion rate for these physicians was 6.79%. In 
addition, the

[[Page 54178]]

authors observed a positive correlation between the rate of conversion 
and the duration of postgraduate training. The conversion rate 
increased with the duration of training, beginning with a cumulative 
percentage of conversion of 2.06% in the first year, 8.62% in the 2nd 
year, 11.11% in the third year and 14.29% in the fourth year, resulting 
in a linear conversion rate of 3.96% per year. As noted by the authors, 
this linear increase suggests the hospital environment as the source of 
the infection. In addition, the prevalence rate of conversions in the 
hospital (17.24%) was much higher than would have been expected in the 
community for individuals of the same age.
    The authors suggested that these high rates of conversion may have 
been a result of the fact that the hospital in this study encounters 5 
to 10 times more active TB cases than most other urban hospitals. In 
addition, the physicians in training also are expected to be the first 
in line to perform physical evaluations and evaluate body fluids and 
secretions. While the authors did not go into detail about what, if 
any, TB infection control precautions were taken by these physicians in 
training, they did note that the evaluation of body fluids and 
secretions was often done in poorly ventilated and ill-equipped 
laboratories.
    Increased rates of conversion were observed among employees in a 
New Orleans hospital in a 1986 study by Ktsanes et al. (Ex. 7-6). 
Similar to Miami, New Orleans also has a high rate of TB in the 
community. This study examined the skin test conversions among a cohort 
of 550 new employees who were followed for five years after assignment 
to the adult inpatient services. Of these 550 employees who were 
initially tuberculin negative, 17 converted to positive status over the 
five-year study period, resulting in an overall five-year cumulative 
conversion probability of 5.2%.
    Regression analyses were done to examine potential contributing 
factors. Factors examined in the regression model included race, job, 
age at employment, and department. Only race (i.e., black vs. white 
employees) and job (i.e., nursing vs. other jobs) were found to be 
associated with skin test conversion. To further examine the potential 
job effect, conversions among blacks in nursing and blacks in other 
jobs were compared. Overall, the cumulative probability of converting 
was higher among blacks in nursing, suggesting that the acquired 
infections resulted from employment at the hospital rather than from 
the community at large. The authors thus concluded that there is an 
increased risk of occupational transmission of TB in TB-prevalent areas 
for those in close patient contact jobs.
    In 1989, Haley et al. (Ex. 5-16) conducted a case study of a TB 
outbreak among emergency room personnel at a Texas hospital. In this 
study, a 70 year old male diagnosed with pulmonary TB and undergoing 
treatment was diverted, due to respiratory arrest, to Parkland Memorial 
Hospital while in route to another hospital. The man was admitted to 
the emergency room for approximately 4 hours until he was stabilized. 
Afterwards, the patient was placed in an intensive care unit, where he 
remained for 2 months until his death.
    Six cases of active TB developed among emergency room employees 
after exposure to the TB patient, i.e., the index case. Five of these 
were among nurses who recalled contact with the index patient and a 
sixth case was an orderly who may have been infected from one of the 
employee TB cases. In addition, a physician exposed while administering 
treatment in the intensive care unit also developed active disease.
    Skin test conversions were evaluated for the 153 employees of the 
emergency room. Of 112 previously negative employees, 16 had positive 
skin tests, including 5 nurses diagnosed with active TB. Fifteen of the 
conversions were a result of exposure to the index case. Skin tests 
were also evaluated for physicians in the intensive care unit. Of 21 
resident physicians, two of whom had intubated the index patient, five 
had newly positive reactions to the tuberculin skin tests. One of the 
remaining three residents later developed active disease.
    The authors attributed the outbreak to several factors. First, the 
index case had a severe case of pulmonary TB in which he produced 
copious amounts of sputum. Second, sixty percent of the emergency room 
air was recirculated without filtration adequate to remove TB bacilli, 
allowing for the recirculation of contaminated air. Finally, employees 
in the emergency room were provided surgical masks that were 
ineffective for protecting against transmission of airborne TB droplet 
nuclei. This study illustrates that the lack of effective measures for 
controlling TB transmission can result in the infection and development 
of active disease in a relatively high number of employees even after 
exposure to only one case of active TB.
    Similarly, the lack of effective controls while performing high-
hazard, cough-inducing procedures on individuals with infectious TB has 
also been shown to result in an increased risk of TB transmission. A 
1990 report by Malasky et al. (Ex. 7-41) investigated the potential for 
TB transmission from high-hazard procedures by examining tuberculin 
skin test conversion rates among pulmonary physicians in training. In 
this study, questionnaires were sent annually, for 3 years, to training 
programs located in the top 25 cities for TB in 1983. The purpose of 
the study was to compare the conversion rates of pulmonary disease 
fellows to the conversion rates of infectious disease fellows. It was 
presumed that both groups have contact with patients with TB but that 
pulmonary disease fellows are usually more involved with invasive 
procedures such as bronchoscopies. Information requested on the 
questionnaires included the type of fellowship (i.e., pulmonary or 
infectious disease fellow), prior tuberculin skin test status, 
tuberculin status by the Mantoux technique at the end of the 3 year 
fellowship program, history of BCG vaccination, age, sex and ethnicity. 
In addition, the pulmonary disease fellows were asked to give 
information on the number of bronchoscopies they performed and their 
use of masks during the procedure.
    Fourteen programs submitted data that were usable. Only programs 
that had both pulmonary and infectious disease fellows in the same 
system were used for the study. From this information, it was observed 
that 7 of 62 (11%) of the pulmonary fellows at risk converted their 
tuberculin skin test from negative to positive during the two year 
training period. In contrast, only 1 of 42 (2.4%) of the infectious 
disease fellows converted. The expected conversion rate from previous 
surveys was 2.3%. In addition, the pulmonary disease fellows were 
grouped according to tuberculin skin status. Skin test status was 
evaluated for its relationship to the number of bronchoscopies 
performed and the pattern of mask usage. No correlations were found 
with these factors and tuberculin skin status at the end of the 
fellowship. The authors suggested that the lack of correlation between 
mask usage during bronchoscopies and skin test conversion implies that 
masks worn by physicians may be inadequate. While little information 
was presented to evaluate this suggestion, the study does suggest that 
high-hazard procedures such as bronchoscopies that induce coughing, 
performed under uncontrolled conditions, present a risk for TB 
transmission.
    Pearson et al. (1992) conducted a case-control study to investigate 
the factors associated with the development of MDR-TB among patients at 
a New

[[Page 54179]]

York City hospital (Ex. 5-24). As a part of this study, tuberculin skin 
test conversion rates were compared among health care workers assigned 
to wards where patients with TB were frequently admitted (e.g., HIV 
unit, general medical ward, respiratory therapy) or rarely admitted 
(operating room, orthopedic ward, outpatient clinic, psychiatry ward). 
In addition, infection control procedures and ventilation systems were 
evaluated.
    Of 79 health care workers who were previously negative, 12 (15%) 
had newly positive skin tests. Those health care workers who were 
assigned to wards where patients with TB were frequently admitted were 
more likely to have skin test conversions (i.e., 11 of 32) than health 
care workers assigned to wards where patients with TB were rarely 
admitted (i.e., 1 of 47).
    Evaluations of the infection control procedures and ventilation 
systems revealed that patients who were receiving isolation precautions 
for suspected or confirmed TB were allowed to go to common areas if 
they wore a surgical mask. However, many of the patients did not keep 
their masks on when out of their rooms. In addition, neither the 
isolation rooms nor rooms used for cough-inducing procedures were under 
negative pressure, thus allowing contaminated air to exhaust to the 
adjacent corridors.
    Edlin et al. (1992) (Ex. 5-9) investigated an outbreak of MDR-TB in 
a New York hospital among patients with acquired immunodeficiency 
syndrome (AIDS). This study compared the exposure period of AIDS 
patients diagnosed with MDR-TB to the exposure period of AIDS patients 
with drug-susceptible TB. The date of diagnosis was defined as the date 
the sputum sample was collected from which tuberculosis bacteria were 
grown in culture. Patients were assumed to be infectious two weeks 
before and two weeks after the date of diagnosis. The period of 
exposure was the period in which the patient may have been infected 
with TB. Because of the rapid progression from infection to disease, 
the exposure period was defined as 6 months preceding the date of 
diagnosis, excluding the last two weeks.
    The patients with MDR-TB were found to be more likely to have been 
hospitalized during their exposure periods. Those who were hospitalized 
were more likely to have been on the same ward and on the same day as a 
patient with infectious TB and were more likely to have been near a 
room housing an infectious patient. Examination of the infectious 
patients' rooms revealed that only 1 of 16 rooms had negative pressure. 
Based on this evidence, the authors concluded that the observed cases 
of MDR-TB were a likely result of infections acquired in the hospital 
(i.e., primary TB) rather than as a result of the reactivation of 
infections acquired in the past. The authors attributed these 
nosocomial infections to the lack of adherence to recommended infection 
control procedures.
    While the primary focus of this study was to investigate the 
transmission of TB among patients, the increased likelihood of 
nosocomial infections among patients in the hospital would seem equally 
likely to apply to health care workers working in the same environment. 
A survey of tuberculin skin test conversions revealed an 18% conversion 
rate for health care workers who previously had negative skin tests and 
were present during this outbreak of MDR-TB. Although no statistics 
were reported, the authors stated that the pattern of skin test 
conversions suggested an ongoing risk over time rather than a recent 
increase during the outbreak period.
    Based on an earlier 1990 report from the CDC (Ex. 5-22), Beck-Sague 
et al. 1992 (Ex. 5-21) conducted a case-control study to investigate an 
outbreak of MDR-TB among the staff and patients in a HIV ward and 
clinic of a Miami hospital. As part of the overall study the authors 
compared the skin test conversion rates of health care workers in the 
HIV ward and clinic to the skin test conversion rates of health care 
workers in the thoracic surgery ward where TB patients were rarely 
seen. In addition, the authors also evaluated the relationship between 
the presence of patients with infectious MDR-TB and patients with 
infectious drug-susceptible TB on the HIV ward and the risk of skin 
test conversion among the HIV ward health care workers. Infection 
control procedures in the HIV ward and clinic were also examined.
    All patients with suspected or confirmed TB were placed in 
isolation. However, some patients whose complaints were not primarily 
pulmonary and whose chest X-rays were not highly suggestive of TB were 
not initially suspected of TB and were not placed in isolation. 
Patients who were admitted to isolation rooms were allowed to leave TB 
isolation 7 days after the initiation of chemotherapy regardless of 
clinical or bacteriologic response. Thus, in some instances, patients 
with MDR-TB were allowed to leave isolation while they were still 
infectious, before drug resistance was recognized. In addition, 
patients in isolation rooms sometimes left the doors open, left their 
rooms, and/or removed their masks while outside their rooms. Patients 
with TB who were readmitted to the HIV ward and who were receiving 
anti-TB drugs were not admitted to isolation. In some cases, these 
patients were later found to have infectious MDR-TB.
    An environmental assessment of the ventilation revealed that among 
23 rooms tested with smoke tubes, 6 had positive pressure and many of 
the rooms under negative pressure varied from negative to positive 
depending on the fan setting and whether the bathroom door was open. 
Aerosolized pentamidine administration rooms were also found to have 
positive pressure relative to adjacent treatment areas. In addition, 
the sputum induction rooms were found to recirculate air back to the 
HIV clinic.
    Skin test conversions were evaluated for all health care workers 
(i.e., nurses and clerical staff) who tested negative on the tuberculin 
skin test before the outbreak period, March 1988 through April 1990. 
Health care workers on the HIV ward and in the HIV clinic exhibited a 
significantly higher rate of skin test conversion than health care 
workers on the thoracic surgery ward (e.g., 13/39 vs. 0/15). Ten of the 
conversions occurred among the 28 health care workers in the HIV ward. 
Among these health care workers, the authors reported a significant 
correlation between the risk of infection in health care workers and 
the number of days that patients with infectious MDR-TB were 
hospitalized on the HIV ward. No correlation was observed between the 
risk of infection among health care workers on the HIV ward and the 
number of days that patients with infectious drug-susceptible TB were 
hospitalized on the ward.
    Based on skin test conversions and the evaluation of infection 
control practices in the HIV ward and clinic, the authors concluded 
that the health care workers most likely were infected by patients on 
the HIV ward with MDR-TB. The factors most likely contributing to this 
increased risk of infection included: (1) The prolonged infectiousness 
and greater number of days that patients with infectious MDR-TB were 
hospitalized, (2) the delayed recognition of TB and failure to suspect 
infectious TB in patients receiving what proved to be ineffective anti-
TB treatment, (3) the inadequate duration of, and lapses in, isolation 
precautions on the HIV ward, and (4) the lack of negative pressure 
ventilation in isolation and treatment rooms. While the evidence in 
this study primarily points to the transmission of MDR-TB

[[Page 54180]]

from patients to health care workers, many of the problems identified 
with infection control procedures and ventilation would also increase 
the risk of acquiring drug-susceptible TB.
    In addition to MDR-TB outbreak investigations in Miami, in 1993 the 
CDC reported an outbreak in New York City in which health care workers 
became infected after being exposed to patients with MDR-TB (Ex. 6-18). 
In this investigation, for the period December 1990 through March 1992, 
32 patients were identified with MDR-TB. Twenty-eight of these patients 
had documented exposure to an undiagnosed infectious MDR-TB patient 
while all of them were in the HIV ward of the hospital.
    During November 1991, health care workers who were assigned to the 
HIV inpatient unit and who were also previously negative on the 
tuberculin skin test, were given an additional skin test. Of 21 health 
care workers tested, 12 (57%) had converted to positive status (7 
nurses, 4 aides and 1 clerical worker). None of the health care workers 
had used respiratory protection.
    An investigation of infection control practices revealed that of 32 
patients with MDR-TB, 16 were not initially suspected of TB and in 
these cases isolation precautions either were not used or were 
instituted late during the patients' hospitalization. In addition, 
patients who were admitted to isolation frequently left their rooms and 
when in their room the doors were frequently left open. Moreover, all 
rooms were found to be under positive pressure relative to the hall. 
Thus, similar to the findings in Miami, the results of this study 
indicate that the inability to properly isolate individuals with MDR-TB 
and also the use of inadequate respiratory protection may increase the 
risk of infection among health care workers.
    Undiagnosed cases may also present a significant source for 
occupational transmission of TB. A case study by Cantanzaro (Ex. 5-14) 
described an outbreak of TB infection among hospital staff at a San 
Diego hospital where the hospital staff were exposed to a single 
patient with undiagnosed TB. In this case, a 64 year old man suffering 
from generalized seizures was transferred from a local jail to the 
emergency room and later admitted to a four bed intermediate care unit. 
While in the intermediate care unit he was treated with anticonvulsants 
but continued to have seizures accompanied with vomiting. He was 
therefore placed in intensive care where he underwent a variety of 
procedures including bronchoscopies and endotracheal intubation. During 
his stay, he received frequent chest therapy and suctioning. Three 
sputum samples were taken from the patient for smears and cultures. All 
AFB smears were negative. However, two cultures were positive for 
tuberculosis.
    Despite the presence of positive cultures the patient was not 
diagnosed with active TB. The problem was not recognized until a 
physician on staff later developed symptoms of malaise and slight cough 
and requested a tuberculin skin test and was found to be positive. 
Because the physician had been tuberculin negative 8 months earlier, a 
contact investigation was initiated. As a part of this investigation, 
all employees who previously had negative tuberculin tests and who also 
worked in the intermediate and intensive care units where the patient 
had been treated were given repeat skin tests. Of 45 employees who 
previously had negative tuberculin skin tests, 14 (31%) converted to 
positive status (6 physicians, 3 nurses, 2 respiratory therapists and 1 
clerk). Ten of these conversions were among the 13 previously 
tuberculin negative staff members who were present at the time 
bronchoscopies  were  conducted  (10/13=76.9%). Four of the conversions 
were among 32 susceptible staff members who were not present at the 
bronchoscopies (4/32=12.5%). The author thus concluded that being 
present during the bronchoscopy of the patient was a major risk factor 
in acquiring the TB infection. However, the evidence did not show a 
significant correlation between skin test conversion and the type of 
exposure, i.e., close (administered direct contact) versus casual (in 
the room) contact. Thus, people who were present in the room during the 
bronchoscopy had an equal risk of infection as those administering 
direct patient care, presumably, as the author suggests, because 
droplet nuclei can disperse rapidly throughout the air of a room.
    Similarly, Kantor et al. (Ex. 5-18) reported an outbreak of TB 
infection among hospital staff exposed to a single undiagnosed case of 
TB. The index case in this investigation was a 50 year old man who was 
admitted for lung cancer and was receiving chemotherapy, steroids and 
radiation treatment. After a month of treatment, the patient complained 
of a cough and chest pain and was found to have emphysema requiring 
additional drug treatment and a chest tube. However, even after the 
emphysema resolved, the patient complained of weakness, loss of 
appetite and fever. A sputum culture and smear were conducted for 
mycobacteria and found to be negative. Lung X-rays were found to be 
irregular but were attributed to the lung cancer. Upon his death the 
autopsy revealed extensive necrosis in the lung but tuberculosis was 
not suspected. Thus, no cultures for mycobacteria were performed and no 
infection control procedures were initiated. It was only upon 
histological examination of tissue samples one month later that the 
presence of TB was confirmed. Five months later one of the staff 
performing the autopsy developed active TB. His only history of 
exposure was to the index case.
    As a result, a contact investigation was initiated for hospital 
personnel who had shared air with the patient during his stay, 
including the autopsy staff. Of susceptible hospital staff (i.e., those 
not previously found to react positive to the tuberculin skin test), 
infection developed in 9 of 56 (16%) exposed employees (4 autopsy 
staff, 4 nursing staff and 1 radiology staff). Only 3 of 333 unexposed 
personnel were found to have converted to positive tuberculin status at 
the hospital during the same period of investigation, thus indicating a 
17.8 fold increase in the infection rate for the exposed group.
    Undiagnosed cases of TB at time of autopsy were also indicated as 
the likely cause for development of active TB among staff and students 
in an autopsy room in a Swedish hospital (Ex. 5-19). In this study, 
three medical students and one autopsy technician, who were present 
during the autopsy of a patient with previously undiagnosed pulmonary 
TB, developed active TB. Both the medical students and the autopsy 
technician had previously received the BCG vaccine but none had any 
other known contact with a tuberculosis subject. Thus, it was concluded 
that the tuberculosis infections were most likely to have been 
transmitted during the autopsy. The findings of this study further 
illustrate the risks that undiagnosed cases of active TB present to 
health care workers. The lack of recognition of an active case of TB 
often results in a failure to initiate appropriate infection control 
procedures and provide appropriate personal protective equipment. In 
addition, this study illustrates that, while TB is most often 
transmitted by individuals with infectious pulmonary TB who generate 
droplet nuclei when they cough or speak, the autopsy procedures on 
deceased individuals with pulmonary TB may also aerosolize bacteria in 
the lungs and generate droplet nuclei.
    Exposure during autopsy procedures was also suspected as a possible 
route of TB transmission in an upstate New

[[Page 54181]]

York Medical Examiner's Office (Ex. 7-152). This Medical Examiner's 
Office conducted autopsies on deceased inmates from upstate New York 
prisons. In 1991, the same year that an outbreak of MDR-TB occurred 
among inmates from an upstate New York prison, the Medical Examiner's 
office conducted autopsies on 8 inmates with TB, six of whom had 
infectious MDR-TB at death and who were also HIV positive and had 
disseminated TB disease.
    Skin tests were administered to employees who had worked for at 
least one month during 1991 at the Medical Examiner's Office. Among 15 
employees who had originally tested negative on a baseline skin test, 2 
were found to have converted. These two employees worked as morgue 
assistants and had recent documented exposure to persons with extensive 
disseminated MDR-TB. No potential exposure to TB outside the Medical 
Examiner's Office could be found.
    The autopsy area of the office had a separate ventilation system. 
However, air was returned to a common air plenum, allowing the air to 
mix between the autopsy area and other areas of the office. In 
addition, the autopsy room was found to be at positive pressure 
relative to the adjacent hallway. Employees performing or assisting at 
autopsies on persons known to be infected with HIV were required to 
wear plastic gowns, latex gloves and surgical masks. Particulate 
respirators were not required until November of 1991, after the 
installation of germicidal UV lamps. However, this was after the last 
MDR-TB autopsy. This study suggests that the conversion of these two 
morgue assistants occurred as a result of exposure to aerosolized M. 
tuberculosis resulting from autopsy procedures, either as a result of 
participation in an autopsy in the autopsy area or from exposure to air 
contaminated with aerosolized M. tuberculosis that was exhausted into 
other areas of the Medical Examiner's Office.
    In addition to autopsy procedures, other procedures, such as the 
irrigation of abscesses at sites of extrapulmonary TB, can result in 
the generation of droplet nuclei. An outbreak investigation in an 
Arkansas hospital (Ex. 5-17) reported the transmission of TB among 
hospital employees exposed to a patient with a tuberculous abscess of 
the hip and thigh. In this study, the source case was a 67 year old man 
who was admitted to the hospital with a fever of unknown origin and 
progressive hip pain. The patient did not present any signs of 
pulmonary TB; however, the examination of soft tissue swelling in the 
hip area revealed an abscess that required drainage and irrigation. Due 
to the suspicion of TB, specimens for AFB smear and culture were 
obtained and the patient was placed in isolation. While in isolation, 
drainage from the abscess continued and irrigation of the abscess 
cavity was initiated on an 8-hour schedule. After four days, acid fast 
bacilli were observed in the AFB smears and TB therapy was begun. The 
patient remained in isolation until his death except for three days 
that he spent in the Intensive Care Unit (ICU) due to high fever.
    An investigation of skin test surveys among the hospital employees 
revealed 55 skin test conversions among 442 previously nonreactive 
employees and 5 conversions among 50 medical students. In addition, 5 
of the employees who had conversions also had active TB, including one 
who developed a tuberculous finger lesion at the site of a needle-stick 
injury incurred during the incision and drainage of the patient's 
abscess. All the skin test converters, except for two, recalled 
exposure to the source case. Of the 442 susceptible employees, 108 
worked at least one day on one of the floors where the patient stayed 
(i.e., the surgical ward, the medical floor of the patient's room and 
the ICU). Four (80%) of 5 surgical suite employees who had direct 
contact with the patient through their assistance with the incision and 
irrigation of the patient's abscess had skin test conversions. In 
addition, 28 (85%) of 33 employees on the general medical floor and 6 
(30%) of 20 ICU employees had skin test conversions. All those 
employees converting recalled exposure to the patient, some of whom had 
no direct contact with the patient.
    Environmental studies revealed that two of the areas in which the 
patient stayed during his hospitalization did not have negative 
pressure. The isolation room was under positive pressure relative to 
adjacent rooms and the corridor. In addition, the patient's cubicle in 
the ICU had neutral pressure relative to the rest of the ICU. Employees 
in these two areas had skin test conversions even in cases where there 
was no direct patient contact. The lack of negative pressure was 
thought to have significantly contributed to the dispersion of droplet 
nuclei generated from the irrigation of the tuberculous abscess. In the 
surgical ward, air was directly exhausted to the outside. However, all 
employees present in the surgical ward when the patient was being 
treated had direct contact with the patient. There was no indication 
that the surgical staff had taken any special infection control 
precautions or had worn any personal protective equipment.
    Thus, similar to other outbreak investigations, the lack of 
appropriate ventilation and respiratory protection stand out as the key 
factors in the transmission of TB to employees who are exposed to 
individuals with infectious TB. Moreover, this particular case study 
demonstrates that certain forms of extrapulmonary TB in conjunction 
with aerosolizing procedures, e.g., the irrigation of a tuberculous 
abscess, have the potential for presenting significant airborne 
exposures to M. tuberculosis.
    Other aerosolizing procedures have also shown evidence of 
presenting airborne exposures to M. tuberculosis. For example, tissue 
processing was associated with the skin conversion of two pathologists 
working at a community hospital in California (Ex. 6-27). In this case 
study, after autopsy, a 62 year old man who had died from bronchogenic 
carcinoma was discovered to have a caseating lung lesion. A stain 
revealed a heavy concentration of acid-fast bacilli, which were 
identified in culture as M. tuberculosis. As a result, a contact 
investigation was initiated.
    This investigation found twenty employees who had contact with the 
patient, including two pathologists and a laboratory assistant. All 
were given a tuberculin skin test and found to be negative. However, 
after follow-up skin testing three months later, the two pathologists 
had converted. Other than contact with the source case, the two had no 
other obvious sources of infection. One of the pathologists had been 
present at the autopsy. Both pathologists were present when the frozen 
lung sections were prepared. During this process, the lung tissue was 
sprayed with a compressed gas coolant, which created a heavy aerosol. 
Masks were not routinely worn during this tissue processing. The 
investigators suspected that this aerosol promoted the transmission of 
TB and was the likely cause of the observed infections.
    While much of the health effects literature has focused on 
outbreaks of TB or MDR-TB, a more recent study investigated the status 
of infection control programs among ``non-outbreak'' hospitals (Ex. 7-
147). Investigators from the Society of Health care Epidemiology of 
America (SHEA) and the CDC surveyed members of SHEA to assess 
compliance in the respondents' hospitals with the 1990 CDC Guidelines 
for Preventing the Transmission of TB in Health Care Facilities for the 
years 1989 to 1992. The survey included questions on tuberculin skin 
testing programs (e.g., frequency of testing,

[[Page 54182]]

positivity at hire, and percent newly converted), AFB isolation 
capabilities (e.g., negative pressure, air changes per hour, HEPA 
filtration) and respiratory protection.
    The survey showed that of the 210 hospitals represented by the SHEA 
members' survey results, 193 (98%) admitted TB patients from 1989 to 
1992, 40% of which had one or more patients with MDR-TB. In addition, 
the proportion of hospitals caring for drug susceptible TB patients 
rose from 88% to 92% and the proportion of hospitals caring for MDR-TB 
patients rose from 5% to 30%. While the number of hospitals caring for 
TB patients increased, the majority of those hospitals cared for a 
small number of patients. In 1992, approximately 89% of the hospitals 
reported 0 to 25 patients per year, while approximately 5% reported 
greater than 100 patients per year.
    Few hospitals reported routine tuberculin skin testing for each of 
the years surveyed. For example, while 109 (52%) of the responding 
hospitals reported tuberculin skin test results for at least one of the 
years from 1989 to 1992, only 63 (30%) reported results for each of 
these years. When examining the conversion rates over time from 1989 to 
1992, the investigators limited their analysis to the 63 hospitals 
reporting skin test data for each of these 4 years. Among these 
hospitals the median percentage of employees newly converting to 
positive skin test status remained constant over the 4 year period at 
approximately 0.34% per year (i.e., 3/1000 per year). However, when 
including all hospitals in the analysis, from 1989 to 1992, the number 
of hospitals reporting conversion rates increased from 63 to 109 and 
the conversion rates increased from 0.26% (i.e., 2/1000) to 0.50% 
(i.e., 5/1000).
    With regard to AFB isolation capabilities, 62% of 181 responding 
hospitals reported that they had isolation facilities consistent with 
the 1990 CDC TB Guidelines (i.e., single-patient room, negative 
pressure, air directly exhausted outside, and 6 air changes 
per hour). Sixty-eight percent of the reporting hospitals had isolation 
facilities meeting the first three of these recommendations. For 
respiratory protection, the majority of health care workers in the 
hospitals used surgical masks. However, there was an increase in the 
use of dust-mist or dust-mist-fume respirators. The use of dust-mist 
respirators increased from 1 to 13% from 1989 to 1992 and the use of 
dust-mist-fume respirators increased from 0 to 10% for the same period. 
The only use of high efficiency particulate air (HEPA) filter 
respirators was by bronchoscopists and respiratory therapists at 4 
hospitals.
    As a second phase of this investigation, the survey responses were 
analyzed to determine the efficacy of the TB infection control programs 
among the member hospitals participating in the survey (Ex. 7-148). In 
this analysis, the reported conversion rates were compared to reported 
infection control measures (i.e., AFB isolation capabilities and 
respiratory protection). For purposes of comparison, hospitals were 
categorized as having either less than or 6 TB patients, 
less than or 437 beds, and admitting or not admitting MDR-TB 
patients.
    Conversion rates were higher among health care workers from 
hospitals with 437 beds than among health care workers from 
smaller hospitals (0.9% vs. 0.6%, p0.05). This difference 
was more pronounced among ``higher-risk'' health care workers (i.e., 
health care workers including bronchoscopists and respiratory 
therapists). ``Higher-risk'' health care workers from hospitals with 
437 or more beds had a 1.9% conversion rate compared to a conversion 
rate of 0.2% for ``higher-risk'' health care workers from smaller 
hospitals. Similarly, health care workers from hospitals where 6 or 
more TB patients were admitted per year had higher conversion rates 
than health care workers from hospitals with fewer than 6 TB patients 
per year (e.g., 1.2% vs. 0.6%).
    For hospitals with 6 or more TB patients, conversion rates also 
varied depending on the level of TB infection control practices that 
were in place in the hospital. For example, among hospitals with 6 or 
more TB patients and whose AFB isolation capabilities included at least 
single-room occupancy, negative pressure and directly exhausted air, 
the conversion rates among health care workers were lower than the 
conversion rates among health care workers at hospitals with 6 or more 
TB patients but which did not have similar isolation capabilities 
(0.62% vs. 1.83%, p=0.03). For respiratory protection, however, no 
differences in conversion rates were observed among health care workers 
wearing surgical masks (0.94%) and health care workers using submicron 
surgical masks, dust-mist respirators or dust-mist-fume respirators 
(0.98%). Very few survey respondents reported use of HEPA filter 
respirators. For example, only four hospitals reported use of any HEPA 
respirators, and these were not the predominant type of respiratory 
protection used (Ex. 7-147). Thus, it is not possible to evaluate the 
efficacy of these particulate respirators in reducing conversion rates 
from the reported survey data.
    For hospitals with fewer than 6 TB patients or with fewer than 437 
beds, no differences in conversion rates were reported among health 
care workers from hospitals that had implemented AFB isolation 
capabilities such as single-room occupancy, negative pressure, or 
directly exhausted air and those hospitals that had not. The 
investigators suggested that this finding may support contentions that 
the efficacy of TB infection control measures vary depending on 
characteristics of the hospital or community exposure. However, given 
the small sample size of the survey, as well as the reduced potential 
for exposure in hospitals with fewer than 6 TB patients per year, it 
would be difficult to detect any differences in conversion rates among 
health care workers from hospitals with or without certain levels of 
infection control. Where more opportunity does exist for exposure 
(e.g., hospitals with 6 TB patients), this analysis does 
show that the implementation of TB infection control procedures can 
reduce the transmission of TB among health care workers.

Hospitals--Summary

    In summary, the evidence clearly shows that in hospital settings, 
employees are at risk of occupational exposure to TB. Various studies 
and TB outbreak investigations have shown that employees exposed to 
individuals with infectious TB have converted to positive tuberculin 
skin status and in some cases have developed active disease. In these 
reports, a primary factor in the transmission of TB has been a failure 
to promptly identify individuals with infectious TB so that appropriate 
infection control measures could be initiated to prevent employee 
exposure. In addition, another major factor identified as contributing 
to occupational exposures was the lack or ineffective implementation of 
appropriate exposure control methods (e.g., lack of negative pressure 
in isolation rooms, lack of appropriate respiratory protection for 
exposed employees, performance of high-hazard procedures under 
uncontrolled conditions). The lack of early identification and 
appropriate control measures resulted in the exposure and subsequent 
infection of various hospital employees. These employees included not 
only health care providers administering direct patient care to 
individuals with infectious TB, but also hospital staff providing 
support services

[[Page 54183]]

to the infectious individuals, hospital staff working in adjacent areas 
of the hospital using shared air, autopsy staff and laboratory staff 
working with infected culture and tissue samples.

Other Occupational Settings

    While hospitals have been historically recognized as the primary 
type of work setting where TB presents an occupational hazard, there 
are other work settings where the transmission of TB presents a hazard 
to workers. There are a variety of occupational settings in which 
workers can reasonably be anticipated to encounter individuals with 
active TB as a part of their job duties. Several work settings have 
been identified by the CDC where exposure to TB presents an 
occupational hazard: correctional facilities, long-term care facilities 
for the elderly, homeless shelters, drug treatment centers, emergency 
medical services, home-health care, and hospices. Similar to the 
hospital setting, these work settings have a higher number of 
individuals with active TB than would be expected for the general 
population. Many of the clients of these work settings have many 
characteristics (e.g., high prevalence of TB infection, high prevalence 
of HIV infection, intravenous drug use) that place them at an increased 
risk of developing active TB. These types of work settings are also 
similar to hospitals in that workers at these sites may also provide 
medical services and perform similar types of high-hazard procedures 
that are typically done in a hospital setting.
    In addition to employees who provide medical services in these 
other types of work settings, there are other types of workers (e.g., 
guards, admissions staff, legal counsel for prisoners) who may also be 
exposed to individuals with infectious TB. Similar to hospitals, these 
work settings have an over-representation of populations at high risk 
for developing active TB, e.g., individuals infected with HIV, 
intravenous drug users, elderly individuals, and individuals with poor 
nutritional status and who are medically underserved. In addition to 
having a higher percentage of individuals with TB infection and a 
higher percentage of individuals at an increased risk for developing 
active TB, many of these work settings also share environmental factors 
that facilitate the transmission of TB, such as overcrowding and 
inadequate ventilation, which increases the occupational hazard. The 
following discussion describes some of the studies available in the 
literature that have examined the occupational transmission of TB in 
other occupational settings such as those listed above. Not all the 
settings listed by the CDC as places where TB transmission may be 
likely to occur have been adequately studied and thus can not be 
included in this discussion. However, the discussion of the following 
sectors clearly demonstrates that the occupational transmission of TB 
is not limited to the hospital setting. Occupational settings where 
there is an increased likelihood of exposure to aerosolized M. 
tuberculosis present the same types of occupational hazards as have 
been documented in the hospital setting.

Correctional Facilities

    Many correctional facilities have a higher incidence of TB cases 
than occur in the general population. For example, the CDC reported 
that the incidence of TB among inmates of correctional facilities was 
more than three times higher than that for nonincarcerated adults aged 
15-64, based on a survey of TB cases in 1984 and 1985 by 29 state 
health departments (Ex. 3-33). In particular, among inmates in the New 
York correctional system, the TB incidence increased from an annual 
average of 15.4 per 100,000 during 1976 to 1978 to 105.5 per 100,000 in 
1986 (Ex. 7-80) to 156.2/100,000 for 1990-1991 (Ex. 7-137). Similarly, 
in 1987, the incidence of TB among inmates in New Jersey was 109.9 per 
100,000 (approximately 11 times higher than the general population in 
New Jersey) and in California the incidence of TB among inmates was 
80.3 per 100,000 (approximately 6 times higher than that for the 
general population for California) (Ex. 3-33). In 1989, the CDC 
reported that since 1985, eleven known outbreaks of TB have been 
recognized in prisons (Ex. 3-33).
    The increased incidence of TB in correctional facilities has been 
attributed to several factors (Ex. 7-25). One, correctional facilities 
have a higher incidence of individuals who are at greater risk for 
developing active TB. For example, the population in prisons and jails 
may be dominated by persons from poor and minority groups, many of whom 
may be intravenous drug users. These particular groups may also suffer 
from poor nutritional status and poor health care, factors that place 
them at increased risk of developing active disease. Two, special types 
of correctional facilities, such as holding facilities associated with 
the Immigration and Naturalization Services, may have inmates/detainees 
from countries with a high incidence of TB. For foreign-born persons 
arriving in the U.S., the case rate of TB in 1989 was estimated to be 
124 per 100,000, compared to an overall TB case rate of 9.5 per 100,000 
for the U.S. (Ex. 6-26). In 1995, TB cases reported among the foreign 
born accounted for 35.7% of the total reported cases, marking a 63.3% 
increase since 1986 (Ex. 6-34). Three, many correctional facilities 
have a high proportion of individuals who are infected with HIV. The 
CDC reported that in addition to the growing increase in AIDS among 
prisoners, the incidence of AIDS in prisons is markedly higher than 
that for the U.S. general population. In 1988, the incidence of AIDS 
cases in the U.S. population was 13.7 per 100,000 compared to an 
estimated aggregate incidence for state/federal correctional systems of 
75 cases per 100,000 (Ex. 3-33). Individuals who are infected with HIV 
or who have AIDS are at an increased risk of developing active TB due 
to their decreased immune capacity. The likelihood of pulmonary TB in 
individuals with HIV infection is reflected in the CDC's Revised 
Classification System for HIV infection (Ex. 6-30). In this revised 
classification system, the AIDS surveillance case definition was 
expanded to include pulmonary TB. Moreover, X-rays of individuals 
infected with HIV who have TB often exhibit radiographic irregularities 
that make the diagnosis of active TB difficult (Exs. 7-76, 7-77, 7-78, 
and 7-79). HIV-infected individuals may have concurrent pulmonary 
infections that confound the radiographic diagnosis of pulmonary TB. In 
addition, it may be difficult to distinguish symptoms of TB from 
Pneumocystis carinii pneumonia or other opportunistic infections. This 
difficulty in TB diagnosis can result in true cases of active TB going 
undiagnosed in this population. Undiagnosed TB has been shown to be an 
important cause of death in some patients with HIV infection (Ex. 7-
76). Fourth, environmental conditions in correctional facilities can 
aid in the transmission of TB. For example, many prisons are old, have 
inadequate ventilation systems, and are overcrowded. In addition, 
inmates are frequently transferred both within and between facilities, 
thus increasing the potential for the spread of TB infection among 
inmates and staff. This increased potential for mobility among inmates 
also enhances the likelihood that inmates undergoing therapy for active 
disease will either discontinue their treatment or inadequately follow 
their prescribed regime of treatment. The inadequacy of their treatment 
may give rise not only to relapses to an infectious state of active 
disease, but also potentially give rise to strains of MDR-

[[Page 54184]]

 TB. These strains of TB have a higher incidence of fatal outcome and 
are generally characterized by prolonged periods of infectiousness 
during which the risk of infection to others is increased.
    The high incidence of TB among the inmate population presents an 
occupational hazard to the staff in these types of facilities. Recent 
outbreak investigations by the CDC have documented the transmission of 
TB to exposed workers. In an investigation of a state correctional 
facility in New York for 1991 (Exs. 6-3 and 7-136), eleven persons with 
TB were identified (10 inmates and one correctional facility guard). 
Nine persons (8 inmates and the guard) had MDR-TB. All eight inmates 
were HIV positive. The guard was HIV negative; however, he was also 
immunocompromised as a result of treatment for laryngeal cancer. Seven 
of the inmates and the guard died from MDR-TB. The eighth inmate was 
still alive and receiving treatment for MDR-TB 2 years after being 
diagnosed as having the disease. DNA analysis identified the strains of 
tuberculosis bacteria from these individuals to be identical.
    The investigation revealed that the source case was an inmate who 
had been transferred from another prison where he had been previously 
exposed to MDR-TB. He arrived at the prison with infectious TB but 
refused evaluation by the infirmary staff. This inmate was placed in 
the general prison population where he stayed for 6 months until he was 
admitted to the hospital where he later died. However, before his 
hospitalization, he exposed two inmates living in his cell block who 
later developed MDR-TB. These two inmates continued to work and live in 
the prison until shortly before their final hospitalization. The other 
inmates who subsequently developed MDR-TB had several potential routes 
of exposure: social contact in the prison yard, contact at work sites 
in the prison, and contact at the prison infirmary where they shared 
rooms with other inmates before diagnosis with TB.
    The guard who developed MDR-TB had exposure to inmates while 
transporting them to and from the hospital. The primary exposure for 
this guard apparently occurred when he was detailed outside the 
inmates' room during their hospitalization for MDR-TB. The inmates were 
hospitalized in an isolation room with negative pressure. However, upon 
investigation it was discovered that the ventilation system for the 
room had not been working correctly and had allowed air to be exhausted 
to the hospital corridors and other patient rooms.
    A contact investigation in the prison was conducted to identify 
other inmates who might have been exposed during this outbreak of MDR-
TB. Of those inmates with previous negative tuberculin skin tests and 
without active disease (306), ninety-two (30%) had documented skin test 
conversions. There was no tuberculin skin test program for prison 
staff; therefore, conversions among prison employees could not be 
evaluated.
    The primary factors identified as contributing to this outbreak 
were deficiencies in identifying TB among transferred inmates, 
laboratory delays, and lapses in isolating inmates with active TB 
within the facility. Inmates with symptoms of active disease were not 
sent for evaluation in some cases until they became so ill they could 
not care for themselves. Some of these inmates were placed in the 
infirmary with other inmates until their diagnosis with TB. On other 
occasions, drug susceptibility testing was not reported until after an 
inmate's death, which means that appropriate patient management was not 
initiated.
    As a result of this outbreak, a retrospective epidemiological 
investigation was conducted to examine the potential extent and spread 
of MDR-TB throughout the New York State prison system during the years 
1990-1991 (Ex. 7-137). This investigation revealed that 69 cases of TB 
were diagnosed in 1990 and another 102 were diagnosed in 1991, 
resulting in a combined incidence of 156.2 cases/100,000 inmate years 
for 1990 and 1991 combined. Of the cases, 39 were identified as being 
MDR-TB, 31 of which were shown to be epidemiologically linked. Thirty-
three of the individuals with MDR-TB never received any treatment for 
MDR-TB, 3 were diagnosed at death, and 23 died before drug 
susceptibility results were known. These inmates were also discovered 
to be highly mobile. The 39 inmates lived in 23 different prisons while 
they were potentially infectious. Twenty transfers were documented for 
12 inmates with potentially infectious MDR-TB (9 shortly before 
diagnosis, one after diagnosis with TB but before diagnosis with MDR-
TB, and 2 after a diagnosis of MDR-TB).
    Several factors were identified as contributing to the spread of 
MDR-TB throughout the New York prison system: delays in identifying and 
isolating inmates, frequent transfers without appropriate medical 
evaluation, lapses in treatment, and delays in diagnosis and 
susceptibility testing.
    A similar investigation in a California state correctional 
institution identified three active cases of TB (two inmates and one 
employee) during September and October 1991 (Ex. 6-5). As a result, an 
investigation was commenced to determine whether transmission of TB was 
ongoing in the institution. Eighteen inmates with active TB were 
identified. TB in 10 of these inmates was recognized for the first time 
while they were in the institution during 1991, resulting in an annual 
incidence of TB of 184 per 100,000, a rate greater than 10 times that 
for the state (17.4 per 100,000). Two of the 10 inmates had negative 
tuberculin skin tests prior to their entry into the institution. Three 
of the cases were determined to have been infectious during 1991.
    A review of skin test data revealed that for the 2944 inmates for 
whom skin test results were available, 324 tested positive for the 
first time while in the prison system. Of these, 106 were tuberculin 
negative before their entry into the prison system, 96 of which 
occurred in the previous two years.
    The employee identified as having active TB had worked as a 
counselor on the prison's HIV ward, where he recalled exposure to one 
of the 3 infectious inmates. This employee could recall no known 
exposures outside the prison. Similarly, two other prison employees had 
documented skin test conversions while working at the prison. Neither 
recalled exposures outside the prison; one reported exposure to an 
inmate with possible TB.
    No information was provided in this report as to whether any 
isolation precautions were implemented at this facility. However, the 
investigators concluded that their findings suggested the likelihood 
that transmission of TB had occurred in the prison. Their conclusion 
was based on the fact that a substantial number of skin test 
conversions were documented among the inmates and that at least two 
inmates with active TB became infected while at the prison.
    The transmission of TB was also reported in another California 
prison among prison infirmary physicians and nurses and correctional 
officers (Ex. 6-6). In this investigation, an inmate with active MDR-TB 
spent 6 months during 1990-1991 in the infirmary. The infirmary had no 
isolation rooms and inmates' cells were found to be under positive 
pressure. Employees occasionally recalled wearing surgical masks when 
entering the rooms of TB patients.
    An analysis of available skin testing data revealed that of the 21 
infirmary health care providers, only 10 had been

[[Page 54185]]

tested twice during the period from 1987 to 1990. Of these 10, two were 
newly positive, one of whom had recently converted in 1991 and had 
spent 5 months in the preceding year providing health care to the 
source case in this investigation. Another health care provider and a 
correctional officer who worked in the infirmary also were identified 
as having newly converted while at the prison. There was no yearly skin 
test screening, and thus their conversions could have occurred at any 
time between 1987 and 1991. However, 13 other inmates were diagnosed 
with pulmonary TB during that same period. An additional correctional 
officer who did not work in the infirmary also was found to have newly 
converted. His reported exposure occurred at a community hospital where 
he was assigned to an inmate with infectious TB. The officer was not 
provided with any respiratory protection. The lack of isolation 
precautions and the lack of appropriate respiratory protection suggest 
transmission of TB from infectious inmates in the infirmary to the 
prison staff, either as a result of exposure to the source case or 
other inmates with pulmonary TB who were also treated in the prison 
infirmary. Because of the lack of contact tracing or routine annual 
screening of inmates or staff, the full extent of transmission from the 
source case or other TB cases could not be determined.
    Thus, similar to the evidence for the hospital setting, the 
evidence on correctional facilities shows that the failure to promptly 
identify individuals with infectious TB and provide appropriate 
infection control measures can result in the exposure and subsequent 
infection of employees with TB. These employees include the 
correctional facility infirmary staff, guards on duty at the facility, 
and guards assigned to escort inmates during transport to other 
facilities (e.g., outside health care facilities and other correctional 
facilities).

Homeless Shelters

    Tuberculosis has also been recognized as a health hazard among 
homeless persons. The growth of the homeless population in the United 
States since the 1980s and the subsequent increase in the number of 
shelters for the homeless, furthers heightens the concern about the 
potential for the increased incidence and transmission of TB among the 
homeless, especially in crowded living conditions such as homeless 
shelters.
    A number of factors are present in homeless shelters which increase 
the potential for the transmission of TB among the shelter residents 
and among the shelter staff. A high prevalence of TB infection and 
disease is common among many homeless shelters. This is not surprising, 
since the residents of these facilities usually come from lower socio-
economic groups and often have characteristics that place them at high 
risk. Screening of selected clinics and shelters for the homeless has 
shown that the prevalence of TB infection ranges from 18 to 51% and the 
prevalence of clinically active disease ranges from 1.6 to 6.8% (Ex. 6-
15). The CDC estimates this to be 150 to 300 times the nationwide 
prevalence rate (Ex. 6-17).
    In addition to having a high prevalence of individuals with TB 
infection in the shelters, many of the shelter residents possess 
characteristics that impair their immunity and thus place them at a 
greater risk of developing active disease. For example, homeless 
persons generally suffer from poor nutrition, poor overall health 
status and poor access to health care. Many also suffer from 
alcoholism, drug abuse and psychological stress. Moreover, a 
significant portion of homeless shelter residents are infected with the 
HIV. In 1988, the Partnership of the Homeless Inc. conducted a survey 
of 45 of the nation's largest cities and estimated that there were 
between 5,000 and 8,000 homeless persons with AIDS in New York City and 
approximately 20,000 nationwide (Ex. 7-55). Due to these factors, 
homeless shelter residents are at increased risk of developing active 
disease. Thus, there is the increased likelihood that these individuals 
will be infectious as a result of active disease and thereby present a 
source of exposure for other homeless persons and for shelter 
employees.
    In addition to having factors which increase their risk of 
developing active TB disease, homeless persons also are a very 
transient population. Because they are transient, homeless persons are 
more likely to discontinue or to erratically adhere to the prescribed 
TB therapy. Inadequately adhering to TB therapy can result in relapses 
to an infectious state of the disease or the development of MDR-TB. 
Both outcomes result in periods of infectiousness, during which they 
present a source of exposure to other residents and staff. In addition, 
environmental factors at homeless shelters, such as crowded living 
conditions and poor ventilation, facilitate the transmission of TB.
    Outbreaks of TB among homeless shelter residents have been 
reported. For example, during 1990, 17 individuals with active 
pulmonary TB were identified among residents of homeless shelters in 
three Ohio cities: Cincinnati, Columbus, and Toledo (Ex. 7-51). In 
Cincinnati, 11 individuals with active TB were identified in a shelter 
for homeless adults. The index case was a man who had resided at the 
shelter and later died from respiratory failure. He was not diagnosed 
with TB until his autopsy. Of these 11 individuals, of which the index 
case was one, 7 were determined to be infectious. There was no 
indication as to whether any infection control measures were in place 
in the shelter. DNA analysis of 10 individual M. tuberculosis isolates 
showed identical patterns. The similarity among these DNA patterns 
suggested that transmission of the TB occurred in the shelter.
    While the primary focus of this investigation was on the active 
cases reported among the residents in this Cincinnati shelter, the risk 
of transmission identified in this shelter also would apply to the 
shelter staff. Possible transmission of TB infection from the 
infectious individuals to the shelter staff might have been identified 
through tuberculin skin test conversions. However, no tuberculin skin 
test information for the staff was reported in this investigation.
    Tuberculin skin testing results were reported in the investigation 
of a Columbus, Ohio shelter. In this investigation, a resident of a 
Columbus homeless shelter was identified with infectious pulmonary TB 
at the local hospital in March of 1990. The patient also had resided in 
a shelter in Toledo. As a result, a city-wide TB screening was 
initiated from April to May 1990 among the residents and staff of the 
city's men's shelters. Tuberculin skin tests were conducted on 363 
shelter residents and 123 shelter employees. Among 81 skin-tested 
residents of the shelter in which the index case had resided, 32 (40%) 
were positive compared to 47 (22%) of 210 skin-tested residents of 
other shelters in Columbus who had positive skin test reactions. 
Similarly, among 27 employees of the shelter where the index case 
resided, 7 (26%) had positive skin test reactions compared to 9 (11%) 
of 85 employees in other men's shelters. These skin test results 
suggest an increased risk of transmission of TB among residents and 
employees of the homeless shelter where the index case resided. 
However, due to the lack of baseline skin test information among these 
residents and employees it is not possible to determine when their 
conversion to positive status occurred and whether this index case was 
their source of exposure. These results, however, do indicate a high 
prevalence of TB infection among homeless residents

[[Page 54186]]

(e.g., 40% and 22%). Many of these individuals are likely to have an 
increased risk of developing active TB and, as a result, they may 
present a source of exposure to residents and staff.
    The transmission of TB has also been observed among residents and 
staff of several Boston homeless shelters (Exs. 7-75 and 6-25). From 
February 1984 through March 1985, 26 cases of TB were confirmed among 
homeless residents of three large shelters in Boston. Nineteen of the 
26 cases occurred in 1984, thus giving an incidence of approximately 
317 per 100,000, 6 times the homeless case rate of 50 per 100,000 
reported for 1983 and nearly 16 times the 1984 case rate of 19 per 
100,000 for the rest of Boston (Ex. 6-25).
    Of the 26 cases of TB reported, 15 had MDR-TB. Phage typing of 
isolates from 13 of the individuals with drug-resistant TB showed 
identical phage types, thus suggesting a common source of exposure. As 
a result of this outbreak, a screening program was implemented in 
November 1984 over a four-night period. Of 362 people who received skin 
tests, 187 returned for reading, 42 (22%) were found to be positive and 
3 were recent converters. Screening also was reported for the shelter 
staff at the three homeless facilities. At the largest of the three 
shelters, 17 of 85 (20%) staff members had skin test conversions. In 
the other two shelters, 3 of 15 (20%) and 3 of 18 (16%) staff members 
had skin test conversions.
    Whereas MDR-TB was primarily involved in the outbreak in Boston, an 
outbreak of drug-susceptible TB was reported in a homeless shelter in 
Seattle, Washington (Ex. 7-73). From December 1986 to January 1987, 
seven cases of TB from homeless residents were reported to the Seattle 
Public Health Department. The report of 7 individuals with active TB in 
one month prompted an investigation, including: (1) A mass screening to 
detect undiagnosed cases, (2) phage typing of isolates from shelter 
clients to detect epidemiologically linked cases, and (3) a case-
control study to investigate possible risk factors for the acquisition 
of TB.
    A review of the case registries revealed that 9 individuals with 
active TB had been reported from the homeless shelter for the preceding 
year and four cases in the year previous to that. As a result of the 
mass screening in late January 1987, an additional 6 individuals with 
active TB were detected. Phage typing of 15 isolates from the shelter-
associated cases revealed that 6 individuals with active TB diagnosed 
around the time of the outbreak were of the same phage type, suggesting 
that there was a predominant chain of infection, i.e., a single source 
of infection. However, there also were other phage types, suggesting 
several sources of infection. Therefore, the investigators suggested 
that there was probably a mixture of primary and reactivated cases.
    In addition to the similarity of phage types among TB cases, 
tuberculin skin testing results suggested the ongoing transmission of 
TB in the shelter. For example, 10 shelter clients who were previously 
tuberculin negative in May 1985 were re-tested in January 1987 and 3 
(30%) had converted. In addition, 43 clients who were negative in 
January 1987 were re-tested in June 1987 or February 1988 and 10 (23%) 
had converted. Factors identified as contributing to the outbreak were 
the increased number of men with undiagnosed infectious pulmonary TB, 
the close proximity of beds in the shelter, and a closed ventilation 
system that provided extensive recirculation of unfiltered air.
    As a result of the outbreak, a control plan was implemented. This 
plan included repetitive mass screening, repetitive skin testing, 
directly observed therapy, preventive therapy and modification of the 
ventilation system to incorporate UV light disinfection in the 
ventilation duct work. After the control plan was in place, five 
additional individuals with active TB were observed over a 2-year 
follow-up period.
    While the primary focus in this study was on clients of the shelter 
rather than the shelter staff, the risk factors present in the shelter 
before implementation of the control plan would have also increased the 
likelihood for transmission of TB to shelter employees from infectious 
clients.
    Thus, similar to correctional facilities, homeless shelters have a 
number of risk factors that facilitate and promote the transmission of 
TB (e.g., high incidence of infected residents with an increased 
likelihood of developing active disease, crowded living conditions and 
poor ventilation). Also, similar to correctional facilities, the 
evidence in homeless shelters shows that the failure to promptly 
identify homeless residents with infectious TB and the lack of 
appropriate TB control measures (e.g., lack of isolation precautions or 
prompt transfer to facilities with adequate isolation precautions) 
resulted in the transmission of TB to shelter employees.

Long-Term Care Facilities for the Elderly

    Long-term care facilities for the elderly also represent a high-
risk population for the transmission of TB. TB disease in persons over 
the age of 65 constitutes a large proportion of TB in the United 
States. Many of these individuals were infected in the past, before the 
introduction of anti-TB drugs and TB control programs when the 
prevalence of TB disease was much greater among the general population, 
and have harbored latent infection over their lifetimes. However, with 
advancing age, these individuals' immune function starts to decline, 
placing them at increased risk of developing active TB disease. In 
addition, they may have underlying disease or overall poor health 
status. Moreover, residents are often clustered together and group 
activities are often encouraged. TB case rates are higher for this age 
group than for any other. For example, the CDC reports that in 1987, 
the 6,150 cases of TB disease reported for persons 65 years 
of age accounted for 27% of the U.S. TB morbidity although this group 
only represented 12% of the U.S. population (Ex. 6-14).
    Because of the higher prevalence of TB cases among this age group, 
employees of facilities that provide long-term care for the elderly are 
at increased risk for the transmission of TB. More elderly persons live 
in nursing homes than in any other type of residential institution. The 
CDC's National Center for Health Statistics reports that elderly 
persons represent 88% of the nation's approximately 1.7 million nursing 
home residents. As noted by the CDC, the concentration of such high-
risk individuals in long-term care facilities creates a high-risk 
situation for the transmission of TB (Ex. 6-14).
    In addition to having a higher prevalence of active TB, the 
recognition of TB in elderly individuals may be difficult or delayed 
because of the atypical radiographic appearance that TB may have in 
elderly persons (Exs. 7-59, 7-81, 7-82, and 7-83). In this situation, 
individuals with active TB may go undiagnosed, providing a source of 
exposure to residents and staff.
    While the increased incidence of TB cases among the elderly in 
long-term care facilities may be a result of the activation of latent 
TB infections, the transmission of TB infection to residents and staff 
from infectious cases in the facilities has been observed and reported 
in the scientific literature.
    For example, Stead et al. (1985) examined the reactivity to the 
tuberculin skin test among nursing home residents in Arkansas (Ex. 7-
59). This study involved a cross-sectional survey in which tuberculin 
skin tests were given to all current nursing home

[[Page 54187]]

residents. In addition, all newly-admitted nursing home residents were 
skin tested. For the three year period evaluated, 25,637 residents of 
the 223 nursing homes in Arkansas were tested.
    Of 12,196 residents who were tested within one month of entry, only 
12 percent were tuberculin positive, including those for whom a booster 
effect was detected. However, among the 13,441 residents for whom the 
first test was delayed for more than a month, 20.8% were positive. In 
addition, the results of retesting 9,937 persons who were tuberculin 
negative showed an annual conversion rate of approximately 5% in 
nursing homes in which an infectious TB case had been recognized in the 
last three years. In nursing homes with no recognized cases, the 
authors reported an annual conversion rate of approximately 3.5%. The 
authors concluded that their data supported the contention that 
tuberculosis may be a rather common nosocomial infection in nursing 
homes and that new infections with tuberculosis is an important risk 
for nursing home residents and staff.
    Brennen et al. (Ex. 5-12) described an outbreak of TB that occurred 
in a chronic care Veteran's Administration Medical Center in 
Pittsburgh. This investigation was initiated as a result of two skin 
test conversions identified through the employee testing program. One 
converter was a nurse working on ward 1B (a locked ward for 
neuropsychiatric patients) and the other was a physician working in an 
adjacent ward, 1U, who also had significant exposure to ward 1B. The 
source of infection in this investigation was traced to two patients 
who had resided on ward 1B and who had either a delayed or undiagnosed 
case of TB. The contact investigation revealed 8 additional conversions 
among patients, 4 in ward 1B and 4 in wards 2B and 4B (units on the 
floor above 1B).
    Because the source cases were initially unidentified, no isolation 
precautions were taken. Smoke tracer studies revealed that air 
discharged from the window air conditioning unit of one of the source 
patients discharged directly into the courtyard. Air from this 
courtyard was the air intake source for window air conditioning units 
in the converters' room on ward 2B and thus was one of the possible 
sources of exposure.
    In addition to the contact investigation on ward 1B and the 
adjacent units, hospital-wide skin testing results were evaluated. Of 
395 employees tested, 110 (28%) were positive. The prevalence in the 
surrounding community was estimated to be 8.8%. Of those employees 
initially negative, 38 (12%) converted to positive status. Included 
among these were employees in nursing (18), medical (3), dental (1), 
maintenance/engineering (3), supply (1), dietary (9), and clerical (2) 
services.
    Occupational transmission of TB was also reported in a nursing home 
in Oklahoma (Ex. 6-28). In August 1978, a 68 year old female residing 
in the east wing of the home was diagnosed with pulmonary TB. She was 
subsequently hospitalized. However, by that time she had already had 
frequent contact with other residents in the east wing. As a result, a 
contact investigation, in which all residents of the home were given 
skin tests, was initiated.
    The investigation revealed that the reaction rate for residents in 
the east wing (34/48, 71%) was significantly higher than the reaction 
rates of residents living in the north and front wings (30/87, 34%). No 
baseline skin test information was presented for the residents to 
determine the level of conversion. However, it was noted that half of 
the nursing home residents were former residents of a state institution 
for the developmentally disabled. A 1970 tuberculin skin test survey of 
that institution had shown a low rate of positive reactions.
    In addition to the nursing home residents, nursing home employees 
were also skin tested. Of the 91 employees tested, 61 (67%) were 
negative and 30 (33%) were positive. Similar to results observed among 
the residents, positive reaction rates were higher for employees who 
had ever worked in the east wing (50%) than for those who had never 
worked in the east wing (23%). Retesting of the employees 3 months 
later revealed 3 conversions. These results suggested that there may 
have been occupational transmission of TB in this facility.
    Occupational transmission has also been observed in a retrospective 
study of residents and employees who lived or worked in an Arkansas 
nursing home between 1972 and 1981 (Ex. 7-83). In this retrospective 
study, investigators reviewed the skin testing and medical chart data 
collected over a 10-year period at an Arkansas nursing home. Among the 
nursing home residents who were admitted between 1972 and 1982, 32 of 
226 residents (17%) who were initially tuberculin negative upon 
admittance became infected while in the home, based on conversion to 
positive after at least two previous negative tests. Twenty-four (63%) 
of these conversions were infected in 1975, following exposure to one 
infectious resident. This resident, who had negative skin tests on 
three previous occasions during his stay in the home, was not diagnosed 
with TB until after he was hospitalized because of fever, loss of 
weight and productive cough. The remaining 37% converted in the absence 
of a known infectious case. Thus, the authors suggested that nosocomial 
infections are likely to result from persons unsuspected of having TB.
    Skin testing was also reviewed for employees of the nursing home. 
Questionnaires were completed by 108 full-time employees. Eleven of 68 
employees with follow-up skin tests converted to positive skin status 
during the study period. Ten of the 11 (91%) converters reported that 
they had been in the nursing home in 1975, the same year in which many 
of the residents were also found to have converted from a single 
infectious case. In addition, employees working at least 10 years in 
the home had a higher percentage of conversions (9 of 22, 40%) than 
employees working less than 10 years (2 of 46, 4.4%). Based on the 
results of this study, the authors concluded that, in addition to 
occurrence of TB cases from the reactivation of latent infections among 
the elderly, TB can also be transmitted from one resident to another 
resident or staff. Consequently, TB must be considered as a potential 
nosocomial infection in nursing homes.
    Thus, long-term care facilities for the elderly represent a high-
risk situation for the transmission of TB. These types of facilities 
possess a number of characteristics that increase the likelihood that 
active disease may be present among the facility residents and may go 
undetected. Similar to other high-risk settings, the evidence shows 
that the primary factors in the transmission of TB among residents and 
staff have been the failure to promptly identify residents with 
infectious TB and initiate and adequately implement appropriate 
exposure control measures.

Drug Treatment Centers

    Another occupational setting that has been identified as a high-
risk environment for the transmission of TB is drug treatment centers. 
Similar to other high-risk sites, drug treatment centers have a higher 
prevalence of TB infection than the general population. For example, in 
1989 the CDC funded 25 state and city health departments to support 
tuberculin testing and administration of preventive therapy in 
conjunction with HIV counseling and testing. In this project, 28,586 
clients from 114 drug treatment centers were given tuberculin skin 
tests. Of those, 2,645 (9.7%) were positive (Ex. 6-8). When persons 
with previously

[[Page 54188]]

documented positive tests were included, 4167 (13.3%) were positive.
    There is also evidence to suggest that drug dependence is a risk 
factor for TB disease. For example, Reichman et al. (Ex. 7-85) 
evaluated the prevalence of TB disease among different drug-dependent 
populations in New York: (1) An in-hospital population, (2) a 
population in a local drug treatment center, and (3) a city-wide 
population in methadone clinics. For the in-hospital population of 
1,283 patients discharged with drug dependence, 48 (3.74%) had active 
disease, for a prevalence rate of 3,740 per 100,000. In comparison, the 
TB prevalence rate for the total inpatient population was 584 per 
100,000 and for New York City as a whole was 86.7 per 100,000. 
Screening of clients at a local drug treatment center in Harlem 
revealed a TB prevalence of 3750 per 100,000 in the drug-dependent 
population. Similarly, in the New York methadone program, the city-wide 
TB prevalence was 1,372 per 100,000. The authors also reported that 
although estimates of TB infection rates for both drug-dependent and 
non-drug dependent people were similar, the prevalence of TB disease 
among the drug-dependent was higher, thus suggesting that drug 
dependency may be a risk factor for disease.
    Clients of drug treatment centers not only have a high prevalence 
of TB infection, a majority of them are intravenous drug users. Of the 
estimated 645,000 clients discharged each year from drug treatment 
centers, approximately 265,000 are intravenous drug users who either 
have or are at risk for HIV infection. In the Northeastern U.S., HIV 
seroprevalence rates of up to 49% have been reported (Ex. 6-8). These 
individuals are at increased risk of developing active TB disease.
    To determine the risk of active TB associated with HIV infection, 
Selwyn et al. (Ex. 5-6) prospectively studied 520 intravenous drug 
users enrolled in a methadone maintenance program. In this study, 217 
HIV seropositive and 303 seronegative intravenous drug users, who had 
complete medical records documenting their history of TB and skin test 
status, were followed from June 1985 to January 1988. On admission to 
the methadone program, and at yearly intervals, all patients were given 
tuberculin skin tests.
    Forty-nine (23%) of the seropositive patients and 62 (20%) of the 
seronegative patients had positive reactions to the skin test before 
entry into the study. Among the patients who initially had negative 
skin tests, 15 of 131 (11%) seropositive patients and 62 of 303 (13%) 
seronegative patients converted to positive tuberculin status. While 
the prevalence and incidence rates of TB infection were similar for the 
two groups of patients, seropositive patients showed a higher incidence 
of developing active disease. Active TB developed in 8 of the 
seropositive subjects with TB infection (4%), whereas none of the 
seronegative patients with TB infection developed active TB during the 
study period.
    Among individuals who are infected with HIV or who have AIDS, TB 
disease may be difficult to diagnosis because of the atypical 
radiographic appearance that TB may present in these individuals. In 
these individuals, TB may go undiagnosed and present an unsuspected 
source of exposure. Clients of drug treatment centers also may be more 
likely to discontinue or inadequately adhere to TB therapy regimens in 
instances where they develop active disease. As in other instances, 
this increases the likelihood of relapse to active disease or possibly 
the development of MDR-TB, both of which result in additional or even 
prolonged periods of infectiousness during which other clients or staff 
can be exposed.
    There is evidence showing the transmission of TB in drug treatment 
facilities among both the clients and the staff. In a CDC case study 
(Ex. 5-6), a Michigan man who was living in a residential substance 
abuse treatment facility and was undergoing therapy for a previously 
diagnosed case of TB disease, was discovered by the local health 
department to have MDR-TB. As a result, a contact investigation was 
initiated at the drug treatment facility in which he resided.
    Of the 160 clients and staff who were identified as potential 
contacts, 146 were tested and given tuberculin skin tests in November. 
No health screening program had been in place at the facility. The 
following March repeat skin tests were given. Of the 70 persons who 
were initially tuberculin negative and were still present in the 
facility, 15 (21%) had converted to positive status (14 clients and 1 
staff member). The investigators noted that the number of converters 
may have been underestimated for two reasons. Many of the clients were 
at risk for HIV infection and thus may have been anergic and not 
responded to the tuberculin skin tests. In addition, nearly half of the 
clients who were initially negative were not available for repeat skin 
testing.
    Several factors may have contributed to the observed conversions in 
this facility. For example, no health screening program was in place. 
Therefore, individuals with TB would go unidentified. In addition, the 
clients were housed in a building with crowded dormitories for 
sleeping. The only ventilation in this building was provided by opening 
windows and doors. Thus, environmental conditions were ideal for the 
transmission of TB.
    Consequently, the high-risk characteristics of clients who frequent 
these centers (e.g., high prevalence of infection and factors 
increasing the likelihood of developing active disease) and 
environmental characteristics of the center (e.g., crowding and poor 
ventilation), lead to drug treatment centers being considered a high-
risk setting for the transmission of TB. The available evidence shows 
that the failure to promptly identify clients with infectious TB and to 
initiate and properly implement exposure control methods (e.g., proper 
ventilation) resulted in the infection of clients and staff at these 
facilities.

Conclusion

    The available evidence clearly demonstrates that the transmission 
of TB represents an occupational hazard in work settings where 
employees can reasonably be anticipated to have contact with 
individuals with infectious TB or air that may reasonably be 
anticipated to contain aerosolized M. tuberculosis as a part of their 
job duties. Epidemiological studies, case reports, and outbreak 
investigations have shown that in various work settings where there has 
been an increased likelihood of encountering individuals with active TB 
or where high-hazard procedures are performed, employees have become 
infected with TB and in some cases developed active disease. While some 
infections were a result of more direct and more prolonged exposures, 
other infections resulted from non-direct and brief or intermittent 
exposures. Because of the variability in the infectiousness of 
individuals with active TB, one exposure may be sufficient to initiate 
infection.
    Several factors, common to many of these work settings, were 
identified as contributing to the transmission of TB: (1) Failure or 
delayed recognition of individuals with active TB within the facility, 
and (2) failure to initiate or adequately implement appropriate 
infection control measures (e.g., performance of high-hazard procedures 
under uncontrolled conditions, lack of negative pressure ventilation, 
recirculation of unfiltered air, and lack of appropriate respiratory 
protection). Thus, in work settings where employees can reasonably be 
anticipated to have contact with individuals with infectious

[[Page 54189]]

TB or air that may contain aerosolized M. tuberculosis and where 
appropriate infection control programs are not in place, employees are 
at increased risk of becoming infected with TB.
    Infection with TB is a material impairment of the worker's health. 
Even though not all infections progress to active disease, infection 
marks a significant change in an individual's health status. Once 
infected, the individual is infected for his or her entire life and 
carries a lifetime risk of developing active disease, a risk they would 
not have had they not been infected. In addition, many individuals with 
infection undergo preventive therapy to stop the progression of 
infection to active disease. Preventive therapy consists of very toxic 
drugs that can cause serious adverse health effects and, in some cases, 
may be fatal.
    Although treatable, active disease is also a serious adverse health 
effect. Some TB cases, even though cured, may result in long-term 
damage to the organ that is infected. Individuals with active disease 
may need to be hospitalized while they are infectious and they must 
take toxic drugs to stop the progressive destruction of the infected 
tissue. These drugs, as noted above, are toxic and may have serious 
side effects. Moreover, even with advancements in treating TB, 
individuals still die from TB disease. This problem is compounded by 
the emergence of multidrug-resistant strains of TB. In these cases, due 
to the inability to find adequate drug regimens which can treat the 
disease, individuals remain infectious longer, allowing the disease to 
progress further and cause more progressive destruction of the infected 
tissue. This increases the likelihood of long-term damage and death.

V. Preliminary Risk Assessment for Occupational Exposure to 
Tuberculosis

Introduction

    The United States Supreme Court, in the ``benzene'' decision 
(Industrial Union Department, AFL-CIO v. American Petroleum Institute, 
448 U.S. 607 (1980)), has stated the OSH Act requires that, prior to 
the issuance of a new standard, a determination must be made, based on 
substantial evidence in the record considered as a whole, that there is 
a significant health risk under existing conditions and that issuance 
of a new standard will significantly reduce or eliminate that risk. The 
Court stated that

``before he can promulgate any permanent health or safety standard, 
the Secretary is required to make a threshold finding that a place 
of employment is unsafe in the sense that significant risks are 
present and can be eliminated or lessened by a change in practices'' 
(448 U.S. 642).

    The Court in the Cotton Dust case (American Textile Manufacturers 
Institute v. Donovan, 452 U.S. 490 (1981)), rejected the use of cost-
benefit analysis in setting OSHA health standards. However, the Court 
reaffirmed its previous position in the ``benzene'' case that a risk 
assessment is not only appropriate, but also required to identify 
significant health risk in workers and to determine if a proposed 
standard will achieve a reduction in that risk. Although the Court did 
not require OSHA to perform a quantitative risk assessment in every 
case, the Court implied, and OSHA as a matter of policy agrees, that 
assessments should be put into quantitative terms to the extent 
possible. The following paragraphs present an overall description of 
OSHA's preliminary quantitative risk assessment for occupational 
exposure to tuberculosis (TB).
    An earlier version of this risk assessment was reviewed by a group 
of four experts in the fields of TB epidemiology and mathematical 
modeling. The reviewers were George Comstock, MD, MPH, DPH, Alumni 
Centennial Professor of Epidemiology, The Johns Hopkins University; 
Neil Graham MBBS, MD, MPH, Associate Professor of Epidemiology, The 
Johns Hopkins University; Bahjat Qaqish, MD, PhD, Assistant Professor 
of Biostatistics, University of North Carolina; and Patricia M. Simone, 
MD, Chief, Program Services Branch, Division of Tuberculosis 
Elimination, CDC. The reader is referred to the peer review report in 
the docket for additional details (Ex. 7-911). The revised version of 
OSHA's risk assessment, as published in this proposed rule, includes 
OSHA's response to the reviewers' comments as well as updated risk 
estimates based on recent purified protein derivative (PPD) skin 
testing data made available to the Agency since the peer review was 
performed and is generally supported by the reviewers or is consistent 
with reviewers' comments. (Note: PPD skin test and tuberculin skin test 
(TST) are synonymous terms.)
    The CDC estimates that, once infected with M. tuberculosis, an 
untreated individual has a 10% lifetime probability of developing 
active TB and that approximately half of those cases will develop 
within the first or second year after infection occurs. Individuals 
with active TB represent a pool from which the disease may spread. 
Based on data from the CDC, OSHA estimates that every index case (i.e., 
a person with infectious TB) results in at least 2 other infections 
(Ex. 7-269). For some percentage of active cases, a more severe 
clinical course can develop which can be attributed to various factors 
such as the presence of MDR-TB, an allergic response to treatment, or 
the synergistic effects of other health conditions an individual might 
have. Further, OSHA estimates that for 7.78% of active TB cases, TB is 
expected to be the cause of death. Section 6(b)(5) of the OSH Act 
states that,

    The Secretary, in promulgating standards dealing with toxic 
materials or harmful physical agents under this subsection, shall 
set the standard which most adequately assures, to the extent 
feasible, on the basis of the best available evidence, that no 
employee will suffer material impairment of health or functional 
capacity even if such employee has regular exposure to the hazard 
dealt with by such standard for the period of his working life.

    For this rulemaking, OSHA defines TB infection as a ``material 
impairment of health'', for several reasons. First, once infected with 
TB, an individual has a 10% lifetime likelihood of developing active 
disease and approximately 1% likelihood of developing more serious 
complications leading to death. Second, allergic reaction and hepatic 
toxicity due to chemoprophylaxis with isoniazid, which is one of the 
drugs used in the recommended course of preventive treatment, pose a 
serious threat to a large number of workers. Third, defining infection 
with M. tuberculosis as material impairment of health is consistent 
with OSHA's position in the Bloodborne Pathogens standard and is 
supported by CDC and several stakeholders who participated in the pre-
proposal meetings, as well as Dr. Neil Graham, one of the peer 
reviewers of this risk assessment. In his comments to OSHA, Dr. Graham 
stated,

    The focus of OSHA on risk of TB infection rather than TB disease 
is appropriate. TB infection is a potentially adverse event, 
particularly if exposure is from a MDR-TB patient, or if the health-
care or institutional worker is HIV seropositive. In addition, a 
skin test conversion will in most cases mandate use of 
chemoprophylaxis for >6 months which is at least inconvenient and at 
worst may involve adverse drug reactions. (Ex. 7-271)

    The approach taken in this risk assessment is similar to the 
approach OSHA took in its risk assessment for the Bloodborne Pathogens 
standard. As with bloodborne pathogens, the health response (i.e., 
infection) associated with exposure to the pathogenic agent does not 
depend on a cumulative level of exposure; instead, it is a function of 
intensity and frequency of each

[[Page 54190]]

exposure incident. However, unlike hepatitis B, where the likelihood of 
infection once an exposure incident occurs is known with some degree of 
certainty, the likelihood of becoming infected with TB after an 
exposure incident is not as well characterized. With TB, the likelihood 
of infection depends on the potency of an exposure incident and the 
susceptibility of the exposed individual (which is a function of the 
person's natural resistance to TB and his or her health status). 
Further, the potency of a given exposure incident is highly dependent 
on several factors, such as the concentration of droplet nuclei in the 
air, the duration of exposure, and the virulence of the pathogen (e.g., 
pulmonary and laryngeal TB are considered more infectious than other 
types).
    The Agency has sufficient data to quantify the risk associated with 
occupational exposure to TB among health care workers in hospitals on a 
state-by-state basis. In addition to hospital employee data, OSHA has 
obtained data on selected health care employee groups from the TB 
Control Office of the Washington State Health Department. These groups 
include workers employed in long-term health care, home health care, 
and home care. Small entities are encouraged to comment and submit any 
data or studies on TB infection rates relevant to their business.
    Because it is exposure to aerosolized M. tuberculosis that places 
workers at risk of infection, and not some factor unique to the health 
care profession, the Agency concluded that the experience of these 
groups of health care workers is representative of that of the other 
``high-risk'' workers covered by this proposal. This means that the 
risk estimates calculated for these groups of workers are appropriate 
to use as the basis for describing the potential range of risks for 
workers in other work settings where workers can be expected to come 
into close and frequent contact with individuals with infectious TB (or 
with other sources of aerosolized M. tuberculosis) as an integral part 
of their job duties. As discussed in section IV (Health Effects), 
epidemiological studies, case reports, and outbreak investigations have 
shown that workers in various work settings, including but not limited 
to hospitals, have become infected with tuberculosis as a result of 
occupational exposure to aerosolized M. tuberculosis when appropriate 
infection control programs for tuberculosis were not in place.
    In this preliminary risk assessment, OSHA presents risk estimates 
for TB infections, cases of active disease, and TB-related deaths 
(i.e., where TB is considered the cause or a major contributing cause 
of death) for workers with occupational exposure to tuberculosis.
    A number of epidemiological studies demonstrate an increased risk 
of TB infection among health care workers in hospitals and other work 
settings. A brief review of a selection of these studies is presented 
below, followed by OSHA's estimates of excess risk due to occupational 
exposure. Finally, OSHA presents a qualitative assessment of the risk 
of TB infection caused by occupational exposure to tuberculosis in 
correctional facilities, homeless shelters, drug treatment centers, 
medical laboratories, and other high-risk work groups.

Review of the Epidemiology of TB Infection in Exposed Workers

    There are several studies in the published scientific literature 
demonstrating the occupational transmission of infectious TB. Reports 
of TB outbreaks and epidemiologic surveillance studies have shown that 
health care and certain other workers are, as a result of their job 
duties, at significantly higher risk of becoming infected than the 
average person.
    OSHA conducted a thorough search of the published literature and 
reviewed all studies addressing occupational exposure to tuberculosis 
and TB infection in hospitals and other work settings. All published 
studies show positive results (i.e., workers exposed to infectious 
individuals have a high likelihood of becoming infected with TB). 
Because there are so many studies, OSHA selected a representative 
subset of the more recent studies conducted in the U.S. to include in 
this section. These studies were chosen because they show occupational 
exposure in various work settings, under various working conditions, 
and under various scientific study designs.
    OSHA's summary of the studies is presented in Table V-1(a) and 
Table V-1(b). These studies represent a wide range of occupational 
settings in hospitals, ranging from TB and HIV wards in high prevalence 
areas, such as New York City and Miami, to hospitals with no known TB 
patients located in low prevalence areas such as the state of 
Washington. The studies include prospective studies of entire hospitals 
or groups of hospitals, retrospective surveys of well-controlled 
clinical environments, such as an HIV ward in a hospital, and case 
studies of single-source infection (i.e., outbreak investigations).

                             Table V-1(a).--Outbreak Investigations of TB infection                             
----------------------------------------------------------------------------------------------------------------
                                                                   Risk of TB in health                         
             Authors/year                    Setting/source            care workers        Contributing factors 
----------------------------------------------------------------------------------------------------------------
Catanzaro (1982)......................  Hospital intensive care  14/45 (31%) PPD          Poor ventilation. No  
                                         unit/San Diego/1 index   conversions, 10/13       report on respirator 
                                         case--7-day hospital     (77%) PPD conversions    use.                 
                                         stay.                    among health care                             
                                                                  workers present at                            
                                                                  bronchoscopy.                                 
Kantor et al. (1988)..................  VA hospital in Chicago   9/56 (16%) PPD           No mechanical         
                                         autopsy room/1 index     conversions among        ventilation on       
                                         case undiagnosed until   exposed workers vs. 3/   medical ward (autopsy
                                         histology exam of        333 (1%) conversions     room): no isolation. 
                                         autopsy tissue.          among unexposed          Autopsy room had 11  
                                                                  (RR=17.8) 3 workers      air changes/hour and 
                                                                  developed active TB.     no air recirculation.
Beck-Sague (1992).....................  Jackson Memorial         13/39 (33%) PPD          Some rooms had        
                                         Hospital in Miami MDR-   conversions on HIV       positive pressure.   
                                         TB in HIV/patients on    ward and clinic.         Inadequate triage of 
                                         HIV ward and clinic                               patients with        
                                         during 1989-91.                                   suspected TB. Delay  
                                                                                           in use of isolation. 
                                                                                           Early discharge from 
                                                                                           isolation.           
----------------------------------------------------------------------------------------------------------------


[[Page 54191]]


               Table V-1(b).--Surveillance Studies of TB Infection in Exposed Health Care Workers               
----------------------------------------------------------------------------------------------------------------
                                                                                Risk of TB in                   
        Authors/year            Setting/source     Study       Population        health care        Comments    
                                                   period                          workers                      
----------------------------------------------------------------------------------------------------------------
Price et al. (1987).........  19 Eastern North     1980-84  All Hospital      1.80% annual PPD                  
                               Carolina                      workers.          conversion rate.                 
                               hospitals.                                                                       
                              29 Central North   .........  ................  0.70% annual PPD                  
                               Carolina                                        conversion rate.                 
                               hospitals.                                                                       
                              8 Western North    .........  ................  0.61% annual PPD                  
                               Carolina                                        conversion rate.                 
                               hospitals.                                                                       
Aitken et al. (1987)........  64 hospitals in      1982-84  All Hospital      0.1% PPD          Strict adherence
                               Washington State.             workers.          conversion rate/  to CDC         
                                                                               in 3 years.       guidelines.    
Malasky et al. (1990).......  14 urban               (\1\)  Physicians in     11% PPD                           
                               hospitals in U.S.             training in       conversion/3                     
                                                             pulmonary         years among                      
                                                             medicine and      pulmonary                        
                                                             infectious        fellows, 2.4%                    
                                                             disease.          PPD conversions/                 
                                                                               3 years among                    
                                                                               infectious                       
                                                                               disease fellows.                 
Dooley et al. (1992)........  Hospital in          1989-90  Hospital workers  Prevalence        Isolation rooms 
                               Puerto Rico TB                (n=908).          study: 54/109     did not have   
                               in HIV-infected                                 (50%) nurses      negative       
                               patients.                                       exposed to TB     pressure.      
                                                                               patients had      Recirculated   
                                                                               positive PPDs     air was not    
                                                                               35/188 (19%)      filtered.      
                                                                               clerical                         
                                                                               workers with no                  
                                                                               exposure to TB                   
                                                                               had positive                     
                                                                               PPDs (p<0.001).                  
NIOSH.......................  Jackson Memorial     1989-92  Hospital workers  60% annual PPD    Incomplete      
                               Hospital, Miami.              in selected       conversion        isolation      
                                                             wards (n=607).    among 263         facilities.    
                                                                               exposed           Improper       
                                                                               workers, 0.6%     application of 
                                                                               annual PPD        isolation      
                                                                               conversion        procedures.    
                                                                               among 344                        
                                                                               unexposed                        
                                                                               workers.                         
Cocchiarella et al. (1996)..  Cook County             1991  Graduating        18.8% 3-year PPD  Residents were  
                               Hospital,                     physicians with   conversion rate   offered limited
                               Chicago.                      at least 1 year   for house staff   respiratory    
                                                             of clinical       in internal       protection     
                                                             work at CCH       medicine vs.      during         
                                                             (n=128).          2.2% PPD          exposures. No  
                                                                               conversion rate   protocol       
                                                                               for house staff   available for  
                                                                               in other          early          
                                                                               specialties.      identification 
                                                                                                 of suspect TB  
                                                                                                 cases. PPD     
                                                                                                 testing program
                                                                                                 incomplete.    
                                                                                                 Inadequate     
                                                                                                 isolation      
                                                                                                 facilities.    
----------------------------------------------------------------------------------------------------------------
\1\ Mid 1980's (3 years).                                                                                       

    Outbreak investigations describe occupational exposure to 
tuberculosis from single index patients or a well-defined group of 
patients. Such investigations are more likely to demonstrate an upper 
limit of occupational risk in different settings, usually under 
conditions of suboptimal environmental and infection controls. Although 
outbreak investigations demonstrate the existence of occupational risk 
under certain conditions and the importance of the early identification 
of suspect TB patients quite well, these studies do not provide 
information conducive to risk assessment estimations. Limitations of 
outbreak investigations include the frequent absence of baseline PPD 
test results, the difficulty of extrapolating the results to non-
outbreak conditions of TB exposure, and, often, small sample sizes. 
Table V-1(a) lists some of the published outbreak investigations and 
shows the risks posed to health care workers by such outbreaks, as well 
as the failures in control programs contributing to these episodes.
    Prospective and/or retrospective surveillance studies are used to 
estimate conversion rates from negative to positive in PPD skin testing 
programs. These conversion rates can be used to estimate the excess 
incidence of TB infection. Surveillance studies among health care 
workers lend themselves to a more systematic evaluation of the risk of 
TB infection than outbreak investigations, for several reasons. First, 
these studies better reflect the risk of TB experienced by workers 
under routine conditions of exposure. Second, these studies are usually 
based on a larger group of workers and therefore yield more precise and 
accurate estimates of the actual risk of infection. However, the extent 
to which results from surveillance studies can be generalized depends 
on a careful evaluation of the study population. Some studies report 
skin test conversion rates for all workers in the hospital(s) under 
study. Such studies often include large groups of employees with little 
or no exposure to TB. Results from such studies may reflect an overall 
estimate of risk in that environment, but may underestimate the 
occupational risk of those with frequent exposure.
    Other surveillance studies report PPD conversion rates of more 
narrowly-defined groups of workers, usually those working in ``high-
risk'' areas within a hospital such as the HIV or TB wards. Some of 
these studies have internal control groups (i.e., they compare PPD 
conversion rates between a group of workers with extensive exposure to 
TB and a group of workers with minimal or no exposure to TB), thus 
making it possible to more precisely quantify the magnitude of excess 
risk due to occupational exposure. However, these studies are also 
limited in their usefulness for risk assessment purposes. They usually 
have small sample sizes, making it more difficult to observe 
statistically significant differences. More

[[Page 54192]]

importantly, internal control groups may overestimate background risk, 
and thus underestimate excess occupational risk, unless painstaking 
efforts are made to eliminate from the control group those individuals 
with the potential for occupational exposure, a difficult task in some 
hospital environments. Table V-1(b) contains a selected list of 
published surveillance studies.
    In reviewing Table V-1(a) and Table V-1(b), the reader should bear 
in mind that these tables are not intended to present an exhaustive 
list of epidemiologic studies with TB conversion rates in occupational 
settings. Instead, these tables present brief summaries of some of the 
epidemiologic evidence of occupational TB transmission found in the 
published literature; they are intended to convey the seriousness of 
the risk posed to health care workers and to illustrate how failures in 
control programs contribute to this risk. Upon reviewing these studies, 
a consistent pattern emerges: these work settings are associated with a 
high likelihood for occupational exposure to tuberculosis, and high 
rates of TB infection are being observed among health care workers.

Quantitative Assessment of Risk

    Data availability usually dictates the direction and analytical 
approach OSHA's risk assessment can take. For this rulemaking, three 
health endpoints will be used: (1) TB infection, which is ``material 
impairment of health'' for this proposed standard; (2) Active disease 
following infection; and, (3) Risk of death from active TB.
    In order to account for regional variability in TB prevalence and 
therefore to account for expected variability in the risk of TB 
infection in different areas, the Agency chose to develop occupational 
risk estimates on a state-by-state basis. This approach was criticized 
by Dr. Neil Graham as being too broad and ''* * * insufficient in light 
of the tremendous variability * * * that can occur within a state.'' 
(Ex. 7-911). The Agency recognizes that risk estimates on a county-by-
county basis would be preferable; however, the unavailability of 
comprehensive county data has prevented the Agency from conducting such 
analysis.
    The annual excess risk of TB infection due to occupational exposure 
is defined as a multiplicative function of the background rate of 
infection and is expressed as:

p = ERRo * Rb

where:

p is the annual excess risk due to occupational exposure,
Rb is the background rate of TB infection, and
ERRo is a multiplicative factor denoting the excess relative 
risk due to occupational exposure (ERRo).

    Estimates of ERRo are derived from surveillance studies 
of workers with occupational exposure to TB. ERRo is defined 
as the relative difference between the overall exposed worker risk and 
the background (population) risk and is calculated as the difference 
between overall worker and background risk divided by the background 
risk.
    The annual excess risk due to occupational exposure is defined as a 
function of the background risk because of data limitations. If data on 
overall worker risk were available for each state, then the excess risk 
due to occupational exposure would simply be the difference between 
overall worker risk and background risk. Instead, the annual excess 
risk due to occupational exposure (i.e., p) is estimated using a 
multiplicative model because data on overall worker risk (i.e., 
Rw) were available only for the states of Washington, and 
North Carolina and for Jackson Memorial Hospital located in Miami, 
Florida. Therefore, the annual excess risk due to occupational exposure 
in state i (pi) is expressed as:
[GRAPHIC] [TIFF OMITTED] TP17OC97.000

where:

Rwj is the overall worker risk estimated from surveillance 
studies (study j),
Rbj is the study control group risk (i.e., study background 
risk), and
Rbi is the background rate for state i.

    When i=j (i.e., Washington State or North Carolina), the excess 
risk due to occupational exposure, is expressed as the straight 
difference between overall worker risk and background risk.

    OSHA calculated estimates of ERRo based on three 
occupational studies: the Washington State study, the North Carolina 
study, and the Jackson Memorial Hospital study (Exs. 7-263, 7-7, 7-
108). These estimates were expressed as percent change above each 
study's background. The derivation of these estimates is described in 
section 2.
    In order to estimate an overall range of occupational risk of TB 
infection, taking into account regional differences in TB prevalence in 
the U.S., OSHA: (1) Estimated background TB infection rates by state 
(Rbi), and (2) applied estimates of ERRo, derived 
from the occupational studies, to the state background rates to 
calculate estimates of excess risk due to occupational exposure by 
state.
    OSHA used a multiplicative function of each state's background 
infection rate to estimate excess risk of TB infection because the 
probability of occupational infection can be viewed as a function of 
the number of contacts and frequency of contacts with infectious 
individuals. Thus, estimates of expected relative increase in risk 
above background due to occupational exposure are calculated for the 
three available studies and these relative increases (i.e. 
ERRo) are multiplied by background rates for each state to 
derive estimates of excess occupational risk by state. These state 
estimates are then used to derive a national estimate of occupational 
risk.
    The CDC compiles and publishes national statistics on the incidence 
of active TB in the U.S. by state based on reported cases. OSHA relied 
on these data to estimate TB infection background rates through the use 
of a mathematical model because information on TB infection is not 
being collected nationwide by CDC. A more detailed discussion on the 
methodology and derivation of background risk estimates by state is 
found in section 3, and discussion on the estimation of occupational 
risk estimates by state is found in section 4 of this risk assessment.
    Because section 6(b)(5) of the OSH Act requires OSHA to assess 
lifetime risks, OSHA has converted the annual excess risk due to 
occupational exposure into an excess lifetime risk based on a 45-year 
working lifetime. The formula used to calculate lifetime occupational 
risk estimates of the probability of at least one occurrence of TB 
infection due to occupational exposure in 45 years is expressed as { 1-
(1-p)45 }, where p is the annual excess risk due to 
occupational exposure. Two assumptions are critical in defining 
lifetime risk: (1) the exposure period is 45 years, and (2) the annual 
excess risk remains constant. The implication of the second assumption 
is that the worker's exposure profile and working conditions, which may 
affect the level and intensity of exposure, and the virulence of the 
pathogen, remain unchanged throughout a working lifetime. The merit of 
this assumption was questioned by Dr. Graham, because, as he states ``* 
* * patient contact may vary greatly throughout a career for many HCWs 
[health care workers].'' and `` * * * physicians (and nurses) often do 
not have extensive patient contact until [their] mid-twenties, while 
other workers increasingly retire early.'' Dr. Graham recommends that 
OSHA's risk assessment be adjusted to account for variable exposure 
levels and variable working lifetimes. Although accounting

[[Page 54193]]

for variable exposure levels could result in more precise risk 
estimates, the unavailability of comprehensive information on lifetime 
TB exposure scenarios by occupational group prevented the Agency from 
developing a more complex risk model.
    OSHA has customarily assumed a 45 year working lifetime in setting 
health standards. The Agency believes that this assumption is 
reasonable and consistent with the Act. The Act requires the Secretary 
to set a standard for toxic substances that would assure ``no employee 
* * * suffer material impairment of health or functional capacity even 
if such employee has regular exposures to the hazard for the period of 
his working lifetime.'' 29 U.S.C. Sec. 655(b)(5) (emphasis added). The 
U.S. Court of Appeals for the District of Columbia upheld the use of a 
45-year lifetime in the asbestos standard against an assertion by the 
Asbestos Information Association that the average duration of 
employment was five years. Building and Construction Trades Department, 
AFL-CIO v. Brock, 838 F.2d 1258, 1264, 1265 (D.C. Cir. 1988). The Court 
said that OSHA's assumption ``appears to conform to the intent of 
Congress'' as the standard must protect even the rare employee who 
would have 45 years of exposure. Id. at 1264. In addition, while 
working lifetimes will vary, risk is significant for some who work as 
little as one year and, at any rate, individual and population risks 
are likely to remain the same so long as employees who leave one job 
are replaced by others, and those who change jobs remain within a 
covered sector. Nevertheless, the Agency solicits information regarding 
the likelihood of exposure to active TB in the workplace and duration 
of employment in various occupational groups. Lifetime risk estimates 
of TB infection by state are described in section 4.
    Lifetime risk estimates of developing active TB are calculated from 
lifetime risk estimates of TB infection assuming that, once infected, 
there is a 10% likelihood of progressing to active TB. These estimates 
are discussed in section 4. Further, the number of deaths caused by TB 
is calculated from the lifetime estimates of active TB using OSHA's 
estimate of TB case fatality rate, also discussed in section 4.
1. Definitions
    For the purpose of estimating incidence rates, TB infection rate is 
defined as the annual probability of an individual converting from 
negative to positive in the tuberculin skin test. Annual occupational 
risk is defined as the annual excess risk of becoming infected with TB 
due to occupational exposure, and is estimated as a function of the 
background risk. Lifetime occupational risk is defined as the excess 
probability of becoming infected with TB due to exposure in the 
workplace, at least once, in the course of a 45-year working lifetime 
and is estimated as { 1-(1-p)45 } where p is the annual 
occupational risk of TB infection.
2. Data Sources for Estimating Occupational Risk
    The quantitative data needed to develop an overall national 
estimate of risk for TB infection due to occupational exposure are not 
available. The CDC does not publish occupational data associated with 
TB infection incidence and active TB on a nationwide basis. There has 
been some effort to include occupational information on the TB 
reporting forms, but only a limited number of states are currently 
using the new forms that capture occupational information in a 
systematic way.
    However, there are a number of sources that permit the risk in 
occupational settings to be reasonably estimated and, with the aid of 
mathematical models, to develop estimates of excess relative 
occupational risk (ERRo), which can then be multiplied by 
the state-specific background rates to yield estimates of excess 
occupational risk. OSHA has identified three data sources that are 
suitable for assessing the excess risk of TB infection in health care 
workers with occupational exposure. These include: (1) A 1994 survey of 
tuberculin skin testing in all health care facilities in Washington 
State; (2) A state-wide survey of hospitals in North Carolina, 
conducted in 1984-1985, which addressed TB skin testing practices, TB 
infection prevalence, and TB infection incidence among hospital 
employees in that state; and (3) the employee tuberculin skin test 
conversion database from Jackson Memorial Hospital in Miami, Florida. 
In addition to these hospital employee data, the Agency has obtained 
data on selected other work groups from the state of Washington. These 
groups include workers employed in long-term health care, home health 
care, and home care.
    On the issue of data availability for this risk assessment, Dr. 
Graham agrees with OSHA that there are no comprehensive data available 
with respect to occupational risk of TB infection in health care and 
other institutions in the U.S. Instead of relying on two state specific 
studies, Dr. Graham recommends, though with serious reservations, the 
use of a review study by Menzies et al. (Ex. 7-130). Dr. Graham admits 
that the ``validity of the estimates in these reports [reviewed in the 
Menzies et al. study] must be open to serious question * * *'' for the 
following reasons, which were pointed out by Dr. Graham: several of the 
studies reviewed are very old and not relevant to TB risk in the 1990s; 
four studies use tine tests and self-reports of skin test results, 
which are not useful for estimation of risk of TB infection; the 
studies were not consistent in the inclusion of high and low risk 
workers; two-step testing was not done; and the participation rates 
were extremely low or unreported in many of the studies included in 
this review.
    OSHA has chosen not to rely on the Menzies et al. review study, 
because, in addition to Dr. Graham's reservations (which the Agency 
shares), OSHA is also concerned about the inclusion in the Menzies et 
al. review article of studies conducted outside the U.S. Factors known 
to affect the epidemiology of TB, such as environmental conditions, 
socio-economic status, and work practices, are expected to differ 
greatly from one country to another, and are not controlled for in the 
statistical analyses of these studies. For all of these reasons, the 
Agency has chosen to rely solely on U.S. studies for its quantitative 
risk estimations.
    Estimates of excess risk due to occupational exposure are expressed 
as the percent increase above background based on relative risk 
estimates derived from occupational studies. Internal control groups 
provided estimates of background risk for the Washington state and 
Jackson Memorial data sets. In the absence of a suitable internal 
control group, the estimated annual state-wide TB infection rate, as 
calculated in Section 3, was used as the background rate in the North 
Carolina study.
    (a) Washington State Data: Initially, OSHA relied on a three-year 
prospective study, conducted between 1982 and 1984 in the state of 
Washington, to derive an estimate of excess risk for TB infection as a 
result of occupational exposure (Ex. 7-42). OSHA received several 
objections to the use of this study. The study used hospitals with no 
known TB cases as ``controls'' based on the assumption that in those 
hospitals the risk of TB infection to employees may be the same as for 
the general population. Dr. Qaqish noted that this assumption is highly 
questionable and that the use of such controls is not appropriate. Dr. 
Graham and Dr. Qaqish pointed out that the published results did not 
include conversions identified through contact investigations, which

[[Page 54194]]

means that the conversion rate reported in that study was likely to be 
an underestimate of the true risk. In addition, the commenters noted 
that the study was designed to estimate the effectiveness of the TB 
screening program and may have produced skin testing results biased 
toward the null; the study is relatively old; and, the study was 
conducted prior to the AIDS epidemic and therefore the results may not 
be relevant to the occupational risk at present because the 
relationship between HIV and TB is not reflected in this study.
    In an effort to respond to reviewers' comments, the Agency chose to 
update the analysis by relying on a data set of tuberculin skin testing 
results from a survey of the state's tuberculin skin testing program in 
1994. This survey is conducted by the TB Control Office in the 
Washington State Health Department and it covers all hospitals in the 
state, as well as long-term care, home health care, and home care 
facilities. OSHA was given access to the database for the 1994 survey 
as well as data on conversions identified through contact 
investigations for the same year (Ex. 7-263). Table V-2 summarizes the 
results of the 1994 survey. Of the 335 health care establishments in 
the state of Washington, 273 responded to the survey, for an overall 
response rate of 81.5%. Of those, 76 were hospitals, 142 were long-term 
care, 47 were home health care, and 8 were home care facilities. 
Hospitals had the highest survey response rate (85%) and home health 
care had the lowest (77%). Every employee at risk for TB infection 
(i.e., who was known to be tuberculin skin test negative at the start 
of the study period) in the participating hospitals and long-term care 
facilities was given a tuberculin skin test, including administrators, 
housekeepers, business office staff, and all part-time employees. 
Testing in home health care facilities was generally confined to those 
nursing staff who had direct client contact. Employees in home care are 
those who provide services to patients in home health care and include 
food handlers, cleaning aides, personal care-givers, and some social 
workers.

                                 Table V-2--Washington State 1994 Survey Results                                
----------------------------------------------------------------------------------------------------------------
                                                                                                        Annual  
            Type of facility                Number of a  establishments     Number of    Number of    rate of TB
                                                                            skin tests  conversions   conversion
----------------------------------------------------------------------------------------------------------------
Hospital................................  76 (85%)                              39,290           50   1.27/1,000
Long-term Care..........................  142 (81%)                             11,332          111   9.80/1,000
Home Health Care........................  47 (77%)                               2,172           11   5.06/1,000
Home Care...............................  8 (80%)                                  537            1   1.86/1,000
                                         -----------------------------------------------------------------------
    Total...............................  273 (81.5%)                           53,331          173   3.24/1,000
----------------------------------------------------------------------------------------------------------------
a Numbers in parentheses are study response rates for each group.                                               

    The overall rate of skin test conversion for workers in the health 
care system in Washington State in 1994 was 3.24 per 1,000 employees 
tested. This is greater than a 4-fold increase from the estimated 
state-wide background rate of 0.69 per 1,000 at risk, as calculated in 
section 3. The annual rate of TB conversion ranged from 1.27 per 1,000 
tested for hospital employees to 9.80 per 1,000 tested for long-term 
care employees.
    The annual rate of 9.8 per 1,000 for long-term care employees 
probably reflects the high potential for exposure to undiagnosed active 
TB in those facilities. As a rule, long-term facilities in Washington 
State do not have AFB isolation rooms. Therefore, residents with no 
obvious TB symptoms but who might be infectious spend most of their 
time in open spaces exposing other residents and workers to infectious 
droplet nuclei. However, once a resident has been identified as a 
suspect TB patient, that person is transferred to a hospital until 
medically determined to be non-infectious.
    Also, since employees who were 35 years of age or younger were not 
given a two-step test at hiring, and a high percentage of employees are 
foreign born and therefore most likely to have been vaccinated during 
childhood with the BCG vaccine, some of the conversions observed might 
be late boosting because of BCG. However, an almost two-fold increase 
in risk for long-term care workers even as compared to the significant 
excess risk among home health care workers clearly indicates that the 
risk of TB infection for workers in long-term care is high and not 
likely to be fully explained by late boosting. Beginning in 1995, two-
step testing has been done on all new hires in Washington State. Thus, 
tuberculin skin testing data for 1995 are not expected to be influenced 
by possible late boosting; OSHA will place the 1995 data in the 
rulemaking record as they become available.
    Hospital workers had the lowest overall rate of conversion (overall 
rate of 1.27 per 1,000). This, in part, can be attributed to the 
existence of extensive TB control measures in that environment in 
Washington State. Compliance with the CDC Guidelines and OSHA's TB 
Compliance Directive is quite high in Washington State because: (a) 
There is a strong emphasis on early identification of suspect TB 
patients; (b) there is a strong emphasis on employee training and 
regular tuberculin skin testing (although on a less-frequent basis than 
recommended in the Guidelines: All employees are tested at hire and 
annually thereafter); (c) the use of respirators is expected when 
entering an isolation room; and (d) all isolation rooms are under 
negative pressure, have UV lights, and exhaust to the outside. In 
addition, conversion data in hospitals are more likely to represent 
true TB infections than in the other health care settings, because 
hospitals are more likely to re-test converters in an effort to 
eliminate false-positive cases.
    A more thorough analysis of the hospital data is presented in table 
V-3. Because the Washington State survey was not designed to compare 
exposed persons with matched controls who have had no exposure, several 
alternative definitions of an internal control (unexposed) group were 
used in analyzing this data set. Three different analyses, shown in 
table V-3, produced estimates of annual occupational infection rates 
ranging from 0.4 to 0.6 per 1,000 above control (i.e., ranging from a 
47% to an 84% increase above control). In order to minimize the 
likelihood of contaminating the control group with persons having 
significant occupational exposure, OSHA defined the control group as 
workers in hospitals located in zero-TB counties and with no known TB 
patients. This analysis is summarized in table V-3 as Definition 1. If 
potential for occupational exposure is defined as

[[Page 54195]]

either working in a hospital in a county that has active TB or in a 
hospital that has had TB patients, then the annual risk due to 
occupational exposure is 47% above background. The excess annual risk 
due to occupational exposure appears to be approximately 60% above 
background, if workers in hospitals with a transfer-out policy for TB 
patients are considered to be the control group, shown as Definition 2 
in table V-3. A 60% increase above background is not statistically 
significantly different from a 47% increase and therefore these two 
``control'' groups can be viewed as producing ``statistically'' 
equivalent results. However, the Agency believes that Definition 1 is 
more appropriate, though the risk estimates are higher if the control 
group is defined based on Definition 2, because there is a higher 
likelihood of potential for exposure to a patient with undiagnosed TB 
under Definition 2 conditions. Comparisons of all hospital TST data to 
the state-wide estimate of TB infection rate resulted in an estimate of 
the annual excess occupational risk of approximately 84% above 
background, shown in table V-3 as Definition 3. Estimates of the annual 
and lifetime occupational risk of TB infection for the average health 
care worker in hospitals by state, extrapolated from this study and 
using Definition 1 as the control group, are presented and summarized 
in section 4.

                                           Table V-3--Washington State Data Hospital PPD Skin Testing Results                                           
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Number of    Number of      Average       Overall      Relative risk  
             Definition of exposed and control groups               Sample size   skin tests  conversions   conversion    conversion  ------------------
                                                                                    given       observed     rate 1 a      rate 2 b     Rate 1   Rate 2 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                           Definition 1                                                                                                                 
Control: Hospitals in zero-TB counties and with no-known TB                                                                                             
 patients.........................................................           16        1,142            1         0.477       0.8756   .......  ........
Exposed: Hospitals in counties reporting TB or having TB patients.           60       38,148           49         1.523       1.28447     3.19     1.47 
                           Definition 2                                                                                                                 
Control: Hospitals that transfer out TB patients..................           35        3,645            3         0.498       0.823    .......  ........
Exposed: Hospitals with isolation rooms...........................           41       35,645           47         1.989       1.3185      3.99     1.602
                           Definition 3                                                                                                                 
Control: State-wide estimates of annual risk of infection.........  ...........  ...........  ...........        c0.69       c0.69     .......  ........
Exposed: All PPD testing data.....................................           76       39,290           50         1.302       1.27        1.89     1.84 
--------------------------------------------------------------------------------------------------------------------------------------------------------
aRate 1 is estimated as the arithmetic average of hospital specific conversion rates.                                                                   
bRate 2 is estimated as the ratio of the sum of all conversions reported divided by the total number of skin tests given within each group.             
cSource: Table V-3(b), state-wide rate of infection.                                                                                                    

    Annual rates of excess risk due to occupational exposure were 
estimated for long-term care, home health care, and home care and are 
presented in Section 4. The same control group used in the hospital 
data analysis, Definition 1 (i.e., 0.876/1,000 workers at risk) was 
used to estimate the background risk among workers in long-term care, 
health care, and home care facilities and settings. Using 0.876 as the 
background infection rate for workers in these settings (a) provided a 
level of consistency among the Washington data analyses, and (b) 
resulted in a lower estimate of occupational risk for the non-hospital 
health care workplaces than would have resulted had the state-wide 
background risk estimate (i.e., 0.67/1,000 see Section 3) been used. 
When industry-specific risk data are used, there is approximately a 10-
fold increase in annual risk for workers in long-term care, a 5-fold 
increase in annual risk for workers in home health care, and a 1-fold 
increase in annual risk for workers in home care (see Section 4).
    Estimates of the range of annual and lifetime occupational risk for 
the average health care worker in long-term care, home health care, and 
home care by state, extrapolated from the Washington State study, are 
presented in Section 4.
    (b) North Carolina Study: A state-wide survey of all hospitals in 
North Carolina (NC) was conducted in 1984-1985 (Ex. 7-7). The survey's 
questionnaire was designed to address three main areas of concern 
affecting hospital employees: (1) Tuberculin skin testing practices; 
(2) TB infection prevalence; and (3) TB infection incidence. The 
incidence of new infections among hospital personnel was assessed over 
a five-year period by reviewing tuberculin skin test conversion data 
during calendar years 1980 through 1984 and was calculated as the 
number of TB skin test conversions divided by the number of skin tests 
administered. (Since most employees were only given annual testing, the 
number of tests administered is a very close estimate of the total 
number of people tested within a year and thus can be used as the 
denominator in estimating infection incidence.) Only 56 out of 167 
hospitals reported information on TB conversion rates (34% response 
rate). The authors estimated a state-wide TB infection rate of 11.9 per 
1,000 per year for hospital employees in 1984 and a five-year mean 
annual infection rate of 11.4 per 1,000, with a range of 0-89 per 1000 
employees at risk for TB infection. An analysis of the data by region 
(i.e., eastern, central, western) showed that the eastern region had 
consistently higher rates (with an average infection rate of 18.0 per 
1,000) followed by the central region (7.0 per 1,000) and the western 
region (6.1 per 1000). Results of this study are shown in table V-4.

[[Page 54196]]



                   Table V-4--Skin Test Conversion Rates a North Carolina Hospital Personnel b                  
----------------------------------------------------------------------------------------------------------------
                                                                     Year                                       
           Region            -----------------------------------------------------------------------------------
                                  1980          1981          1992          1993          1984       5-year mean
----------------------------------------------------------------------------------------------------------------
Eastern.....................          19.3                                                                      
                                     (7)            30.8                                                        
                                                  (10)            17.7                                          
                                                                (11)            11.2                            
                                                                              (12)            15.7              
                                                                                            (18)            18.0
                                                                                                          (19)  
Central.....................           3.0                                                                      
                                     (6)             3.7                                                        
                                                   (8)             7.2                                          
                                                                (13)             6.6                            
                                                                              (23)            10.0              
                                                                                            (25)             7.0
                                                                                                          (29)  
Western.....................           1.9                                                                      
                                     (2)            13.5                                                        
                                                   (4)             5.3                                          
                                                                 (4)             4.1                            
                                                                               (4)             7.2              
                                                                                             (8)             6.1
                                                                                                          (8)   
----------------------------------------------------------------------------------------------------------------
a Conversion rates are expressed as number of conversions per 1,000 workers tested.                             
b In parentheses is the number of hospitals included in the study.                                              

    Use of this study's overall results for risk estimates was 
criticized by the peer reviewers because of design flaws in the study 
(e.g., high non-response rate, inconsistent skin testing practices, and 
limited two-step testing) and, most importantly, the presence of 
atypical mycobacteria (contributing to false positive results) in the 
eastern part of the state. Based on further input from Dr. Comstock, 
the Agency chose to rely on the study results from the western region 
only, because they are considered to be more representative of the 
``true'' risk of infection and are expected to be less confounded by 
cross-reactions to atypical mycobacteria. Further, the Agency chose to 
rely on the conversion rate estimated for 1984 because it was the most 
recent data reported in the study. Therefore, the western region 
conversion rate of 7.2 per 1,000, estimated based on responses to the 
survey from eight hospitals in 1984, was used as an overall worker 
conversion rate. Further, the 1984 rate was adjusted by the percent 
decrease of active TB between 1984 and 1994 in North Carolina so that 
the final worker conversion rate for 1994 based on the western region 
rates reported in this study was estimated to be 5.98 (7.2 * 532/641 = 
5.98) per 1,000 employees at risk for TB infection.
    The North Carolina study did not have an internal control group to 
use as the basis for estimating excess risk due to occupational 
exposure because the conversion rates presented in this study were 
based on TST results for the entire hospital employee population. In 
the absence of an internal control group, the Agency used the estimated 
state-wide background rate of 1.20 per 1,000 as the background rate of 
infection for the western region in North Carolina (see Section 3) to 
estimate excess risk due to occupational exposure.1 Based on 
this study, annual occupational risk is approximately four times 
greater than background [(5.98-1.2)/1.2 = 3.98]. Estimates of the 
annual and lifetime occupational risk of TB infection based on this 
study by state are presented in Section 4.
---------------------------------------------------------------------------

    \1\ Using the state-wide estimate of population risk as the 
background estimate of risk for this study most likely results in an 
underestimate of the true excess risk due to occupational exposure, 
because the true background estimate of risk for the western region 
in North Carolina is expected to be less than the state-wide 
estimate, which is influenced by the large number of infections 
found in the eastern region of that state.
---------------------------------------------------------------------------

    (c) Jackson Memorial Hospital Study: Jackson Memorial Hospital 
(JMH) is a 1500-bed general facility located in Miami, Florida, 
employing more than 8,000 employees. It is considered one of the 
busiest hospitals in the U.S. It is the primary public hospital for 
Dade County and the main teaching hospital for the University of Miami 
School of Medicine. JMH treats most of the TB and HIV cases in Dade 
County and, consequently, there is a higher likelihood of occupational 
exposure to TB in this facility than in the average hospital in the 
U.S. From March 1988 to September 1990, an outbreak of multidrug-
resistant TB (MDR-TB) occurred among patients and an increased number 
of TST conversions was observed among health care workers on the HIV 
ward. This prompted a re-evaluation of the hospital's infection control 
practices and the installation of engineering controls to minimize 
exposure to TB. As part of the evaluation of the outbreak, NIOSH did a 
Health Hazard Evaluation and issued a report (Ex. 7-108). In addition, 
NIOSH conducted a retrospective cohort study of JMH to determine 
whether the risk of TB infection was significantly greater for health 
care workers who work on wards having patients with infectious TB than 
those who work on wards without TB patients.
    For the data analysis of this study, ``potential for occupational 
exposure'' was defined based on whether an employee worked on a ward 
that had records of 15 or more positive cultures for pulmonary or 
laryngeal TB during 1988-1989. In other words, positive culture was 
taken as a surrogate for exposure to infectious TB. The authors 
restricted the ``exposed'' group to employees on wards with exposures 
to pulmonary or laryngeal TB because they intended to restrict the 
study to hospital workers with exposure to patients with the highest 
potential for being infectious. There were 37 wards at JMH that had 
submitted at least one positive culture during 1988-1989. Seven wards 
met the criteria of 15 or more and were therefore included in the 
``exposed'' group. These were the medical intensive care unit, five 
medical wards, and the emergency room. The ``control'' group was 
defined as hospital workers assigned to wards with no TB patients 
(i.e., wards with no records of positive cultures during 1988-89). The 
``control'' wards were post-partum, labor and delivery, newborn 
intensive care unit, newborn intermediate care unit, and well newborn 
unit. The results of this analysis are presented in Table V-5.

         Table V-5--Skin Test Conversion Rates for Hospital Personnel at Jackson Memorial Hospital a, b         
----------------------------------------------------------------------------------------------------------------
                                                                                                         95%    
                           Year                                Exposed       Control      Relative    confidence
                                                                group         group         risk       interval 
----------------------------------------------------------------------------------------------------------------
1989......................................................          62.2                                        
                                                              (13/209)             6.2                          
                                                                             (2/324)           10.1    2.3--44.2

[[Page 54197]]

                                                                                                                
1990......................................................          75.5                                        
                                                              (16/212)             6.5                          
                                                                             (2/309)           11.7    2.7--50.2
1991......................................................          31.7                                        
                                                               (6/189)             3.5                          
                                                                             (1/282)            9.0    1.1--73.8
----------------------------------------------------------------------------------------------------------------
a Rates are expressed as number of conversions per 1,000 workers tested.                                        
b Source: Ex. 7-108                                                                                             

    Table V-5 shows a substantially elevated risk for those workers 
with potential exposure to patients with infectious TB. The relative 
risk ranges from 9 to 11.7 between 1989 and 1991 and is statistically 
significant for all of those years. This suggests that the excess risk 
due to occupational exposure is approximately 8-fold above background; 
this is an overall risk estimate that reflects the occupational risk of 
TB infection for JMH employees with patient contact, because this 
analysis included everyone tested in the ``exposed'' and ``control'' 
group, regardless of his or her specific job duties or length of 
patient contact.
    An analysis of various occupational groups within this cohort 
showed that nurses and ward clerks in the ``exposed'' groups had the 
highest conversion rates: 182 and 156 conversions per 1,000 workers 
tested, respectively. Other studies have shown that health care workers 
who provide direct patient care are at greater risk for infection than 
workers who do not provide direct patient care. The high risk seen in 
ward clerks was unexpected since these workers are not involved in 
direct patient care. However, in the emergency room, the risk for TST 
conversion for the ward clerks was almost three times higher than for 
the nurses, 222 and 83 per 1,000, respectively. Ward clerks in the 
emergency room are responsible for clerical processing of patients 
after triage, handling specimens for the laboratory, and gathering 
clothing and valuables from admitted patients. During these 
interactions, there may have been less strict adherence to infection 
control measures, and this could explain the high conversion rate.
    OSHA used the results from the 1991 analysis of the data in the JMH 
study to estimate occupational risk of TB infection in hospital workers 
with a relatively high likelihood of occupational exposure, for the 
following reasons: (a) 1991 represents the most recent year for which 
conversion data are available prior to the time when TB infection 
control measures were fully implemented at JMH; and (b) The higher 
conversion rates reported for 1990 and 1989 (75.5 and 62.2 per 1,000 
respectively) may be atypical, i.e., they may to some extent reflect 
the effect of the outbreak and not the long-term occupational risk.
    Based on the results of this study, OSHA estimates that the annual 
excess risk of TB infection due to occupational exposure is 7.95 times 
greater than background. Estimates of annual and lifetime occupational 
risk of TB infection for the average health care worker in hospitals by 
state, extrapolated from this study, are presented and summarized in 
section 4.
3. Estimation of Background Risk of TB Infection
    OSHA's methodology for estimating population (background) TB 
infection rates relies on the assumption that TB infection occurring in 
an area can be expressed as a numerical function of active TB cases 
reported in the same area. If the likelihood of observing any infection 
in a population is minimal, then the likelihood of observing active 
disease diminishes. Conversely, the presence of active TB implies the 
presence of infection, since active disease can only progress from 
infection. Therefore, there is a functional relationship linking TB 
infections to active disease being observed in a particular area during 
a specified time period.
    Peer reviewer comments on this assumption varied. Neil Graham 
states in his comment ``Although factors such as migration and 
distribution of the population may influence this relationship it seems 
probable that this assumption is largely correct and justifiable.'' 
(Ex. 7-271). On the other hand, Dr. Simone expresses concern over this 
assumption and states ``It is not necessarily true that a change in 
cases now reflects the risk of infection now.'' Dr. Qaqish demonstrates 
in his comment that the net effect of assuming a proportional 
relationship between the number of active cases and the number of new 
infections is to introduce a possible bias into the estimate of 
background risk of TB infection, although such a bias could work in 
either direction, i.e., toward increasing or decreasing the estimate of 
risk. Dr. Qaqish further states that in the absence of more ``relevant 
data,'' it is not possible to determine the actual net effect in 
magnitude and direction of the bias and ``without obtaining additional 
data, it would be impossible for the Agency to improve on the accuracy 
of the risk estimates * * * '' OSHA has considered all of the reviewer 
comments and is aware of the inherent uncertainty and the potential for 
bias associated with the use of this assumption; however, in the 
absence of the additional ``relevant'' data to which Dr. Qaqish refers, 
the Agency believes this approach to be justifiable.
    In defining the model used to estimate the annual infection rates 
occurring in a geographical area based on data on active disease cases 
reported for the same area, infections progressing to active disease 
are assigned to one of three distinct groups: those occurring this 
year, last year, and in previous years.

BILLING CODE 4510-26-P

[[Page 54198]]

[GRAPHIC] [TIFF OMITTED] TP17OC97.001



BILLING CODE 4510-26-C
    TB cases reported to CDC each year are a combination of new and old 
infections that have, for various reasons, progressed to active 
disease. Until recently, it was believed that most of the active cases 
were the product of old infections. However, with the use of DNA 
fingerprinting techniques, researchers have reported that a larger 
percentage of active cases may be attributed to new or recent 
infections. Small et al. reported, in an article on tracing TB through 
DNA fingerprinting, that as many as 30% of the active cases reviewed in 
the study may be the result of recent infections (Ex. 7-196).
    In this risk assessment, the Agency assumes the lifetime risk that 
an infection will progress to active TB to be approximately 10%. This 
estimate is supported by CDC and in her comment, Dr. Simone states 
that: ``The assumption * * * is generally agreed upon.'' Dr. Comstock 
and Dr. Qaqish both questioned the validity and accuracy of CDC's 
estimate. Their comments suggest that the true lifetime rate of 
progression from infection to active disease for adults may be less 
than 10 percent. However, as Dr. Graham points out, the 10% assumption 
is a widely accepted ``rule of thumb'' and is also in relative 
agreement with data from the unvaccinated control group of the British 
Medical Research Council (MRC) vaccination trial in adolescents (Ex. 7-
266).
    In the MRC study, 1,338 adolescents' skin tests converted following 
TB exposure where the precise date of conversion was known. Of these, 
108 (8.1%) individuals developed active TB during follow-up. Of these, 
54% developed active TB within one year and 78% within 2 years. This 
results in a risk of approximately 4% at one year, 6% at two years, and 
an overall risk of 8%. Given that the risk of TB reactivation increases 
with age, the lifetime risk is expected to be higher than the 8% 
attained in this study and, as Dr. Graham points out, a 10% overall 
lifetime risk seems reasonable.
    Based on Dr. Graham's recommendation to rely on the progression 
rates from the MRC study, OSHA changed the assumption on the 
progression parameters from 2.5% (first year), 2.5% (second year), and 
5% (remaining lifetime) to 4%, 2% and 4%, respectively. Therefore the 
total 10% progression from infection to active disease is partitioned 
into 3 groups: progression during the first year after infection (40% 
of all infections that eventually progress, for a net probability of 
4%), progression during the second year (20% of all infections that 
eventually progress, for a net probability of 2%), and progression 
during all subsequent years (the remaining 40% of progressing 
infections). This last probability (4%) is assumed to be uniformly 
distributed across the remaining lifespan.
    TB rates vary considerably by geographic area, socio-economic 
status, and other factors. In an attempt to account for some of those 
factors, to the extent possible, background TB infection rates have 
been estimated separately for each state. The derivation of background 
infection rates involves several steps for which the process and 
formulae are presented below.
    Step 1: Background rate of TB infection for state i in year j is 
defined as:

Bi(j)=Ii(j)/Xi(j)    (1)

where:

Bi(j) is the background TB infection rate for state i in 
year j
Ii(j) is an estimate of the number of new infections that 
occurred in state i in year j
Xi(j) is the population at risk for TB infection in state i 
in year j.

    Step 2: Estimation of Ii(j), the number of new TB 
infections:

Let:

Ai(j) be the total number of adult TB cases reported to CDC 
by state i in year j.
A(j) be the total number of adult TB cases reported to CDC 
by all states in year j.
Pi(j) be the estimated prevalence of adult TB infection in 
state i during year j.
Ri be the ratio of the number of adult TB cases reported in 
1993 to the number of adult cases reported in 1994 in state i.

    The number of TB cases reported in 1994 can be expressed as a 
function of TB infections expected to have progressed to active 
disease, by the following formula:

Ai(1994)=.04*Ii(1994)+.02*Ii(1993)+(.04
/73)*Ii(1992)*prob(alive in 1994)
    +(.04/73)*Ii(1991)*prob(alive in 1994)
    +....
    +....
    +(.04/73)*Ii(1919)*prob(alive in 1994)

    This can be expressed as:

Ai(1994)=.04*Ii(1994)+.02*Ii(1993)+(.04
/73)* [Ii(j)*prob(alive in 1994)],

where j ranges from 1919 to 1992. The quantity inside the summation 
symbol is the sum of all people who were infected with TB between 1919 
and 1992 and are still alive in 1994. This summation can be 
approximated by the prevalence of TB infection in 1992, 
Pi(1992). Therefore, the number of active TB cases reported 
in 1994 can be expressed as:
Ai(1994)=.04*Ii(1994)+.02*Ii(1993)+(.04
/73)*Pi(1992)     (2)

Further, if we assume that the number of new infections is directly 
proportional to the number of active cases, then Ii(1993) 
can be expressed as follows:

Ii(1993)=Ii(1994)*(Ai(1993)/
Ai(1994))     (3)

and (2) can be expressed as:

Ai(1994)=[(.02*(Ai(1993)/
Ai(1994))+.04]*Ii(1994)+(.04/
73)*Pi(1992)
Ai(1994)=[(.02*Ri+.04]*Ii(1994)+(.04/
73)*Pi(1992)     (4)

then solving for Ii(1994) becomes: 2

    \2\ Using the prevalence of TB infection in 1992 (i.e., 
Pi(1992)) to approximate the quantity inside the 
summation sign (i.e., everyone infected between 1919 and 1992 and 
alive in 1994) slightly overestimates the quantity inside the 
summation (i.e., Pi(1992) is slightly larger than the 
quantity it approximates.) It includes a small number of people who 
were infected with TB and were alive as of 1992 and who were 
therefore included in the prevalence figure, but who died before 
1994, and, technically, are not included in the summation. This 
implies that, in equation (5), a slightly larger number is being 
subtracted from Ai(1994) than should be, resulting in an 
underestimate of the number of new infections in 1994 and an 
underestimate of the occupational risk.

---------------------------------------------------------------------------

[[Page 54199]]

Ii(1994)=[Ai(1994)-.04/73*Pi(1992)]/
---------------------------------------------------------------------------
(.02*Ri+.04)     (5)

    Step 3: Estimation of Xi(1994):
    Xi(1994), the population at risk for TB infection in 
state i in 1994, is estimated as follows:

Xi(1994)=Ni-Pi(1993)     (6)

Where:

Ni is the adult population for state i as reported by U.S. 
Census in 1994.
Pi(1993) is the estimated number of infected adults in state 
i in 1993 (i.e., prevalence of TB infection in state i among adults).
To estimate the number of adults currently at risk for TB infection in 
each state, the number of already infected adults (i.e., prevalence of 
TB infection Pi in 1993) is subtracted from the adult 
population in 1994.
    Step 4: Estimation of population currently infected as of 1993 by 
state, Pi(1993):
    The prevalence of TB infection in each state is estimated as a 
function of TB infection prevalence in the U.S. in 1993 and the percent 
TB case rate for each state.

Pi(1993)=P(1993)*(Ai(1993)/
A(1993))     (7)

Where:

P(1993) is the prevalence of TB infections in the U.S. in 
1993 (Ex. 7-66) and
A(1993) is the total number of adult TB cases reported in 
1993.

    Estimates of TB infection prevalence in the U.S. were developed for 
OSHA by Dr. Christopher Murray of the Harvard Center for Population and 
Development Studies and are presented in Table V-6 (Ex. 7-267). The 
mathematical model used by Dr. Murray to estimate TB infection 
prevalence has been designed to capture the transmission dynamics of TB 
by modeling transfers between a series of age-stratified compartments 
using a system of differential equations. The model adjusts for various 
epidemiological factors known to influence the course of active TB, 
such as onset of infection (i.e., old vs. new infections) and the 
impact of immigration rates and the HIV epidemic. However, it does not 
differentiate among gender or race categories. The model has been 
successfully validated using actual epidemiological data on active TB 
from 1965 to 1994. The estimates of TB prevalence rates presented here 
are specific for adults (i.e., older than 18 years of age), which make 
them more appropriate for estimating risk of transmission in an 
occupational setting.

                       Table V-6.--National Prevalence of TB Infection in Adults (18+) a b                      
----------------------------------------------------------------------------------------------------------------
                             Year                                  Expected         Minimum          Maximum    
----------------------------------------------------------------------------------------------------------------
1992.........................................................            6.87%                                  
                                                                  (12,978,461)            6.53%                 
                                                                                   (12,336,150)            7.22%
                                                                                                    (13,639,663)
1993.........................................................            6.64%                                  
                                                                  (12,667,062)            6.31%                 
                                                                                   (12,037,524)            6.97%
                                                                                                    (13,296,599)
1994.........................................................            6.47%                                  
                                                                  (12,449,445)            6.14%                 
                                                                                   (11,814,465)            6.79%
                                                                                                   (13,065,182) 
----------------------------------------------------------------------------------------------------------------
a Numbers in parentheses are population prevalence figures.                                                     
b Estimated for OSHA by Christopher Murray MD, PhD, Harvard University, Center for Population and Development   
  Studies (Ex. 7-267).                                                                                          

    To estimate the number of previously infected adults in each state 
(Pi), the estimated national TB prevalence figure was 
multiplied by the active cases for each state and divided by the total 
number of active cases reported [see equation (7)] (i.e., the national 
prevalence estimate was apportioned among the states based on each 
state's percent contribution to active TB reported for 1993). To 
estimate the number of adults at risk of TB infection, (Xi), 
the number of already infected adults was subtracted from the adult 
population estimate for each state (see equation (6)). The number of 
new infections expected to have occurred in 1994 was estimated using 
equation (5).
    The background rate of TB infection for 1994 was then estimated by 
dividing the number of new infections (Ii) by the number of 
susceptible adults in each state (Xi) (see equation (1)).
    Results on estimated TB background annual infection rates for each 
state are presented in Table V-7(a)--Table V-7(c). In Table V-7(a) TB 
infection rates are based on an average value of TB infection 
prevalence, as estimated by Dr. Murray, in the U.S. (i.e., 12,667,062). 
In Table V-7(b), infection rates are based on the minimum value of TB 
infection prevalence in the U.S. (i.e., 12,037,524). In Table V-7(c), 
infection rates are based on the maximum value of TB infection 
prevalence in the U.S. (i.e., 13,296,599). An overall range of 
background annual TB infection rates was constructed by combining all 
three sets of infection rates and was estimated to be between 0.194 and 
3.542 per 1,000 individuals at risk of TB infection, with a weighted 
average of 1.46 per 1,000 using state population size as weights.

                                           Table V-7(a).--Estimates of Annual Background TB Infection Rates a                                           
                                                                  [Referent Year 1994]                                                                  
                                                                                                                                                        
                                                                                                                                              Annual    
                                                             TB cases       Population      Population     Population at    Estimate of     population  
                          State                             reported in       size a         currently         risk       new infections    rate of TB  
                                                               1994                         infected b                                       infection  
                                                                      Ai              Ni        Pi(1993)              Xi              Ii              Bi
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama (01)............................................             413           3,139         250,083       2,888,917           4,779            1.65
Alaska (02).............................................              78             414          27,787         386,213           1,182            3.06
Arizona (04)............................................             233           2,936         118,231       2,817,769           2,858            1.01
Arkansas (05)...........................................             235           1,813         107,334       1,705,666           2,906            1.70
California (06).........................................           4,291          22,754       2,437,044      20,280,956          47,852            2.36

[[Page 54200]]

                                                                                                                                                        
Colorado (08)...........................................              90           2,686          52,850       2,633,150           1,045            0.40
Connecticut (09)........................................             144           2,487          81,182       2,405,818           1,665            0.69
Delaware (10)...........................................              51             531          26,152         504,848             671            1.33
D.C. (11)...............................................             116             451          80,092         370,908           1,162            3.13
Florida (12)............................................           1,675          10,691         846,687       9,844,314          20,545            2.09
Georgia (13)............................................             676           5,162         396,646       4,765,354           7,082            1.49
Hawaii (15).............................................             234             875         132,942         742,058          25,890            3.49
Illinois (17)...........................................           1,021           8,669         622,211       8,046,789          10,994            1.37
Indiana (18)............................................             201           4,279         129,673       4,149,327           2,083            0.50
Iowa (19)...............................................              62           2,180          31,056       2,068,943             859            0.42
Kansas (20).............................................              77           1,864          37,049       1,826,951           1,065            0.58
Kentucky (21)...........................................             316           2,857         203,227       2,653,773           3,273            1.23
Louisiana (22)..........................................             412           3,080         185,792       2,894,208           5,582            1.93
Maine (23)..............................................              31             934          14,712         919,289             419            0.46
Maryland (24)...........................................             344           3,743         211,399       3,531,601           3,582            1.01
Massachusetts (25)......................................             299           4,617         183,067       4,433,933           2,889            0.65
Michigan (26)...........................................             438           6,971         246,269       6,724,731           5,036            0.75
Minnesota (27)..........................................             127           3,326          68,105       3,257,895           1,413            0.43
Mississippi (28)........................................             262           1,913         141,659       1,771,341           3,120            1.76
Missouri (29)...........................................             241           3,899         128,583       3,770,417           2,922            0.78
Montana (30)............................................              22             618          11,987         606,013             290            0.48
Nebraska (31)...........................................              22           1,181          12,531       1,168,469             233            0.20
Nevada (32).............................................             111           1,181          50,670       1,130,330           1,514            1.34
New Hampshire (33)......................................              17             845          13,076         831,924             182            0.22
New Jersey (34).........................................             764           5,973         456,579       5,516,421           8,150            1.48
New Mexico (35).........................................              78           1,156          35,415       1,120,585             944            0.84
New York (36)...........................................           3,414          13,658       2,044,797      11,613,203          34,728            2.99
North Carolina (37).....................................             532           5,314         298,574       5,015,426           6,000            1.20
North Dakota (38).......................................              10             466           3,813         426,186             132            0.29
Ohio (39)...............................................             318           8,248         161,274       8,086,726           3,763            0.47
Oklahoma (40)...........................................             231           2,378         101,886       2,276,114           3,064            1.35
Oregon (41).............................................             146           2,303          78,457       2,224,543           1,793            0.81
Pennsylvania (42).......................................             583           9,154         379,211       8,774,789           5,886            0.67
Rhode Island (44).......................................              47             757          31,601         725,399             495            0.68
South Carolina (45).....................................             362           2,712         205,406       2,506,594           4,273            1.70
South Dakota (46).......................................              26             513           8,173         504,827             342            0.68
Tennessee (47)..........................................             494           3,878         283,863       3,594,137           5,759            1.60
Texas (48)..............................................           2,276          13,077       1,199,200      11,877,800          27,306            2.30
Utah (49)...............................................              47           1,236          23,973       1,212,027             427            0.35
Vermont (50)............................................              10             434           2,724         431,276             160            0.37
Virginia (51)...........................................             330           4,949         226,110       4,722,890           3,220            0.68
Washington (53).........................................             241           3,935         142,729       3,792,251           2,554            0.67
West Virginia (54)......................................              80           1,393          40,318       1,352,682             919            0.68
Wisconsin (55)..........................................             104           3,735          50,126       3,684,874           1,307            0.35
Wyoming (56)............................................              12             339           3,814         335,186             188           0.56 
--------------------------------------------------------------------------------------------------------------------------------------------------------
a Expressed in thousands.                                                                                                                               
b Based on 6.64% rate of TB infection prevalence in the U.S. (expected)                                                                           


                                            Table V-7(b).--Estimates of Annual Background TB Infection Rates                                            
                                                                 [Referent Year 1994 a]                                                                 
                                                                                                                                                        
                                                                                                                                              Annual    
                                                             TB cases       Population      Population     Population at    Estimate of     population  
                          State                             reported in       size a         currently         risk       new infections    rate of TB  
                                                               1994                         infected b                                       infection  
                                                                      Ai              Ni        Pi(1993)              Xi              Ii              Bi
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama (01)............................................             413           3,139         237,654       2,901,346           4,871            1.68
Alaska (02).............................................              78             414          26,406         387,594           1,196            3.09
Arizona (04)............................................             233           2,936         112,355       2,823,645           2,913            1.03
Arkansas (05)...........................................             235           1,813         102,000       1,711,000           2,967            1.73
California (06).........................................           4,291          22,754       2,350,136      20,403,864          48,956            2.40
Colorado (08)...........................................              90           2,686          50,223       2,635,777           1,066            0.40
Connecticut (09)........................................             144           2,487          77,147       2,409,853           1,700            0.71
Delaware (10)...........................................              51             531          24,853         506,147             681            1.34
D.C. (11)...............................................             116             451          76,111         374,889           1,192            3.18

[[Page 54201]]

                                                                                                                                                        
Florida (12)............................................           1,675          10,691         804,607       9,886,393          20,944            2.12
Georgia (13)............................................             676           5,162         376,933       4,785,067           7,275            1.52
Hawaii (15).............................................             234             875         126,335         748,665           2,652            3.54
Illinois (17)...........................................           1,021           8,669         591,288       8,077,712          11,260            1.39
Indiana (18)............................................             201           4,279         123,228       4,155,772           2,136            0.51
Iowa (19)...............................................              62           2,180          29,513       2,070,487             869            0.42
Kansas (20).............................................              77           1,864          35,208       1,828,792           1,079            0.59
Kentucky (21)...........................................             316           2,857         193,126       2,663,874           3,357            1.26
Louisiana (22)..........................................             412           3,080         176,558       2,903,442           5,667            1.95
Maine (23)..............................................              31             934          13,980         920,020             425            0.46
Maryland (24)...........................................             344           3,743         200,893       3,542,107           3,677            1.04
Massachusetts (25)......................................             299           4,617         173,969       4,443,031           2,983            0.67
Michigan (26) ,.........................................             438           6,971         234,030       6,736,970           5,144            0.76
Minnesota (27)..........................................             127           3,326          64,721       3,261,279           1,448            0.44
Mississippi (28)........................................             262           1,913         134,619       1,778,381           3,183            1.79
Missouri (29)...........................................             241           3,899         122,193       3,776,807           2,978            0.79
Montana (30)............................................              22             618          11,391         606,609             294            0.48
Nebraska (31)...........................................              22           1,181          11,909       1,169,091             240            0.21
Nevada (32).............................................             111           1,181          48,152       1,132,848           1,536            1.36
New Hampshire (33)......................................              17             845          12,426         832,574             185            0.22
New Jersey (34).........................................             764           5,973         433,887       5,539,113           8,357            1.51
New Mexico (35).........................................              78           1,156          33,655       1,112,345             965            0.86
New York (36)...........................................           3,414          13,658       1,943,173      11,714,827          35,735            3.05
North Carolina (37).....................................             532           5,314         283,735       5,030,265           6,138            1.22
North Dakota (38).......................................              10             466           3,624         462,376             134            0.29
Ohio (39)...............................................             318           8,248         153,259       8,094,741           3,845            0.48
Oklahoma (40)...........................................             231           2,378          96,822       2,281,178           3,116            1.37
Oregon (41).............................................             146           2,303          74,558       2,228,442           1,825            0.82
Pennsylvania (42).......................................             583           9,154         360,365       8,793,635           6,047            0.69
Rhode Island (44).......................................              47             757          30,030         726,970             506            0.70
South Carolina (45).....................................             362           2,712         195,197       2,516,803           4,356            1.73
South Dakota (46).......................................              26             513           7,766         505,234             350            0.69
Tennessee (47)..........................................             494           3,878         269,756       3,608,244           5,875            1.63
Texas (48)..............................................           2,276          13,077       1,139,601      11,937,399          27,853            2.33
Utah (49)...............................................              47           1,236          22,782       1,213,218             446            0.37
Vermont (50)............................................              10             434           2,589         431,411             162            0.37
Virginia (51)...........................................             330           4,949         214,873       4,734,127           3,311            0.70
Washington (53).........................................             241           3,935         135,654       3,799,346           2,621            0.69
West Virginia (54)......................................              80           1,393          38,315       1,354,685             941            0.69
Wisconsin (55)..........................................             104           3,735          47,634       3,687,366           1,332            0.36
Wyoming (56)............................................              12             339           3,624         335,376             190            0.57
--------------------------------------------------------------------------------------------------------------------------------------------------------
a Expressed in thousands.                                                                                                                               
b Based on a 6.31% rate of TB infection in the U.S.                                                                                                     


                                            Table V-7(c).--Estimates of Annual Background TB Infection Rates                                            
                                                                 [Referent Year 1994 a]                                                                 
                                                                                                                                                        
                                                                                                                                              Annual    
                                                             TB cases       Population      Population     Population at    Estimate of     population  
                          State                             reported in        size          currently         risk       new infections    rate of TB  
                                                               1994                         infected b                                      infection,  
                                                                      Ai              Ni       Pi (1993)              Xi              Ii              Bi
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama (01)............................................             413           3,139         262,512       2,876,488           4,685            1.63
Alaska (02).............................................              78             414          29,168         384,832           1,167            3.03
Arizona (04)............................................             233           2,936         124,107       2,811,893           2,801            1.00
Arkansas (05)...........................................             235           1,813         112,669       1,700,332           2,843            1.67
California (06).........................................           4,291          22,754       2,595,951      20,158,049          46,720            2.32
Colorado (08)...........................................              90           2,686          55,476       2,630,524           1,024            0.39
Connecticut (09)........................................             144           2,487          85,216       2,401,784           1,629            0.68
Delaware (10)...........................................              51             531          27,452         503,508             661            1.31
D.C.....................................................             116             451          84,072         366,928           1,131            3.08
Florida (12)............................................           1,675          10,691         888,766       9,802,234          20,137            2.05
Georgia (13)............................................             676           5,162         416,359       4,745,641           6,884            1.45
Hawaii (15).............................................             234             875         139,539         735,451           2,526            3.43
Illinois (17)...........................................           1,021           8,669         653,134       8,015,866          10,721            1.34

[[Page 54202]]

                                                                                                                                                        
Indiana (18)............................................             201           4,279         136,117       4,142,883           2,029            0.49
Iowa (19)...............................................              62           2,180          32,600       2,067,401             849            0.41
Kansas (20).............................................              77           1,864          38,891       1,825,109           1,052            0.58
Kentucky (21)...........................................             316           2,857         213,327       2,643,673           3,187            1.21
Louisiana (22)..........................................             412           3,080         195,025       2,884,975           5,496            1.91
Maine (23)..............................................              31             934          15,442         918,558             413            0.45
Maryland (24)...........................................             344           3,743         221,905       3,521,095           3,484            0.99
Massachusetts (25)......................................             299           4,617         192,166       4,424,834           2,793            0.63
Michigan (26)...........................................             438           6,971         258,508       6,712,492           4,925            0.73
Minnesota (27)..........................................             127           3,326          71,490       3,254,510          1',377            0.42
Mississippi (28)........................................             262           1,913         148,700       1,764,300           3,057            1.73
Missouri (29)...........................................             241           3,899         134,973       3,764,027           2,865            0.76
Montana (30)............................................              22             618          12,582         605,418             286            0.48
Nebraska (31)...........................................              22           1,181          13,154       1,167,846             227            0.20
Nevada (32).............................................             111           1,181          53,189       1,127,811           1,491            1.32
New Hampshire (33)......................................              17             845          13,726         831,274             178            0.21
New Jersey (34).........................................             764           5,973         479,270       5,493,730           7,938            1.44
New Mexico (35).........................................              78           1,156          37,175       1,118,825             922            0.82
New York (36)...........................................           3,414          13,658       2,146,421      11,511,421          33,696            2.92
North Carolina (37).....................................             532           5,314         313,413       5,000,587           5,859            1.17
North Dakota (38).......................................              10             466           4,003         461,997             129            0.28
Ohio (39)...............................................             318           8,248         169,289       8,078,711           3,678            0.46
Oklahoma (40)...........................................             231           2,378         106,949       2,271,051           3,011            1.33
Oregon (41).............................................             146           2,303          82,357       2,220,643           1,760            0.80
Pennsylvania (42).......................................             583           9,154         398,057       8,755,943           5,722            0.66
Rhode Island (44).......................................              47             757          33,171         723,829             483            0.67
South Carolina (45).....................................             362           2,712         215,614       2,496,386           4,188            1.68
South Dakota (46).......................................              26             513           8,579         504,421             334            0.67
Tennessee (47)..........................................             494           3,878         297,971       3,580,029           5,641            1.58
Texas (48)..............................................           2,276          13,077       1,258,799      11,818,201          26,746            2.26
Utah (49)...............................................              47           1,236          25,165       1,210,835             408            0.34
Vermont (50)............................................              10             434           2,860         431,140             158            0.37
Virginia (51)...........................................             330           4,949         237,347       4,711,653           3,126            0.66
Washington (53).........................................             241           3,935         149,843       3,785,157           2,485            0.66
West Virginia (54)......................................              80           1,393          42,322       1,350,679             896            0.66
Wisconsin (55)..........................................             104           3,735          52,617       3,682,383           1,283            0.35
Wyoming (56)............................................              12             339           4,003         334,997             185            0.55
--------------------------------------------------------------------------------------------------------------------------------------------------------
a Expressed in thousands.                                                                                                                               
b Based on 6.97% rate of TB infection prevalence in the U.S. (maximum estimate).                                                                        

    Step 5 Model validation:
    An alternative, but less sophisticated, way to estimate annual risk 
of infection, if prevalence is known in a specific age group, is to use 
the following formula:

Annual Rate of Infection = -ln(1-P)/d    (8)

Where:

P is the percent prevalence of infection and
d is the average age of the population (Ex. 7-265).

    In order to validate the model used by OSHA to estimate background 
infection rates, estimates of TB infection prevalence for 1994 were 
used to calculate predicted infection rates using equation (8). Based 
on Murray's model, TB infection prevalence is expected to range from 
6.31% to 6.97% in 1994 among adults (18+). Using these figures and 
assuming the average age to be 45 years, formula (8) predicts that 
infection rates can range from 1.45 to 1.61 per 1,000. These results 
are in close agreement with OSHA's weighted average estimate of the 
national TB infection rate, which is 1.46 per 1,000.
4. Occupational Risk Estimations
    OSHA used the three different data sources to obtain estimates of 
risk of TB infection for health care employees: the Washington State 
data, the North Carolina study, and the NIOSH Health Hazard Evaluation 
(HHE) from Jackson Memorial Hospital (Exs. 7-263, 7-7, 7-108). The 
Washington State data represent workplaces located in low TB prevalence 
areas, where TB infection control measures and engineering controls are 
required by state health regulations. The North Carolina data represent 
workplaces located in areas with moderate TB prevalence and inadequate 
TB infection control programs. Finally, the Jackson Memorial Hospital 
data are representative of county hospitals serving high-risk patients 
whose employees have a high frequency of exposure to infectious TB. 
These data sources provide information on the magnitude of the expected 
excess risk in three different environments, and are used to provide a 
range of possible values of excess risk.
    Based on the Washington State data, the annual risk is expected to 
be 1.5 times the background rate for hospital employees, approximately 
11 times the background rate for long-term care employees, 6 times the 
background rate for home health care workers, and double the background 
rate for home care employees. Based on the North Carolina data, the 
annual risk is

[[Page 54203]]

expected to be approximately 5 times the background rate. Based on the 
Jackson Memorial Hospital data, the annual risk is expected to be 
approximately 9 times the background.
    Estimates of expected excess risk of TB infection for workers with 
occupational exposure by state are calculated by applying the excess 
relative risk ratios, derived from the three occupational studies, to 
the overall background rate of infection for each state and are 
presented in table V-8(a)--table V-8(c). A range of excess risk of TB 
infection due to occupational exposure is constructed by using the 
minimum and maximum estimates of excess risk among all states for each 
data source. These results are presented in table V-9 and table V-10 
for workers in hospitals and for workers in other work settings, 
respectively.

BILLING CODE 4510-26-P
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                        Table V-9.--Occupational Risk Estimates for Hospital Employees a                        
----------------------------------------------------------------------------------------------------------------
                                                                                   Range of excess occupational 
                                   Overall risk/    Background      Excess risk               risk d            
             Source                  (exposed)     risk based on  based on study -------------------------------
                                                       study         (percent)        Annual         Lifetime   
----------------------------------------------------------------------------------------------------------------
Washington State 1994 data......       1.24/1000       0.88/1000              47  0.09-1.66        4.1-72.2     
North Carolina Western Counties.     b 5.98/1000     d 1.20/1000             398  0.77-14.1        34.2-472     
Jackson Memorial (1991).........       31.7/1000        3.5/1000             795  1.54-28.2        67.1-723     
----------------------------------------------------------------------------------------------------------------
a Background TB infection rate ranges from 0.194 to 3.542 per 1,000 at risk for TB infection.                   
b Ajusted for 1994, i.e., 5.98=7.2*(532/641)                                                                    
c The range reflects regional differences in TB prevalence as well as inherent uncertainty in the estimate of TB
  infection prevalence in the U.S., as estimated by Dr. Christopher Murray, and used in the internal            
  calculations of annual background TB infection rate.                                                          
d State-wide estimate of population risk for North Carolina, shown in Table V-3(a).                             


                      Table V-10.--Occupational Risk Estimates for Other Work Settings a,b                      
----------------------------------------------------------------------------------------------------------------
                                                                                   Range of excess occupational 
                                   Overall risk/    Background      Excess risk               risk d            
              Type                   (exposed)      risk State-   based on study -------------------------------
                                                      wide c         (percent)        Annual         Lifetime   
----------------------------------------------------------------------------------------------------------------
Long-term Care..................        9.8/1000     0.8756/1000            1019  1.98-36.1          85-807     
Home Health Care................       5.06/1000     0.8756/1000             478  0.93-16.9        40.9-526     
Home Care.......................       1.86/1000     0.8756/1000             112  0.22-3.97        9.7-164      
----------------------------------------------------------------------------------------------------------------
a Background TB infection rate ranges from 0.194 to 3.542 per 1,000 employees at risk of infection.             
b Based on the Washington State data.                                                                           
c Background rate for this analysis is assumed to be the same as in the case-control analysis of the Washington 
  State hospital data (i.e. 0.8756 per 1,000 employees).                                                        
d The range reflects regional differences in TB prevalence as well as inherent uncertainty in the estimate of TB
  infection prevalence in the U.S., as estimated by Dr. Christopher Murray, and used in the internal            
  calculations of annual background TB infection rate.                                                          

    Lifetime estimates of the excess risk of TB infection were 
estimated based on the annual excess risk by using the formula {1-(1-p) 
45}, where p is the annual excess risk. Lifetime excess 
estimates of TB infection are presented in table V-9 and table V-10. 
Lifetime risk estimates of developing active TB are calculated from 
lifetime risk estimates of TB infection assuming that, once infected, 
there is a 10% likelihood of progressing to active TB; these estimates 
are presented in table V-11 and table V-12. Further, the risk of death 
caused by TB is calculated from the lifetime estimates of active TB 
using OSHA's estimate of the TB case fatality rate (also presented in 
table V-11 and table V-12). The methodology used to estimate a TB case 
fatality rate is presented below.

                 Table V-11.--Lifetime Occupational Risk Estimates for Hospital Employees a b c                 
----------------------------------------------------------------------------------------------------------------
                                                                                  Active disease   Death caused 
                             Source                               TB infection d         e             by TB    
----------------------------------------------------------------------------------------------------------------
Washington State (1994).........................................   4.1-72.2         0.4-7.2             0.03-0.6
North Carolina Western Region...................................   34.2-472        3.4-47.2              0.3-3.7
Jackson Memorial Hospital (Miami)...............................   67.1-723        6.7-72.3             0.5-5.6 
----------------------------------------------------------------------------------------------------------------
a Risk estimates reflect excess risk due to occupational exposure and are expressed per 1,000 employees at risk.
                                                                                                                
b Estimates of death caused by TB due to occupational exposure are derived based on an estimated TB case death  
  rate of 77.85 per 1,000 TB cases and are estimated by multiplying the lifetime active disease rate by .07785. 
c The ranges of risk presented in this TABLE reflect expected variance in the annual background TB infection    
  rate by state. They are estimated based on the assumption that the annual background TB infection rate ranges 
  from 0.194 to 1.542 per 1,000 employees at risk.                                                              
d Lifetime infection rate is estimated by (1-(1-p) 45), where p is the annual excess TB infection rate due to   
  occupational exposure.                                                                                        
e Lifetime active disease rate is estimated to be 10% of lifetime infection rate.                               


           Table V-12--Lifetime Occupational Risk Estimates for Employees in Other Work Settings a b c          
----------------------------------------------------------------------------------------------------------------
                                                                                  Active disease   Death caused 
                          Work setting                            TB infection d         e             by TB    
----------------------------------------------------------------------------------------------------------------
Long-term Care..................................................      85-807       8.5-80.7          0.7-6.2    
Home Health Care................................................    40.9-536       4.1-53.6          0.3-4.2    
Home Care.......................................................     9.7-164       1.0-16.4         0.1-1.3     
----------------------------------------------------------------------------------------------------------------
a Risk estimates reflect excess risk due to occupational exposure and are expressed per 1,000 employees at risk 
  of TB infection.                                                                                              
b Estimates of death caused by TB due to occupational exposure are derived based on an estimated TB case death  
  rate of 77.85 per 1,000 cases and are estimated by multiplying the lifetime active disease rate by .07785.    
c The ranges of risk presented in this TABLE reflect expected variance in the annual background TB infection    
  rate by state. They are estimated based on the assumption that the annual background TB infection rate ranges 
  from 0.194 to 3.542 per 1,000 employees at risk.                                                              
d Lifetime infection rate is estimated by (1-(1-p)\45\), where p is the annual excess TB infection rate due to  
  occupational exposure.                                                                                        
e Lifetime active disease rate is estimated to be 10% of lifetime infection rate.                               


[[Page 54207]]

    As outlined in the Health Effects section, several possible 
outcomes are possible following an infection. Approximately 90% of all 
infections never progress to active disease. An estimated 10% of 
infections is expected to progress to active disease; most of these 
cases are successfully treated. However, a percentage of active TB 
cases develop further complications. Approximately 7.8% of active TB 
cases may take a more severe clinical course and lead to death. The TB 
case fatality rate was estimated using information on reported deaths 
caused by TB from table 8-5 of the Vital Statistics for the U.S. and 
cases of TB reported in CDC's TB Surveillance system for 1989 through 
1991 (Exs. 7-270, 7-264). As shown in table V-13, the TB case death 
rate ranged from 69.94 to 89.18 per 1,000 with a 3-year average of 
77.85 per 1,000 TB cases. The Agency used the 3-year average (77.85 per 
1,000) for its estimate of deaths caused by TB. This estimate is in 
close agreement with published results from a retrospective cohort 
study conducted in Los Angeles County on TB cases in 1990 (Ex. 7-268). 
In this study, all confirmed TB cases reported in the county in 1990 
were tracked and the number of deaths where TB was the direct or 
contributing cause was ascertained. ``Contributing cause'' was defined 
as a case of TB of such severity that it would have caused the death of 
the patient had the primary illness not caused death earlier. Of the 
1,724 cases included in the study, TB was considered the cause of death 
or the contributing cause of death in 135 cases (78.31 per 1,000).

                                Table V-13.--TB Case Death Rates for Adults (18+)                               
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Number of TB    TB case death
                              Year                                   deaths a         cases b         rate c    
----------------------------------------------------------------------------------------------------------------
1991............................................................           1,700          24,307           69.94
1990............................................................           1,796          23,795           75.48
1989............................................................           1,956          21,934           89.18
3-year Average..................................................           1,817          23,345          77.85 
----------------------------------------------------------------------------------------------------------------
a Source: Vital Statistics for the U.S., Table 8-5, (age 20+).                                                  
b Source: CDC, TB surveillance system, (age 18+).                                                               
c Rate expressed per 1,000 TB cases. Any deaths caused by TB in persons 18 or 19 years of age are not included  
  in the numerator.                                                                                             

    National estimates of annual and lifetime risk for TB infection, 
active disease and death caused by TB due to occupational exposure are 
computed as weighted averages of the state estimates and are presented 
in table V-14.

                 Table V-14.--Average Occupational Risk Estimates a, b per 1,000 Workers at Risk                
----------------------------------------------------------------------------------------------------------------
                                                     Annual TB      Lifetime TB      Lifetime      Death caused 
                  Work setting                       infection       infection       active TB        by TB c   
----------------------------------------------------------------------------------------------------------------
Hospitals:                                                                                                      
    WA..........................................            0.68              30             3.0             0.2
    NC..........................................            5.7              219            22.0             1.7
    JM..........................................           11.8              386            38.6             3.0
Long-term Care..................................           14.6              448            44.8             3.5
Home Health Care................................            6.9              225            25.5             2.0
Home Care.......................................            1.6               69             6.9             0.5
----------------------------------------------------------------------------------------------------------------
a Weighted by each state's population in 1994.                                                                  
b Risk estimates reflect excess risk due to occupational exposure and are expressed per 1,000 employees at risk.
c Number of deaths caused by TB due to occupational exposure are derived based on an estimated TB case death    
  rate of 77.85 per 1,000 cases and are computed by multiplying the lifetime active disease rate by .07785.     

    (a) Risk Estimates for Hospital Employees: Logistic regression 
analysis of the Washington state hospital data indicated an increase in 
annual risk (47% above background) for employees with potential 
exposure to TB. For this particular analysis the control group was 
defined as those hospitals with no-known TB patients that are located 
in counties that did not report any active TB cases in 1994. However, 
an increased risk of 47% above background in the annual infection rate 
is expected to produce a range of 4 to 72 TB infections per 1000 
exposed workers in a working lifetime, which could result in as many as 
7 cases of active TB and approximately 1 death per 1,000 exposed 
workers.
    Based on the survey of hospitals in North Carolina's western 
region, the expected overall risk due to occupational exposure is 
estimated to be 4 times the background rate. This results in an 
expected range of lifetime risk between 34 and 472 infections per 1,000 
employees at risk for TB infection. Lifetime estimates of active TB 
cases resulting from these infections are expected to range between 3 
and 47, resulting in as many as 4 deaths per 1,000 exposed employees at 
risk of TB infection. As done previously, the North Carolina study 
results were adjusted to reflect 1994 TB disease trends.
    Based on the data from Jackson Memorial Hospital, the overall risk 
due to occupational exposure is estimated to be 8 times the background 
rate. This results in an expected range of lifetime risk between 67 and 
723 infections per 1,000 employees at risk. Lifetime estimates of the 
number of active TB case per 100 exposed workers are expected to range 
between 7 and 72, resulting in as many as 6 deaths per 1,000 exposed 
employees at risk for TB infection.
    In summary, table V-9 and table V-14 show that the annual 
occupational risk of infection is expected to range:
    (a) From .09 to 1.66 with a weighted average of 0.68 per 1,000 for 
workplaces located in relatively low TB prevalence areas, and where TB 
infection measures and engineering controls are required;
    (b) From 0.77 to 14.1 with a weighted average of 5.7 per 1,000 for 
workplaces located in areas with moderate TB prevalence and inadequate 
TB control programs; and
    (c) From 1.54 to 28 with a weighted average of 11.8 per 1,000 for 
workplaces

[[Page 54208]]

located in high TB prevalence areas, serving high risk patients, with 
high frequency of exposure to infectious TB.
    Similarly, the lifetime occupational risk is expected to range:
    (a) From 4 to 72 with a weighted average of 30 per 1,000 for 
workplaces located in relatively low TB prevalence areas, and where TB 
infection measures and engineering controls are required;
    (b) From 34 to 472 with a weighted average of 219 per 1,000 for 
workplaces located in areas with moderate TB prevalence and inadequate 
TB control programs; and
    (c) From 67 to 723 with a weighted average of 386 per 1,000 for 
workplaces located in high TB prevalence areas, serving high risk 
patients, with high frequency of exposure to infectious TB.
    Risk estimates derived from either study (Washington State or North 
Carolina) represent an overall rate of occupational risk, because both 
studies include PPD skin testing results from the entire hospital 
employee population, whereas the Jackson Memorial study addresses the 
occupational risk to workers where exposure to infectious TB is highly 
probable.
    Although the exact compliance rate is not known, hospitals in 
Washington State have been required to implement the CDC TB guidelines 
with respect to engineering controls (requiring isolation rooms with 
negative pressure) and infection control measures (advocating early 
patient identification, employee training, respiratory protection, and 
PPD testing).
    Neither the facilities in North Carolina nor Jackson Memorial had 
engineering controls fully implemented at the time these data were 
collected. Early identification of suspect TB patients has always been 
recommended in North Carolina. However, engineering controls in 
isolation rooms were either not present or did not function properly 
because of modifications in the physical structure of the building 
(i.e., isolation rooms had been subdivided using partitions, air ducts 
had been re-directed because of remodeling, etc.). Tuberculin skin 
testing was very inconsistent and sporadic. In addition, employee 
training and use of respiratory protection were not emphasized.
    By 1991, Jackson Memorial had most of the engineering controls in 
place in the HIV ward (where the first outbreak took place) and in 
selected areas with high TB exposure, but not in the entire hospital. 
However, the staff training program was still being developed and 
respiratory protection was not always adequate. Although exposures had 
been greatly reduced, ``high risk'' procedures were still being 
performed in certain areas of the hospital without adequate engineering 
controls, such as the Special Immunology clinic where HIV-TB patients 
received pentamidine treatments. Like the hospitals in the North 
Carolina study, Jackson Memorial represents a working environment that 
serves a patient population known to have high TB prevalence. In 
addition, Jackson Memorial only tested employees with patient contact 
in areas where active TB had been detected.
    (b) Risk Estimates for Workers in Other Work Settings: In long-term 
care facilities for the elderly there is also a significantly increased 
likelihood that employees will encounter individuals with infectious 
TB. Persons over the age of 65 constitute a large proportion of the TB 
cases in the United States. In 1987, CDC reported that persons aged 65 
and over accounted for 27% (6150) of the reported cases of active TB in 
the U.S., although they account for only 12% of the U.S. population. 
Many of these individuals were infected in the past and advancing age 
and decreasing immunocompetence have caused them to develop active 
disease. In 1990 the CDC estimated that approximately 10 million people 
were infected with TB. As the U.S. population steadily ages, many of 
these latent infections may progress to active disease. Because elderly 
persons represent a large proportion of the nation's nursing home 
residents and because the elderly represent a large proportion of the 
active cases of TB, there is an increased likelihood that employees at 
long-term care facilities for the elderly will encounter individuals 
with infectious TB.
    Similarly, there are other occupational settings that serve high-
risk client populations and thus have an increased likelihood of 
encountering individuals with infectious TB. For example, hospices, 
emergency medical services, and home-health care services provide 
services to client populations similar to those in hospitals and thus 
are likely to experience similar risks.
    OSHA used information from the 1994 Washington state PPD skin 
testing survey to estimate occupational risk for workers in long-term 
care, home health care, and home care. Annual estimates of excess risk 
for TB infection are presented in TABLE V-10 and lifetime estimates for 
TB infection, active TB, and death caused by occupational TB are 
presented in TABLE V-12.
    Based on the Washington State data, the overall annual excess risk 
for TB infection is estimated to be 10-fold over background for workers 
in long-term care. This results in an expected range of lifetime risk 
of between 85 and 800 infections per 1,000 employees at risk for TB 
infection. Lifetime estimates of the number of active TB cases 
resulting from these infections range from 9 to 81 and are projected to 
cause as many as 6 deaths per 1,000 exposed employees at risk of TB 
infection. Similarly, the overall annual excess risk of TB infection 
for workers in home health care is estimated to be approximately 500% 
above background. This results in an expected range of lifetime risk of 
between 41 and 536 infections per 1,000 employees at risk for TB 
infection. Lifetime estimates of the number of active TB cases range 
from 4 to 54 per 1,000, and are projected to cause as many as 4 deaths 
per 1,000 exposed employees at risk of TB infection. Similarly, the 
overall annual excess risk of TB infection for workers in home care is 
estimated to be approximately 100% above background. This results in an 
expected range of lifetime risk of between 10 and 164 infections per 
1,000 employees at risk for TB infection. Lifetime estimates of the 
number of active TB cases range from 1 to 16, and are expected to 
result in approximately 1 death per 1,000 exposed employees at risk of 
TB infection.
    Clearly, employees in all three groups (long-term care for the 
elderly, home health care, and home care) have higher risks than 
hospital employees in Washington. This could be attributed, in part, to 
the lack of engineering controls in these work settings. That 
respirators may be used only intermittently may also play a role. 
Although workers in these three groups are encouraged by local health 
authorities to use respiratory protection while tending to a suspect TB 
patient, the actual rate of respirator usage is difficult to ascertain. 
A third factor that may contribute to higher risk in these work 
settings is delayed identification of suspect TB patients due to 
confounding symptoms presented by the individuals. For example, many 
long-term care residents exhibit symptoms of persistent coughing from 
decades of smoking. Consequently, an individual in long-term care with 
a persistent cough may be infectious for several days before he or she 
is identified as having suspected infectious TB.

Qualitative Assessment of Risk for Other Occupational Settings

    The quantitative estimates of the risk of TB infection discussed 
above are based primarily upon data from hospitals and selected other 
health care settings. Data from hospitals and certain health care 
settings were selected because OSHA believes that these data

[[Page 54209]]

represent the best information available to the Agency for purposes of 
quantifying the occupational risks of TB infection and disease. 
However, as discussed above, it is their exposure to aerosolized M. 
tuberculosis that places these workers at risk of infection and not 
factors unique to these particular kinds of health care activities. 
Thus, OSHA believes that the risk estimates derived from hospitals and 
selected other work settings can be used to describe the potential 
range of risks for other health care and other occupational settings in 
which workers can reasonably anticipate frequent and substantial 
exposure to aerosolized M. tuberculosis.
    In order to extrapolate the quantitative risk estimates calculated 
for hospital employees and other selected health care settings, OSHA, 
as a first step, identified risk factors that place employees at risk 
of exposure. Some amount of exposure to TB could occur in any workplace 
in the United States. TB is an infectious disease that occurs in the 
community and thus, individuals may bring the disease into their own 
workplace or to other businesses or work settings that they may visit. 
However, there are particular kinds of work settings where risk factors 
are present that substantially increase the likelihood that employees 
will be frequently exposed to aerosolized M. tuberculosis. First among 
these factors is the increased likelihood of exposure to individuals 
with active, infectious TB. Individuals who are infected with TB have a 
higher risk of developing active TB if they are (1) immunocompromised 
(e.g., elderly, undergoing chemotherapy, HIV positive), (2) intravenous 
drug users, or (3) medically underserved and of generally poor health 
status (Exs. 6-93 and 7-50). Thus, in work settings in which the client 
population is composed of a high proportion of individuals who are 
infected with TB, are immunocompromised, are intravenous drug users or 
are of poor general health status, there is a greatly increased 
likelihood that employees will routinely encounter individuals with 
infectious TB and be exposed to aerosolized M. tuberculosis. A second 
factor that places employees at high risk of exposure to aerosolized M. 
tuberculosis is the performance of high-hazard procedures, i.e., 
procedures performed on individuals with suspected or confirmed 
infectious TB where there is a high likelihood of the generation of 
droplet nuclei. A third factor that places employees at risk of 
exposure is the environmental conditions at the work setting. Work 
settings that have overcrowded conditions or poor ventilation will 
facilitate the transmission of TB. Thus, given that a case of 
infectious TB does occur, the conditions at the work setting itself may 
promote the transmission of disease to employees who share airspace 
with the individual(s) with infectious TB.
    The second step in extrapolating the quantitative risks is to 
identify the types of work settings which have some or all of the risk 
factors outlined above. Once these work settings have been identified, 
OSHA believes that it is reasonable to assume that the quantitative 
risk estimates calculated for hospitals and other selected health care 
settings can be used to describe the risks in the identified work 
settings.

Correctional Facilities

    Employees in correctional facilities or other facilities that house 
inmates or detainees have an increased likelihood of frequent exposure 
to individuals with infectious TB. Many correctional facilities have a 
higher incidence of TB cases in comparison to the incidence in the 
general population. In 1985, the CDC estimated that the incidence of TB 
among inmates of correctional facilities was more than three times 
higher than that for nonincarcerated adults aged 15-64 (Ex. 3-33). In 
particular, in states such as New Jersey, New York, and California, the 
increased incidence of annual TB cases in correctional facilities 
ranged from 6 to 11 times greater than that of the general population 
for their respective states (Exs. 7-80 and 3-33). A major factor in the 
increased incidence of TB cases in correctional facilities is the fact 
that the population of correctional facilities is over-represented by 
individuals who are at greater risk of developing active disease, e.g., 
persons from poor and minority groups who may suffer from poor 
nutritional status and poor health care, intravenous drug users, and 
persons infected with HIV. Similarly, certain types of correctional 
facilities, such as holding facilities associated with the Immigration 
and Naturalization Service, may have inmates/detainees from countries 
with a high incidence of TB. For foreign-born persons arriving in the 
U.S., the case rate of TB in 1989 was estimated to be 124 per 100,000, 
compared to an overall TB case rate of 9.5 per 100,000 for the U.S. 
(Ex. 6-26). Moreover, in the period from 1986 to 1989, 22% of all 
reported cases of TB disease occurred in the foreign-born population. 
Given the increased prevalence of individuals at risk for developing 
active TB, there is an increased likelihood that employees working in 
these facilities will encounter individuals with infectious TB. In 
addition, environmental factors such as overcrowding and poor 
ventilation facilitate the transmission of TB. Thus, given that a case 
of infectious TB does occur, the conditions in the facility itself 
promote the transmission of the disease to other inmates and employees 
in the facility who share airspace.
    As discussed in the Health Effects section, a number of outbreak 
investigations (Exs. 6-5, 6-6) have shown that where there has been 
exposure to aerosolized M. tuberculosis in correctional facilities, the 
failure to promptly identify individuals with infectious TB and provide 
appropriate infection control measures has resulted in employees being 
infected with TB. These studies demonstrate that, as in hospitals or 
health care settings, where there is exposure to aerosolized TB bacilli 
and where effective control measures are not implemented, exposed 
employees are at risk of infection. Thus, estimates based on the risk 
observed among employees in hospitals and in selected other work 
settings that involve an increased likelihood of exposure can be 
appropriately applied to employees in correctional facilities.
    Recently, scientists at NIOSH have completed a prospective study of 
the incidence of TB infection among New York State correctional 
facilities employees (Ex. 7-288). This study is the first prospective 
study of TB infection among employees in correctional facilities in an 
entire state. Other studies have reported on contact investigations, 
which seek to identify recent close contacts with an index case and 
determine who might subsequently have been infected. Studies based on 
contact investigations have the advantage of a good definition of 
potential for exposure and they serve to identify infected persons for 
public health purposes. On the other hand, prospective studies of an 
entire working group have the advantage of covering the entire 
population potentially at risk, of considering all inmate cases 
simultaneously as potential sources of infection, and, most 
importantly, of permitting the calculation of incidence rates and risk 
attributable to occupational exposure.
    Following an outbreak of active TB among inmates that resulted in 
transmission to employees in 1991, the state of New York instituted a 
mandatory annual tuberculin skin testing program to detect TB infection 
among employees. The authors used data from the first two years of 
testing to estimate the incidence of TB infection

[[Page 54210]]

among 24,487 employees of the NY Department of Corrections. Subjects 
included in the study had to have two sequential PPD skin tests, have a 
negative test the first year, and have complete demographic 
information. The overall conversion rate was estimated to be 1.9%. 
Preliminary results show that after controlling for age, ethnicity, 
gender, and residence in New York City, corrections offices and medical 
personnel, working in prisons with inmate active TB cases, had odds 
ratios of TB infection of 1.64 and 2.39, respectively, compared to 
maintenance and clerical personnel who had little opportunity for 
prisoner contact. Based on these results, the annual excess risk due to 
occupational exposure is estimated to be 1.22% and 2.64% for 
corrections officers and medical personnel, respectively. This 
translates into lifetime occupational risks of 423 and 700 per 1,000 
exposed employees, respectively. In prisons with no known inmate TB 
cases, there were no significant differences in TB infection rates 
among employees in different job categories.

Homeless Shelters

    Employees in homeless shelters also have a significantly increased 
likelihood of frequent exposure. A high prevalence of TB infection and 
disease is common in many homeless shelters. Screening in selected 
shelters has shown the prevalence of TB infection to range from 18 to 
51% (Ex. 6-15). Many shelter residents also possess characteristics 
that impair their immunity and thus place them at greater risk of 
developing active disease. For example, homeless persons often suffer 
from poor nutrition and poor overall health status, and they also have 
poor access to health care. In addition, they may suffer from 
alcoholism, drug abuse and infection with HIV. Screening of selected 
shelters has shown the prevalence of active TB disease to range from 
1.6 to 6.8% (Ex. 6-15). Thus, there is an increased likelihood that 
employees at homeless shelters will frequently encounter individuals 
with infectious TB in the course of their work.
    In addition, as in the case for correctional facilities, homeless 
shelters also tend to be overcrowded and have poor ventilation, factors 
that promote the transmission of disease and place shelter residents 
and employees at risk of infection. Outbreaks reported among homeless 
shelters (Exs. 7-51, 7-75, 7-73, 6-25) also provide evidence that where 
there is exposure to individuals with infectious TB and effective 
infection control measures are not implemented, employees are at risk 
of infection. It is reasonable to assume, therefore, that risk 
estimates calculated for hospital employees who have an increased 
likelihood of exposure to individuals with infectious TB can be used to 
estimate the risks for homeless shelter employees.

Facilities That Provide Treatment for Drug Abuse

    Employees in facilities that provide treatment for drug abuse have 
an increased likelihood of frequent exposure to individuals with 
infectious TB. Surveys of selected U.S. cities by the CDC have shown 
the prevalence of TB infection among the clients of drug treatment 
centers to range from approximately 10% to 13% (Ex. 6-8). Clients of 
these centers are also generally at higher risk of developing active 
disease. The clients typically come from medically underserved 
populations and may suffer from poor overall health status. As 
discussed in the Health Effects section, drug dependence has also been 
shown to be a possible risk factor in the development of active TB. 
Moreover, many of the drug treatment center clients are intravenous 
drug users and are infected with HIV, placing these individuals at an 
increased risk of developing active TB. Given these risk factors for 
the clients served at drug treatment centers, there is an increased 
likelihood that employees in these work settings will be exposed 
frequently to individuals with infectious TB.

Medical Laboratories

    Medical laboratory work is a recognized source of occupational 
hazards. CDC considers workers in medical laboratories that handle M. 
tuberculosis to be at high risk for occupational transmission of TB 
either because of the volume of material handled by routine diagnostic 
laboratories or the high concentrations of pathogenic agents often 
handled in research laboratories.
    Few surveys of laboratory-acquired infections have been undertaken; 
most reports are of small outbreaks in specific laboratories. Sulkin 
and Pike's study of 5,000 laboratories suggested that brucellosis, 
tuberculosis, hepatitis, and enteric diseases are among the most common 
laboratory-acquired infections (Ex. 7-289). In 1957, Reid noted that 
British medical laboratory workers had a risk of acquiring tuberculosis 
two to nine times that of the general population (Ex. 7-289). This 
result was validated in 1971 by Harrington and Channon in their study 
of medical laboratories (Ex. 7-289). A retrospective postal survey of 
approximately 21,000 medical laboratory workers in England and Wales 
showed a five-times increased risk of developing active TB among these 
workers as compared with the general population. Technicians were at 
greater risk, especially if they worked in anatomy departments. A 
similar survey carried out in 1973 of 3,000 Scottish medical laboratory 
workers corroborates the results from England and Wales. Three cases, 
one doctor and two technicians, were noted in the 1973 survey, which 
resulted in an overall incidence rate of 109 per 100,000 person-years. 
The general population incidence rate for active TB was 26 per 100,000 
person-years, giving a risk ratio of 4.2 (Ex. 7-289).
    The studies reviewed in this section indicate that workers in 
medical laboratories with potential for exposure to M. tuberculosis 
during the course of their work have a several-fold (ranging from 2- to 
9-fold) increased risk of developing active disease compared with the 
risk to the general population. Although these studies were conducted 
over two decades ago, they represent the most recent data available to 
the Agency, and OSHA has no reason to believe that the conditions 
giving rise to the risk of infection at that time have changed 
substantially in the interim. The Agency is not aware of any more 
current data on transmission rates in medical laboratories. OSHA 
solicits information on additional studies addressing occupational 
exposure to active TB in laboratories; such studies would then be 
considered by OSHA in the development of a final rule.

Other Work Settings and Activities

    In addition to the information available for correctional 
facilities, homeless shelters, and facilities that provide treatment 
for drug abuse, there are other work settings and activities where 
there is an increased likelihood of frequent exposure to aerosolized M. 
tuberculosis. For example, hospices serve client populations similar to 
those of hospitals and perform similar services for these individuals. 
Individuals who receive care in hospices are likely to suffer from 
medical conditions (e.g., HIV disease, end-stage renal disease, certain 
cancers) that increase their likelihood of developing active TB disease 
once infected. Thus, employees providing hospice care have an increased 
likelihood of being exposed to aerosolized M. tuberculosis. CDC has 
recommended that hospices follow the same guidelines for controlling TB 
that hospitals follow.
    Emergency medical service employees also have an increased 
likelihood of

[[Page 54211]]

encountering individuals with infectious TB. Like hospices, emergency 
medical services cater to the same high risk client populations as 
hospitals. Moreover, emergency medical services are often used to 
transport individuals identified with suspected or confirmed infectious 
TB from various types of health care settings to facilities with 
isolation capabilities.
    In addition, other types of services (e.g., social services, legal 
counsel, education) are provided to individuals who have been 
identified as having suspected or confirmed infectious TB and have been 
placed in isolation or confined to their homes. Employees who provide 
social welfare services, teaching, law enforcement or legal services to 
those individuals who are in AFB isolation are exposed to aerosolized 
M. tuberculosis. In particular, employees performing high-hazard 
procedures are likely to generate aerosolized M. tuberculosis by virtue 
of the procedure itself. Thus, employees providing these types of 
services also have an increased likelihood of exposure to aerosolized 
M. tuberculosis and are therefore likely to experience risks similar to 
those described above for hospital workers.
    Although they do not have contact with individuals with infectious 
TB, employees who repair and maintain ventilation systems which carry 
air contaminated with M. tuberculosis and employees in laboratories who 
manipulate tissue samples or cultures contaminated with M. tuberculosis 
also have an increased likelihood of being exposed to aerosolized M. 
tuberculosis. Like employees in the work settings discussed above, 
these employees have an increased risk of frequent exposure to 
aerosolized M. tuberculosis.
    Therefore, OSHA believes that the quantitative risk estimates 
derived from data observed among health care workers in the hospital 
setting can be generally used to describe the potential range of risks 
for workers in other occupational settings where there is a reasonable 
anticipation of exposure to aerosolized M. tuberculosis. The 
reasonableness of this assumption is supported by the overall weight of 
evidence of the available health data. As discussed in the Health 
Effects section, epidemiological studies, case reports and outbreak 
investigations have shown that in correctional facilities, homeless 
shelters, long-term care facilities for the elderly, drug treatment 
centers, and laboratories where appropriate TB infection control 
programs have not been implemented, employees have become infected with 
TB as a result of occupational exposure to individuals with infectious 
TB or to other sources of aerosolized M. tuberculosis. Thus, although 
the data on employee conversion rates in other work settings cannot be 
used to directly quantify the occupational risk of infection for those 
work settings, there is strong evidence that employees in various work 
settings other than hospitals can reasonably be anticipated to have 
exposure to aerosolized M. tuberculosis and that TB can be transmitted 
in these workplaces when appropriate TB infection control programs are 
not implemented.

VI. Significance of Risk

    Section 6(b)(5) of the OSH Act vests authority in the Secretary of 
Labor to issue health standards. This section provides, in part, that:

    The Secretary, in promulgating standards dealing with toxic 
materials or harmful physical agents under this subsection, shall 
set the standard which most adequately assures, to the extent 
feasible, on the basis of the best available evidence, that no 
employee will suffer impairment of health or functional capacity 
even if such employee has regular exposure to the hazard dealt with 
by such standard for the period of his working life.

    OSHA's overall analytical approach to making a determination that 
workplace exposure to certain hazardous conditions presents a 
significant risk of material impairment of health is a four step 
process consistent with interpretations of the OSH Act and rational, 
objective policy formulation. In the first step, a quantitative risk 
assessment is performed where possible and considered with other 
relevant information to determine whether the substance to be regulated 
poses a significant risk to workers. In the second step, OSHA considers 
which, if any, of the regulatory alternatives being considered will 
substantially reduce the risk. In the third step, OSHA examines the 
body of ``best available evidence'' on the effects of the substance to 
be regulated to set the most protective requirements that are both 
technologically and economically feasible. In the fourth and final 
step, OSHA considers the most cost-effective way to achieve the 
objective.
    In the Benzene decision, the Supreme Court indicated when a 
reasonable person might consider the risk significant and take steps to 
decrease it. The Court stated:

    It is the Agency's responsibility to determine in the first 
instance what it considers to be ``significant'' risk. Some risks 
are plainly acceptable and others are plainly unacceptable. If, for 
example, the odds are one in a billion that a person will die from 
cancer by taking a drink of chlorinated water, the risk could not be 
considered significant. On the other hand, if the odds are one in a 
thousand that regular inhalation of gasoline vapors that are 2% 
benzene will be fatal, a reasonable person might well consider the 
risk significant and take the appropriate steps to decrease or 
eliminate it. (I.U.D. v. A.P.I.), 448 U.S. at 655).

    The Court indicated that ``while the Agency must support its 
findings that a certain level of risk exists with substantial evidence, 
we recognize that its determination that a particular level of risk is 
`significant' will be based largely on policy considerations.'' The 
Court added that the significant risk determination required by the OSH 
Act is ``not a mathematical straitjacket'' and that ``OSHA is not 
required to support its findings with anything approaching scientific 
certainty.'' The Court ruled that ``a reviewing court (is) to give OSHA 
some leeway where its findings must be made on the frontiers of 
scientific knowledge and that the Agency is free to use conservative 
assumptions in interpreting the data with respect to carcinogens, 
risking error on the side of overprotection rather than 
underprotection.'' (448 U.S. at 655, 656).
    As a part of the overall significant risk determination, OSHA 
considers a number of factors. These include the type of risk 
presented, the quality of the underlying data, the reasonableness of 
the risk assessments, and the statistical significance of the findings.
    The hazards presented by the transmission of tuberculosis, such as 
infection, active disease, and death are very serious, as detailed 
above in the section on health effects. If untreated, 40-60% of TB 
cases have been estimated to result in death (Exs. 5-80, 7-50, 7-66). 
Fortunately, TB is a treatable disease. The introduction of antibiotic 
drugs for TB has helped to reduce the mortality rate by 94% since 1953 
(Ex. 5-80). However, TB is still a fatal disease in some cases. From 
1989-1991 CDC reported 5,452 deaths among adults from TB (see TABLE V-
13, Risk Assessment section). In addition, there has been an increase 
in certain forms of drug-resistant TB, such as MDR-TB, in which the 
tuberculosis bacilli are resistant to one or more of the front line 
drugs such as isoniazid and rifampin, two of the most effective anti-TB 
drugs. The information available today is not adequate to estimate the 
future course of MDR-TB, but the reduction in the potential of 
transmitting this deadly form of the disease is itself another benefit 
of this standard. The current data indicate that among MDR-TB cases, 
the risk of death is increased compared to drug-susceptible forms of 
the disease. A CDC investigation of 8

[[Page 54212]]

outbreaks of MDR-TB revealed that among 253 people infected with MDR-
TB, 75% died within a period 4 to 16 weeks after the time of diagnosis 
(Ex. 38-A). MDR-TB may be treated, but due to the difficulty in finding 
adequate therapy which will control the bacilli's growth, individuals 
with this form of the disease may remain infectious for longer periods 
of time, requiring longer periods of hospitalization, additional lost 
worktime, and an increased likelihood of spreading TB infection to 
others until treatment renders the patient non-infectious. Because of 
the difficulty in controlling these drug-resistant forms of the disease 
with antibiotics, progressive lung destruction may progress to the 
point where it is necessary to remove portions of the lung to treat the 
advance of the disease.
    The OSH Act directs the Agency to set standards that will 
adequately assure, to the extent feasible, that no employee will suffer 
``material impairment of health or functional capacity.'' TB infection 
represents a material impairment of health that may lead to active 
disease, tissue and organ damage, and death. Although infected 
individuals may not present any signs or symptoms of active disease, 
being infected with TB bacilli is a serious threat to the health status 
of the infected individual. Individuals who are infected have a 10% 
chance of developing active disease at some point in their life, a risk 
they would not have had without being infected. The risk of developing 
active disease is even greater for individuals who are 
immunocompromised, due to any of a large number of factors. For 
example, individuals infected with HIV have been estimated as having an 
8-10% risk per year of developing active disease (Ex. 4B).
    In addition, since infected individuals commonly undergo treatment 
with anti-TB drugs to prevent the onset of active disease, they face 
the additional risk of serious side effects associated with the highly 
toxic drugs used to treat TB. Preventive treatment with isoniazid, one 
of the drugs commonly used to treat TB infection, has been shown in 
some cases to result in death from hepatitis or has damaged the 
infected person's liver to the extent that liver transplantation was 
performed (Ex. 6-10). Thus, the health hazards associated with TB 
infection clearly constitute material impairment of health.
    Clinical illness, i.e., active disease, also clearly constitutes 
material impairment of health. Left untreated, 40 to 60 percent of 
active cases may lead to death (Exs. 7-50, 7-66, 7-80). Individuals 
with active disease may be infectious for various periods of time and 
often must be hospitalized. Active disease is marked by a chronic and 
progressive destruction of the tissues and organs infected with the 
bacteria. Active TB disease is usually found in the lungs (i.e., 
pulmonary tuberculosis). Long-term damage can result even when cases of 
TB are cured; a common result of TB is reduced lung function (impaired 
breathing) due to lung damage (Ex. 7-50, pp. 30-31). Inflammatory 
responses caused by the disease produce weakness, fever, chest pain, 
cough, and, when blood vessels are eroded, bloody sputum. Also, many 
individuals have drenching night sweats over the upper part of the body 
several times a week. The intensity of the disease varies, ranging from 
minimal symptoms of disease to massive involvement of many tissues, 
with extensive cavitation and debilitating constitutional and 
respiratory problems. Long-term damage can also result from 
extrapulmonary forms of active disease; such damage may include mental 
impairment from meningitis (infection of membranes surrounding the 
brain and spinal cord) and spinal deformity and leg weakness due to 
infection of the vertebrae (i.e., skeletal TB) (Ex. 7-50, p. 31). 
Active disease is treatable but it must be treated with potent drugs 
that have to be taken for long periods of time. The drugs currently 
used to treat active TB disease may be toxic to other parts of the 
body. Commonly reported side effects of anti-TB drugs include 
hepatitis, peripheral neuropathy, optic neuritis, ototoxicity and renal 
toxicity (Ex. 7-93). Active disease resulting from infection with MDR-
TB is of even greater concern due to the inability to find adequate 
drug regimens. Although OSHA has not been able to precisely quantify 
the increase in incidence of MDR-TB, the number of cases of MDR-TB is 
clearly on the rise. In these cases, individuals may remain infectious 
for longer periods of time and may suffer more long-term damage from 
the chronic progression of the disease until adequate therapy can be 
identified.
    In this standard, OSHA has presented quantitative estimates of the 
lifetime risk of TB infection, active disease and death from 
occupational exposure to M. tuberculosis. Qualitative evidence of 
occupational transmission is also included in OSHA's risk assessment.
    In preparing its quantitative risk assessment, OSHA began by 
seeking out occupational data associated with TB infection incidence in 
order to calculate an estimate of risk for TB infection attributable to 
occupational exposure for all U.S. workers. Unfortunately, an overall 
national estimate of risk for TB infection attributable to occupational 
exposure is not available. CDC, which collects and publishes the number 
of active TB cases reported nationwide each year, does not publish 
occupational data associated with the incidence of TB infection and 
active TB on a nationwide basis. There has been some effort to include 
occupational information on the TB reporting forms, but only a limited 
number of states are currently using the new forms and capturing 
occupational information in a systematic way. In the absence of a 
national database, OSHA used two statewide studies, from North Carolina 
and Washington (Exs. 7-7, 7-263), and data from an individual hospital, 
Jackson Memorial Hospital (Ex. 7-108), on conversion rates of TB 
infection for workers in hospitals. The Washington State database also 
contained information on three additional occupational groups: long-
term care, home health care and home care employees. OSHA used these 
data to model average TB infection rates and estimate the range of 
expected risks in the U.S. among workers with occupational exposure to 
TB.
    The conversion rates in the selected studies were used to estimate 
the annual excess relative risk due to occupational exposure, which was 
expressed as the percent increase of infection above each study's 
control group. In order to estimate an overall range of occupational 
risk of TB infection, taking into account regional differences in TB 
prevalence in the U.S. and indirectly adjusting for factors such as 
socio-economic status, which might influence the rate of TB observed in 
different parts of the country, OSHA: (1) Estimated background rates of 
infection for each state by assuming that the number of new infections 
is functionally related to the number of active cases reported by the 
state each year (i.e., the distribution of new infections is directly 
proportional to the distribution of active cases), and 2) applied 
estimates of the annual excess relative risk, derived from the 
occupational studies, to the state background rates to calculate 
estimates of excess risk due to occupational exposure by state. Thus, 
the excess occupational risk estimates are actually calculated from the 
three available studies, on a relative increase basis, and these 
relative increases are multiplied by background rates for each state to 
derive estimates of excess occupational risk by state. The state 
estimates are then used to derive a national estimate of annual 
occupational risk of TB infection. Given an annual rate of infection, 
the lifetime risk of infection was calculated assuming that workers

[[Page 54213]]

are exposed for 45 years and that the worker's exposure profile and 
working conditions remain constant throughout his or her working 
lifetime. Lifetime infection rates are then used to calculate the 
lifetime risk of developing active disease based on the estimate that 
10% of all infections result in active disease. Given a number of 
active cases of TB, the number of expected deaths can be calculated 
based on the estimated average TB case death rate (i.e., number of TB 
deaths per number of active TB cases averaged over 3 years as reported 
by CDC).
    OSHA estimates that the risk of material impairment of health or 
functional capacity, that is, the average lifetime occupational risk of 
TB infection for hospital workers ranges from 30 to 386 infections per 
1,000 workers who are occupationally exposed to TB. These are different 
national averages, each derived by calculating the risk in each state 
and weighting it by the state's population. The low end of this range 
is derived by using the Washington State data, and is likely to 
seriously underestimate the true risk to which workers are exposed. 
This is because the Washington data represent occupational exposures 
among employees in hospitals which are located in areas of the country 
with a low prevalence of active TB and which have implemented TB 
controls (e.g., early identification procedures, annual skin testing, 
and negative pressure in AFB isolation rooms). The high end of this 
range is derived by using the Jackson Memorial Hospital study, and 
represents occupational risk for workers in hospitals located in high 
TB prevalence areas, serving high risk patients, and with a high 
frequency of exposure to infectious TB.
    OSHA also used information from the Washington State database to 
estimate national average estimates of lifetime risk for workers in 
long-term care (i.e., nursing homes), home health care, and home care. 
The national average lifetime risk of TB infection is estimated to be 
448 per 1,000 for workers in long-term care facilities, 225 per 1,000 
for workers in home health care (primarily nursing staff), and 69 per 
1,000 for workers in home care. The higher likelihood of occupational 
exposure in long-term care facilities (early identification of suspect 
TB cases is often difficult among the elderly) and the presence of 
fewer engineering controls in these facilities may explain the high 
observed occupational risk in that work setting.
    The national average lifetime risk of developing active disease 
ranges from approximately 3 to 39 cases per 1,000 exposed employees for 
workers in hospital settings. Similarly, the average lifetime risk of 
active disease is estimated to be approximately 45 per 1,000 for 
workers in long-term care, 26 per 1,000 in home health care, and 7 per 
1,000 in home care. This range is based on the estimate that 10% of 
infections will progress to active disease over one's lifetime. This 
risk may be greater for immunocompromised individuals.
    The national average lifetime risk of death from TB ranges from 0.2 
to approximately 3 deaths per 1,000 exposed employees for workers in 
hospital settings. Similarly, the average lifetime risk of death from 
TB is estimated to be approximately 3.5 per 1,000 for workers in long-
term care, 2 per 1,000 for workers in home health care, and 0.5 per 
1,000 in home care. The lower range of the national lifetime risk of 
deaths, 0.2 per 1,000, is based on the Washington State hospital data 
where the prevalence of TB is low and infection control measures have 
been implemented. Thus, this lower range of risk underestimates the 
risk of death from TB for other employees who work in settings where 
infection control measures, such as those outlined in this proposed 
standard, have not been implemented. The risk assessment data show that 
where infection control measures were not in place, the estimated risk 
of death from TB was as high as 6 deaths per 1,000 exposed employees.
    The quantitative risk estimates are based primarily upon data from 
hospitals and selected other work settings. However, it is frequent 
exposure to aerosolized M. tuberculosis which places workers at 
substantially increased risk of infection and not factors unique to the 
health care profession or any job category therein. Qualitative 
evidence, such as that from the epidemiological studies, case reports 
and outbreak investigations reported for various types of work 
settings, as discussed earlier in the Health Effects section, clearly 
demonstrates that employees exposed to aerosolized M. tuberculosis have 
become infected with TB and have gone on to develop active disease. 
These work settings share risk factors that place employees at risk of 
transmission. For example, these work settings serve client populations 
that are composed of a high prevalence of individuals who are infected 
with TB, are immunocompromised, are injecting drug users or are 
medically underserved and of poor general health status. Therefore, 
there is an increased likelihood that employees in these work settings 
will encounter individuals with active TB. In addition, high-hazard 
procedures, such as bronchoscopies, are performed in some of these work 
settings, which greatly increases the likelihood of generating 
aerosolized M. tuberculosis. Moreover, some of the work settings have 
environmental conditions such as overcrowding and poor ventilation, 
factors that facilitate the transmission of disease. Therefore, OSHA 
believes that the quantitative risk estimates based on hospital data 
and other selected health care settings can be extrapolated to other 
occupational settings where there is a similar increased likelihood of 
exposure to aerosolized M. tuberculosis.
    Having specific data for non-health care workers and workplace 
conditions would add more precision to the quantitative risk 
assessment, but that level of detail is not possible with the currently 
available information. However, the Agency believes that such a level 
of detail is not necessary to make its findings of significant risk 
because the risk of infection is based upon occupational exposure to 
aerosolized M. tuberculosis. Nevertheless, OSHA seeks information on 
conversion rates and the incidence of active disease among employees in 
non-health care work settings in order to give more precision to its 
estimates of risk.
    OSHA's risk estimates for TB infection are comparable to other 
risks which OSHA has concluded are significant, and are substantially 
higher than the example presented by the Supreme Court in the Benzene 
Decision. After considering the magnitude of the risk as shown by the 
quantitative and qualitative data, OSHA preliminarily concludes that 
the risk of material impairment of health from TB infection is 
significant.
    OSHA also preliminarily concludes that the proposed standard for 
occupational exposure to TB will result in a substantial reduction in 
that significant risk. The risk of infection is most efficiently 
reduced by implementing TB exposure control programs for the early 
identification and isolation of individuals with suspected or confirmed 
infectious TB. Engineering controls to maintain negative pressure in 
isolation rooms or areas where infectious individuals are being 
isolated will reduce the airborne spread of aerosolized M. tuberculosis 
and subsequent exposure of individuals, substantially reducing the risk 
of infection. In addition, for those employees who must enter isolation 
rooms or provide services to individuals with infectious TB, 
respiratory protection will reduce exposure to aerosolized M. 
tuberculosis and thus reduce the risk of infection.

[[Page 54214]]

    Several studies have shown that the implementation of infection 
control measures such as those outlined in this proposed standard have 
resulted in a reduction in the number of skin test conversions among 
employees with occupational exposure to TB. For example, results of a 
survey conducted by the Society of Healthcare Epidemiology of America 
(SHEA) of its member hospitals (Exs. 7-147 and 7-148) revealed that 
among hospitals that treated 6 or more patients with infectious TB per 
year there were 68% fewer tuberculin skin test conversions in hospitals 
that had AFB isolation rooms with one patient per room, negative 
pressure, exhaust air directed outside and six or more air changes per 
hour, compared to hospitals that did not have AFB isolation rooms with 
these same characteristics. Similarly, an 88% reduction in tuberculin 
skin test conversions was observed in an Atlanta hospital after the 
implementation of infection control measures such as an expanded 
respiratory isolation policy, improved diagnostic and testing 
procedures, the hiring of an infection control coordinator, expanded 
education of health care workers, increased frequency of tuberculin 
skin tests, implementation of negative pressure, and use of submicron 
masks for health care workers entering isolation rooms (Ex. 7-173). 
Improvements in infection control measures in a Florida hospital after 
an outbreak of MDR-TB reduced tuberculin skin test conversions from 28% 
to 18% to 0% over three years (Ex. 7-167). These improvements included 
improved early identification procedures, restriction of high-hazard 
procedures to AFB isolation rooms, increased skin testing, expansion of 
initial TB treatment regimens, and daily inspection of negative 
pressure in AFB isolation rooms. Thus, these investigations show that 
the implementation of infection control measures such as those included 
under OSHA's proposed standard for TB can result in substantial 
reductions in infections among exposed employees.
    As discussed in further detail in the following section of the 
Preamble to this proposed standard, OSHA estimates that full 
implementation of the proposed standard for TB will result in avoiding 
approximately 21,400 to 25,800 work-related infections per year, 1,500 
to 1,700 active cases of TB resulting from these infections and 115 to 
136 deaths resulting from these active cases. In addition, because the 
proposed standard encourages the identification and isolation of active 
TB cases in the client populations served by workers in the affected 
industries, there will also be non-occupational TB infections that will 
be averted. OSHA estimates that implementation of the proposed standard 
will result in avoiding approximately 3,000 to 7,000 non-occupational 
TB infections, 300 to 700 active cases of TB resulting from these 
infections, and 23 to 54 deaths resulting from these active cases. OSHA 
preliminarily concludes that the proposed standard for TB will 
significantly reduce the risk of infection, active disease and death 
from exposure to TB and that the Agency is thus carrying out the 
Congressional intent and is not attempting to reduce insignificant 
risks.
    Although the current OSHA enforcement program, which is based on 
the General Duty Clause of the Act, Section 5(a)(1), and the 
application of some general industry standards, such as 29 CFR 
1910.134, Respiratory Protection, has reduced the risks of occupational 
exposure to tuberculosis to some extent, significant risks remain and 
it is the Agency's opinion that an occupational health standard 
promulgated under section 6(b) of the Act will much more effectively 
reduce these risks for the following reasons. First, because of the 
standard's specificity, employers and employees are given more guidance 
in reducing exposure to tuberculosis. Second, it is well known that a 
standard is more protective of employee health than an enforcement 
program based upon the general duty clause and general standards. 
Unlike the proposed standard, the general duty clause specifies no 
abatement methods and the general industry standards do not set forth 
abatement methods specifically addressing occupational exposure to TB. 
Third, the general duty clause imposes heavy litigation burdens on OSHA 
because the Agency must prove that a hazard exists at a particular 
workplace and that it is recognized by the industry or the cited 
employer. Since the proposed standard specifies both the conditions 
that trigger the application of the standard and the employer's 
abatement obligations, thereby establishing the existence of the 
hazard, no independent proof that the hazard exists in the particular 
workplace need be presented. The reduction in litigation burdens will 
mean that the Labor Department, as well as the employer, will save time 
and money in the investigation and litigation of occupational TB cases. 
Finally, the promulgation of this proposed standard will result in 
increased protection for employees in state-plan states which, although 
not required to adopt general duty clauses, must adopt standards at 
least as effective as Federal OSHA standard.
    In summary, the institution of the enforcement guidelines has been 
fruitful, but it has not eliminated significant risks among 
occupationally exposed employees. Therefore, OSHA preliminarily 
concludes that a standard specifically addressing the risks of 
tuberculosis is necessary to further substantially reduce significant 
risk. OSHA's preliminary economic analysis and regulatory flexibility 
analysis indicate that the proposed standard is both technologically 
and economically feasible. OSHA's analysis of the technological and 
economic feasibility is discussed in the following section of the 
preamble.

VII. Summary of the Preliminary Economic Analysis and Regulatory 
Flexibility Analysis

    OSHA is required by the Occupational Safety and Health Act of 1970 
and several court cases pertaining to that Act to ensure that its rules 
are technologically and economically feasible for firms in the affected 
industries. Executive Order (EO) 12866 and the Regulatory Flexibility 
Act (as amended) also require Federal agencies to estimate the costs, 
assess the benefits, and analyze the impacts on the regulated community 
of the regulations they propose. The EO additionally requires agencies 
to explain the need for the rule and examine regulatory and non-
regulatory alternatives that might achieve the objectives of the rule. 
The Regulatory Flexibility Act requires agencies to determine whether 
the proposed rule will have a significant economic impact on a 
substantial number of small entities, including small businesses and 
small government entities and jurisdictions. For proposed rules with 
such impacts, the agency must prepare an Initial Regulatory Flexibility 
Analysis that identifies those impacts and evaluates alternatives that 
will minimize such impacts on small entities. OSHA finds that the 
proposed rule is ``significant'' under Executive Order 12866 and 
``major'' under Section 804(2) of the Small Business Regulatory 
Enforcement Fairness Act of 1996. Accordingly, the Occupational Safety 
and Health Administration (OSHA) has prepared this Preliminary Economic 
and Regulatory Flexibility Analysis (PERFA) to support the Agency's 
proposed standard for occupational exposure to tuberculosis (TB). The 
following is an executive summary of that analysis. The entire test of 
the PERFA can be found in the rulemaking docket as Exhibit 13.

[[Page 54215]]

The complete PERFA is composed of various chapters that describe in 
detail the information summarized in the following section.

Statement of Need

    TB is a communicable, potentially lethal disease caused by the 
inhalation of droplet nuclei containing the bacillus Mycobacterium 
tuberculosis (M. tuberculosis). Persons exposed to these bacteria can 
respond in different ways: by overcoming the challenge without 
developing TB, by becoming infected with TB, or by developing active TB 
disease. Those who become infected harbor the infection for life, and 
have a 10 percent chance of having their infection progress to active 
disease at some point in their life. Those with active disease have the 
signs and symptoms of TB (e.g., prolonged, productive cough; fatigue; 
night sweats; weight loss) and have about an 8 percent risk of dying 
from their disease.
    TB has been a worldwide health problem for centuries, causing 
millions of deaths worldwide. In the United States, however, there has 
been a decline in the number of active TB cases over the last four 
decades. Between 1953 and 1994, the number of active cases declined 
from 83,304 to 24,361, an annual rate of decline of 3.6 percent over 
the period as a whole (Figure VII-1). The 1988-1992 period, however, 
saw the first substantial increase in the number of active cases since 
1953. A number of outbreaks of this disease have occurred among workers 
in health care settings, as well as other work settings, in recent 
years. To add to the seriousness of the problem, some of these 
outbreaks have involved the transmission of multi-drug resistant 
strains of M. tuberculosis, which are often fatal. Very recently, i.e., 
after 1992, this trend has reversed, and the number of such cases 
appears once again to have begun to decline. Nevertheless, TB remains a 
major health problem, with 22,813 active cases reported in 1995. 
Because active TB is endemic in many U.S. populations--including groups 
in both urban and rural areas--workers who come into contact with 
diseased individuals are at risk of contracting the disease themselves.

BILLING CODE 4510-26-P

[[Page 54216]]

[GRAPHIC] [TIFF OMITTED] TP17OC97.005



BILLING CODE 4510-26-C

[[Page 54217]]

    Many occupational groups, including workers in health care, nursing 
homes, homeless shelters, hospices, correctional facilities, 
laboratories, physicians' offices, and other settings are at risk of 
contracting TB on the job. These workers are at risk because they are 
exposed in the course of their work to patients and others with active 
TB disease, perform procedures that expose them to airborne 
concentrations of M. tuberculosis, or serve client populations where 
the incidence of active disease is unusually high.
    The purpose of OSHA's standard is to reduce these risks in health 
care and other work settings where active TB cases are likely to be 
encountered by employees. To accomplish this goal, the proposed 
standard requires those employers who are responsible for the working 
conditions where such encounters occur to implement a program of 
infection prevention and infection control that is designed to prevent 
occupational infections in the first place, and to identify and treat 
any job-related infections that do occur. The approach taken in the 
proposed standard is similar to that adopted by OSHA in its 1991 
bloodborne pathogens standard, which is given credit for achieving a 
dramatic reduction in the number of cases of hepatitis among health 
care and other workers since it was issued. OSHA predicts that, once 
implemented, the proposed TB standard will have similar results, 
achieving reductions on the order of 70 to 90 percent in the number of 
TB infections, active cases, and directly related deaths.
    This Preliminary Economic and Regulatory Flexibility Analysis 
includes an introductory chapter that describes the major provisions of 
the standard. The proposal would apply to occupational exposure to TB 
occurring in, during, or through the provision of services by:
     Hospitals.
     Nursing homes.
     Correctional facilities.
     Immigration detainment facilities.
     Law enforcement facilities.
     Hospices.
     Substance abuse treatment centers.
     Homeless shelters.
     Medical examiners' offices.
     Home health care providers.
     Emergency medical services.
     Research and clinical laboratories handling TB.
     Contract work on ventilation systems or areas of buildings 
that may contain aerosolized M. tuberculosis.
     Physicians performing certain high hazard procedures.
     Social service workers providing services to individuals 
identified as having suspected or confirmed infectious TB.
     Personnel service agencies when providing workers to 
covered facilities.
     Attorneys visiting known or suspected infectious TB 
patients.
    The groups, industries, and work settings covered by the standard 
have been included in its scope for specific reasons. For example, 
hospitals are included because they treat patients with active TB 
disease, while hospices, certain laboratories, pulmonary and certain 
other physicians, medical examiners, and contract HVAC workers are 
covered because employees in these settings/jobs are exposed to 
aerosolized M. tuberculosis during the performance of high-hazard 
procedures, such as bronchoscopies, sputum induction, autopsies, and 
during work on ventilation systems that may contain TB bacteria. Other 
work settings, such as homeless shelters and nursing homes, are covered 
because their employees serve a client population known to have a high 
incidence of TB infection. Another group of employees included within 
the scope of the standard are workers who must occasionally serve 
patients with active TB who are being treated in ``isolation,'' i.e., a 
room or area specifically designed to contain the TB microorganism and 
prevent its spread to surrounding areas. Attorneys and social workers 
are typical of this group. Finally, the proposed standard covers 
personnel service agencies that provide temporary, seasonal, or 
``leased'' personnel to hospitals and other covered work settings.
    OSHA estimates that the standard would apply to approximately 
102,000 establishments and provide protection to more than 5 million 
workers currently at risk of occupational exposure to TB. More than 
half of these workers--almost 4 million--work in the two industries 
most affected by the standard: hospitals and nursing homes. Other 
covered industries with large numbers of workers are home health care, 
emergency medical services, and correctional institutions.
    Table VII-1 shows the number of affected establishments and the 
population at risk for each covered industry. (Table VII-1 does not 
include all sectors that might hypothetically be covered by the 
standard. For example, a chiropractor who engaged in high hazard 
procedures would be covered by the standard. However, this possibility 
is sufficiently rare for this activity not to have been included in 
this analysis. OSHA solicits comments on any affected job categories or 
industries it may have omitted.) Because the standard requires 
employers in the covered industries to make an initial determination 
that will identify which job classifications, employees, and activities 
within their workplace involve occupational exposure to TB, its 
requirements are narrowly targeted to those workers most at risk. Thus, 
for example, only approximately 57 percent of hospital workers are 
potentially affected by the standard; these workers would include those 
working on infectious disease floors or wards, radiology units, autopsy 
suites, and in other, similarly exposed locations.

 Table VII-1.--Number of Affected Establishments and Population at Risk,
                               by Industry                              
------------------------------------------------------------------------
                                                Number of               
                  Industry                      affected      Population
                                             establishments    at risk  
------------------------------------------------------------------------
Hospitals..................................          5,749     2,663,996
Nursing Homes..............................         20,254     1,200,034
Correctional Institutions..................          2,079       268,432
Immigration Detainment.....................             12           990
Law Enforcement............................          4,950        27,469
Hospices...................................          1,755        17,250
Homeless Shelters..........................         10,450        85,168
Substance Abuse Treatment Centers..........          9,730       120,115
Medical Examiners..........................            100         2,000
Home Health Care...........................         10,921       418,538
Emergency Medical Services.................          5,099       255,200
Laboratories...............................            851        11,108
Contract HVAC..............................            300         2,500
Social Services............................          2,342        20,000
Physicians.................................         21,698        43,395
Pulmonary Physicians.......................          1,853         3,705
Personnel Services.........................          1,426       161,608
Attorneys..................................          2,306         4,611
                                            ----------------------------
    Total..................................        101,875     5,306,119
------------------------------------------------------------------------
Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.  

Technological Feasibility

    Chapter III of the analysis evaluates the technological feasibility 
of the proposed standard for affected establishments. OSHA 
preliminarily concludes that no provisions of the rule pose 
technological feasibility problems for any potentially affected 
entities. This is the case because the standard emphasizes 
administrative controls, such as the early identification of suspected 
or confirmed cases of TB and employee information and training, rather 
than engineering controls. In

[[Page 54218]]

addition, the engineering controls that are required, such as AFB 
isolation rooms, biological safety cabinets, and temporary AFB 
isolation facilities, would be mandated only in those situations where 
individuals with suspected or confirmed infectious TB are admitted and 
isolated, where high hazard procedures are performed, and in situations 
where individuals cannot be placed into AFB isolation rooms within five 
hours of being identified as having suspected or confirmed infectious 
TB. All of the engineering controls required by the standard are 
currently available and in widespread use in many affected 
establishments.

Benefits of the Proposed Standard

    Workers employed in the work settings covered by the standard are 
at significant risk of material impairment of health as a result of 
exposure to M. tuberculosis on the job. These workers will be the 
primary beneficiaries of the protection provided by the rule. However, 
because TB is a communicable disease, many other individuals will also 
benefit from the standard. Reducing the number of cases of TB among 
workers who are regularly in contact both with patients and infected 
members of client populations will reduce the incidence of TB 
infections and active cases in these client populations (since infected 
individuals spend the most time with other members of their group) and 
among members of the families of exposed workers. OSHA has expressed 
the benefits of the standard in terms of the numbers of TB infections, 
active cases, and TB-related deaths averted by the standard. In 
addition to reducing morbidity and mortality among workers, their 
families, and client populations, the standard will also generate 
readily quantifiable cost savings in the form of lower medical costs, 
less lost production, and reduced costs for administering workers' 
compensation claims and other private and social insurance system 
transactions.
    OSHA's estimates of the potential benefits of the standard take 
into account the extent of current industry compliance with the 
provisions of the proposed standard, i.e., the benefits estimates do 
not include the benefits that employers in affected sectors are already 
garnering as a result of their voluntary efforts to provide protections 
to their TB-exposed employees. The benefits assessment presented in 
Chapter IV of the economic analysis is based on OSHA's Preliminary Risk 
Assessment (see that section of the preamble), which quantifies the 
occupational risk of TB infection among workers in hospitals, nursing 
homes, home health care work settings, and home care work settings. The 
estimates of risk are based on the rate of tuberculin skin test (TST) 
conversions among these populations. TST conversions are a widely used 
and well-documented index of TB infection; rates of conversion among 
the exposed populations are then compared with rates in unexposed or 
less-exposed ``control'' populations to obtain an estimate of the 
``excess'' risk associated with occupational exposure. Table VII-2 
shows the results of OSHA's estimates of the risks confronting workers 
in various work settings, based on statistical analyses and studies in 
the literature.

              Table VII-2.--Estimates of Occupational Risk Confronting Workers in Various Settings              
----------------------------------------------------------------------------------------------------------------
                                                                                                      Estimated 
                                                                                                       annual   
                                                                                                     excess rate
                    Setting                               Location and date            Excess risk      of TB   
                                                                                        (percent)     infection 
                                                                                                      per 1,000 
                                                                                                       workers  
----------------------------------------------------------------------------------------------------------------
Hospital......................................  North Carolina Western Region--1984-           398          5.7 
                                                 1985.                                                          
Hospital......................................  Washington State--1994...............           47           .68
Hospital......................................  Jackson Memorial Hospital, Miami,              795         11.8 
                                                 Florida--1991.                                                 
Nursing Homes.................................  Washington State--1994...............         1019         14.6 
Home Health Care..............................  Washington State--1994...............          478          6.9 
Home Care.....................................  Washington State--1994...............          112          1.6 
----------------------------------------------------------------------------------------------------------------
Source: OSHA, Preliminary Assessment of Risk.                                                                   

    Where risk data of good quality were available for a specific 
industry, OSHA relied on that data. However, such data were available 
only for the hospital, nursing home, home health care, and home care 
industries. Accordingly, OSHA identified the best data to use to 
characterize the occupational risk of TB infection posed to workers in 
the other work settings covered by the proposed rule. After a careful 
review of the available data, OSHA chose to rely on data from western 
North Carolina that looked at occupational risk in a total of eight 
hospitals. These data were selected because they derived from hospitals 
that were relatively ``uncontrolled,'' i.e., that had not yet 
implemented many of the controls that would be required by the proposed 
standard. Data from the other hospitals shown in Table VII-2 were 
judged to be less appropriate for the purpose of extrapolation because 
Washington State hospitals are already generally in compliance with the 
requirements of the proposed rule and Jackson Memorial Hospital had 
recently experienced an outbreak of multi-drug resistant TB among its 
patients at the time the risk data were gathered. OSHA believes that 
using occupational risk data from hospitals to characterize the risk in 
other occupational settings for which risk data are unavailable is 
appropriate because employees in these other settings serve client 
populations that have a high incidence of active TB cases, perform 
high-hazard procedures, or visit hospitalized TB patients. The use of a 
hospital-based risk estimate results in a lower estimate of risk than 
would be the case if OSHA had used risk data from nursing homes or home 
health care to characterize the risk in other settings, but a higher 
risk than if OSHA had used risk data from the home care industry to do 
so.
    To predict the effectiveness of the proposed standard, OSHA 
evaluated the reduction in occupational risk that various control 
measures required by the standard can be expected to achieve. 
Effectiveness is measured as the percent reduction in TST conversions 
and in the TB infections, active cases, and deaths represented by those 
conversions. Based on a thorough review of the available literature on 
the effectiveness of control programs that have actually been 
implemented in a number of hospitals, OSHA believes that the proposed 
standard, once implemented, would

[[Page 54219]]

reduce TB infections among occupationally exposed hospital workers by 
90 percent, and would decrease such infections in the other work 
settings covered by the standard by 70 to 90 percent. OSHA also 
estimated the effectiveness and medical surveillance and follow-up in 
preventing infections from advancing to active cases of TB. OSHA found 
that such measures reduced the probability of an infection advancing to 
an active case by 35 to 47 percent, depending on the frequency of 
testing.
    Using these effectiveness data, taking account of the current 
levels of compliance in various workplaces, and relying on the 
estimates of excess risk presented in OSHA's Preliminary Risk 
Assessment, OSHA predicts that the proposed standard will avert about 
21,000 to 26,000 work-related TB infections per year, 1,500 to 1,750 
active disease cases resulting directly from these infections, and 115 
to 136 deaths directly related to the same infections. Preventing this 
number of infections among workers will, in turn, prevent about 3,000 
to 7,000 infections, 300 to 700 active cases, and 23 to 54 deaths among 
the families, friends, clients, and contacts of these workers. In 
addition, the standard will annually generate cost savings of $89 to 
$116 million dollars in avoided medical costs, lost production caused 
by absence from work and other factors, and insurance administration 
costs. Table VII-3 shows the benefits of the proposed standard.

                                         Table VII-3.--Summary of Benefits Associated With the Proposed Standard                                        
--------------------------------------------------------------------------------------------------------------------------------------------------------
       Type of benefit                        Work-related                 Transmissions from work-related sources           Total number averted       
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infections Avoided...........  21,380-25,769............................  2,954-6,978..............................  24,334-32,747.                     
Active Cases Avoided.........  1,477-1,744..............................  295-698..................................  1,772-2,442.                       
Deaths Avoided...............  115-136..................................  23-54....................................  138-190.                           
Cost Savings.................  $80,721,000-$95,393,000..................  $8,614,000-$20,381,000...................  $89,335,000-$115,774,000.          
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Office of Regulatory Analysis, OSHA, DOL.                                                                                                       

    Chapter V of the economic analysis projects the costs employers in 
the various industries covered by the standard are estimated to incur 
to achieve compliance with the rule's requirements. OSHA estimated 
costs for each covered industry and for each provision of the standard. 
These costs take account of the baseline levels of compliance 
prevailing in each industry at the present time and are presented as 
annualized costs discounted at 7 percent. Annualized costs are the sum 
of annualized initial costs and recurring annual costs. For example, a 
temporary AFB isolation room costing $4,095 with annual maintenance 
costs of $50 would have annualized costs of $633 ($583 + $50).
    The total estimated costs of compliance for the standard as a whole 
are $245 million per year. The most costly provisions of the standard 
are those requiring medical surveillance and training for 
occupationally exposed employees. Together, these two provisions 
account for 60 percent of the costs of compliance. The two industries 
projected to incur the highest costs are hospitals and nursing homes. 
Together, the costs incurred by these two industries are estimated to 
be $138 million  per  year.  Tables  VII-4  and VII-5 summarize the 
annualized costs of compliance, by provision and industry, 
respectively.

           Table VII-4.--Total Annualized Costs, by Provision           
------------------------------------------------------------------------
                                                               Total    
                        Provision                           annualized  
                                                               cost     
------------------------------------------------------------------------
Exposure Control........................................     $12,858,183
Work Practice Controls..................................       9,740,559
    Transfers...........................................       9,740,559
Engineering Controls....................................      22,529,248
    AFB Isolation Rooms.................................       7,547,912
    Temporary AFB Isolation.............................      10,792,678
    Laboratories........................................         780,270
    Autopsies...........................................       2,903,077
    Daily Testing of Negative Pressure..................         505,310
Respiratory Protection..................................      45,771,276
    Respirators.........................................      32,225,228
    Respirator Program..................................       1,670,677
    Fit Testing.........................................       8,905,821
    Evaluation of Program...............................       2,969,549
Medical Surveillance....................................      94,901,455
    Medical History/Physical Exam.......................      62,974,255
    Tuberculin Skin Testing (TST).......................      21,907,252
    Medical Management/Follow-up........................       4,773,377
    Medical Removal.....................................       5,246,570
Communication of Hazards................................      52,268,172
    Signs and Labels....................................          58,284
    Training............................................      52,209,888
Recordkeeping...........................................       7,228,533
    Engineering Control Maintenance.....................          20,052
    Medical.............................................       6,785,014
    Training............................................         423,467
                                                         ---------------

[[Page 54220]]

                                                                        
        Total...........................................     245,297,426
------------------------------------------------------------------------
Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.  


         Table VII-5.--Summary of Compliance Costs, by Industry         
------------------------------------------------------------------------
                                                               Total    
                        Provision                           annualized  
                                                               cost     
------------------------------------------------------------------------
Hospitals...............................................     $61,819,637
Nursing Homes...........................................      76,500,314
Correctional Institutions...............................      20,187,666
Immigration Detainment..................................         145,378
Law Enforcement.........................................       6,708,174
Hospices................................................       2,237,959
Homeless Shelters.......................................      11,287,278
Substance Abuse Treatment Centers.......................      12,751,545
Medical Examiners.......................................         557,811
Home Health Care........................................      16,448,605
Emergency Medical Services..............................       4,981,780
Laboratories............................................       1,696,383
Contract HVAC...........................................         396,197
Social Services.........................................       3,063,444
Physicians..............................................       5,663,949
Pulmonary Physicians....................................         930,775
Personnel Services......................................      18,363,135
Attorneys...............................................       1,557,398
                                                         ---------------
    Total...............................................     245,297,426
------------------------------------------------------------------------
Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.  

    Chapter VI assesses the economic impacts of the proposed standard 
on the industries affected by the proposed standard and also analyzes 
the impacts on the small businesses within each of these industries. 
OSHA preliminarily concludes that the standard is economically feasible 
for affected firms. On average, annualized compliance costs for all 
entities amount only to 0.06 percent of revenues and only 1.8 percent 
of profits. For all industries, costs as a percentage of revenues are 
less than 1 percent. For two industries, costs as a percentage of 
profits exceed 5 percent; these industries are substance abuse 
treatment centers and personnel services. OSHA does not believe, 
however, that these profit impacts will actually be incurred by 
facilities in these two sectors. Only 18.5 percent of substance abuse 
treatment centers operate on a for-profit basis. If substance abuse 
treatment centers can increase their revenues by as little as 0.34 
percent, they can completely offset their compliance costs. The revenue 
increases or reductions in services needed to achieve cost passthrough 
are not expected to represent significant impacts for these facilities. 
The situation for personnel service firms is similar; these firms would 
have to increase the prices charged to their customers by as little as 
0.56 percent to completely offset the costs of compliance. It is likely 
that these agencies will be able to pass such a small increase in costs 
through to their customers, i.e., to facilities purchasing personnel 
services. Table VII-6 shows compliance costs as a percentage of 
revenues, by industry.

          Table VII-6.--Screening Analysis to Identify Potential Economic Impacts on Affected Entities          
----------------------------------------------------------------------------------------------------------------
                                                                                     Percent of for-            
                                                                        Number of        profit       Cost as a 
                              Industry                                  affected     establishments   percentage
                                                                     establishments    in industry   of revenues
----------------------------------------------------------------------------------------------------------------
Hospitals..........................................................          5,749            15.5          0.02
Nursing Homes......................................................         20,254            71.4          0.16
Correctional Institutions..........................................          2,079             0.0          0.10
Immigration Detainment.............................................             12             0.0          0.16
Law Enforcement....................................................          4,950             0.0          0.03
Hospices...........................................................          1,755            12.0          0.09
Homeless Shelters..................................................         10,450             0.0          0.64
Substance Abuse Treatment Centers..................................          9,730            18.5          0.34
Medical Examiners..................................................            100             0.0          0.28
Home Health Care...................................................         10,921            40.6          0.11
Emergency Medical Services.........................................          5,099            14.5          0.11

[[Page 54221]]

                                                                                                                
Laboratories.......................................................            851           100.0          0.13
Contract HVAC......................................................            300           100.0          0.17
Social Services....................................................          2,342             0.0          0.27
Physicians.........................................................         21,698            95.0          0.03
Pulmonary Physicians...............................................          1,853            95.0          0.06
Personnel Services.................................................          1,426           100.0          0.56
Attorneys..........................................................          2,306            89.8          0.10
                                                                    --------------------------------------------
    Total..........................................................        101,875            48.7          0.06
----------------------------------------------------------------------------------------------------------------
Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.                                          

    OSHA has preliminarily concluded that the proposed standard will 
have a significant impact on a substantial number of small entities and 
has therefore, as required by the Regulatory Flexibility Act Amendments 
of 1996, conducted an Initial Regulatory Flexibility Analysis (IRFA). 
This analysis has identified significant impacts on the small entity 
portion of the hospital, nursing home, correctional institution, 
homeless shelter, substance abuse treatment center, contract HVAC, and 
personnel services industries.
    For the purposes of this analysis, OSHA defines small for-profit 
entities using the Small Business Administration's (SBA's) Table of 
Size Standards. For businesses affected by the proposed standard, the 
SBA classifies entities with annual revenues of less than $5 million as 
small for all industries, with the exception of contract HVAC firms, 
for which entities with less than $7 million in annual revenues are 
classified as small.
    A small not-for-profit entity is defined as any nonprofit 
enterprise that is independently owned and operated and is not dominant 
in its field. Based on this definition, all not-for-profit entities 
affected by the proposed standard are considered small.
    Many of the affected industries consist almost entirely of public 
sector facilities, such as correctional facilities, immigration 
detainment facilities, law enforcement facilities, medical examiners' 
offices, and social service organizations. Several other affected 
industries include some government-owned facilities, such as hospitals, 
nursing homes, and emergency medical services. Under the Regulatory 
Flexibility Act, ``small governmental jurisdiction'' refers to 
governments of cities, counties, towns, townships, villages, school 
districts, or special districts with populations of less than 50,000. 
For most of the affected industries, information on the number of such 
entities was not readily available. Where data were unavailable, the 
number of small publicly-owned entities was estimated based on the 
average number of people served per employee in each industry, from 
which OSHA estimated the average employment size of establishments 
serving populations of less than 50,000. These entities are considered 
small for the purposes of this analysis. OSHA requests information on 
size standards for public-sector entities.
    OSHA requests comment on these definitions and estimates of the 
number of small entities. The complete IRFA is presented in Chapter VI 
of the economic analysis, and is also presented here.

Initial Regulatory Flexibility Analysis

    The Regulatory Flexibility Act, as amended in 1996, requires that 
an Initial Regulatory Flexibility Analysis contain the following 
elements:
    (1) A description of the reasons why action by the agency is being 
considered;
    (2) A succinct statement of the objectives of, and legal basis for, 
the proposed rule;
    (3) A description of, and, where feasible, an estimate of the 
number of small entities to which the proposed rule will apply;
    (4) A description of the projected reporting, recordkeeping and 
other compliance requirements of the proposed rule, including an 
estimate of the classes of small entities that will be subject to the 
requirement and the type of professional skills necessary for 
preparation of the report or record; and
    (5) An identification, to the extent practicable, of all relevant 
Federal rules that may duplicate, overlap or conflict with the proposed 
rule.
    In addition, a regulatory flexibility analysis must contain a 
description of any significant alternatives to the proposed rule that 
accomplish the stated objectives of applicable statutes (in this case 
the OSH Act) and that minimize any significant economic impact of the 
proposed rule on small entities.3 This section of the 
analysis closes with a review of the recommendations of the SBREFA 
Panel concerning this proposed rule and discusses how OSHA has 
responded to these recommendations.
---------------------------------------------------------------------------

    \3\ The Regulatory Flexibility Act states that a Regulatory 
Flexibility Analysis need not contain all of the above elements in 
toto if these elements are presented elsewhere in the documentation 
and analysis of the rule. The Regulatory Flexibility Analysis 
should, however, summarize where these elements can be found 
elsewhere in the rulemaking record.
---------------------------------------------------------------------------

Reasons for the Proposed Rule

    From 1985 to 1994, the number of active TB cases in the United 
States increased by 9.4 percent, reversing a 30-year downward trend. 
Although the number of cases reported to the CDC has declined over the 
past few years, TB remains a serious problem in the United States. In 
1994, 24,361 active TB cases were reported to the Centers for Disease 
Control and Prevention (CDC), and TB was reported to have caused 1,590 
deaths in that year alone (Ex. 7-283).
    Transmission of M. tuberculosis is a recognized risk in several 
work settings. A number of outbreaks of this dreaded disease have 
occurred among workers in health care settings, as well as other work 
settings, in recent years. To add to the seriousness of the problem, 
some of these outbreaks have involved the transmission of multidrug-
resistant strains of M. tuberculosis, a form of the disease that is 
often fatal.

Objectives of the Proposed Rule

    The objective of this proposal is to reduce the risk of 
occupational exposure to M. tuberculosis in exposed working populations 
through the use of engineering controls, work practice controls, 
respiratory protection, medical

[[Page 54222]]

surveillance, training, signs and labels, and recordkeeping. 
Implementation of these measures has been shown to minimize or 
eliminate occupational exposure to M. tuberculosis, and thus to reduce 
the risk of TB infection among workers. The legal authority for this 
proposed standard is the Occupational Safety and Health Act, 29 U.S.C. 
655(b).

Description of the Number of Small Entities

    The proposed rule would cover 80,400 establishments operated by 
67,116 small entities, as defined above. Of the 67,116 small entities, 
about 49 percent (32,605 entities) are for-profit small entities, 20 
percent (13,622 entities) are publicly-owned, and 31 percent (20,889 
entities) are not-for-profit. About 79 percent of the total number of 
affected establishments are operated by small entities. The proposed 
rule covers 48,804 establishments operated by 48,044 very small 
entities, defined as entities of all kinds employing fewer than 20 
workers. Almost 48 percent of the affected establishments are operated 
by very small entities.

Description of Proposed Reporting, Recordkeeping and Other Compliance 
Requirements

    Avoiding a One-Size-Fits-All Standard. Occupational TB occurs in a 
wide variety of settings, which means that the risk varies 
substantially, and control measures differ, from one facility to 
another. OSHA's proposed TB standard has been tailored to recognize 
these differences. With respect to the background risk of exposure, the 
OSHA standard distinguishes between work settings in counties that have 
had no cases of TB in one of the past two years and fewer than 6 cases 
in the other of the past two years, work settings in counties with one 
or more cases of TB in both of the past two years or that have had 6 or 
more cases of TB in one of the past two years, and work settings that 
have encountered 6 or more cases of TB in the past 12 months. In 
addition, the OSHA standard treats different types of exposure to TB 
differently. For example, the standard has different requirements for 
employers who own facilities that treat TB patients, employers whose 
client populations have high TB rates, employers whose employees (such 
as attorneys and social service providers) visit patients who have been 
identified as having suspected or confirmed cases of TB, employers 
whose employees engage in various high hazard procedures, employers 
whose employees provide maintenance for ventilation systems serving 
confirmed or suspected TB patients, and employers who provide personnel 
to treat patients in their own homes. In part because of these many 
distinctions, the SBREFA Panel found that the regulation was difficult 
for many employers to understand (Ex. 12). To make the tailoring of the 
standard to specific situations easier to see, OSHA has developed 
tables showing which provisions of the standard are most likely to 
apply to employers in different circumstances and in various affected 
sectors (see the Scope paragraph discussion in Section X of the 
Preamble, ``Summary and Explanation''). In addition, OSHA intends to 
provide extensive outreach when the standard is published in final 
form. OSHA solicits comments on other ways to avoid a ``one-size-fits-
all'' standard while at the same time making the standard easier to 
follow. For example, would developing a flow chart and/or expert system 
that asks employers a series of questions and then directs employers to 
applicable requirements be an aid to affected small entities?
    Description of the Proposed Standard. The proposed rule would 
require that employers develop and implement exposure control plans; 
institute work practice and engineering controls; provide respiratory 
protection in various situations; provide medical surveillance (e.g., 
tuberculin skin testing, medical histories, medical management, medical 
follow-up, medical removal); and communicate hazards through the use of 
signs, labels, and training. These proposed requirements are discussed 
in greater detail in the Introduction (Chapter I) of this analysis.
    The proposed standard would also require that employers establish 
and maintain medical, training, illness/injury, and engineering control 
maintenance and performance monitoring records. All establishments 
affected by the proposed rule would be affected by these proposed 
requirements. However, only establishments with engineering controls 
would be required to maintain records of the maintenance and monitoring 
of engineering controls.
    In estimating the cost of establishing and maintaining medical 
records, OSHA used the wage rate of a clerical worker with some 
knowledge of medical recordkeeping as the base wage. However, the 
knowledge required to perform such duties can be acquired by most 
clerical workers with little effort. All recordkeeping requirements 
included in the proposed rule could therefore be performed by the 
existing staff in any of the covered industries. A detailed description 
of the proposed requirements appears in the Introduction and in the 
Costs of Compliance chapters of this analysis.

Relevant Federal Rules That May Duplicate, Overlap, or Conflict With 
the Proposed Rule

    On October 28, 1994, the Centers for Disease Control and Prevention 
(CDC) of the U.S. Department of Health and Human Services published 
``Guidelines for Preventing the Transmission of Mycobacterium 
tuberculosis in Health-Care Facilities,'' which recommends that 
facilities adopt many of the requirements included in this proposed 
standard. CDC has also published guidelines for the prevention of 
transmission of TB in homeless shelters, long-term care facilities for 
the elderly, and correctional institutions. OSHA has consulted with CDC 
in developing the proposed standard, and the basic elements of the 
standard correspond to the basic elements in the CDC guidelines. 
However, the CDC publication is only recommendatory and is therefore 
not enforceable. OSHA's studies (see chapters IV and V) show that few 
facilities are following all elements of these guidelines. Further, 
many portions of the CDC guidelines are written in language that does 
not lend itself to enforcement even if the guidelines were made 
mandatory. For example, portions of the CDC guidelines for health care 
facilities suggest that the employer ``consider'' adopting certain 
controls. A fuller discussion of the similarities and differences 
between OSHA's proposed rule and the CDC's recommendations is provided 
in Section III of the Preamble, which describes the events leading to 
the proposed standard. Although the U.S. Public Health Service has 
overall responsibility for the control of TB in the U.S. population, 
OSHA is the only agency specifically mandated to address the problem of 
TB transmission in occupational settings.
    The Health Care Financing Administration (HCFA) of the U.S. 
Department of Health and Human Services requires that facilities 
undergo an initial accreditation inspection prior to receiving Medicare 
and Medicaid funding. Such facilities include hospitals, nursing homes 
and other long-term care facilities, and clinical laboratories. 
Hospitals are reinspected annually, nursing homes every 15 months, and 
laboratories every two years. One of the requirements of such 
accreditation is the implementation of an infection control program. 
However, unlike the OSHA proposed rule, HCFA's requirements do not 
specify the elements that must be included in such

[[Page 54223]]

a program. HCFA may cite facilities with poor results for specific 
program deficiencies but does not have the authority to cite facilities 
for failing to include specific elements in their infection control 
programs, unless those program elements are specifically required by an 
OSHA standard. This means that in the absence of an OSHA TB standard, 
HCFA could not require implementation of specific controls. The 
proposed rule does not in any way conflict with HCFA requirements. 
Further, the existing HCFA requirements have not ensured that health 
care facilities adopt the elements of an effective infection control 
and have not prevented outbreaks of TB in this workforce.
    One small entity representative to the SBREFA Panel suggested that 
the OSHA regulation might conflict with state and local requirements 
for skin testing and for tracing contacts of active cases of TB (Ex. 
12). OSHA has considered this suggestion and believes there is no 
conflict. Some states do have rules covering TB testing and contact 
tracing, but most states do not. In 1993, only 18 states had 
requirements for TB screening of employees in medical facilities, and 
only 23 states had testing requirements for nursing home employees. 
Further, these requirements are sometimes not as stringent as those 
OSHA is proposing; for example, some states require only an initial 
skin test. Although 49 states require the investigation of reported 
cases of TB, only 29 states require contact tracing by health 
departments. In states where local health departments provide contact 
tracing, such contact tracing would constitute compliance with OSHA's 
requirements for contact tracing by employers. Employers merely need to 
assure that contact tracing takes place; they need not do the contact 
tracing themselves if others are available to do this job for them. 
Thus, there is no conflict between the OSHA standard and existing state 
requirements, nor do existing state laws obviate the need for a 
standard that requires TB testing of exposed employees and the 
investigation of reported TB exposures. However, OSHA solicits comment 
on the interaction of state rules regarding testing and tracing and the 
proposed standard.
    One small entity representative was concerned with how medical 
removal protection and worker compensation programs would interact (Ex. 
12). Medical removal protection requires that workers receive full 
salaries, full benefits, and no loss of job position or seniority while 
the employee is unable to work, or unable to work at his/her usual 
position, as a result of incurring an occupational case of TB. The 
purpose of medical removal protection is to assure that workers provide 
timely and accurate information to their employers concerning their 
medical symptoms. In the absence of medical removal protection, workers 
have financial and job security incentives to avoid reporting symptoms. 
OSHA counts any payments workers receive from workers' compensation 
toward the goal of assuring medical removal protection; that is, 
employers may deduct from the amount they pay out to the worker any 
monies paid to the ill worker by workers' compensation. Workers' 
compensation is not an adequate substitute for medical removal 
protection because workers' compensation does not fully replace lost 
wages and provides no guarantee of maintenance of seniority, job 
security, current position, or non-wage benefits. Medical removal 
protection requires the employer to provide any of these elements that 
are not a part of workers' compensation. Thus, the employer of a worker 
already receiving workers' compensation would need to provide an 
additional salary increment in order to restore the employee's full 
salary and would need to provide the worker his or her full non-wage 
benefits.
    One small entity representative expressed concern over a possible 
conflict between the proposed rule and Federal Confidentiality 
Regulations covering chemically abusive or dependent clients 
participating in licensed and federally-funded programs [Ex. 12]. These 
regulations prohibit disclosing information regarding the 
identification of a patient as a substance abuser without the patient's 
consent. This representative noted that, without patient consent, a 
disclosure may be made only to medical personnel to meet a situation 
that has been declared a medical emergency by the Surgeon General. This 
small entity representative was referring to Public Health regulations: 
Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR 2, 
and a similar state statute: Confidentiality of Records, Minnesota 
Statute 254A.09. Both the Federal Confidentiality Regulations and the 
state statute cover records that would identify a patient as an 
alcoholic or drug abuser or concern his or her prognosis, diagnosis, 
treatment, attendance, status or physical whereabouts. No requirements 
of the standard would require the disclosure of records of this kind. 
These are not the kinds of records that are relevant to determining 
whether an individual has suspect or confirmed infectious TB. In 
addition, a medical referral for the client who is exhibiting signs and 
symptoms of TB can be made without revealing any of the prohibited 
confidential information. Moreover, in the case of an exposure 
incident, the identity of the individual with suspected or confirmed 
infectious TB need not be told to employees. Records maintained by 
employers on their employees are not covered by the regulations or 
statute, but would be subject to the same confidentiality requirements 
that govern all medical records. The identification and notification 
requirements in the proposed TB standard are the minimum necessary to 
prevent transmission of TB to employees. The contagious nature of the 
disease mandates early detection and early monitoring of individuals 
who have had an exposure incident.
    One small entity representative to the SBREFA Panel expressed 
concern over possible interactions between the proposed standard and 
the Family and Medical Leave Act (FMLA) (Ex. 12). The Family and 
Medical Leave Act does not provide for leave with pay, and does not 
guarantee the continuation of any benefits other than health insurance. 
Further, the Family and Medical Leave Act covers a more limited 
timeframe (12 weeks) than the proposed standard's medical removal 
protection provisions (18 months). Thus, the only overlap between the 
proposed standard and the FMLA would occur in the area of health 
insurance benefits in the first 12 weeks of the worker's absence from 
work. Since the standard would specifically allow the employer to 
deduct from medical removal protection benefits any benefits paid to 
the worker from other sources, employers would not pay for the same 
benefits twice.
    One small entity representative felt that the Americans with 
Disabilities Act (ADA) may offer protection to the ``worker who becomes 
ill as a result of an occupational exposure or who cannot work because 
of an inability to wear a PR [respirator].'' (Ex. 12) The ADA prohibits 
employers of 15 or more employees from discriminating, because of the 
disability, against a qualified individual with a disability with 
regard to terms, conditions and privileges of employment. An employer 
must provide reasonable accommodation for known physical or mental 
limitations for a qualified individual with a disability, unless 
accommodation can be shown to impose undue hardship on the employer. 
OSHA representatives noted that there is no conflict between an OSHA 
standard and the ADA requirements prohibiting discrimination. The ADA 
says that:


[[Page 54224]]


    Nothing in this Act shall be construed to invalidate or limit 
the remedies, rights and procedures of any Federal law * * * that 
provides greater or equal protection for the rights of individuals 
with disabilities that are afforded by this Act. 42 U.S.C.A. 
12201(b).

Further, the ADA would not provide the same protections as medical 
removal protection. In order for an employee to take advantage of the 
provisions of the ADA, certain conditions must be met. For example, the 
employee must work for a covered employer and be a qualified individual 
with a disability, i.e., one who can perform his or her job with or 
without reasonable accommodation. Thus, while the ADA may offer some 
protection to an employee who has or is suspected of having infectious 
TB or who cannot work because he or she cannot wear a respirator, the 
protection proposed to be provided by the OSHA standard for TB is more 
comprehensive and will lead to greater participation in the entire 
medical surveillance program. The OSHA proposed standard, in paragraph 
(g)(5)(ii), would provide to the employee with suspected or confirmed 
infectious TB:

* * * his or her total normal earnings, seniority, and all other 
employee rights and benefits, including the employee's right to his 
or her former job status * * * until the employee is determined to 
be noninfectious or for a maximum of 18 months, whichever comes 
first.

For each employee who must be removed for his or her job because he or 
she cannot wear a respirator (paragraph (g)(5)(iii)), the employer is 
required to:

transfer the employee to comparable work for which the employee is 
qualified or can be trained in a short period (up to 6 months), 
where the use of respiratory protection is not required [and] * * * 
maintain the total normal earnings, seniority, and all other 
employee rights and benefits. If there is no such work available, 
the employer shall maintain the employee's total normal earnings, 
seniority, and all other employee rights and benefits until such 
work becomes available or for a maximum of 18 months, whichever 
comes first.

    OSHA's MRP provisions provide each employee, who must be medically 
removed, with the level of protection that is needed to assure that the 
employee promptly reports his or her symptoms of TB (which makes the 
workplace safer for all employees) and reports his or her difficulty 
with wearing a respirator (which makes the workplace safer for that 
employee).

Significant Alternatives to the Rule Considered by OSHA

    This section first considers alternatives that OSHA was urged to 
consider by the SBREFA Panel and then turns to other alternatives 
considered by the Agency.

Alternatives Suggested by SBREFA Panel Members

    Small entity representatives and SBREFA Panel members suggested a 
wide variety of possible clarifications and alternatives to the 
regulation. In response to these suggestions, OSHA has made a number of 
changes to the regulation, clarified the meaning of many sections of 
the rule, provided additional analysis, and added tables to the 
Preamble designed to clarify the requirements of the rule in various 
situations. A full discussion of OSHA's responses to all of the SBREFA 
Panel recommendations is given in the next section. This section only 
presents alternative approaches to the proposed rule and a discussion 
of the extent to which OSHA has adopted these alternative approaches. 
OSHA welcomes comments on these and other alternatives and on ways OSHA 
could adopt additional aspects of these alternative approaches and 
still meet the requirements of the OSH Act, particularly that Act's 
requirement to control significant risk to the extent feasible.
Less Stringent Trigger Mechanisms for the More Burdensome Portions of 
the Standard, Including Raising the Zero-Case Per County Per Year 
Trigger
    OSHA has re-examined each provision of the proposed standard to 
ensure that it is necessary and appropriate to reduce risk. In the 
draft of the proposal reviewed by the Panel, OSHA required that a 
facility would only be eligible for the reduced TB control program 
requirements of Appendix A if the facility did not treat TB patients 
and if there had been no cases of TB in the county or the facility in 
the previous year. In its review, OSHA found that applying the 
standard's Appendix A requirements to facilities in counties with no TB 
cases in one of the last two years and fewer than 6 TB cases in the 
other of the last two years would not substantially increase the risk 
to employees in facilities located in such counties. This change from 
the trigger OSHA originally considered increases the number of counties 
qualifying for the Appendix A program from 43 percent to 55 percent of 
all U.S. counties.
Consider Allowing Portability of Training
    The draft proposal reviewed by the SBREFA Panel required that all 
new employees be provided complete training. OSHA has examined its 
training provisions and decided that the non-site-specific components 
of training, such as training in the difference between tuberculosis 
infection and disease, can be transferred between employers without 
reducing the protection such training affords employees.
Do Not Require Annual Retraining
    The draft proposal reviewed by the SBREFA Panel required annual 
retraining of all employees. OSHA believes that some method of assuring 
continuing competency is necessary, and that one-time training will not 
provide such assurance. However, the proposal now would allow employers 
to develop methods of assuring the competency of their employees, such 
as asking them questions about procedures, controls, etc., as an 
alternative to retraining. This change in the regulation will result in 
cost savings of $20 million per year.
Cooperative Initiatives, Such as Expanding OSHA's Current Cooperative 
Initiative With JCAHO
    Some Panel members felt that cooperative initiatives could 
substitute for regulation in some areas. As noted above, however, in 
the absence of an OSHA standard, HCFA (and accrediting associations 
working with HCFA, such as JCAHO) does not have the authority to 
enforce specific infection control requirements. As a result, a 
cooperative initiative alone would leave employees exposed to TB in 
hospitals, who account for 13 percent of the active cases of TB 
projected to be prevented by the standard, without any new initiative 
designed to prevent these active cases of TB. If this approach were 
extended to nursing homes, and all nursing homes chose to be 
accredited, then 70 percent of the active cases of TB projected to be 
prevented by the standard would be denied coverage. Thus, OSHA does not 
feel that cooperative initiatives, even with accrediting organizations, 
can substitute for regulation.
    Others suggested that OSHA could turn over enforcement of any TB 
regulation to HCFA, JCAHO or another accrediting or standards 
organization. In the eyes of its proponents, the suggestion that others 
could enforce OSHA's regulation has several major advantages. First, it 
would assure regular and more frequent inspections at health care 
facilities and nursing homes than OSHA alone could provide. Second, it 
would require health care facilities and nursing homes to deal only 
with a single inspection for infection control procedures, rather than

[[Page 54225]]

inspections by two different federal agencies. Third, these 
organizations may have greater penalty powers than OSHA, in that denial 
of HCFA acceptance or of accreditation can result in a health care 
facility losing significant funding or even being required to close.
    For several reasons, providing exclusive HCFA enforcement of OSHA's 
TB requirements is an unsound approach. First, OSHA inspectors already 
inspect health care facilities, just as they inspect any other facility 
covered by the OSH Act, for possible violations of any OSHA 
requirement, e.g., safety as well as health requirements. The need for 
these OSHA inspections would not change even if HCFA or accrediting 
agencies enforced OSHA's TB requirements. Second, OSHA does not believe 
that it is legally appropriate under the OSH Act to tell its inspectors 
that, when they inspect health care facilities, they must ignore 
violations of the Agency's occupational exposure to TB requirements. 
Third, OSHA also cannot legally ignore employee complaints relating to 
occupational exposure to TB. For all of these reasons, OSHA believes 
that exclusive enforcement of the rule by HCFA or by agencies, such as 
JCAHO, that are authorized to provide accreditation, is not an 
appropriate or legally defensible approach.
    However, OSHA does favor expanding its cooperative agreements, such 
as the current agreement with JCAHO, in any ways that both agencies 
agree would be beneficial, and OSHA is currently pursuing this option. 
On August 5, 1996, OSHA and JCAHO announced a 3-year partnership to 
promote health and safety for healthcare workers. This partnership will 
help health care facilities to meet accreditation expectations and OSHA 
compliance requirements. The initiatives of this partnership will 
include cataloging and evaluating duplicative compliance activities; 
undertaking cross-education and training of JCAHO and OSHA staff on 
corresponding requirements that relate to the management of worker 
safety and health; and developing a series of collaborative 
publications and user education programs.
A Federal-State Government Public Health Partnership to Develop 
Guidelines in Various Industry Sectors
    The CDC is already charged with developing guidelines for the 
control of TB, and has already issued guidelines for correctional 
institutions, laboratories, health care facilities, long-term care 
facilities for the elderly, and homeless shelters. In fact, OSHA has 
made extensive use of these guidelines in developing its proposed 
occupational exposure to TB standard. OSHA feels that the CDC 
guidelines alone have not served adequately to protect TB-exposed 
workers, however. OSHA research indicates that the CDC guidelines are 
not being followed in most facilities, and believes that this is the 
reason that occupational exposure to TB remains such a serious problem 
in this country. In Chapter VII of the analysis, OSHA shows that these 
guidelines are not being followed and explains why many employers have 
little economic incentive to implement these guidelines.
Performance Standards Developed With the Assistance of Federal, State, 
and Local Government, and Labor and Industry
    OSHA feels that its standard is a performance oriented standard 
that has benefited from both CDC's expertise and from many stakeholder 
meetings (which include representatives of other federal, state and 
local government agencies, labor, and industry) and the SBREFA Panel 
Process.
    OSHA's proposed standard is performance oriented in a variety of 
ways. For example, OSHA does not specify procedures by which facilities 
must achieve AFB isolation, but instead allows any workable design. 
Similarly, OSHA sets performance criteria for respirators, but does not 
specify the types of respirators that must be used. OSHA does specify 
procedures for identification of suspect cases, but allows any method 
that assures that persons with the appropriate symptoms are identified 
as suspect cases. However, OSHA did not consider it appropriate to 
specify performance in terms of rates of TB cases or TB skin test 
conversions. Such an approach is not preventive, in that application of 
proper procedures would only occur after TB infection had occurred. 
Furthermore, most smaller facilities do not have enough TST conversions 
for statistically meaningful trends to be established. OSHA requests 
comments on this issue.
    Some proponents of this approach feel that OSHA's proposed standard 
may not reflect the best ideas for controlling occupational exposure to 
TB and argue that stakeholder meetings would be a useful way of 
developing a better approach. OSHA held five stakeholder meetings 
involving representatives from more than thirty interested 
organizations. Furthermore, the CDC has made use of the best expertise 
in the country in developing its guidelines, and OSHA has adopted most 
elements of these guidelines and will hold public hearings on the 
standard at which interested parties can present their views. OSHA 
welcomes comments about alternative approaches to reducing occupational 
exposure to TB, particularly suggestions concerning more performance 
oriented approaches, but feels that this proposal is the result of an 
extensive review of the literature and of input from stakeholders on 
the available prevention and control methods and should be issued as a 
proposal at this time to prompt further discussion and exchange of 
information. OSHA is particularly interested in alternative methods of 
identifying suspected cases of TB and in whether the proposed 
requirements would preclude or impede programs that employers have 
found to be effective.
Separate Approaches for Health and Non-Health Industries The Approach 
for Health Industries Should Be Keyed to Existing Industry Standards 
and That for Non-Health Industries to Guidelines
    This suggested alternative incorporates several concepts. First, it 
assumes that the health and non-health care sectors should be given 
separate treatment because of differences in existing regulations and 
expertise. OSHA agrees that sectors that differ in relevant ways should 
be given different treatment, and the standard therefore has provided 
for different approaches to different sectors. For example, OSHA's 
standard does treat facilities that treat TB patients differently from 
the way it treats those that transfer TB patients out of their 
facilities, and treats employers whose employees are routinely in 
contact with client populations with high rates of infectious TB (such 
as homeless shelters and drug abuse treatment centers) differently from 
employers whose employees only come into contact with infectious TB 
cases on an occasional basis (such as attorneys and social workers).
    Second, this alternative posits that the health care sector is 
already subject to an extensive regulatory system with respect to 
occupational exposure to TB. Although some states have laws on contact 
tracing and skin testing, and HCFA inspects infection control systems 
in hospitals and long-term care facilities for the elderly, there are 
no existing enforceable standards aimed specifically at occupational 
exposure to TB. Thus OSHA's proposed provisions with respect to 
preventive measures have no equivalent in existing regulations, and 
only a limited number of states require skin testing of the kind OSHA's 
proposed standard requires. OSHA (and CDC) believes that these

[[Page 54226]]

provisions are essential to any program to control occupational 
exposure to TB. Third, proponents of this alternative believe that the 
non-health care sectors, particularly those engaged in charitable work 
such as homeless shelters, are better approached through guidelines 
than regulations. OSHA believes that there is relatively little need to 
develop guidelines for non-healthcare sectors, such as correctional 
institutions and homeless shelters, because such guidelines already 
exist and have not been implemented in many, if not most, facilities. 
Some proponents of this approach believe that the failure of non-health 
care sectors to implement existing guidelines is due to the absence of 
outreach and information. OSHA is not substituting a system of 
regulation for a system of outreach. OSHA intends to continue a program 
of outreach on occupational TB, and hopes that facilities in all 
sectors will adopt appropriate policies before the regulation is 
finalized. However, given that even in the relatively knowledgeable 
health care sector, implementation of the CDC guidelines has been 
limited, it is unlikely that outreach alone can assure the full 
implementation of suitable measures for control of occupational 
exposure to TB.
Different Levels of Requirements for Different Industries, Depending on 
Their Expertise, Resources, and Risk
    OSHA's proposed standard recognizes three levels of risk and 
provides separate treatment for employers engaged in different kinds of 
activities, where those differences are relevant to the purposes of the 
standard. This subject is discussed in the next sections. Such 
tailoring, however, must be consistent with the mandate of the 
Occupational Safety and Health Act to reduce significant risk to the 
full extent feasible. OSHA has preliminarily found all of the 
standard's provisions to be technologically and economically feasible, 
within the meaning of the Act, for facilities in all affected 
industries. (The special potential problems of homeless shelters and 
substance abuse treatment centers are discussed further below.) The 
statutory requirement to eliminate significant risk to the extent 
feasible means that if inadequate resources and expertise would make 
any provision of the proposed standard infeasible, then OSHA would have 
to consider alternative approaches. However, it also means that the 
resources and expertise that are feasible for an employer to acquire 
must be employed if they will reduce significant risk.
Separate Standards for Each Affected Industry
    Proponents of this alternative had two goals: first, to assure that 
OSHA gave full consideration to the circumstances of each affected 
industry, and second, to make the standard easier to follow for 
affected small entities. With respect to the first goal, OSHA has 
recognized a wide variety of distinctions in risk of exposure and 
practice among affected employers. Some of these differences follow 
industry lines. Accordingly, the proposed standard includes special 
provisions for laboratories and home health care providers. However, 
most of the relevant differences among employers do not strictly follow 
industry lines, and attempts to write separate standards for different 
industries would not significantly reduce the complexity of the 
regulation. For example, all industries need to realize that different 
requirements are applicable for each of three types of risk of 
exposure. Similarly, the applicability of certain requirements depends 
on whether TB patients are treated onsite and on whether certain 
hazardous procedures are performed. While, for example, the typical 
nursing home would not treat TB patients or perform high hazard 
procedures on site, some might, and thus these provisions would need to 
be included in an industry standard written for nursing homes. OSHA's 
proposed standard carefully distinguishes a variety of activities that 
may occur in different industries and has different requirements for 
each activity. Although this makes the standard somewhat more complex, 
this approach is essential to avoid a ``one size fits all'' standard. 
In addition, as presented in the discussion of the scope in the Summary 
and Explanation of the Preamble, OSHA has developed charts showing the 
requirements of the proposed standard that are applicable to each 
industry. OSHA welcomes any suggestions on ways to make the standard 
easier to understand, or on ways to adapt the standard to the situation 
of specific industries while reducing significant risk.
Revise the Proposed Standard for Consistency With CDC Guidelines
    The issue of how the CDC Guidelines fit into a regulatory scheme to 
prevent or reduce occupational exposure to TB has been considered by 
OSHA and other reviewers. OSHA's view is embodied in the proposed 
standard, in which the Agency has attempted to translate the CDC's 
recommendations into enforceable regulatory language that can be 
applied to a variety of occupational settings where the risk of 
transmission of TB is significant. The Agency believes that, in 
addition to the basic difference between a ``guideline'' and a 
``regulation,'' there are only three general areas where the proposed 
standard differs substantially from the CDC Guidelines for health care 
facilities: the use of site-specific risk assessment, the frequency of 
skin testing in certain situations, and the required use of respiratory 
protection around unmasked individuals with suspected or confirmed 
infectious TB. Several small entity representatives, along with some 
SBREFA Panel members, have suggested that the Agency consider allowing 
employers to follow the CDC Guidelines as an additional option to 
comply with the OSHA standard.
    Both the OMB and SBA Panel representatives believe that for at 
least some of the work sites OSHA has proposed to cover, the CDC 
Guidelines currently provide an adequate measure of protection. They 
believe it would be burdensome for employers who are already in 
compliance with the Guidelines to have to become familiar with the OSHA 
proposal and to implement its provisions. These employers have already 
invested in a TB prevention and response program consistent with the 
Guidelines. In other words, the employers have conducted their risk 
assessments, implemented the suggested provisions and trained their 
workers to comply. Moreover, these reviewers point out that where the 
Guidelines have allowed for discretion on the part of the employer as, 
for example, where an employer may first consider the symptoms 
specified in the several CDC Guidelines' definition of ``suspected 
infectious TB'' before adopting a definition for his or her own work 
site, prevention of the transmission will more easily be achieved 
because the employer is allowed to tailor the requirements to actual 
conditions in his or her workplace. To assure that the employer's 
adoption of the CDC Guidelines is effective, these reviewers 
recommended that the employer assert or certify that he or she is in 
compliance and, if challenged in an OSHA inspection, prove the efficacy 
of his or her program through a performance measure, such as skin test 
conversion rates. These reviewers believe that this approach will 
result in a more efficient use of scarce health resources.
    OSHA agrees that the various CDC Guidelines are the most important 
sources for setting an occupational health standard that will reduce or 
prevent the spread of TB. However, although certain facilities adhere 
to the

[[Page 54227]]

Guidelines, OSHA's research has shown that most facilities have not 
fully implemented the CDC recommendations. TB remains an occupational 
hazard, and OSHA has preliminarily concluded that the risk of 
transmission of TB to employees is significant. OSHA believes there are 
a number of reasons why the Guidelines cannot take the place of an OSHA 
standard. First, the Guidelines are not written in language that can be 
enforced. For example, the Guidelines suggest, recommend and set forth 
what an employer could or should do, not what he or she must do. Unless 
the Guidelines are converted to regulations, an employer may adhere to 
some applicable recommendations while not implementing others, which 
could result in uneven and inadequate employee protection. OSHA 
standards are written in mandatory language, letting employers and 
employees know what they have to do in order to be in compliance with 
the regulation. This permits an employer, an employee or a compliance 
officer to determine easily whether an entity is in compliance with a 
standard. Second, the establishment-specific risk assessment approach 
of the Guidelines imposes a tremendous paperwork burden on covered 
entities and requires a level of professional expertise in risk 
assessment that few entities outside of large hospitals possess. OSHA 
believes that recommendations or regulations that necessitate this 
level of expertise could make it difficult to determine if an entity is 
in compliance. Third, OSHA knows of no objective criterion that could 
be reliably used as a measure of proof of an effective program. 
Tuberculin skin testing has been suggested as a means of proving 
compliance with the CDC Guidelines, e.g., zero conversions would be 
accepted as proof that an entity was complying with the Guidelines. 
However, the use of conversions as a compliance measurement has two 
problems. First, skin test conversions are not necessarily indicative 
of implementation of the Guidelines' recommendations. For example, an 
entity may have implemented very few of the Guidelines' 
recommendations, yet been fortunate enough to experience no 
conversions. Therefore, compliance with the Guidelines' recommendations 
has not been achieved even though there have been no employee 
conversions. Furthermore, while an increase in the number of 
conversions indicates employee exposure, a lack of conversions does not 
necessarily mean that employees are not being exposed. For example, 
some employees have already skin-tested positive, not all exposures 
result in conversions, and many entities will not have enough TST-
negative employees to generate sufficient statistical power to 
accurately determine an increased conversion rate. With regard to this 
last point, the CDC states:

    A low number of HCWs in a specific area may result in a greatly 
increased rate of conversion for that area, although the actual risk 
may not be significantly greater than that for other areas. Testing 
for statistical significance (e.g., Fisher's exact test or chi 
square test) may assist interpretation; however, lack of statistical 
significance may not rule out a problem (i.e., if the number of HCWs 
tested is low, there may not be adequate statistical power to detect 
a significant difference). Thus, interpretation of individual 
situations is necessary. (Ex. 4B)

Second, OSHA believes that reliance on number of TST conversions as a 
performance measure is reactive rather than proactive, because it 
emphasizes the identification of employees who have already incurred a 
status change as a result of an exposure instead of averting exposures.
    OSHA believes that compliance with the proposed standard by all 
affected facilities within the covered sectors is the way to assure 
that employees will be protected from occupational transmission of TB. 
The Agency believes that compliance will not be difficult for employers 
who have already implemented the Guidelines, because many of the 
elements of the Guidelines have been incorporated into the proposed 
standard. Also, employers who are not in compliance with the Guidelines 
will find that the standard gives them clear instructions on what to 
do. In addition, the structure of OSHA's proposed TB standard is 
similar to that of the Bloodborne Pathogens standard (BBP). Since the 
vast majority of workplaces that will be covered by the TB standard are 
subject to BBP, becoming familiar with and implementing the 
requirements of the TB standard should not be difficult.
    Another issue raised in the review process was what would happen 
if, after the OSHA standard was promulgated, the CDC issued a new 
guideline that was different from the OSHA standard on an item 
addressed by the standard. OSHA believes this is already addressed by 
OSHA's citation policy, in particular, the policy for De Minimis 
Violations, which states that violations of standards which have no 
direct or immediate relationship to safety or health are not to be 
included in citations. An example of a de minimis violation occurs when 
an employer complies with a proposed OSHA standard or a consensus 
standard rather than with the OSHA standard in effect at the time of 
the inspection and the employer's action clearly provides equal or 
greater employee protection [OSHA Field Inspection Reference Manual, 
Instruction CPL 2.103, September 26, 1994]. In cases where an employer 
is complying with another provision, such as a consensus standard, the 
Agency looks at the consensus standard to make sure the consensus 
standard is at least as protective as the OSHA standard. Because CDC 
Guidelines reflect the views of many of the country's leading experts 
and practitioners in public health measures to prevent the spread of 
TB, the updated CDC Guidelines can be assumed to provide equal or 
greater protection against occupational transmission of TB to 
employees. Because these guidelines carry great authority, the De 
Minimis Violation policy would not only be a defense, but would be 
accorded such deference that OSHA would incur a heavy burden in showing 
that an updated CDC guideline on an item addressed by the OSHA TB 
standard did not provide equal or greater protection against 
occupational transmission of TB to employees. In order to ensure that 
the new CDC Guidelines would be communicated to the OSHA Regions and 
others who would need to know, OSHA will issue a Memorandum for 
Regional Administrators that will address how the new Guideline could 
be implemented in the work place, include a copy of the new Guideline, 
and instruct the Regional Administrator to contact area offices and the 
OSHA state designees. In addition, the Memorandum would be posted on 
the OSHA Computer Information Service (OCIS) and OSHA CD-ROM, which are 
accessible to the public.
    OSHA seeks comment on all issues related to the CDC Guidelines, 
particularly whether they could be implemented in lieu of an OSHA 
standard and, if so, how compliance and efficacy could be determined.
Change the Approach to the Identification of Suspect Cases for Homeless 
Shelters or Substance Abuse Treatment centers
    The SBREFA Panel found that ``Given the current definition of 
suspect cases, it is not clear that homeless shelters can comply fully 
with the standard. Accordingly, OSHA should reexamine the definition of 
suspect cases and/or reexamine its approach to homeless shelters.'' The 
SBREFA Panel also noted that this same finding might be relevant to 
substance abuse treatment centers. The Panel arrived at this finding as 
a

[[Page 54228]]

result of statements made by small entity representatives from the 
homeless shelter sector. Small entity representatives concerned with 
homeless shelters had serious problems with OSHA's definition of a 
suspect case and questioned the feasibility of screening the homeless 
by using questions about symptoms. Mr. Wayne Anderson of the National 
Health Care for the Homeless Council argued that OSHA's definition of a 
suspect case would result in the identification of most of the homeless 
as suspect cases during the winter months. Major Dalberg of the 
Salvation Army found OSHA's definition of a suspect case confusing and 
ambiguous, and stated that it would cover a substantial portion of the 
homeless. All three small entity representatives from this sector 
questioned whether the standard's screening procedures were workable in 
the homeless shelter context. They asserted that the homeless might 
avoid screening questions, be unable to answer them, learn how to lie 
in response to such questions, or choose to remain on the street rather 
than be transferred to a hospital. The small entity representatives for 
this sector felt that this portion of the standard should be abandoned. 
Because substance abuse treatment centers serve a similar clientele, 
the Panel was concerned that the same problems might apply to substance 
abuse treatment centers.
    To address this issue, and other issues related to the feasibility 
of the proposed standard for homeless shelters, OSHA has decided to 
hold special sessions during the public hearings on the proposed 
standard and to study these issues further through an onsite survey of 
a number of homeless shelters. The study will address the following 
issues:
     Percentage of homeless persons that would be identified by 
OSHA's definition of a suspected infectious TB case. (Breakdown of 
which symptoms are particularly common so a better definition might be 
designed.)
     Turnover among the homeless who use shelters.
     Employee turnover in homeless shelters.
     Trends in number of homeless persons served in shelters.
     Criteria currently used by some homeless shelters to 
identify suspected infectious TB cases.
     Current practices used in homeless shelters to address the 
TB hazard (baseline compliance with the draft proposed standard).

--Methods of isolation.
--How suspected TB cases are handled.

     Feasibility of having hospitals provide cards to the 
homeless indicating TB skin test status.
     Number of TB skin test conversions and active cases among 
the homeless and homeless shelter employees.
     Types of benefits offered to homeless shelter employees 
(e.g., health insurance).
     Economic feasibility:

--Costs of running a shelter.
--Revenue sources.
--How costs are accommodated as the number of homeless persons served 
increases.
--Opportunities for cost pass-through.

     Number, location and types (e.g., family-oriented, walk-
in, all-male) of homeless shelters.
     Number or proportion of homeless shelter workers who are 
unpaid volunteers.
    The study will also address the issue of volunteers. The OSH Act 
applies to employees, not bona fide volunteers; however, OSHA 
understands that some states may, as a matter of state law, require 
facilities to provide volunteers with the protections established by 
OSHA standards. Thus, OSHA's study will address the following issues:
     Economic impacts, in such states, of covering volunteers 
(e.g., how costs would be handled, cost pass-through opportunities).
     Protections currently offered to volunteers.
    The results of the study will be made available for comment in the 
public record.
    OSHA does not feel that the same problems apply to substance abuse 
treatment centers, even if a high percentage of clients might be 
defined as suspect cases. Inpatient substance abuse treatment centers 
routinely provide some form of entrance physical: this would be an 
appropriate time to screen for suspect cases and provide for their 
referral.
    Outpatient substance abuse treatment centers do not provide any 
form of shelter for patients, and thus could readily refer suspect 
cases to a hospital without either denying them shelter or having to 
pay for the referral. Such a facility could simply insist that suspect 
cases not return without data showing that they had been to a doctor 
and did not have TB. Since outpatient facilities handle a known 
population, such an approach might involve high initial referrals, but 
could thereafter settle into a system that checked for suspect cases on 
entry to the program.
    OSHA estimates that the proposed standard will result in a 
reduction of 28 to 33 active disease cases and 2 to 3 deaths per year 
in the homeless shelter sector. A standard requiring skin testing and 
follow-up treatment alone would have only one third the benefits (such 
an approach would reduce the number of active disease cases to only 10 
per year and the number of lives saved to 1 per year). The annual costs 
of the proposed standard for homeless shelters are estimated to be 
$11,287,278, or approximately $1,080 per shelter per year.
    OSHA solicits comments on all of the issues listed above to be 
covered by its study of homeless shelters, and solicits comment on the 
feasibility of the standard for substance abuse treatment centers, and 
particularly on the extent to which substance abuse treatment centers 
already provide for medical examinations prior to entry into their 
programs.
Other Alternatives Considered by OSHA
    OSHA considered several additional alternatives but has 
preliminarily concluded that the proposed rule will better carry out 
the objectives of the OSH Act, while minimizing the economic impact on 
affected establishments, and especially on small establishments. OSHA 
requests comment on the validity of this preliminary conclusion. First, 
OSHA considered making all of the proposed requirements applicable to 
every establishment in the covered industries. The prevalence of TB, 
however, varies by geographical areas and by the populations served by 
facilities in different industries. OSHA therefore believes it will be 
possible to reduce significant risk without imposing the full 
regulatory requirements on each covered employer. Second, OSHA 
considered proposing requirements similar to the CDC's guidelines, 
which recommend that risk assessments be conducted to determine the 
level of risk in each facility and that the controls implemented vary 
in accordance with the level of risk in each facility. This would 
require that employers conduct risk assessments by evaluating factors, 
such as the number of suspected or confirmed TB cases among patients 
and employees, employee tuberculin skin testing results, and the amount 
of TB in the community. The CDC recommendations include five levels of 
risk (i.e., minimal, very-low, low, intermediate, and high), and the 
recommended controls vary by the level of risk. However, adopting such 
a requirement in the OSHA standard would impose a large cost and a 
heavy paperwork burden on affected facilities.
    To avoid imposing unnecessary burdens on facilities where the risk 
of

[[Page 54229]]

occupational exposure to M. tuberculosis may be lower, OSHA is 
proposing to exempt facilities from certain requirements (i.e., 
respiratory protection, annual medical histories, and annual skin 
tests) if the facility transfers, instead of admits, individuals with 
suspected or confirmed infectious TB and can additionally demonstrate 
that there have been (1) no reported confirmed infectious TB cases in 
the county within one of the last two 12-month reporting periods; (2) 
fewer than 6 infectious cases of TB in the other 12-month reporting 
period; and (3) no infectious cases of TB encountered within their 
employees' work settings within the past 12 months.
    OSHA also considered proposing a requirement that facilities 
implement engineering controls in all intake areas in which early 
identification procedures are performed, if the facility had 
encountered six or more individuals with confirmed infectious TB in the 
past 12 months. The engineering controls considered were single-pass 
ventilation, filtration of air through the use of HEPA filters 
installed as part of the ventilation system, or stand-alone auxiliary 
HEPA filtration units. However, areas where early identification 
procedures are performed vary widely in size and configuration, making 
it difficult to assess the effectiveness of such controls in reducing 
the risk of occupational exposure to M. tuberculosis in a particular 
setting. Given the high cost of such controls and the lack of data on 
their effectiveness, OSHA is not proposing such a requirement. However, 
the Agency requests comment on the potential effectiveness of such 
controls in intake areas.
    Another alternative considered was to propose that each 
occupationally exposed employee be provided with a baseline medical 
examination, including a physical examination that emphasized the 
pulmonary system and an evaluation for the signs and symptoms of active 
TB disease and factors affecting immunocompetence. However, requiring a 
baseline physical examination for all exposed employees would impose a 
heavy cost burden on affected establishments, and OSHA could find no 
evidence that providing a baseline physical examination would 
accomplish more than a baseline and annual medical history and 
tuberculin skin test in identifying or reducing occupationally induced 
TB infections. Thus, OSHA is proposing to require physical examinations 
only when they are deemed necessary by the physician or other licensed 
health care professional, as appropriate.
    OSHA also considered providing medical management and follow-up to 
each employee who had been exposed to air originating from an area 
where an individual with suspected or confirmed infectious TB was 
present. However, stakeholders contacted prior to the issuance of this 
proposal stated that a requirement for medical management and follow-up 
would impose an unnecessary burden on affected establishments for those 
cases that were suspected but were subsequently ruled out. In response 
to stakeholders' comments, the Agency is proposing that medical 
management and follow-up be provided only when an employee is actually 
exposed to an individual with confirmed infectious TB or to air 
containing aerosolized M. tuberculosis without the benefit of the 
applicable exposure control measures (e.g., respiratory protection) 
that would be required under the proposed rule.
    Another alternative considered was to require tuberculin skin tests 
every six months for all employees assigned to wear respirators. 
However, to reduce the burden on facilities that do not encounter many 
infectious TB cases, OSHA is not requiring 6-month skin testing for 
workers assigned to wear respirators and who work in the intake areas 
of facilities where fewer than six confirmed infectious TB cases are 
encountered each year.
    Rejecting these regulatory alternatives has reduced the estimated 
costs of the proposed rule by a minimum of $100 million.
    The RFA emphasizes the importance of performance-based standards 
for small businesses. OSHA considers the proposed standard to be highly 
performance oriented. The proposed standard emphasizes the early 
identification and isolation of individuals with suspected or confirmed 
infectious TB. Affected employers have been allowed wide discretion in 
the selection of procedures they use to achieve this. Without early 
identification and isolation, prevention of the spread of TB from 
patients and clients to workers is virtually impossible. OSHA has also 
limited requirements for work settings located in a county that, in the 
past 2 years, has had zero cases of confirmed infectious TB reported in 
one year and fewer than 6 cases of confirmed infectious TB reported in 
the other year. OSHA welcomes comment on other ways that the standard 
can be made more performance oriented.
    Another approach considered is compliance date phase-ins for small 
businesses. OSHA is proposing to extend the standard's compliance 
deadlines for engineering controls and has considered extending the 
compliance deadlines for the other proposed requirements; however, 
since these other requirements are not capital-intensive for most 
affected facilities, such an extension would do little to reduce the 
burden on small entities and would only result in a delay in the 
protection of workers provided by compliance with the proposed rule. 
OSHA solicits comment on the effects of extending phase-in dates for 
the other proposed requirements, particularly those for respirators, 
for small entities.
    After considering all of the above alternatives and adopting those 
that were consistent with the mandate imposed by the OSH Act, OSHA has 
developed a proposed rule that will minimize the burden on affected 
employers, while maintaining the necessary level of worker protection.
OSHA's Response to SBREFA Panel Recommendations
    Table VII-7 lists the SBREFA Panel Recommendations and OSHA's 
response to these recommendations. The complete SBREFA Panel Report is 
available for comment in the record as Exhibit 12 of Docket H-371.

     Table VII-7.--OSHA's Responses to SBREFA Panel Recommendations     
------------------------------------------------------------------------
          Panel recommendation                    OSHA response         
------------------------------------------------------------------------
OSHA should define the terms             These terms are now defined in 
 ``establishment,'' ``firm'' and          Chapter VI of the PEA.        
 ``facility'' in the IRFA.                                              
OSHA should consider analyzing           OSHA now uses the SBA          
 additional size classes of firms.        definitions of small entities 
                                          and also analyzes entities    
                                          with fewer than 20 employees  
                                          in the IRFA.                  
OSHA should clarify and more carefully   OSHA has provided tables       
 explain the requirements and engage in   illustrating requirements for 
 extensive outreach efforts to assure     groups of affected firms,     
 that the regulated community             added many clarifications to  
 understands the regulation.              the Preamble and regulatory   
                                          text, and plans extensive     
                                          outreach upon publication of  
                                          the final standard (see       
                                          Preamble Section IX).         

[[Page 54230]]

                                                                        
OSHA should reexamine the definition of  OSHA will conduct a special    
 a suspect case and/or reexamine its      study of homeless shelters.   
 approach to homeless shelters.           This study is discussed in the
                                          IRFA. OSHA will also designate
                                          certain hearing dates for     
                                          persons who wish to testify on
                                          homeless shelter issues.      
OSHA should reconsider applying the      OSHA has explained in the IRFA 
 standard to substance abuse centers.     why it thinks that its        
                                          treatment of substance abuse  
                                          treatment centers is feasible 
                                          and has solicited comment on  
                                          this issue in the Issues      
                                          Section of the Preamble.      
OSHA should more carefully address the   OSHA has added a discussion of 
 economic impacts on facilities that      this issue to Chapter VI of   
 rely on Medicaid/Medicare or             the PEA.                      
 charitable funding.                                                    
OSHA's preamble and IRFA should explain  OSHA has added a preamble      
 OSHA's role and authority as compared    discussion of why OSHA        
 to other voluntary and regulatory        regulates occupational        
 organizations; preamble should explain   exposure to TB, why other     
 ongoing cooperative efforts; solicit     organizations are unable to do
 comments on conflicts and ways of        so effectively, and how OSHA  
 better coordinating with other           has worked with other         
 organizations.                           organizations. OSHA solicits  
                                          comments on possible conflicts
                                          and better methods of         
                                          coordination.                 
OSHA should examine additional           OSHA has added a discussion of 
 alternatives, such as revising the       additional alternatives       
 proposed standard for greater            suggested by SBREFA Panel     
 consistency with CDC guidelines.         members to the IRFA and has   
                                          solicited comment on these    
                                          alternatives in the Preamble. 
OSHA should clarify that employers       OSHA has clarified this issue  
 would only be required by the standard   in the Preamble.              
 to determine the TB status of their                                    
 county once per year, rather than                                      
 monthly.                                                               
OSHA should reexamine the standard and   OSHA has modified the standard 
 the economic analysis to ensure that     to allow portability of non-  
 the issues of part-time, multi-          site specific elements of     
 employer, and off-site workers have      training and to allow         
 been adequately addressed. OSHA should   portability of skin tests. For
 also specifically address the issue of   off-site workers, OSHA has    
 portability of training. OSHA should     clarified in the Preamble that
 clarify the term ``accessibility'' in    the standard may be made      
 the context of employers with off-site   available at the primary      
 employees.                               workplace facility, provided  
                                          there is a mechanism for      
                                          immediate availability of     
                                          information during the        
                                          workshift.                    
OSHA should clarify exactly what is      The Summary and Explanation    
 required for temporary AFB isolation.    Section of the Preamble       
                                          describes temporary AFB       
                                          isolation, and OSHA's         
                                          assumptions concerning the    
                                          costs of such units are given 
                                          in Chapter V of the PEA.      
OSHA should clarify that engineering     OSHA has clarified the point in
 control provisions do not apply to       Section IX of the Preamble.   
 home health care.                                                      
OSHA should explain the differences in   OSHA has explained this        
 protection provided by surgical masks    difference in Section IX of   
 and respirators.                         the Preamble.                 
OSHA should explain the reasons for its  OSHA has discussed this issue  
 detailed respiratory protection          in the Summary and Explanation
 program, why it considers                Section of the Preamble.      
 manufacturers' instruction inadequate                                  
 as a substitute for a respirator                                       
 program, and why annual respirator                                     
 program evaluation is necessary.                                       
OSHA should explain its intent to fold   OSHA has discussed this issue  
 many aspects of respiratory protection   in the Summary and Explanation
 provisions for occupational exposure     Section of the Preamble.      
 to TB into the upcoming respirator                                     
 standard.                                                              
OSHA should explain the number of        OSHA provides an estimate of   
 employees required to have medical       the number of employees       
 surveillance in homeless shelters, the   requiring medical surveillance
 elements of a written medical opinion,   in Chapter V of the PEA. The  
 and the importance of two-step skin      regulation lists the elements 
 testing.                                 of a medical opinion. The     
                                          Preamble explains the         
                                          importance of two-step skin   
                                          testing.                      
OSHA should explain its basis for        OSHA has discussed this issue  
 believing that two-step skin testing     in the Summary and Explanation
 is appropriate for employees who have    Section of the Preamble.      
 had BCG vaccinations.                                                  
OSHA should clarify the interaction of   OSHA has addressed this        
 workers' compensation and medical        interaction in both the       
 removal protection and examine more      Preamble and the IRFA, and has
 carefully the costs and impacts of       provided a special discussion 
 medical removal protection on small      in Chapter VI of the PEA on   
 firms that actually have an employee     the economic impacts of the   
 with a serious and costly active case    medical removal protection    
 of TB.                                   provision on small firms. OSHA
                                          has solicited comment on this 
                                          issue.                        
OSHA should examine the potential cost   OSHA has modified the proposed 
 savings associated with a provision      regulation to allow           
 that allows training to be               portability of non-site       
 ``portable'' (assuming the training is   specific training and to allow
 equivalent to that required by the       employers to demonstrate      
 standard). OSHA should clarify that      employee competence rather    
 posting a copy of the standard will be   than provide annual           
 considered an adequate means of          retraining. OSHA has clarified
 providing employees with the standard.   in the Preamble that posting a
 OSHA should clarify its performance-     copy of the standard will be  
 oriented interpretations of the          considered an adequate means  
 training requirements in the Preamble,   of providing employees with   
 and OSHA should examine the need for     the standard. OSHA has        
 annual retraining for all employees.     clarified in the preamble that
                                          the training is performance   
                                          oriented and need not include 
                                          training in topics not        
                                          relevant to an employee's     
                                          duties.                       
OSHA should clarify how the              OSHA has added a discussion of 
 identification, referral, and            this issue to the IRFA and the
 notification requirements of the         Preamble.                     
 proposed standard can be met without                                   
 breaching federal and state                                            
 confidentiality regulations and                                        
 statutes.                                                              
OSHA should include a discussion of the  OSHA has added a discussion of 
 interaction between medical removal      this issue to the IRFA and the
 protection provisions and the            preamble.                     
 Americans with Disabilities Act and                                    
 the Family and Medical Leave Act.                                      
OSHA should solicit comment and request  OSHA has solicited comment on  
 data on industry turnover rates in the   this issue.                   
 Summary of the Preliminary Economic                                    
 Analysis in the Preamble.                                              
OSHA should reexamine its estimate of    OSHA has reexamined the issue  
 the number of hospices and adopt the     of the number of hospices and 
 most accurate figure.                    retained its original         
                                          estimate. OSHA has clarified  
                                          that this estimate includes   
                                          only free-standing hospices.  
                                          Hospices that are parts of    
                                          nursing homes and hospitals   
                                          are included in estimates for 
                                          those sectors.                

[[Page 54231]]

                                                                        
OSHA should clarify why family practice  OSHA has added physicians who  
 physicians were not included in the      conduct high hazard procedures
 analysis, and solicit comment on the     to its economic analysis and  
 extent to which family practitioners     has sought comment on whether 
 conduct the kind of hazardous            family practitioners commonly 
 procedures that would place them         conduct such procedures.      
 within the scope of the rule.                                          
OSHA should consider estimating the      OSHA has explained in the      
 effects of the rule on volunteers and    Preamble that the standard    
 should include a discussion explaining   does not apply to bona fide   
 that the proposed rule does not apply    volunteers. OSHA has solicited
 to volunteers, although some states      comments on states or         
 may choose to apply it to these          localities that elect to      
 categories of individuals.               extend OSHA requirements to   
                                          volunteers and on the number  
                                          of affected volunteers. OSHA  
                                          will further examine the issue
                                          of the number of potentially  
                                          affected volunteers in        
                                          homeless shelters in its      
                                          homeless shelter study.       
OSHA should solicit comment on the       OSHA has solicited comments on 
 number of small government               this issue in the Preamble.   
 jurisdictions affected by the draft                                    
 proposed standard.                                                     
OSHA should include a discussion of      OSHA has provided an estimate  
 tribal governments in its analysis and   of the number of affected     
 solicit comment on this issue.           tribal facilities and has     
                                          sought comment from tribal    
                                          governments in the Preamble.  
OSHA should remind small entities that   OSHA has solicited comments on 
 OSHA's risk assessment will be part of   several specific aspects of   
 the public record and is subject to      the risk assessment and       
 comment, and that small entities may     benefits analysis, and on     
 submit any appropriate additional        these analyses as a whole.    
 literature or studies that OSHA should                                 
 consider in determining the risk of                                    
 occupational TB.                                                       
OSHA should discuss the annualization    Chapter V of the PEA and the   
 of costs in greater detail in the        summary of the PEA in the     
 economic analysis.                       Preamble now discuss the      
                                          annualization of costs.       
OSHA should clarify its position on the  OSHA has reanalyzed the costs  
 costs and durability of various          of respirators in hospitals,  
 respirators that can be used to comply   and has added a discussion of 
 with the standard, and should seek       the uncertainties concerning  
 additional comment on the costs and      the costs and durability of   
 durability of respirators.               respirators to the PEA. OSHA  
                                          has solicited comments on     
                                          these issues in the Preamble. 
OSHA should perform further analyses to  OSHA specifically addresses    
 identify the marginal costs of medical   this issue in Chapter VI of   
 removal protection above and beyond      the PEA and has sought comment
 worker compensation, should further      on this issue.                
 assess the probability that employers                                  
 will actually incur costs for medical                                  
 removal protection if they have an                                     
 employee with an active case of TB,                                    
 and should incorporate the results of                                  
 this reexamination into its                                            
 determination of feasibility.                                          
OSHA should reassess whether affected    OSHA has further examined this 
 facilities have reasonable access to     issue, and found that affected
 facilities with AFB isolation rooms,     facilities do have reasonable 
 solicit comments on this issue, and      access to AFB isolation rooms;
 incorporate the results of this          however, OSHA is seeking      
 reexamination into its determination     comments on whether some      
 of feasibility.                          affected facilities may not   
                                          have adequate local access to 
                                          facilities with AFB isolation.
OSHA should reexamine its analysis of    OSHA has discussed this issue  
 the economic impacts of the proposed     in Chapter VI of the PEA.     
 rule on firms, such as emergency                                       
 medical services firms, that operate                                   
 under the constraint of being unable                                   
 to charge some of their clients.                                       
------------------------------------------------------------------------

VIII. Unfunded Mandates Analysis

    The proposed TB standard has been reviewed in accordance with the 
Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.) and 
Executive Order 12875. OSHA estimates that compliance with the proposed 
standard will require expenditures of more than $100 million each year 
by employers in the private sector. Therefore, the proposed TB standard 
establishes a federal private sector mandate and is a significant 
regulatory action within the meaning of Section 202 of UMRA (2 U.S.C. 
1532). OSHA has included this statement to address the anticipated 
effects of the proposed TB standard pursuant to Section 202.
    OSHA standards do not apply to state and local governments except 
in states that have voluntarily elected to adopt an OSHA State Plan. 
Consequently, the proposed TB standard does not meet the definition of 
a ``federal intergovernmental mandate'' (Section 421(5) of UMRA (2 USC 
658 (5)). In sum, the proposed TB standard does not impose unfunded 
mandates on state, local, and tribal governments.
    The remainder of this section summarizes OSHA's findings as 
required by Section 202 of UMRA (2 U.S.C. 1532):
    This standard is proposed under Section 6(b) of the OSH Act. The 
proposed standard has annualized costs estimated at $245 million and 
would save an estimated 138 to 190 lives per year as a result of TB 
infections avoided. An estimated 1,772 to 2,442 active TB cases will be 
averted annually as a result of the proposed rule. Compliance will also 
result in an estimated 24,333 to 32,719 infections averted. The 
proposed standard will impose no more than minimal costs on state, 
local or tribal governments. OSHA pays 50 percent of State plan costs 
but does not provide funding for state, local or tribal governments to 
comply with its rules.
    OSHA does not anticipate any disproportionate budgetary effects 
upon any particular region of the nation or particular state, local, or 
tribal governments, or urban or rural or other types of communities. 
Chapters V and VI of the economic analysis provide detailed analyses of 
the costs and impacts of the proposed standard on particular segments 
of the private sector. OSHA has analyzed the economic impacts of the 
standard on the affected industries and found that compliance costs 
are, on average, only 0.18 percent of sales, and that few, if any, 
facility closures or job losses are anticipated in the affected 
industries. As a result, impacts on the national economy would be too 
small to be measurable by economic models. OSHA requests information on 
state and local government issues.
    Pursuant to Section 205 of the UMRA (2 U.S.C. 1535), and having 
considered a variety of alternatives outlined in the Preamble and in 
the Regulatory Flexibility Analysis above, the Agency preliminarily 
concludes that the

[[Page 54232]]

proposed rule is the most cost-effective alternative for implementation 
of OSHA's statutory objective of reducing significant risk among 
employees to the extent feasible. OSHA solicits comment on these 
issues.

IX. Environmental Impacts

    The provisions of this proposed standard have been reviewed in 
accordance with the requirements of the National Environmental Policy 
Act (NEPA) of 1969 [42 U.S.C. 432, et seq.], the Council on 
Environmental Quality (CEQ) NEPA regulations [40 CFR Part 1500], and 
OSHA's DOL NEPA Procedures [29 CFR Part 11]. As a result of this 
review, OSHA has preliminarily determined that this proposed standard 
will have no significant effect on air, water, or soil quality, plant 
or animal life, use of land, or other aspects of the environment.

X. Summary and Explanation of the Standard

    Based on currently available data in the record, OSHA has 
preliminarily concluded that the requirements set forth in this 
proposed standard are those that are necessary and appropriate to 
provide adequate protection to employees exposed to tuberculosis (TB). 
In the development of this proposed standard, OSHA has carefully 
considered the numerous reference works, journal articles, and other 
data collected by OSHA since the initiation of this proceeding. In 
particular, OSHA has carefully considered the recommendations given in 
the document, ``Guidelines for Preventing the Transmission of 
Mycobacterium tuberculosis in Health-Care Facilities'' published by the 
Centers for Disease Control and Prevention beginning on page 54242 in 
the Federal Register of October 28, 1994 (Ex. 4B). OSHA also held a 
series of informal stakeholder meetings during the development of the 
proposal and considered the major points raised by the stakeholders 
during these meetings (Ex. 10). In addition, the proposal has undergone 
the Panel review process required by the Small Business Regulatory 
Enforcement Fairness Act (SBREFA)(5 U.S.C. Chapter 8) (Exs. 11 and 12). 
All of the information developed to assist the small entity 
representatives involved in the SBREFA panel process, the comments of 
these representatives, and the Panel's findings and recommendations to 
OSHA have been placed in the rulemaking record (Exs. 11 and 12).
    Upon publication of the final standard, the Agency will undertake a 
number of compliance assistance activities that will be particularly 
beneficial to small entities. Past compliance assistance activities 
have included: publication of booklets summarizing the provisions of 
the standard; development of a compliance directive that answers 
compliance-related questions about the standard; development of 
compliance guides directed at assisting small businesses in complying 
with the standard; designation of certain OSHA employees in each 
Regional office with the responsibility of answering questions from the 
public about the standard; development of training materials; and 
provision of speakers and information for meetings and workshops of 
affected parties (particularly small business entities). OSHA 
anticipates initiating similar activities upon publication of the final 
standard for occupational exposure to tuberculosis.

Paragraph (a)  Scope

    Tuberculosis is a well-recognized occupational hazard (Ex. 4B). As 
discussed in the Health Effects section above, there are numerous 
epidemiological studies, case reports, and outbreak investigations that 
provide evidence to show that employees who are exposed to aerosolized 
M. tuberculosis have become infected with TB and in some cases have 
developed active TB disease. Of particular concern is the emergence of 
strains of multidrug-resistant TB. MDR-TB presents an additional hazard 
because individuals with MDR-TB may be infectious for weeks or months 
until an effective drug regimen can be successfully implemented and the 
patient rendered noninfectious. This in turn increases the likelihood 
that employees who must provide health care or other services to these 
individuals will be exposed. The risk of death from infections with 
MDR-TB is markedly increased. Outbreaks involving strains of MDR-TB 
have had mortality rates as high as 75% with death occurring 4 to 16 
weeks after the diagnosis of disease (Ex. 3-38A).
    Most of the TB outbreaks investigated occurred in large 
metropolitan areas. However, a recent study has shown that MDR-TB 
spread from New York City to patients in Florida and Nevada and health 
care workers in Atlanta, Georgia and Miami, Florida and to staff and 
patients in a nursing home in Denver, Colorado (Ex. 7-259). In 
addition, a growing percentage of TB cases are occurring among the 
foreign born. CDC reported that in 1995 the number and proportion of 
cases among the foreign-born had increased 63% since 1986 (Ex. 6-34). 
These two pieces of information taken together clearly illustrate the 
relationship between population mobility and the spread of TB disease. 
Thus, TB is a nationwide problem. Although the total number of cases 
declined to its pre-1985 levels after a resurgence from 1985 to 1994, 
the rate of active TB cases reported in 1995 (i.e., 8.7/100,000) is 
still two and one half times greater than the target rate of 3.5 active 
cases per 100,000 population for the year 2000 proposed by the Advisory 
Committee on the Elimination of Tuberculosis (Ex. 6-19). In addition, 
there is substantial variability from year to year in the increases and 
decreases in the number of cases reported by each state. In 1995, all 
fifty states reported cases of TB, and fifteen of these reported 
increases over 1994 (Ex. 6-34). At the county level, approximately 57% 
of counties in the U.S. reported one or more cases of active TB, with 
17% of the counties in the U.S. reporting 5 or more cases (Ex. 7-262). 
In addition, approximately 91% of the U.S. population resides in the 
counties that reported one or more cases of active TB. Thus, while 43% 
of the counties in the U.S. reported no cases of active TB, 10% of the 
U.S. population resides in those counties. The nationwide prevalence of 
TB infection in the U.S. population in 1994 (age 18 years an older) is 
approximately 6.5 percent.
    The recent resurgences in the number of reported cases of active TB 
have brought to attention a number of problems in existing TB control 
plans. The problem is most apparent in health care facilities such as 
hospitals, but it also extends to other work settings where the 
population served is at increased risk for tuberculosis, such as 
shelters for the homeless, correctional institutions and settings where 
high-hazard procedures are performed.
    There are a number of factors that make occupational exposure to 
tuberculosis an important concern at the present time. One factor is 
that the results from OSHA's quantitative risk assessment show a high 
potential for TB infection for employees who work in close proximity to 
individuals with infectious TB. A second factor is that the cases of 
tuberculosis are not distributed evenly throughout the entire 
population. There is a relatively high prevalence of tuberculosis 
infection and disease in certain populations, such as residents of 
nursing homes and inmates of correctional institutions. A third factor 
is the rise of MDR-TB. These factors increase the risk for workers who 
have occupational exposure. Occupational exposure occurs through 
contact with air that may contain aerosolized M. tuberculosis as a 
result of the performance of an employee's

[[Page 54233]]

duties. Most often this occurs when an employee is working in the same 
environment with an individual with infectious TB. It could also occur 
when repairing air systems that may be carrying aerosolized M. 
tuberculosis. 
    Individuals with infectious tuberculosis expel airborne particles 
called droplet nuclei when they cough, sneeze, or speak. These droplet 
nuclei contain the organism that causes tuberculosis, M. tuberculosis. 
Normal air currents can keep these droplet nuclei airborne for long 
periods of time and spread them throughout a building (Ex. 5-5). When 
employees breathe the air that contains M. tuberculosis, they are at 
risk for TB infection which may result in illness and, in some cases, 
death. Employees also may be exposed when laboratory procedures produce 
aerosols of M. tuberculosis. There is an extensive discussion of the 
scientific literature related to occupational transmission in Section 
IV, Health Effects, which will not be repeated here.
    Because the CDC does not consider fomites, e.g., objects such as 
clothing or silverware, to present a hazard for transmission of M. 
tuberculosis, this standard is designed to eliminate or reduce airborne 
exposures only. Even though it is well established that exposure to TB 
contaminated air is the route of exposure related to the development of 
disease, it is not known what levels of contamination in the air cause 
the disease. Unlike toxic chemicals, a Permissible Exposure Limit (PEL) 
for air concentration of TB cannot be determined. As described in the 
Health Effects section of this preamble, it is known that a number of 
factors contribute to the probability of infection. For example, 
exposures of relatively short duration, such as a day or two, can 
result in infection of the employee. OSHA has used these findings to 
show that certain types of work, in certain industries, can result in 
significant risk of TB infection. For these reasons, OSHA is defining 
the scope of the standard by listing the locations and services where 
this proposed standard would apply. Employers with employees working at 
those locations, and employers whose employees provide the listed 
services, are covered by the standard. The proposed standard applies to 
occupational exposures to tuberculosis that occur in certain specified 
workplaces, such as a hospital, or as the result of providing services, 
such as emergency medical treatment. Paragraphs (a)(1) through (10) of 
the proposal describe the various work settings and services that are 
covered under the scope of the standard.
    Paragraph (a)(1) states that the standard applies to occupational 
exposure to TB occurring in hospitals. The record contains many 
examples of occupational exposures with resultant TB infection and 
disease that have occurred in hospitals (e.g., Exs. 5-11; 5-15; 7-43; 
7-45). Recent outbreaks involving multidrug-resistant strains of M. 
tuberculosis have compounded the long recognized risk of TB in such 
settings.
    Hospitals not only provide medical care for persons with diagnosed 
tuberculosis, they also provide medical care for individuals who may be 
at increased risk for TB. For example, hospitals provide isolation for 
individuals with suspected or confirmed infectious TB and contain rooms 
or areas where high-hazard procedures on individuals with infectious TB 
are performed that place employees at risk of exposure. In addition, 
the client population encountered in hospitals is generally at higher 
risk of developing active TB. Individuals with HIV disease, for 
example, are at increased risk for developing disease when they have 
been infected with M. tuberculosis. In addition, medically underserved 
populations with an increased prevalence of tuberculosis (e.g., 
homeless persons) may seek acute care in the emergency rooms of 
hospitals.
    Employees who are at risk for occupational exposure and potential 
infection and disease include all employees who have direct contact 
with persons with infectious tuberculosis. These may include but are 
not limited to physicians, nurses, aides, dental workers, medical 
technicians, workers in laboratories and autopsy suites, and emergency 
medical service personnel (Ex. 4B). They may also include persons not 
involved in direct patient care but who have occupational exposure as a 
result of providing other services such as dietary, housekeeping, and 
maintenance staff.
    Paragraph (a)(2) covers occupational exposure occurring in long-
term care facilities for the elderly. Persons aged 65 and older 
constitute a large repository of M. tuberculosis infection in the 
United States (Ex. 6-14). Many of these individuals were infected many 
decades ago when TB was a much more common disease. Some of the TB 
occurring in this age group arises from preexisting infection of long 
duration and other cases may be the result of recent infections. In 
addition, elderly persons residing in nursing homes are at greater risk 
than elderly persons living in the community. In its 1990 guidelines, 
``Prevention and Control of Tuberculosis in Facilities Providing Long-
term Care to the Elderly,'' the CDC cited 1984-1985 data indicating a 
TB case rate of 39.2 per 100,000 population, a rate that was twice that 
of elderly persons living in the community (Ex. 6-14). The same 
document stated that CDC had found that the increased risk for nursing 
home employees was three times higher than the rate expected for 
employed adults of similar age, race, and sex. Examples of employees in 
long-term care facilities who may have occupational exposure include, 
but are not limited to, registered nurses, licensed practical nurses, 
nursing assistants, and auxiliary personnel. OSHA has not included 
other long-term care facilities under the scope of the standard. The 
Agency requests comment and supporting data on whether it is 
appropriate to expand the scope of the standard to include other long-
term care facilities that may provide health care or other services to 
individuals who may be at an increased risk of developing infectious 
TB, thereby presenting a potential source of exposure to employees 
working in those facilities. An example of another long-term care 
facility is a psychiatric hospital.
    Paragraph (a)(3) covers occupational exposure occurring in 
correctional facilities and other facilities that house inmates or 
detainees. Facilities such as prisons, jails and detainment centers 
operated by the Immigration and Naturalization Service (INS) would be 
included in the scope of the standard. The CDC considers TB to be a 
``major'' problem in correctional institutions, with cases occurring at 
a frequency three times that of the general population (Ex. 7-25). In 
addition to a number of outbreaks that have occurred, the overall 
incidence of tuberculosis in the prison population is increasing. This 
can be attributed to, (1) the over-representation of populations at 
high risk for TB in prisons and jails, and (2) environmental factors 
that promote the transmission of TB. Compared to the general 
population, inmates have a higher prevalence of TB infection. The 
population of correctional facilities is also characterized as having a 
high prevalence of individuals with HIV infection and intravenous drug 
users, factors that place these inmates at a higher risk of developing 
active TB. In addition, many prisons and jails are old, overcrowded, 
and have inadequate ventilation. Inmates may be moved frequently within 
a facility and between facilities, increasing the number of persons, 
both inmates and employees, exposed to an infected individual and 
making contact tracing difficult.

[[Page 54234]]

Medical records and treatment information may not follow the inmate in 
a timely manner, which may, in turn, lead to inadequate drug therapy.
    Detention facilities, such as those operated by the INS, may house 
persons who are entering this country from countries with a prevalence 
of TB many times that of the U.S. population (Ex. 6-26). In addition, 
there may be a substantial number of individuals in these facilities 
currently awaiting deportation who have an additional increased risk of 
TB because they have been previously incarcerated in correctional 
institutions. In 1995, CDC reported that approximately 36% of the total 
reported cases of active TB were among the foreign-born (Ex. 6-34). 
This marks a 63% increase since 1986. In addition, among those persons 
whose records contained information on date of arrival to the U.S., 
approximately 30% developed active TB within one year of entering the 
country and approximately 53% developed active TB within 5 years of 
entering the country. Employees who may have occupational exposure in 
these facilities include, but are not limited to, correctional 
officers, physicians, dentists, nurses, and other health care workers.
    Paragraph (a)(4) covers occupational exposure occurring in 
hospices. CDC identified hospices as one of the inpatient health care 
facilities to which its 1994 TB guidelines apply. CDC's Guidelines 
recommend that individuals with suspected or confirmed infectious TB be 
managed in the same manner using similar methods of infection control 
as recommended for hospitals. Hospices serve the same high-risk 
populations that hospitals serve. In addition, individuals receiving 
hospice care may be at increased risk for tuberculosis if they are 
members of a high risk group, which includes groups whose members have 
a medical condition that increases the likelihood of developing active 
tuberculosis (e.g., HIV disease, end stage renal disease, certain 
carcinomas). Employees who may have occupational exposure include, but 
are not limited to, physicians, nurses, aides, social workers, and 
other health care workers.
    Occupational exposure occurring in shelters for the homeless is 
covered under paragraph (a)(5). Residents of shelters for the homeless 
comprise a population that is also at increased risk for tuberculosis. 
Members of this population are more likely to have risk factors that 
are associated with TB than the general population although the exact 
prevalence of TB in this population is unknown. The data quoted in 
CDC's 1992 document ``Prevention and Control of Tuberculosis Among 
Homeless Persons'' indicated a prevalence of clinically active 
tuberculosis among homeless adults ranging from 1.6% to 6.8% (Ex. 6-
15). The prevalence of latent tuberculosis ranged from 18% to 51% and 
there was a point prevalence of active TB of 968 cases/100,000 homeless 
adults (Ex. 6-15). Similar to the population in correctional 
facilities, residents of homeless shelters have a high prevalence of 
HIV infection and intravenous drug use, factors that increase the 
likelihood that their infections will progress to active TB. In 
addition, environmental factors such as overcrowding and poor 
ventilation promote the transmission of disease. Examples of employees 
who may have occupational exposure include, but are not limited to, 
intake workers and health care workers who have contact with residents 
of homeless shelters.
    Paragraph (a)(6) covers occupational exposure occurring in 
facilities that provide treatment for drug abuse. Based on tuberculin 
skin testing reported in 1993, 13.3% of the clients of drug treatment 
facilities had evidence of TB infection (Ex.6-8). Many of these persons 
have a history of intravenous-drug use and either have or are at risk 
for HIV infection. These persons are at increased risk for developing 
active TB and transmitting the disease to others. Many of these 
individuals may discontinue treatment prematurely even if they are 
diagnosed and started on effective drug treatment. In addition, the CDC 
reported that studies in some areas have shown that over 20% of 
selected inner city intravenous drug user populations have tuberculous 
infection (Ex. 3-37). The CDC thus concluded that drug center clients 
and staff are at risk of becoming infected. Employees in drug treatment 
facilities who may have occupational exposure include, but are not 
limited to, counselors, nurses, physicians and other staff.
    Work settings where occupational exposure occurs as a result of the 
performance of high-hazard procedures, which, for the purposes of this 
standard, are certain procedures performed on individuals with 
suspected or confirmed infectious TB, are also covered under the scope 
of the standard as stated under paragraph (a)(7). High-hazard 
procedures are procedures that are cough-inducing or aerosol-generating 
that are likely to result in droplet nuclei being expelled into the 
air. A definition and discussion of high-hazard procedures can be found 
under paragraph (j), Definitions, of this Summary and Explanation. 
Health care workers and other employees who are either performing or 
assisting with these procedures or are in the general vicinity are at 
an increased risk of inhaling droplet nuclei and therefore have 
occupational exposure. The 1994 CDC guidelines recommend in Section G, 
``Cough-Inducing and Aerosol-Generating Procedures'' that special 
precautions be taken when these procedures are performed (Ex. 4B). 
Health care workers, such as physicians, nurses, technicians and others 
who perform or assist in the performance of high-hazard procedures have 
occupational exposure. Other employees who may be in the room or area 
when such procedures are performed would be expected to have 
occupational exposure as well.
    Paragraph (a)(8) applies to occupational exposure that occurs in 
laboratories that handle specimens that may contain M. tuberculosis, 
process or maintain those specimens or the resulting cultures, or 
perform any related activity that may result in the aerosolization of 
M. tuberculosis. M. tuberculosis is a proven hazard to laboratory 
personnel (Exs. 7-68, 7-72, 7-142, 7-143). Aerosols present the 
greatest hazard in laboratories. Tubercle bacilli may be present in 
sputum, gastric lavage fluids, cerebrospinal fluid, urine, and in 
lesions from a variety of tissues. In addition, the bacilli are grown 
in culture to increase their concentration beyond what would normally 
be found in the sample for purposes of identification and 
susceptibility testing. The bacilli may survive in heat-fixed smears 
and may be aerosolized in the preparation of frozen sections and during 
manipulation of liquid cultures. CDC/NIH's manual ``Biosafety in 
Microbiological and Biomedical Laboratories'' recommends Biosafety 
Level 2 or 3 for such laboratories depending on the procedures being 
performed (Ex. 7-72). Employees who may have occupational exposure 
include a wide variety of laboratorians. Examples include, but are not 
limited to, medical technologists, laboratory technicians, physicians, 
and research scientists.
    Occupational exposure incurred by temporary or contract employees 
is also covered under the Scope to the extent that the occupational 
exposure occurs in one of the work settings listed under paragraphs 
(a)(1) through (a)(8). For example, if a nurse working for a temporary 
employment service were hired by a hospital to work on a TB ward, that 
temporary nurse would be covered under the scope of the standard. 
Physicians who are employees (e.g., of an independent corporation) yet 
who

[[Page 54235]]

practice and are exposed in a covered facility, such as a hospital, are 
also covered by the standard. Similarly, in any of the work settings 
listed under paragraph (a)(1), temporary or contract personnel who 
incur occupational exposure to TB as a result of their temporary or 
contract work would be covered by the standard. The occupational 
exposure experienced by these employees would be expected to be similar 
to that of other employees performing the same tasks and procedures in 
the work setting that has contracted for their services. A note has 
been added to the proposed standard to make clear that these types of 
employees are covered under the scope.
    This note also clarifies that repair, replacement, or maintenance 
personnel, working in any of the work settings covered under paragraphs 
(a)(1) through (a)(8), who service air systems or equipment or who 
renovate, repair or maintain areas of buildings that may reasonably be 
anticipated to contain aerosolized M. tuberculosis are also covered 
under the scope of the standard. The standard requires the use of 
engineering controls, such as isolation rooms, to reduce the 
concentration of droplet nuclei and therefore reduce the likelihood of 
TB infection and subsequent illness. The ventilation systems that 
exhaust air from isolation rooms may reasonably be anticipated to 
contain aerosolized M. tuberculosis. Maintenance and other workers who 
are responsible for the servicing and repair of ventilation systems 
that handle air that may contain aerosolized M. tuberculosis are at 
risk for occupational exposure when, as the result of performing their 
duties, they are exposed to TB contaminated air moving through the 
ventilation system. Examples of employees who may have occupational 
exposure include heating, ventilation, and air conditioning (HVAC) 
maintenance personnel.
    In addition, there may be employees who are responsible for 
renovating, repairing, or maintaining areas of buildings where exposure 
to aerosolized M. tuberculosis may occur other than those associated 
with the ventilation systems. Maintenance staff who need to repair 
fixtures in an isolation room, or contractor personnel hired to provide 
housekeeping in isolation rooms or areas, are examples of such 
employees who would also be covered under the standard. OSHA expects 
that such exposures would occur only rarely. In many circumstances, 
minor non-emergency maintenance activities could be performed by health 
care personnel required to enter the isolation rooms or areas for other 
reasons, such as to care for a patient. However, there may be 
activities that necessitate the expertise of certain maintenance 
employees which could place those employees at risk of occupational 
exposure. Those employees would therefore be covered under the scope of 
the standard.
    Paragraph (a)(9) applies to occupational exposure occurring during 
the provision of social work, social welfare services, teaching, law 
enforcement or legal services, where the services are provided in the 
facilities included in paragraphs (a)(1) through (a)(8), or in 
residences, to individuals who are in AFB isolation, or are segregated 
or otherwise confined due to having suspected or confirmed infectious 
tuberculosis. This paragraph is intended to cover those types of 
employees who must provide services to individuals who have been 
identified beforehand as having suspected or confirmed infectious 
tuberculosis and who have either been isolated or segregated in 
isolation rooms or areas or have been confined in their homes. For 
example, certain social workers may need to enter AFB isolation rooms 
or areas or visit homes of people who have suspected or confirmed 
infectious tuberculosis for the purposes of collecting information or 
providing discharge planning. While OSHA believes that it would be 
preferable to collect such information over the telephone in order to 
prevent occupational exposure, the Agency realizes that there may be 
situations where direct contact with these isolated or confined 
individuals may be necessary. In these limited situations, these 
employees would be covered under the scope of the standard. There may 
also be situations where teachers may be providing tutoring to 
individuals isolated with suspected or confirmed infectious 
tuberculosis. Again, OSHA believes that such situations would be 
limited and that most educational instruction could be delayed until an 
individual was determined to be noninfectious. However, where teachers 
must provide instruction to individuals identified as having suspected 
or confirmed infectious TB, those teachers would be covered under the 
scope of the standard. In addition, certain law enforcement officers 
might have to be in contact with individuals who have been identified 
as having suspected or confirmed infectious tuberculosis. For example, 
they may have to transfer such an individual from a correctional or 
detainment facility to a hospital for diagnosis or treatment. Because 
these workers must be in direct contact with the individual during 
transport, perhaps for long periods of time and probably in an enclosed 
vehicle, such employees could incur significant occupational exposure. 
Paragraph (a)(9) would assure that such employees would be covered 
under the standard. Similarly, there may be occasions where attorneys 
must consult with clients or inmates who have been isolated or 
segregated because they have been identified as having suspected or 
confirmed infectious tuberculosis. Such attorneys would be covered 
under the standard in the limited situations where these consultations 
cannot be done by phone or delayed until the individual has been 
determined to be noninfectious. Under paragraph (a)(9), OSHA has 
specified certain employee groups that it believes would have to enter 
AFB isolation rooms or areas or homes where individuals are confined 
due to suspected or confirmed infectious TB, in order to provide 
services which may result in occupational exposure. OSHA requests 
comments and data as to whether there are other employee groups that 
may incur occupational exposure and thus need protection under this 
paragraph.
    Paragraph (a)(10) applies to occupational exposure occurring during 
the provision of emergency medical services, home health care, and 
home-based hospice care. Emergency medical service employees may 
provide emergency treatment and transportation for individuals with 
suspected or confirmed tuberculosis. For example, in addition to 
serving the same high-risk client population as hospitals, emergency 
medical services are often used to transport individuals who have been 
identified as having either suspected or confirmed infectious 
tuberculosis from a facility with inadequate isolation capabilities to 
another facility better equipped to isolate these individuals. 
Proximity to the patient and time spent within an ambulance or other 
emergency vehicle affects the likelihood of occupational exposure as 
the result of breathing droplet nuclei generated when the patient 
coughs or speaks. Examples of employees who may have occupational 
exposure include but are not limited to emergency medical technicians, 
paramedics, and, in some localities, fire fighters.
    The 1994 CDC guidelines identify health care workers who provide 
medical services in the homes of patients with suspected or confirmed 
infectious tuberculosis as being at risk and recommend precautions to 
be used in these settings (Ex. 4B). Employees who provide home-based 
care serve a

[[Page 54236]]

client population similar to that of hospitals (e.g., individuals who 
may be immunocompromised). Employees such as nurses and aides who 
provide care to these individuals would be expected to have 
occupational exposure.
    OSHA is also proposing that certain limited construction activities 
be included under the scope of the standard; however, the Agency 
believes that the proposed standard would have little impact on this 
sector. The standard would apply to construction operations occurring 
in the work settings covered by the scope of the standard where there 
is a reasonable anticipation of exposure to aerosolized M. 
tuberculosis, e.g., while rebuilding an HVAC system that would connect 
to an existing one that is in use. The standard is not intended to 
cover employees involved in other construction operations where they 
would not have occupational exposure to air which may reasonably be 
anticipated to contain aerosolized M. tuberculosis (e.g., a crane 
operator constructing a new wing of a hospital). The standard would 
apply only to construction employees who would incur occupational 
exposure to tuberculosis. Such a case might arise during maintenance 
operations on an air system that carries air that may reasonably be 
anticipated to contain aerosolized M. tuberculosis or during 
renovation, repair, or alteration of areas of buildings that may 
reasonably be anticipated to contain aerosolized M. tuberculosis. The 
probability of exposure to M. tuberculosis during these activities may 
be high and it is necessary, therefore, for employees performing the 
work to wear respirators, receive medical surveillance and be protected 
by the other provisions of the proposed TB standard. Employees of such 
contractors are subject to the same levels of TB exposure and need the 
same protection as other exposed employees. Therefore, OSHA proposes to 
cover these employees under the TB standard and has included 
construction within the standard's scope.
    Thus, although the impact of the standard will be limited, OSHA 
believes that construction should not be exempted from the proposed 
standard. OSHA believes that a loophole would be opened in the 
enforcement of the standard if construction were exempted. The 
distinction between maintenance and construction is often an ambiguous 
one. If construction were excluded, contractors, such as HVAC 
contractors, might argue that their work is ``construction'' and that 
they are not covered by the standard. By covering construction, this 
ambiguity does not arise. This approach is consistent with that taken 
in other standards (e.g., Ethylene Oxide, 29 CFR 1910.1047; Benzene, 29 
CFR 1910.1028).
    Several of the sectors covered by the proposed standard may be 
utilizing volunteers for assistance in the workplace. Under the OSH 
Act, OSHA is mandated to protect employees against workplace hazards. 
Consequently, volunteers are not covered by OSHA standards because they 
are not employees. However, employers should be aware that simply 
labeling a person as a volunteer is not determinative of whether an 
employer/employee relationship exists, if the person is compensated for 
his or her services. Some states or localities may decide to extend the 
protections of OSHA standards to volunteers; however, such action is 
the independent decision of these jurisdictions and is not a 
requirement of the OSH Act.
    In addition, the proposed standard applies in situations when an 
employer has part-time employees, or where employees of other employers 
are working in a covered facility. These employees are covered by the 
standard in the same manner as other employees who have occupational 
exposure to tuberculosis. For example, they would be provided with the 
same protections as full-time on-site employees, such as being included 
in the exposure determination, being trained, being provided with 
medical surveillance, and being issued respiratory protection if 
necessary. With regard to employers who provide employees to other 
employers (e.g., personnel providers, temporary help agencies, nurse 
registries), a shared responsibility for worker protection exists 
between the provider and the client or ``host'' employer. The safety 
and health rights of temporary or ``leased'' or contracted employees 
are the same as the rights of those who are employed directly by the 
host employer. The host employer is generally responsible for safety 
and health measures taken to address hazards that are an integral part 
of the workplace the host employer controls. Where other employers are 
involved, contractors or other ``providers,'' a joint employer-employee 
relationship may exist in which both (or more) employers share 
responsibility for the safety and health of the employees. OSHA's 
concern is to assure that workers receive full protection under this 
standard. Who provides which protections to the various employees may 
be specified as a matter of contract or employment agreement existing 
between the client/host and the contractor/provider. In a typical 
arrangement, for example, the provider employer might provide the 
generic training required by the standard and assure that proper 
follow-up medical evaluation occurs after an exposure incident. Host 
employers would typically control potential exposure conditions and 
fulfill other requirements of the standard, such as site-specific 
training and respiratory protection.
    While the proposed standard covers a number of different work 
settings, as described above, OSHA recognizes that many different types 
of activities occur in these different settings. Thus, not all 
provisions of the proposed standard would apply in each work setting. 
The provisions that are required will vary to some degree, depending on 
the type of activities done in the work setting. In order to give 
employers guidance as to what provisions would be applicable in their 
work setting, OSHA has developed a series of charts of the requirements 
that are most likely to be applicable for the affected industries.
    The following charts outline provisions that would be required for 
employers covered under the scope of the proposed TB standard. 
(Employers who qualify for the limited program as outlined under 
Paragraph (b), Application, should consult Appendix A for applicable 
provisions.) The charts are categorized either by the types of 
infection control activities that may be common among different work 
settings (e.g., early identification and transfer of individuals with 
suspected or confirmed infectious TB) or by a particular occupational 
work group (e.g., emergency medical services, home health care). These 
charts are designed to give employers a guide to the regulatory text by 
outlining the provisions of the proposed standard that are applicable 
for various types of work settings. These charts summarize the general 
responsibilities of a particular required provision. The regulatory 
text should be consulted for more specific details on particular 
provisions.
    In addition, it should also be kept in mind that even though these 
charts are categorized by the type of activities occurring at a 
worksite, the categories do not necessarily always follow industry 
lines (i.e., an employer under a specific industry sector may not 
always fall under a particular category outlined in the following 
charts). The charts are not designed to serve as a stand alone check 
list for any one industry sector. Due to the varying activities that 
may take place in work settings encompassed by an industry sector, the 
charts may not account for every applicable provision in every work 
setting. The charts are intended to provide general guidance as to what

[[Page 54237]]

OSHA anticipates to be applicable provisions. Therefore, it is 
important that employers evaluate the types of activities occurring in 
settings where their employees work to determine which of the 
provisions of the proposed standard would be applicable. In order to 
give employers guidance, OSHA has listed some of the types of industry 
sectors that the Agency assumes are likely to fall under a particular 
category, given OSHA's current understanding of the activities commonly 
occurring in these work settings.
    OSHA requests comments on these assumptions and on the charts, and 
particularly, on how the charts can be made more user friendly and be 
better organized to help serve as a guide for employers trying to 
comply with the standard. The following charts are included:

Chart 1: What Would Be Required in Work Settings Where Individuals with 
Suspected or Confirmed Infectious TB are Admitted or Provided Medical 
Services?
Chart 2: What Would Be Required in Work Settings Where Early 
Identification and Transfer Procedures are Used for Individuals with 
Suspected or Confirmed Infectious TB?
Chart 3: What Would Be Required for Employers with Employees Who 
Provide Services to Individuals Who Have Been Isolated or Otherwise 
Confined Due to Having Suspected or Confirmed Infectious TB or Who Work 
in Areas Where the Air Has Been Identified As Reasonably Anticipated to 
Contain Aerosolized M. tuberculosis?
Chart 4: What Would Be Required for Home Health Care and Home-Based 
Hospice Care?
Chart 5: What Would Be Required for Emergency Medical Services?
Chart 6: What Would Be Required for Clinical and Research Laboratories?
Chart 7: What Would Be Required for Personnel Services?

Chart 1: What Would Be Required in Work Settings Where Individuals with 
Suspected or Confirmed Infectious TB Are Admitted or Provided Medical 
Services?

    OSHA anticipates that Hospitals will be the primary type of 
facility falling under this category. In general, individuals requiring 
isolation are transferred to hospitals that have isolation 
capabilities. In addition, medical services such as diagnostic testing 
for evaluating TB disease are performed in a hospital setting. This 
category also covers work settings where high-hazard procedures are 
performed, e.g., medical examiners' offices. (Laboratories are covered 
in a later chart). However, there may be other work settings such as 
correctional facilities or long-term care facilities for the elderly 
that provide isolation or perform high-hazard procedures on individuals 
with suspected or confirmed infectious TB. In these cases, employers at 
these facilities would be required to comply with the provisions 
outlined in this chart.

------------------------------------------------------------------------
What Would Be Required in Work Settings Where Individuals With Suspected
  or Confirmed Infectious TB Are Admitted or Provided Medical Services? 
-------------------------------------------------------------------------
(c) Exposure Control                                                    
    (c)(1) Exposure Determination                                       
    (c)(2)(i) Written Exposure Control Plan including:                  
        (A) the exposure determination                                  
        (B) procedures for providing information to occupationally      
         exposed employees about individuals with suspected or confirmed
         infectious TB or air that may reasonably be anticipated to     
         contain aerosolized M. tuberculosis                            
        (C) procedures for reporting exposure incidents                 
    (c)(2)(iii):                                                        
        (A) procedures for prompt identification of individuals with    
         suspected or confirmed infectious TB                           
        (B) procedures for isolating and managing the care of           
         individuals with suspected or confirmed infectious TB (e.g.,   
         minimizing the time and number of employees entering an        
         isolation room)                                                
        (C) a list of high-hazard procedures                            
        (D) a schedule for inspection, maintenance, and performance     
         monitoring of engineering controls                             
    (c)(2)(iv) If the employer operates an onsite laboratory, the plan  
     must include a determination as to whether the facility should     
     operate at Biosafety Level 2 or 3 containment and document the need
     for controlled access, anterooms, sealed windows, directional      
     airflow, measures to prevent the recirculation of lab exhaust air, 
     filtration of exhaust air and thimble exhaust connections.         
    (c)(2)(vi) Document the number of confirmed cases of TB if claiming 
     reduced responsibilities under paragraph (g)(3)(iii)(D)            
    (c)(2)(vii) The exposure control plan must be:                      
        (A) accessible                                                  
        (B) reviewed annually and updated whenever necessary            
        (C) available for copying by the Assistant Secretary and        
         Director upon request                                          
(d) Work Practices and Engineering Controls                             
    All provisions of paragraph (d) are applicable                      
(e) Clinical and Research Laboratories                                  
    If the facility operates an onsite laboratory, the additional       
     provisions under paragraph (e) must be followed (See Chart 6 for   
     Clinical and Research Laboratories)                                
(f) Respiratory Protection                                              
    (f)(1)(i) Provide respirators to employees who:                     
        (A) enter isolation rooms or areas in use for TB isolation      
        (B) are present during the performance of procedures or services
         for an individual with suspected or confirmed infectious TB who
         is not masked                                                  
        (C) transport an unmasked individual with suspected or confirmed
         infectious TB within the facility                              
        (D) repair, replace, or maintain air systems or equipment that  
         may reasonably be anticipated to contain aerosolized M.        
         tuberculosis                                                   
        (E) work in an area where an unmasked individual with suspected 
         or confirmed infectious TB has been segregated or otherwise    
         confined                                                       
    (f)(1)(iii) Provide respirators at no cost and assure that the      
     employee uses the respirator in accordance with this standard      
    (f)(1)(iv) Assure that the employee dons the respirator before      
     entering any of the work settings or performing any of the tasks   
     identified in paragraph (f)(1)(i) (A) through (E) and uses it until
     leaving the work setting or the task has been completed            
    All remaining provisions of paragraph (f) are applicable, i.e.,     
     (f)(2)-(f)(8)                                                      
(g) Medical Surveillance                                                
    All provisions of paragraph (g) are applicable                      
(h) Communication of Hazards and Training                               

[[Page 54238]]

                                                                        
    (h)(1)(i) Label air systems that may reasonably be anticipated to   
     contain aerosolized M. tuberculosis ``Contaminated Air--Respiratory
     Protection Required''                                              
    (h)(1)(ii) If the employer operates an onsite laboratory, label     
     clinical and research laboratory wastes with the biohazard symbol  
    (h)(2)(i) Post signs at entrances to:                               
        (A) isolation rooms or areas                                    
        (B) areas where procedures or services are being performed on an
         individual with suspected or confirmed infectious TB           
        (C) clinical and research laboratories where M. tuberculosis is 
         present if the employer operates an onsite laboratory          
    (h)(2)(ii) Ventilate isolation rooms or areas vacated by individuals
     with suspected or confirmed infectious TB, in accordance with      
     Appendix C, unless those individuals are medically determined to be
     noninfectious                                                      
    (h)(2)(iii) Signs must be readily visible and have a stop sign with 
     the legend ``No Admittance Without Wearing a Type N95 or More      
     Protective Respirator''                                            
    (h)(2)(iv) Signs at the entrances to clinical or research           
     laboratories (for employers who operate onsite laboratories) and   
     autopsy suites where procedures are being performed that may       
     generate aerosolized M. tuberculosis                               
    (h)(3) Information and Training                                     
        All elements are applicable                                     
(i) Recordkeeping                                                       
    All recordkeeping is applicable                                     
------------------------------------------------------------------------

Chart 2: What Would Be Required in Work Settings Where Early 
Identification and Transfer Procedures Are Used for Individuals With 
Suspected or Confirmed Infectious TB ?
    OSHA anticipates that the types of establishments falling under 
this category are likely to be long term care facilities for the 
elderly, correctional facilities, immigration detainment facilities, 
hospices, homeless shelters, substance abuse treatment centers, and 
hospitals that do not admit individuals with suspected or confirmed 
infectious TB. In these work settings, employers will use the signs and 
symptoms of active TB as well as any other available information (e.g., 
tuberculin skin test status) to identify individuals with suspected or 
confirmed infectious TB. These individuals will then be transferred to 
facilities with appropriate isolation capabilities. Therefore, 
facilities that transfer do not need to have engineering controls. 
Temporary engineering controls will only be necessary in limited 
situations where transfer cannot be accomplished within 5 hours.

------------------------------------------------------------------------
 What Would Be Required in Work Settings Where Early Identification and 
Transfer Procedures Are Used for Individuals With Suspected or Confirmed
                             Infectious TB?                             
-------------------------------------------------------------------------
(c) Exposure Control                                                    
    (c)(1) Exposure Determination                                       
    (c)(2)(i) Written Exposure Control Plan including:                  
        (A) the exposure determination                                  
        (B) procedures for providing information to occupationally      
         exposed employees about individuals with suspected or confirmed
         infectious TB or air that may reasonably be anticipated to     
         contain aerosolized M. tuberculosis                            
        (C) procedures for reporting exposure incidents                 
    (c)(2)(ii) Employers who transfer individuals with suspected or     
     confirmed infectious TB must include in the plan: procedures for   
     prompt identification, masking or segregation, and transfer of such
     individuals                                                        
    (c)(2)(vi) Document the number of confirmed cases of TB if claiming 
     reduced responsibilities under paragraph (g)(3)(iii)(D)            
    (c)(2)(vii) The exposure control plan must be:                      
        (A) accessible                                                  
        (B) reviewed annually and updated whenever necessary            
        (C) available for copying by the Assistant Secretary and        
         Director upon request                                          
(d) Work Practices and Engineering Controls                             
    (d)(1) Use work practices and engineering controls to eliminate or  
     minimize employee exposure to M. tuberculosis                      
    (d)(2) Implement the work practices in the Exposure Control Plan    
    (d)(3) Identify individuals with suspected or confirmed infectious  
     TB and:                                                            
        (i) mask or segregate the individual until transfer can be      
         accomplished                                                   
        (ii) place the individual in temporary isolation if transfer    
         cannot be accomplished within 5 hours from the time of         
         identification                                                 
    (d)(5) Engineering controls (i.e., negative pressure, direct exhaust
     or HEPA filtration, etc.) shall be used when temporary isolation is
     used                                                               
    (d)(6) Provide information about TB hazards to any contractor who   
     provides temporary or contract employees who will incur            
     occupational exposure                                              
(f) Respiratory Protection                                              
    (f)(1)(i) Provide respirators to employees who:                     
        (A) enter a temporary isolation room or area                    
        (E) work in an area where an unmasked individual with suspected 
         or confirmed infectious TB has been segregated or otherwise    
         confined and is awaiting transfer                              
    (f)(1)(iii) Provide respirators at no cost and assure that the      
     employee uses the respirator in accordance with this standard      
    (f)(1)(iv) Assure that the employee dons the respirator before      
     entering the work setting and uses it until leaving the work       
     setting                                                            
    All remaining provisions of paragraph (f) are applicable, i.e.,     
     (f)(2)-(f)(8)                                                      
(g) Medical Surveillance                                                
    All provisions of paragraph (g) are applicable                      
(h) Communication of Hazards and Training                               
    (h)(1)(i) Label air systems that may reasonably be anticipated to   
     contain aerosolized M. tuberculosis ``Contaminated Air--Respiratory
     Protection Required'' if temporary isolation is used               
    (h)(2)(i)(A) Post signs at entrances to temporary isolation rooms or
     areas                                                              
    (h)(2)(ii) Ventilate temporary isolation rooms or areas vacated by  
     individuals with suspected or confirmed infectious TB in accordance
     with Appendix C, unless those individuals are medically determined 
     to be noninfectious                                                
    (h)(2)(iii) Signs used for temporary isolation must be readily      
     visible and have a stop sign with the legend ``No Admittance       
     Without Wearing a Type N95 or More Protective Respirator''         

[[Page 54239]]

                                                                        
    (h)(3) Information and Training                                     
        All elements are applicable                                     
(i) Recordkeeping                                                       
    All recordkeeping is applicable                                     
------------------------------------------------------------------------

Chart 3: What Would Be Required for Employers With Employees Who 
Provide Services to Individuals Isolated or Otherwise Confined Due to 
Having Suspected or Confirmed Infectious TB or Who Work in Areas 
Identified as Reasonably Anticipated to Contain Aerosolized M. 
tuberculosis?

    OSHA anticipates that the type of employees falling under this 
category will be workers providing social work services, social welfare 
services, teaching, law enforcement or legal services to individuals 
who are in isolation or confined to their homes due to having suspected 
or confirmed infectious TB. Also included in this category are 
maintenance employees such as contract HVAC maintenance employees who 
work on air systems that have been identified as carrying air that may 
reasonably be anticipated to contain aerosolized M. tuberculosis. 
Employers in these situations will not need to perform early 
identification procedures since the identification of individuals with 
suspected or confirmed infectious TB has already been accomplished. 
Similarly, air systems will already be labeled as containing 
``Contaminated Air''.

------------------------------------------------------------------------
What Would Be Required for Employers with Employees Who Provide Services
to Individuals Isolated or Otherwise Confined Due to Having Suspected or
  Confirmed Infectious TB or Who Work in Areas Identified as Reasonably 
           Anticipated to Contain Aerosolized M. tuberculosis?          
-------------------------------------------------------------------------
(c) Exposure Control                                                    
    (c)(1) Exposure Determination                                       
    (c)(2)(i) Written Exposure Control Plan including:                  
        (A) the exposure determination                                  
        (B) procedures for providing information to occupationally      
         exposed employees about individuals with suspected or confirmed
         infectious TB or air that may reasonably be anticipated to     
         contain aerosolized M. tuberculosis                            
        (C) procedures for reporting exposure incidents                 
    (c)(2)(vii) The exposure control plan must be:                      
        (A) accessible                                                  
        (B) reviewed annually and updated whenever necessary            
        (C) available for copying by the Assistant Secretary and        
         Director upon request                                          
(d) Work Practices and Engineering Controls                             
    (d)(1) Use work practices to eliminate or minimize employee exposure
     to M. tuberculosis                                                 
    (d)(2) Implement the work practices in the Exposure Control Plan    
    (d)(6) Provide information about TB hazards to any contractor who   
     provides temporary or contract employees who will incur            
     occupational exposure                                              
(f) Respiratory Protection                                              
    (f)(1)(i) Provide respirators to employees who:                     
        (A) enter isolation rooms or areas                              
        (D) repair, replace or maintain air systems or equipment that   
         may reasonably be anticipated to contain aerosolized M.        
         tuberculosis                                                   
        (F) work in a residence where an individual with suspected or   
         confirmed infectious TB is known to be present                 
    (f)(1)(iii) Provide respirators at no cost and assure that the      
     employee uses the respirator in accordance with this standard      
    (f)(1)(iv) Assure that the employee dons the respirator before      
     entering the work setting and uses it until leaving the work       
     setting                                                            
    All remaining provisions of paragraph (f) are applicable, i.e.,     
     (f)(2)--(f)(8)                                                     
(g) Medical Surveillance                                                
    All provisions of paragraph (g) are applicable                      
(h) Communication of Hazards and Training                               
    (h)(3) Information and Training                                     
        All elements are applicable                                     
(i) Recordkeeping                                                       
    All recordkeeping, except for engineering controls records, is      
     applicable                                                         
------------------------------------------------------------------------

Chart 4: What Would Be Required for Home Health Care and Home-Based 
Hospice Care?

    In general, most of the provisions of the proposed standard would 
be applicable for employers providing home health care or home-based 
hospice care. However, OSHA realizes that home health care providers do 
not have control over the home environment and therefore, the standard 
would not require these employers to provide or maintain engineering 
controls in the homes of their clients. OSHA also realizes that some 
individuals with infectious TB may be sent home instead of being 
admitted to the hospital; OSHA would not expect employers to transfer 
such individuals out of their home. However, individuals with suspected 
or confirmed infectious TB need to be identified so that home health 
care providers can take appropriate precautions to protect themselves 
while in the home.

------------------------------------------------------------------------
What Would Be Required for Home Health Care and Home-Based Hospice Care?
-------------------------------------------------------------------------
(c) Exposure Control                                                    
    (c)(1) Exposure Determination                                       
    (c)(2)(i) Written Exposure Control Plan including:                  

[[Page 54240]]

                                                                        
        (A) the exposure determination                                  
        (B) procedures for providing information to occupationally      
         exposed employees about individuals with suspected or confirmed
         infectious TB or air that may reasonably be anticipated to     
         contain aerosolized M. tuberculosis                            
        (C) procedures for reporting exposure incidents                 
    (c)(2)(v) Employers who provide home health care or home-based      
     hospice care must include procedures for prompt ID of individuals  
     with suspected or confirmed infectious TB, procedures for          
     minimizing exposure to such individuals, a list of high-hazard     
     procedures performed, if any, and procedures for delaying elective 
     high-hazard procedures or surgery until the individual is          
     noninfectious                                                      
    (c)(2)(vii) The exposure control plan must be:                      
        (A) accessible                                                  
        (B) reviewed annually and updated whenever necessary            
        (C) available for copying by the Assistant Secretary and        
         Director upon request                                          
(d) Work Practices and Engineering Controls                             
    (d)(1) Use work practices to eliminate or minimize employee exposure
     to M. tuberculosis                                                 
    (d)(2) Implement the work practices in the Exposure Control Plan    
    (d)(3) Identify individuals with suspected of confirmed infectious  
     TB                                                                 
    (d)(6) Provide information about TB hazards to any contractor who   
     provides temporary or contract employees who will incur            
     occupational exposure                                              
(f) Respiratory Protection                                              
    (f)(1)(i) Provide respirators to employees who:                     
        (F) work in a residence where an individual with suspected or   
         confirmed infectious TB is known to be present                 
    (f)(1)(iii) Provide respirators at no cost and assure that the      
     employee uses the respirator in accordance with this standard      
    (f)(1)(iv) Assure that the employee dons the respirator before      
     entering the work setting and uses it until leaving the work       
     setting                                                            
    All remaining provisions of paragraph (f) are applicable, i.e.,     
     (f)(2)-(f)(8)                                                      
(g) Medical Surveillance                                                
    All provisions of paragraph (g) are applicable                      
(h) Communication of Hazards and Training                               
    (h)(3) Information and Training                                     
    All elements are applicable except those related to the use of      
     engineering controls                                               
(i) Recordkeeping                                                       
    All recordkeeping, except for engineering controls records, is      
     applicable                                                         
------------------------------------------------------------------------

Chart 5: What Would Be Required for Emergency Medical Services?

    Similar to Home Health Care or Home-Based Hospice Care, employers 
providing emergency medical services do not have control over many of 
the work settings in which they may provide services. Thus, OSHA would 
not require these employers to provide or maintain engineering 
controls. In addition, while these types of employers are likely to be 
transferring individuals with infectious TB, it is not their 
responsibility to initiate the transfer of an individual identified as 
having suspected or confirmed infectious TB to a facility with 
appropriate isolation capabilities. However, where it is feasible to do 
so, such individuals need to be identified so that emergency medical 
service employees can take precautions to protect themselves.

------------------------------------------------------------------------
         What Would Be Required for Emergency Medical Services?         
-------------------------------------------------------------------------
(c) Exposure Control                                                    
    (c)(1) Exposure Determination                                       
    (c)(2)(i) Written Exposure Control Plan including:                  
        (A) the exposure determination                                  
        (B) procedures for providing information to occupationally      
         exposed employees about individuals with suspected or confirmed
         infectious TB or air that may reasonably be anticipated to     
         contain aerosolized M. tuberculosis                            
        (C) procedures for reporting exposure incidents                 
    (c)(2)(iii):                                                        
        (A) Procedures for prompt identification of individuals with    
         suspected or confirmed infectious TB                           
        (B)(4) Procedure or policy for using properly-fitted masks on   
         individuals with suspected or confirmed infectious TB          
        (C) A list of high-hazard procedures                            
    (c)(2)(vii) The exposure control plan must be:                      
        (A) accessible                                                  
        (B) reviewed annually and updated whenever necessary            
        (C) available for copying by the Assistant Secretary and        
         Director upon request                                          
(d) Work Practices and Engineering Controls                             
    (d)(1) Use work practices to eliminate or minimize employee exposure
     to M. tuberculosis                                                 
    (d)(2) Implement the work practices in the Exposure Control Plan    
    (d)(3) Identify individuals with suspected or confirmed infectious  
     TB                                                                 
    (d)(6) Provide information about TB hazards to any contractor who   
     provides temporary or contract employees who will incur            
     occupational exposure                                              
(f) Respiratory Protection                                              
    (f)(1)(i) Provide respirators to employees who:                     
        (A) enter an isolation room or area                             
        (B) are present during the performance of procedures or services
         for an individual with suspected or confirmed infectious TB who
         is not masked                                                  
        (C) transport an individual with suspected or confirmed         
         infectious TB in an enclosed vehicle or who transport an       
         unmasked individual with suspected or confirmed infectious TB  
         within the facility                                            
        (F) work in a residence where an individual with suspected or   
         confirmed infectious TB is known to be present                 
    (f)(1)(iii) Provide respirators at no cost and assure that the      
     employee uses the respirator in accordance with this standard      
    (f)(1)(iv) Assure that the employee dons the respirator before      
     entering the work setting and uses it until leaving the work       
     setting                                                            

[[Page 54241]]

                                                                        
    All remaining provisions of paragraph (f) are applicable, i.e.,     
     (f)(2)-(f)(8)                                                      
(g) Medical Surveillance                                                
    All provisions of paragraph (g) are applicable                      
(h) Communication of Hazards and Training                               
    (h)(3) Information and Training                                     
        All elements are applicable except those related to the use of  
         engineering controls                                           
(i) Recordkeeping                                                       
    All recordkeeping, except for engineering controls records, is      
     applicable                                                         
------------------------------------------------------------------------

Chart 6: What Would Be Required for Clinical and Research Laboratories?

    Employers in clinical and research laboratories that handle 
specimens that may contain M. tuberculosis or process or maintain the 
resulting cultures or perform activities that may result in the 
aerosolization of M. tuberculosis must follow most of the provisions of 
the proposed standard. In addition, a special paragraph has been added 
to address the unique hazards of the lab environment. Clinical and 
research labs are not responsible for developing or implementing 
procedures for the early ID of individuals with suspected or confirmed 
infectious TB or the transfer of those individuals.

------------------------------------------------------------------------
     What Would Be Required for Clinical and Research Laboratories?     
-------------------------------------------------------------------------
(c) Exposure Control                                                    
    (c)(1) Exposure Determination                                       
    (c)(2)(i) Written Exposure Control Plan including:                  
        (A) the exposure determination                                  
        (B) procedures for providing information to occupationally      
         exposed employees about individuals with suspected or confirmed
         infectious TB or air that may reasonably be anticipated to     
         contain aerosolized M. tuberculosis                            
        (C) procedures for reporting exposure incidents                 
    (c)(2)(iv) Employers who operate a laboratory must include a        
     determination as to whether the facility should operate a          
     laboratory at Biosafety Level 2 or 3 containment and document the  
     need for controlled access, anterooms, sealed windows, directional 
     airflow, measures to prevent the recirculation of lab exhaust air, 
     filtration of exhaust and thimble exhaust connections              
    (c)(2)(vii) The exposure control plan must be:                      
        (A) accessible                                                  
        (B) reviewed annually and updated whenever necessary            
        (C) available for copying by the Assistant Secretary and        
         Director upon request                                          
(d) Work Practices and Engineering Controls                             
    (d)(1) Use work practices and engineering controls to eliminate or  
     minimize employee exposure to M. tuberculosis                      
    (d)(2) Implement the work practices in the Exposure Control Plan    
    (d)(6) Provide information about TB hazards to any contractor who   
     provides temporary or contract employees who will incur            
     occupational exposure                                              
(e) Clinical and Research Laboratories                                  
    All provisions of paragraph (e) are applicable                      
(f) Respiratory Protection                                              
    (f)(1)(ii) For research laboratories, provide respirators to        
     employees who are present when aerosols of M. tuberculosis cannot  
     be safely contained                                                
    (f)(1)(iii) Provide respirators at no cost and assure that the      
     employee uses the respirator in accordance with this standard      
    (f)(1)(iv) Assure that the employee dons the respirator before      
     performing the tasks under (f)(1)(ii) and uses it until completing 
     the tasks                                                          
    All remaining provisions of paragraph (f) are applicable, i.e.,     
     (f)(2)-(f)(8)                                                      
(g) Medical Surveillance                                                
    All provisions of paragraph (g) are applicable                      
(h) Communication of Hazards and Training                               
    (h)(1)(i) Labels:                                                   
        (h)(1)(i) Label air systems that may reasonably be anticipated  
         to contain aerosolized M. tuberculosis ``Contaminated Air--    
         Respiratory Protection Required''                              
        (h)(1)(ii) Label clinical and research laboratory wastes with   
         the biohazard symbol                                           
    (h)(2) Signs:                                                       
        (h)(2)(i)(C) Post signs at entrances to clinical and research   
         laboratories where M. tuberculosis is present                  
        (h)(2)(iv) Include on the sign the biohazard symbol, the name   
         and telephone number of the laboratory director or other       
         designated responsible person, the infectious agent designation
         M. tuberculosis, and special requirements for entering the     
         laboratory                                                     
    (h)(3) Information and Training                                     
        All elements are applicable                                     
(i) Recordkeeping                                                       
    All recordkeeping is applicable                                     
------------------------------------------------------------------------

Chart 7: What Would Be Required for Personnel Services?

    This category covers employers who provide temporary employees to 
any of the other employers covered under the scope of the standard 
(e.g., temporary nurses hired to work at a hospital, temporary lab 
technicians working in a clinical laboratory). Employees in these 
situations are covered by the standard in the same manner as other 
employees who have occupational exposure to tuberculosis. A shared 
responsibility for worker protection exists between the personnel 
service employer and the client (or ``host'') employer. These matters 
may be specified as a matter of contract or employment agreement 
existing between the personnel service employer and the host employer. 
In this chart OSHA has assumed that a typical contract or employment 
agreement exists between the two employers with the personnel provider 
accepting responsibility for the general requirements and the host 
employer being responsible for site-specific measures. Therefore, the 
personnel service provider is shown complying with non-site specific 
provisions such as exposure determination, medical surveillance, and 
non-site specific employee training. The host employer would comply 
with more site-specific

[[Page 54242]]

provisions such as procedures for early ID, engineering controls and 
site-specific employee training. In addition, the chart assumes that 
the personnel service provider has accepted the responsibility for 
respiratory protection. OSHA requires that workers in these situations 
receive full protection under the standard.

------------------------------------------------------------------------
             What Would Be Required for Personnel Services?             
-------------------------------------------------------------------------
(c) Exposure Control                                                    
    (c)(1) Exposure Determination                                       
    (c)(2)(i) Written Exposure Control Plan including:                  
        (A) the exposure determination                                  
        (B) procedures for providing information to occupationally      
         exposed employees about individuals with suspected or confirmed
         infectious TB or air that may reasonably be anticipated to     
         contain aerosolized M. tuberculosis                            
        (C) procedures for reporting exposure incidents                 
    (c)(2)(vii) The exposure control plan must be:                      
        (A) accessible                                                  
        (B) reviewed annually and updated whenever necessary            
        (C) available for copying by the Assistant Secretary and        
         Director upon request                                          
(d) Work Practices and Engineering Controls                             
    (d)(1) Use work practices to eliminate or minimize employee exposure
     to M. tuberculosis                                                 
    (d)(2) Implement the work practices in the Exposure Control Plan    
(f) Respiratory Protection                                              
    All provisions of paragraph (f) are applicable                      
(g) Medical Surveillance                                                
    All provisions of paragraph (g) are applicable except those related 
     to conducting site-specific follow-up investigations after an      
     exposure incident or skin test conversion                          
(h) Communication of Hazards and Training                               
    (h)(3) Information and Training                                     
        All elements are applicable except those training elements which
         are site-specific                                              
(i) Recordkeeping                                                       
    All recordkeeping, except for engineering control records, is       
     applicable                                                         
------------------------------------------------------------------------

    OSHA's preliminary conclusion is that all employees who have 
occupational exposure to aerosolized M. tuberculosis, as a result of 
performing their duties, are at risk of infection. Under paragraph (a) 
the Agency has listed those facilities, work settings and services 
where it believes that significant occupational exposure is most likely 
to occur. OSHA requests comment and supporting data as to whether there 
are other work settings or services where significant occupational 
exposures can be reasonably anticipated.

Paragraph (b)  Application

    As discussed above, OSHA has preliminarily determined that there 
are elevated risks of TB infection associated with certain types of 
work settings and services. However, the Agency realizes that there may 
be employers covered under the scope of the standard who have work 
settings in counties where the risk of TB infection is low. Some 
geographical areas in the U.S. have not reported cases of TB to CDC and 
facilities in these areas have not encountered any individuals with 
confirmed infectious TB in their work settings within the recent past.
    In consideration of the lessened likelihood of employee exposure in 
these work settings, OSHA is proposing that some employers be permitted 
to qualify for a more limited program. Paragraph (b), Application, 
states that an employer covered under paragraph (a), Scope, other than 
the operator of a laboratory, may choose to comply only with the 
provisions of Appendix A if the Exposure Control Plan demonstrates that 
his or her facility or work setting: (1) does not admit or provide 
medical services to individuals with suspected or confirmed infectious 
TB; (2) has not encountered a case of confirmed infectious TB in the 
past 12 months; and (3) is located in a county that, in the past 2 
years, has had no cases of confirmed infectious TB reported in one year 
and fewer than 6 cases of confirmed infectious TB reported in the other 
year. Thus, in the past two year period, the number of reported TB 
cases must be 0 for at least one of the two years. (It may even be zero 
for both years). In the other year, the number of cases must be no 
greater than 5. For example, if in the first year of the preceding two-
year period the number of reported cases was 0, but in the second year 
there were 4 reported cases of confirmed infectious TB in the county, 
an employer would still qualify for the limited program under paragraph 
(b), provided that none of the cases were encountered in his or her 
employees' work setting. However, for the employer in this scenario to 
continue to qualify for the limited program, the number of cases 
reported in the third year would have to return to zero. Similarly, 
employers would not qualify for the limited program if the number of 
cases of confirmed infectious TB reported in the county was greater 
than zero in both of the preceding two years or if 6 or more cases were 
reported in one of the preceding two years.
    OSHA has taken this approach because the number of TB cases 
fluctuates widely and different locations and geographical areas may be 
affected at different times. For example, many counties report no cases 
in one year or even in two consecutive years, or report a few cases in 
one year but then have no cases in the following year. From 1992 to 
1994 (Ex.7-262), 55.3 percent of the counties in the U.S., representing 
12.9 percent of the population, reported no confirmed cases of TB in 
one year of the preceding two-year period and fewer than 6 cases in the 
other year. OSHA believes that the approach described above is 
appropriate given these fluctuations and that it reduces the burden on 
employers who rarely encounter TB cases by allowing them to qualify for 
the limited program. OSHA initially considered allowing employers to 
qualify for the limited program only if there had been no cases of 
confirmed infectious TB reported in the county in the preceding one-
year period. This would have meant that an employer would be required 
to comply with the full program if even a single case was reported in 
the county in any year. OSHA requests comment on the approach taken in 
the proposed rule and the appropriateness of the ``zero-county'' 
trigger used in the standard.

[[Page 54243]]

    Although OSHA believes that the risk of incurring TB is 
substantially reduced in facilities located in counties qualifying for 
the limited program, the risk of infection continues because all 
counties have residents who are infected and who may therefore develop 
active TB and transmit it. In addition, the mobility of the U.S. 
population means that it is easy to carry the disease from higher risk 
areas to lower risk areas. Thus, OSHA believes that certain TB exposure 
control provisions, i.e., those reflected in the limited program 
required by the standard, need to be in place in all work settings 
where cases of TB could be encountered.
    Under the limited program, employers are responsible for (1) 
preparing a written exposure control plan with certain minimal 
elements, (2) providing a baseline skin test and medical history, (3) 
making medical management and follow-up available after an exposure 
incident, (4) providing medical removal protection if necessary, (5) 
providing information and training to employees with potential 
occupational exposure, and (6) complying with pertinent recordkeeping 
requirements. The specific paragraphs of the proposed standard that 
would apply in these situations are outlined in Appendix A.
    OSHA believes that these provisions are the minimum requirements 
necessary for employee protection, even in work settings where no TB 
has recently been reported in the county and no individuals with 
confirmed infectious TB have been encountered within the work setting 
during the past 12 months. OSHA's reasoning is that, although no cases 
of confirmed infectious TB have been reported for the preceding two 
years, there is considerable fluctuation among counties from one year 
to the next, as explained above. In addition, as discussed in the 
preliminary risk assessment section of the preamble, there is a high 
prevalence of TB infection nationwide, approximately 6.5 percent. 
Infections may become active after a latency period of years. 
Therefore, the absence of a reported active case in the immediate past 
does not mean that active cases will not be manifested in the current 
or subsequent years. For these reasons, it is necessary for covered 
facilities to maintain, at a minimum, a TB program that incorporates 
the basic TB exposure control provisions that will protect employees 
from exposures.
    A primary element of the limited program is a written exposure 
control plan. The exposure control plan includes an exposure 
determination to identify those employees who would incur occupational 
exposure if an individual with infectious TB were encountered in the 
work setting. The exposure control plan would also have to contain 
procedures and policies for the early identification and masking of 
individuals with suspected or confirmed infectious TB and procedures 
for transferring those individuals to other facilities. This would 
assure that if an individual with suspected or confirmed infectious TB 
were to enter the workplace, he or she would be promptly identified and 
transferred to a facility with AFB isolation capabilities. In addition, 
while awaiting transfer, these individuals could be masked to the 
extent that it is feasible (e.g., in the case of a non-combative 
individual) in order to prevent transmission. Similarly, the exposure 
control plan must include procedures for reporting exposure incidents 
should they occur. Employees need to know what steps to take if an 
exposure occurs so that appropriate follow-up can be initiated for the 
medical management of the exposed employee and investigation of the 
incident.
    In order to qualify for the limited program pursuant to paragraph 
(b), the employer must include in his or her exposure control plan the 
number of TB cases reported in the county and the number of individuals 
with confirmed infectious TB who have been encountered within the work 
setting. An employer is required by the standard to check and document 
the number of confirmed infectious TB cases in the county once a year. 
Typically, county health departments collect this information for 
reporting purposes and report it both on a monthly and an annual basis. 
Obtaining the annual count from the county health department would meet 
the requirements of the proposed rule. County case counts must be 
recorded for the two most recent annual reporting periods, i.e., the 
two preceding years. This count must be reflected in the employer's 
Exposure Control Plan, as described below in paragraph (c), Exposure 
Control Plan, of this Summary and Explanation. The count of cases and 
the notation in the Plan can be kept in any media, e.g., paper or 
electronic.
    In addition to an abbreviated exposure control plan, the limited 
program would include some of the basic elements of medical 
surveillance, i.e., baseline skin tests and medical histories for 
employees identified under the exposure determination and medical 
management and follow-up for those employees who have had an exposure 
incident. Baseline skin tests and histories will help to assure that 
true conversions are appropriately identified should an exposure 
incident occur. Medical management and follow-up provisions will assure 
that exposed employees receive the proper medical evaluation after an 
exposure incident and that the incident is properly investigated so 
that it will not occur again. Under this limited program, no periodic 
medical surveillance would be required.
    Where necessary, the employer is also required to provide medical 
removal and protection (MRP) of benefits for those employees who 
develop active TB. OSHA anticipates that the need to provide MRP would 
be a rare event because little active TB has been reported in many of 
these counties. In addition, if employees are properly trained to 
identify suspected and confirmed infectious TB and to promptly transfer 
those individuals, few occupational exposures should occur, thus 
minimizing the likelihood that employees will become infected. 
Therefore, training is an important element of the limited program. 
Training is a key element in assuring that employees know how to 
identify individuals with suspected or confirmed infectious TB and the 
necessary steps to take if such an individual is encountered.
    Certain minimal records must also be kept by the employer. Medical 
records for documenting baseline skin tests and any potential medical 
evaluations made as a result of an exposure incident, as well as 
records for training and records for OSHA illnesses and injuries, would 
have to be kept. Keeping records should not be burdensome for the 
employer since it is likely that only a minimal number of employees 
would be identified by the exposure determination as having potential 
occupational exposure (e.g., intake workers in admitting areas or 
emergency departments); only such employees need medical surveillance 
or training.
    The elements of the limited program outlined under this paragraph 
closely track the recommendations of the CDC for facilities designated 
as having ``minimal risk'' under the CDC's TB Guidelines for Health 
Care Facilities (Ex. 4B). Under these guidelines, CDC considers 
facilities to have ``minimal risk'' if there is no TB in the community 
and no TB in the facility. CDC's recommendations for such facilities 
include a written TB control plan, procedures for early identification 
and prompt transfer of individuals with suspected or confirmed 
infectious TB, and employee training. CDC does not specifically 
recommend baseline skin testing. However, CDC's guidelines do say that 
baseline testing would be

[[Page 54244]]

advisable in these facilities so that, if an unexpected exposure does 
occur, conversions can be distinguished from positive skin test results 
caused by previous exposures. CDC also recommends that a risk 
assessment be conducted by such facilities each year. In the case of a 
``minimal risk'' facility, as defined by CDC, this would essentially 
involve checking on the number of reported cases of TB in the community 
and within the facility, which is essentially what OSHA requires under 
the exposure control plan as documentation to qualify for the limited 
program available under paragraph (b).

Paragraph (c)  Exposure Control

    Employees incur risk each time they are exposed to aerosolized M. 
tuberculosis. A worker can become infected from a single exposure 
incident, and thus it is necessary to prevent exposure incidents 
whenever possible. The goal of this proposed standard is to reduce the 
significant risk of infection by minimizing or eliminating occupational 
exposure to aerosolized M. tuberculosis.
    One purpose of paragraph (c), Exposure Control, is to identify the 
tasks and procedures where occupational exposure may occur and to 
identify those employees whose duties include these tasks and 
procedures. An additional purpose of the paragraph is to develop and 
document, in an exposure control plan, policies and procedures for 
eliminating or minimizing occupational exposure, e.g., developing 
procedures for identifying individuals with suspected or confirmed TB, 
for appropriately isolating and minimizing employee contact with those 
individuals, and for reporting exposure incidents.
    Paragraph (c)(1) requires each employer who has an employee with 
occupational exposure to prepare an exposure determination that 
identifies those employees who have occupational exposure to 
aerosolized M. tuberculosis. As discussed under paragraph (j), 
Definitions, ``occupational exposure'' means ``reasonably anticipated 
contact that results from the performance of an employee's duties, with 
an individual with suspected or confirmed infectious TB or air that may 
contain aerosolized M. tuberculosis.'' Thus, the exposure determination 
needs to include, in addition to those employees who have direct 
contact with individuals with suspected or confirmed infectious TB and 
employees who perform procedures that may aerosolize M. tuberculosis, 
those employees who can reasonably be anticipated as part of their job 
duties to be exposed to air that may contain aerosolized M. 
tuberculosis.
    For example, while an admissions clerk in a homeless shelter will 
not perform medical procedures on a client with suspected infectious 
tuberculosis, the clerk may reasonably be anticipated to encounter and 
share the same airspace with such an individual. Therefore, the 
admissions clerk would be included in the Exposure Control Plan and 
would be covered by this standard.
    Exposure determination is a key provision of exposure control 
because the employer must know which tasks or procedures involve 
occupational exposure in order to determine what measures can be taken 
to eliminate or minimize exposure incidents. In addition, an exposure 
determination is necessary in order to ascertain which employees are to 
be provided with respiratory protection, medical surveillance, and 
training.
    Each employer is required to consider the duties, tasks, and 
procedures of all employees in each job classification in each work 
area where occupational exposure occurs when making the exposure 
determination. OSHA believes that it is appropriate to allow the 
employer to identify and document job classifications where all or some 
employees have occupational exposure as a basis for the required 
exposure determination. By identifying the job classification, each 
employee included in the description will know that he or she is within 
the scope of the standard. Listing of every employee's name is not 
required, however, because that may be burdensome for employers who 
have many employees with occupational exposure.
    The term ``job classification'' is used generically. During the 
development of the Bloodborne Pathogens standard, commenters used 
several terms (e.g., ``job category'', ``job responsibility'', ``job 
title'', ``position description'') to identify and document employees 
at risk in the exposure determination. OSHA sought to use a term that 
would encompass all of these terms. Therefore, as in the Bloodborne 
Pathogens standard, OSHA has chosen to use the term ``job 
classification'' because it has the broadest application to facilities 
of all sizes that use formal and less formal designations to classify 
employees. Thus, the standard would allow employers to use existing job 
titles, job descriptions, or other designations to identify those job 
classifications in which occupational exposure occurs. OSHA solicits 
comment on whether this term needs further defining in this paragraph 
or in paragraph (j), Definitions.
    The standard does not require that every task and procedure that 
could result in occupational exposure be listed in the exposure control 
plan, but instead gives the employer a choice in how to document the 
exposure determination. Paragraph (c)(1)(i) states that the exposure 
determination shall contain:

    (A) A list of the job classifications in which all employees 
have occupational exposure; and
    (B) A list of the job classifications in which some employees 
have occupational exposure, and a list of all tasks and procedures 
(or groups of closely related tasks and procedures) that these 
employees perform and that involve occupational exposure.

This means that the employer may choose to extend ``blanket'' coverage 
to those job classifications where essentially all employees have 
occupational exposure [the paragraph (c)(1)(i)(A) option]. In this 
case, the employer would not have to list all tasks and procedures for 
those employees in the exposure control plan, since all of these 
employees would be covered by the standard. For example, if a hospital 
determines that all employees within the job classification 
``respiratory therapist'' have duties or responsibilities that involve 
tasks and procedures where occupational exposure occurs, the job 
classification ``respiratory therapist'' can simply be listed in the 
exposure determination in accordance with paragraph (c)(1)(i)(A) and no 
subsequent listing of those tasks and procedures is required. 
Similarly, the job classification of ``homeless shelter admissions 
clerk'' in the previous example could be included under the ``blanket'' 
job classification list in paragraph (c)(1)(i)(A).
    On the other hand, the employer may determine that job 
classifications exist in which only some employees have occupational 
exposure. The employer may determine that it is not necessary to 
include all employees in such job classifications under the standard 
since only a portion of them have occupational exposure. In these 
situations [paragraph (c)(1)(i)(B)], the employer must list the job 
classification as well as the tasks and procedures or groups of closely 
related tasks and procedures performed by employees within that job 
classification that result in occupational exposure. For example, 
within the job classification ``laboratory technician,'' there may be 
some employees who experience occupational exposure (e.g., laboratory 
technicians who perform microbiological procedures on M. tuberculosis 
cultures), while others would not be expected to

[[Page 54245]]

have such exposure (e.g., laboratory technicians who work in clinical 
chemistry). In such a case, the employer may not wish to extend 
coverage to all employees in the job classification ``laboratory 
technician''. Consequently, the job classification ``laboratory 
technician'' would be listed in the exposure determination along with 
the tasks and procedures in which occupational exposure occurs. This 
approach would inform employees within the job classification 
``laboratory technician'' about those tasks that they perform that 
involve occupational exposure and that employees performing those tasks 
and procedures triggers their inclusion in the scope of the standard. 
However, it would not be necessary for the employer to list each 
procedure performed by a ``laboratory technician''. For example, 
performing sputum smears, culturing the bacteria in the sputum, and 
conducting drug-susceptibility testing on the culture all involve 
manipulation of specimens that could contain M. tuberculosis. 
Therefore, these tasks could be grouped under the designation 
``manipulation of specimens that may contain M. tuberculosis.''
    Although the standard permits the exposure determination to list 
job classifications, grouping job classifications according to location 
would not be sufficient to meet the requirement for identifying job 
classifications with occupational exposure. For example, identifying 
job classifications by using the ``Emergency Department'' would not 
fulfill this requirement because it does not identify the specific 
employee job classifications that have occupational exposure. An 
employer who has determined that employees in the ``Emergency 
Department'' warrant coverage under the standard would have to list the 
job classifications that involve occupational exposure and identify the 
tasks and procedures that result in occupational exposure. OSHA 
believes that merely grouping employees by location, e.g., designating 
all employees who work in the Emergency Department, may exclude 
employees who have occupational exposure since such a grouping could 
overlook employees who may occasionally enter the Emergency Department 
but are not routinely assigned there. OSHA seeks comment about the 
protectiveness of permitting exposure determinations to be made by 
location within a work setting in certain specific instances where the 
employer believes such a delineation is useful and will not misclassify 
employees and specifically requests examples of regulatory language 
that could achieve these objectives.
    Paragraph (c)(1)(ii) requires that the exposure determination be 
made without regard to the use of respiratory protection. It has been 
OSHA's long-standing position that the determination of occupational 
exposure be made without regard to the use of personal protective 
equipment such as respirators. The reason for this is that several 
conditions must be met for respiratory protection to effectively lessen 
exposures. First, the employee must be trained to use the equipment 
properly. Second, respiratory protection must be used each time the 
task requiring such protection is performed. Third, respiratory 
protection must fit properly. If even one of these conditions is not 
fully met, protection cannot be assured. Therefore, all tasks that 
entail occupational exposure need to be included in the exposure 
determination, regardless of the use of respiratory protection. This 
approach is consistent with other OSHA standards (e.g., Bloodborne 
Pathogens, 29 CFR 1910.1030; Formaldehyde, 29 CFR 1910.1048; Cadmium, 
29 CFR 1910.1027) and is essential to designing an appropriate exposure 
control program. Utilizing this approach assures that workers who 
perform tasks requiring respiratory protection will receive the 
training, medical surveillance, and other provisions of this standard 
that will enhance their safety should respiratory protection fail.
    Paragraph (c)(2) requires that each employer covered under the 
scope of the standard establish a written exposure control plan. The 
exposure control plan is a key provision of the standard because it 
requires the employer to identify the employees who receive training, 
respiratory protection and medical surveillance and to develop a number 
of policies and procedures that will eliminate or minimize employees' 
exposure to sources of aerosolized M. tuberculosis. However, because 
not all employers' work settings are the same, not all employers' 
exposure control plans will need to contain the same elements. The goal 
of the exposure control plan is to address the type of exposure that 
occurs in a given work setting, as identified under the exposure 
determination, and then to develop procedures and policies to minimize 
or eliminate that exposure. Thus, the size and complexity of the 
exposure control plan will be relative to the types of exposure 
encountered in the employer's work setting. For example, social service 
employees who must provide services to individuals who are in AFB 
isolation are covered under the scope of the standard. The employer in 
this case would only have to include certain minimal elements in his or 
her exposure control plan. This employer would not have to include 
elements for identifying individuals with suspected or confirmed 
infectious TB since these individuals will already have been identified 
by someone else. Similarly, the exposure control plan of such employers 
would not have to include procedures for isolating or managing the care 
of individuals with infectious TB. On the other hand, hospitals that 
admit or provide medical services to individuals with suspected or 
confirmed infectious TB would be required to have a more extensive 
exposure control plan since the employer in this case would be 
responsible for identifying, isolating and possibly performing high-
hazard procedures on individuals with suspected or confirmed infectious 
TB.
    Under paragraph (c)(2)(i), the proposed standard requires that the 
exposure control plan be written. There are several reasons for having 
the plan in writing. First, because exposure control must be practiced 
by everyone--employee and employer--it is imperative that an employee 
be able to find out what provisions are in place in his or her 
workplace. In addition, the exposure determination gives an employee 
who may be unfamiliar with the job a ready reference for ascertaining 
which job classifications, tasks, and procedures entail occupational 
exposure. Second, the exposure control plan also serves as an on-site 
adjunct to the overall infection control plan for the work setting and 
reinforces the employer's training program. Employees will be trained 
about the various procedures developed by the employer to eliminate and 
minimize exposure. Having the procedures written and available at the 
work site will provide a ready reference for employees and will serve 
as an adjunct to their training. Third, having the plan in writing is 
also important for enforcement purposes. By reviewing the exposure 
control plan, an OSHA compliance officer will be able to become 
familiar with the employer's determination of tasks and procedures with 
occupational exposure, the job classifications whose duties include 
those identified tasks, and the policies and procedures the employer 
uses to minimize occupational exposure along with any revisions to the 
exposure control plan.
    OSHA realizes that many workplaces covered under the scope of the 
proposed standard may already have comprehensive infection control 
plans

[[Page 54246]]

that may include many of the measures required by the proposed 
standard. It is not OSHA's intent for employers to duplicate current 
infection control plans solely for the purpose of complying with the 
standard. Therefore, the exposure control plan may be comprised of 
existing documents that are part of a larger infection control plan. 
However, all elements of the exposure control plan for TB required by 
the proposed standard must be included. In addition, the plan must be 
in some manner a cohesive entity by itself or a guidance document must 
exist that states the overall policy goals and directs the reader to 
the location of the separate documents that are being used to fulfill 
the requirements of the standard.
    While there will be differences in the elements of employers' 
exposure control plans, each employer covered under the scope of the 
standard must have certain minimal elements in his or her plan. 
Paragraphs (c)(2)(i)(A) through (c)(2)(i)(C) contain the minimal 
elements that must be included in the exposure control plans of every 
employer covered under the scope of the standard. Paragraph 
(c)(2)(i)(A) requires that the exposure control plan must include the 
exposure determination required under paragraph (c)(1). As discussed 
above, the exposure determination is necessary to identify those 
employees who have occupational exposure so that the employer can 
determine which employees are to be given respiratory protection, 
medical surveillance and training.
    Paragraph (c)(2)(i)(B) requires that the employer develop 
procedures for informing occupationally exposed employees about 
suspected or confirmed infectious TB cases and about air that may 
reasonably be anticipated to contain aerosolized M. tuberculosis in 
order that the employees can take proper precautions against M. 
tuberculosis exposure. Once individuals with suspected or confirmed 
infectious tuberculosis have been identified, it is necessary to convey 
this information to employees who may be exposed so that they may take 
the steps necessary to eliminate or minimize their exposure. When 
patient confidentiality may be a concern, it is not necessary to use an 
individual's name to satisfy this provision. For example, lists do not 
need to be made of all patients in the hospital with active TB. 
Information may be conveyed to employees by simply labeling the 
isolation room with the warning sign required under paragraph 
(h)(2)(iii) while the room is in use for TB isolation. Labeling the 
room will inform the employees that the individual in the room is in 
respiratory isolation and the employee must stay out of the room or don 
the appropriate respiratory protection before entering. Another 
scenario in which such notification is necessary would be when such an 
individual must be transported to another facility in an ambulance. In 
this case, the employees who will be present in the ambulance would 
have to be notified so that they could utilize proper precautions 
during the transport.
    Paragraph (c)(2)(i)(C) requires that the employer include in the 
exposure control plan procedures for reporting exposure incidents, 
including identification of the person to whom the incident is to be 
reported, and the procedures the employer will use for evaluating the 
circumstances surrounding exposure incidents as required by paragraph 
(g)(4)(iv). Under paragraph (j), Definitions, an exposure incident * * 
* is defined as

* * * an event in which an employee has been exposed to an 
individual with confirmed infectious TB or to air containing 
aerosolized M. tuberculosis without the benefit of all applicable 
exposure control measures required by this section.

    In the event that unprotected employees are exposed to aerosolized 
M. tuberculosis, it is necessary that this exposure incident be 
reported to the employer as soon as feasible in order to promptly 
initiate proper medical management and follow-up of the exposed 
employee. In addition, quick reporting of exposure incidents permits 
the employer to investigate the circumstances surrounding such 
incidents while pertinent conditions remain relatively unchanged and 
are fresh in the employee's memory.
    Procedures need to be in place describing how the exposure incident 
is to be investigated. Having investigation procedures in place 
beforehand will help to assure that such investigations are able to be 
done promptly and in a consistent and thorough manner from case to 
case. This will assist the employer in complying with the requirement 
of paragraph (g)(4)(iv) that directs the employer to investigate and 
document the circumstances surrounding the exposure incident to 
determine if changes can be instituted that will prevent similar 
occurrences in the future.
    Paragraph (c)(2)(ii) applies to employers who transfer individuals 
with suspected or confirmed infectious TB to a facility with AFB 
isolation capabilities. This would apply to employers who operate a 
facility from which an individual with suspected or confirmed 
infectious TB is transferred and would not apply to employers whose 
employees provide certain services such as social welfare services to 
individuals who have been isolated and in settings where home health 
care and home hospice care is provided.
    The standard does not require any employer to transfer individuals 
with suspected or confirmed infectious TB. Transfer is an option that 
employers have that relieves the employer of many provisions of the 
standard, such as AFB isolation rooms. If an employer chooses to use 
the transfer option, the employer must include the procedure for 
implementing the transfer in the exposure control plan.
    Paragraph (c)(2)(ii) requires employers who transfer individuals 
with suspected or confirmed infectious TB to develop exposure control 
plan procedures that address the following: (1) prompt identification 
of individuals with suspected or confirmed infectious TB; (2) masking 
or segregation of individuals with suspected or confirmed infectious 
TB; and (3) transfer of such individuals to a facility with AFB 
isolation capabilities.
    One of the most important steps in preventing TB transmission is 
the early detection of individuals who may have infectious TB (Exs. 3-
33, 3-34, 3-35, 4B). It is essential that individuals with suspected or 
confirmed infectious TB be identified as soon as possible so that 
employees who must have contact with them will be warned early and be 
able to use appropriate infection control practices to protect 
themselves from exposure. Obviously, the sooner this is done, the less 
occupational exposure there will be and the less likely that TB will be 
transmitted. In addition, early identification of individuals with 
suspected or confirmed infectious TB will allow for the timely transfer 
and initiation of effective treatment of those individuals for whom the 
diagnosis of TB is likely. By promptly administering effective 
treatment, these individuals can be rendered noninfectious, thus 
decreasing the time they are infectious and their potential for 
exposing employees and other people.
    OSHA is proposing that employers develop a procedure for the prompt 
identification of individuals with suspected or confirmed infectious TB 
as part of the exposure control plan. In order to assure prompt 
identification, it is necessary for the employer to have procedures in 
place regarding how this identification will be made. CDC has 
recommended that identification procedures be based on the prevalence 
and characteristics of TB in the population served by the specific 
facility (Ex. 4B). For example,

[[Page 54247]]

individuals who come from communities with a high prevalence of TB and 
exhibit certain signs of TB may be more highly suspected as having 
infectious TB than individuals from communities with a low prevalence 
of TB. OSHA, therefore, expects that the procedures may be different 
depending upon the local conditions.
    The procedure needs to contain the following:
    Methodology--The employer must describe how he or she will make the 
determination that an individual should be considered as having 
suspected or confirmed infectious TB. There are several ways of doing 
this. The employer can use information provided by a physician or other 
health care provider in advance of an individual's admission to the 
employer's facility that the individual has been diagnosed with 
suspected or confirmed infectious TB. If this is not available the 
employer must determine whether an individual should be considered as 
having suspected infectious TB. OSHA defines suspected infectious TB 
as:

    * * * a potential disease state in which an individual is known, 
or with reasonable diligence should be known, by the employer to 
have one or more of the following conditions, unless the 
individual's condition has been medically determined to result from 
a cause other than TB: (1) to be infected with M. Tuberculosis and 
to have the signs or symptoms of TB; (2) to have a positive acid-
fast bacilli (AFB) smear; or (3) to have a persistent cough lasting 
3 or more weeks and two or more symptoms of TB, e.g., bloody sputum, 
night sweats, anorexia, weight loss and fever. An individual with 
suspected infectious TB has neither confirmed infectious TB nor has 
he or she been medically determined to be noninfectious.

Although the definition specifies the criteria the employer must 
incorporate in his or her plan, the employer will still need to 
exercise judgment in determining whether an individual meets one or 
more prongs of the definition. Of course, an employer, such as one who 
operates a facility in an area of particularly high TB prevalence, is 
free to use more stringent (i.e., additional) criteria for considering 
an individual to have suspected infectious TB in his or her particular 
work setting.
    In situations where a medical diagnosis is not available either 
before or at the time of admission, an employer must collect the 
information he or she needs to make the determination. This can be 
accomplished in two ways. The employer can have an employee administer 
a medical history questionnaire to individuals seeking services from 
the facility. Another way to obtain information to make this 
determination is by having an employee observe the individual to 
ascertain his or her health status, looking for the signs, and asking 
about the symptoms included in OSHA's definition that may indicate 
infectious TB. Many employers will use both questionnaires and 
observation. The employee collecting the information will have to be 
trained on how to conduct the investigation effectively and with 
respect for the privacy of the individual.
    Responsibilities--The employer must designate responsibilities for 
determining whether an individual should be considered as having 
suspected or confirmed infectious TB. However, all employees need to be 
given clear instructions regarding their roles in the prompt 
identification of suspected or confirmed infectious TB cases. For 
example, the health care workers who are the first points of contact in 
ambulatory care settings and emergency rooms in hospitals could be 
involved with the initial screening of patients. They may be given 
several questions to ask a patient, which would be used as information 
to begin the determination. The next actions would depend upon the 
responses, and the authority of the health care workers. Some 
employees, for example, would only report answers to questions or their 
observation of signs of infectious TB in the client population to 
someone more knowledgeable. Other employees would be making 
determinations. The hospital would probably have a different procedure 
that would be used before or at admission to the hospital for scheduled 
services. The same hospital might have still another procedure 
designating responsibility to other employees for identifying patients 
who develop TB while in the hospital. The Exposure Control Plan must 
designate those employees who make the determination as to whether an 
individual has suspected or confirmed infectious TB. An employer should 
consider such designation(s) carefully because, regardless of who 
determines that an individual has suspected infectious TB, it is the 
employer who is responsible for ensuring that the employee knows and 
uses the proper criteria.
    The identification procedures will likely vary among 
establishments, depending upon the type of work done in the facility. 
For example, facilities that provide long-term care for the elderly 
will likely have a different procedure from hospitals that have an open 
admissions policy. OSHA also expects that the methods different 
employers use may vary depending on whether the employer is in an area 
of high or low TB prevalence. This approach is consistent with CDC 
recommendations.
    Promptness--Prompt identification of an individual with suspected 
or confirmed infectious TB is important because it allows isolation 
before the disease is spread through the facility. CDC recommends that 
procedures be in place for prompt identification. However, OSHA expects 
that the determination will be made as soon as reasonably practical 
since an employer cannot always make such a determination immediately. 
For many situations, such as those occurring in a hospice, the employer 
will have information regarding an individual's health status prior to 
admitting the individual to the facility. The employer can use this 
information to determine whether the individual should be considered as 
having suspected or confirmed infectious TB. In a long-term health care 
facility, the employer needs to be continually aware of each resident's 
health status because it can change rapidly. Information regarding the 
signs or symptoms suspected infectious TB needs to be reported and 
processed as soon as possible.
    Effectiveness--OSHA believes that an effective procedure, when 
implemented, will identify individuals as having suspected or confirmed 
infectious TB. OSHA believes that many employers affected by this 
proposed standard currently use effective procedures and find them to 
be practical. However, OSHA also recognizes that it will not be 
possible to ensure that the identification procedure will promptly 
detect all individuals with infectious TB each time. In homeless 
shelters, for example, the clients may withhold information requested 
in a questionnaire because they believe that such information may 
persuade the shelter to refuse to admit them. Therefore, homeless 
shelters may have to place greater reliance on observation of the 
residents for the cluster of signs and symptoms associated with 
infectious TB. Although this standard would require that homeless 
shelter workers and others be trained to look for signs in individuals, 
it is unlikely that all cases will be identified. However, if the 
employer finds that individuals with suspected and confirmed infectious 
TB are not being identified, the employer must investigate in order to 
determine what procedures need to be modified. During an inspection, an 
OSHA compliance officer will review the adequacy of the procedures, and 
although a citation would not be issued solely on the basis of failure 
to identify an individual with suspected infectious TB because no 
identification system is fool-proof,

[[Page 54248]]

failure to identify a number of individuals with undetected suspected 
or confirmed infectious TB would be good evidence that the procedures 
or their implementation need to be investigated and improved and could 
result in a citation.
    The employer must also include in the exposure control plan 
procedures for transferring individuals with suspected or confirmed 
infectious TB to facilities with AFB isolation capabilities. The 
procedures must address how those transfers are to take place in order 
that the transfers may be conducted promptly and with minimal exposure 
to employees. Specifically, they will include where the cases are to be 
transferred, how the transfer will occur, and what precautions 
employees are to take while individuals with suspected or confirmed TB 
are awaiting transfer.
    As the note to paragraph (c)(2)(ii) states, an employer's duties 
regarding transfer of an individual with suspected or confirmed 
infectious TB will vary with the type of facility the employer operates 
and the work performed by his or her employees. For example, the 
transfer responsibilities of hospitals, long-term care for the elderly, 
correctional facilities, and hospices may include contacting the 
receiving facility, providing transport, and taking other steps to 
ensure the individual can get to the receiving facility. These types of 
facilities often exercise custodial care over such individuals and, 
hence, have more responsibility for assuring completion of the 
transfer. Conversely, the responsibilities a homeless shelter or a 
facility that offers drug treatment for drug abuse, but that does not 
have custody over individuals, may only include providing information 
about the receiving facility, contacting the facility, and providing 
directions to the facility. An employer who provides home health care 
or home-based hospice care has no obligation to transfer an individual 
from his or her home to a receiving facility. Transferring an 
individual with suspected or confirmed infectious TB protects employees 
within the facility by making sure the source of occupational exposure 
is removed and, of course, benefits the individual in that he or she 
receives help in locating and getting to a receiving facility with the 
capability for appropriately managing their care.
    Paragraph (c)(2)(iii) outlines the additional elements required of 
employers who have work settings where individuals with suspected or 
confirmed infectious TB are admitted or provided with medical services. 
Paragraph (c)(2)(iii)(A) requires that their exposure control plans 
include procedures for the prompt identification of individuals with 
suspected or confirmed infectious TB. As discussed above, the early 
identification of individuals with infectious TB will help to assure 
that employees who must have contact with those individuals will be 
warned early and be able to use appropriate infection control practices 
to protect themselves from exposure. In addition, for employers who 
have facilities where individuals with suspected or confirmed 
infectious TB are admitted and provided medical services, prompt 
identification is essential so that isolation precautions and effective 
treatment can be initiated as soon as possible, thereby reducing 
exposure to employees and other people.
    Paragraph (c)(2)(iii)(B) requires that the employer develop 
procedures for isolating and managing the care of individuals with 
suspected or confirmed infectious TB. Having isolation procedures in 
place will help to assure that employees are aware of the steps to take 
in the event that individuals with suspected or confirmed infectious TB 
are identified. If employees know the proper procedures to follow, they 
will be better equipped to initiate isolation promptly, thereby 
reducing the likelihood that individuals with infectious TB will infect 
others. This provision is in accordance with the most recent CDC 
guidelines, which also recommend the procedures include:

(1) The indications for isolation, (2) who is authorized to initiate 
and discontinue isolation, (3) isolation practices, (4) monitoring 
of isolation, (5) management of patients who will not comply with 
isolation practices, and (6) criteria for discontinuing isolation. 
(Ex. 4B)

While OSHA allows the employer to determine what criteria should be 
included in the procedures to isolate, the Agency believes that it is 
prudent for the employer also to consider the elements listed in the 
CDC guidelines.
    Paragraph (c)(2)(iii)(B) also requires that the employer develop 
policies and procedures for managing the care of individuals with 
suspected or confirmed infectious TB once they have been placed in 
isolation. The exposure control plan must include procedures and 
polices addressing: (1) Minimization of the time an individual with 
suspected or confirmed infectious TB remains outside of an AFB 
isolation room or area, (2) minimization of employee exposure in AFB 
isolation rooms or areas, (3) delay of elective transport or relocation 
of individuals with infectious TB within the facility and, to the 
extent feasible, performance of services or procedures for such 
individuals in an AFB isolation room or area, (4) masking of 
individuals with infectious TB or use of portable containment 
engineering controls during transport outside of AFB isolation rooms 
and return of the individual to an AFB isolation room or area as soon 
as is practical after completion of the service or procedure, and (5) 
delay of elective high-hazard procedures and elective surgery until an 
individual with suspected or confirmed infectious TB is determined to 
be noninfectious.
    It is important to minimize, to the extent feasible, exposure of 
employees to aerosolized M. tuberculosis even while maintaining a high 
quality of health care and other required services. Developing policies 
and procedures addressing the items listed above will help to assure 
that this overall goal is met. For example, there may be times when an 
individual with suspected or confirmed infectious TB must leave the 
isolation room or area (e.g., when certain equipment necessary for 
providing care to the patient cannot be brought into the room). On 
these occasions having policies in place that minimize the time those 
individuals must be outside the isolation room or area will help to 
reduce the likelihood that droplet nuclei are spread. For example, if a 
particular procedure must be performed outside of the isolation room, 
time could be minimized by taking the individual directly to the 
procedure area, performing the procedure upon arrival, and returning 
the individual to isolation immediately after completion of the 
procedure. In addition, if a procedure is to be performed outside of 
the isolation room, a time could be chosen when the procedure area is 
not being used by others.
    The exposure control plan must also contain procedures for 
minimizing employee exposure in AFB isolation rooms or areas. For 
example, policies addressing minimizing both the number of employees 
and time that such employees spend in isolation rooms can reduce 
exposure. This can be accomplished in a variety of ways. For example, 
in order to minimize the number of employees entering an isolation 
room, certain tasks or procedures that might normally be done by 
several different employees could be done by one person. A nurse coming 
into the room to administer daily TB treatment could also bring in the 
patient's breakfast at the same time rather than have a hospital 
dietician deliver the meal. In addition, the

[[Page 54249]]

employer must address minimization of time that employees spend in an 
isolation room or area. For example, rather than conducting an entire 
discharge planning interview with an individual in person, the employee 
may be able to collect and convey a large part of the information over 
the phone with the individual. Personal contact could be limited to 
just the time needed to obtain items requiring direct interaction, such 
as the individual's signature.
    Policies are to be included that address the masking of individuals 
with infectious TB during transport outside of AFB isolation rooms or 
areas. Masking of individuals may be accomplished, for example, through 
the use of surgical masks or valveless respirators. A barrier such as a 
surgical mask, when placed over the mouth of an individual who is 
coughing, will reduce the formation of droplet nuclei because the mask 
will collect and contain the droplets as they are discharged before 
they have time to evaporate and form droplet nuclei. A respirator that 
does not have an exhalation valve can also be used to capture droplets 
being discharged. An exhalation valve would permit droplets to pass 
through and discharge into the air, where they could evaporate and form 
droplet nuclei. However, while surgical masks prevent the formation of 
droplet nuclei, they do not prevent exposure to droplet nuclei. As the 
document ``Biosafety Precautions for Airborne Pathogens'' states:

    There is no reciprocity between the means of prevention of the 
actual formation of droplet nuclei (coughing into a tissue) and the 
means of prevention of exposure (barriers to breathing in the 
droplet nuclei). Once a droplet nucleus has been allowed to form, 
its small size can penetrate the fiber of a tissue or a surgical 
mask. Thus these products do not represent adequate physical 
barriers to the aerosol transmission of droplet nuclei. The 
appropriate barrier is a well fitted respirator that does not allow 
leakage of air around the edges and blocks passage of microorganisms 
in the filter media (fibers or pores) through which air is inspired. 
Although a simple surgical mask applied to a tuberculosis patient 
who must be transported outside the isolation room will prevent the 
dispersal of organisms as droplet nuclei, such a mask does not 
provide adequate protection to the individual who must breathe air 
containing droplet nuclei. (Ex. 7-134)

    Since masking of an individual with suspected or confirmed 
infectious TB will reduce the number of droplet nuclei expelled into 
the air, the employer is required to develop policies addressing the 
masking of such individuals during transport outside of an AFB 
isolation room.
    It is not OSHA's intent to dictate patient management practices, 
nor will it be the Compliance Officer's responsibility to determine the 
correctness of certain patient management policies. However, the Agency 
believes that the employer must consider the above situations and 
develop policies that address them, keeping in mind the goal of 
minimizing employee exposure. This provision is in accordance with CDC 
recommendations (Ex. 4B).
    The exposure control plan must also contain policies for the delay 
of elective transport or relocation within the facility of individuals 
with suspected or confirmed infectious TB outside of an AFB isolation 
room or area. For example, delaying the transfer of an inmate with 
suspected or confirmed infectious TB from one prison to another, where 
possible, until the inmate has been determined to be noninfectious, 
will reduce not only the number of employees exposed, but will also 
minimize the exposure of other inmates, thereby decreasing the risk of 
transmission of disease.
    Similarly, the exposure control plan is to include policies for the 
delay of elective high-hazard procedures until an individual with 
suspected or confirmed infectious TB has been determined to be 
noninfectious. Elective high-hazard procedures (e.g., pulmonary 
function testing) or elective surgery (e.g., noncritical dental 
procedures) might be easily delayed, without compromising care, until 
an individual with infectious TB has been determined to be 
noninfectious.
    Paragraph (c)(2)(iii)(C) requires the employer to list all high-
hazard procedures performed in the workplace. As discussed in paragraph 
(j), Definitions, high-hazard procedures are defined as ``* * * those 
procedures performed on an individual with suspected or confirmed 
infectious tuberculosis in which the potential for being exposed to M. 
tuberculosis is increased due to the reasonably anticipated generation 
of aerosolized M. tuberculosis * * *'' Under paragraph (d)(4) of Work 
Practice and Engineering Controls, the proposed standard requires that 
all employers assure that high-hazard procedures are conducted in an 
AFB isolation room or area. Thus, listing the high-hazard procedures 
will serve to identify those procedures that require special 
ventilation considerations (e.g., maintaining negative pressure and 
properly exhausting contaminated air). This will assist employees in 
determining which procedures must be performed using such engineering 
controls and, consequently, will help minimize employee exposure.
    For employers who have work settings where TB cases are isolated, 
paragraph (c)(2)(iii)(D) requires the employer to develop a schedule 
for the inspection, maintenance, and performance monitoring of 
engineering controls. Engineering controls required by the proposed 
standard play an essential role in reducing employee exposures to M. 
tuberculosis. Thus, it is necessary that these controls be 
appropriately maintained, inspected and monitored in order to assure 
that they are functioning properly. Since engineering controls are 
mechanical systems, they are prone to occasional lapses in performance 
caused by occurrences such as clogged filters, slipping or broken drive 
belts, burned-out motors, obstructed ducts, and so forth. Since these 
situations cannot be predicted, it is necessary to regularly inspect 
engineering controls for proper functioning. Hence, a schedule must be 
developed for such activities. In addition, employees who are 
responsible for the maintenance will have a record that they can check 
to see when certain engineering controls need to be inspected, 
maintained or monitored. In general, OSHA has left the time frame for 
these activities up to the employer, except as required under 
paragraphs (d)(5)(ii) and (d)(5)(iii), since the employer is familiar 
with the characteristics of the workplace that could affect the 
performance of these controls (e.g., dusty conditions, high heat and 
humidity, seasonal variations).
    For facilities with clinical or research laboratories, Paragraph 
(c)(2)(iv) requires that the exposure control plan contain a 
determination from the director of the laboratory as to whether the 
laboratory facility should operate at Biosafety Level 2 or 3 
containment according to CDC/NIH recommendations. Under paragraph (e), 
Clinical and Research Laboratories, the proposed standard requires a 
number of provisions to eliminate or minimize exposure in clinical and 
research laboratory settings. These provisions are based on CDC/NIH 
recommendations (Ex. 7-72) for laboratory procedures performed under 
Biosafety Levels 2 and 3 for an infectious agent such as M. 
tuberculosis. However, as noted in the CDC/NIH recommendations, the 
selection of a biosafety level depends on a number of factors and it 
may be necessary to adapt the biosafety level based upon such factors. 
For example, the CDC/NIH recommendations state that:


[[Page 54250]]


    Occasions will arise when the laboratory director should select 
a biosafety level higher than that recommended. For example, a 
higher biosafety level may be indicated by the unique nature of the 
proposed activity (e.g., the need for special containment for 
experimentally generated aerosols for inhalation studies) or by the 
proximity of the laboratory to areas of special concern (e.g., a 
diagnostic laboratory located near patient care areas). Similarly, a 
recommended biosafety level may be adapted to compensate for the 
absence of certain recommended safeguards. For example, in those 
situations where Biosafety Level 3 is recommended, acceptable safety 
may be achieved for routine or repetitive operations (e.g., 
diagnostic procedures involving the propagation of an agent for 
identification, typing and susceptibility testing) in laboratories 
where facilities satisfy Biosafety Level 2 recommendations, provided 
the recommended Standard Biological Practices, Special Practices, 
and Safety Equipment for Biosafety Level 3 are rigorously followed. 
(Ex. 7-72, pg. 70)

    OSHA agrees that it is appropriate that such decisions be made by 
the laboratory director and would allow such adaptations to the CDC/NIH 
recommendations. However, regardless of adaptations, OSHA requires the 
laboratory director to determine and document the need for controlled 
access, anterooms, sealed windows, directional airflow, preventing 
recirculation of laboratory exhaust air, filtration of exhaust air 
before discharge outside, and thimble exhaust connections for 
biological safety cabinets. These determinations, along with any 
adaptations to the CDC/NIH biosafety level, must be made a part of the 
exposure control plan. The documentation will provide information to 
the laboratory employees of adaptations to and changes in recommended 
biosafety levels.
    For employers who provide home health care or home-based hospice 
care, paragraph (c)(2)(v) specifies the elements that are to be 
included in the exposure control plan. In home health care and home-
based hospice care situations, individuals are in their private homes 
receiving health care and other services and thus the employer has 
limited control over the work site in which he or she provides those 
services. In addition, employers providing such home-based care will 
not be transferring individuals identified as having suspected or 
confirmed infectious TB from their homes to facilities with isolation 
capabilities, nor will the employer be initiating isolation precautions 
in the home. In recognition of the uniqueness of home-based work 
settings, OSHA has limited the elements of the exposure control plan 
for an employer who provides home health care and home-based hospice 
care. The elements included under this paragraph are intended to 
address the type of activities that are likely to occur in the home 
health care work setting. Under this paragraph the employer must 
include procedures for prompt identification of individuals with 
suspected or confirmed infectious TB and for minimizing employee 
exposure to such individuals. As discussed above, in order for 
employees to take proper precautions in protecting themselves from 
exposure to TB, it is essential that there be procedures to identity 
potentially infectious individuals. In many cases the home health care 
employer may already know that the individual has been identified as 
having suspected or confirmed infectious TB and has been confined to 
their home. However, in other cases, an individual may be suffering 
from other immunocompromised conditions and may develop active TB. 
Because employees in home health care and home-based hospice care may 
be providing services to individuals at risk of developing active TB, 
it is necessary that there be procedures in place for identifying those 
individuals. In addition, the exposure control plan must include 
procedures for minimizing employee exposure. Such procedures might 
include minimizing the time spent in the home by combining tasks to 
limit the number of entries or by minimizing the number of employees 
who must enter the home along with the time they spend there. Paragraph 
(c)(2)(v) also requires that the exposure control plan include a list 
of high-hazard procedures, if any, performed in the workplace and 
procedures for delaying elective high-hazard procedures until the 
individual is noninfectious. Listing the high-hazard procedures will 
serve to identify those procedures that may require special 
considerations. In the home setting, this would not include the use of 
AFB isolation precautions. To the extent possible the employer should 
also include procedures for when these types of procedures can be 
delayed. This will decrease the exposure of employees to aerosolized M. 
tuberculosis that might be generated performing these procedures.
    Paragraph (c)(2)(vi) stipulates that the employer must document the 
number of confirmed infectious tuberculosis cases encountered in the 
work setting in the past 12 months in the Exposure Control Plan 
whenever the employer is using this information to claim reduced 
responsibilities related to paragraph (b), Application, and paragraph 
(g)(3)(iii)(D), Medical Surveillance, of the standard. Under paragraph 
(b), employers are relieved from implementing certain provisions of the 
standard if they do not admit or provide medical services to 
individuals with suspected or confirmed infectious TB and they can 
demonstrate that, in the past 2 years, there have been no cases of 
confirmed infectious TB reported in the local county in one or both 
years and, if any cases have occurred in one of the past 2 years, fewer 
than 6 confirmed infectious cases were reported in that year. 
Furthermore, employers desiring to follow the limited program must 
demonstrate that no such cases have been encountered in his or her 
employees' work setting in the past 12 months. Under paragraph 
(g)(3)(iii)(D) of Medical Surveillance, employees with negative TB skin 
tests are to be provided with a TB skin test every 6 months if the 
employee works in an intake area where early identification procedures 
are performed in facilities where six or more individuals with 
confirmed infectious TB have been encountered in the past 12 months. 
However, if the employer can document that fewer than 6 individuals 
with confirmed infectious TB have been encountered in the facility, the 
employee in the intake area would only have to be provided with a TB 
skin test annually. The count of the number of confirmed infectious TB 
cases in the exposure control plan would serve to document that fewer 
than 6 individuals with confirmed infectious TB had been encountered in 
the past 12 months, thus relieving the employer of the burden of 
providing skin tests every 6 months for those affected employees.
    Paragraph (c)(2)(vii)(A) requires that a copy of the exposure 
control plan be accessible to employees. The reason for this is to 
assure that an employee can get and consult the exposure control plan 
within a reasonable time, place and manner. Having access to the plan 
encourages employees to develop a complete understanding of the plan 
and its application, so that the program can be carried out by both 
employer and employees. Having the plan available also serves as an on-
site adjunct to the overall infection control program and may reinforce 
the training programs.
    For fixed work sites and primary workplace facilities, the plan 
must be maintained on-site at all times. For those situations where an 
employee(s) travels between work sites or where the employee's work is 
carried out at more than one geographical location, the plan may be 
maintained at the primary workplace facility. To ensure access, the 
plan should be in a central location

[[Page 54251]]

where an employee may see it whenever he or she wishes. However, in 
order to allow flexibility, OSHA is not specifying where the plan must 
be kept. The employer is permitted to determine where the plan is kept 
provided that the employee can access a copy of the plan at the 
workplace, within the workshift. For example, if the plan is maintained 
on a computer, access to the computer or hard copy must be available to 
the employee. Likewise, if the plan is comprised of several separate 
policy documents, copies of all documents must be accessible in 
addition to any general policy statement or guiding document that may 
exist.
    Paragraph (c)(2)(vii)(B) requires that the exposure control plan be 
reviewed at least annually and updated whenever necessary to reflect 
new or modified tasks, procedures, or engineering controls that affect 
occupational exposure and to include new or revised employee positions 
with occupational exposure. An example of such a situation would be 
when an employer in a facility that had previously transferred 
individuals with suspected or confirmed infectious TB decided that such 
individuals would be admitted and provided medical services. The 
purpose of this requirement is to assure that all new tasks and 
procedures are evaluated in order to determine whether they could 
result in occupational exposure. New and revised job classifications 
must be added to the lists of job classifications and tasks and 
procedures identified in (c)(1)(i) of this section in order to assure 
full coverage of occupationally exposed employees. The updating must 
occur as soon as feasible and may not be postponed until the annual 
review.
    Paragraph (c)(2)(vii)(C) requires that the exposure control plan be 
made available to the Assistant Secretary and the Director upon request 
for examination and copying. The purpose of this requirement is to 
allow the OSHA representative to review an employer's plan, including 
the exposure determination of employees at risk for occupational 
exposure. Although the Assistant Secretary or the Director could 
request the plan at any time, it will usually be requested by an OSHA 
compliance safety and health officer (CSHO) during the course of a 
workplace inspection. The CSHO needs to examine the plan in order to 
see what procedures and program planning for the control of 
occupational exposures have been instituted and whether they meet the 
requirements of the standard.

Paragraph (d)  Work Practices and Engineering Controls

    It is generally acknowledged that protection of the employee is 
most effectively attained by elimination or minimization of the hazard 
at its source, which engineering controls and work practices are both 
designed to do. Industrial hygiene principles also teach that control 
methods that depend upon the vagaries of human behavior are inherently 
less reliable than well-maintained mechanical methods. For these 
reasons, OSHA has preferred engineering and work practice controls and 
has required, under paragraph (d)(1), that they be used to eliminate or 
minimize employee exposure to M. tuberculosis. Nevertheless, OSHA 
recognizes that situations may exist in which neither of these control 
methods is feasible and that, in these circumstances, employee 
protection must be achieved through the use of personal protective 
equipment, primarily respirators. In other situations, personal 
protective equipment may have to be utilized in conjunction with 
engineering controls and/or work practices to obtain a further 
reduction in employee exposure.
    Engineering controls serve to reduce employee exposure in the 
workplace by either removing the hazard or isolating the worker from 
exposure. These controls include process or equipment redesign, process 
or equipment enclosure (e.g., biosafety cabinets), and employee 
isolation. In general, engineering controls act on the source of the 
hazard and eliminate or reduce employee exposure without reliance on 
the employee to take self-protective action.
    In comparison, work practice controls reduce the likelihood of 
exposure through alteration of the manner in which a task is performed 
(e.g., closing the door of an AFB isolation room immediately upon 
entering or exiting). Although work practice controls also act on the 
source of the hazard, the protection they provide is based upon 
employer and employee behavior rather than installation of a physical 
device. In many instances these two control methodologies work in 
tandem, because it is often necessary to employ work practice controls 
to assure effective operation of engineering controls. Under the 
provisions of the preceding paragraph, Exposure Control Plan, the 
employer is required to develop a number of work practices relative to 
controlling occupational exposure to TB. In paragraph (d)(2), these 
work practices are required to be implemented in the work setting.
    In developing the methods of compliance section for this proposal, 
OSHA carefully considered the work environments that have the potential 
for producing occupational exposures. Since the source of the hazard is 
frequently a living person, typical methods of reducing or eliminating 
the hazard at the source may not always be feasible. For example, in an 
industrial operation a process may be entirely enclosed and operated or 
monitored by an employee at a remote location, a situation that would 
rarely, if ever, occur in the work settings covered by this standard. 
The Agency believes, therefore, that prevention of exposures to M. 
tuberculosis will often require use of a combination of control methods 
to achieve adequate protection of employees. Paragraph (d)(1) requires 
work practices and engineering controls to be used to eliminate or 
minimize employee exposures.
    Not all facilities will have the capabilities to admit or provide 
medical services to individuals with suspected or confirmed infectious 
tuberculosis. Consequently, these facilities will have to transfer such 
individuals to another facility where isolation rooms or areas are 
available. Paragraph (d)(3) requires that individuals with suspected or 
confirmed infectious TB must be identified and, except in settings 
where home health care or home-based hospice care is provided, shall 
be: (i) masked or segregated in such a manner that contact with 
employees who are not wearing respiratory protection is eliminated or 
minimized until transfer or placement in an AFB isolation room or area 
can be accomplished; and (ii) placed in an AFB isolation room or area 
or transferred to a facility with AFB isolation rooms or areas within 5 
hours from the time of identification, or temporarily placed in AFB 
isolation within 5 hours until placement or transfer can be 
accomplished.
    Masking or segregation of individuals with suspected or confirmed 
infectious TB while those individuals are awaiting placement in 
isolation or transfer to another facility is done to assure that 
employee exposure is minimized to the extent feasible. This provision, 
drawn from CDC recommendations (Ex. 4B), is aimed at minimizing the 
exposure of employees in areas where individuals are first identified 
as having suspected or confirmed infectious TB. Although CDC recommends 
masking such individuals, OSHA presents a choice of masking or 
segregation because the Agency believes that this practice is directly 
involved with the medical management of such individuals. It is OSHA's 
mission to protect employees

[[Page 54252]]

from occupational exposure to tuberculosis and it is not the Agency's 
intent to dictate medical practice relative to individuals with 
suspected or confirmed infectious TB. Therefore, where the employer has 
chosen not to mask individuals with suspected or confirmed infectious 
TB when they are not in isolation rooms or areas or when such 
individuals cannot be masked (e.g., because they are combative), the 
employer must segregate these individuals in a manner such that contact 
with employees who are not wearing respiratory protection is eliminated 
or minimized. Segregation could be accomplished, for example, by having 
the individual wait in an area out of the main traffic of a waiting 
room or intake area or in a vacant examination room that is not needed 
for patient/client consultations. The time that a facility can permit 
an individual to await placement or transfer is limited to 5 hours. 
After that the individual must be placed in isolation.
    The primary purposes of AFB isolation rooms or areas are to (1) 
isolate patients who are likely to have infectious TB from unprotected 
employees, (2) prevent escape of droplet nuclei from the room, thus 
preventing entry of M. tuberculosis into the corridor and other areas 
of the facility where unprotected employees may be exposed, and (3) 
provide an environment that will promote reduction of the concentration 
of droplet nuclei through various engineering controls (Ex. 4B). All of 
these will reduce employee exposure. Indeed, placement of individuals 
with suspected or confirmed infectious TB in an AFB isolation room is 
the most effective way to prevent or lessen transmission.
    OSHA has proposed that individuals with suspected or confirmed 
infectious TB be isolated or transferred within 5 hours from the time 
of being identified as a suspected or confirmed case. The Agency 
realizes that the time it will take to isolate or transfer an 
individual once he or she is identified as having suspected or 
confirmed infectious TB may vary and that circumstances may arise that 
cause delays in initiating isolation (e.g., all isolation rooms may be 
occupied by other patients). However, OSHA is also concerned about the 
amount of time an individual, who has been identified as having 
suspected or confirmed infectious TB, should be permitted to stay in 
non-isolation areas. Individuals who must wait for extended periods of 
time before placement in AFB isolation or transfer may present a risk 
of exposure to employees working in these areas even though these 
individuals may be masked. A study by Moran et. al. shows that 
emergency departments that made a presumptive diagnosis of TB were able 
to initiate isolation in an average of 5 hours from the time of patient 
registration (Ex. 7-251). Patient registration usually precedes 
identification. The standard requires that procedures be in place for 
prompt identification of individuals with suspected or confirmed 
infectious TB. In view of this requirement and the fact that the study 
was based on time elapsed from patient registration to isolation, which 
included the time the patient waited to be medically observed, the 
Agency has preliminarily concluded that five hours from the time of 
being identified is a reasonable cutoff point for transfer or placement 
in isolation.
    The Agency's concern regarding permitting identified individuals to 
wait for extended periods, even though they are masked, before they are 
transferred or isolated is not unfounded. The American Thoracic 
Society, in its document Control Of Tuberculosis In The United States, 
states:

    * * *Patients unable to cooperate in covering coughs and sneezes 
can wear ordinary surgical masks for short periods, for example, 
while being transported within institutions. For longer periods, 
masks on patients are stigmatizing, uncomfortable, and probably 
ineffective. (Ex. 5-80) (emphasis added)

Consequently, a cutoff point of 5 hours has been proposed as the 
maximum amount of time individuals who have been identified with 
suspected or confirmed infectious TB may await transfer or placement 
into AFB isolation. As discussed under the Exposure Control Plan, 
paragraph (c), employers are required to have procedures in place for 
isolating or transferring individuals identified with suspected or 
confirmed infectious TB so that AFB isolation can be executed 
expeditiously. Five hours would appear to be a reasonable amount of 
time to carry out these procedures. OSHA believes that longer periods 
of time are likely to pose too great a risk of exposure to employees in 
the vicinity. The longer an individual with suspected or confirmed 
infectious TB remains outside of AFB isolation, the greater the risk of 
transmission.
    It should be noted that the 5-hour cutoff is the amount of time 
allotted per facility to accomplish AFB isolation or transfer of these 
individuals. More specifically, if an individual spent 4 hours awaiting 
transfer at an identifying facility, the receiving facility would still 
be allowed 5 hours to accomplish isolation, not just the one hour 
remaining since initial identification of the individual. The intent of 
the proposed facility-based 5-hour period is to allow the receiving 
facility adequate time to accomplish isolation and to recognize that 
the receiving facility should not be held responsible for circumstances 
beyond the facility's control (e.g., the time the individual waited 
before arrival at the receiving facility).
    If placement or transfer cannot be completed within five hours, it 
must be done as soon as possible thereafter. In addition, the employer 
must assure in such a case that his or her facility has AFB isolation 
rooms or areas for the isolation of the individual until placement or 
transfer can be accomplished. More specifically, it is not necessary to 
construct a dedicated AFB isolation room or area to isolate such 
individuals while awaiting transfer or placement within the facility. 
The definition of ``AFB isolation room or area'' states that this may 
be a room, area, booth, tent, or other enclosure that is maintained at 
negative pressure to adjacent areas in order to control the spread of 
aerosolized M. tuberculosis. For example, such isolation might be 
achieved by placing a portable stand-alone HEPA filtration unit (vented 
to the outside) in an unused examination room. Another method is the 
use of a rigid enclosure on casters with a ventilation unit to achieve 
negative pressure, a window kit to safely exhaust the enclosure's air 
to the outside, and a digital pressure monitor to assure maintenance of 
negative pressure within the enclosure. As is the case with any AFB 
isolation room or area, the means used to isolate an individual 
awaiting placement or transfer must achieve negative pressure and have 
its air safely discharged to the outside. OSHA seeks comment regarding 
the 5-hour limit on placement or transfer and measures that can be used 
for AFB isolation in those situations when transfer or placement cannot 
be accomplished within that time.
    Paragraph (d)(4) stipulates that high-hazard procedures must be 
conducted in AFB isolation rooms or areas. High-hazard procedures as 
defined in paragraph (b), Definitions, are procedures performed on an 
individual with suspected or confirmed infectious TB in which the 
probability of M. tuberculosis being expelled into the air is 
increased. These procedures include, but are not limited to, 
endotracheal intubation and suctioning, diagnostic sputum induction, 
aerosol treatments (including pentamidine therapy), pulmonary function 
testing, and bronchoscopy. These procedures also include autopsy, 
clinical, surgical, and laboratory procedures that may

[[Page 54253]]

aerosolize M. tuberculosis. In view of the increased probability of 
droplet nuclei generation associated with these procedures, all high-
hazard procedures are required to be performed in rooms, areas, or 
booths that meet AFB isolation criteria (e.g., negative pressure) in 
order to contain the droplet nuclei and eliminate or minimize employee 
exposure. Other procedures that may generate aerosols (e.g., irrigation 
of tuberculous abscesses, homogenizing or lyophilizing infectious 
tissue), are also covered by this provision. (See paragraph (e) of this 
proposal for requirements for microbiological practices and containment 
equipment in laboratories.)
    Paragraph (d)(5) requires that engineering controls be used in 
facilities that admit or provide medical services or AFB isolation to 
individuals with suspected or confirmed infectious TB except in 
settings where home health care or home-based hospice care is being 
provided. For example, engineering controls must be used in isolation 
rooms or areas, areas where high hazard procedures are performed, and 
autopsy rooms where M. tuberculosis may be aerosolized. This provision 
specifically excepts settings where home health care or home-based 
hospice care is being provided. In such situations, the employer is not 
in control of the employee's work setting because the setting is the 
private home of the individual being provided with care. In view of 
this, an employer providing home health care or home-based hospice care 
would not be required to implement engineering controls in the 
individual's home.
    In conjunction with this provision, paragraph (d)(5)(i) requires 
that negative pressure be maintained in AFB isolation rooms or areas. 
The purpose of this provision is to prevent the escape of aerosolized 
M. tuberculosis from a room and into the corridors and other areas of 
the facility where unprotected employees may be exposed. In order for 
air to flow from one area to another, there must be a difference in the 
pressure between the two areas. Air will flow from the higher pressure 
to the lower pressure area. The lower pressure area is at ``negative 
pressure'' relative to the higher pressure area. The level of negative 
pressure achieved will depend on the physical configuration of the 
area, including the air flow path and flow openings. A pressure 
differential of 0.001 inch of water and an inward air velocity of 100 
feet per minute (fpm) are minimum acceptable levels. The pressure 
difference necessary to achieve and maintain negative pressure in a 
room is very small and may be difficult to measure accurately. Negative 
pressure can be achieved by balancing the room supply and exhaust flows 
to set the exhaust flow to a value of 10% [but no less than 50 cubic 
feet per minute (cfm)] greater than the supply (Ex. 4B).
    As stated above, the negative pressure principle plays an important 
role in controlling the spread of M. tuberculosis to other areas of the 
facility where unprotected workers may be exposed. In isolation rooms 
and areas, and in areas where high hazard procedures (including 
autopsies) are performed, engineering controls creating negative 
pressure will prevent the escape of droplet nuclei from the room, thus 
preventing dispersion of M. tuberculosis into the corridor and other 
areas of the facility where unprotected employees may be working.
    In addition, negative pressure fulfills the secondary purpose of 
general ventilation by reducing the concentration of contaminants in 
the air. General ventilation maintains air quality by two processes, 
dilution and removal of airborne contaminants. Dilution reduces the 
concentration of contaminants in a room by supplying air that does not 
contain those contaminants. The supply air mixes with and then 
displaces some of the contaminated room air, which is subsequently 
removed from the room by the exhaust system. This process reduces the 
concentration of droplet nuclei in the room air and the risk of TB 
transmission.
    OSHA is not proposing to allow the use of ultraviolet germicidal 
irradiation (UVGI) in place of ventilation for controlling aerosolized 
M. tuberculosis. Although the germicidal properties of certain 
wavelengths of ultraviolet light (UV-C) are generally recognized, the 
Agency has not included UVGI as a primary engineering control in the 
proposed standard. With regard to the use of UVGI, CDC states:

    Because the clinical effectiveness of UV systems varies, and 
because of the risk for transmission of M. tuberculosis if a system 
malfunctions or is maintained improperly, UVGI is not recommended 
for the following specific applications: 1. Duct systems using UVGI 
are not recommended as a substitute for HEPA filters if air from 
isolation rooms must be recirculated to other areas of a facility. 
2. UVGI alone is not recommended as a substitute for HEPA filtration 
or local exhaust of air to the outside from booths, tents, or hoods 
used for cough-inducing procedures. 3. UVGI is not a substitute for 
negative pressure. (Ex. 4B)

The CDC goes on to discuss a number of factors that affect the 
effectiveness of UVGI and UV lamps in killing airborne tubercle 
bacilli. These factors include the intensity of UVGI, the duration of 
irradiation of the organism, the relative humidity of the environment, 
the age of the UV lamp, and the amount of dust on the lamp's surface 
(Ex. 4B). In light of this information, the Agency does not believe 
that UVGI can reliably and uniformly control airborne tubercle bacilli. 
Consequently, UVGI is not acceptable as a primary engineering control. 
However, some employers may choose to use UVGI as a supplement to 
ventilation or HEPA filtration. In recognition of this, OSHA has 
included information regarding UVGI safety and health concerns in 
Appendix D of this section.
    Paragraph (d)(5)(ii) requires that in those areas where negative 
pressure is required (i.e., AFB isolation rooms or areas), maintenance 
of negative pressure must be qualitatively demonstrated (e.g., by smoke 
trails) daily while in use for tuberculosis isolation. In Supplement 3 
of its 1994 guidelines, CDC states:

    TB isolation rooms should be checked daily for negative pressure 
while being used for TB isolation. (Ex. 4B)

The principle and advantages of negative pressure have been discussed 
above. Proper maintenance of negative pressure will prevent the 
contaminated air from escaping from the room or area and exposing 
unprotected employees. One means of qualitatively demonstrating 
negative pressure is through the use of smoke trail testing (see 
Appendix G of this section). Other methods include flutter strips or 
continuous monitoring devices. With regard to the safety and 
effectiveness of these methods, the CDC states:

    The concern over the use of smoke tubes is unfounded. Controlled 
tests by NIOSH have shown that the quantity of smoke that is 
released is so minute that it is not measurable in the air. The 
location of the patient and the length of time the patient is 
exposed dilute the smoke to several orders of magnitude below an 8-
hour exposure limit. It is not practical and often not effective to 
use flutter strips or continuous monitoring devices as alternatives 
to indicate directional air movement. The air flow (due usually to 
the small clearance area under the door) is insufficient to move the 
flutter strip. Likewise, low negative pressure, which will 
satisfactorily provide adequate directional air flow into the 
isolation room, may not be readable on continuous monitoring 
devices. Devices must be capable of reading 0.001 inch of water, the 
established minimum, to be effective. (Ex. 4B)

In light of this information, employers should be aware that when 
choosing a method other than smoke trails to demonstrate maintenance of 
negative pressure, the method chosen should be

[[Page 54254]]

reviewed carefully in order to assure that the intended test can be 
effectively conducted.
    Paragraph (d)(5)(iii) stipulates that engineering controls must be 
maintained, and inspected and performance monitored for filter loading 
and leakage every six months, whenever filters are changed, and more 
often if necessary to maintain effectiveness. The primary intent of 
this provision is to assure that engineering controls are maintained in 
such a manner that they continue to function effectively. As discussed 
previously, a number of factors can affect the functioning of 
engineering controls, such as frozen bearings, broken belts, and burned 
out motors. It is the employer's responsibility to maintain engineering 
controls in proper working condition. That is, if a belt breaks on a 
fan motor, it is not appropriate to delay repairs until the six-month 
inspection. This provision does, however, stipulate a maximum time 
period of six months between inspections and performance monitoring of 
engineering controls and HEPA filters in air systems carrying air that 
may reasonably be anticipated to contain aerosolized M. tuberculosis. 
The employer's maintenance schedule may specify more frequent 
inspection, maintenance, and performance monitoring based upon 
conditions found in that particular work site. For example, the 
employer, being more familiar with his or her own work setting, may 
have knowledge that the work environment is very dusty, thus 
necessitating a more frequent period for changing the filters. When 
filters are changed, performance monitoring must be conducted to assure 
that the filter has been correctly installed and is functioning 
properly. In view of the importance of these systems in reducing the 
concentration of droplet nuclei and thereby the risk of TB 
transmission, OSHA believes that six months is the longest period that 
these systems should be allowed to operate without inspection and 
performance monitoring. This maximum six-month period of time between 
consecutive inspections and performance monitoring of HEPA filters is 
supported by CDC (Ex. 4B).
    Paragraph (d)(5)(iv) requires that air from AFB isolation rooms or 
areas must be exhausted directly outside, away from intake vents and 
employees. If the air from these areas cannot be exhausted in such a 
manner or must be recirculated, it must pass through HEPA filters 
before discharge or recirculation.
    In order for the air to be safely discharged, exhaust ducts must 
not be located near areas that may be populated (e.g., sidewalks or 
windows that may be opened). In addition, ventilation system exhaust 
discharges must be designed to prevent re-entry of exhaust air. Wind 
blowing over a building creates a highly turbulent recirculation zone, 
which can cause re-entry of the exhaust into the building. Exhaust flow 
needs to be discharged above the zone. When exhaust air cannot be 
safely discharged, it must pass through HEPA filters to remove droplet 
nuclei, thereby precluding re-entry of potentially contaminated air or 
exposure of individuals who may have to pass through the exhaust 
airstream. The employer should be aware that exhausting of this air may 
also fall under federal, state and local regulations concerning 
environmental discharges.
    This provision also states that if a portion of this air is 
recirculated, it must pass through a properly designed, installed, and 
maintained HEPA filter before discharge back into general facility 
ventilation. HEPA filters clean air through the physical removal of 
particulates from the airstream. These filters have a minimum removal 
efficiency of 99.97% for particles  0.3 microns in diameter. 
Droplet nuclei of M. tuberculosis range in size from 1 micron to 5 
microns in diameter. Therefore, HEPA filtration can be expected to 
remove most droplet nuclei from the air. It should be noted that 
whenever feasible, exhaust air from the AFB isolation rooms or areas 
must be exhausted to the outside. In its 1994 guidelines, CDC states:

    Air from TB isolation rooms and treatment rooms used to treat 
patients who have confirmed or suspected infectious TB should be 
exhausted to the outside in accordance with applicable Federal, 
state, and local regulations. The air should not be recirculated 
into the general ventilation. In some instances, recirculation of 
air into the general ventilation system from such rooms is 
unavoidable (i.e., in existing facilities in which the ventilation 
system or facility configuration makes venting the exhaust to the 
outside impossible). In such cases, HEPA filters should be installed 
on the exhaust duct leading from the room to the general ventilation 
system to remove infectious organisms and particulates the size of 
droplet nuclei from the air before it is returned to the general 
ventilation system (Section II.F; Suppl. 3). Air from TB isolation 
rooms and treatment rooms in new or renovated facilities should not 
be recirculated into the general ventilation system. (Ex. 4B)

The Agency agrees with CDC that exhaust air should be vented to the 
outside. However, OSHA recognizes that there may be instances where 
outside discharge may not be feasible and has, therefore, permitted 
recirculation with HEPA filtration of the recirculated air, in such 
instances.
    Paragraph (d)(5)(v) states that ducts carrying air that may 
reasonably be anticipated to contain aerosolized M. tuberculosis must 
be maintained under negative pressure for their entire length before 
in-duct HEPA filtration or until the ducts exit the building for 
discharge. Ducts maintained under negative pressure will contain 
exhaust air within the system. Air will not escape to the outside as it 
would under positive pressure even if there are leaks in the ducts. The 
purpose of this provision is to prevent escape of air that may contain 
aerosolized M. tuberculosis into areas where occupational exposure is 
not anticipated and unprotected employees may be exposed.
    Paragraph (d)(5)(vi) requires that, while in use for TB isolation, 
doors and windows of AFB isolation rooms or areas must be kept closed 
except when doors are opened for the purpose of entering or exiting and 
when windows are part of the ventilation system being used to achieve 
negative pressure. For example, the window may be serving as the exit 
for the exhaust from an in-room HEPA filtration unit. As stated above, 
AFB isolation rooms and areas are to be maintained under negative 
pressure while in use for TB isolation. Negative pressure in a room can 
be altered by small changes in the ventilation system operation, or by 
the opening and closing of the isolation room doors or windows. In 
order to assure that the ventilation system functions as intended, it 
is essential that, once an operating configuration has been 
established, doors and windows be opened only when necessary.
    Paragraph (d)(5)(vii) stipulates that when an AFB isolation room or 
area is vacated by an individual with suspected or confirmed infectious 
TB, the room or area must be ventilated for an appropriate period of 
time, according to current CDC recommendations for a removal efficiency 
of 99.9%, before permitting employees to enter without respiratory 
protection (see Appendix C of this section). The time required for 
removing airborne particles from an enclosed space depends on several 
factors. These include the number of air changes per hour (which is 
determined, in part, by the number of cubic feet of air in the room or 
booth), the rate at which air is entering the room or booth at the 
intake source versus the rate at which it is being exhausted, the 
location of the ventilation inlet and outlet, and the physical 
configuration of the room or booth. The times needed to achieve a given 
removal efficiency (i.e., 90%, 99%, and 99.9%) presented in

[[Page 54255]]

Appendix C of this section assume perfect air mixing within a space. 
However, perfect mixing of air normally does not occur because a number 
of factors, such as room configuration, may influence the movement of 
air. Because perfect air mixing is not likely to occur, the necessary 
time required for a specific removal efficiency, as presented in 
Appendix C of this section, may be underestimated. In order to 
compensate for this shortcoming, OSHA has proposed that the most 
conservative (i.e., protective) removal efficiency, i.e., 99.9%, be 
used to determine the appropriate amount of time an AFB isolation room 
or area must be ventilated before permitting employees to enter without 
respiratory protection. Using this conservative approach will help to 
assure that an appropriate time has passed before unprotected employees 
enter the area, even in situations where perfect air mixing has not 
occurred. Ventilation of the room would not be necessary if the room 
was previously occupied by an individual with suspected infectious 
tuberculosis and that individual was medically determined to be 
noninfectious, since there would be no droplet nuclei present.
    Paragraph (d)(6) requires that the employer must inform any outside 
contractor who provides temporary or contract employees who may incur 
occupational exposure of the hazard, so that the contractor can 
institute precautions to protect his or her employees. OSHA is 
concerned that the contractor be aware of the existence of TB hazards 
so that appropriate actions can be undertaken to prevent the 
contractor's employees from being unwittingly exposed. By conveying 
such information to the contractor, accountability for these employees 
is established. If the contractor is aware of the hazards, then it is 
the responsibility of the contractor to institute procedures to protect 
his or her employees from occupational exposure to M. tuberculosis.

Paragraph (e)  Clinical and Research Laboratories

    This paragraph addresses requirements that must be met by clinical 
and research laboratories engaged in the culture, production, 
concentration, experimentation, and manipulation of M. tuberculosis. 
These requirements apply in addition to the other requirements of the 
standard.
    The risks associated with direct and routine work with pathogens 
have long been recognized:

    Microbiology laboratories are special, often unique, work 
environments that may pose special infectious disease risks to 
persons in or near them. Personnel have contracted infections in the 
laboratory throughout the history of microbiology. (Ex. 7-72)

Clinical and research laboratories working with M. tuberculosis are no 
exception, and the risks associated with work in such facilities 
warrant additional protective measures.
    Prior to 1984, no single code of practice, standards, guidelines or 
other publication providing detailed descriptions of techniques or 
equipment for laboratory activities involving pathogens was available. 
In that year, the CDC and the National Institutes of Health (NIH) 
published guidelines entitled ``Biosafety in Microbiological and 
Biomedical Laboratories''. These biosafety guidelines were based on 
combinations of standard and special practices, equipment, and 
facilities recommended for use when working with various infectious 
agents in laboratory settings. The most current revision of these 
guidelines is dated 1993. (Ex. 7-72)
    The biosafety guidelines are not limited to M. tuberculosis, which 
is the subject of this standard. They are applicable to work with any 
infectious agent. The basic format for the biosafety guidelines 
categorizes infectious agents and laboratory activities into four 
classes or levels denoted as Biosafety Levels 1 through 4. These 
biosafety levels (BSL) are comprised of combinations of laboratory 
practices and techniques, safety equipment, and laboratory facilities 
appropriate for the operations performed and the hazard posed. The 
Guidelines indicate the BSL to be used when working with various 
infectious agents and infected animals.
    There is a risk to employees working with materials containing M. 
tuberculosis. When the concentration of this bacterium is increased as 
the result of growing it in cell culture or through artificial 
concentration, then the risk of transmission to employees increases if 
the bacteria are not contained. Therefore, the proposed standard 
requires the employer to implement a number of provisions specifically 
related to these laboratory work settings.
    The requirements in paragraph (e), including those regarding 
biosafety cabinets, are derived primarily from the CDC/NIH 
recommendations found in ``Biosafety in Microbiological and Biomedical 
Laboratories'' (Ex. 7-72). Only those provisions that relate to the 
health and safety of employees are required by the standard. The 
provisions in paragraph (e) are a minimal program, and OSHA anticipates 
that employers affected by this paragraph will continue to follow any 
other appropriate portions of the above recommendations in addition to 
the requirements of this standard. In addition, the employer is 
responsible for following this entire standard (e.g. training 
employees, medical surveillance).
    Paragraph (e) applies to two types of facilities that OSHA has 
designated as ``clinical laboratories'' and ``research laboratories.'' 
For the purpose of this standard a clinical laboratory is a laboratory 
or area of a facility that conducts routine and repetitive operations 
for the diagnosis of TB, such as preparing acid-fast smears and 
culturing sputa or other clinical specimens for identification, typing 
or susceptibility testing. A research laboratory is a laboratory that 
propagates and manipulates cultures of M. tuberculosis in large volumes 
or high concentrations that exceed those used for the identification 
and typing activities common to clinical laboratories.
    The proposed standard requires, in paragraphs (e)(2)(i)(A) through 
(D), that both clinical and research laboratories follow several 
standard microbiological practices. All procedures are to be performed 
in a manner that minimizes the creation of aerosols. In view of the 
mode of transmission of M. tuberculosis, that is, through inhalation of 
airborne organisms, this provision is extremely important in 
eliminating or minimizing employee exposure. It is the responsibility 
of the employer to evaluate laboratory tasks and institute the measures 
necessary to minimize the creation of aerosols.
    OSHA also proposes to adopt the good laboratory and infection 
control practice of prohibiting pipetting or suctioning by mouth. The 
use of cotton plugs or other barriers does little to reduce the hazards 
of mouth pipetting. Even a technician who is skilled in mouth pipetting 
may inadvertently suck fluids containing M. tuberculosis into the 
mouth. In addition to producing M. tuberculosis-containing aerosols 
when the fluid is expelled, these fluids may also contain bloodborne 
pathogens that would have contacted the employee's mucous membranes 
(i.e., the mouth) as well as any blisters, cuts, or other lesions in 
the mouth or on the lips.
    Work surfaces and laboratory equipment must be decontaminated at 
the end of each shift and after any spill of viable material. This is 
recognized as good laboratory practice in minimizing the spread of 
contamination.
    Finally, the proposed standard requires that all cultures, stocks, 
and other wastes contaminated with M. tuberculosis be decontaminated 
before

[[Page 54256]]

disposal by a decontamination method, such as autoclaving, known to 
effectively destroy M. tuberculosis. Materials to be decontaminated 
outside of the immediate laboratory are to be placed in a durable 
leakproof container, closed to prevent leakage for transport from the 
laboratory, and labeled or color coded in accordance with paragraph 
(h)(1)(ii) of this section. Decontamination before disposal helps 
assure that other employees are not inadvertently exposed to the 
bacterium.
    Although the proposed standard requires proper containerization of 
laboratory wastes, it includes no such requirement for wastes 
originating from the provision of care or services to individuals with 
suspected or confirmed infectious TB (e.g., facial tissues that the 
individual has used). The reason for this is that items, such as facial 
tissues, capture and contain the liquids generated by the individual. 
Once captured, the liquid is not readily aerosolized. In their 
guidelines, the CDC states:

    Disposable items contaminated with respiratory secretions are 
not associated with transmission of M. tuberculosis. (Ex. 4B)

In the laboratory, however, the liquids containing M. tuberculosis are 
generally not captured or contained on an item but exist as an 
individual specimen or culture. Also, in some instances, the bacilli 
have been concentrated. The possibility, therefore, for formation of 
droplet nuclei from these wastes is increased. Consequently, it is 
necessary to properly containerize and label laboratory wastes to 
assist in preventing droplet nuclei formation and possible infection. 
Proper containerization and labeling of wastes to be decontaminated 
outside a laboratory not only help prevent employee exposure but also 
warn employees who come in contact with this waste of the hazard within 
the container.
    Paragraphs (e)(2)(ii)(A) through (E) describe special practices to 
be followed in clinical and research laboratories, such as limiting 
access to the laboratory to authorized personnel, preparing and 
maintaining a biosafety manual, properly containerizing materials 
contaminated with M. tuberculosis, immediately containerizing and 
cleaning up all spills potentially contaminated with M. tuberculosis, 
and posting a sign with the universal biohazard symbol on access doors 
when materials containing or animals infected with M. tuberculosis are 
present. Limiting access to these laboratories assures that 
unauthorized individuals are not placed at risk, and that they do not 
distract or otherwise interfere with the activity of the authorized 
employees. This provision works in concert with the requirement for 
signs in paragraph (h)(2)(iv) and ensures that only employees who meet 
the special requirements set forth by the laboratory director, which 
will include training, personal protective equipment, and other 
requirements, could enter the area.
    The requirement for a biosafety manual helps assure that any 
additional procedures are developed to address situations that are 
unique to a particular facility and to provide appropriate protection 
to exposed employees. The manual must be reviewed as necessary and at 
least annually. The manual must also be updated as necessary to reflect 
changes in the work setting. The phrase ``as necessary'' has been used 
to indicate that updating of the manual to reflect work setting changes 
is to be done as soon as possible and is not to be postponed until the 
annual review. Employees are required to read the biosafety manual's 
sections on potential hazards and practices and procedures.
    The requirement that contaminated material removed from the work 
area be placed in a container that prevents leakage during collection, 
handling, processing, storage, transport, or shipping is to assure that 
there are no accidental spills or other contamination that may place 
other employees at risk.
    Paragraph (e)(2)(ii)(D) requires that spills be cleaned up 
immediately by employees trained and equipped to work with potentially 
concentrated M. tuberculosis. Because M. tuberculosis can become 
aerosolized during cleanup procedures, the task cannot be done by 
someone who is not skilled and properly equipped. In addition, exposure 
incidents must be reported so that the post-exposure management and 
follow-up required by paragraph (g) can be initiated and the 
circumstances surrounding the exposure incidents can be investigated.
    Paragraph (e)(2)(ii)(E) requires that, when materials or animals 
infected with M. tuberculosis are present in the laboratory, a hazard 
warning sign, in accordance with paragraph (h)(2)(iv) of Communication 
of Hazards and Training, incorporating the universal biohazard symbol, 
shall be posted on all laboratory and animal room access doors. Because 
M. tuberculosis is present in the materials listed above, it is 
necessary to warn individuals who may enter this area of the hazards 
that are present so that they can take proper precautions to guard 
themselves against exposure.
    The requirements of paragraph (e)(2)(iii)(A) stipulate that 
whenever activities with the potential for generating aerosols of M. 
tuberculosis are conducted, and whenever high concentrations or volumes 
of M. tuberculosis are used, a certified Class 2 biological safety 
cabinet must be used. Such materials may be centrifuged in the open 
laboratory, i.e., outside of a biosafety cabinet, if sealed rotor heads 
or centrifuge safety cups are used. These requirements protect 
employees from exposure during the performance of procedures by 
assuring that aerosolized M. tuberculosis will be contained and kept 
away from the worker's breathing zone.
    Paragraph (e)(2)(iii)(B) requires that biological safety cabinets 
shall be certified when they are installed, annually thereafter, 
whenever they are moved, and whenever filters are changed. Biological 
safety cabinets must be certified to ensure that they will provide the 
proper protection. The National Sanitation Foundation (NSF) Standard 49 
describes design, construction, and performance criteria for biosafety 
cabinets. (Ex. 7-135) Moreover, this NSF standard is subject to 
periodic review by the NSF in order to keep the requirements consistent 
with new technology. OSHA has incorporated the current NSF Standard 49 
performance criteria into the OSHA standard. For example, Standard 49 
states:

    * * * that each cabinet be tested and performance evaluated on 
site, assuring that all physical containment criteria are met at the 
time of installation, prior to use, and periodically thereafter. 
(Ex. 7-135)

NSF Standard 49 also calls for recertification of cabinets at least 
annually, when HEPA filters are changed, and after maintenance repairs 
or relocation of a cabinet. Therefore, OSHA believes that the 
requirements in the proposed standard are appropriate and that cabinets 
that are certified by the manufacturer as Class 2 or 3 will provide 
adequate protection to employees.
    Paragraph (e)(2)(iv) requires that a method for decontamination of 
wastes contaminated with M. tuberculosis (e.g., autoclave, chemical 
disinfection, incinerator, or other approved decontamination system 
known to effectively destroy M. tuberculosis) must be available within 
or as near as feasible to the work area. The availability of such 
methods of decontamination is required for inactivating or destroying 
M. tuberculosis in or on a variety of media, including culture fluids, 
plastic ware, and equipment. These materials must be decontaminated to 
prevent potential aerosolization of M.

[[Page 54257]]

tuberculosis and inadvertent exposure of employees outside of the 
laboratory.
    Research laboratories working with M. tuberculosis are held to 
several additional requirements. Paragraph (e)(3)(i)(A) requires that 
research facilities keep laboratory doors closed when working with M. 
tuberculosis. Paragraph (e)(3)(i)(B) requires that access to the work 
area be limited to persons who comply with specified entry and exit 
requirements. These provisions are adopted from the CDC/NIH 
recommendations for ``Biosafety in Microbiological and Biomedical 
Laboratories'' (Ex. 7-72). In addition, paragraph (e)(3)(i)(C) requires 
that respiratory protection shall be worn in research laboratories when 
aerosols cannot be safely contained (e.g., when aerosols are generated 
outside a biological safety cabinet). As stated previously, research 
laboratories are working with larger volumes and higher concentrations 
of M. tuberculosis than clinical laboratories. As such, the risk to 
employees from aerosolized bacilli is increased, necessitating that 
these employees be protected whenever lapses in containment occur. An 
example of when aerosols would be generated would be when a flask 
containing M. tuberculosis is dropped and broken outside of the 
biosafety cabinet. Another example would be centrifugation of M. 
tuberculosis-containing cultures in an open centrifuge without aerosol-
proof centrifuge safety containers, or utilizing such containers but 
then opening them outside of the biosafety cabinet (Ex. 7-134).
    Paragraph (e)(3)(ii) requires employers to ensure that employees 
manipulating cultures and clinical or environmental materials that may 
generate M. tuberculosis-containing aerosols, challenging animals with 
M. tuberculosis aerosols, harvesting tissues or fluids from infected 
animals, or performing necropsies on infected animals use the 
appropriate containment equipment and/or devices when performing these 
activities. Such equipment and devices include Class 2 or 3 biosafety 
cabinets, or appropriate combinations of personal protective equipment 
and physical containment devices (such as respirators, centrifuge 
safety cups, sealed centrifuge rotors, and containment caging for 
animals). This requirement, like the others in this paragraph, is 
intended to ensure that employees are protected during the performance 
of these potentially high-hazard procedures.
    Research laboratories are also held to additional requirements with 
regard to facility construction. Paragraph (e)(3)(iii)(A) requires that 
the laboratory be separated from areas that are open to unrestricted 
traffic flow within the building. Passage through two sets of self-
closing doors is the requirement for entry into the work area from 
access corridors or other contiguous areas. This type of entrance 
reduces the likelihood of untrained employees accidentally entering the 
work area, since such entry necessitates deliberate action on the part 
of the individual.
    Paragraph (e)(3)(iii)(B) requires that windows in the laboratory be 
closed and sealed. This helps assure containment of any aerosols and 
helps maintain proper operation of biosafety cabinets through 
minimization of cross drafts.
    Paragraph (e)(3)(iii)(C) requires that a ducted exhaust air 
ventilation system shall be provided which creates directional airflow 
that draws air from clean areas into the laboratory toward contaminated 
areas. The proper direction of the airflow shall be verified (i.e., 
into the work area) by the employer at least every six months. The 
exhaust air shall not be recirculated to any other area of the 
building, shall be discharged to the outside, and shall be dispersed 
away from occupied areas and air intakes. The requirement that research 
laboratories have verified directional airflow into the work area is to 
assure that air is drawn into the laboratory toward contaminated areas 
to assist in maintaining containment of aerosols within the laboratory.
    Paragraph (e)(3)(iii)(D) requires that the HEPA-filtered exhaust 
from Class 2 or 3 biosafety cabinets is to be discharged to the outside 
of the building or through the building exhaust system. If it is 
discharged through the building exhaust system, it must be connected to 
this system in a manner that avoids any interference with the air 
balance of the cabinets or the building exhaust system. This is 
required to assure that biosafety cabinets and the building exhaust 
system continue to function as intended.
    Paragraph (e)(3)(iii)(E) requires that continuous flow centrifuges 
or other equipment that may produce aerosols must be contained in 
devices that exhaust air through a HEPA filter before discharge into 
the laboratory. This assures that any aerosols which may contain M. 
tuberculosis are effectively filtered from the exhaust air before 
discharge into the laboratory, thereby protecting employees against 
inadvertent exposure.
    All of the requirements discussed above were derived directly from 
the CDC/NIH's ``Biosafety in Microbiological and Biomedical 
Laboratories.'' OSHA requests comment on the applicability and OSHA's 
application of CDC/NIH's guidelines for their use in laboratories which 
handle M. tuberculosis.

Paragraph (f)  Respiratory Protection

    Respirators serve as supplemental protection to reduce employee 
exposures when engineering and work practice controls are not 
sufficient to provide adequate protection against airborne 
contaminants.
    At the opening of the public hearings for the revision of OSHA's 
General Industry Respiratory Standard, 29 CFR 1910.134, the Agency 
stated that all aspects of respirator use for protection against 
tuberculosis would be addressed in the rulemaking for Occupational 
Exposure to Tuberculosis. Consequently, the respiratory protection 
portion of this proposal contains all of the respiratory protection 
provisions that have been preliminarily determined to be applicable to 
respirator use for TB. In the past, OSHA standards have referred to the 
Respirator Standard (29 CFR 1910.134) for the general requirements for 
respirator use (e.g., written respiratory protection program; 
respirator maintenance) and have included only the respirator 
provisions specific to the hazard addressed by the standard. OSHA's 
approach in this proposal, however, is to include provisions relative 
to all aspects of respirator use for tuberculosis. This will provide 
interested parties with the opportunity to review and comment on these 
aspects. To assure consistency across OSHA respiratory protection 
standards, however, OSHA is considering including in the final TB rule 
cross-referencing to the general requirements of the Respiratory 
Protection Standard (29 CFR 1910.134) and retaining in the final TB 
rule only those provisions specific to respirator use for TB. OSHA 
seeks comment on this intended approach in the final standard for TB.
    Paragraph (f)(1)(i) states that each employer must provide a 
respirator to each employee who: (A) enters an AFB isolation room or 
area in use for TB isolation; (B) is present during performance of 
procedures or services for an individual with suspected or confirmed 
infectious TB who is not masked; (C) transports an individual with 
suspected or confirmed infectious TB in an enclosed vehicle or who 
transports an individual with suspected or confirmed infectious TB 
within the facility whenever that individual is not masked; (D) 
repairs, replaces, or maintains air systems or equipment that may 
reasonably be anticipated to contain aerosolized M. tuberculosis; (E)

[[Page 54258]]

is working in an area where an unmasked individual with suspected or 
confirmed infectious TB has been segregated or otherwise confined 
(e.g., while awaiting transfer), and (F) is working in a residence 
where an individual with suspected or confirmed infectious TB is known 
to be present. In addition, paragraph (f)(1)(ii) requires that each 
employer who operates a research laboratory provide a respirator to 
each employee who is present when aerosols of M. tuberculosis cannot be 
safely contained.
    In discussing the use of respiratory protection in their 
guidelines, CDC states:

    Personal respiratory protection should be used by (a) persons 
entering rooms where patients with known or suspected infectious TB 
are being isolated, (b) persons present during cough-inducing or 
aerosol-generating procedures performed on such patients, and (c) 
persons in other settings where administrative and engineering 
controls are not likely to protect them from inhaling infectious 
airborne droplet nuclei. These other settings include transporting 
patients who may have infectious TB in emergency transport vehicles 
and providing urgent surgical or dental care to patients who may 
have infectious TB before a determination has been made that the 
patient is noninfectious. (Ex. 4B)

The guidelines also state that respiratory protection should be worn by 
personnel who are performing maintenance and testing procedures on HEPA 
filtration systems (Ex. 4B). Furthermore, the CDC/NIH document 
``Biosafety in Microbiological and Biomedical Laboratories'' recommends 
that respiratory protection be worn whenever aerosols of organisms such 
as M. tuberculosis cannot be safely contained (Ex. 7-72). Consequently, 
employees who may need to wear respirators could include not only 
health care providers but also employees such as housekeepers, dietary 
personnel, laboratory technicians, employees in intake areas, 
maintenance personnel, social workers, and so forth. It is the 
employer's responsibility to determine which occupationally exposed 
employees would be covered under this provision and, therefore, would 
need to wear a respirator.
    With regard to utilization of respiratory protection when entering 
an AFB isolation room or area, the reader is referred to the definition 
of ``AFB isolation room or area'' in paragraph (j), Definitions. This 
definition clarifies that the requirement refers not only to situations 
such as entering a patient room occupied by an individual with 
suspected or confirmed infectious TB but also refers to entering any 
area where high-hazard procedures are being performed and entering an 
autopsy room where M. tuberculosis may be aerosolized.
    Paragraph (f)(1)(i)(B) requires respirator use when an employee is 
present during performance of procedures or services for an unmasked 
individual with suspected or confirmed infectious TB. This provision is 
intended to cover those situations in which a procedure or service is 
performed outside of an AFB isolation room or area. For example, a 
facility may not have a portable X-ray and may, therefore, perform this 
procedure in a standard X-ray room. If the individual is not masked in 
such a situation, all employees present (i.e., the X-ray technician and 
any other employees in the room) must utilize respiratory protection.
    As stated previously under discussion of Scope, employees rendering 
emergency medical services may spend time in very close proximity to 
individuals with suspected or confirmed infectious TB within an 
enclosed vehicle. Even though the individual may be masked, droplet 
nuclei that escape capture in the mask are contained within the 
vehicle, thereby increasing the likelihood that employees will breathe 
droplet nuclei generated when the patient coughs or speaks. In 
addition, under paragraph (f)(1)(i)(D), employees who repair, replace, 
on maintain air systems or equipment that may reasonably be anticipated 
to contain aerosolized M. tuberculosis are at risk of occupational 
exposure as a result of exposure to air that could contain aerosolized 
bacilli. Therefore, respirator use would be required in this situation.
    As discussed under Scope, aerosolized M. tuberculosis is a 
recognized hazard to laboratory personnel. When aerosols of M. 
tuberculosis cannot be safely contained, such as during a spill, the 
employer is required to provide a respirator to each employee who is 
present during this time. This is consistent with CDC/NIH 
recommendations regarding respirator use in research laboratories (Ex. 
7-72).
    Unlike some other airborne contaminants, the quantity of M. 
tuberculosis that, when inhaled, will result in infection (i.e., 
infectious dose) has not been determined conclusively. The number of 
droplet nuclei expelled into a room by an infectious individual or 
aerosol-producing procedure and the concentration of droplet nuclei in 
a room or area are unknown. Consequently, there is no basis to judge 
the effectiveness of other control measures present even though they 
may be operating as intended. OSHA therefore agrees with the CDC that, 
in the above situations, other controls that may be in place cannot be 
assumed to adequately protect employees against exposure to airborne TB 
droplet nuclei and therefore that the use of respiratory protection is 
necessary.
    While OSHA agrees with and has adopted most of the CDC's 
recommendations regarding when respiratory protection is necessary, the 
Agency has extended respirator use to two additional situations. More 
specifically, when an individual with suspected or confirmed infectious 
TB is not masked and is transported within a facility, the employee 
transporting the individual must wear a respirator. While CDC 
recommends masking individuals with suspected or confirmed infectious 
TB prior to transporting them, there may be special circumstances in 
which the individual may not be masked (e.g., individual is combative 
and will not wear a mask). The employee transporting the individual 
would most likely spend an extended period of time in close proximity 
to the individual, either walking beside or behind (e.g., pushing a 
wheelchair) the individual. The employee would, therefore, be walking 
directly through the airspace into which the individual would be 
expelling droplet nuclei, receiving exposure each time the individual 
coughed, resulting in multiple relatively concentrated exposures. In 
view of this, the latter portion of paragraph (f)(1)(i)(C) addresses 
the Agency's belief that it is necessary and justified that respiratory 
protection be worn by the employee to protect against occupational 
exposure if the individual is not masked.
    The second situation, under paragraph (f)(1)(i)(E), requires 
respirator use by an employee when working in an area where an unmasked 
individual with suspected or confirmed infectious TB has been 
segregated or otherwise confined, for example while awaiting transfer. 
As discussed above, it is assumed that such individuals would normally 
be masked. Here again, however, there may be circumstances that 
preclude the individual from being masked (e.g., the individual is 
combative). Therefore, employees who must work in the area where these 
unmasked individuals are located, whether working directly with the 
individual or performing other duties, must wear a respirator to 
protect against possible tuberculosis infection.
    Paragraph (f)(1)(i)(F) requires that a respirator be worn by an 
employee who is working in a residence where an individual with 
suspected or confirmed

[[Page 54259]]

infectious TB is known to be present. In this situation, whether the 
individual is masked or unmasked does not trigger respirator use since 
the individual has been releasing droplet nuclei into the residence 
airspace. The CDC refers to this type of situation in its discussion of 
the provision of home health care and states:

    Health care workers who provide medical services in the homes of 
patients who have suspected or confirmed infectious TB should 
instruct such patients to cover their mouths and noses with a tissue 
when coughing or sneezing. Until such patients are no longer 
infectious, HCWs should wear respiratory protection when entering 
these patients' homes. (Ex. 4B)

    In addition to home health care and home-based hospice care 
workers, other employees, such as social workers who are entering these 
residences, would come under this provision. It is the Agency's intent 
that a respirator be used by an employee in these situations for the 
time that the employee is in the residence and that respirator use 
continue until the individual is noninfectious.
    The proposed standard, in paragraphs (f)(1)(iii) and (f)(1)(iv), 
places several general responsibilities upon the employer regarding 
respiratory protection. Paragraph (f)(1)(iii) states that where 
respirators are required by the standard, the employer shall provide 
them at no cost to the employee and assure that they are used in 
accordance with the requirements of the standard. Paragraph (f)(1)(iv) 
stipulates further that the employer must assure that the employee dons 
a respirator before entering the work settings or performing the tasks 
set forth in paragraphs (f)(1)i and (f)(1)(ii) above and uses it until 
leaving the work setting or completing the task, regardless of other 
control measures in place.
    It has been OSHA's long-standing policy to hold the employer 
responsible for controlling exposure to hazards in his or her workplace 
and to fulfill this responsibility at no cost to the employee. 
Therefore, the financial burden for purchasing and providing personal 
protective equipment, including respirators, rests upon the employer 
just as it does for all other control measures (e.g., engineering 
controls). OSHA believes that in order to assure that employees are 
adequately protected, the employer has the responsibility not only to 
provide respiratory protection, but also to assure that it is utilized 
when necessary. Furthermore, respiratory protection must be donned 
prior to entering the above work settings or performing the tasks, for 
the period of time that the employee remains in these work settings, 
and must not be removed until the employee leaves the work setting or 
completes the tasks. In this way, the employee is protected for the 
entire period of occupational exposure.
    It is not OSHA's intent that each employee be monitored constantly 
for compliance; however, the Agency does believe that the employer has 
the power to assure that employees follow specific rules. For example, 
most employers have requirements that they require employees to follow, 
such as reporting to work on time, working a minimum number of hours 
per day, notifying the employer when the individual is unable to report 
for work, and taking certain precautions to prevent nosocomial 
infections. Following these requirements is not left to the employee's 
discretion, and employers generally have some process to ensure 
conformance with these procedures. Therefore, the Agency believes that 
the employer has not only the responsibility, but also the ability, to 
assure that respiratory protection is used in accordance with the 
requirements of this section.
    Paragraph (f)(2)(i) requires that each employer who has any 
employee whose occupational exposure is based on entering any of the 
work settings or performing any of the tasks described in paragraph 
(f)(1) must establish and implement a written respiratory protection 
program that assures that respirators are properly selected, fitted, 
used, and maintained. The program must include the following elements: 
(A) Procedures for selecting respirators for use in the work setting; 
(B) a determination of each employee's ability to wear a respirator, as 
required under paragraph (g)(3)(ii), Medical Surveillance, for each 
employee required to wear a respirator; (C) procedures for the proper 
use of respirators; (D) fit testing procedures for tight-fitting 
respirators; (E) procedures and schedules for cleaning, disinfecting, 
storing, inspecting, repairing, or otherwise maintaining respirators; 
(F) training of employees to assure the proper use and maintenance of 
the respirators as required under paragraph (h), Communication of 
Hazards and Training; and (G) procedures for periodically evaluating 
the effectiveness of the program. Written standard operating procedures 
are essential to an effective respiratory protection program. 
Developing and writing down standard operating procedures require 
employers to think through how all of the requirements pertaining to 
respirators will be met in their workplace. In addition, this provision 
assures that the employer establishes standardized procedures for 
selecting, using, and maintaining respirators in the workplace. OSHA's 
long-standing position has been that a systematic respiratory 
protection program is necessary to provide for consistency in 
protection. Guidance that has been developed by an outside party (e.g., 
a respirator manufacturer) on the general use of a particular 
respirator would not address the site-specific aspects of the 
employer's work setting and would not be an appropriate substitute for 
a respiratory protection program.
    Paragraph (f)(2)(ii) requires the employer to designate a person 
qualified by appropriate training or experience to be responsible for 
the administration of the respiratory protection program and for 
conducting the required periodic evaluations of its effectiveness. To 
assure that the integrity of the respiratory protection program is 
maintained through the continuous oversight of one responsible 
individual, OSHA is proposing that a qualified person be designated as 
responsible for the administration of the program. That individual can 
work with a committee or assign responsibility for portions of the 
program to other personnel, but the overall responsibility for the 
operation of the program remains with the designated person. This 
approach ensures coordination of all facets of the program. The level 
of training or experience necessary for a designated person has been 
left performance oriented since this will vary with the complexity of 
the respirator program. However, the person chosen would need to have 
sufficient knowledge of respiratory protection and the workplace to 
properly supervise the program.
    Employers are required, in paragraph (f)(2)(iii), to review and 
update the written program as necessary to reflect current workplace 
conditions and respirator use. Reviewing and updating will assure that 
the program addresses current conditions. The reason OSHA has not set a 
schedule for reviewing the program is because conditions may change 
frequently in some work settings while remaining relatively stable in 
others. Thus, the employer determines the frequency of the review. 
However, when an employer is aware of changes in the workplace or 
respirator use which could necessitate changes in the written program, 
it is not appropriate to delay revising the written program. OSHA's use 
of the phrase ``as necessary'' in the requirement is intended to assure 
that such changes are incorporated into the written program 
expeditiously. As the workplace situation or respirator use

[[Page 54260]]

changes, the program is to be revised. In addition, paragraph 
(f)(2)(iv) requires that employers, upon request, make the written 
respiratory protection program available to affected employees, their 
designated representatives, the Assistant Secretary, and the Director. 
This provision also requires that a copy of the program be submitted to 
the Assistant Secretary and/or the Director, if requested.
    Paragraph (f)(3) sets out the respirator characteristics that must 
be satisfied in order to provide employees with a respirator that will 
protect them against aerosolized M. tuberculosis. These criteria are 
presented in performance-oriented language to provide flexibility in 
choice of respirators and have been drawn from CDC recommendations (Ex. 
4B). CDC has based these criteria on currently available information 
relative to respirators that includes:

    * * * (a) data on the effectiveness of respiratory protection 
against noninfectious hazardous material in workplaces other than 
health-care settings and on an interpretation of how these data can 
be applied to respiratory protection against M. tuberculosis; (b) 
data on the efficiency of respirator filters in filtering biological 
aerosols; (c) data on face-seal leakage; and (d) data on the 
characteristics of respirators that were used in conjunction with 
administrative and engineering controls in outbreak settings where 
transmission to HCWs and patients was terminated (Ex. 4B).

    The CDC Guidelines go on to state:

    Available data suggest that infectious droplet nuclei range in 
size from 1 [micron] to 5 [microns]; therefore, respirators used in 
health-care settings should be able to efficiently filter the 
smallest particle in this range. Fifty liters per minute is a 
reasonable estimate of the highest airflow rate an HCW is likely to 
achieve during breathing, even while performing strenuous work 
activities (Ex. 4B).

    In their 1994 TB guidelines, the CDC states:

    Respiratory protective devices used in health-care settings for 
protection against M. tuberculosis should meet the following 
standard performance criteria:
    1. The ability to filter particles 1 um in size in the unloaded 
state with a filter efficiency of  95% (i.e., filter 
leakage of  5%), given flow rates of up to 50 L per 
minute.
    2. The ability to be qualitatively or quantitatively fit tested 
in a reliable way to obtain a face-seal leakage of  10%.
    3. The ability to fit different facial sizes and characteristics 
of HCWs [health care workers], which can usually be met by making 
the respirators available in at least three sizes.
    4. The ability to be checked for facepiece fit, in accordance 
with standards established by the Occupational Safety and Health 
Administration (OSHA) and good industrial hygiene practice, by HCWs 
each time they put on their respirators. (Ex. 4B)

The various respirator provisions that OSHA is proposing rely heavily 
on the CDC's aforementioned respirator performance criteria. The 
second, third, and fourth CDC criteria are addressed by paragraphs 
(f)(3)(i) (A) and (B) and paragraph (f)(5)(ii). Paragraph (f)(3)(i) 
requires the employer to select and provide properly fitted negative 
pressure or more protective respirators. Negative pressure respirators 
must be capable of being: (A) Qualitatively or quantitatively fit 
tested in a reliable way to verify a face-seal leakage of no more than 
10%; and (B) fit checked by the employee each time the respirator is 
donned. Paragraph (f)(5)(ii) requires that employers assure that each 
employee who must wear a tight-fitting respirator is fit tested and 
passes the fit test. All of these provisions deal with the ability of 
the respirator to achieve a good face seal with a particular employee.
    Good face fit is critical in assuring proper performance of 
respiratory protection. When an employee inhales through a respirator 
that does not fit properly, contaminated workplace air can enter the 
respirator through gaps and leaks in the seal between the face and the 
facepiece. OSHA is requiring the employer to provide each employee who 
must wear a respirator with one that fits. To do so, the employer will 
have to consider the facial sizes and characteristics in his or her 
workplace. It is not necessary for the employer to have respirators of 
different sizes of characteristics unless the employees need them. In 
other words, an employer may need only one or two styles and sizes. 
However, in workplaces where employees have different facial sizes and 
characteristics, obtaining proper respirator fit for each employee may 
require the fit testing of different mask sizes, possibly from several 
manufacturers. Proper respirator fit reduces inhalation leakage through 
the face-to-facepiece seal to a minimum.
    Once a respirator has been selected based on its ability to achieve 
an adequate face-to-facepiece seal, the employee must be able to check 
that the respirator is properly seated and sealed to his or her face 
each time it is donned. The respirator, therefore, must be able to be 
fit checked by the employee. This is a procedure in which the employee 
covers the filter surface of the respirator and inhales (negative fit 
check) and exhales (positive fit check). If the respirator has an 
exhalation valve, this valve must be covered during the positive fit 
check. A respirator that is properly sealed will firmly adhere to the 
wearer's face upon inhalation due to the negative pressure created 
inside the mask. Upon exhalation, the mask should lift slightly off of 
the wearer's face to allow air to escape around the face seal. 
Employers should be aware that a problem could exist with fit checking 
some disposable negative pressure respirators. That is, it is difficult 
to cover the entire filter surface, thereby hindering the employee's 
ability to perform a proper fit check. At least one respirator 
manufacturer has developed a ``fit-check cup'' that covers the filter 
surface of their disposable respirator, thereby permitting the user to 
more easily perform a fit check. Reusable elastomeric facepiece 
respirators utilize filter cartridges that can be covered for 
performing a fit check.
    CDC's first criteria, regarding filter efficiency, is addressed 
under paragraph (f)(3)(ii) of the standard. This provision requires the 
employer to select a respirator that will function effectively in the 
conditions of the work setting. In addition to meeting the criteria in 
paragraph (f)(3)(i) above, the respirator shall be, at a minimum, 
either a High Efficiency Particulate Air (HEPA) respirator selected 
from among those jointly approved as acceptable by the Mine Safety and 
Health Administration (MSHA) and by the National Institute for 
Occupational Safety and Health (NIOSH) under the provisions of 30 CFR 
part 11, or an N95 respirator certified by NIOSH under the provisions 
of 42 CFR part 84.
    NIOSH and MSHA are the government agencies charged with testing and 
certifying respiratory protective devices. It has always been OSHA's 
policy that respiratory protection must be certified by these agencies 
before being deemed acceptable. Until recently, HEPA respirators were 
the only NIOSH certified negative pressure respirators that met the 
CDC's filter efficiency criteria. However, on July 10, 1995, NIOSH's 
original respirator certification procedures for air-purifying 
particulate respirators, 30 CFR part 11, were replaced by revised 
procedures, 42 CFR part 84 (Ex. 7-261). Under the new procedures, all 
nonpowered air-purifying particulate respirators are challenged with a 
0.3 micron particle (the most penetrating size) at a flow rate of 85 
liters per minute. At the conclusion of the test, those respirators 
that pass are placed into one of nine classes of filters (three levels 
of filter efficiency, with three categories of resistance to filter 
efficiency degradation). The three levels of filter efficiency are 
99.97%, 99%, and 95%. The three categories of resistance to filter 
efficiency degradation are labeled N (not resistant to oil), R 
(resistant to

[[Page 54261]]

oil), and P (oil proof). Given these categories, a type N95 respirator 
would meet or exceed the filter efficiency performance criteria set 
forth in the CDC guidelines which state that a respirator appropriate 
for use in protecting against transmission of tuberculosis must be able 
to filter particles 1 micron in size in the unloaded state with a 
filter efficiency of 95%, given flow rates up to 50 liters 
per minute (Ex. 4B). The underlying reasoning for the acceptability of 
type N95 respirators is that their filter efficiency of 95% for a 0.3 
micron particle will exceed 95% filtering efficiency for a particle 
three times as large (i.e., 1 micron). Also, the Agency assumes that 
oil aerosols are not likely to be found in the work settings covered by 
the standard, and therefore, that the use of a category N respirator 
would be sufficient. However, if oil aerosols are present, the employer 
would be expected to consider this when selecting the category of 
respirator to be used in his or her workplace.
    OSHA is permitting the employer to select either a HEPA respirator 
certified under 30 CFR part 11 or a respirator certified under 42 CFR 
part 84, since particulate respirators certified under both of these 
regulations are currently on the market. HEPA respirators are the only 
nonpowered particulate respirators certified under 30 CFR part 11 that 
meet the CDC guidelines filtration criteria. However, applications for 
certification of nonpowered particulate respirators under 30 CFR part 
11 are no longer being accepted by NIOSH. Therefore, dwindling stocks 
of HEPA respirators certified under that regulation will eventually 
lead to their unavailability, and employers will of necessity be 
selecting respirators from those approved under 42 CFR part 84.
    Paragraph (f)(4)(i) states that the employer shall not permit any 
respirator that depends on a tight face-to-facepiece seal for 
effectiveness to be worn by employees having any conditions that 
prevent such a seal. Examples of these conditions include, but are not 
limited to, facial hair that comes between the sealing surface of the 
facepiece and the face or facial hair that interferes with valve 
function, absence of normally worn dentures, facial scars, or headgear 
that projects under the facepiece seal. Paragraph (f)(4)(ii) requires 
the employer to assure that each employee who wears corrective glasses 
or goggles wears them in such a manner that they do not interfere with 
the seal of the facepiece to the face of the wearer. Tight-fitting 
facepiece respirators rely on a good face-to-facepiece seal in order to 
achieve effective protection. Therefore, the employer must not allow 
employees to wear such respirators with conditions that prevent such a 
seal. Several studies support the prohibition of facial hair that comes 
between the sealing surface of the facepiece and the face (Exs. 7-243, 
7-242, 7-182). A study by Skretvedt and Loschiavo found that bearded 
subjects wearing half-mask respirators had a median face seal leakage 
246 times greater than clean shaven subjects. They go on to state:

    Even though a number of bearded individuals did obtain fit 
factors above OSHA's minimum requirement for half-mask respirators, 
they all failed the qualitative fit test. No relationship was found 
between the length, shape, density and texture of beards and the 
amount of face seal leakage. Therefore, the only way to identify 
bearded negative-pressure respirator wearers obtaining fit factors 
above OSHA's minimum requirements would be by performing a 
quantitative fit test on them. However, even if quantitative fit 
tests are performed on all bearded individuals, another problem must 
be faced. The drop in the fit factor experienced when a beard is 
present is of such magnitude that no confidence can be placed in the 
protection the respirator will provide in the workplace or in future 
donnings. All respirator users experience variability from one 
donning to the next. This fit variability from donning to donning 
occurs due to changes in strap tension, positioning on the face, and 
a host of other variables. Donning-to-donning fit variability for 
bearded individuals will be even greater since additional variables 
will be introduced. A beard is a dynamically changing thing. The 
hair length constantly changes as well as the orientation of the 
hair in the sealing surface. Beards also accumulate moisture, 
natural oils, and debris from the workplace. Even though a 
percentage of bearded respirator wearers obtain fit factors slightly 
above OSHA's minimum requirements, the tremendous drop in fit factor 
resulting from the presence of a beard is such that the safety 
factor necessary to accommodate the variability of fit no longer 
exists. In summary, although bearded individuals may be able to 
achieve fit factors above OSHA's minimum requirements during a 
specific quantitative fit test, the drop in protection caused by a 
beard coupled with the large fit variability from donning to donning 
makes it quite likely that the individual will not obtain the 
minimum required protection in the workplace. (Ex. 7-243)

    Therefore, while a bearded respirator wearer may be able to obtain 
a satisfactory fit on a particular occasion, one cannot assume that the 
individual can reliably be expected to achieve that same protection 
level each time the respirator is used. Beards grow and change daily. 
Each time a respirator is donned there is fit variability. Such 
variability in face seal is greatly increased for bearded workers. This 
large variability in fit means that a reliable seal cannot be 
reasonably expected. This provision should not be construed as a 
blanket prohibition on beards among respirator wearers. There are other 
types of respiratory equipment such as hoods, helmets and suits that 
can be worn by employees with beards, since they do not rely upon a 
tight facepiece fit. In addition, this provision refers to facial hair 
that interferes with the facepiece seal rather than simply growth of 
beard or sideburns. It is the interference with the facepiece seal that 
is the concern, not the presence of facial hair. Other conditions such 
as the absence of normally worn dentures, facial scarring and cosmetic 
surgery change the geometry of the face, thereby changing the ability 
of the respirator wearer to achieve a facepiece seal. Facepiece seal 
may also be compromised when headgear, temple pieces and nose pieces of 
glasses, the edges of goggles and so forth project underneath the 
respirator's sealing surface. Both of the above provisions are intended 
to eliminate or minimize conditions that jeopardize face-to-facepiece 
seal and could permit leakage of outside air into the facepiece.
    Paragraph (f)(4)(iii) states that disposable respirators must be 
discarded when excessive resistance, physical damage, or any other 
condition renders the respirator unsuitable for use. It is not expected 
that the filter media of respiratory protective devices would become 
occluded with particulates in the work settings covered by this 
standard. However, if excessive resistance is noted, the respirator 
must be discarded. Also, such respirators must be structurally sound in 
order to provide a proper face seal and maintain their effectiveness. 
Whenever physical damage occurs (e.g., the respirator is crumpled or 
torn; the flexible face seal is damaged; a head strap is broken), 
effective functioning cannot be assured and the respirator must be 
replaced. In addition, other conditions may render the respirator 
unsuitable for use (e.g., the respirator may become contaminated with 
blood), thereby requiring discard.
    In view of the types of activities carried out and the 
environmental conditions encountered in the work settings covered by 
this standard, OSHA is proposing to allow the multiple use of 
disposable respirators. However, this action should in no way be 
construed as setting a precedent for the use of disposable respirators 
in any other OSHA standards or in how OSHA views multiple use of 
disposable respirators in other work settings. OSHA requests comment on 
the approach taken in this proposal toward the reuse of disposable 
respirators.

[[Page 54262]]

    Paragraph (f)(4)(iv) requires the employer to assure that each 
employee, upon donning a tight-fitting respirator, performs a facepiece 
fit check prior to entering a work area where respirators are required. 
In performing the fit check, the procedures in Appendix B or other 
procedures recommended by the respirator manufacturer that provide 
equivalent protection to the procedures in Appendix B must be used. 
This provision is supported by a recent study by Meyers et al. that 
concluded:

    * * * for wearers of respirators that have been properly fit by 
a recognized fit test, conducting fit checks according to the 
manufacturer's instructions can be a useful tool for more 
consistently maintaining the quality of respirator donning. (Ex. 7-
233)

The use of such seal checks are a way of helping to assure that 
attention is paid to obtaining an adequate facepiece seal each time a 
respirator is used.
    The standard requires, under paragraph (f)(4)(v), that respirators 
be immediately repaired, or discarded and replaced when they are no 
longer in proper working condition. Examples of these changes in 
condition would be that a strap has broken, the respirator has lost its 
shape, or the face seal can no longer be maintained. As discussed 
above, respirators must be in good working condition in order to 
function effectively. Therefore, it is imperative that they not be used 
if they have been impaired in any way. The respirator manufacturers can 
supply replacement parts for damaged portions of their elastomeric 
respirators. Disposable respirators cannot be repaired and must be 
discarded when damaged.
    Paragraph (f)(4)(vi) stipulates that the employer shall permit each 
employee to leave the respirator use area as soon as practical to: (A) 
change the filter elements or replace the respirator whenever the 
ability of the respirator to function effectively is compromised or the 
employee detects a change in breathing resistance; or (B) wash his or 
her face and respirator facepiece as necessary to prevent skin 
irritation associated with respirator use. This provision encourages 
and facilitates the proper use of respirators by employees by 
authorizing employees to take specific actions to assure the effective 
functioning of their respirators. This provision is consistent with 
requirements in other health standards (e.g., Lead, 29 CFR 1910.1025; 
Cadmium, 29 CFR 1910.1027).
    Considering the health problems that may be exacerbated with 
respirator use and their associated detrimental effects on an employee, 
the proposal states in paragraph (f)(4)(vii) that each employee 
required to wear a respirator under this section shall be evaluated in 
accordance with paragraph (g), Medical Surveillance, of this section to 
determine whether any health conditions exist that could affect the 
employee's ability to wear a respirator. In addition, paragraph 
(f)(4)(viii) states that no employee shall be assigned a task requiring 
the use of a respirator if, based upon the employee's most recent 
evaluation, the physician or other licensed health care professional, 
as appropriate, determines that the employee will be unable to continue 
to function adequately while wearing a respirator. If the physician or 
other licensed health care professional, as appropriate, determines 
that the employee's job activities must be limited, or that the 
employee must be removed from the employee's current job because of the 
employee's inability to wear a respirator, the limitation or removal 
shall be in accordance with paragraph (g)(5)(iii) under Medical Removal 
Protection of this section.
    Common health problems that could interfere with respirator use 
include claustrophobia (an intolerance of feeling enclosed and a 
subjective feeling of breathing difficulty), chronic rhinitis, nasal 
allergies that would necessitate frequent removal of the respirator to 
deal with nasal discharges, and chronic sinusitis. In addition, 
difficulties with the use of respirators may arise in employees with 
respiratory or cardiac diseases. Respiratory diseases include chronic 
obstructive pulmonary disease, emphysema, asthma, and moderate to 
severe pneumoconiosis. Cardiac or cardiorespiratory diseases that may 
affect respirator wear include any type of congestive heart disease, 
other ischemic heart diseases, and hypertension.
    As discussed further under paragraph (g)(5)(iv), Medical 
Surveillance, of this section, employees who are removed from work due 
to the inability to wear a respirator are afforded certain medical 
removal protection relative to retention of earnings, seniority, rights 
and benefits. The Agency believes that these provisions will encourage 
all employees, including those experiencing difficulty with respirator 
use, to participate in the Medical Surveillance Program and will 
minimize an employee's fear of losing his or her job due to the 
possible inability to wear a respirator.
    Paragraph (f)(5)(i) requires the employer to perform either 
quantitative or qualitative face fit tests in accordance with the 
procedures outlined in Appendix B of this section.
    Quantitative fit testing is an assessment of the adequacy of 
respirator fit by numerically measuring the amount of leakage into the 
facepiece. One method of accomplishing this assessment utilizes a 
procedure whereby the level of penetration of a test agent of a known 
concentration is measured inside the facepiece of the respirator. In 
this quantitative fit test procedure, the respirator is worn in a 
stable test atmosphere containing a suitable challenge agent. The 
adequacy of fit is determined by measuring the actual levels of the 
challenge agent, both outside and inside the facepiece of the 
respirator. This provides a quantitative assessment of the fit (the fit 
factor). Fit testing allows the employer to continue testing different 
facepieces until a properly fitting respirator is identified and 
selected for the employee. Quantitative fit testing requires the use of 
moderately sophisticated testing equipment and is more expensive to 
perform than qualitative fit testing, which may reduce its availability 
in some work sites. Also, testing services may not be available in all 
parts of the country to provide quantitative fit testing services for 
small businesses.
    Qualitative fit testing does not provide a numerical measure of the 
quality of the fit but simply determines whether a respirator fits or 
not. The outcome of the test is simply a pass or fail result. 
Qualitative fit testing involves the detection of a gas, vapor, or 
aerosol challenge agent through subjective means such as odor, taste, 
or nasal irritation. If the challenge agent's presence is detected, the 
respirator fit is considered to be inadequate. Qualitative fit testing 
is more subjective than quantitative testing because it depends on the 
individual's ability to detect the test agent.
    OSHA believes that while quantitative fit testing has some 
advantages, qualitative fit testing conducted in accordance with the 
protocols described in Appendix B of this section can generally 
accomplish the intent of the standard, which is to assure that each 
employee is assigned and wears a respirator that provides a proper fit.
    Paragraph (f)(5)(ii) states that the employer shall assure that 
each employee who must wear tight-fitting respirator passes a fit test: 
(A) at the time of initial fitting; (B) whenever changes occur in the 
employee's facial characteristics that affect the fit of the 
respirator; (C) whenever a different size or make of respirator is 
used; and (D) at least annually thereafter unless the annual 
determination required under paragraph (g)(3)(ii)(A), Medical 
Surveillance, indicates that the annual

[[Page 54263]]

fit test of the employee is not necessary. This frequency of fit 
testing is necessary to assure that factors that may affect the proper 
fit of a respirator are detected and necessary adjustments are 
performed to assure the integrity of the faceseal. For example, the fit 
of respirators is not standardized among manufacturers. Fit testing 
would be required, therefore, whenever a different size or make of 
respirator is used. In addition, a change in an employee's facial 
structure can compromise a respirator's faceseal. Examples of such 
changes include loss of weight, cosmetic surgery, facial scarring, and 
the installation of dentures or the absence of dentures that are 
normally worn by the individual. Therefore, fit testing is required 
when any facial changes, such as those mentioned above, occur.
    Requiring annual fit testing, unless the annual determination by 
the physician or other licensed health care professional indicates that 
the annual fit test is not necessary, assures that factors that could 
affect respirator fit are detected and the employee's respirator is 
adjusted or replaced as necessary. It is OSHA's intent in this 
provision that each employee be evaluated annually for respirator fit. 
This can be accomplished through either an actual fit test or through a 
person-to-person evaluation consisting of a questionnaire and personal 
observation by the evaluator carried out under paragraph (g)(3)(ii)(A), 
Medical Surveillance, of this section. It should be noted that an 
annual determination of respirator fit is required, either through fit 
testing or the person-to-person evaluation. The employer may use the 
determination of the need for the annual fit test in lieu of an annual 
fit test if that determination indicates that a fit test is not 
necessary.
    One of the criteria that must be satisfied when selecting 
respirators is a faceseal leakage of 10% or less. OSHA considers any 
respirator that passes a qualitative fit test to meet this criteria. 
However, quantitative fit testing necessitates that a particular 
numerical value be achieved. Therefore, paragraph (f)(5)(iii) requires 
that when quantitative fit testing is performed, the employer shall not 
permit an employee to wear a tight-fitting respirator unless a minimum 
fit factor of one hundred (100) is obtained in the test chamber. This 
value corresponds to a faceseal leakage of 10% or less.
    In order to assure that continuing protection is achieved by 
reusable and powered air purifying respiratory protective devices, it 
is necessary to establish and implement proper maintenance and care 
procedures. A lax attitude toward this part of the respiratory 
protection program will negate successful selection and fit because the 
devices will not deliver the assumed protection unless they are kept in 
proper working order. A basic program for assuring proper respirator 
function would contain procedures for cleaning, inspection, repair, and 
replacement of respirators used in the workplace.
    Paragraph (f)(6)(i) requires that the employer clean and disinfect 
the respirators using the manufacturer's recommended procedures at the 
following intervals: (A) as necessary for respirators issued for the 
exclusive use of an employee; and (B) after each use for respirators 
issued to more than one employee. Respirators that are not cleaned and 
disinfected can cause skin irritation and dermatitis. When more than 
one employee uses the same respirator, cleaning and disinfecting after 
each use provides the additional benefit of minimizing the respirator's 
role as a vehicle for spreading infections (e.g., skin, respiratory) 
between employees.
    In order to assure continued respirator reliability, they must be 
inspected on a regular basis. Therefore, paragraph (f)(6)(ii) requires 
that respirators be inspected before each use and during cleaning after 
each use. As stipulated in paragraph (f)(6)(iii), such inspections must 
include: (A) a check of respirator function, tightness of connections 
and condition of the facepiece, head straps, valves, connecting tube, 
and cartridges, canisters, or filters; and (B) a check of the rubber or 
elastomer parts for pliability and signs of deterioration. In this way, 
the employer can assure that the respirator is functioning as intended, 
is able to be adjusted by the user, will not allow leakage through 
cracks or breaks in the respirator, and is pliable enough to achieve a 
proper faceseal.
    The standard also contains provisions regarding those respirators 
that are found to be deficient upon inspection. Paragraph (f)(6)(iv) 
states that respirators that fail to pass inspection must be removed 
from service and repaired or adjusted in accordance with the following: 
(A) repairs or adjustments to respirators are only to be made with 
NIOSH-approved parts designed for the respirator by the respirator 
manufacturer and by persons appropriately trained to perform such 
operations; (B) only repairs of the type and extent covered by the 
manufacturer's recommendations may be performed; and (C) reducing or 
admission valves or regulators shall be returned to the manufacturer or 
given to an appropriately trained technician for adjustment or repair. 
It is self-evident that repairs to respirators should only be performed 
by trained individuals, using parts designed for the specific 
respirator under repair (not all respirator designs are identical), and 
that the individual should not attempt repairs that he or she is not 
qualified to undertake or which are not recommended by the 
manufacturer.
    Another important aspect of assuring appropriate respirator 
function is proper storage. Therefore, paragraph (f)(6)(v) stipulates 
that the employer assure that respirators are stored in a manner that 
protects them from contamination, damage, dust, sunlight, extreme 
temperatures, excessive moisture, damaging chemicals and that prevents 
deformation of the facepiece or exhalation valve. Proper storage, of 
both new respirators and those already in service, assists in 
maintaining appropriate respirator function by minimizing conditions 
that may cause deterioration of the respirator or filter, interfere 
with filter efficiency, change faceseal geometry, and prevent sealing 
of valves against inhalation of contaminated air.
    As discussed previously, OSHA accepts those respirators certified 
by MSHA and NIOSH. Therefore, paragraph (f)(7)(i) requires that 
filters, cartridges, and canisters used in the workplace are properly 
labeled and color-coded with the NIOSH approval label as required by 30 
CFR part 11 or 42 CFR part 84, whichever is applicable, before they are 
placed into service. The employer must assure that the existing NIOSH 
approval label on a filter, cartridge, or canister is not intentionally 
removed, obscured, or defaced while it is in service in the workplace, 
as required by paragraph (f)(7)(ii) of this section.
    Paragraph (f)(8) requires the employer to review the overall 
respiratory protection program at least annually, and conduct 
inspections of the workplace as necessary to assure that the provisions 
of the program are being properly implemented for all affected 
employees. The reason an employer must conduct an annual review and 
inspections as necessary is because respirators are utilized as 
supplemental and, in some instances, sole protection to prevent 
transmission of infectious TB. Therefore, it is of primary importance 
to assure proper implementation of the program. The review of the 
program must include an assessment of each element required under 
paragraph (f)(2) of this section. Once the respiratory protection 
program is implemented, the employer retains responsibility for 
detecting and

[[Page 54264]]

addressing problems that arise. While the written respiratory 
protection program is required to be reviewed and updated under 
paragraph (f)(2)(iii) of the standard, the overall review requires that 
the employer evaluate actual implementation in the workplace. 
Consequently, this provision stipulates inspections of the workplace 
and an assessment of each element required under paragraph (f)(2) of 
this section to assure proper implementation of the program.
    OSHA believes that the proposed provisions regarding respirators 
are both appropriate and justified. OSHA seeks comments and data on all 
aspects of the proposed respirator requirements.

Paragraph (g)  Medical Surveillance

(1) General
    The purpose of this section is early detection and prevention of 
disease through employee medical histories and physical examinations, 
TB skin testing, medical management and follow-up of exposure incidents 
and skin test conversions, and medical removal of employees with 
suspected or confirmed infectious TB. These requirements are designed 
to ensure early detection of TB infections and disease by providing 
appropriate medical examinations to enable identification of infection 
or disease and to minimize the spread of TB to other employees in the 
workplace. Additionally, there are requirements in this section to 
assure that employees required to wear respiratory protection are 
evaluated to determine their ability to wear a respirator and advised 
about the need for annual fit testing. The needs of employees who have 
health conditions that might require special attention are also 
addressed (e.g., anergy testing, more frequent screening, or further 
medical examinations to diagnose TB).
    Paragraph (g)(1) calls for medical surveillance to be provided for 
each employee who has occupational exposure, as defined in this 
standard. Occupational exposure may result in TB infection and the 
subsequent development of TB disease. Paragraphs (c)(1)(i, ii), 
(exposure determination) require the employer to identify employees 
with occupational exposure in the facility. These employees must be 
offered medical surveillance.
    OSHA believes that early detection and management of exposed 
employees helps prevent severe illness and death. According to CDC's 
1994 edition of the Core Curriculum on Tuberculosis (Ex. 7-93), 
approximately ten percent of the persons infected will develop active 
TB disease at some point in their lives (Exs. 4B, 7-50, 7-93). Five per 
cent of those infected develop disease within the first two years 
following infection and another five percent develop disease later in 
their lives. Immunosuppressed persons are at a considerably greater 
risk of developing active disease following a TB infection. For 
example, individuals infected with HIV and TB have been estimated to 
have a 8-10% risk per year of developing active disease (Ex. 7-50). 
However, according to the American Thoracic Society:

    Clinical trials have shown that daily isoniazid preventive 
therapy for 12 months will reduce the risk of developing 
tuberculosis in infected persons by about 70 percent and in over 90 
percent of patients who are compliant in taking the medications. 
(Ex. 5-80)

Most infected people have a positive reaction to the TB skin test 
within 2-10 weeks after exposure. Consequently, early detection of 
newly infected workers is critical as it permits early initiation of 
appropriate therapy and results in a decrease in morbidity and 
mortality.
    Paragraph (g)(1)(ii) requires that information about the signs and 
symptoms of pulmonary tuberculosis disease, a medical history, a 
physical examination, TB skin testing, medical management and follow-
up, and if indicated, other related tests and procedures and medical 
removal protection if the employee develops infectious TB, be provided 
to each employee in work settings described in paragraph (a) Scope who 
sustains an ``exposure incident.'' This provision is applicable when 
the employee has not been categorized as having occupational exposure 
in the employer's Exposure Control Plan. OSHA recognizes that there may 
be times when employees who are not ``reasonably anticipated'' to have 
occupational exposure to TB may be exposed, (e.g., if engineering 
controls break down or an individual with infectious tuberculosis is 
unidentified during intake procedures). Employees exposed under such 
circumstances incur the risk of TB infection and subsequent disease 
(Ex. 7-93) as a result of their work duties. OSHA includes this 
provision so that these employees are provided protection.
    Paragraph (g)(1)(iii)(A) requires the employer to provide all 
medical surveillance at no cost to the employee. This is consistent 
with OSHA policy. Providing services at no cost to the employee is an 
important factor in successful workplace health and safety programs 
because it encourages employee participation in medical surveillance 
programs.
    Paragraph (g)(1)(iii)(B) requires that all medical surveillance be 
provided at a reasonable time and place for the employee. Convenience 
of these procedures increases the likelihood of employee participation 
in the program. This helps assure that employees receive the full 
benefits provided by the standard. OSHA recognizes the need for this 
provision and has included it in other standards (e.g., Ethylene Oxide, 
29 CFR 1910.1047; Asbestos, 29 CFR 1910.1001; and Bloodborne Pathogens 
29 CFR 1910.1030).
    Paragraph (g)(1)(iii)(C) states that all medical surveillance is 
required to be performed by or under the supervision of a physician or 
other licensed health care professional, as appropriate. OSHA has 
included in paragraph (j) Definitions, a description of the licensed 
health care professional. Such an individual is a physician or other 
health care professional who holds a license enabling her or him to 
independently provide or be delegated the responsibilities to provide 
some or all of the health care services required by this paragraph. In 
several states, nurse practitioners may be licensed to independently 
perform or supervise the evaluations and procedures required by this 
paragraph. In such cases, the requirements of this standard can be 
accomplished by those practitioners. In addition, where registered 
nurses are licensed to perform or supervise some of the requirements of 
this standard, those requirements can be accomplished by those 
professionals.
    Paragraph (g)(1)(iii)(D) requires that medical surveillance 
procedures be provided according to recommendations of the CDC, current 
at the time these procedures are performed, except as specified by this 
paragraph (g). In other words, employers must comply with paragraph 
(g), and with the most current CDC recommendations in providing medical 
surveillance. OSHA has set forth what an employer must do to prevent or 
minimize occupational exposure in the employer's workplace. However, 
CDC, an agency of the U.S. Public Health Service (USPHS), follows the 
epidemiology of M. tuberculosis and periodically revises and updates 
its guidelines and recommendations to reflect changes in the diagnosis 
and treatment of TB. OSHA believes that in addition to meeting the 
requirements of paragraph (g), it is appropriate to follow CDC 
recommendations, which address screening, medical evaluations, TB skin 
test procedures and follow-up (e.g., the administration and 
interpretation of skin tests).
    OSHA recognizes the dynamic nature of medical knowledge relating to

[[Page 54265]]

tuberculosis and notes that CDC recommendations current at the time of 
the standard's publication may differ from recommendations at some 
future time when an employee evaluation takes place. Knowledge about 
tuberculosis is expanding. For example, the medical response to HIV/
AIDS as related to tuberculosis continues to evolve. These are the 
reasons why OSHA has not simply required the employer to comply with a 
particular CDC guideline. OSHA believes that incorporating the CDC 
recommendations into the standard by reference enhances the quality of 
medical surveillance. This assures that employees are provided the most 
current and effective evaluation and treatment. Furthermore, the CDC 
recommendations provide consistency with regularly updated medical 
science and health care practice. A similar provision was included in 
the Bloodborne Pathogens standard 29 CFR 1910.1030 and met with 
widespread acceptance from the regulated community. The CDC 
recommendations cover the specific details of the medical protocols.
    Paragraph (g)(1)(iv) requires that all laboratory tests be 
performed by an accredited laboratory. Accreditation by a national 
accrediting body or its state equivalent means that the laboratory has 
participated in a recognized quality assurance program. (For an 
explanation of ``accredited laboratory'' see paragraph (j) Definitions 
below). This accreditation process is required to assure a measure of 
quality control so that employees receive accurate information 
concerning their laboratory tests. The accreditation requirement 
assures long-term stability and consistency among laboratory test 
procedures and interpretations of results. OSHA recognizes the need for 
this requirement and has included it in other standards (e.g., Benzene, 
29 CFR 1910.1028; Bloodborne Pathogens, 29 CFR 1910.1030).
(2) Explanation of Terms
    This paragraph explains the terms used in paragraph (g) Medical 
Surveillance. Paragraphs (g)(2)(i) to (g)(2)(vii) include explanations 
of the ``medical history'', the ``physical examination (with emphasis 
on the pulmonary system, signs and symptoms of infectious tuberculosis, 
and factors affecting immunocompetence)'', ``TB skin testing'', the 
``face-to-face determination of ability to wear a respirator and need 
to be re-fit tested'', ``medical management and follow-up'', ``other 
related procedures or tests determined to be necessary'', and ``Medical 
Removal Protection''. The applications section, paragraph (g)(3), 
describes what must be provided and at what time.
    Paragraph (g)(2)(i) describes a medical history, during which the 
examiner questions the employee in order to gather information on the 
employee's pulmonary system, TB exposure, vaccination, testing and 
disease status and factors affecting immunocompetence. A medical 
history questionnaire may be used as a starting point for this 
discussion. OSHA believes that a medical history is essential for 
interpreting the TB skin test results, which are also required by this 
paragraph (g). The CDC Core Curriculum states:

    TB skin testing is a useful tool, but is not perfect. Several 
factors can affect the skin test reaction: for example, infection 
with mycobacteria other than M. tuberculosis and vaccination with 
BCG. These factors can lead to false-positive reactions * * * Other 
factors, such as anergy, can lead to false-negative reactions. (Ex. 
7-93).

    Therefore, the medical history is used to assist in interpreting 
the TB skin test results. The medical history also provides information 
regarding the employee's potential for increased risk if exposed to 
tuberculosis. Based on this information, discussions between the 
employee and the examiner regarding the employee's increased risk can 
assist the employee in decision-making.
    Paragraph (g)(2)(ii) describes the physical examination. The 
physical examination is to emphasize the pulmonary system, signs and 
symptoms of active TB disease, and factors affecting immunocompetence. 
Such an examination assists the examiner in detecting evidence of 
active disease (e.g., rales), differentiating TB disease from other 
causes of cough or other signs/symptoms associated with TB disease, and 
ascertaining whether signs are present that are compatible with an 
immunocompromising health condition. The physical examination is also 
required when an employee has signs or symptoms of TB or after a TB 
skin test conversion and at other times, if indicated.
    That the pulmonary system is emphasized in both the medical history 
and physical examination assures that the employee is evaluated with 
specific attention to the most common site of infectious TB. Although 
extrapulmonary tuberculosis can occur (e.g., in bone, meninges of the 
brain, and draining abscesses), it is not usually a source of infection 
for others. The language ``with emphasis on the pulmonary system'' is 
used to indicate that while the history and physical examinations 
evaluate the health of the patient as a whole, particular emphasis 
should be placed on the pulmonary system.
    Paragraph (g)(2)(iii) explains the required TB skin testing. TB 
skin testing is the cornerstone for early detection of TB transmission 
among exposed workers. The American Thoracic Society notes that:

    Although currently available TB skin tests are substantially 
less than 100% sensitive and specific for detection of infection 
with M. tuberculosis, no better diagnostic methods have yet been 
devised. (Ex. 5-4)

The TB skin test is an important tool that is useful in identifying 
employees who may be eligible for appropriate, early treatment; 
initiating contact investigations; and evaluating the effectiveness of 
the facility's control program. The requirement for TB skin testing is 
supported by AHA (Exs. 7-61, 7-29 ), APIC (Ex. 7-30), AIHA (Ex. 7-170) 
and the CDC 1994 Core Curriculum which states, ``TB screening should be 
done in groups for which rates of TB are substantially higher than the 
general population.'' [Ex. 7-93]. In this document, CDC specifically 
mentions screening for health care workers, staff of long term care 
facilities, correctional facilities, hospices, drug treatment centers, 
and nursing homes.
    Paragraph (g)(2)(iii) describes the requirement for TB skin 
testing. TB skin testing, which only applies to employees whose TB skin 
test status is not known to be positive, includes anergy testing if 
indicated, and consists of an initial 2-step protocol for each employee 
who has not been previously skin tested and/or for whom a negative test 
in the past 12 months cannot be documented. If the employer has 
documentation that the employee has had a negative TB skin test within 
the past 12 months, that test may be used to fulfill the skin testing 
portion of the initial medical surveillance requirements. For example, 
if an employer has a new or existing employee for whom: (1) a TB skin 
test has not previously been performed, or (2) a negative skin test 
result within the past 12 months that cannot be documented, the 
employer is required to provide an initial two-step skin test for the 
employee. Conversely, if the employer can document a negative skin test 
result from a test performed on the employee within the past 12 months, 
that test can be used to fulfill the initial skin testing requirement 
of this section. Subsequent periodic retesting of the employee is to be 
performed in accordance with paragraph (g)(3), as discussed below.
    It is important for the employer to determine the current TB skin 
test status

[[Page 54266]]

of employees prior to their initial assignment to a job with 
occupational exposure. This ``baseline'' status can then be used to 
evaluate changes in the employees' TB skin test.
    In their 1992 guidelines, the American Thoracic Society recommended 
the following:

    Individuals at high risk for TB should have a TB skin test at 
least once to assess their need for preventive therapy and to alert 
the health care providers of those with positive skin tests of this 
medical problem. In institutional settings, baseline information on 
the TB skin test status of staff and residents is a means of 
identifying candidates for preventive therapy as well as determining 
whether transmission of TB is occurring in the facility. For this 
reason, TB skin testing upon employment or upon entry should be 
mandatory for staff and residents * * * (Ex. 5-80)

    Previous BCG vaccination is not a contraindication for skin 
testing. In its 1994 guidelines, the CDC states:

    During the pre-employment physical or when applying for hospital 
privileges, HCWs who have the potential for exposure to M. 
tuberculosis [sic], including those with a history of BCG 
vaccination, should have baseline PPD skin testing performed * * *
    BCG vaccination may produce a PPD reaction that cannot be 
distinguished reliably from a reaction caused by infection with M. 
tuberculosis. For a person who was vaccinated with BCG, the 
probability that a PPD test reaction results from infection with M. 
tuberculosis increases (a) as the size of the reaction increases, 
(b) when the person is a contact of a person with TB, (c) when the 
person's country of origin has a high prevalence of TB, and (d) as 
the length of time between vaccination and PPD testing increases. 
For example, a PPD test reaction of 10 mm probably can be 
attributed to M. tuberculosis in an adult who was vaccinated with 
BCG as a child and who is from a country with a high prevalence of 
TB. (Ex. 4B)

CDC does not state that BCG vaccination negates the need for baseline 
and periodic skin testing but does state that skin tests on vaccinated 
individuals need to be interpreted carefully. OSHA's proposed rule is 
consistent with the CDC Guidelines on this point. PPD testing is thus 
not contraindicated for BCG vaccinated employees; however, such prior 
vaccination does mean that other factors, such as the age of the 
employee and the extent of induration, must be considered in 
interpreting the results.
    The purpose of performing a two-step test is to correctly identify 
the baseline TB skin test status of those employees who are infected 
with TB but whose sensitivity to the tuberculin testing material may 
have waned over the years. This procedure enhances the proper 
interpretation of subsequent positive TB skin test results and is based 
upon current CDC and American Thoracic Society recommendations (Exs. 5-
80, 6-15, 7-52, 7-93, 7-169).
    Two-step testing requires an employee to be tested initially and, 
if the test results are negative, to be tested again within 1-3 weeks. 
This second test stimulates or ``boosts'' the body's response to the 
testing material and results in a more valid reaction. For example, an 
employee who has not been recently tested but who is infected with TB 
from an earlier exposure may fail to respond to this current test 
because his or her immune response has waned over time. However, a 
second test of this employee will produce a positive TB skin test that 
more accurately reflects his or her true TB skin test status. Thus, the 
initial use of a two-step testing procedure ensures that the baseline 
TB skin test is an accurate reflection of the employee's TB status and 
will reduce the likelihood of misinterpreting a ``boosted'' reaction on 
subsequent tests as a conversion. Two-step testing is also appropriate 
for individuals who have been BCG vaccinated, since these individuals 
can exhibit a boosted reaction. Therefore, two-step testing of BCG 
vaccinated individuals can be used to determine their baseline status, 
although the skin test results must be interpreted in light of their 
previous BCG vaccination.
    The two-step testing procedure does not identify those persons who 
are truly anergic and, therefore, are not capable of mounting a typical 
immune response to the test material. Evaluation of adequate immune 
response, when determined to be necessary by the physician or other 
licensed health care professional, as appropriate, is determined 
through anergy testing, and this is provided for in the explanation of 
TB skin testing in paragraph (g)(2)(iii).
    The CDC recommendations are the guiding documents for TB skin test 
protocols. By referring the employer to these recommendations in 
Paragraph (g)(1)(iii)(D), OSHA allows for future changes in protocols 
and procedures that result from continuing research. Consistent with 
the CDC guidelines (Exs. 3-33, 3-35, 3-32, 6-15), the American Thoracic 
Society recommends:

    The Mantoux test with 5 Tuberculin Units (TU) of PPD may be used 
as a diagnostic aid to detect tuberculous infection and to determine 
the prevalence of infection in groups of people. (Ex. 5-4)

    Proper administration of a TB skin test results in a reaction 
described as a classic example of a delayed (cellular) hypersensitivity 
reaction. This reaction indicates infection with mycobacterium, most 
commonly M. tuberculosis. The reaction characteristically begins in 5-6 
hours, is maximal at 48-72 hours, and subsides over a period of days 
(Ex. 5-4).
    Proper administration and interpretation of the test is critical 
and can be complex. In 1990, the American Thoracic Society revised the 
criteria for interpreting the TB skin test (Ex. 5-4). Information such 
as the health status of the tested employee, history of BCG 
vaccination, recent close contact with persons with active TB, chest x-
ray results, and other factors must be considered when interpreting the 
TB skin test results. CDC has established criteria for a TB skin test 
conversion; that is, when an employee's TB skin test results change 
from negative to positive, indicating a recent TB infection (Ex. 4-B).
    Because of the complexity in properly administering and 
interpreting TB skin tests, it is essential that only trained 
individuals perform this function. For this reason, TB skin testing is 
to be administered and interpreted by or under the supervision of a 
physician or other licensed health care professional as appropriate and 
according to CDC recommendations. This language allows employers to 
chose from a variety of health care professionals who can administer 
and interpret TB skin tests. OSHA is aware that in some worksites, 
employees have been allowed to read and interpret their own skin test 
results. A surveillance system that allows self-reading and 
interpretation of TB skin tests can be problematic. With regard to 
interpretation of TB skin test results, the American Thoracic Society 
states:

    Intelligent interpretation of skin test results requires a 
knowledge of the antigen used (tuberculin), the immunologic basis 
for the reaction to the antigen, the technique(s) of administering 
and reading the test, and the results of epidemiologic and clinical 
experience with the test. (Ex. 5-4)

    In its 1994 Core Curriculum on Tuberculosis (Ex. 7-93), CDC 
describes the complexities of interpreting the induration resulting 
from TB skin testing. A number of factors can affect the size of a TB 
skin test induration relative to whether or not the test should be 
interpreted as being positive. For example, induration of 5 mm or more 
is classified as positive for persons with known or suspected HIV 
infection, while an induration must be 10 mm to be classified as 
positive in persons who are foreign-born in high prevalence countries. 
An induration of 15 mm or more is classified as positive in certain 
other situations. In addition, TB skin

[[Page 54267]]

testing can result in both false positive and false negative results.
    Clearly, interpreting TB skin test results requires professional 
expertise and must be performed by or under the supervision of a 
physician or other licensed health care professional, as appropriate, 
by an individual with training and experience in performing the test 
and interpreting the result. Proper use of the TB skin test as a 
medical surveillance tool will require two visits to the health care 
professional: one to receive the test and one to read/interpret the 
test results. However, considering the critical importance of this 
element, OSHA believes that allowing employees to read and interpret 
their own tests or allowing their peers to do so (unless they meet the 
criteria discussed above) compromises the quality and accuracy of the 
testing procedure.
    Paragraph (g)(2)(iv) describes the determination of each employee's 
ability to wear a respirator and of his or her need for re-fit testing 
for employees required to wear a respirator. This face-to-face 
determination includes a verbal exchange between the employee and the 
examiner regarding the employee's health factors such as illness or 
injuries, that may impact his or her ability to wear a respirator (e.g. 
vascular or heart disease, asthma, claustrophobia, facial structure 
defects, certain skin conditions, etc.) (Ex.7-64). Based on this 
history and the observation of the employee, the need for further 
testing or physical examinations for the ability to wear a respirator 
can be determined. In addition, assessment of the need for re-fit 
testing is to be performed, which assures that the examiner consider 
whether re-fit testing is needed. OSHA has included a note stating that 
the determination of the need for re-fit testing may only be performed 
after the required initial fit test of the employee and cannot be used 
in lieu of any other required fit tests, as, for example, when a 
different size or make of respirator is used.
    Paragraph (g)(2)(v) explains that medical management and follow-up 
include diagnosis, and, where appropriate, prophylaxis and treatment 
related to TB infection and disease. The employer must provide medical 
management and follow-up for occupationally exposed employees with skin 
test conversions [paragraph (g)(3)(i)(D)], or those who undergo an 
exposure incident whether or not they are categorized as occupationally 
exposed [paragraphs (g)(1)(ii) and (g)(3)(i)(C)]. In addition, any time 
an occupationally exposed employee develops signs and symptoms of 
infectious tuberculosis, medical management and follow-up are required 
[paragraph (g)(3)(i)(B)]. John E. McGowan addressed follow-up in the 
1995 article entitled ``Nosocomial Tuberculosis: New Progress in 
Control and Prevention,'' published in Clinical Infectious Diseases. He 
states,

    If the PPD skin testing program for health care workers is to be 
useful, several steps are crucial. * * * The institution also must 
make sure that the occupational health service undertakes careful 
follow-up of workers found to have positive TB skin tests or 
tuberculosis disease. This follow-up should include counseling, 
careful monitoring of therapy (when prescribed) until its completion 
and evaluation of fitness to return to work. (Ex. 7-248).

    Paragraph (g)(2)(vi) explains that other related tests and 
procedures are any TB-related tests and procedures determined to be 
necessary by the physician or other licensed health care professional, 
as appropriate. These procedures or tests could include chest 
radiographs, sputum smears, or other testing determined to be necessary 
to make an assessment, a diagnosis, or medically manage the employee. 
An example of a program that integrates testing and examinations was 
given at the 1994 meeting of the Society for Occupational and 
Environmental Health, by Carol Murdzak who presented the University of 
Manitoba's Medical Surveillance program. Her presentation, entitled 
``Conducting a Medical Surveillance Program to Prevent and Control 
Transmission of TB in a Health Care Institution'' demonstrates the use 
of skin testing and general review of health status for employee 
surveillance. Results of TB skin testing and the review of health 
status determine the need for chest x-ray and further medical 
evaluation in this program (Ex.7-169).
(3) Application
    Medical examinations in the form of medical histories, physical 
examinations, TB skin testing and other related tests and procedures 
are necessary in order to promptly identify and treat employees with 
infectious tuberculosis.
    Paragraph (g)(3), Application, specifies what an employer must 
provide. In each situation set forth in paragraph (g)(3), the employer 
must provide medical examinations, tests and procedures as specified. 
Some of the provisions are offered only ``if indicated,'' which means 
that the physician or other licensed health care professional, as 
appropriate, has determined that further tests or procedures are 
needed. For example, an employee who has no history of illness or being 
immunocompromised and whose TB skin test is negative at the time of 
initial assignment is not required to be offered a physical examination 
unless the examiner determines that a physical examination is 
indicated. However, if at the time of annual skin test, the employee 
has a skin test conversion, a physical examination is required.
    Paragraph (g)(3)(i)(A) requires that, before the time an employee 
is initially assigned to a job with occupational exposure (or within 60 
days from the effective date of the standard for employees already 
assigned to jobs with occupational exposure), the employee be provided 
with a medical history, TB skin testing, and, if indicated, a physical 
examination and other related tests and procedures.
    OSHA requires the initial medical history to assist in assessing 
the employee's health. This information will provide a baseline health 
status that can be used to evaluate (1) whether the employee has a pre-
existing condition that may be exacerbated by occupational exposure to 
TB and (2) any future health conditions that may arise that are 
relevant to occupational exposure to TB.
    OSHA does not believe that an initial physical examination for all 
occupationally exposed employees is necessarily warranted. However, the 
Agency does believe that a physical examination, if determined to be 
indicated by the examiner based on the medical history and TB skin test 
results, is useful and effective.
    The note to paragraph (g)(3)(i)(A) specifies that if an employee 
has had a medical examination within the twelve (12) months preceding 
the effective date of the standard and the employer has documentation 
of that examination, only the medical surveillance provisions required 
by the standard that were not included in the examination need to be 
provided. The Agency realizes that employees may have received at least 
some of the elements of the required medical surveillance provisions 
shortly before the effective date of the standard. In these situations, 
a full TB examination would not need to be repeated.
    In addition, the proposed standard allows the baseline TB skin 
testing status of an employee to be established by documentation of a 
TB skin test that was administered within the previous 12 months. For 
example, if an employee has a written record of a TB skin test within 
the last 12 months, that information can be used to document the 
employee's baseline TB skin test status and another TB skin test at the

[[Page 54268]]

time of the initial medical examination is not necessary. When 
utilizing results from a previous medical examination and skin test to 
fulfill the initial medical surveillance requirements, the employer 
must use the date(s) of the previous medical exam and skin test to 
determine the date(s) of the employee's next medical examination and 
skin test. In no case shall the interval between the previous 
examination and skin test and the next examination and skin test exceed 
12 months. These provisions are designed to avoid unnecessary testing 
of employees and do not compromise the quality of the medical 
surveillance.
    Information (e.g., medical history) obtained from a medical 
examination in the past 12 months is unlikely to change within this 
span of time. However, this may not be the case with regard to previous 
skin testing results. While OSHA is proposing to accept a skin test 
performed within the past 12 months as a substitute for performing an 
initial baseline skin test, an employer utilizing a new employee's 
negative skin testing result obtained more than 3 months prior to 
beginning the new job may be uncertain as to the source and time of 
infection if the employee tests positive at his or her next skin test. 
More specifically, conversion normally occurs within 3 months of 
infection. Therefore, an employee would have been negative at his or 
her last skin test, e.g., 7 months previously, and have been infected 
just after the skin test and subsequently converted. In such a case, an 
employer may rely on the previous negative skin test as the baseline 
does not need to test the new employee until 5 months later (i.e., 
annual skin test frequency), at which time the employee would test 
positive and be identified as a converter. In this situation, the new 
employer would not be able to determine if the employee's conversion 
had occurred as a result of exposure occurring previous to hire or from 
exposure in his or her current work setting. Regardless of the source 
of the conversions, the employer would be required by the standard to 
initiate medical management and a follow-up investigation, which might 
also entail skin testing other employees in the worksite to determine 
if other conversions had taken place, a step that would not be 
necessary if the employee had been correctly identified as positive 
upon entry into the workplace. In view of this, employers may choose to 
perform an initial baseline skin test on each new employee before the 
employee enters the work setting.
    Once an employee is on the job, paragraph (g)(3)(i)(A) requires 
employers to periodically retest employees who have negative TB skin 
tests in order to identify those employees whose skin test status 
changes, indicating that they have been infected. Because the baseline 
TB skin test provides only a ``snapshot'' of the TB skin test status of 
the employee and because exposure and subsequent infection can occur at 
any time, periodic testing is necessary. The American Thoracic Society 
recommends:

    * * * follow-up skin-testing should be conducted on at least an 
annual basis among the staffs of TB clinics, health care facilities 
caring for patients with HIV infection, mycobacteriology 
laboratories, shelters for the homeless, nursing homes, substance-
abuse treatment centers, dialysis units, and correctional 
institutions. (Ex. 5-80)

When TB exposure results in infection, early identification allows 
employees to have options regarding prophylactic treatment, thereby 
reducing the likelihood that the infection will progress to disease.
    OSHA recognizes the importance of periodic testing to monitor the 
status of employee's skin test results. In their 1994 Guidelines for 
Preventing the Transmission of Tuberculosis in Health-Care Facilities, 
the CDC recommends that the frequency of PPD skin testing of employees 
be based upon the individual facility's risk assessment in conjunction 
with the criteria put forth by the CDC (Ex. 4B). For situations that 
meet certain CDC criteria, CDC recommends that employees receive a 
repeat TB skin test every 3 months, six months or annually, depending 
upon the risk assessment.
    OSHA's proposed standard does not require a risk assessment of the 
type described by CDC and would extend coverage to worksites other than 
``health-care facilities'' as described in the CDC document (Ex. 4B). 
Consequently, OSHA is proposing that repeat TB skin test be performed 
every 6 months or annually, depending upon the exposure determination. 
This testing frequency is expected to be both practical and effective 
in early identification of skin test conversions in the various 
worksites described in the Scope. The requirements for more frequent TB 
skin tests (e.g., 3 months after an exposure incident, or if deemed 
necessary by a licensed health care professional) ensures that 
employees' health is not compromised.
    An exemption to this annual testing is permitted for an employer 
who can demonstrate that his or her facility or work setting: (1) Does 
not admit or provide medical services to individuals with suspected or 
confirmed infectious TB, (2) has had no cases of confirmed infectious 
TB in the past 12 months, and (3) is located in a county that, in the 
past two years, has had 0 cases of confirmed infectious TB reported in 
one year and fewer than 6 cases of confirmed infectious TB reported in 
the other year. In these settings only a baseline TB skin test is 
required. This is discussed earlier under paragraph b, application.
    Paragraph (g)(3)(i)(B) requires that, when an employee has signs or 
symptoms of TB, either observed or self-reported, the employee be 
provided a medical history, physical examination, TB skin testing, 
medical management and follow-up, and other related tests and 
procedures determined to be necessary. CDC states that the presence of 
signs or symptoms of tuberculosis in the employee requires prompt 
medical evaluation (Ex. 7-52, 7-93), and such evaluation provides an 
opportunity for initiating drug therapy. Furthermore, identifying those 
with infectious pulmonary TB disease enables the employer to remove 
them from the workplace, preventing exposure of other employees.
    Paragraph (g)(3)(i)(C) requires that when an employee incurs an 
exposure incident, a medical history, TB skin testing, medical 
management and follow-up, and, if indicated, a physical examination and 
other related tests and procedures be provided. Evaluation and follow-
up after each exposure incident help detect any resultant infections, 
as well as prevent infection in other employees, benefitting the health 
of all employees.
    Following exposure, infected workers will usually develop a 
positive response to a TB skin test (Exs. 7-50, 7-93, 5-4). In certain 
cases, workers may also display signs or symptoms compatible with 
tuberculosis disease such as complaints of persistent cough (over 3 
weeks in duration), bloody sputum, night sweats, weight loss, loss of 
appetite or fever. Use of the TB skin test has been recognized as a 
tool in the early identification of infection and for disease 
surveillance and follow-up. In paragraph (g)(3)(i)(C), the proposed 
standard also requires employers to provide testing for employees as 
soon as feasible after an exposure incident, unless a negative TB skin 
test has been documented within the preceding 3 months. If this 
baseline skin test is negative, another TB skin test shall be repeated 
3 months after the exposure incident.
    In order to accurately determine if an exposure incident has 
resulted in infection, the employer must first know the baseline skin 
test status of the affected employee(s) at the time of the exposure 
incident. Typically, skin test conversion can be documented 
approximately 2-10 weeks following

[[Page 54269]]

infection (Ex. 7-52). Consequently, it can be reasonably assumed that a 
negative TB skin test within the three months prior to the incident is 
sufficiently indicative of the employee's status at the time of the 
exposure incident.
    For those employees who do not have a documented negative skin test 
within the past three months, the employer must determine their TB skin 
test status as soon as feasible after the exposure incident. The 
requirement of ``as soon as feasible'' in the provision puts the 
employer under the obligation of performing the TB skin test quickly, 
i.e., before infection resulting from the exposure would be manifested 
as a conversion. This assures that a true indication of the employee's 
skin test status at the time of the incident is obtained.
    The purpose of the initial TB skin test following an exposure 
incident is to establish the TB skin test status of the employee(s) at 
the time of the incident. From this baseline, changes in TB skin test 
status can be identified. This initial test would not detect infection 
resulting from the exposure, since there would not have been sufficient 
time for conversion to occur. Hence, the employer is required to 
provide a repeat TB skin test three months after the exposure incident 
to determine if infection has occurred. This requirement reflects 
current CDC recommendations (Ex. 4B).
    Paragraph (g)(3)(i)(D) requires that when an employee has a TB skin 
test conversion, the employee receive a medical history, a physical 
examination, medical management and follow-up, and other tests and 
procedures determined to be necessary. This provision assures that 
employees with skin test conversions receive appropriate evaluation for 
preventive therapy and for infectious tuberculosis. OSHA included the 
provision for early identification of disease since, as the CDC has 
stated in their guidelines, infectious tuberculosis disease can be 
prevented by the early treatment of tuberculosis infection.
    In paragraph (g)(3)(i)(E), the proposed standard requires employers 
to provide TB skin testing within 30 days prior to termination of 
employment. The rationale for this requirement is two-fold. First, this 
requirement permits employees whose employment is terminated after an 
unrecognized exposure incident, but before their next regularly 
scheduled TB skin test, to determine their current (exit) TB skin test 
status. OSHA recognizes that in some instances employees may be in the 
process of converting from negative to positive TB skin test results at 
the time of the exit testing and that some of these cases will be 
missed. Also missed will be employees who decline testing or who vacate 
their position immediately or without notice. While such situations are 
possible, the Agency believes that these occurrences would be rare. 
Secondly, by detecting recent conversions, appropriate steps can be 
taken by the employer to investigate the cause of the exposure. This 
helps prevent future exposures in those areas or situations where the 
exiting employee's infection may have occurred.
    Paragraph (g)(3)(i)(F) requires that a medical history, physical 
examination, TB skin testing, determinations of the employee's ability 
to wear a respirator, medical management and follow-up or other related 
tests and procedures be conducted at any other time determined 
necessary by the physician or other licensed health care professional, 
as appropriate. This allows the physician or other licensed health care 
professional, as appropriate, to recognize the individual differences 
in employees' medical status and response to TB infection and increase 
the frequency or content of examination as needed. Some workers who 
have certain health conditions may need more frequent evaluation (Ex. 
4B). For example, individuals who have a condition that may interfere 
with an accurate interpretation of TB skin test results (e.g., the 
development of test anergy in an employee who is on chemotherapy for 
cancer treatment), may warrant more frequent evaluations because of the 
high risk for rapid progression to TB disease if he or she becomes 
infected. (Ex. 4B)
    Paragraph (g)(3)(ii) sets forth provisions regarding employees who 
wear respirators. Paragraph (g)(3)(ii)(A) requires that a face-to-face 
determination of the employee's ability to wear the respirator be 
accomplished before initial assignment to a job with occupational 
exposure (or within 60 days of the effective date of the standard) and 
at least annually thereafter. As discussed above under explanation of 
terms, this is a verbal exchange to assess health factors that could 
affect the employee's ability to wear a respirator. An initial 
determination is made before assignment to a job requiring respirator 
use to assure that the employee's health factors have been properly 
evaluated prior to incurring exposure to M. tuberculosis. This 
determination must also be made annually to assure that no health 
conditions have arisen that might limit an employee's ability to wear a 
respirator.
    Such conditions may arise and be noted prior to the annual 
determination. For example, the employee may experience unusual 
difficulty while being fitted or while using the respirator. In these 
situations, it is not appropriate to wait until the annual 
determination. Therefore, paragraph (g)(3)(ii)(B) requires that a face-
to-face determination of the employee's ability to wear a respirator, 
including relevant components of a medical history and, if indicated, a 
physical examination and other related tests and procedures, be 
provided whenever the employee experiences unusual difficulty while 
being fitted or while using a respirator.
    Paragraph (g)(3)(iii) requires employers to provide TB skin tests 
every 6 months for each employee who enters AFB isolation rooms or 
areas, performs or is present during the performance of high-hazard 
procedures, transports or is present during the transport of an 
individual with suspected or confirmed infectious TB in enclosed 
vehicles, or works in intake areas where early identification is 
performed in facilities where 6 or more individuals with confirmed 
infectious TB have been encountered within the past 12 months. OSHA 
believes that employees who perform these activities are exposed more 
intensely and frequently to individuals with suspected or confirmed 
infectious tuberculosis and should, therefore, be tested more 
frequently.
(4) Additional Requirements
    Paragraph (g)(4) (i) through (iv) contain the additional 
requirements an employer must meet. Paragraph (g)(4)(i) requires that 
the physician or other licensed health care professional, as 
appropriate, verbally notifies the employer and the employee as soon as 
feasible if an employee is determined to have suspected or confirmed 
infectious tuberculosis. In this way an infectious employee can be 
removed from the workplace, thereby minimizing occupational exposure 
for other workers. Paragraph (g)(7)(i), Written Opinion, allows 15 days 
before the employer must provide the employee with the written opinion 
of medical evaluations from the physician or other licensed health care 
professional, as appropriate. In situations where an employee is 
determined to be potentially infectious, this time period leads to 
unnecessary delays in removal from the workplace and disease treatment. 
Therefore, OSHA requires the verbal notification to expedite treatment

[[Page 54270]]

and prevent spread of disease to other employees.
    The proposed standard, in paragraph (g)(4)(ii), requires the 
employer to notify each employee who has had an exposure incident when 
the employer identifies an individual with confirmed infectious TB who 
was previously unidentified. For example, if a newly admitted patient 
undergoes diagnostic and therapeutic evaluation for suspected pulmonary 
malignancy, and the diagnosis of infectious tuberculosis is not made 
until several days after hospitalization, all hospital staff who have 
had exposure must be identified and provided TB skin test and follow-
up. OSHA intends to assure that employees are provided with 
opportunities for early detection of tuberculosis infection. These 
provisions are consistent with the general purpose of tuberculosis 
medical surveillance as recommended by the CDC, and they are included 
to assist all employees in receiving the full benefits provided by the 
standard.
    Determination of the drug susceptibility of the M. tuberculosis 
isolate from the source of an exposure incident resulting in a TB skin 
test conversion is required by paragraph (g)(4)(iii) unless the 
employer can establish that such a determination is infeasible. 
Information regarding drug susceptibility assists the examiner in 
deciding the most effective treatment therapy for the exposed employee, 
particularly if the source is a drug resistant strain of M. 
tuberculosis. Drug susceptibility testing of the source isolate is 
recommended by CDC (Ex. 4B). OSHA includes the provision regarding 
infeasibility because certain TB skin test conversions may involve 
unknown exposure sources. This can make identification of the isolate 
and therefore drug susceptibility testing infeasible or even 
impossible. It is the responsibility of the employer to establish that 
this is infeasible, if such is the case. Employers must make a good 
faith effort to identify M. tuberculosis isolates and obtain the drug 
susceptibility testing.
    Paragraph (g)(4)(iv) requires the employer to investigate and 
document the circumstances surrounding an exposure incident or TB skin 
test conversion and to determine if changes can be instituted that will 
prevent similar occurrences in the future.
    The provision assures that employers obtain feedback regarding the 
circumstances of employee exposures and use the information to 
eliminate or decrease specific circumstances leading to exposure. For 
example, exposure incident investigation shows that an employee was 
exposed to tuberculosis as a result of recirculation of air containing 
infectious droplet nuclei. Further investigation shows inadequate local 
or general ventilation in the workplace. The employer can now repair 
the ventilation system and prevent future exposure incidents. Another 
example of corrective measures may be including a stronger training 
emphasis on certain procedures where proper work practices might have 
decreased the likelihood of transmission of tuberculosis. Employers can 
obtain further guidance regarding investigations for TB skin test 
conversions and exposure incidents in health care workers by reading 
the 1994 CDC guidelines.
(5) Medical Removal Protection
    Paragraph (g)(5)(i) requires that employees with suspected or 
confirmed infectious tuberculosis be removed from the workplace until 
determined to be non-infectious according to current CDC 
recommendations. Infectious TB is contagious and removal is essential 
for the protection of other workers. An employee's ``infectiousness'' 
is determined by the physician or other licensed health care 
professional, as appropriate, who informs the employer as required in 
paragraphs (g)(4)(i) and (g)(7) of this section.
    Paragraph (g)(5)(ii) states that for employees removed from the 
workplace under paragraph (g)(5)(i), the employer shall maintain the 
total normal earnings, seniority, and all other employee rights and 
benefits, including the right to former job status, as if the employee 
had not been removed from the job or otherwise been medically limited 
until the employee is determined to be noninfectious or for a maximum 
of 18 months, whichever comes first. Paragraph (g)(5)(iii) provides 
medical removal protection for employees removed from the workplace 
under paragraph (f)(4)(viii) of Respiratory Protection. The provision 
requires the employer to transfer the employee to comparable work for 
which the employee is qualified or can be trained in a short period (up 
to 6 months), where the use of respiratory protection is not required. 
OSHA requires that if no such work is available, the employer shall 
maintain the employee's total normal earnings, seniority, and all other 
employee rights and benefits until such work becomes available or for 
18 months, whichever comes first.
    The requirement referring to the employee's right to return to his 
or her former job is not intended to expand upon or restrict any rights 
an employee has or would have had, to a specific job classification or 
position under the terms of a collective bargaining agreement. Where 
the employer removes an employee from exposure to tuberculosis, the 
employee is entitled to full medical removal protection benefits as 
provided for under the standard.
    The medical removal requirement is an indispensable part of this 
standard. The medical removal protection helps assure that affected 
employees participate in medical surveillance and seek appropriate 
care. If employees fear losing their jobs as a result of their medical 
condition they may attempt to hide the illness, thereby infecting many 
more workers and other people and jeopardizing their own health. The 
requirement for medical removal assures that an infectious employee 
will not be terminated, laid off, or transferred to another job 
(possibly at a lower pay grade) upon returning to work. Consequently, 
this protection should reduce reluctance on the part of the employee to 
participate in medical surveillance. The employee's health will be 
protected and the health of co-workers and others who come into contact 
with that employee will be protected, also.
    OSHA believes that the cost of protecting worker health to the 
extent feasible is an appropriate cost of doing business since 
employers are obligated by the OSH Act to provide safe and healthful 
places of employment. Consequently, the costs of medical removal, like 
the costs of respirators and engineering controls, are borne by 
employers rather than individual workers.
    If a removed employee files a claim for workers' compensation 
payments for a tuberculosis-related disability, then the employer must 
continue to provide medical removal protection benefits pending 
disposition of the claim. To the extent that an award is made to the 
employee for earnings lost during the period of removal, the employer's 
medical removal protection obligation may be reduced by such amount. 
The employer's obligation to provide medical removal protection 
benefits to a removed employee may be reduced to the extent that the 
employee receives compensation for earnings lost during the period of 
removal either from a publicly or employer-funded compensation program, 
or receives income from employment with another employer which was made 
possible by virtue of the employee's removal.
    Medical removal should not be viewed as an alternative to primary 
control (prevention) of workers' exposure to tuberculosis; rather, it 
should be used as a secondary means of

[[Page 54271]]

protection, where other methods of control have failed to protect. The 
stipulation of an 18 month time period of protection is consistent with 
other OSHA standards (e.g., Cadmium, 29 CFR 1910.1027; Lead in 
Construction, 29 CFR 1926.62). The provision of medical removal and the 
costs associated with the program may indirectly provide employers with 
economic incentives to comply with other provisions of the standard. It 
can be expected that the costs of medical removal will decrease as 
employer compliance with other provisions of the standard increases.
(6) Information Provided to Physician or Other Licensed Health Care 
Professionals
    Paragraph (g)(6)(i) requires the employer to assure that the health 
care professionals responsible for the medical surveillance receive a 
copy of this regulation. OSHA believes it is the employer's 
responsibility to inform the health care professionals responsible for 
medical surveillance of the requirements of this standard. This will 
help assure that these individuals are aware of and implement the 
requirements. This provision is included in other OSHA standards (e.g., 
Benzene, 29 CFR 1910.1028; Bloodborne Pathogens, 29 CFR 1910.1030).
    Paragraph (g)(6)(ii) requires the employer to assure that the 
physician or other licensed health care professional, as appropriate, 
evaluating an employee after an exposure incident receives: (A) A 
description of the exposed employee's duties as they related to the 
exposure incident; (B) a description of the circumstances under which 
the exposure incident occurred; (C) the employee's diagnostic test 
results, including drug susceptibility pattern, or other information 
relating to the source of exposure that could assist in the medical 
management of the employee; and (D) all of the employee's medical 
records relevant to the medical evaluation of the employee, including 
TB skin test results. Since the individual responsible for medical 
surveillance may not necessarily be the person evaluating an employee 
after an exposure incident, it is necessary to also provide a copy of 
this standard to the evaluating physician or other appropriate licensed 
health care professional, as required by paragraph (g)(6)(i). In this 
way, the evaluator will also be informed of and implement the 
standard's requirements. All of the above information is essential to 
follow-up evaluation, and helps assure that an accurate determination 
can be made regarding appropriate medical treatment of the exposed 
employee. This provision is consistent with other OSHA standards (e.g., 
Bloodborne Pathogens, 29 CFR 1910.1030, Benzene, 29 CFR 1910.1028).
(7) Written Opinion
    Paragraph (g)(7)(i) states that the employer shall obtain and 
provide the employee with a copy of the written opinion of the 
physician or other licensed health care professional, as appropriate, 
within 15 days of the completion of all medical evaluations required by 
this section. The purpose of requiring the employer to obtain a written 
opinion is to assure that the employer is provided with documentation 
that the medical evaluation of the employee (1) has taken place and 
that the employee has been informed of the results; (2) has included an 
evaluation of the employee's need for medical removal or work 
restriction; (3) describes the employee's TB skin test status so that 
the employer can assess action needed to prevent further exposure; and 
(4) informs the employer of the employee's infectivity status so that 
the employer can take action to prevent the employee from becoming a 
source of infection for other employees.
    The employer has a right to know the information contained in the 
written opinion and may retain the original written opinion, but must 
provide a copy to the employee. The 15 day provision assures that the 
employee is informed in a timely manner regarding information received 
by the employer and is consistent with other OSHA standards (e.g., 
Formaldehyde, 29 CFR 1910.1048; Benzene, 29 CFR 1910.1028; Bloodborne 
Pathogens, 29 CFR 1910.1030).
    In addition, the written opinion is required to assure the employer 
that the employee has been provided with information about any medical 
conditions resulting from exposure to tuberculosis which require 
further evaluation or treatment.
    OSHA believes it is important that employers know if their 
employees have had evaluations for tuberculosis infection or exposure 
incidents, and that physicians or other appropriate licensed health 
care professionals, acting as agents for the employer, have provided 
the employer with written documentation that these evaluations 
occurred. However, paragraph (g)(7)(ii) limits the information the 
employer is provided in order to protect the privacy of the employee. 
The requirement for a written opinion after a medical evaluation has 
been included in other OSHA standards (e.g., Occupational Exposures to 
Hazardous Chemicals in Laboratories, 29 CFR 1910.1450; Formaldehyde, 29 
CFR 1910.1048; Bloodborne Pathogens, 29 CFR 1910.1030).
    Paragraph (g)(7)(ii)(E) requires the written opinion to state any 
recommendations for medical removal or work restrictions and the 
employee's ability to wear a respirator. This recommendation must be in 
accordance with paragraphs (g)(5)(i) and (f)(5)(viii) of this section. 
Including this information in the written opinion assures that the 
employer is provided with written documentation of the need for removal 
of an employee with infectious tuberculosis from the workplace. The 
provision also assures that the employer is aware of any work 
restrictions on the employee and the employee's ability or inability to 
wear a respirator. This information enables the employer to take 
appropriate steps in managing the employee's duties upon return to the 
workplace. OSHA recognizes the need for this provision and has included 
it in other standards (e.g., Lead in Construction, 29 CFR 1926.62).
    Paragraph (g)(7)(iii) states that all other findings or diagnoses 
shall remain confidential and shall not be included in the written 
report. OSHA believes that all health care professionals have an 
obligation to view medical information gathered or learned during 
tuberculosis medical surveillance or post-exposure evaluation as 
confidential medical information. As stated previously, the maintenance 
of confidentiality encourages participation in medical surveillance by 
allaying employee concern that medical conditions unrelated to 
tuberculosis exposure will be communicated to the employer. OSHA also 
recognizes that successful medical surveillance and medical management 
and follow-up programs must guarantee this confidentiality, the 
specific requirements on confidentiality can be found in applicable 
state and federal laws and regulations that cover medical privacy and 
confidentiality. Finally, OSHA recognizes the need for this provision 
and has included it in other standards (e.g., Bloodborne Pathogens, 29 
CFR 1910.1030).

Paragraph (h)  Communication of Hazards and Training

    Paragraph (h), Communication of Hazards and Training, addresses the 
issues of transmitting information to employees about the hazards of 
tuberculosis through the use of labels, signs, and information and 
training. These provisions apply to all operations that come under the 
coverage of

[[Page 54272]]

paragraph (a), Scope, of this section. Although OSHA has an existing 
standard, Hazard Communication (29 CFR 1910.1200), which requires an 
employer to inform employees about the hazards of chemical substances 
they are exposed to occupationally, that standard does not apply to 
biological hazards such as TB. Consequently, it is OSHA's intent in 
this paragraph to assure that employees will receive adequate warning 
through labels, signs, and training so that the employee understands 
the hazard and can take steps to eliminate or minimize his or her 
exposure to tuberculosis.
    Paragraphs (h)(1) and (h)(2) of the proposed standard for 
tuberculosis provide the specific labeling and sign requirements that 
are to be used to warn employees of hazards to which they are exposed. 
The requirements for labels and signs are consistent with section 
6(b)(7) of the OSH Act, which prescribes the use of labels or other 
appropriate forms of warning to apprise employees of occupational 
hazards. As noted in paragraphs (c)(2)(v), (d)(3), and (d)(5) above, 
settings where home health care and home-based hospice care are 
provided are not required to have engineering controls and, therefore, 
the signs and labeling would not be required in these cases.
Labels
    Paragraph (h)(1)(i) requires that air systems that may reasonably 
be anticipated to contain aerosolized M. tuberculosis must be labeled 
at all points where ducts are accessed prior to a HEPA filter and at 
duct access points, fans, and discharge outlets of non-HEPA filtered 
direct discharge systems. The label must state ``Contaminated Air--
Respiratory Protection Required.'' The provision for labeling of air 
ducts that may reasonably be anticipated to contain aerosolized M. 
tuberculosis, with the proposed hazard warning, is supported by the CDC 
in its discussion of HEPA filter systems. This discussion states:

    Appropriate respiratory protection should be worn while 
performing maintenance and testing procedures. In addition, filter 
housing and ducts leading to the housing should be labeled clearly 
with the words ``Contaminated Air'' (or a similar warning). (Ex. 4B)

    The intent of this provision is to assure that employees who may be 
accessing these systems for the purposes of activities such as 
maintenance, replacement of filters, and connection of additional 
ductwork are warned of the presence of air that may contain aerosolized 
M. tuberculosis so that appropriate precautions can be taken. 
Consequently, labels are to be placed at all points where these systems 
are accessed.
    In situations where air that may reasonably be anticipated to 
contain aerosolized M. tuberculosis is discharged directly to the 
outside, the exhaust outlets are also to be labeled. This is especially 
important since these outlets will most likely be at a remote location 
from the contaminated air source. Employees working in these locations 
would have no warning of the hazard if these ducts were not labeled. In 
addition, a number of exhaust outlets from a variety of sources may be 
present in an area (e.g., a hospital roof). In such situations, 
labeling also serves to distinguish contaminated air exhaust outlets 
from others in the vicinity.
    The proposed provision does not require that a symbol (e.g., 
``STOP'' sign) be included on the duct labels. OSHA believes that, in 
many situations, the label will be stenciled onto the duct, similar to 
the labeling used on other piping and duct labels currently being 
employed in some of these facilities. In addition, the group of workers 
accessing ducts will likely be a well-defined, skilled group that can 
be trained to recognize the text's warning. However, OSHA seeks comment 
on whether a symbol on duct labels is necessary and any information 
regarding the current use of such symbols.
    Paragraph (h)(1)(ii) requires that clinical and research laboratory 
wastes that are contaminated with M. tuberculosis and are to be 
decontaminated outside of the immediate laboratory must be labeled with 
the biohazard symbol or placed in a red container(s). This provision is 
intended to assure that employees are adequately warned that these 
containers require special handling. In addition, the label or color-
coding serves as notice that certain precautions may be necessary 
should materials in the container be released (e.g., a spill). This 
provision closely follows the recommendations outlined in the CDC-NIH 
publication ``Biosafety in Microbiological and Biomedical 
Laboratories'' (Ex. 7-72) and is in accordance with the labeling 
requirements of paragraph (e)(2)(i)(D), Clinical and Research 
Laboratories, of this section.
Signs
    Paragraph (h)(2) contains the provisions relative to the posting of 
warning signs in areas where employees may be exposed to droplet nuclei 
or other aerosols of M. tuberculosis. More specifically, paragraph 
(h)(2)(i)(A) requires that signs be posted at the entrances to rooms or 
areas used to isolate an individual with suspected or confirmed 
infectious TB. The term ``rooms or areas'' is used in order to expand 
the requirement beyond the AFB isolation room or area. Throughout the 
course of a day various employees may enter such rooms or areas in 
order to carry out their duties. These employees can include 
physicians, nurses, respiratory therapists, housekeepers, and dietary 
workers. Posting a sign at the entrance of those rooms or areas where 
an individual with suspected or confirmed infectious TB is isolated 
serves to warn employees that entry into the room or area requires that 
certain precautions be taken. In addition, the employer may have 
implemented a program to minimize the number of employees who enter 
such rooms or areas. In this case, the sign serves as notice that entry 
may not be permitted for a particular employee or group of employees. 
As an additional public health benefit, such signs will also provide 
warning to visitors or family members who may be entering the area and 
are unaware of the hazard.
    Paragraph (h)(2)(i)(B) requires that signs be posted at the 
entrances to areas where procedures or services are being performed on 
an individual with suspected or confirmed infectious TB. Although it is 
critically important to provide appropriate warning to employees who 
may inadvertently enter an isolation room, other areas of the facility 
are of concern as well. Special treatment areas, such as bronchoscopy 
suites, respiratory therapy areas where cough-inducing procedures are 
performed, or radiology examination rooms may, at one time or another, 
be occupied by an individual with suspected or confirmed infectious TB. 
When individuals with suspected or confirmed tuberculosis are occupying 
these areas, the area must have signs placed at the entrances in order 
to warn employees of the hazard.
    The risk of exposure to aerosolized M. tuberculosis also exists in 
clinical and research laboratories where specimens, cultures, and 
stocks containing the bacilli are present. Therefore, paragraph 
(h)(2)(i)(C) requires that a sign be posted at the entrance to 
laboratories where M. tuberculosis is present. Posting of such a sign 
is consistent with the recommendations of the CDC/NIH publication 
``Biosafety in Microbiological and Biomedical Laboratories'' (Ex. 7-72) 
and is in accordance with the sign posting requirement of paragraph 
(e)(2)(ii)(E), Clinical and Research Laboratories, of this section.

[[Page 54273]]

    Even though a suspected or confirmed infectious individual is no 
longer present in a room or area, the droplet nuclei generated by that 
individual may continue to drift in the air. Consequently, the air in 
the room or area presents a risk of TB infection until the droplet 
nuclei are removed. With this in mind, paragraph (h)(2)(ii) requires 
that when an AFB isolation room or area is vacated by an individual 
with suspected or confirmed infectious TB, unless the individual has 
been medically determined to be noninfectious, the sign shall remain 
posted at the entrance until the room or area has been ventilated 
according to CDC recommendations for a removal efficiency of 99.9%, to 
prevent entry without the use of respiratory protection [The rationale 
for specifying this removal efficiency has been discussed previously 
under paragraph (d), Work Practices and Engineering Controls]. This 
provision is supported by the CDC's current recommendations for 
tuberculosis control (Ex. 4B).
    The CDC has published guidelines regarding the length of time for 
such sanitation of the room air based upon the air exchanges per hour 
(see Appendix C of this section). Requiring that the sign remain posted 
until the room or area is adequately ventilated will assure that 
unprotected employees do not inadvertently enter while an infection 
risk is still present.
    Until such time as the room or area has been adequately ventilated, 
employees entering the area must wear respiratory protection. This 
paragraph is designed to address the situations where employees will be 
entering or using a room or area previously occupied by an individual 
with suspected or confirmed infectious TB before the room or area has 
been satisfactorily ventilated. For example, when an infectious 
tuberculosis patient is discharged from a facility and the room is 
needed for an incoming new patient, certain housekeeping and 
maintenance functions need to be done between patient occupancies. 
Employees who must perform the tasks required to prepare the room for 
the next patient must wear respiratory protection until such time as 
the room has been adequately ventilated, based upon the CDC criteria. 
Obviously, if the room was previously occupied by an individual with 
suspected infectious TB and that individual is medically determined to 
be noninfectious, it would not be necessary to ventilate the room to 
remove M. tuberculosis nor to continue to post a sign at the entrance 
to the room since there would be no tuberculosis bacilli present.
    OSHA has given much consideration to what sign should be required 
for posting outside of isolation rooms or areas and for areas where 
procedures or services are performed on individuals with suspected or 
confirmed infectious TB. The purpose of the sign is to convey a uniform 
warning along with the necessary precautions to be used for the 
particular situation.
    The sign recommended by the CDC in 1983 in their ``CDC Guidelines 
for Isolation Precautions in Hospitals'' (Ex. 7-112) read ``AFB 
Isolation'' and then listed the requirements for entry. However, the 
instructions on the CDC sign are different from OSHA's requirements. 
For example, the sign instructed workers that ``Masks are indicated 
only when patient is coughing and does not reliably cover mouth'', a 
recommendation that is currently outdated and no longer recommended by 
CDC. The document contained another sign for ``Respiratory Isolation'' 
but this sign was designed for use with a number of respiratory hazards 
(rubella, meningococcal meningitis, chickenpox) that are not addressed 
in OSHA's proposed standard. Neither the 1990 CDC tuberculosis 
guidelines (Ex. 3-32) nor the 1994 CDC tuberculosis guidelines (Ex. 4B) 
provided help with this issue. OSHA also considered using a sign having 
the words ``AFB Isolation'' however, there is some concern that ``AFB 
Isolation'' could compromise patient confidentiality. For example, that 
sign outside of a treatment area or isolation room would allow members 
of the public or employees with no ``need to know'' to discern the 
potential diagnosis of the individual being isolated.
    In addition, OSHA was unable to find uniform recommendations about 
signs in sources outside of the CDC. A number of facilities use signs 
to warn employees of the hazard of TB, but these signs vary widely and 
often had been developed for a particular facility. Thus, facilities 
that were using TB warning signs did not appear to be universally 
applying a specific sign.
    The Agency does not believe, however, that development of a sign 
should be left to individual employers since this could lead to a 
variety of signs that may not provide adequate warning of the hazard. 
In the work settings covered by the proposal, there are many employees 
who move from facility to facility or even from industry to industry. 
In fact, a substantial number, like contract nurses, will work in 
several facilities at one time. A universal sign will enable these 
employees to recognize the hazard wherever it occurs and then take 
proper precautions. The issue of whether OSHA should specify colors 
that must be included on the sign was raised at TB stakeholder 
meetings. OSHA realizes there is a part of the population, perhaps as 
high as 10% of all men, that is color blind and that at some work sites 
some colors have been employed that are different from the red that 
OSHA proposes be used. However, stakeholders, particularly those whose 
jobs took them to several different work sites, urged OSHA to require a 
standardized sign and, of those who considered the issue, there was 
general agreement that the red on the familiar ``stop'' sign was 
appropriate. OSHA has preliminarily concluded that the colors required 
provide needed warning even though not all employees (e.g., those who 
are color blind) may benefit from them, and that the colors chosen are 
consistent with conventions on health signage. The Agency has developed 
a sign that it believes will provide appropriate warning and be easily 
recognizable. Failing to find either a guideline recommendation or a 
generally accepted community standard regarding what sign should be 
placed at the entrances to these areas, OSHA looked to generic, broad-
based sources for symbols which would be easily identifiable, 
understandable to workers who were not able to read well or are non-
English speaking, and simple to construct.
    In paragraph (h)(2)(iii), therefore, OSHA is proposing that a 
``STOP'' sign with the accompanying legend, ``No Admittance Without 
Wearing A Type N95 Or More Protective Respirator'', meets these 
criteria. The sign is easily recognizable, requires a simple color 
scheme, and should be understandable to employees with minimal 
training.
    OSHA is seeking information on the effectiveness of the proposed 
sign to warn workers of the presence of a hazard, as well as 
information on other signs that may be more effective. Please be 
specific when providing information, keeping in mind the wide variety 
of work sites where signs will be needed. Where an alternative is being 
proposed, please enclose a model or drawing as well as the rationale 
for believing that it will be more effective than OSHA's proposed sign.
    Paragraph (h)(2)(iv) requires that signs at the entrances of 
clinical or research laboratories and autopsy suites where procedures 
are being performed that may generate aerosolized M. tuberculosis 
include the biohazard symbol, name and telephone number of the 
laboratory director or other designated responsible person, the 
infectious agent designation

[[Page 54274]]

``Mycobacterium tuberculosis'', and special requirements for entering 
the laboratory or autopsy suite. This provision has been taken directly 
from the CDC/NIH publication ``Biosafety in Microbiological and 
Biomedical Laboratories'' (Ex. 7-72). As previously discussed, the 
purpose for this sign is to warn employees of the potential TB hazard 
and inform them of precautions that must be taken to prevent exposure.
Information and Training
    It is OSHA's position that employees must understand the nature of 
the hazards in their workplace and the procedures to follow in order to 
eliminate or minimize their risks of exposure to these hazards. (Exs. 
4-B, 7-169, 7-170, 7-61, 7-64) In the case of M. tuberculosis, employee 
exposures may result in a TB infection, which may ultimately result in 
disease and even death. The provisions in paragraph (h)(3) of this 
proposed standard set forth the training that each employer must 
provide to his or her employees. OSHA believes that effective training 
is a critical element in any occupational safety and health program. In 
this proposed standard, the employer would be required to provide 
training for each employee covered by the scope of the standard.
    Paragraph (h)(3)(i) requires that employers assure that each 
employee with occupational exposure participates in training, which 
must be provided at no cost to the employee and be made available at a 
reasonable time and place. Since appropriate training is considered to 
be critical in assuring employee protection, the employer is 
responsible for making sure that each employee with occupational 
exposure participates in the training program. Having the employee pay 
in some manner for all or part of the training or requiring the 
employee to attend training at an unreasonable time and place would be 
a disincentive to participation. If training cannot feasibly be 
provided during work hours, employees are to be paid for training 
scheduled outside of normal working hours.
    In view of the importance of training, OSHA is proposing that it be 
provided at several particular points in time. (Exs. 7-169; 4-B) More 
specifically, paragraph (h)(3)(ii) requires that training be provided: 
(A) before initial assignment to tasks where occupational exposure may 
occur, for those employees without previous occupational exposure; (B) 
within 60 days after the effective date of the final standard, for 
those employees who have occupational exposure at the time of the 
standard's promulgation; and (C) at least annually thereafter, unless 
the employer can demonstrate that the employee has the specific 
knowledge and skills required under paragraph (h)(3)(vii). The employer 
must provide re-training to an employee in any of the topic(s) in 
paragraph (h)(3)(vii) in which that employee cannot demonstrate the 
necessary knowledge and/or skill. This approach to training frequency 
assures that employees entering jobs with occupational exposure will be 
fully trained before exposure occurs. In addition, employees who are 
already working in jobs with occupational exposure at the time of the 
standard's promulgation will receive training and must become 
knowledgeable in all of the required aspects of the standard (e.g., 
employer's exposure control plan, medical surveillance program, warning 
signs and labels) within a short period of time.
    Annual re-training reinforces the initial training and provides an 
opportunity to present new information that was not available at the 
time of initial training. The Agency recognizes that, as a result of 
training previously provided by the employer, employees may possess 
some of the knowledge and skills listed in the training topics in 
paragraph (h)(3)(vii). Consequently, OSHA is proposing that re-training 
be provided annually unless the employer can demonstrate that the 
employee has the specific knowledge and skills required by this 
paragraph. The employer must provide re-training to an employee in any 
topic(s) in paragraph (h)(3)(vii) in which the employee cannot 
demonstrate specific knowledge and skills.
    An employee with occupational exposure to TB who moves to a job 
with another employer that also involves occupational exposure to TB 
would not need to meet all of the initial training requirements. In 
such instances, the Agency has determined that the employee's prior 
training in the general topics required by the standard (e.g., the 
general epidemiology of tuberculosis, the difference between 
tuberculosis infection and tuberculosis disease) would remain relevant 
in the new work setting and that the new employer need not re-train in 
these topics. However, the employee would not possess knowledge of the 
topics required by the standard that are specific to the new employer's 
particular work setting (e.g., the new employer's exposure control plan 
and respiratory protection program and the means by which the employee 
could access the written plans for review). OSHA is proposing to permit 
limited ``portability'' of training, as noted in the standard. This 
note states that training in the general topics listed in paragraph 
(h)(3)(vii) that has been provided in the past 12 months by a previous 
employer may be transferred to an employee's new employer. However, the 
new employer must provide training in the site-specific topics listed 
in paragraph (h)(3)(vii) in accordance with the requirements of 
paragraph (h) (e.g., at no cost to the employee and at a reasonable 
time and place).
    OSHA is aware that some employers have already established training 
for their occupationally exposed employees. (Ex. 7-169) In light of 
this, paragraph (h)(3)(iii) of the proposed standard requires only that 
limited training be conducted for those employees who already have 
received training on tuberculosis in the year preceding the effective 
date of the standard. The additional training would only have to 
address those provisions of the standard not previously covered in the 
earlier training.
    The requirement for annual training within one year of the 
employee's previous training, in paragraph (h)(3)(iv), assures that 
each employee receives training within 12 calendar months of his or her 
last training. Annual training is not based on a calendar year; that 
is, training will not be permitted to be provided to an employee in 
January of one year and in December of the following year, essentially 
a 23-month span between training sessions. Employers may establish 
schedules for training around this requirement.
    Also, paragraph (h)(3)(v) stipulates that the employer must provide 
additional training whenever changes in the occupational environment, 
such as modification of tasks or procedures or institution of new tasks 
or procedures, affect the employee's occupational exposure to M. 
tuberculosis. This provision will assure that employees remain apprised 
of any new exposure hazards and the precautions necessary to protect 
themselves from exposure. This additional training does not need to 
entail a complete reiteration of the annual training, but may be 
limited to addressing the new sources of potential exposure.
    The proposed standard requires that training material be used that 
is appropriate in content and vocabulary to the educational level, 
literacy and language of employees. Employees must be able to 
comprehend the information being conveyed in order for it to be useful. 
Therefore, the employer has the responsibility for assuring that the 
training is provided in an understandable manner to the audience being 
addressed. This provision would

[[Page 54275]]

assure that employees, regardless of their educational or cultural 
background, will receive adequate training.
    Paragraph (h)(3)(vii) of the proposed standard contains the 
specific elements that would comprise a minimum training program. (Exs. 
4-B; 7-169; 7-64) The provisions for employee training are performance 
oriented, stating the categories of information to be transmitted to 
employees and not the specific ways that this is to be accomplished. 
This assures that important information is communicated to employees 
about the nature of this occupational hazard while allowing employers 
the most flexible approach to providing training. OSHA has set forth 
the objectives to be met and the intent of training. The specifics of 
how the employer assures that employees are made aware of the hazards 
in their workplace and how they can help to protect themselves are left 
up to the employer who is best qualified to tailor the training to the 
TB hazards in his or her workplace.
    The proposed standard would require the employer to explain a 
number of particular topics in the training session(s). Paragraph 
(h)(3)(vii)(A) requires the employer to provide an explanation of the 
contents of this standard and the location of an accessible copy of the 
regulatory text and appendices to this standard. This enables the 
employee to have access to the standard and to become familiar with its 
provisions. It is not necessary for the employer to provide each 
employee with a copy of the standard; it is sufficient for the employer 
simply to make a copy accessible. For example, a copy of the standard 
could be posted in a location where it could be readily and easily 
viewed by employees.
    An important element in the training involves an overview of the 
epidemiology of tuberculosis, the pathogenesis of the disease and an 
explanation of various aspects of risk to employees. (Ex. 4B) More 
specifically, paragraph (h)(3)(vii)(B) requires that the training 
include an explanation of: the general epidemiology of tuberculosis, 
including multidrug-resistant TB and the potential for exposure in the 
facility; the signs and symptoms of TB, including the difference 
between TB infection and TB disease; the modes of transmission of 
tuberculosis, including the possibility of reinfection in persons with 
a positive tuberculin skin test; and the personal health conditions 
that increase an employee's risk of developing TB disease if infected.
    Since the employer can tailor the training to the needs of his or 
her employees, the training program will likely be more technical for 
some audiences and less technical for others. The general goal of this 
paragraph is to assure that each employee being trained understands 
what tuberculosis is, how it is spread, and possible risks that may 
affect the employee.
    Employees need to be able to recognize symptoms associated with TB 
disease. (Ex. 4B) The employee must understand that certain symptoms 
(e.g., a persistent cough lasting 3 or more weeks, bloody sputum, night 
sweats, anorexia, weight loss, fever) may be related to TB. In 
addition, information on non-occupational risk factors that place 
employees at increased risk of developing tuberculosis disease 
following an infection permits those individuals at increased risk to 
make informed decisions about their employment situations.
    Paragraph (h)(3)(vii)(C) requires an explanation of the employer's 
exposure control plan and respiratory protection program. Employees 
must also be informed about what steps they need to take to review the 
written plans, if they so desire.
    Paragraph (h)(3)(vii)(D) requires the employer to train employees 
regarding the tasks and other activities that may involve occupational 
exposure to tuberculosis. Employees must be made aware of those job 
duties which may expose them to tuberculosis. For example, although 
certain health care professionals may easily recognize the hazard 
involved in transporting a person with infectious TB, the staff of a 
correctional facility may not. On the other hand, some health care 
professionals may not immediately recognize that their mere presence in 
a room where an individual with suspected or confirmed infectious TB is 
being X-rayed presents an exposure risk and necessitates wearing a 
respirator. All occupationally exposed employees need training that 
will enable them to recognize those activities that put them at risk of 
exposure.
    Paragraph (h)(3)(vii)(E) of this section requires employers to 
train employees regarding both the uses and limitations of various 
control measures, specifically those used at the employees' worksite. 
Exposed employees must be familiar with the employer's tuberculosis 
policies and procedures in order for them to be properly implemented. 
Control of exposure frequently involves using a variety or combination 
of engineering controls, administrative controls, work practice 
procedures and personal protective equipment. To assure that employees 
will be able to identify and implement methods of reducing occupational 
exposure to tuberculosis, they must understand how these controls are 
applied in their work sites and the limitations thereof. With this 
understanding, employees will be more likely to use the appropriate 
control for the situation at hand and to use it correctly. For example, 
employees must be able to recognize the labels and signs used to 
identify rooms or areas where suspected or confirmed infectious 
individuals are present so that they can take appropriate precautions 
before entering. Understanding of the limitations of control measures 
will also enable employees to recognize when inappropriate or 
inadequate control measures have been taken and increases the 
likelihood that they will report such situations.
    Training must be relevant to the specific site where the employee 
will be working. Each employee must know, for example, the procedures 
used in his or her particular facility to identify suspected infectious 
TB cases, where respiratory protection is kept, and what engineering 
controls are in place within the facility. This training is 
particularly important for workers who move between several facilities 
in the course of their work, for example, ``leased'' personnel, part-
time employees, ``moonlighters'', or contractors.
    The provision covering the selection, types, proper use, location, 
removal and handling of respiratory protection, paragraph 
(h)(3)(vii)(F), is particularly important because many of the employees 
and employers proposed to be covered by the tuberculosis standard may 
not be accustomed to the use, selection, and upkeep of respiratory 
protection. Consequently, training on aspects such as the necessity for 
respiratory protection, the appropriate type of respiratory protection, 
where to obtain it, and its proper use, fit, and the general upkeep is 
necessary to assure the effectiveness of respirator use. (Ex. 7-64)
    OSHA believes that employees who have a clear understanding of the 
medical surveillance program (its purpose, methodology, and the 
significance of the results of examinations and tests), will be much 
more likely to participate in that program. Therefore, paragraph 
(h)(3)(vii)(G) requires that the training include an explanation of the 
employer's medical surveillance program, including the purpose of 
tuberculin skin testing, the importance of a positive or negative skin 
test result, anergy testing, and the importance of participation in the 
program. This increased participation by trained

[[Page 54276]]

employees helps the employee to identify changes in his or her personal 
health status and also aids the employer in assessing the effectiveness 
of his or her TB control program.
    Each employee must understand the actions to be taken if an 
occupational exposure occurs as well as what is available to them 
regarding appropriate medical treatment, prophylaxis, and post exposure 
follow-up in order for the employee to lessen the chance of developing 
active disease. Therefore, paragraph (h)(3)(vii)(H) would require an 
explanation of the procedures to follow if an exposure incident occurs, 
including the method of reporting the incident, an explanation of the 
medical management and follow-up that the employer is required to 
provide, and the benefits and risks of drug prophylaxis. In addition, 
the employee must be provided with an explanation of the procedures to 
follow if the employee develops signs or symptoms of tuberculosis 
disease [paragraph (h)(3)(vii)(I)]. In this way, an employee who notes 
the signs or symptoms of personal disease development will be aware of 
the appropriate steps to take, thereby speeding initiation of medical 
evaluation. Quick evaluation protects the employee, co-workers, and the 
public.
    In paragraph (h)(3)(viii), the proposed standard mandates that the 
person conducting the training must be knowledgeable in the subject 
matter as it relates to the specific workplace being addressed. OSHA 
believes that a variety of persons are capable of providing effective 
training to employees. OSHA has approached this section of the proposed 
standard in much the same way as the trainer requirements were 
addressed in the standard for Occupational Exposure to Bloodborne 
Pathogens. That is, a knowledgeable trainer is one who is able to 
demonstrate expertise in the area of the occupational hazard of 
tuberculosis and is familiar with the manner in which the elements of 
the training program relate to the particular workplace.
    A number of resources are available through the Centers for Disease 
Control and Prevention and professional organizations such as the 
American Lung Association and the American Thoracic Society that can be 
used to educate trainers and prepare them for this task. In addition, 
specialized training courses in the area of tuberculosis control can 
also assist in educating trainers (Ex. 7-189).
    In addition to general knowledge of the subject matter, it is 
important that the trainer be able to instruct the participants in 
site-specific features of the Exposure Control Plan that will reduce 
their risk in the particular facility. This benefits not only employees 
within the facility but also provides temporary employees with the 
information needed to protect themselves against exposure while working 
in the facility. For example, workers who have received general 
training by their employer (e.g., a personnel staffing agency) will 
also receive training about the facility where they will actually 
perform their duties (e.g., a specific hospital).
    An important component of an effective learning experience is the 
opportunity for the learner to interact with the trainer for the 
purposes of asking questions and obtaining clarification. Paragraph 
(h)(3)(ix) would require that the employer provide employees with this 
opportunity as part of the training program. The trainer must be 
available at the time that the training takes place. OSHA would expect 
that in most instances, the individual who would provide answers to the 
employee's question would be physically present when the employee is 
trained. The Agency does recognize, however, that there may be some 
instances where this is not possible. In these cases, it would be 
acceptable for the employee to ask questions by telephone.
    An employer would not be expected to train employees in site-
specific topics that are not applicable to the employer's work setting. 
For example, if a facility was not required by the standard to utilize 
engineering controls, the employer would not be responsible for 
training his or her employees about the various aspects of engineering 
controls.
    OSHA believes that the information and training requirements 
incorporated into this proposed standard are needed to inform employees 
about the hazard of tuberculosis and to provide employees with an 
understanding of the degree to which they can minimize the health 
hazard. Training is essential to an effective overall hazard 
communication program and serves to explain and reinforce the 
information presented to employees on signs and labels. These forms of 
information and warning will be meaningful only when employees 
understand the information presented and are aware of the actions to be 
taken to avoid or minimize exposure.
    OSHA seeks comment on the proposed content of the training program 
and requests that model TB training programs be submitted to the 
docket, particularly those designed for audiences whose participants 
may have language difficulties or have no health care background, and 
those that have been judged to be successful in communicating 
information to employees. It is OSHA's intent, upon publication of the 
final standard, to include information on training programs in 
compliance guides to be developed for small entities.

Paragraph (i)  Recordkeeping

    This proposed standard requires employers to keep records related 
to TB, including medical surveillance and training records for all 
employees with occupational exposure and engineering control 
maintenance and monitoring records. OSHA has made a preliminary 
determination that, in this context, medical and training records are 
necessary to assure that employees receive appropriate information on 
hazards and effective prevention and treatment measures, as well as to 
aid in the general development of information on the occupational 
transmission of TB. Specifically, OSHA believes that maintenance of 
medical records is essential because documentation is necessary to 
ensure proper evaluation of an employee's infection status and for 
prompt and proper healthcare management following an exposure incident. 
OSHA has also preliminarily determined that maintenance and monitoring 
records for engineering controls are necessary for two reasons: to 
enable the employer to know that the control methods remain in good 
working order so as to assure their effectiveness and to aid the Agency 
in enforcement of the standard.
    In paragraph (i)(1), OSHA proposes to require employers to 
establish and maintain a medical record in accordance with 29 CFR 
1910.1020 for each employee with occupational exposure to TB. The 
record must include: (A) The name, social security number, and job 
classification of the employee; (B) A copy of all results of 
examinations, medical testing, including the employee's tuberculin skin 
test status; and follow-up procedures required by paragraph (g); (C) 
The employer's copy of the physician's or other licensed health care 
professional's written opinion as required by paragraph (g)(7); and (D) 
A copy of the information provided to the physician or other health 
care professional required by paragraph (g)(6). The information that 
must be included in the medical record is necessary for the proper 
evaluation of the employee's infection status and management of 
occupational exposure incidents. This record will aid OSHA in enforcing 
the standard and the information therein, when analyzed, will further 
the development of health

[[Page 54277]]

data on the causes and prevention of occupational transmission of TB. 
Similar provisions for collection and retention of such information 
have been included in other OSHA health standards including, most 
recently, Bloodborne Pathogens (29 CFR 1910.1030) and Cadmium (29 CFR 
1910.1027).
    In paragraph (i)(1)(iii), OSHA is proposing to require that the 
employee medical records be kept confidential and not be disclosed or 
reported to anyone without the employee's express written consent 
except as required by section i or as may be required by law. In nearly 
every health standard rulemaking, employees have told the Agency that 
keeping medical records confidential is extremely important to them. 
Employees stated that, without assurance of confidentiality, they would 
be reluctant to participate in medical surveillance, a predicament that 
would be detrimental to their health and could affect health and safety 
conditions in the workplace. During the Bloodborne Pathogens 
rulemaking, confidentiality of medical records was a major issue due to 
the nature of the diseases addressed. Of particular concern was keeping 
the medical records from being disclosed to the employer. It was 
explained in the Bloodborne Pathogens standard and is applicable here 
that such confidentiality can be accomplished by having the records 
kept by the physician or other licensed health care provider at the 
expense of the employer. In those cases where the employer is the 
health care provider, the records can be maintained separately from 
other employee records so that disclosure can be strictly limited to 
the physician or other licensed health care professional and his or her 
staff who are responsible for the medical management of the employee. 
It was pointed out in the preamble to the Bloodborne Pathogens 
standard, and bears repeating here, that the confidentiality provisions 
in the proposed standard are reiterations of existing standards of 
conduct in the health care professions and that the OSHA requirements 
do not abridge, enlarge or alter existing ethical or statutory codes 
(56 FR 64170). This section of the proposal requires that medical 
records be disclosed to the Assistant Secretary or the Director (of 
NIOSH) and as may be required by law, which means that this proposed 
standard would not prevent employers from reporting TB cases to 
federal, state, or municipal health departments where that reporting is 
required by law.
    Paragraph (i)(1)(iv) proposes to require that medical records be 
maintained in accordance with 29 CFR 1910.1020 for at least the 
duration of employment plus 30 years. The Access to Medical Records 
Standard contains an exception to the 30-year requirement that provides 
that the medical records of an employee who has worked less than one 
year must be maintained throughout his or her employment, but need not 
be retained afterwards as long as they are given to the employee upon 
termination of employment. Maintaining the records for the duration of 
employment serves several purposes: the records can provide valuable 
information to the employee's healthcare provider; the records enable 
the employer to know that employees are benefitting from regular 
surveillance and timely intervention following occupational exposure to 
TB; analysis and aggregation of the records can provide insight into 
the causes and consequences of occupational exposure to TB; and, the 
records will aid in the enforcement of the standard. Requiring the 
records to be kept 30 years beyond employment is necessary because TB 
can have a long incubation period, with disease often appearing only 
many years after initial infection. This retention time is also 
consistent with other OSHA health standards (See for example Benzene, 
29 CFR 1910.1028; Bloodborne Pathogens, 29 CFR 1910.1030; Ethylene 
Oxide, 29 CFR 1910.1047).
    In paragraph (i)(2), OSHA proposes to require employers to record 
TB infection and disease in accordance with 29 CFR 1904, Recording and 
Reporting Occupational Injuries and Illnesses, and 29 CFR 1960, the 
equivalent requirement for Federal Agency programs. This should not be 
an unfamiliar requirement to employers because occupational TB 
infections and disease must be reported in accordance with 29 CFR 1904 
and 29 CFR 1960, as directed by current OSHA enforcement policy (Ex. 7-
1).
    In paragraph (i)(3), OSHA proposes to require training records, 
which include: (A) The dates of the training sessions; (B) The contents 
or a summary of the training sessions; (C) The names and qualifications 
of persons conducting the training; and (D) The name and job 
classification of all persons attending the training sessions. This 
requirement is consistent with other OSHA standards, particularly 
Bloodborne Pathogens, and it represents the minimum amount of 
information an employer, an employee, or an OSHA compliance officer 
would need in order to determine when and what training had been 
provided, who administered it and who attended. Additionally, such a 
record is an invaluable aid to the employer when evaluating his or her 
training program.
    OSHA proposes, in paragraph (i)(3)(ii) to require that training 
records be maintained for three years beyond the date the training 
occurred. The Agency anticipates that employers will not have 
difficulty maintaining the records for three years because the 
information to be included is not extensive and many employers are 
already keeping training records three years as required by other OSHA 
standards (e.g., Bloodborne Pathogens, 29 CFR 1910.1030). Moreover, 
these records are not required to be kept confidential and so may 
become part of an employee's personnel file or part of a larger file, 
at the discretion of the employer.
    In paragraph (i)(4), OSHA proposes to require engineering control 
maintenance and monitoring records be kept that include: (A) Date; (B) 
Equipment identification; (C) Task performed; and (D) Sign-off. The 
performance monitoring records must include: (A) Date and time; (B) 
Location; (C) Parameter measured; (D) Results of Monitoring; and (E) 
Sign-off. Only two of these items will require more than a few words or 
numbers to record; the two items that require more extensive 
information are the maintenance task performed and the results of the 
performance monitoring. Where the employer has not already developed a 
method for recording the task performed, the maintenance person can 
list the tasks or use a previously prepared check-list. The results of 
performance monitoring can be recorded in the same way or another way 
that meets the needs of the particular workplace so long as it includes 
all of the information required by the paragraph. OSHA believes that 
the information in these records is the usual data that are generated 
by persons maintaining and servicing equipment so that the status of 
the equipment and its effectiveness can be known for a given time. The 
information is also useful in determining when further servicing is 
needed.
    Proposed paragraph (i)(4)(iii) requires engineering control 
maintenance and monitoring records to be maintained for three years. 
The three year period is a reasonable period of time and it will enable 
the employer to develop and sustain a proper maintenance program and to 
track the effectiveness of the controls. Moreover, the records will aid 
the OSHA compliance officer in enforcing the standard's requirements 
for engineering controls.
    Availability of medical records is specified in section 8(c) of the 
Act. In paragraph (i)(5) of this standard, OSHA

[[Page 54278]]

proposes to restrict the availability of employee medical records while 
making employee training records and engineering control and monitoring 
records generally available upon request. Medical records must be 
provided to the subject employee, to anyone having written consent from 
the employee, to the Director and to the Assistant Secretary in 
accordance with 29 CFR 1910.1020, which sets forth the procedures that 
will protect the privacy concerns of the employees. This paragraph does 
not affect existing legal and ethical obligations concerning 
maintenance and confidentiality of employee medical records. An 
employer's access is governed by existing federal, state and local laws 
and regulation. This standard, like Bloodborne Pathogens (29 CFR 
1910.1030) and other OSHA standards, limits employer access to 
confidential information while allowing the employer access to the 
information needed to make appropriate decisions relative to his or her 
medical surveillance program. For example, paragraph (g)(7)(ii) limits 
the information that can be included in the physician's or other 
licensed health care professional's written opinion and paragraph 
(g)(7)(iii) requires that other medical diagnoses or findings be kept 
confidential. There is no language in this proposed standard that 
grants an employer access to the confidential information in an 
employee's medical file. OSHA illness and injury records are accessible 
under 29 CFR 1904 and 29 CFR 1960, as appropriate, to the facility. In 
this proposal, as in OSHA's other health standards, training records 
and engineering control maintenance and monitoring records are to be 
provided upon request to the employees, their representatives, the 
Director and the Assistant Secretary. Employers should not have 
difficulty complying with this provision because most will have 
experience with such recordkeeping from other standards. There are no 
confidentiality issues raised by these records.
    In paragraph (i)(6), an employer who goes out of business is 
required to transfer medical records as set forth in 29 CFR 
1910.1020(h) and 29 CFR 1904, which address the transfer of medical 
records. Specifically, medical records must be transferred to a 
successor employer who must accept them and keep them in accordance 
with the requirements of 29 CFR 1910.1020. In the event the employer 
ceases to do business and there is no successor employer, the employer 
is required to notify the Director, at least three months prior to 
disposal of the records, and transmit them to the Director if required 
by the Director to do so. This is consistent with other health 
standards and ensures that a successor employer (and the employees) can 
benefit from the information contained in the records. The reason the 
records are transferred (if requested) to the Director of NIOSH is that 
NIOSH has a vested interest in maintaining records of occupational 
injuries and illnesses and is in an excellent position to decide how 
the records can be best used to be of value to the exposed employee, 
subsequent employees in the field and OSHA. At NIOSH, the records 
remain confidential as required by 29 CFR 1910.1020(e). Thus, only the 
employee or his or her representative with the permission of the 
employee retains access to the medical records transferred to NIOSH.

Paragraph (j)  Definitions

    Acid-Fast Bacilli (AFB) means bacteria that retain certain dyes 
after being washed in an acid solution. Most acid-fast organisms are 
mycobacteria. Smears of sputum samples and other clinical specimens may 
be stained with dyes to detect acid-fast mycobacteria such as M. 
tuberculosis. However, AFB smear tests cannot distinguish one type of 
mycobacteria from another. Therefore, as noted by CDC, when AFB are 
seen on a stained smear of sputum or other clinical specimens, a 
diagnosis of TB should be suspected; however, the diagnosis of TB is 
not confirmed until a culture is grown and identified as M. 
tuberculosis (Ex. 4B).
    Accredited Laboratory for purposes of this standard means a 
laboratory that has participated in a quality assurance program leading 
to a certification of competence administered by a governmental or 
private organization that tests and certifies laboratories. Under the 
medical surveillance provisions of the proposed standard, paragraph 
(g)(1)(iv) requires that all laboratory tests required by the standard 
be conducted by an accredited laboratory. This definition makes clear 
OSHA's intent about the type of laboratory that would be required to 
conduct these types of tests.
    The term AFB Isolation Room or Area refers specifically to the 
rooms or areas where individuals with suspected or confirmed infectious 
TB are isolated. For purposes of this standard this term includes, but 
is not limited to, rooms, areas, booths, tents or other enclosures that 
are maintained at negative pressure relative to adjacent areas in order 
to control the spread of aerosolized M. tuberculosis. Such rooms or 
areas are able to contain droplet nuclei through unidirectional airflow 
into the room (i.e., negative pressure). A definition of negative 
pressure is presented below and a more detailed explanation can be 
found in the Summary and Explanation of paragraph (d), Work Practices 
and Engineering Controls.
    Air purifying respirator means a respirator that is designed to 
remove air contaminants from the ambient air or air surrounding the 
respirator. Air purifying respirators remove particular contaminants 
(e.g., particulates, organic vapors, acid gases) from the ambient air 
by drawing the air through appropriate filters, cartridges, of 
canisters.
    Anergy means the inability of a person to react to skin test 
antigens (even if the person is infected with the organism(s)tested 
because of immunosuppression. More specifically, an anergic 
individual's immune system has become so compromised that it is unable 
to mount a sufficient reaction to the test organism. Because of their 
inability to respond immunologically, persons with anergy will have a 
negative tuberculin skin test even if they are infected with M. 
tuberculosis. Therefore, as noted by the CDC, it may be necessary to 
consider other epidemiologic factors (e.g., the proportion of other 
persons with the same level of exposure who have positive tuberculin 
skin test results and the intensity or duration of exposure to 
infectious TB patients that the anergic person experienced) when making 
a determination as to whether that anergic individual has been infected 
with M. tuberculosis (Ex. 4B). As discussed under paragraph 
(g)(2)(iii), Medical Surveillance, tuberculin skin testing is to 
include anergy testing when the physician or other licensed health care 
professional, as appropriate, determines such testing is necessary. 
Knowing which individuals are anergic will help to determine those 
situations where information other than skin test status will need to 
be ascertained and considered in order to assess the likelihood of 
infection for exposed employees.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, or designated representative, and is a 
definition consistent across all OSHA standards.
    BCG (Bacille Calmette-Guerin) vaccine means a tuberculosis vaccine 
used in many parts of the world. Because of its variable efficacy and 
its impact upon tuberculin skin tests (i.e., making skin test 
interpretation more difficult), routine BCG vaccination is not 
currently recommended in the

[[Page 54279]]

United States (Ex. 7-50). However, many foreign countries still use BCG 
as part of their tuberculosis control programs, especially for infants 
(Ex. 7-72). Since individuals vaccinated with BCG may have a tuberculin 
skin test that cannot be distinguished reliably from a reaction caused 
by infection with M. tuberculosis, it is helpful to know whether an 
individual has been vaccinated with BCG and when such vaccination 
occurred. Thus, under the medical surveillance provisions of the 
proposed standard, the medical history is to include a history of BCG 
vaccination.
    Cartridge or canister means a container with a filter, sorbent, or 
catalyst, or a combination of these items, that removes specific air 
contaminants from the air drawn through the container. With respect to 
this standard, respirators would be equipped with cartridges or 
canisters containing particulate filters.
    Clinical laboratory has been defined for purposes of this standard 
as a facility or an area of a facility that conducts routine and 
repetitive operations for the diagnosis of TB, such as preparing acid-
fast smears and culturing sputa or other clinical specimens for 
identification, typing or susceptibility testing. This definition is 
meant to apply to laboratories where routine diagnostic tests for TB 
are conducted as compared to research laboratories where M. 
tuberculosis may be cultured in large volumes or concentrated for 
research or commercial production. Clinical laboratories may be located 
within facilities such as hospitals or clinics, or they may be 
freestanding facilities.
    Confirmed infectious tuberculosis (TB) means a disease state that 
has been diagnosed by positive identification of M. tuberculosis from 
body fluid or tissue through positive culture, positive gene probe, or 
positive polymerase chain reaction (PCR); and the individual is capable 
of transmitting the disease to another person. The disease state may be 
manifested as pulmonary or laryngeal TB or extrapulmonary TB if the 
infected tissue is exposed and could generate droplet nuclei.
    As discussed under the definition for AFB, a positive AFB smear 
indicates only that an individual has an identifiable mycobacterium. 
The three methods listed here provide positive confirmation of M. 
tuberculosis. In addition, the definition states that the disease state 
must be capable of being transmitted to another person (i.e., 
infectious). This provision of the definition is to differentiate this 
state of the disease from other active forms of TB disease where the 
individual is not infectious. For example, an individual may contract 
active TB disease and become infectious. After adequate drug therapy 
has been initiated the individual may become noninfectious, at which 
point he or she cannot transmit the disease to other individuals. 
However, the individual, while no longer infectious, still has active 
disease and must continue treatment for several months because living 
bacilli are still in his or her body. The definition also states that 
the disease may be manifested as pulmonary or laryngeal TB or 
extrapulmonary TB if the infected tissue is exposed and could generate 
droplet nuclei. In most cases, it is the pulmonary or laryngeal forms 
of infectious TB that present a risk of infection for other 
individuals. This is due to the fact that tuberculosis bacilli in the 
pulmonary or laryngeal tracts may be easily dispelled when infectious 
individuals cough or speak. Other body sites infected with the bacilli, 
i.e., extrapulmonary TB, do not present an infection hazard in most 
cases because the bacilli are not capable of being dispelled outside 
the body. However, in some situations, such as a lesion or an abscess 
where the infected tissue is exposed, there may be a risk of 
transmission of disease when certain procedures are performed (e.g., 
tissue irrigation) that could generate droplet nuclei containing the 
bacilli.
    Conversion means a change in tuberculin skin test results from 
negative to positive, based upon current Centers for Disease Control 
and Prevention (CDC) guidelines. Under paragraph (g), the employer is 
required to provide medical management and follow-up to employees who 
have converted to positive tuberculin skin test status (e.g., providing 
preventive therapy, if appropriate, and conducting follow-up 
investigations of circumstances surrounding the conversion). Since a 
number of specific actions are required of the employer as a result of 
a conversion, it is necessary that conversions be correctly identified. 
An important part of this identification is the interpretation as to 
whether an employee has a positive skin test response. As such, this 
definition states that the interpretation of the positive reaction 
should be based upon current CDC guidelines (Ex. 4B). It is not OSHA's 
intent to define what should constitute a positive reaction, but rather 
to assure that such determinations are made using currently accepted 
public health guidelines.
    Director means the Director of the National Institute for 
Occupational Safety and Health, U.S. Department of Health and Human 
Services, or designated representative. Similar to the definition for 
Assistant Secretary, the definition for Director is consistent across 
OSHA standards.
    Disposable respirator means a respiratory protective device that 
cannot be resupplied with an unused filter or cartridge and that is to 
be discarded in its entirety after its useful service life has been 
reached. In general, the facepiece of these respirators is constructed 
from the particular filter media of interest (e.g., particulate 
filter).
    Exposure incident for purposes of this standard means an event in 
which an employee has been exposed to an individual with confirmed 
infectious TB or to air containing aerosolized M. tuberculosis without 
the benefit of all of the applicable exposure control measures required 
by this section. This definition is limited to those situations 
involving exposure to an individual with confirmed infectious TB or air 
originating from an area where a source of aerosolized M. tuberculosis 
is present; it does not include exposure to individuals with suspected 
infectious TB. OSHA has limited the definition in this way because 
several provisions in the proposed standard are triggered by the 
occurrence of an exposure incident. For example, under paragraph (g), 
Medical Surveillance, the employer is required to provide additional 
tuberculin skin testing to each affected employee and to investigate 
and document the circumstances surrounding each exposure incident to 
determine if changes can be instituted to prevent similar occurrences 
in the future. OSHA believes that it would be burdensome and 
unnecessary for the employer to conduct follow-up investigations for 
those occurrences where an employee's exposure is to an individual 
suspected of having infectious TB but for whom infectious disease is 
subsequently ruled out.
    An example of an exposure incident is an employee entering an AFB 
isolation room or area occupied by an individual with confirmed 
infectious TB without the employee wearing appropriate personal 
respiratory protection equipment. This occurrence would not be defined 
under the standard as an exposure incident if the individual in the AFB 
isolation room had only suspected infectious TB. If the individual in 
AFB isolation room was later confirmed to have infectious TB, the 
employee entering the isolation room without appropriate respiratory 
equipment would then be considered to have had an exposure incident and 
the required medical management and follow-up provisions for an 
exposure

[[Page 54280]]

incident under paragraph (g), Medical Surveillance, would be required.
    Another example of an exposure incident is a failure of engineering 
controls, e.g., the ventilation system in an AFB isolation room housing 
an individual with confirmed infectious TB malfunctioned, negative 
pressure was lost, and air containing M. tuberculosis was dispelled 
into the hall corridor, exposing unprotected employees. Although OSHA 
would consider this type of loss of negative pressure in an AFB 
isolation room to be an exposure incident, the Agency does not intend 
that each opening of the door to an AFB isolation room be considered an 
exposure incident, even though some loss of negative pressure may 
result when the door to an AFB isolation room is opened. As a practical 
matter, OSHA believes it would be infeasible to consider every instance 
that a door to an isolation was opened as an exposure incident. In 
addition, these losses of negative pressure are generally small, if 
doors are kept open only briefly for purposes of entry and exit and are 
kept closed at all other times while the room is in operation for TB 
isolation as required under the Work Practices and Engineering Controls 
paragraph (d)(5)(vi).
    There is a significant difference in the meaning of the terms 
``exposure incident'' and ``occupational exposure'' as they are used in 
this standard. This difference is discussed further under the 
definition of ``occupational exposure''.
    Filter means a component used in respirators to remove solid or 
liquid aerosols from the inspired air. The filter is the medium that 
captures the aerosol, preventing it from passing through to the 
respirator wearer.
    Fit factor is a quantitative measure of the fit of a particular 
respirator on a particular individual. Fit factor is derived from the 
ratio of the concentration of a challenge agent (or air pressure) 
outside of the respirator to the concentration of the test agent (or 
air pressure) inside the respirator.
    High Efficiency Particulate Air (HEPA) Filter means a specialized 
filter that is capable of removing 99.97 percent of particles greater 
than or equal to 0.3 micrometer in diameter.
    High-hazard procedures are those procedures performed on an 
individual with suspected or confirmed infectious tuberculosis in which 
the potential for being exposed to M. tuberculosis is increased due to 
the induction of coughing or the generation of aerosolized M. 
tuberculosis. Such procedures include, but are not limited to, sputum 
induction, bronchoscopy, endotracheal intubation or suctioning, 
aerosolized administration of pentamidine or other medications, and 
pulmonary function testing. They also include autopsy, clinical, 
surgical and laboratory procedures that may aerosolize M. tuberculosis. 
The procedures listed above present a high hazard because they are 
performed on individuals with suspected or confirmed infectious TB or 
on specimens or deceased individuals where M. tuberculosis may be 
present. For example, some of the procedures listed above, such as 
bronchoscopies and pentamidine administration, cause people to cough. 
For individuals with pulmonary TB, coughing will increase the 
likelihood that they will generate aerosols with a high concentration 
of droplet nuclei. In addition, certain autopsy procedures, such as 
cutting into a lung containing M. tuberculosis, and certain laboratory 
procedures, such as processing infected tissue samples with pressurized 
freezants, can generate aerosols containing droplet nuclei. In the 
absence of M. tuberculosis, these procedures would not be high-hazard. 
For example, endotracheal intubation on an individual who does not have 
suspected or confirmed infectious TB would not be considered a high-
hazard procedure.
    M. tuberculosis means Mycobacterium tuberculosis, the scientific 
name of the bacillus that causes tuberculosis.
    Negative Pressure means the relative air pressure difference 
between two areas. A room that is under negative pressure has lower 
pressure than adjacent areas, which keeps air from flowing out of the 
room and into adjacent rooms or areas. Paragraph (d)(5)(i) of Work 
Practices and Engineering Controls requires that negative pressure be 
maintained in all AFB isolation rooms or areas, and paragraph (d)(4) 
requires that all high-hazard procedures be performed in such rooms or 
areas. Maintaining negative pressure in such rooms or areas helps to 
assure that droplet nuclei are contained and not spread to other areas 
of the facility where unprotected employees may be exposed. A further 
discussion of this principle can be found in the Summary and 
Explanation of paragraph (d), Work Practices and Engineering Controls.
    Negative pressure respirator means a respirator in which the air 
pressure inside the facepiece is negative during inhalation with 
respect to the ambient air pressure outside the respirator. In a 
negative pressure respirator, the wearer's inhalation creates a drop in 
pressure inside the facepiece, consequently drawing outside air through 
the filter and into the respirator.
    Occupational exposure is one of the key terms upon which the 
proposed standard rests. It contains the criteria that trigger 
application of the standard for employees in work settings covered 
under the scope of the standard as listed in paragraphs (a)(1) through 
(a)(8) and for employees providing the care and services listed in 
paragraphs (a)(9) and (a)(10). Although a variety of work settings and 
several specific types of work are covered within the scope of the 
standard, it is only employees who have ``occupational exposure'' in 
those work settings and who are providing the particular services that 
must be given the protection mandated by the standard. The exception to 
this is that an employer covered under paragraph (a), scope, must 
provide medical management and follow-up to other employees who have an 
exposure incident.
    For purposes of this standard, occupational exposure means 
reasonably anticipated contact, which results from the performance of 
an employee's duties, with an individual with suspected or confirmed 
infectious TB or air that may contain aerosolized M. tuberculosis. An 
example of reasonably anticipated contact between an employee and an 
individual with suspected or confirmed infectious TB would be an 
admissions clerk working in a homeless shelter. In view of the high 
incidence of TB among the homeless, it can reasonably be anticipated 
that an employee screening people for admission into the shelter would 
have contact with a person with infectious TB during the performance of 
his or her job duties. Another, more obvious, example would be a 
bronchoscopist in a hospital that provides care for individuals with 
suspected or confirmed infectious TB. Others could include some 
physicians, nurses, paramedics and emergency medical technicians, 
health aides, prison guards, and intake workers in the facilities 
listed in paragraph (a) of this section. An example of an employee who 
would not be reasonably anticipated to have occupational exposure is an 
worker, in a covered facility, whose duties were limited to working in 
an area where suspected or confirmed TB patients or clients do not go 
and where the air would not contain aerosolized Mycobacterium 
tuberculosis. The risk of exposure for this employee is comparable to 
the exposure potential by the general population.
    The term occupational exposure is used differently than the term 
exposure incident in the proposed standard. Occupational exposure is 
used to define

[[Page 54281]]

a condition of the employee's work and to identify which employees are 
affected in a way that can reasonably be anticipated, due to their job 
duties, to involve potential exposure to aerosolized M. tuberculosis, 
i.e., contact with an individual with suspected or confirmed infectious 
TB or with air that may contain aerosolized M. tuberculosis. The intent 
of the standard is to prevent exposure to aerosolized M. tuberculosis; 
therefore, certain proactive measures are required by the standard, 
e.g., training and medical surveillance, when occupational exposure is 
present. In order to provide these measures, it is necessary to 
identify which employees may be exposed before exposure occurs. The 
definition of ``occupational exposure'' is the basis for making this 
identification.
    An exposure incident, on the other hand, is a discrete event in 
which it is known that an employee has had contact with aerosolized M. 
tuberculosis, i.e., with an individual with confirmed infectious TB or 
air containing aerosolized M. tuberculosis. The term ``exposure 
incident'' is used to define those occasions when certain reactive 
measures are required by the standard, such as medical management and 
follow-up. It is exposure to an individual with confirmed infectious TB 
that matters, since it is not necessary to take reactive measures after 
being exposed to an individual with suspected infectious TB if that 
individual has subsequently been determined not to have infectious TB.
    Physician or Other Licensed Health Care Professional means an 
individual whose legally permitted scope of practice (i.e., license, 
registration, or certification) allows her or him to independently 
perform or be delegated to perform some or all of the health care 
services required by paragraph (g) of this section. Paragraph (g) 
requires that all medical evaluations and procedures and medical 
management and follow-up be performed by or under the supervision of a 
physician or other licensed health care professional, as appropriate. 
OSHA is aware that a variety of health care professionals are licensed 
by their respective states to legally perform different medical 
provisions required under this proposed standard. This definition 
clarifies that it is not OSHA's intent to dictate the specific type of 
health care professional to perform the activities required by the 
medical surveillance paragraph. OSHA's intent is merely that these 
activities be performed by persons who are legally permitted to 
independently perform or be delegated to perform some or all of the 
health care services required under the medical surveillance provisions 
of the standard. Employers wishing to use the services of a variety of 
health care providers must be familiar with the licensing laws of their 
state to ensure that the activities being performed are within the 
scope of that health care provider's licensure.
    Powered air-purifying respirator (PAPR) means an air-purifying 
respirator that uses a blower to deliver air through the air-purifying 
element to the wearer's breathing zone. A PAPR uses a blower to draw 
ambient air through a filter and provide this filtered air, under 
pressure, to the facepiece of the wearer.
    Qualitative fit test means a pass/fail fit test to assess the 
adequacy of respirator fit that relies on the respirator wearer's 
response. Generally, this assessment of adequacy of respirator fit is 
made by determining whether an individual wearing the respirator can 
detect the odor, taste, or irritation of a challenge agent introduced 
into the vicinity of the wearer's breathing zone.
    Quantitative fit test means an assessment of the adequacy of 
respirator fit by numerically measuring the amount of leakage into the 
respirator. Leakage can be assessed through means such as measuring the 
concentration of a challenge agent (or air pressure) outside of the 
respirator versus the concentration of the agent (or air pressure) 
inside the respirator. The ratio of the two measurements is an index of 
the leakage of the seal between the respirator facepiece and the 
wearer's face.
    Research laboratory is defined as a laboratory that propagates and 
manipulates cultures of M. tuberculosis in large volumes or high 
concentrations that are in excess of those used for identification and 
typing activities common to clinical laboratories. The purpose of this 
definition is to distinguish research laboratories from clinical 
laboratories. Under paragraph (e) of the proposed standard, research 
laboratories are required to meet additional provisions beyond those 
required for clinical laboratories (e.g., use of a hazard warning sign 
incorporating the biohazard symbol when materials containing M. 
tuberculosis are present in the laboratory and use of two sets of self-
closing doors for entry into the work area from access corridors). 
These additional requirements are proposed due to the higher degree of 
hazard that may be present in research laboratories as a result of the 
presence of research materials that may contain M. tuberculosis in 
larger volumes and higher concentrations than would normally be found 
in diagnostic specimens or cultures in clinical laboratories.
    Respirator means a device worn by an individual and intended to 
provide the wearer with respiratory protection against inhalation of 
airborne contaminants. While the term ``respirator'' may be used in 
medical situations to refer to a device that provides breathing 
assistance to an individual who is experiencing breathing difficulty, 
this section utilizes this term only in reference to the type of 
protective device defined above.
    Suspected infectious tuberculosis means a potential disease state 
in which an individual is known, or with reasonable diligence should be 
known, by the employer to have one or more of the following conditions, 
unless the individual's condition has been medically determined to 
result from a cause other than TB: (1) to be infected with M. 
tuberculosis and to have the signs or symptoms of TB; (2) to have a 
positive acid-fast bacilli (AFB) smear; or (3) to have a persistent 
cough lasting 3 or more weeks and two or more symptoms of active TB 
(e.g., bloody sputum, night sweats, weight loss, fever, anorexia). An 
individual with suspected infectious TB has neither confirmed 
infectious TB nor has he or she been medically determined to be 
noninfectious.
    Suspected infectious TB is another key term in the proposed 
standard. The presence of a person with suspected infectious TB 
triggers and is associated with a number of the provisions required of 
employers. Applying the criteria associated with suspected infectious 
TB is the first step in the early identification of individuals with 
infectious TB and is therefore a key factor in the elimination and 
minimization of occupational transmission of TB. Therefore, for 
purposes of implementing the standard it is important that what 
constitutes ``suspected infectious TB'' is clear.
    The first criterion in identifying an individual as having 
suspected infectious TB is the presence of TB infection and the signs 
and symptoms of active TB. Under the second criterion, an individual 
would be suspected of having infectious TB if that individual had a 
positive AFB smear. The third criterion is based primarily on 
observation of an individual. The CDC states that:

    * * * A diagnosis of TB may be considered for any patient who 
has a persistent cough (i.e., a cough lasting for  3 
weeks) or other signs or symptoms compatible with active TB (e.g., 
bloody sputum, night sweats, weight loss, anorexia

[[Page 54282]]

or fever). * * * Diagnostic measures for identifying TB should be 
conducted for patients in whom active TB is being considered. These 
measures include obtaining a medical history and performing a 
physical examination, PPD skin test, chest radiograph, and 
microscopic examination and culture of sputum or other appropriate 
specimens. (Ex. 4B)

OSHA has relied on the CDC's list of symptoms, but does not agree that 
employers need only ``consider'' a TB diagnosis when any of the 
symptoms appear. The Agency believes that requiring employers merely to 
consider a TB diagnosis under these circumstances may allow too many 
individuals with infectious TB to slip through this screen and remain 
unidentified. In addition, the CDC recommendations do not identify the 
minimum number of signs or symptoms that should trigger employer 
concern. The problem with the CDC's approach is that the signs and 
symptoms are so general that they would be difficult to apply in many 
of the occupational exposure circumstances covered by the standard. For 
example, if OSHA required employers to identify each individual with 
even one of the signs or symptoms of TB as having suspected infectious 
TB, too many individuals would be likely to be identified, thereby 
wasting valuable health care resources. For these reasons, OSHA has 
proposed that employers be required to determine that an individual has 
suspected infectious TB when the individual has a prolonged cough and 
at least two of the other signs or symptoms of infectious TB. The 
Agency believes that requiring the employer to identify individuals as 
suspect cases when they have only a prolonged cough, which is the 
primary mode of transmission, and at least 2 other signs or symptoms 
strikes the appropriate balance between over inclusion and under 
inclusion, i.e., between considering almost every individual in poor 
health as a suspect case and missing individuals who should be 
suspected of having infectious TB. OSHA believes that setting forth 
these more definitive criteria will meet the needs of the many 
employers covered by this standard who will not have skilled medical 
persons making initial determinations about whether or not an 
individual has suspected infectious TB. Employer who are in a position 
to make medical determinations are permitted by the standard to rule 
out infectious TB by determining that a given individual's signs and 
symptoms are the result of a cause other than TB.
    That an employer knows or with reasonable diligence should know 
that an individual meets one or more of these criteria means that an 
employer must utilize the means at his or her disposal to gather 
relevant information about the individual. For example, the employer 
may have access to the medical records of the individual or may 
question an individual who has signs or symptoms of TB in order to 
obtain information about the individual, such as skin test status, AFB 
smear status, and so forth. How much questioning the employer might do 
depends on the work setting. For example, a hospital will have intake 
procedures that include asking questions, as will most homeless 
shelters and other fixed work sites. In other work settings, such as 
the many places in which emergency medical services and home health 
care are provided to unidentified individuals with infectious TB, the 
employer's obligation will be to respond when an employee notices signs 
or symptoms compatible with TB. In many of these instances, it is the 
training employees receive in identifying individuals with suspected TB 
that will be the most important factor.
    In addition, as noted above, an individual who meets one or more of 
the above criteria but whose condition has been medically determined to 
result from a cause other than TB need not be considered to have 
suspected infectious TB. For example, a physician or other licensed 
health care professional, as appropriate, could determine that the 
signs and symptoms exhibited by the individual were the result, for 
example, of pneumonia and not TB.
    Tight-fitting respirator means a respiratory inlet covering that is 
designed to form a complete seal with the face. A half-facepiece covers 
the nose and mouth while a full facepiece covers the nose, mouth, and 
eyes.
    Tuberculosis (TB) means a disease caused by M. tuberculosis.
    Tuberculosis infection means a condition in which living M. 
tuberculosis bacilli are present in the body, without producing 
clinically active disease. Although the infected individual has a 
positive tuberculin skin test reaction, the individual may have no 
symptoms related to the infection and may not be capable of 
transmitting the disease.
    Tuberculosis disease is a condition in which living M. tuberculosis 
bacilli are present in the body, producing clinical illness. The 
individual may or may not be infectious.
    Tuberculin skin test means a method used to evaluate the likelihood 
that a person is infected with M. tuberculosis. The method utilizes an 
intradermal injection of tuberculin antigen with subsequent measurement 
of reaction induration. It is also referred to as a PPD skin test.
    Two-step testing is a baseline skin testing procedure used to 
differentiate between a boosted skin test reaction and a skin test 
reaction that signifies a new infection. If the initial skin test is 
negative, a second skin test is administered 1 to 3 weeks later. If the 
second skin test is positive, the reaction is probably due to boosting. 
If the second skin test is negative, the individual is considered to be 
not infected. A subsequent positive skin test in this individual would 
thus indicate a new infection. Boosting is discussed in more detail in 
connection with the Medical Surveillance paragraph.

Paragraph (k)  Dates

    As proposed, the final rule would become effective ninety (90) days 
after publication in the Federal Register. This will allow time for 
public distribution and give employers time to familiarize themselves 
with the standard. The various provisions have phased-in effective 
dates.
    The employer's initial duty under the standard is the exposure 
determination and establishment of the written Exposure Control Plan 
required by paragraph (c) of this section. The plan would need to be 
completed 30 days after the effective date.
    Thirty days later, 60 days after the effective date, paragraphs 
(h)(3), Information and Training, (g) Medical Surveillance, and (i) 
Recordkeeping would take effect.
    Ninety (90) days after the effective date, the work practice 
procedures and engineering controls required by paragraph (d) (in work 
settings other than those noted below), the respiratory protection 
required by paragraph (f), and the labels and signs required by 
paragraphs (h) (1) and (2) would take effect. The work practices that 
are directly related to the engineering controls would have to be 
implemented as soon as the engineering controls were functional. 
Finally, the requirements for clinical and research laboratories 
contained in paragraph (e) would also take effect 90 days after the 
effective date.
    For businesses with fewer than 20 employees, the engineering 
controls required by paragraph (d) of this section would take effect 
270 days after the effective date. As noted above, the work practices 
directly related to the engineering controls being installed in 
accordance with paragraph (d) of this section must be implemented as 
soon as the engineering controls are

[[Page 54283]]

implemented. Since engineering controls may necessitate more extensive 
planning than is required to comply with other provisions of the 
standard, OSHA is proposing an extended phase-in for the smallest 
employers.
    Since many employers have many of these provisions already in 
effect through current infection control plans, OSHA believes that 
these dates provide adequate time for compliance. Nevertheless, OSHA 
seeks comment on the appropriateness of the dates for compliance with 
the various provisions of the standard.

XI. Public Participation--Notice of Hearing

    Interested persons are invited to submit written data, views, and 
arguments with respect to this proposed standard. These comments must 
be postmarked on or before December 16, 1997, and submitted in 
quadruplicate to the Docket Officer, Docket No. H-371, Room N2625, U.S. 
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. 
Comments limited to 10 pages or less also may be transmitted by 
facsimile to (202) 219-5046, provided the original and three copies are 
sent to the Docket Officer thereafter.
    Written submissions must clearly identify the provisions of the 
proposal that are being addressed and the position taken with respect 
to each issue. The data, views, and arguments that are submitted will 
be available for public inspection and copying at the above address. 
All timely written submissions will be made a part of the record of the 
proceeding.
    Pursuant to section 6(b)(3) of the Act, an opportunity to submit 
oral testimony concerning the issues raised by the proposed standard 
will be provided at an informal public hearing scheduled to begin at 
10:00 A.M. on February 3, 1998, in Washington, DC in the Auditorium of 
the Frances Perkins Building, U.S. Department of Labor, 200 
Constitution Avenue, NW., Washington, DC 20210.

Notice of Intention to Appear

    All persons desiring to participate at the hearings must file in 
quadruplicate a notice of intention to appear postmarked on or before 
December 16, 1997 addressed to the Docket Officer, Docket No. H-371, 
Room N-2625, U.S. Department of Labor, 200 Constitution Avenue, NW., 
Washington, DC 20210; telephone (202) 219-7894. The Notice of Intention 
to Appear also may be transmitted by facsimile to (202) 219-5046, 
provided the original and 3 copies of the notice are sent to the above 
address thereafter.
    The Notices of Intention to Appear, which will be available for 
inspection and copying at the OSHA Docket Office, must contain the 
following information:
    (1) The name, address, and telephone number of each person to 
appear;
    (2) The hearing site that the party is requesting to attend;
    (3) The capacity in which the person will appear;
    (4) The approximate amount of time requested for the presentation;
    (5) The specific issues that will be addressed;
    (6) A detailed statement of the position that will be taken with 
respect to each issue addressed;
    (7) Whether the party intends to submit documentary evidence, and 
if so, a brief summary of that evidence; and
    (8) Whether the party wishes to testify on the days set aside to 
focus on homeless shelters.

Filing of Testimony and Evidence Before Hearings

    Any party requesting more than 10 minutes for a presentation at the 
hearing, or who will submit documentary evidence, must provide in 
quadruplicate the complete text of the testimony, including any 
documentary evidence to be presented at the hearing to the Docket 
Officer at the above address. This material must be postmarked by 
December 31, 1997 and will be available for inspection and copying at 
the OSHA Docket Office. Each such submission will be reviewed in light 
of the amount of time requested in the Notice of Intention to Appear. 
In those instances where the information contained in the submission 
does not justify the amount of time requested, a more appropriate 
amount of time will be allocated and the participant will be notified 
of that fact.
    Any party who has not substantially complied with this requirement 
may be limited to a 10-minute presentation. Any party who has not filed 
a Notice of Intention to Appear may be allowed to testify, as time 
permits, at the discretion of the Administrative Law Judge.
    OSHA emphasizes that the hearing is open to the public, and that 
interested persons are welcome to attend. However, only persons who 
have filed proper notices of intention to appear will be entitled to 
ask questions and otherwise participate fully in the proceeding.

Conduct and Nature of Hearings

    The hearings will commence at 10:00 a.m. on February 3, 1998. At 
that time any procedural matters relating to the proceeding will be 
resolved.
    The nature of an informal hearing is established in the legislative 
history of section 6 of the Act and is reflected by the OSHA hearing 
regulations (see 29 CFR 1911.15 (a)). Although the presiding officer is 
an Administrative Law Judge and questioning by interested persons is 
allowed on crucial issues, the proceeding shall remain informal and 
legislative in type. The essential intent is to provide an opportunity 
for effective oral presentations that can proceed expeditiously in the 
absence of rigid procedures that would impede or protract the 
rulemaking process.
    Additionally, since the hearing is primarily for information 
gathering and clarification, it is an informal administrative 
proceeding, rather than an adjudicative one. The technical rules of 
evidence, for example, do not apply. The regulations that govern 
hearings and the pre-hearing guidelines to be issued for this hearing 
will ensure fairness and due process and also facilitate the 
development of a clear, accurate and complete record. Those rules and 
guidelines will be interpreted in a manner that furthers that 
development. Thus, questions of relevance, procedure and participation 
generally will be decided so as to favor development of the record.
    The hearing will be conducted in accordance with 29 CFR Part 1911. 
The hearing will be presided over by an Administrative Law Judge who 
makes no recommendation on the merits of OSHA's proposal. The 
responsibility of the Administrative Law Judge is to ensure that the 
hearing proceeds at a reasonable pace and in an orderly manner. The 
Administrative Law Judge, therefore, will have all the powers necessary 
and appropriate to conduct a full and fair informal hearing as provided 
in 29 CFR Part 1911 and the prehearing guidelines, including the 
powers:
    (1) To regulate the course of the proceedings;
    (2) To dispose of procedural requests, objections, and comparable 
matters;
    (3) To confine the presentation to the matters pertinent to the 
issues raised;
    (4) To regulate the conduct of those present at the hearing by 
appropriate means;
    (5) At the Judge's discretion, to question and permit the 
questioning of any witness and to limit the time for questioning; and
    (6) At the Judges's discretion, to keep the record open for a 
reasonable, stated time to written information and additional data, 
views and arguments from any person who has participated in the oral 
proceeding.

[[Page 54284]]

Information on Homeless Shelter Issues for the Public Hearing

    OSHA seeks to gather additional information related to homeless 
shelters during the written comment period and the public hearing. OSHA 
recognizes the unique service provided by homeless shelters, yet is 
also aware that shelters serve a client population that has been 
identified as possessing a high prevalence of active TB. OSHA is 
seeking information on all aspects of TB and employee protection 
against occupational transmission of TB in homeless shelters (e.g., 
means successfully being used by shelters to achieve early 
identification of shelter clients with suspected or confirmed 
infectious TB; successful programs currently being used to protect 
employees against occupational transmission of TB).
    The Agency intends to designate a special session during the 
Washington, D.C. hearing to focus on the issues surrounding homeless 
shelters. We encourage hearing participants whose primary testimony 
will involve homeless shelters to indicate this in their Notice of 
Intention to Appear; OSHA will attempt to schedule these participants 
on the day(s) of the hearing set aside to focus on homeless shelters. 
Other participants whose testimony will not be primarily on homeless 
shelter issues but who wish to address the topic of homeless shelters 
will be scheduled another day, but they may enter a separate statement 
in the record during this period. In any case, participants are free to 
discuss homeless shelters or any other issue related to this proposed 
standard whenever they present their testimony.

Certification of Record and Final Determination After Hearing

    Following the close of the posthearing comment period, the 
presiding Administrative Law Judge will certify the record to the 
Assistant Secretary of Labor for Occupational Safety and Health. The 
Administrative Law Judge does not make or recommend any decisions as to 
the content of the final standard.
    The proposed standard will be reviewed in light of all testimony 
and written submissions received as part of the record, and a standard 
will be issued based on the entire record of the proceeding, including 
the written comments and data received from the public.

List of Subjects

29 CFR Part 1910

    Health professionals, Occupational safety and health, Reporting and 
recordkeeping requirements, Tuberculosis.

XII. Authority and Signature

    This document was prepared under the direction of Greg Watchman, 
Acting Assistant Secretary of Labor, 200 Constitution Avenue, N.W., 
Washington, D.C., 20210.
    It is issued under sections 4, 6, and 8 of the Occupational Safety 
and Health Act of 1970 (29 U.S.C. 653, 655, 657), Secretary of Labor's 
Order 1-90 (55 FR 9033) and 29 CFR Part 1911.

    Signed at Washington, DC, this 15th day of September, 1997.
Greg Watchman,
Acting Assistant Secretary of Labor.

XIII. The Proposed Standard

General Industry

    Part 1910 of Title 29 of the Code of Federal Regulations is 
proposed to be amended as follows:

PART 1910--[AMENDED]

Subpart Z--[Amended]

    1. The general authority citation for Subpart Z of 29 CFR Part 1910 
continues to read as follows and a new citation for Sec. 1910.1035 is 
added:

    Authority: Secs. 6 and 8, Occupational Safety and Health Act, 29 
U.S.C. 655, 657, Secretary of Labor's Orders Nos. 12-71 (36 FR 
8754), 8-76 (41 FR 25059), or 9-83 (48 FR 35736), as applicable; and 
29 CFR Part 1911.
* * * * *
    Section 1910.1035 also issued under 29 U.S.C. 653.
* * * * *
    2. Section 1910.1035 is added to read as follows:


Sec. 1910.1035  Tuberculosis

    (a) Scope. This section applies to occupational exposure to 
tuberculosis (TB) occurring:
    (1) In hospitals;
    (2) In long term care facilities for the elderly;
    (3) In correctional facilities and other facilities that house 
inmates or detainees;
    (4) In hospices;
    (5) In shelters for the homeless;
    (6) In facilities that offer treatment for drug abuse;
    (7) In facilities where high-hazard procedures (as defined by this 
section) are performed;
    (8) In laboratories that handle specimens that may contain M. 
tuberculosis, or process or maintain the resulting cultures, or perform 
related activity that may result in the aerosolization of M. 
tuberculosis;

    Note to paragraph (a)(8): Occupational exposure incurred in any 
of the work settings listed in paragraphs (a)(1) through (a)(8) of 
this section by temporary or contract employees or by personnel who 
service or repair air systems or equipment or who renovate, repair, 
or maintain areas of buildings that may reasonably be anticipated to 
contain aerosolized M. tuberculosis is covered by this section.

    (9) During the provision of social work, social welfare services, 
teaching, law enforcement or legal services if the services are 
provided in any of the work settings listed in paragraphs (a)(1) 
through (a)(8) of this section, or in residences, to individuals who 
are in AFB isolation or are segregated or otherwise confined due to 
having suspected or confirmed infectious TB.
    (10) During the provision of emergency medical services, home 
health care and home-based hospice care.
    (b) Application. An employer covered under paragraph (a) of this 
section, Scope (other than the operator of a laboratory), may choose to 
comply only with the provisions of appendix A to this section if the 
Exposure Control Plan demonstrates that his or her facility or work 
setting: (1) Does not admit or provide medical services to individuals 
with suspected or confirmed infectious TB; and
    (2) Has had no case of confirmed infectious TB in the past 12 
months; and
    (3) Is located in a county that, in the past 2 years, has had 0 
cases of confirmed infectious TB reported in one year and fewer than 6 
cases of confirmed infectious TB reported in the other year.
    (c) Exposure control--(1) Exposure determination. (i) Each employer 
who has any employee with occupational exposure shall prepare an 
exposure determination that contains the following:
    (A) A list of the job classifications in which all employees have 
occupational exposure; and
    (B) A list of the job classifications in which some employees have 
occupational exposure, and a list of all tasks and procedures (or 
groups of closely related tasks and procedures) that these employees 
perform and that involve occupational exposure.

[[Page 54285]]

    (ii) The exposure determination shall be made without regard to the 
use of respiratory protection.
    (2) Exposure Control Plan. (i) Each employer who has any employee 
with occupational exposure shall establish a written Exposure Control 
Plan that must include:
    (A) The exposure determination required by paragraph (c)(1) of this 
section;
    (B) Procedures for providing information about individuals with 
suspected or confirmed infectious TB or about air that may reasonably 
be anticipated to contain aerosolized M. tuberculosis to occupationally 
exposed employees who need this information in order to take proper 
precautions; and
    (C) Procedures for reporting an exposure incident, including 
procedures specifying the individual to whom the incident is to be 
reported, and procedures for evaluating the circumstances surrounding 
the exposure incident.
    (ii) Each employer who transfers individuals with suspected or 
confirmed infectious TB to a facility with AFB isolation capabilities 
shall include in the Exposure Control Plan procedures for prompt 
identification, masking or segregation, and transfer of such 
individuals.

    Note to paragraph (c)(2)(ii): An employer's duties regarding 
transfer will vary with the type of facility the employer operates 
and the work performed by his or her employees. For example, the 
transfer responsibilities of hospitals, long-term care facilities 
for the elderly, correctional facilities, and hospices may include 
contacting the receiving facility, providing transport, and taking 
other steps to ensure that the individual with suspected or 
confirmed infectious TB reaches the receiving facility. By contrast, 
the responsibilities of facilities that do not maintain custody over 
individuals, such as homeless shelters or facilities that offer 
treatment for drug abuse, might only include providing information 
about the receiving facility, contacting the facility, and providing 
directions to the facility.

    (iii) Each employer in whose facility individuals with suspected or 
confirmed infectious TB are admitted or provided medical services shall 
include each of the following provisions in the Exposure Control Plan:
    (A) Procedures for prompt identification of individuals with 
suspected or confirmed infectious TB;
    (B) Procedures for isolating and managing the care of individuals 
with suspected or confirmed infectious TB, including:
    (1) Minimizing the time an individual with suspected or confirmed 
infectious TB remains outside of an AFB isolation room or area (e.g., 
in an emergency room);
    (2) Minimizing employee exposure in AFB isolation rooms or areas by 
combining tasks to limit the number of entries into the room or area 
and by minimizing the number of employees who must enter and minimizing 
the time they spend in the room or area;
    (3) Delaying elective transport or relocation within the facility 
of an individual with suspected or confirmed infectious TB. Procedures 
are to be established to assure that, to the extent feasible, services 
and procedures for individuals with suspected or confirmed infectious 
TB are brought into or conducted in an AFB isolation room or area;
    (4) Using properly-fitted masks (e.g., surgical masks, valveless 
respirators) on individuals with suspected or confirmed infectious TB 
or transporting such individuals in portable containment engineering 
controls when relocation or transport outside of AFB isolation rooms or 
areas is unavoidable. Procedures are to be established to assure that 
the individual is returned to an AFB isolation room or area as soon as 
is practical after completion of the service or procedure;
    (5) Delaying elective high-hazard procedures or surgery until an 
individual with suspected or confirmed infectious TB is determined to 
be noninfectious;
    (C) A list of all high-hazard procedures, if any, performed in the 
work setting; and
    (D) A schedule for inspection, maintenance, and performance 
monitoring of engineering controls (see appendix E to this section).
    (iv) Each employer who operates a laboratory shall include in the 
Exposure Control Plan a determination from the director of the 
laboratory as to whether the facility should operate at Biosafety Level 
2 or 3 containment according to current CDC recommendations (CDC/NIH 
Biosafety in Microbiological and Biomedical Laboratories). The 
laboratory director shall determine and document the need for:
    (A) Controlled access;
    (B) Anterooms;
    (C) Sealed windows;
    (D) Directional airflow;
    (E) Measures to prevent recirculation of laboratory exhaust air;
    (F) Filtration of exhaust air before discharge outside; and
    (G) Thimble exhaust connections for biological safety cabinets.
    (v) Each employer who provides home health care or home-based 
hospice care shall include in the Exposure Control Plan procedures for 
prompt identification of individuals with suspected or confirmed 
infectious TB and procedures for minimizing employee exposure to such 
individuals; a list of the high-hazard procedures, if any, performed in 
the work setting; and procedures for delaying elective high-hazard 
procedures or surgery until the individual is noninfectious.
    (vi) Each employer who claims reduced responsibilities related to 
paragraph (b), Application, or paragraph (g)(3)(iii)(D), Medical 
Surveillance, of this section shall document in the Exposure Control 
Plan the number of individuals with confirmed infectious tuberculosis 
encountered in the work setting in the past 12 months.
    (vii) The Exposure Control Plan shall be:
    (A) Accessible to employees in accordance with 29 CFR 1910.20(e);
    (B) Reviewed at least annually and updated whenever necessary to 
reflect new or modified tasks, procedures, or engineering controls that 
affect occupational exposure and to reflect new or revised employee job 
classifications with occupational exposure; and
    (C) Made available for examination and copying to the Assistant 
Secretary and/or the Director upon request.
    (d) Work Practices and Engineering Controls. (1) Work practices and 
engineering controls shall be used to eliminate or minimize employee 
exposures to M. tuberculosis.
    (2) The work practices in the Exposure Control Plan shall be 
implemented.
    (3) Individuals with suspected or confirmed infectious TB shall be 
identified, and except in settings where home health care or home-based 
hospice care is being provided, shall be:
    (i) Masked or segregated in such a manner that contact with 
employees who are not wearing respiratory protection is eliminated or 
minimized until transfer or placement in an AFB isolation room or area 
can be accomplished; and
    (ii) Placed in an AFB isolation room or area or transferred to a 
facility with AFB isolation rooms or areas within 5 hours from the time 
of identification, or temporarily placed in AFB isolation within 5 
hours until placement or transfer can be accomplished as soon as 
possible thereafter.
    (4) High-hazard procedures shall be conducted in an AFB isolation 
room or area.
    (5) Engineering controls shall be used in facilities that admit or 
provide medical services or AFB isolation to individuals with suspected 
or confirmed infectious TB except in

[[Page 54286]]

settings where home health care or home-based hospice care is being 
provided.
    (i) Negative pressure shall be maintained in AFB isolation rooms or 
areas.
    (ii) Negative pressure shall be qualitatively demonstrated (e.g., 
by smoke trails) daily while a room or area is in use for TB isolation 
(see appendix G to this section).
    (iii) Engineering controls shall be maintained, and inspected and 
performance monitored for filter loading and leakage every 6 months, 
whenever filters are changed, and more often if necessary to maintain 
effectiveness (see appendix E to this section).
    (iv) Air from AFB isolation rooms or areas shall be exhausted 
directly outside, away from intake vents, employees, and the general 
public. Air that cannot be exhausted in such a manner or must be 
recirculated must pass through HEPA filters before discharge or 
recirculation.
    (v) Ducts carrying air that may reasonably be anticipated to 
contain aerosolized M. tuberculosis shall be maintained under negative 
pressure for their entire length before in-duct HEPA filtration or 
until the ducts exit the building for discharge.
    (vi) Doors and windows of AFB isolation rooms or areas shall be 
kept closed while in use for TB isolation, except when doors are opened 
for entering or exiting and when windows are part of the ventilation 
system being used to achieve negative pressure.
    (vii) When an AFB isolation room or area is vacated by an 
individual with suspected or confirmed infectious TB, the room or area 
shall be ventilated according to current CDC recommendations for a 
removal efficiency of 99.9% before permitting employees to enter 
without respiratory protection (see appendix C to this section).
    (6) The employer shall provide information about the TB hazard to 
any contractor who provides temporary or contract employees who may 
incur occupational exposure so that the contractor can institute 
precautions to protect his or her employees.
    (e) Clinical and Research Laboratories. (1) This paragraph applies 
to clinical and research laboratories that engage in the culture, 
production, concentration, experimentation, or manipulation of M. 
tuberculosis. The requirements in this paragraph apply in addition to 
the other requirements of the standard.
    (2) Clinical and research laboratories shall meet the following 
criteria:
    (i) Standard microbiological practices.
    (A) Procedures shall be performed in a manner that minimizes the 
creation of aerosols.
    (B) Mouth pipetting shall be prohibited.
    (C) Work surfaces and laboratory equipment shall be decontaminated 
at the end of each shift and after any spill of viable material.
    (D) Cultures, stocks and other wastes contaminated with M. 
tuberculosis shall be decontaminated before disposal by a 
decontamination method, such as autoclaving, known to effectively 
destroy M. tuberculosis. Materials to be decontaminated outside of the 
immediate laboratory shall be placed in a durable, leakproof container, 
closed and sealed for transport from the laboratory and labeled or 
color-coded in accordance with paragraph (h)(1)(ii) of this section.
    (ii) Special practices. (A) Access to the laboratory shall be 
limited by the laboratory director when work with M. tuberculosis is in 
progress.
    (B) A biosafety manual that includes procedures for spill 
management shall be adopted. The employer shall review the manual as 
necessary and at least annually. The employer shall update the 
biosafety manual as necessary to reflect changes in the work setting. 
Employees shall be advised of potential hazards, shall be required to 
read instructions on practices and procedures, and shall be required to 
follow them.
    (C) Cultures, tissues, or specimens of body fluids contaminated 
with M. tuberculosis shall be placed in a container that prevents 
leakage during collection, handling, processing, storage, transport, or 
shipping.
    (D) All spills shall be immediately contained and cleaned up by 
employees who are properly trained and equipped to work with 
potentially concentrated M. tuberculosis. A spill or accident that 
results in an exposure incident shall be reported immediately to the 
laboratory director or other designated person.
    (E) When materials containing or animals infected with M. 
tuberculosis are present in the laboratory or containment module, a 
hazard warning sign, in accordance with paragraph (h)(2)(iv), 
incorporating the universal biohazard symbol, shall be posted on all 
laboratory and animal room access doors.
    (iii) Containment equipment. (A) Certified biological safety 
cabinets (Class 2) shall be used whenever procedures with a potential 
for generating aerosols of M. tuberculosis are conducted or whenever 
high concentrations or large volumes of M. tuberculosis are used. Such 
materials may be centrifuged in the open laboratory if sealed rotor 
heads or centrifuge safety cups are used, and if these rotors or safety 
cups are opened in a biological safety cabinet.
    (B) Biological safety cabinets shall be certified when installed, 
annually thereafter, whenever they are moved, and whenever filters are 
changed.
    (iv) Laboratory facilities. A method for decontamination of wastes 
contaminated with M. tuberculosis (e.g., autoclave, chemical 
disinfection, incinerator, or other decontamination system known to 
effectively destroy M. tuberculosis) shall be available within or as 
near as feasible to the work area.
    (3) Research laboratories shall meet the following additional 
criteria:
    (i) Special practices. (A) Laboratory doors shall be kept closed 
when work involving M. tuberculosis is in progress.
    (B) Access to the work area shall be limited to authorized persons. 
Written policies and procedures shall be established so that only 
persons who have been advised of the potential biohazard, who meet any 
specific entry requirements, and who comply with all entry and exit 
procedures shall be allowed to enter the work areas and animal rooms.
    (C) Respiratory protection shall be worn when aerosols cannot be 
safely contained (e.g., when aerosols are generated outside of a 
biological safety cabinet).
    (ii) Containment equipment. Certified biological safety cabinets 
(Class 2 or 3) or appropriate combinations of personal protection or 
physical containment devices, such as respirators, centrifuge safety 
cups, sealed centrifuge rotors, and containment caging for animals, 
shall be used for manipulations of cultures and those clinical or 
environmental materials that may be a source of aerosols containing M. 
tuberculosis; aerosol challenge of animals with M. tuberculosis; 
harvesting of tissues or fluids from animals infected with M. 
tuberculosis; or the necropsy of animals infected with M. tuberculosis.
    (iii) Laboratory facilities. (A) The laboratory shall be separated 
from areas that are open to unrestricted traffic flow within the 
building. Passage through two sets of self-closing doors shall be 
required for entry into the work area from access corridors or other 
contiguous areas.
    (B) Windows in the laboratory shall be closed and sealed.
    (C) A ducted exhaust air ventilation system shall be provided. This 
system shall create directional airflow that draws air from ``clean'' 
areas into the laboratory toward ``contaminated'' areas. The employer 
shall verify the proper direction of the airflow (i.e., into

[[Page 54287]]

the work area) at least every six months. The exhaust air shall not be 
recirculated to any other area of the building, shall be discharged to 
the outside, and shall be dispersed away from occupied areas and air 
intakes.
    (D) The high efficiency particulate air (HEPA)-filtered exhaust air 
from Class 2 or Class 3 biological safety cabinets shall be discharged 
directly to the outside or through the building exhaust system. If the 
HEPA-filtered exhaust air from Class 2 or 3 biological safety cabinets 
is to be discharged to the outside through the building exhaust air 
system, it shall be connected to this system in a manner (e.g., thimble 
units) that avoids any interference with the air balance of the 
cabinets or building exhaust system.
    (E) Continuous flow centrifuges or other equipment that may produce 
aerosols shall be contained in devices that exhaust air through HEPA 
filters before discharge into the laboratory.
    (f) Respiratory Protection--(1) General. (i) Each employer shall 
provide a respirator to each employee who:
    (A) Enters an AFB isolation room or area in use for TB isolation;
    (B) Is present during the performance of procedures or services for 
an individual with suspected or confirmed infectious TB who is not 
masked;
    (C) Transports an individual with suspected or confirmed infectious 
TB in an enclosed vehicle (e.g., ambulance, helicopter) or who 
transports an individual with suspected or confirmed infectious TB 
within the facility when that individual is not masked;
    (D) Repairs, replaces, or maintains air systems or equipment that 
may reasonably be anticipated to contain aerosolized M. tuberculosis;
    (E) Is working in an area where an unmasked individual with 
suspected or confirmed infectious TB has been segregated or otherwise 
confined (e.g., while awaiting transfer); or
    (F) Is working in a residence where an individual with suspected or 
confirmed infectious TB is known to be present.
    (ii) Each employer who operates a research laboratory shall provide 
a respirator to each employee who is present when aerosols of M. 
tuberculosis cannot be safely contained (e.g., when aerosols are 
generated outside of a biological safety cabinet).
    (iii) The employer shall provide the respirator at no cost to the 
employee and shall assure that the employee uses the respirator in 
accordance with the requirements of this section.
    (iv) The employer shall assure that the employee dons the 
respirator before entering any of the work settings or performing any 
of the tasks set forth in paragraphs (f)(1)(i) and (f)(1)(ii) of this 
section and uses it until leaving the work setting or completing the 
task, regardless of other control measures in place.
    (2) Respiratory Protection Program. (i) Each employer who has any 
employee whose occupational exposure is based on entering any of the 
work settings or performing any of the tasks described in paragraph 
(f)(1) of this section shall establish and implement a written 
respiratory protection program that assures respirators are properly 
selected, fitted, used, and maintained. The program shall include the 
following elements:
    (A) Procedures for selecting the appropriate respirators for use in 
the work setting;
    (B) A determination of each employee's ability to wear a 
respirator, as required under paragraph (g)(3)(ii) of this section, 
Medical Surveillance, for each employee required to wear a respirator;
    (C) Procedures for the proper use of respirators;
    (D) Fit testing procedures for tight-fitting respirators;
    (E) Procedures and schedules for cleaning, disinfecting, storing, 
inspecting, repairing, or otherwise maintaining respirators;
    (F) Training of employees to assure the proper use and maintenance 
of the respirator, as required under paragraph (h) of this section, 
Communication of Hazards and Training; and
    (G) Procedures for periodically evaluating the effectiveness of the 
program.
    (ii) The employer shall designate a person qualified by appropriate 
training or experience to be responsible for the administration of the 
respiratory protection program and for conducting the periodic 
evaluations of its effectiveness.
    (iii) The employer shall review and update the written program as 
necessary to reflect current workplace conditions and respirator use.
    (iv) The employer shall, upon request, make the written respiratory 
protection program available to affected employees, their designated 
representatives, the Assistant Secretary, and the Director. A copy of 
the program shall be submitted to the Assistant Secretary and/or the 
Director, if requested.
    (3) Respirator Selection. (i) The employer shall select and provide 
properly fitted negative pressure or more protective respirators. 
Negative pressure respirators shall be capable of being:
    (A) Qualitatively or quantitatively fit tested in a reliable way to 
verify a face-seal leakage of no more than 10%; and
    (B) Fit checked by the employee each time the respirator is donned.
    (ii) The employer shall select a respirator that will function 
effectively in the conditions of the work setting. In addition to 
meeting the criteria in paragraph (f)(3)(i) of this section, the 
respirator shall be, at a minimum, either a HEPA respirator selected 
from among those jointly approved as acceptable by the Mine Safety and 
Health Administration and by the National Institute for Occupational 
Safety and Health (NIOSH) under the provisions of 30 CFR part 11, or an 
N95 respirator certified by NIOSH under the provisions of 42 CFR part 
84.
    (4) Respirator Use. (i) The employer shall not permit any 
respirator that depends on a tight face-to-facepiece seal for 
effectiveness to be worn by employees having any condition that 
prevents such a seal. Examples of these conditions include, but are not 
limited to, facial hair that comes between the sealing surface of the 
facepiece and the face or if facial hair interferes with valve 
function, absence of normally worn dentures, facial scars, or headgear 
that projects under the facepiece seal.
    (ii) The employer shall assure that each employee who wears 
corrective glasses or goggles wears them in a manner that does not 
interfere with the seal of the facepiece to the face of the wearer.
    (iii) Disposable respirators shall be discarded when excessive 
resistance, physical damage, or any other condition renders the 
respirator unsuitable for use.
    (iv) The employer shall assure that each employee, upon donning a 
tight-fitting respirator, performs a facepiece fit check prior to 
entering a work area where respirators are required. The procedures in 
appendix B to this section or other procedures recommended by the 
respirator manufacturer that provide protection equivalent to that 
provided by the procedures in appendix B shall be used.
    (v) Respirators shall be immediately repaired, or discarded and 
replaced, when they are no longer in proper working condition.
    (vi) The employer shall permit each employee to leave the 
respirator use area as soon as practical to:
    (A) Change the filter elements or replace the respirator whenever 
the ability of the respirator to function effectively is compromised or 
the employee detects a change in breathing resistance; or

[[Page 54288]]

    (B) Wash his or her face and respirator facepiece as necessary to 
prevent skin irritation associated with respirator use.
    (vii) Each employee required to wear a respirator under this 
section shall be evaluated in accordance with paragraph (g), Medical 
Surveillance, of this section.
    (viii) No employee shall be assigned a task requiring the use of a 
respirator if, based upon the employee's most recent evaluation, the 
physician or other licensed health care professional, as appropriate, 
determines that the employee will be unable to function adequately 
while wearing a respirator. If the physician or other licensed health 
care professional, as appropriate, determines that the employee's job 
activities must be limited, or that the employee must be removed from 
the employee's current job because of the employee's inability to wear 
a respirator, the limitation or removal shall be performed in 
accordance with paragraph (g)(5)(iii) of this section.
    (5) Fit Testing. (i) The employer shall perform either quantitative 
or qualitative face fit tests in accordance with the procedures 
outlined in appendix B to this section.
    (ii) The employer shall assure that each employee who must wear a 
tight-fitting respirator passes a fit test:
    (A) At the time of initial fitting;
    (B) Whenever changes occur in the employee's facial characteristics 
which affect the fit of the respirator;
    (C) Whenever a different size or make of respirator is used; and
    (D) At least annually thereafter unless the annual determination 
required under paragraph (g)(3)(ii)(A), Medical Surveillance, of this 
section indicates that the annual fit test is not necessary.
    (iii) When quantitative fit testing is performed, the employer 
shall not permit an employee to wear a tight-fitting half-mask 
respirator unless a minimum fit factor of one hundred (100) is obtained 
in the test chamber.
    (6) Maintenance and care of reusable and powered air purifying 
respirators. (i) Respirators shall be cleaned and disinfected using the 
cleaning procedures recommended by the manufacturer at the following 
intervals:
    (A) As necessary for respirators issued for the exclusive use of an 
employee; and
    (B) After each use for respirators issued to more than one 
employee.
    (ii) Respirators shall be inspected before each use and during 
cleaning after each use;
    (iii) Respirator inspections shall include:
    (A) A check of respirator function, tightness of connections and 
the condition of the facepiece, head straps, valves, connecting tube, 
and cartridges, canisters, or filters; and
    (B) A check of the rubber or elastomer parts for pliability and 
signs of deterioration.
    (iv) Respirators that fail to pass inspection shall be removed from 
service and shall be repaired or adjusted in accordance with the 
following:
    (A) Repairs or adjustments to respirators are only to be made with 
NIOSH-approved parts designed for the respirator by the respirator 
manufacturer, and conducted by persons appropriately trained to perform 
such operations;
    (B) Only repairs of the type and extent covered by the 
manufacturer's recommendations may be performed; and
    (C) Reducing or admission valves or regulators shall be returned to 
the manufacturer or given to an appropriately trained technician for 
adjustment or repair.
    (v) Respirators shall be stored in a manner that protects them from 
contamination, damage, dust, sunlight, extreme temperatures, excessive 
moisture, and damaging chemicals and prevents deformation of the 
facepiece or exhalation valve.
    (7) Identification of filters, cartridges, and canisters. (i) 
Filters, cartridges, and canisters used in the workplace shall be 
properly labeled and color-coded with the NIOSH approval label as 
required by 30 CFR part 11 or 42 CFR part 84, whichever is applicable, 
before they are placed into service.
    (ii) The NIOSH approval label on a filter, cartridge, or canister 
shall not be intentionally removed, obscured, or defaced while it is in 
service in the workplace.
    (8) Respiratory protection program evaluation. The employer shall 
review the overall respiratory protection program at least annually, 
and shall conduct inspections of the workplace as necessary to assure 
that the provisions of the program are being properly implemented for 
all affected employees. The review of the program shall include an 
assessment of each element required under paragraph (f)(2) of this 
section.
    (g) Medical Surveillance--(1) General. (i) Each employer who has 
any employee with occupational exposure shall provide the employee with 
medical surveillance as described in this paragraph.
    (ii) Each employer covered under paragraph (a), Scope, of this 
section shall provide information about the signs and symptoms of 
pulmonary TB, a medical history, a physical examination, TB skin 
testing, medical management and follow-up and, if indicated, other 
related tests and procedures, and medical removal protection if the 
employee develops infectious TB, to any of his or her employees who 
have an exposure incident while working in a covered work setting, even 
if such employee is not categorized as having occupational exposure.
    (iii) Medical surveillance provisions, including examinations, 
evaluations, determinations, procedures, and medical management and 
follow-up, shall be:
    (A) Provided at no cost to the employee;
    (B) Provided at a reasonable time and place for the employee;
    (C) Performed by or under the supervision of a physician or other 
licensed health care professional, as appropriate; and
    (D) Provided according to recommendations of CDC current at the 
time these evaluations and procedures take place, except as specified 
by this paragraph (g).
    (iv) Laboratory tests shall be conducted by an accredited 
laboratory.
    (2) Explanation of Terms. This paragraph explains the terms used in 
paragraph (g).
    (i) Medical history emphasizes the pulmonary system, and includes 
previous exposure to M. tuberculosis, BCG vaccination, TB skin test 
results, TB disease, prior and current preventive or therapeutic 
treatment, current signs or symptoms of active TB disease, and factors 
affecting immunocompetence;
    (ii) Physical examination emphasizes the pulmonary system, signs 
and symptoms of active TB disease, and factors affecting 
immunocompetence;
    (iii) TB skin testing, includes anergy testing if indicated, and is 
only for employees whose TB skin test status is not known to be 
positive. An initial 2-step protocol is to be used for each employee 
who has not been previously skin tested and/or for whom a negative test 
cannot be documented within the past 12 months. If the employer has 
documentation that the employee has had a negative TB skin test within 
the past 12 months, that test may be utilized to fulfill the skin 
testing portion of this requirement. Periodic retesting shall be 
performed in accordance with paragraph (g)(3) of this section.
    (iv) ``Determination of the employee's ability to wear a 
respirator'' is a face-to-face assessment of the health factors 
affecting respirator use and the need for the annual fit test.

    Note to paragraph (g)(2)(iv): A determination of the need for 
the annual fit

[[Page 54289]]

test may only be performed after the required initial fit test of 
the employee and cannot be used in lieu of any other required fit 
tests, for example, when a different size or make of respirator is 
used.

    (v) ``Medical management and follow-up'' include diagnosis, and, 
where appropriate, prophylaxis and treatment related to TB infection 
and disease.
    (vi) Other related tests and procedures include those associated 
with TB infection and disease and determined to be necessary by the 
physician or other licensed health care professional, as appropriate.
    (vii) Medical Removal Protection is the maintenance of earnings, 
seniority and other benefits specified in paragraph (g)(5) of this 
section for an employee who has confirmed or suspected infectious TB or 
is unable to wear a respirator.
    (3) Application. (i) Each employee with occupational exposure shall 
be provided with the following at the times specified:
    (A) Before initial assignment to a job with occupational exposure 
or within 60 days of the effective date of this standard and at least 
annually thereafter: A medical history and TB skin testing, and, if 
indicated, a physical examination and other related tests and 
procedures;

    Note to paragraph (g)(3)(i)(A): If an employee has had a medical 
examination within the twelve (12) months preceding the effective 
date of the standard and the employer has the documented results of 
that examination, only the medical surveillance provisions required 
by the standard that were not included in the examination need to be 
provided. The date(s) of the previous medical examination and skin 
test shall be used to determine the date(s) of the employee's next 
medical examination and skin test but in no case shall the interval 
between the previous examination and skin test and the next 
examination and skin test exceed 12 months.

    (B) When the employee has signs or symptoms of TB, either observed 
or self-reported: A medical history, a physical examination, TB skin 
testing, medical management and follow-up, and, if indicated, other 
related tests and procedures;
    (C) When an employee undergoes an exposure incident: A medical 
history, TB skin testing as soon as feasible (unless there is 
documented negative TB skin testing within the past 3 months), and if 
the result is negative, another skin test 3 months later, medical 
management and follow-up and, if indicated, a physical examination and 
other related tests and procedures;
    (D) When the employee has a TB skin test conversion: A medical 
history, a physical examination, medical management and follow-up, and, 
if indicated, other related tests;
    (E) Within 30 days of the termination of employment: A TB skin 
test; and
    (F) At any other time the physician or other licensed health care 
professional, as appropriate, deems it necessary: Any or all the 
provisions of paragraph (g).
    (ii) Each employee who must wear a respirator shall be provided 
with the following at the times specified:
    (A) Before initial assignment to a job with occupational exposure 
or within 60 days of the effective date of this standard and at least 
annually thereafter: A determination of the employee's ability to wear 
a respirator; and
    (B) When the wearer experiences unusual difficulty while being 
fitted or while using a respirator: A determination of the employee's 
ability to wear a respirator, including relevant components of a 
medical history, and, if indicated, a physical examination and other 
related tests and procedures.
    (iii) An employee with negative TB skin test status shall be 
provided with a TB skin test every 6 months if the employee in the 
course of his or her duties:
    (A) Enters an AFB isolation room or area;
    (B) Performs or is present during the performance of high-hazard 
procedures;
    (C) Transports or is present during the transport of an individual 
with suspected or confirmed infectious TB in an enclosed vehicle; or
    (D) Works in an intake area where early identification procedures 
are performed (e.g., emergency departments, admitting areas) in 
facilities where six (6) or more individuals with confirmed infectious 
TB have been encountered in the past twelve months.
    (4) Additional Requirements. (i) The employer shall assure that 
when the physician or other licensed health care professional, as 
appropriate, determines that an employee has suspected or confirmed 
infectious TB, the physician or other licensed health care 
professional, as appropriate, shall notify the employer and the 
employee as soon as feasible.
    (ii) When the employer first identifies an individual with 
confirmed infectious TB, the employer shall notify each employee who 
has had an exposure incident involving that individual of his or her 
exposure to confirmed TB; and
    (iii) When an exposure incident results in a TB skin test 
conversion, the employer shall assure that a determination is made of 
the drug susceptibility of the M. tuberculosis isolate from the source, 
unless the employer can demonstrate that such a determination is not 
feasible.
    (iv) When an exposure incident or a TB skin test conversion occurs, 
the employer shall investigate and document the circumstances 
surrounding the exposure incident or conversion (e.g. failure of 
engineering controls or work practices and events leading to the 
exposure incident) to determine if changes can be instituted to prevent 
similar occurrences in the future.
    (5) Medical Removal Protection. (i) Each employee with suspected or 
confirmed infectious TB shall be removed from the workplace until 
determined to be noninfectious.
    (ii) For each employee who is removed from the workplace under 
paragraph (g)(5)(i) of this section, the employer shall maintain the 
total normal earnings, seniority, and all other employee rights and 
benefits, including the employee's right to his or her former job 
status, as if the employee had not been removed from the employee's job 
or otherwise medically limited until the employee is determined to be 
noninfectious or for a maximum of 18 months, whichever comes first.
    (iii) For each employee who is removed from his or her job under 
paragraph (f)(4)(viii), Respiratory Protection, of this section the 
employer shall transfer the employee to comparable work for which the 
employee is qualified or can be trained in a short period (up to 6 
months), where the use of respiratory protection is not required. The 
employer shall maintain the total normal earnings, seniority, and all 
other employee rights and benefits. If there is no such work available, 
the employer shall maintain the employee's total normal earnings, 
seniority, and all other employee rights and benefits until such work 
becomes available or for a maximum of 18 months, whichever comes first.
    (iv) An employer's obligation to provide earnings, seniority and 
other benefits to a removed employee may be reduced to the extent that 
the employee receives compensation for earnings lost during the period 
of removal either from a publicly or employer-funded compensation 
program or from employment with another employer made possible by 
virtue of the employee's removal.
    (6) Information Provided to Physician or Other Licensed Health Care 
Professionals. (i) Each employer shall assure that all physicians or 
other licensed health care professionals responsible for making 
determinations and performing procedures as part of the medical 
surveillance program are

[[Page 54290]]

provided a copy of this regulation and, for those employees required to 
wear respirators under this section, information regarding the type of 
respiratory protection used, a description of the work effort required, 
any special environmental conditions (e.g., heat, confined space 
entry), additional requirements for protective clothing and equipment, 
and the duration and frequency of usage of the respirator.
    (ii) Each employer shall assure that the physician or other 
licensed health care professional, as appropriate, who evaluates an 
employee after an exposure incident is provided the following 
information:
    (A) A description of the exposed employee's duties as they relate 
to the exposure incident;
    (B) Circumstances under which the exposure incident occurred;
    (C) Any diagnostic test results, including drug susceptibility 
pattern or other information relating to the source of exposure which 
could assist in the medical management of the employee; and
    (D) All of the employee's medical records relevant to the 
management of the employee, including tuberculin skin testing results.
    (7) Written Opinion. (i) Each employer shall obtain and provide the 
employee with a copy of the written opinion of the physician or other 
licensed health care professional, as appropriate, within 15 days of 
the completion of all medical evaluations required by this section.
    (ii) The written opinion shall be limited to the following 
information:
    (A) The employee's TB skin test status;
    (B) The employee's infectivity status;
    (C) A statement that the employee has been informed of the results 
of the medical evaluation;
    (D) A statement that the employee has been told about any medical 
conditions resulting from exposure to TB that require further 
evaluation or treatment;
    (E) Recommendations for medical removal or work restrictions and 
the physician's or other licensed health care professional's opinion 
regarding the employee's ability to wear a respirator.
    (iii) All other findings or diagnoses shall remain confidential and 
shall not be included in the written report.
    (h) Communication of Hazards and Training--(1) Labels. (i) Air 
systems that may reasonably be anticipated to contain aerosolized M. 
tuberculosis shall be labeled ``Contaminated Air--Respiratory 
Protection Required.'' The label shall be placed at all points where 
ducts are accessed prior to a HEPA filter and at duct access points, 
fans, and discharge outlets of non-HEPA filtered direct discharge 
systems.
    (ii) Clinical and research laboratory wastes that are contaminated 
with M. tuberculosis and are to be decontaminated outside of the 
immediate laboratory shall be labeled with the biohazard symbol or 
placed in a red container(s).
    (2) Signs. (i) Signs shall be posted at the entrances to:
    (A) Rooms or areas used to isolate an individual with suspected or 
confirmed infectious TB;
    (B) Areas where procedures or services are being performed on an 
individual with suspected or confirmed infectious TB; and
    (C) Clinical and research laboratories where M. tuberculosis is 
present.
    (ii) When an AFB isolation room or area is vacated by an individual 
with suspected or confirmed infectious TB, unless the individual has 
been medically determined to be noninfectious, the sign shall remain 
posted at the entrance until the room or area has been ventilated 
according to CDC recommendations for a removal efficiency of 99.9% (see 
Appendix C to this section).
    (iii) Signs for AFB isolation rooms or areas, except as required in 
paragraph (h)(2)(iv) of this section, shall be readily observable and 
shall bear the following legend with symbol and text in white on a red 
background:
BILLING CODE 4510-26-P
[GRAPHIC] [TIFF OMITTED] TP17OC97.006


BILLING CODE 4510-26-C

No Admittance Without Wearing a Type N95 or More Protective 
Respirator

    Note to paragraph (h)(2)(ii): Employers may include additional 
information on signs provided it does not interfere with conveyance 
of this message.

    (iv) Signs at the entrances of clinical or research laboratories 
and autopsy suites where procedures are being performed that may 
generate aerosolized M. tuberculosis shall include the biohazard 
symbol, name and telephone number of the laboratory director or other 
designated responsible person, the infectious agent designation 
Mycobacterium tuberculosis, and special requirements for entering the 
laboratory or autopsy room.
    (3) Information and Training. (i) Each employer shall assure that 
each employee with occupational exposure participates in a training 
program, which must be provided at no cost to the employee and be made 
available at a reasonable time and place.
    (ii) Training shall be provided as follows:
    (A) Before initial assignment to tasks where occupational exposure 
may occur;
    (B) Within 60 days after the effective date of the standard; and
    (C) At least annually thereafter, unless the employer can 
demonstrate that the employee has the specific knowledge and skills 
required under paragraph (h)(3)(vii) of this section. The employer must 
provide re-training to the employee in any topic(s) in which specific 
knowledge and skills cannot be demonstrated.

    Note to paragraph (h)(3)(ii): Training in the general topics 
under paragraph (h)(3)(vii) of this section which has been provided 
in the past 12 months by a previous employer may be transferred to 
an employee's new employer. However, the new employer must provide 
training in the site-specific topics under paragraph (h)(3)(vii) in 
accordance with the requirements of paragraph (h).

    (iii) For employees who have received training on TB in the year 
preceding the effective date of the standard, only training with 
respect to the provisions of the standard that were not included in 
such training need be provided. The annual retraining shall be 
conducted within one year from the date of the training that occurred 
before the effective date of the standard.
    (iv) Annual training for each employee shall be provided within one 
calendar year of the employee's previous training.
    (v) The employer shall provide additional training when changes 
such as modification of tasks or procedures or institution of new tasks 
or procedures affect the employee's occupational exposure. The 
additional training may be limited to addressing the new or modified 
exposures.
    (vi) Material appropriate in content and vocabulary to the 
educational level, literacy, and language of employees shall be used.
    (vii) The training program shall include an explanation of:
    (A) The contents of this standard and the location of an accessible 
copy of the regulatory text of this standard;
    (B) The general epidemiology of TB, including Multidrug-Resistant 
TB (MDR-TB), and the potential for exposure within the facility; the 
signs and symptoms of TB, including the difference between tuberculosis

[[Page 54291]]

infection and tuberculosis disease; the modes of transmission of 
tuberculosis, including the possibility of reinfection in persons with 
a positive tuberculin skin test; and the personal health conditions 
that increase the employee's risk of developing TB disease if infected 
(e.g., HIV infection, prolonged corticosteroid therapy, other 
immunocompromising conditions);
    (C) The employer's exposure control plan and respiratory protection 
program and the means by which the employee can review the written 
plans;
    (D) The tasks and other activities that may involve exposure to M. 
tuberculosis;
    (E) The use and limitations of methods that will prevent or reduce 
exposure, including appropriate engineering controls, work practices, 
respiratory protection, and site-specific control measures;
    (F) Why a respirator is necessary, and the basis of selection of 
the respirators used, the types of respirators used, upkeep and storage 
of the respirators used, and their location and proper use, including 
procedures for inspection, donning and removal, checking the fit and 
seals, and wearing the respirator. This instruction shall allow 
sufficient practice to enable the employee to become thoroughly 
familiar with and effective in performing these tasks;
    (G) The employer's medical surveillance program, including the 
purpose of tuberculin skin testing, the importance of a positive or 
negative skin test result, anergy testing, and the importance of 
participation in the program;
    (H) The procedures to follow if an exposure incident occurs, 
including the method of reporting the incident and the medical 
management and follow-up that the employer is required to provide, and 
the benefits and risks of prophylaxis; and
    (I) The procedures to follow if the employee develops signs or 
symptoms of TB disease.
    (viii) The person(s) conducting the training shall be knowledgeable 
in the subject matter covered by the elements contained in the training 
program as it relates to the workplace that the training will address.
    (ix) The employer shall provide employees with an opportunity for 
interactive questions and answers with the person conducting the 
training session.
    (i) Recordkeeping--(1) Medical Records. (i) Each employer shall 
establish and maintain an accurate record for each employee with 
occupational exposure, in accordance with 29 CFR 1910.1020.
    (ii) This record shall include:
    (A) The name, social security number, and job classification of the 
employee;
    (B) A copy of all results of examinations; medical testing, 
including the employee's tuberculin skin test status; and follow-up 
procedures;
    (C) The employer's copy of the physician's or other licensed health 
care professional's written opinion; and
    (D) A copy of the information provided to the physician or other 
licensed health care professional.
    (iii) Confidentiality. The employer shall assure that employee 
medical records required by paragraph (i) are:
    (A) Kept confidential; and
    (B) Not disclosed or reported without the employee's express 
written consent to any person within or outside the workplace, except 
as required by this section or as may be required by law.
    (iv) The employer shall maintain the records required by paragraph 
(i)(1) for at least the duration of employment plus 30 years, in 
accordance with 29 CFR 1910.1020. The medical records of employees who 
have worked for less than one year for the employer need not be 
retained beyond the term of employment if they are provided to the 
employee upon termination of employment.
    (2) OSHA Illness and Injury Records. The employer shall record TB 
infection or disease in accordance with 29 CFR 1904 and 29 CFR 1960, as 
applicable.
    (3) Training Records. (i) Training records shall include the 
following information:
    (A) The dates of the training sessions;
    (B) The contents or a summary of the training sessions;
    (C) The names and qualifications of persons conducting the 
training; and
    (D) The name and job classification of all persons attending the 
training sessions.
    (ii) Training records shall be maintained for 3 years from the date 
on which the training occurred.
    (4) Engineering Control Maintenance and Monitoring Records. (i) 
Engineering control maintenance records shall include the following 
information:
    (A) Date;
    (B) Equipment identification;
    (C) Task performed; and
    (D) Sign-off.
    (ii) Performance monitoring records shall include the following 
information:
    (A) Date and time;
    (B) Location;
    (C) Parameter measured, including units when appropriate;
    (D) Results of monitoring; and
    (E) Sign-off.
    (iii) Engineering control maintenance and monitoring records shall 
be maintained for three years.
    (5) Availability. (i) Employee medical records required by 
paragraph (i)(1), Recordkeeping, of this section shall be provided upon 
request for the examination and copying to the subject employee, to 
anyone having the written consent of the subject employee, to the 
Director, and to the Assistant Secretary in accordance with 29 CFR 
1910.1020. OSHA Illness and Injury Records shall be accessible under 
the provisions of 29 CFR 1904 and 29 CFR 1960, as applicable.
    (ii) Employee training records required by paragraph (i)(3), 
Recordkeeping, of this section shall be provided upon request for 
examination and copying to employees, to their representatives, to the 
Director, and to the Assistant Secretary.
    (iii) Engineering control maintenance and monitoring records 
required by paragraph (i)(4), Recordkeeping, of this section shall be 
provided upon request for examination and copying to employees, their 
representatives, to the Director, and to the Assistant Secretary.
    (6) Transfer of Records. (i) The employer shall comply with the 
requirements involving transfer of records set forth in 29 CFR 
1910.1020(h) and 29 CFR 1904 and 29 CFR 1960, as applicable.
    (ii) If the employer ceases to do business and there is no 
successor employer to receive and retain the records for the prescribed 
period, the employer shall notify the Director at least three months 
before their disposal and transmit them to the Director, if required by 
the Director to do so, within the three month period.
    (j) Definitions. For the purposes of this section, the following 
shall apply:
    Acid-fast bacilli (AFB) means bacteria that retain certain dyes 
after being washed in an acid solution. Most acid-fast organisms are 
mycobacteria.
    Accredited laboratory means a laboratory that has participated in a 
quality assurance program leading to a certification of competence 
administered by a governmental or private organization that tests and 
certifies laboratories.
    Air-purifying respirator means a respirator that is designed to 
remove air contaminants from the ambient air or air surrounding the 
respirator.
    AFB isolation room or area includes, but is not limited to, rooms, 
areas, booths, tents, or other enclosures that are maintained at 
negative pressure to adjacent areas in order to control the spread of 
aerosolized M. tuberculosis.

[[Page 54292]]

    Anergy means the inability of a person to react to skin test 
antigens (even if the person is infected with the organisms tested) 
because of immunosuppression.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, or designated representative.
    BCG (Bacille Calmette-Guerin) vaccine is a tuberculosis vaccine.
    Canister or cartridge means a container with a filter, sorbent, or 
catalyst, or a combination of these items, that removes specific air 
contaminants from the air drawn through the container.
    Clinical laboratory is a laboratory or area of a facility that 
conducts routine and repetitive operations for the diagnosis of TB such 
as preparing acid-fast smears and culturing sputa or other clinical 
specimens for identification, typing or susceptibility testing.
    Confirmed infectious tuberculosis is a disease state that has been 
diagnosed by positive identification of M. tuberculosis from body fluid 
or tissue through positive culture, positive gene probe, or positive 
polymerase chain reaction (PCR). The disease state must be capable of 
being transmitted to another individual (e.g., pulmonary or laryngeal 
TB or extrapulmonary TB where the infected tissue is exposed and could 
generate droplet nuclei).
    Conversion means a change in tuberculin skin test results from 
negative to positive, based upon current Centers for Disease Control 
and Prevention (CDC) guidelines.
    Director means the Director of the National Institute for 
Occupational Safety and Health, U.S. Department of Health and Human 
Services, or designated representative.
    Disposable respirator means a respiratory protective device that 
cannot be resupplied with an unused filter or cartridge and that is to 
be discarded in its entirety after its useful service life has been 
reached.
    Exposure incident means an event in which an employee has been 
exposed to an individual with confirmed infectious TB or to air 
containing aerosolized M. tuberculosis without the benefit of 
applicable exposure control measures required by this section.
    Filter means a component used in respirators to remove solid or 
liquid aerosols from the inspired air.
    Fit factor means a quantitative measure of the fit of a particular 
respirator on a particular individual.
    High efficiency particulate air (HEPA) filter means a specialized 
filter that is capable of removing 99.97% of particles greater than or 
equal to 0.3 micrometer in diameter.
    High hazard procedures are procedures performed on an individual 
with suspected or confirmed infectious tuberculosis in which the 
potential for being exposed to M. tuberculosis is increased due to the 
reasonably anticipated generation of aerosolized M. tuberculosis. Such 
procedures include, but are not limited to, sputum induction, 
bronchoscopy, endotracheal intubation or suctioning, aerosolized 
administration of pentamidine or other medications, and pulmonary 
function testing. They also include autopsy, clinical, surgical and 
laboratory procedures that may aerosolize M. tuberculosis.
    M. tuberculosis means Mycobacterium tuberculosis, the scientific 
name of the bacillus that causes tuberculosis.
    Negative pressure means the relative air pressure difference 
between two areas. A room that is under negative pressure has lower 
pressure than adjacent areas, which keeps air from flowing out of the 
room and into adjacent rooms or areas.
    Negative pressure respirator means a respirator in which the air 
pressure inside the facepiece is negative during inhalation with 
respect to the ambient air pressure outside the respirator.
    Occupational exposure means reasonably anticipated contact, that 
results from the performance of an employee's duties, with an 
individual with suspected or confirmed infectious TB or air that may 
contain aerosolized M. tuberculosis.
    Physician or other licensed health care professional means an 
individual whose legally permitted scope of practice (i.e., license, 
registration, or certification) allows him or her to independently 
provide or be delegated the responsibility to provide some or all of 
the health care services required by paragraph (g) of this section.
    Powered air-purifying respirator (PAPR) means an air-purifying 
respirator that uses a blower to deliver air through the air-purifying 
element to the wearer's breathing zone.
    Qualitative fit test means a pass/fail fit test to assess the 
adequacy of respirator fit that relies on the respirator wearer's 
response to a challenge agent.
    Quantitative fit test means an assessment of the adequacy of 
respirator fit by numerically measuring the amount of leakage into the 
respirator.
    Research laboratory is a laboratory that propagates and manipulates 
cultures of M. tuberculosis in large volumes or high concentrations 
that are in excess of those used for identification and typing 
activities common to clinical laboratories.
    Respirator means a device worn by an individual and intended to 
provide the wearer with respiratory protection against inhalation of 
airborne contaminants.
    Suspected infectious tuberculosis means a potential disease state 
in which an individual is known, or with reasonable diligence should be 
known, by the employer to have one or more of the following conditions, 
unless the individual's condition has been medically determined to 
result from a cause other than TB:
    (1) To be infected with M. tuberculosis and to have the signs or 
symptoms of TB;
    (2) To have a positive acid-fast bacilli (AFB) smear; or
    (3) To have a persistent cough lasting 3 or more weeks and two or 
more symptoms of active TB (e.g., bloody sputum, night sweats, weight 
loss, fever, anorexia). An individual with suspected infectious TB has 
neither confirmed infectious TB nor has he or she been medically 
determined to be noninfectious.
    Tight-fitting facepiece means a respiratory inlet covering that is 
designed to form a complete seal with the face. A half-facepiece covers 
the nose and mouth; a full facepiece covers the nose, mouth, and eyes.
    Tuberculosis (TB) means a disease caused by M. tuberculosis.
    Tuberculosis infection means a condition in which living M. 
tuberculosis bacilli are present in the body without producing 
clinically active disease. Although the infected individual has a 
positive tuberculin skin test reaction, he or she may have no symptoms 
related to the infection and may not be capable of transmitting the 
disease.
    Tuberculosis disease is a condition in which living M. tuberculosis 
bacilli are present in the body, producing clinical illness. The 
individual may or may not be infectious.
    Tuberculin skin test means a method used to evaluate the likelihood 
that a person is infected with M. tuberculosis. The method utilizes an 
intradermal injection of tuberculin antigen with subsequent measurement 
of the reaction induration. It is also referred to as a PPD skin test.
    Two-step testing is a baseline skin testing procedure used to 
identify a boosted skin test reaction from that of a new infection. The 
procedure involves placing a second skin test 1 to 3 weeks after an 
initial negative test. A positive reaction on the second test indicates 
a boosted reaction.

[[Page 54293]]

    (k) Dates.--(1) Effective Date. The standard shall become effective 
on [insert date 90 days after publication of final rule in the Federal 
Register].
    (2) Start-up dates. (i) Exposure control. The exposure control 
provisions required by paragraph (c) of this section shall take effect 
on [insert date 30 days after effective date of final rule].
    (ii) The Information and Training provisions required under 
paragraph (h)(3), the Medical surveillance provisions required by 
paragraph (g), and the Recordkeeping provisions required by paragraph 
(i) of this section shall take effect on [insert date 60 days after 
effective date of final rule].
    (iii) Work practices and Engineering controls. The work practice 
and engineering control provisions required by paragraph (d) of this 
section shall take effect on [insert date 90 days after effective date 
of final rule]. For businesses with fewer than 20 employees, 
engineering controls required by paragraph (d) of this section shall 
take effect [insert 270 days after effective date of final rule]. Work 
practice controls that are directly related to engineering controls 
being installed in accordance with this paragraph shall be implemented 
as soon as those engineering controls are implemented.
    (iv) Respiratory protection. Respiratory protection provisions 
required by paragraph (f) of this section shall take effect on [insert 
date 90 days after effective date of final rule].
    (v) Labels and signs. The labels and signs provisions required by 
paragraphs (h)(1) and (h)(2) of this section shall take effect on 
[insert date 90 days after effective date of final rule].
    (vi) Clinical and research laboratories. The additional 
requirements for Clinical and Research Laboratories contained in 
paragraphs (e)(1) through (e)(3) shall take effect on [insert date 90 
days after effective date of final rule].

Appendix A to Sec. 1910.1035--Provisions for Employers Claiming 
Reduced Responsibilities Under Paragraph (b), Application 
(Mandatory)

(c) Exposure Control

Paragraph (c)(1)(i & ii)  Exposure Determination
(c)(2)(i)  Written Exposure Control Plan with the following 
elements:
(c)(2)(i)(A)  The exposure determination
(c)(2)(i)(B)  Procedures for providing information to employees 
about individuals identified with suspected or confirmed infectious 
TB or air that may reasonably be anticipated to contain aerosolized 
M. tuberculosis
(c)(2)(i)(C)  Procedures for reporting an exposure incident
(c)(2)(ii)  Procedures for identifying, masking or segregating and 
transferring individuals with suspected or confirmed infectious TB
(c)(2)(vi)  Documentation of the number of individuals with 
confirmed infectious TB encountered in the past 12 months
(c)(2)(vii) (A-C)  Accessible exposure control plan, reviewed 
annually and updated as necessary, and made available to the 
Assistant Secretary and Director

(d) Work Practice Procedures and Engineering Controls

(d)(1)  Use of work practices to eliminate or minimize employee 
exposure
(d)(2)  Implementation of the work practice procedures in the 
exposure control plan
(d)(3)(i)  Identification and masking or segregating of individuals 
with suspected or confirmed infectious TB
(d)(3)(ii)  Temporary isolation of individuals who cannot be 
transferred within 5 hours
(d)(5)(i-vii)  Engineering controls if temporary isolation is used
(d)(6)  Provide information about TB hazards to temporary or 
personnel who may incur occupational exposure

(g) Medical Surveillance

(g)(1)(i-iv)  Medical surveillance program for each employee with 
occupational exposure or who has an exposure incident in one of the 
covered work settings, at no cost, at a reasonable time, by a 
physician or other licensed health care professional, according to 
current recommendations of the CDC and with laboratory tests 
conducted by an accredited laboratory
(g)(2)(i, ii, iii, v, vi & vii) Explanation of terms: Medical 
history, Physical examination, tuberculin skin testing, medical 
management and follow-up, medical removal protection, and other 
related tests and procedures
(g)(3)(i)(A)  Initial TB skin testing and medical history (NOTE: 
Annual skin testing and medical histories are not required)
(g)(3)(i)(B)  Medical history, TB skin testing and follow-up for 
employees who develop signs or symptoms of TB
(g)(3)(i)(C)  Medical history, TB skin testing and medical 
management and follow-up of employees after an exposure incident
(g)(4)(i)  Notification of employee and employer as soon as feasible 
about infectious TB disease status of the employee
(g)(4)(ii)  Notification of employees about previously unidentified 
individuals with infectious TB
(g)(4)(iii)  Determination of drug susceptibility of M. tuberculosis 
source after an exposure incident
(g)(4)(iv)  Investigations of exposure incidents and TB skin test 
conversions
(g)(5)(i, ii & iv)  Medical removal and protection of benefits for 
individuals with infectious TB
(g)(6)(i & ii)  Information provided to the physician or other 
licensed health care professional
(g)(7)(i-iii)  Physician or other licensed health care 
professional's written opinion

(h) Communication of Hazards and Training

(h)(1)(i)  If temporary isolation is used, label air systems that 
may reasonably be anticipated to contain aerosolized M. tuberculosis
(h)(2)(i)(A)  If temporary isolation is used, post signs at entrance 
to temporary isolation
(h)(2)(ii)  When temporary isolation room or area is vacated by an 
individual with suspected or confirmed infectious TB, ventilate for 
an appropriate period
(h)(2)(iii)  Signs for temporary isolation rooms or areas must have 
a stop sign with the legend ``No Admittance Without Wearing a Type 
N95 or More Protective Respirator''
(h)(3)(i-viii)  Annual training with specified elements for 
employees with occupational exposure

(i) Recordkeeping

(i)(1)(i-iv)  Medical Records
(i)(2)  OSHA Illness and Injury Records
(i)(3)(i & ii)  Training Records
(i)(4)(i-iii)  If temporary isolation is used, engineering control 
maintenance records
(i)(5)(i & ii)  Availability of medical and training records
(i)(6)(i & ii)  Transfer of records

(k) Dates

(k)(1)  Effective date
(k)(2)(i, ii & iii)  Start up dates for exposure control, medical 
surveillance, information and training, recordkeeping, and work 
practices and engineering controls

Appendix B to Sec. 1910.1035--Fit Testing Procedures (Mandatory)

Part I. Approved Fit Test Protocols

A. Fit Testing Procedures

    The employer shall conduct fit testing using the following 
procedures. These provisions apply to both QLFT and QNFT.
    1. The test subject shall be allowed to pick the most acceptable 
respirator from a selection of respirators of various sizes and 
models.
    2. Prior to the selection process, the test subject shall be 
shown how to put on a respirator, how it should be positioned on the 
face, how to set strap tension and how to determine an acceptable 
fit. A mirror shall be available to assist the subject in evaluating 
the fit and positioning the respirator. This instruction may not 
constitute the subject's formal training on respirator use, as it is 
only a review.
    3. The test subject shall be informed that he or she is being 
asked to select the respirator that provides the most acceptable 
fit. Each respirator represents a different size and shape, and if 
fitted and used properly, will provide adequate protection.
    4. The test subject shall be instructed to hold each chosen 
facepiece up to the face and eliminate those that obviously do not 
give an acceptable fit.
    5. The more acceptable facepieces are noted; the most acceptable 
mask is donned

[[Page 54294]]

and worn at least five minutes to assess acceptability. Assistance 
in assessing acceptability can be given by discussing the points in 
item 6 below. If the test subject is not familiar with using a 
particular respirator, the test subject shall be directed to don the 
mask several times and to adjust the straps each time to become 
adept at setting proper tension on the straps.
    6. Assessment of acceptability shall include reviewing the 
following points with the test subject and allowing the test subject 
adequate time to determine the acceptability of the respirator:
    (a) Position of the mask on the nose,
    (b) Room for eye protection,
    (c) Room to talk;
    (d) Position of mask on face and cheeks.
    7. The following criteria shall be used to help determine the 
adequacy of the respirator fit:
    (a) Chin properly placed;
    (b) Adequate strap tension, not overly tightened;
    (c) Fit across nose bridge;
    (d) Respirator of proper size to span distance from nose to 
chin;
    (e) Tendency of respirator to slip;
    (f) Self-observation in mirror to evaluate fit and respirator 
position.
    8. The test subject shall conduct the negative and positive 
pressure fit checks as described in this appendix or other fit check 
procedures recommended by the respirator manufacturer providing 
equivalent protection to the procedures in this appendix. Before 
conducting the negative or positive pressure fit checks, the subject 
shall be told to seat the mask on the face by moving the head from 
side-to-side and up and down slowly while taking in a few slow deep 
breaths. Another facepiece shall be selected and retested if the 
test subject fails the fit check tests.
    9. The test shall not be conducted if there is any hair growth 
between the skin and the facepiece sealing surface, such as stubble 
beard growth, beard, mustache or sideburns that cross the respirator 
sealing surface. Any type of apparel which interferes with a 
satisfactory fit shall be altered or removed.
    10. If a test subject exhibits difficulty in breathing during 
the tests, she or he shall be referred to a physician or other 
licensed health care professional, as appropriate, to determine 
whether the test subject can wear a respirator while performing her 
or his duties.
    11. If the employee finds the fit of the respirator 
unacceptable, the test subject shall be given the opportunity to 
select a different respirator and to be retested.
    12. Exercise regimen. Prior to the commencement of the fit test, 
the test subject shall be given a description of the fit test and 
the test subject's responsibilities during the test procedure. The 
description of the process shall include a description of the test 
exercises that the subject will be performing. The respirator to be 
tested shall be worn for at least 5 minutes before the start of the 
fit test.
    13. Test Exercises. The test subject shall perform exercises, in 
the test environment, while wearing any applicable safety equipment 
that may be worn during actual respirator use which could interfere 
with fit, in the manner described below:
    (a) Normal breathing. In a normal standing position, without 
talking, the subject shall breathe normally.
    (b) Deep breathing. In a normal standing position, the subject 
shall breathe slowly and deeply, taking caution so as to not 
hyperventilate.
    (c) Turning head side to side. Standing in place, the subject 
shall slowly turn his or her head from side to side between the 
extreme positions on each side. The head shall be held at each 
extreme momentarily so the subject can inhale at each side.
    (d) Moving head up and down. Standing in place, the subject 
shall slowly move his/her head up and down. The subject shall be 
instructed to inhale in the up position (i.e., when looking toward 
the ceiling).
    (e) Talking. The subject shall talk out loud slowly and loud 
enough so as to be heard clearly by the test conductor. The subject 
can read from a prepared text such as the Rainbow Passage, count 
backward from 100, or recite a memorized poem or song.

Rainbow Passage

    When the sunlight strikes raindrops in the air, they act like a 
prism and form a rainbow. The rainbow is a division of white light 
into many beautiful colors. These take the shape of a long round 
arch, with its path high above, and its two ends apparently beyond 
the horizon. There is, according to legend, a boiling pot of gold at 
one end. People look, but no one ever finds it. When a man looks for 
something beyond reach, his friends say he is looking for the pot of 
gold at the end of the rainbow.

    (f) Grimace. The test subject shall grimace by smiling or 
frowning. (Only for QNFT testing, not performed for QLFT)
    (g) Bending over. The test subject shall bend at the waist as if 
he/she were to touch his/her toes. Jogging in place shall be 
substituted for this exercise in those test environments such as 
shroud type QNFT units which prohibit bending at the waist.
    (h) Normal breathing. Same as exercise (a). Each test exercise 
shall be performed for one minute except for the grimace exercise 
which shall be performed for 15 seconds.
    The test subject shall be questioned by the test conductor 
regarding the acceptability of the respirator upon completion of the 
protocol. If it has become unacceptable, another model of respirator 
shall be tried.

B. Qualitative Fit Test (QLFT) Protocols

1. General

    (a) The employer shall assign specific individuals who shall 
assume full responsibility for implementing the respirator 
qualitative fit test program.
    (b) The employer shall ensure that persons administering QLFT 
are able to prepare test solutions, calibrate equipment and perform 
tests properly, recognize invalid tests, and assure that test 
equipment is in proper working order.
    (c) The employer shall assure that QLFT equipment is kept clean 
and well maintained so as to operate within the parameters for which 
it was designed.

2. Isoamyl Acetate Protocol

    Note: This protocol is not appropriate, by itself, for fit 
testing particulate respirators. If chosen for use in fit testing 
particulate respirators, the respirator must be equipped with an 
organic vapor cartridge, provided the employee will be using the 
same facepiece in the work setting except that it will be equipped 
with particulate filters.

    (a) Odor threshold screening. The odor threshold screening test, 
performed without wearing a respirator, is intended to determine if 
the individual tested can detect the odor of isoamyl acetate.
    (1) Three 1 liter glass jars with metal lids are required.
    (2) Odor free water (e.g. distilled or spring water) at 
approximately 25 degrees C shall be used for the solutions.
    (3) The isoamyl acetate (IAA) (also known at isopentyl acetate) 
stock solution is prepared by adding 1 cc of pure IAA to 800 cc of 
odor free water in a 1 liter jar and shaking for 30 seconds. A new 
solution shall be prepared at least weekly.
    (4) The screening test shall be conducted in a room separate 
from the room used for actual fit testing. The two rooms shall be 
well ventilated to prevent the odor of IAA from becoming evident in 
the general room air where testing takes place.
    (5) The odor test solution is prepared in a second jar by 
placing 0.4 cc of the stock solution into 500 cc of odor free water 
using a clean dropper or pipette. The solution shall be shaken for 
30 seconds and allowed to stand for two to three minutes so that the 
IAA concentration above the liquid may reach equilibrium. This 
solution shall be used for only one day.
    (6) A test blank shall be prepared in a third jar by adding 500 
cc of odor free water.
    (7) The odor test and test blank jars shall be labeled 1 and 2 
for jar identification. Labels shall be placed on the lids so they 
can be periodically peeled off and switched to maintain the 
integrity of the test.
    (8) The following instruction shall be typed on a card and 
placed on the table in front of the two test jars (i.e., 1 and 2): 
The purpose of this test is to determine if you can smell banana oil 
at a low concentration. The two bottles in front of you contain 
water. One of these bottles also contains a small amount of banana 
oil. Be sure the covers are on tight, then shake each bottle for two 
seconds. Unscrew the lid of each bottle, one at a time, and sniff at 
the mouth of the bottle. Indicate to the test conductor which bottle 
contains banana oil.
    (9) The mixtures used in the IAA odor detection test shall be 
prepared in an area separate from where the test is performed, in 
order to prevent olfactory fatigue in the subject.
    (10) If the test subject is unable to correctly identify the jar 
containing the odor test solution, the IAA qualitative fit test 
shall not be performed.
    (11) If the test subject correctly identifies the jar containing 
the odor test solution, the test subject may proceed to respirator 
selection and fit testing.
    (b) Isoamyl acetate fit test. (1) The fit test chamber shall be 
similar to a clear 55-gallon drum liner suspended inverted over a 2-
foot

[[Page 54295]]

diameter frame so that the top of the chamber is about 6 inches 
above the test subject's head. The inside top center of the chamber 
shall have a small hook attached.
    (2) Each respirator used for the fitting and fit testing shall 
be equipped with organic vapor cartridges or offer protection 
against organic vapors.
    (3) After selecting, donning, and properly adjusting a 
respirator, the test subject shall wear it to the fit testing room. 
This room shall be separate from the room used for odor threshold 
screening and respirator selection, and shall be well ventilated, as 
by an exhaust fan or lab hood, to prevent the test medium that is 
not contained will be removed from the general room air.
    (4) A copy of the test exercises and any prepared text from 
which the subject is to read shall be taped to the inside of the 
test chamber.
    (5) Upon entering the test chamber, the test subject shall be 
given a 6-inch by 5-inch piece of paper towel, or other porous, 
absorbent, single-ply material, folded in half and wetted with 0.75 
cc of pure IAA. The test subject shall hang the wet towel on the 
hook at the top of the chamber.
    (6) Allow two minutes for the IAA test concentration to 
stabilize before starting the fit test exercises. This would be an 
appropriate time to talk with the test subject; to explain the fit 
test, the importance of his/her cooperation, and the purpose for the 
test exercises; or to demonstrate some of the exercises.
    (7) If at any time during the test, the subject detects the 
banana like odor of IAA, the test is failed. The subject shall 
quickly exit from the test chamber and leave the test area to avoid 
olfactory fatigue.
    (8) If the test is failed, the subject shall return to the 
selection room and remove the respirator. The test subject shall 
repeat the odor sensitivity test, select and put on another 
respirator, return to the test area and again begin the fit test 
procedure described in (1) through (7) above. The process continues 
until a respirator that fits well has been found. Should the odor 
sensitivity test be failed, the subject shall wait about 5 minutes 
before retesting. Odor sensitivity will usually have returned by 
this time.
    (9) When the subject wearing the respirator passes the test, its 
efficiency shall be demonstrated for the subject by having the 
subject break the face seal and take a breath before exiting the 
chamber.
    (10) When the test subject leaves the chamber, the subject shall 
remove the saturated towel and return it to the person conducting 
the test, so there is no significant IAA concentration buildup in 
the chamber during subsequent tests. The used towels shall be kept 
in a self sealing bag to keep the test area from being contaminated.

3. Saccharin Solution Aerosol Protocol

    The entire screening and testing procedure shall be explained to 
the test subject prior to the conduct of the screening test.
    (a) Taste threshold screening. The saccharin taste threshold 
screening, performed without wearing a respirator, is intended to 
determine whether the individual being tested can detect the taste 
of saccharin.
    (1) During threshold screening as well as during fit testing, 
subjects shall wear an enclosure about the head and shoulders that 
is approximately 12 inches in diameter by 14 inches tall with at 
least the front portion clear and that allows free movements of the 
head when a respirator is worn. An enclosure substantially similar 
to the 3M hood assembly, parts # FT 14 and # FT 15 combined, is 
adequate.
    (2) The test enclosure shall have a \3/4\-inch hole in front of 
the test subject's nose and mouth area to accommodate the nebulizer 
nozzle.
    (3) The test subject shall don the test enclosure. Throughout 
the threshold screening test, the test subject shall breathe through 
his/her slightly open mouth with tongue extended.
    (4) Using a nebulizer device such as the DeVilbiss Model 40 
Inhalation Medication Nebulizer or equivalent, the test conductor 
shall spray the threshold check solution into the enclosure. This 
nebulizer shall be clearly marked to distinguish it from the fit 
test solution nebulizer.
    (5) The threshold check solution consists of 0.83 grams of 
sodium saccharin USP in 100 ml of warm water. It can be prepared by 
putting 1 ml of the fit test solution (see (b)(5) below) in 100 ml 
of distilled water.
    (6) To produce the aerosol, the nebulizer bulb is firmly 
squeezed so that it collapses completely, and is then released and 
allowed to fully expand.
    (7) Ten squeezes are repeated rapidly and then the test subject 
is asked whether the saccharin can be tasted.
    (8) If the first response is negative, ten more squeezes are 
repeated rapidly and the test subject is again asked whether the 
saccharin is tasted.
    (9) If the second response is negative, ten more squeezes are 
repeated rapidly and the test subject is again asked whether the 
saccharin is tasted.
    (10) The test conductor will take note of the number of squeezes 
required to solicit a taste response.
    (11) If the saccharin is not tasted after 30 squeezes (step 10), 
the test subject may not perform the saccharin fit test.
    (12) If a taste response is elicited, the test subject shall be 
asked to take note of the taste for reference in the fit test.
    (13) Correct use of the nebulizer means that approximately 1 ml 
of liquid is used at a time in the nebulizer body.
    (14) The nebulizer shall be thoroughly rinsed in water, shaken 
dry, and refilled at least each morning and afternoon or at least 
every four hours.
    (b) Saccharin solution aerosol fit test procedure.
    (1) The test subject may not eat, drink (except plain water), 
smoke, or chew gum for 15 minutes before the test.
    (2) The fit test uses the same enclosure described in (a) above.
    (3) The test subject shall don the enclosure while wearing the 
respirator selected in section I.A. above. The respirator shall be 
properly adjusted and equipped with a particulate filter(s).
    (4) A second nebulizer device such as the DeVilbiss Model 40 
Inhalation Medication Nebulizer or equivalent is used to spray the 
fit test solution into the enclosure. This nebulizer shall be 
clearly marked to distinguish it from the screening test solution 
nebulizer.
    (5) The fit test solution is prepared by adding 83 grams of 
sodium saccharin to 100 ml of warm water.
    (6) As before, the test subject shall breathe through the 
slightly open mouth with tongue extended.
    (7) The nebulizer is inserted into the hole in the front of the 
enclosure and the fit test solution is sprayed into the enclosure 
using the same number of squeezes required to elicit a taste 
response in the screening test. A minimum of 10 squeezes is 
required.
    (8) After generating the aerosol the test subject shall be 
instructed to perform the exercises in section I. A. 13 above.
    (9) Every 30 seconds the aerosol concentration shall be 
replenished using one half the number of squeezes as initially.
    (10) The test subject shall indicate to the test conductor if at 
any time during the fit test the taste of saccharin is detected.
    (11) If the taste of saccharin is detected, the fit is deemed 
unsatisfactory and a different respirator shall be tried.

4. Bitrex (Denatonium benzoate) Solution Aerosol Qualitative Fit Test 
Protocol

    The Bitrex (Denatonium benzoate) solution aerosol QLFT protocol 
uses the published saccharin test protocol because of its current 
acceptance and past validation. Bitrex is routinely used as a taste 
aversion agent in household liquids which children should not be 
drinking and is endorsed by the American Medical Association, the 
National Safety Council, and the American Association of Poison 
Control Centers. The entire screening and testing procedure shall be 
explained to the test subject prior to the conduct of the screening 
test.
    (a) Taste Threshold Screening. The Bitrex taste threshold 
screening, performed without wearing a respirator, is intended to 
determine whether the individual being tested can detect the taste 
of Bitrex.
    (1) During threshold screening as well as during fit testing, 
subjects shall wear an enclosure about the head and shoulders that 
is approximately 12 inches (30.5 cm) in diameter by 14 inches (35.6 
cm) tall. The front portion of the enclosure shall be clear from the 
respirator and allow free movement of the head when a respirator is 
worn. An enclosure substantially similar to the 3M hood assembly, 
parts # 14 and # 15 combined, is adequate.
    (2) The test enclosure shall have a \3/4\ inch (1.9 cm) hole in 
front of the test subject's nose and mouth area to accommodate the 
nebulizer nozzle.
    (3) The test subject shall don the test enclosure. Throughout 
the threshold screening test, the test subject shall breathe through 
his or her slightly open mouth with tongue extended.
    (4) Using a nebulizer device such as a DeVilbiss Model 40 
Inhalation Medication Nebulizer or equivalent, the test conductor 
shall spray the threshold check solution into the enclosure. This 
nebulizer shall be clearly marked to distinguish it from the fit 
test solution nebulizer.

[[Page 54296]]

    (5) The threshold check solution consists of 13.5 milligrams of 
Bitrex in 100 ml of 5% NaCl solution in distilled water.
    (6) To produce the aerosol, the nebulizer bulb is firmly 
squeezed so that the bulb collapses completely, and is then released 
and allowed to fully expand.
    (7) Ten squeezes are repeated rapidly and then the test subject 
is asked whether the Bitrex can be tasted.
    (8) If the first response is negative, ten more squeezes are 
repeated rapidly and the test subject is again asked whether the 
Bitrex is tasted.
    (9) If the second response is negative, ten more squeezes are 
repeated rapidly and the test subject is again asked whether the 
Bitrex is tasted.
    (10) The test conductor will take note of the number of squeezes 
required to solicit a taste response.
    (11) If the Bitrex is not tasted after 30 squeezes (step 10), 
the test subject may not perform the Bitrex fit test.
    (12) If a taste response is elicited, the test subject shall be 
asked to take note of the taste for reference in the fit test.
    (13) Correct use of the nebulizer means that approximately 1 ml 
of liquid is used at a time in the nebulizer body.
    (14) The nebulizer shall be thoroughly rinsed in water, shaken 
to dry, and refilled at least each morning and afternoon or at least 
every four hours.
    (b) Bitrex solution aerosol fit test procedure.
    (1) The test subject may not eat, drink (except plain water), 
smoke, or chew gum for 15 minutes before the test.
    (2) The fit test uses the same enclosure described in (a) above.
    (3) The test subject shall don the enclosure while wearing the 
respirator selected in section I.A. of this appendix. The respirator 
shall be properly adjusted and equipped with a particulate 
filter(s).
    (4) A second nebulizer device such as a DeVilbiss Model 40 
Inhalation Medication Nebulizer or equivalent is used to spray the 
fit test solution into the enclosure. This nebulizer shall be 
clearly marked to distinguish it from the screening test solution 
nebulizer.
    (5) The fit test solution is prepared by adding 337.5 mg of 
Bitrex in 200 ml of a 5% solution of NaCl in warm water.
    (6) As before, the test subject shall breathe through his or her 
slightly open mouth with tongue extended.
    (7) The nebulizer is inserted into the hole in the front of the 
enclosure and the fit test solution is sprayed into the enclosure 
using the same number of squeezes required to elicit a taste 
response in the screening test.
    (8) After generating the aerosol the test subject shall be 
instructed to perform the exercises in section I.A.13 of this 
appendix.
    (9) Every 30 seconds the aerosol concentration shall be 
replenished using half the number of squeezes as initially.
    (10) The test subject shall indicate to the test conductor if at 
any time during the fit test the taste of Bitrex is detected.
    (11) If the taste of Bitrex is detected, the fit is deemed 
unsatisfactory and a different respirator shall be tried.

5. Irritant Fume Protocol

    (a) The respirator to be tested shall be equipped with high-
efficiency particulate filters (i.e., HEPA, N100, R100, or P100) .
    (b) No form of test enclosure or hood for the test subject shall 
be used.
    (c) The test subject shall be allowed to smell a weak 
concentration of the irritant smoke before the respirator is donned 
to become familiar with its irritating properties.
    (d) Break both ends of a ventilation smoke tube containing 
stannic chloride. Attach one end of the smoke tube to an aspirator 
squeeze bulb and cover the other end with a short piece of tubing to 
prevent potential injury from the jagged end of the smoke tube.
    (e) Advise the test subject that the smoke can be irritating to 
the eyes and instruct the subject to keep his or her eyes closed 
while the test is performed.
    (f) The test conductor shall direct the stream of irritant smoke 
from the smoke tube towards the face seal area of the test subject 
beginning at least 12 inches from the facepiece and gradually moving 
to within one inch, moving around the whole perimeter of the mask.
    (g) The exercises identified in section I.A. 13 above shall be 
performed by the test subject while the respirator seal is being 
challenged by the smoke.
    (h) Each test subject passing the smoke test without evidence of 
a response (involuntary cough) shall be given a sensitivity check of 
the smoke from the same tube once the respirator has been removed to 
determine whether he or she reacts to the smoke. Failure to evoke a 
response shall void the fit test.
    (i) The fit test shall be performed in a location with exhaust 
ventilation sufficient to prevent general contamination of the 
testing area by the test agent.

C. Quantitative Fit Test (QNFT) Protocols

    The following quantitative fit testing procedures have been 
demonstrated to be acceptable:
    (1) Quantitative fit testing using a non-hazardous challenge 
aerosol (such as corn oil or sodium chloride) generated in a test 
chamber, and employing instrumentation to quantify the fit of the 
respirator.
    (2) Quantitative fit testing using ambient aerosol as the 
challenge agent and appropriate instrumentation (condensation nuclei 
counter) to quantify the respirator fit.
    (3) Quantitative fit testing using controlled negative pressure 
and appropriate instrumentation to measure the volumetric leak rate 
of a facepiece to quantify the respirator fit.

1. General

    (a) The employer shall assign specific individuals who shall 
assume full responsibility for implementing the respirator 
quantitative fit test program.
    (b) The employer shall ensure that persons administering QNFT 
are able to calibrate equipment and perform tests properly, 
recognize invalid tests, calculate fit factors properly and assure 
that test equipment is in proper working order.
    (c) The employer shall assure that QNFT equipment is kept clean, 
maintained and calibrated according to the manufacturer's 
instructions so as to operate at the parameters for which it was 
designed.

2. Generated Aerosol Protocol

    (a) Apparatus. (1) Instrumentation. Aerosol generation, 
dilution, and measurement systems using particulates (corn oil or 
sodium chloride) or gases or vapors as test aerosols shall be used 
for quantitative fit testing.
    (2) Test chamber. The test chamber shall be large enough to 
permit all test subjects to perform freely all required exercises 
without disturbing the challenge agent concentration or the 
measurement apparatus. The test chamber shall be equipped and 
constructed so that the challenge agent is effectively isolated from 
the ambient air, yet uniform in concentration throughout the 
chamber.
    (3) When testing air-purifying respirators, the normal filter or 
cartridge element shall be replaced with a high-efficiency 
particulate filter (i.e., HEPA, N100, R100, P100) supplied by the 
same manufacturer in the case of particulate QNFT aerosols or a 
sorbent offering contaminant penetration protection equivalent to 
high-efficiency filters where the QNFT test agent is a gas or vapor.
    (4) The sampling instrument shall be selected so that a computer 
record or strip chart record may be made of the test showing the 
rise and fall of the challenge agent concentration with each 
inspiration and expiration at fit factors of at least 2,000. 
Integrators or computers that integrate the amount of test agent 
penetration leakage into the respirator for each exercise may be 
used, provided a record of the readings is made.
    (5) The combination of substitute air-purifying elements, 
challenge agent and challenge agent concentration shall be such that 
the test subject is not exposed in excess of an established exposure 
limit for the challenge agent at any time during the testing process 
based upon the length of the exposure and the exposure limit 
duration.
    (6) The sampling port on the test specimen respirator shall be 
placed and constructed so that no leakage occurs around the port 
(e.g. where the respirator is probed), a free air flow is allowed 
into the sampling line at all times and so that there is no 
interference with the fit or performance of the respirator. The in-
mask sampling device (probe) shall be designed and used so that the 
air sample is drawn from the breathing zone of the test subject, 
midway between the nose and mouth and with the probe extending into 
the facepiece cavity at least \1/4\ inch.
    (7) The test set-up shall permit the person administering the 
test to observe the test subject inside the chamber during the test.
    (8) The equipment generating the challenge atmosphere shall 
maintain the concentration of challenge agent constant to within a 
10 percent variation for the duration of the test.
    (9) The time lag (interval between an event and the recording of 
the event on the strip chart or computer or integrator) shall be 
kept to a minimum. There shall be a clear association between the 
occurrence of an event and its being recorded.
    (10) The sampling line tubing for the test chamber atmosphere 
and for the respirator sampling port shall be of equal diameter and

[[Page 54297]]

of the same material. The length of the two lines shall be equal.
    (11) The exhaust flow from the test chamber shall pass through 
an appropriate filter (i.e., high efficiency or sorbent) before 
release.
    (12) When sodium chloride aerosol is used, the relative humidity 
inside the test chamber shall not exceed 50 percent.
    (13) The limitations of instrument detection shall be taken into 
account when determining the fit factor.
    (14) Test respirators shall be maintained in proper working 
order and inspected for deficiencies such as cracks, missing valves 
and gaskets, etc.
    (b) Procedural Requirements. (1) When performing the initial 
positive or negative pressure fit check, the sampling line shall be 
crimped closed in order to avoid air pressure leakage during either 
of these fit checks.
    (2) An abbreviated screening QLFT test may be utilized in order 
to quickly identify poor fitting respirators which passed the 
positive and/or negative pressure test and thus reduce the amount of 
QNFT time. The use of the CNC QNFT instrument in the count mode is 
another method that can be used to obtain a quick estimate of fit 
and eliminate poor fitting respirators before going on to perform a 
full QNFT.
    (3) A reasonably stable challenge agent concentration shall be 
measured in the test chamber prior to testing. For canopy or shower 
curtain type of test units the determination of the challenge agent 
stability may be established after the test subject has entered the 
test environment.
    (4) Immediately after the subject enters the test chamber, the 
challenge agent concentration inside the respirator shall be 
measured to ensure that the peak penetration does not exceed 5 
percent for a half mask or 1 percent for a full facepiece 
respirator.
    (5) A stable challenge concentration shall be obtained prior to 
the actual start of testing.
    (6) Respirator restraining straps shall not be over tightened 
for testing. The straps shall be adjusted by the wearer without 
assistance from other persons to give a reasonable fit typical of 
normal use.
    (7) The test shall be terminated whenever any single peak 
penetration exceeds 5 percent for half masks and 1 percent for full 
facepiece respirators. The test subject shall be refitted and 
retested.
    (c) Calculation of fit factors. (1) The fit factor shall be 
determined for the quantitative fit test by taking the ratio of the 
average chamber concentration to the concentration measured inside 
the respirator for each test exercise except the grimace exercise.
    (2) The average test chamber concentration shall be calculated 
as the arithmetic average of the concentration measured before and 
after each test (i.e., 8 exercises) or the arithmetic average of the 
concentration measured before and after each exercise or the true 
average measured continuously during the respirator sample.
    (3) The concentration of the challenge agent inside the 
respirator shall be determined by one of the following methods:
    (i) Average peak penetration method, which is the method of 
determining test agent penetration into the respirator utilizing a 
strip chart recorder, integrator, or computer. The agent penetration 
is determined by an average of the peak heights on the graph or by 
computer integration, for each exercise except the grimace exercise. 
Integrators or computers that calculate the actual test agent 
penetration into the respirator for each exercise also meet the 
requirements of the average peak penetration method.
    (ii) Maximum peak penetration method means the method of 
determining test agent penetration in the respirator as determined 
by strip chart recordings of the test. The highest peak penetration 
for a given exercise is taken to be representative of average 
penetration into the respirator for that exercise.
    (iii) Integration by calculation of the area under the 
individual peak for each exercise except the grimace exercise is 
another method. This includes computerized integration.
    (iv) The calculation of the overall fit factor using individual 
exercise fit factors involves first converting the exercise fit 
factors to penetration values, determining the average, and then 
converting that result back to a fit factor is also appropriate. 
This procedure is described in the following equation:

 [GRAPHIC] [TIFF OMITTED] TP17OC97.007

    Where ff1, ff2, ff3, etc. are 
the fit factors for exercise 1,2,3, etc.
    (4) The test subject shall not be permitted to wear a half mask 
or quarter facepiece respirator unless a minimum fit factor of 100 
is obtained, or a full facepiece respirator unless a minimum fit 
factor of 500 is obtained.
    (5) Filters used for quantitative fit testing shall be replaced 
whenever increased breathing resistance is encountered, or when the 
test agent has altered the integrity of the filter media. Organic 
vapor cartridges/canisters shall be replaced if there is any 
indication of breakthrough by a test agent.

3. Ambient Aerosol Condensation Nuclei Counter (CNC) Protocol

    The ambient aerosol condensation nuclei counter (CNC) 
quantitative fit testing (PortacountTM) protocol 
quantitatively fit tests respirators with the use of a probe. The 
probed respirator is only used for quantitative fit tests. A probed 
respirator has a special sampling device, installed on the 
respirator, that allows the probe to sample the air from inside the 
mask. A probed respirator is required for each make, model, and size 
that is intended to be used and can be obtained from the respirator 
manufacturer or distributor. The CNC instrument manufacturer TSI 
also provides probe attachments (TSI sampling adapters) that permit 
fit testing in an employee's own respirator. A minimum fit factor 
pass level of 100 is necessary for a half-mask respirator and a 
minimum fit factor of at least 500 is required for a full facepiece 
respirator. The Agency does not recommend the use of homemade 
sampling adapters. The entire screening and testing procedure shall 
be explained to the test subject prior to the conduct of the 
screening test.
    (a) Portacount Fit Test Requirements.
    (1) Check the respirator to make sure the respirator is fitted 
with a high efficiency filter (i.e., HEPA, N100, R100, P100) and 
that the sampling probe and line are properly attached to the 
facepiece.
    (2) Instruct the person to be tested to don the respirator 
several minutes before the fit test starts. This purges the 
particles inside the respirator and permits the wearer to make 
certain the respirator is comfortable. This individual should have 
already been trained on how to wear the respirator properly.
    (3) Check the following conditions for the adequacy of the 
respirator fit: Chin properly placed; Adequate strap tension, not 
overly tightened; Fit across nose bridge; Respirator of proper size 
to span distance from nose to chin; Tendencies for the respirator to 
slip; Self-observation in a mirror to evaluate fit; and respirator 
position.
    (4) Have the person wearing the respirator do a fit check. If 
leakage is detected, determine the cause. If leakage is from a 
poorly fitting facepiece, try another size of the same type of 
respirator.
    (5) Follow the instructions for operating the Portacount and 
proceed with the test.
    (b) Portacount Test Exercises--(1) Normal breathing. In a normal 
standing position, without talking, the subject shall breathe 
normally for 1 minute.
    (2) Deep breathing. In a normal standing position, the subject 
shall breathe slowly and deeply for 1 minute, taking caution so as 
not to hyperventilate.
    (3) Turning head side to side. Standing in place, the subject 
shall slowly turn his or her head from side to side between the 
extreme positions on each side for 1 minute. The head shall be held 
at each extreme momentarily so the subject can inhale at each side.
    (4) Moving head up and down. Standing in place, the subject 
shall slowly move his or her head up and down for 1 minute. The 
subject shall be instructed to inhale in the up position (i.e., when 
looking toward the ceiling).
    (5) Talking. The subject shall talk out loud slowly and loud 
enough so as to be heard clearly by the test conductor. The subject 
can read from a prepared text such as the Rainbow Passage, count 
backward from 100, or recite a memorized poem or song for 1 minute.

[[Page 54298]]

    (6) Grimace. The test subject shall grimace by smiling or 
frowning for 15 seconds.
    (7) Bending Over. The test subject shall bend at the waist as if 
he or she were to touch his or her toes for 1 minute. Jogging in 
place shall be substituted for this exercise in those test 
environments such as shroud type QNFT units that prohibit bending at 
the waist.
    (8) Normal Breathing. Remove and re-don the respirator within a 
one-minute period. Then, in a normal standing position, without 
talking, the subject shall breathe normally for 1 minute.
    After the test exercises, the test subject shall be questioned 
by the test conductor regarding the acceptability of the respirator 
upon completion of the protocol. If it has become unacceptable, 
another model of respirator shall be tried.
    (c) Portacount Test Instrument. (1) The Portacount will 
automatically stop and calculate the overall fit factor for the 
entire set of exercises. The overall fit factor is what counts. The 
Pass or Fail message will indicate whether or not the test was 
successful. If the test was a Pass, the fit test is over.
    (2) A record of the test needs to be kept on file assuming the 
fit test was successful. The record must contain the test subject's 
name; overall fit factor; make, model and size of respirator used, 
and date tested.

4. Controlled Negative Pressure (CNP) Protocol

    The CNP protocol provides an alternative to aerosol fit test 
methods. The CNP fit test method technology is based on exhausting 
air from a temporarily sealed respirator facepiece to generate and 
then maintain a constant negative pressure inside the facepiece. The 
rate of air exhaust is controlled so that a constant negative 
pressure is maintained in the respirator during the fit test. The 
level of pressure is selected to replicate the mean inspiratory 
pressure that causes leakage into the respirator under normal use 
conditions. With pressure held constant, air flow out of the 
respirator is equal to air flow into the respirator. Therefore, 
measurement of the exhaust stream that is required to hold the 
pressure in the temporarily sealed respirator constant yields a 
direct measure of leakage air flow into the respirator.
    The CNP fit test method measures leak rates through the 
facepiece as a method for determining the facepiece fit for negative 
pressure respirators. The CNP instrument manufacturer Dynatech 
Nevada also provides attachments (sampling manifolds) that replace 
the filter cartridges to permit fit testing in an employee's own 
respirator. To perform the test, the test subject closes his or her 
mouth and holds his or her breath, then an air pump removes air from 
the respirator facepiece at a pre-selected constant pressure. The 
facepiece fit is expressed as the leak rate through the facepiece, 
expressed as milliliters per minute. The quality and validity of the 
CNP fit tests are determined by the degree to which the in-mask 
pressure tracks the challenge pressure during the system measurement 
time of approximately five seconds. Instantaneous feedback in the 
form of a real-time pressure trace of the in-mask pressure is 
provided and used to determine test validity and quality. A minimum 
fit factor pass level of 100 is necessary for a half-mask respirator 
and a minimum fit factor of at least 500 is required for a full 
facepiece respirator.
    The entire screening and testing procedure shall be explained to 
the test subject prior to the conduct of the screening test.
    (a) CNP Fit Test Requirements--(1) The inst