# Occupational Exposure to Tuberculosis

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URL: https://www.frixlaw.com/law-library/documents/fr%3A97-27020

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** October 17, 1997
- **Citation:** 62 FR 54160

## Text

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.

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

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,

[[Page 54163]]

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)

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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

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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

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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

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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

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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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-27020. Public record. Not legal advice.