54160 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

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 TBexposed 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.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 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.
54162 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

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 inpatient 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,
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 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?
54164 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

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

§ 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 § 1320.5(a)(1)(iv) and

§ 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
54166 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

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 homebased 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

Information collection requirement Number of

responses Frequency of response Average time per response1 Total burden (hours)

Exposure Control Plan:

(c)(2)(i) ........................................ 101,875 All Affected Employers to Develop

Plan.

• 24 hours per Hospital ...................

• 8 hours per Facility for all Other

Industries

906,980

(c)(2)(vii)(B) ................................. 101,875 Annual Reviews and Updates for All

Affected Employers.

• 8 hours per Hospital .....................

• 2 hours per Facility for all Other

Industries

238,243

Respiratory Protection:

(f)(2) ............................................ 82,138 All Employers not Qualified for Appendix A Program to Develop Program.• 8 hours per Hospital .....................

• 4 hours per Facility for all Other

Industries

335,323

(f)(5), Appendix B ....................... 2,207,580 Initially, for all employees assigned

respirators.

• 30 minutes per employee ............. 551,962

22,078 Annual refit tests for 1% of population assigned respirators.• 30 minutes per employee ............. 5,520

(f)(8) ............................................ 82,138 Annual Evaluation of Program for All

Affected Employers not Qualified

for Appendix A Program.

• 2 hours per Hospital .....................

• 1 hour per Facility for all Other Industries

83,831

Medical Surveillance:

• Medical History (g)(3)(i)(A) ..... 1,831,724 Initially for All Affected Employees ... • 1 hour per Hospital Employee

(inc. LHCP time).

• 1 hour per Employee in all Other

Industries (inc. travel time)

1,831,724

1,595,432 Annually for All Affected Employees

in Facilities not Qualified for Appendix A.

• 1 hour per Hospital Employee

(inc. LHCP time).

• 1 hour per Employee in all Other

Industries (inc. travel time)

1,595,432

47,953 Initially, for New Employees ............. • 1 hour per Hospital Employee

(inc. LHCP time).

• 1 hour per Employee in all Other

Industries (inc. travel time)

47,953

• Medical Examination (inc. History and Physical) (g)(3)(i)

(B)–(D).

47,863 Annually, 3% of Controlled Population at Risk estimated to request

exam as a result of having signs

or symptoms of TB; have a TST

conversion; or indicated as a result of an exposure incident.

• 2 hours per Hospital Employee in

Facilities not Qualified for Appendix A (inc. LHCP time).

• 11⁄2 hour per Employee in All

Other Industries (inc. travel time)

72,518

• Tuberculin Skin Tests

Initial 2-Step TST (g)(3)(i)(A) 474,627 Initially, for Entire Controlled Population at Risk.• 11⁄2 hours per Hospital Employee

(inc. LHCP time).

• 21⁄4 hour per Employee in All

Other Industries (inc. travel time)

1,026,377

Exposure Incident

(g)(3)(i)(C).

8,268 Annually, 2% of Controlled Population at Risk in Facilities Qualified

for Appendix A.

• 11⁄2 hours per Hospital Employee

(inc. LHCP time).

• 21⁄4 hour per Employee in All

Other Industries (inc. travel time)

17,879

Pre-Exit (g)(3)(i)(E) .............. 76,257 Annually for Employment Turnover .. • 1 hour for each Hospital Employee (inc. LHCP time).

• 11⁄2 hour per Employee in All

Other Industries (inc. travel time)

110,504

Prior to Initial Assignment ... 76,257 All New Employees with Occupational Exposure.• 11⁄2 hour per Hospital Employee

(inc. LHCP time).

165,756
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54167

SUMMARY OF THE COLLECTION OF INFORMATION—Continued

Information collection requirement Number of

responses Frequency of response Average time per response1 Total burden (hours)

Annual (g)(3)(ii)(A) ............... 413,400 All employees in facilities not qualified for Appendix A.• 1⁄2 hour per Hospital Employee

(inc. LHCP time).

• 45 minutes per Employee in all

Other Industries (inc. travel time)

297,991

Additional 6-month TST

(g)(3)(iii).

131,367 All employees who:

• Enter an AFB isolation room or

area

• Perform or are present during the

performance of high-hazard procedures

• 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

• 1 hour per Hospital Employee

(inc. LHCP time).

• 11⁄2 hour for each Employee in All

Other Industries (inc. travel time)

171,314

• Information Provided to

Licenced Health Care Professional (LHCP) (g)(6)(I).

1,965,967 Information for each affected establishment to provide a copy of the

rule, and for information on each

employee with a respirator.

• 10 minutes per employee ............. 327,661

558,549 Information for each new employee

assigned a respirator.

• 10 minutes per employee ............. 93,091

64,692 Information surrounding exposure incidents (2% of controlled population at risk).• 10 minutes per employee ............. 10,782

• LHCP Written Opinion (g)(7) .. 2,745,188 Initially, for each medical procedure

performed.

• 5 minutes per written opinion ....... 228,766

2,034,269 Annually, for each medical procedure performed.• 5 minutes per written opinion ....... 169,522

Training:

(h)(3)(ii)(B) .................................. 202,066 Number of training sessions in first

year.

• 2 hours for employees required to

wear respirators.

• 1 hour for employees with occupational exposure who are not assigned respirators

• Assumes 20 employees per session

237,829

(h)(3)(ii)(A) .................................. 106,258 Number of training sessions for new

employees entering affected occupations for the first time + number

of training sessions for employees

staying in affected occupations,

but starting new jobs.

• For new employees: .....................

2 hours for employees required to

wear respirators

1 hour for employees with occupational exposure who are not assigned respirators 1⁄2 hours for employees required to

wear respirators

15 minutes for employees with occupational exposure who are not assigned respirators

50,193

(h)(3)(ii)(C) .................................. 154,966 Recurring number of training sessions.• For 25% of 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

57,313

Recordkeeping:

Medical (I)(1)(I) ........................... 3,713,645 Initially, to create a medical record

for each affected employee.

• 10 minutes to set up each record 631,320

1,358,800 Create medical records for each

new employee with occupational

exposure.

• 10 minutes to set up each record 230,996

2,447,669 Annually, for each medical procedure performed.• 5 minutes to update each record 195,814
54168 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

SUMMARY OF THE COLLECTION OF INFORMATION—Continued

Information collection requirement Number of

responses Frequency of response Average time per response1 Total burden (hours)

Training (I)(3)(I) .......................... 264,451 Initially, to create records for each

training session.

• 10 minutes to create each training

record.

44,957

217,351 Annually, to reflect recurring training

sessions and initial training for

new employees.

• 10 minutes to create each training

record.

36,950

Engineering controls (I)(4)(I) ...... 24,761 Annually, for each engineering control.• 5 minutes per record .................... 3,962

Availability (I)(5) .......................... 2,037 Annually, for 2% of affected employers.• 5 minutes per employer ................ 163

Transfer to NIOSH ...................... 1 Annually, for estimated 1 employer

per year to transfer records.

• 1 hour per employer ..................... 1

Totals.

• First-Year .................. .................... ........................................................... ........................................................... 7,098,011

• Recurring .................. .................... ........................................................... ........................................................... 3,655,728

1Estimates 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
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 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. § 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. §§ 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. § 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. § 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. § 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. § 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 antidiscrimination language and medical

removal protection.
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Eight months later, on August 25,

1993, the Coalition petitioned OSHA to

initiate rulemaking for a permanent

standard issued under § 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 nonmandatory 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, postexposure 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’’, ‘‘verylow’’, ‘‘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 ‘‘verylow’’ 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)
54172 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

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 coughinducing procedures or aerosolgenerating 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 highhazard 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 drugresistant 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
54174 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

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 Xrays 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.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 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 antituberculosis 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 multidrugresistant TB or MDR–TB. MDR–TB

represents a significant form of drugresistant 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
54176 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

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. Sixtysix 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
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54177

for TB patients. Despite the dramatic

decreases in conversion rates among

these student nurses, conversion rates

were observed at levels as high as 10%

for a given year, indicating that while

the infection rates had decreased

substantially since 1939, there still

remained a significant amount of

occupational transmission of TB in

1971. Moreover, this study shows that

short term exposure, i.e., 4 weeks, is

capable of infecting hospital employees.

Similar rates of conversion among

hospital employees initially tuberculin

negative were observed in a 1977 study

by Ruben et al. (Ex. 7–43) which

analyzed the results of a tuberculin skin

testing program 31 months after its

inception at a university hospital in

Pittsburgh. Of 626 employees who were

tested twice with the tuberculin skin

test, 28 (4.5%) converted from negative

to positive. The employees were

classified as either having a ‘‘presumed

high degree of patient exposure’’ or a

‘‘presumed low degree of patient

exposure’’. Employees presumed to

have high patient exposure included

nurses, X-ray and isotope laboratory

personnel and central escort workers.

Employees presumed to have low

exposure included secretaries, persons

in housekeeping and dietary work, and

business office, laundry and central

supply personnel. The rates of

conversion for employees with

presumed high exposure (6%) and for

employees with presumed low exposure

(8%) were not significantly different.

However, this study excluded

physicians and medical and nursing

students. These groups of employees

would also presumably have had high

exposure to patients since they are often

the hospital staff most directly involved

in administering patient care. Had these

employees been included the number of

conversions among employees with

presumably high exposure may have

been significantly increased.

The study was not designed to

determine the source of exposure for

any of the employees who converted.

However, the authors suggested that the

high level of conversions among those

employees with presumed low exposure

to patients may have resulted from

exposures at home. A majority of this

group was comprised of housekeeping

staff who were of low socio-economic

status. The authors also suggested that

unrecognized cases of tuberculosis may

be playing an important role in the

occupational transmission of TB in the

hospital.

Unrecognized cases of TB have been

shown to play a significant role in the

outbreak of TB in a general hospital. In

1972, Ehrenkranz and Kicklighter (Ex.

5–15) reported a case study in which 23

employees converted after exposure to a

patient with an undetected case of

tuberculosis bronchopneumonia. In this

study, the source case was an individual

who was admitted to the emergency

room with pulmonary edema. Upper

lobe changes of the lung were noted in

the chest X-ray, and TB was mentioned

as a possible cause. However, no

sputum cytology was conducted. The

patient spent 3 hours in the emergency

room, 57 hours in a private room and

another 67 hours in intensive care until

his death. Treatment of the patient

included intubation with an

endotracheal tube and vigorous

nasotracheal suctioning. It was only

upon microscopic examination of tissue

samples of the lung and lymph nodes

after the autopsy of the patient that

tuberculosis mycobacteria were

detected.

Employees who worked in the

emergency room, the intensive care unit

and on the floor of the private room

(NW 3) and who were also tuberculin

negative before the admission of the

patient, were retested to detect possible

conversion. In addition, 21 initially

tuberculin negative employees on an

adjacent floor (NW 2) were also retested.

Of the 121 employees tested, 24 were

identified as having converted to

positive status (21 working on NW 3, 2

working in the intensive care unit and

1 working on NW 2). No conversions

were observed among those working in

the emergency room.

The employees who were retested

were classified as either having close

contact (e.g., providing direct care),

little contact (e.g., more distant contact),

unknown contact (e.g., no record or

recollection of contact) or indirect

contact (e.g., in the same room a day or

two after the patient’s stay). Conversions

occurred in 50% (13 of 26) of those

employees with close contact, 18.5% (6

of 33) of those with little contact, 21.4%

(3 of 14) of those with unknown contact

and 3.7% (1 of 29) of those with indirect

contact.

While the majority of conversions

seems to have occurred in those

employees on NW 3 who had close or

little contact, there also were employees

with more distant contact who were

infected. An analysis of the ventilation

of NW 3 indicated that the central air

conditioning recycled 70% of the air

with no high efficiency filter and no

record of balancing the air conditioning

system, thus allowing the air from the

patients’ rooms to mix with and return

to the central corridor air. In addition,

smoke tube tests detected direct air flow

from the patients’ rooms to the hall

corridor. Perhaps the more important

factor was that the patient was not

diagnosed with infectious TB until after

his death, by which time he had already

infected 24 employees.

These earlier studies illustrate that

despite the decrease in TB morbidity

since the advent of anti-tuberculosis

drugs in the 1940’s, occupational

transmission of TB continues to be a

problem. In addition, while many

improvements have been made in

infection control procedures for TB in

hospitals, evidence of occupational

transmission of TB continues to be

reported.

Hospitals—1985 to Present

As discussed above, the transmission

of TB has been well established as an

occupational hazard in the hospital

setting. Many improvements were made

in infection control practices. However,

the resurgence in TB from 1985 to 1992

has brought to attention the fact that

many TB control measures have not

been implemented or have been

inadequately applied. These studies

demonstrate that TB continues to be an

occupational hazard in the hospital

setting. In addition, similar to the earlier

studies, the more recent data show that

the lack of early identification

procedures and the lack of appropriate

ventilation, performance of high-hazard

procedures under uncontrolled

conditions and the lack of appropriate

respiratory protection have resulted in

the infection of employees and in some

cases the development of active disease.

The more current outbreaks are even

more troubling due to the emergence of

multidrug-resistant forms of TB disease,

which in some cases have resulted in

fatality rates approaching 75%.

In a 1985 study, Chan and Tabak (Ex.

7–3) investigated the risk of TB

infection among physicians in training

at a Miami hospital. In this study a

survey was conducted among 665

physicians in training who were in their

first four years of postgraduate training.

Only 404 responded to the survey, of

which 13 were illegible. Another 72

were excluded because they had

received the BCG vaccination. Of the

remaining 319 physicians, 55 were

tuberculin positive.

Of the 279 who were tuberculin

negative at the beginning of their post

graduate training, 15 were excluded

because they had more than four years

of training and 43 were excluded

because they had not had repeat skin

tests. Of the 221 remaining available for

evaluation, 15 converted to positive

tuberculin status, of which two

developed active disease.

The overall conversion rate for these

physicians was 6.79%. In addition, the
54178 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

authors observed a positive correlation

between the rate of conversion and the

duration of postgraduate training. The

conversion rate increased with the

duration of training, beginning with a

cumulative percentage of conversion of

2.06% in the first year, 8.62% in the

2nd year, 11.11% in the third year and

14.29% in the fourth year, resulting in

a linear conversion rate of 3.96% per

year. As noted by the authors, this linear

increase suggests the hospital

environment as the source of the

infection. In addition, the prevalence

rate of conversions in the hospital

(17.24%) was much higher than would

have been expected in the community

for individuals of the same age.

The authors suggested that these high

rates of conversion may have been a

result of the fact that the hospital in this

study encounters 5 to 10 times more

active TB cases than most other urban

hospitals. In addition, the physicians in

training also are expected to be the first

in line to perform physical evaluations

and evaluate body fluids and secretions.

While the authors did not go into detail

about what, if any, TB infection control

precautions were taken by these

physicians in training, they did note

that the evaluation of body fluids and

secretions was often done in poorly

ventilated and ill-equipped laboratories.

Increased rates of conversion were

observed among employees in a New

Orleans hospital in a 1986 study by

Ktsanes et al. (Ex. 7–6). Similar to

Miami, New Orleans also has a high rate

of TB in the community. This study

examined the skin test conversions

among a cohort of 550 new employees

who were followed for five years after

assignment to the adult inpatient

services. Of these 550 employees who

were initially tuberculin negative, 17

converted to positive status over the

five-year study period, resulting in an

overall five-year cumulative conversion

probability of 5.2%.

Regression analyses were done to

examine potential contributing factors.

Factors examined in the regression

model included race, job, age at

employment, and department. Only race

(i.e., black vs. white employees) and job

(i.e., nursing vs. other jobs) were found

to be associated with skin test

conversion. To further examine the

potential job effect, conversions among

blacks in nursing and blacks in other

jobs were compared. Overall, the

cumulative probability of converting

was higher among blacks in nursing,

suggesting that the acquired infections

resulted from employment at the

hospital rather than from the

community at large. The authors thus

concluded that there is an increased risk

of occupational transmission of TB in

TB-prevalent areas for those in close

patient contact jobs.

In 1989, Haley et al. (Ex. 5–16)

conducted a case study of a TB outbreak

among emergency room personnel at a

Texas hospital. In this study, a 70 year

old male diagnosed with pulmonary TB

and undergoing treatment was diverted,

due to respiratory arrest, to Parkland

Memorial Hospital while in route to

another hospital. The man was admitted

to the emergency room for

approximately 4 hours until he was

stabilized. Afterwards, the patient was

placed in an intensive care unit, where

he remained for 2 months until his

death.

Six cases of active TB developed

among emergency room employees after

exposure to the TB patient, i.e., the

index case. Five of these were among

nurses who recalled contact with the

index patient and a sixth case was an

orderly who may have been infected

from one of the employee TB cases. In

addition, a physician exposed while

administering treatment in the intensive

care unit also developed active disease.

Skin test conversions were evaluated

for the 153 employees of the emergency

room. Of 112 previously negative

employees, 16 had positive skin tests,

including 5 nurses diagnosed with

active TB. Fifteen of the conversions

were a result of exposure to the index

case. Skin tests were also evaluated for

physicians in the intensive care unit. Of

21 resident physicians, two of whom

had intubated the index patient, five

had newly positive reactions to the

tuberculin skin tests. One of the

remaining three residents later

developed active disease.

The authors attributed the outbreak to

several factors. First, the index case had

a severe case of pulmonary TB in which

he produced copious amounts of

sputum. Second, sixty percent of the

emergency room air was recirculated

without filtration adequate to remove

TB bacilli, allowing for the recirculation

of contaminated air. Finally, employees

in the emergency room were provided

surgical masks that were ineffective for

protecting against transmission of

airborne TB droplet nuclei. This study

illustrates that the lack of effective

measures for controlling TB

transmission can result in the infection

and development of active disease in a

relatively high number of employees

even after exposure to only one case of

active TB.

Similarly, the lack of effective

controls while performing high-hazard,

cough-inducing procedures on

individuals with infectious TB has also

been shown to result in an increased

risk of TB transmission. A 1990 report

by Malasky et al. (Ex. 7–41) investigated

the potential for TB transmission from

high-hazard procedures by examining

tuberculin skin test conversion rates

among pulmonary physicians in

training. In this study, questionnaires

were sent annually, for 3 years, to

training programs located in the top 25

cities for TB in 1983. The purpose of the

study was to compare the conversion

rates of pulmonary disease fellows to

the conversion rates of infectious

disease fellows. It was presumed that

both groups have contact with patients

with TB but that pulmonary disease

fellows are usually more involved with

invasive procedures such as

bronchoscopies. Information requested

on the questionnaires included the type

of fellowship (i.e., pulmonary or

infectious disease fellow), prior

tuberculin skin test status, tuberculin

status by the Mantoux technique at the

end of the 3 year fellowship program,

history of BCG vaccination, age, sex and

ethnicity. In addition, the pulmonary

disease fellows were asked to give

information on the number of

bronchoscopies they performed and

their use of masks during the procedure.

Fourteen programs submitted data

that were usable. Only programs that

had both pulmonary and infectious

disease fellows in the same system were

used for the study. From this

information, it was observed that 7 of 62

(11%) of the pulmonary fellows at risk

converted their tuberculin skin test from

negative to positive during the two year

training period. In contrast, only 1 of 42

(2.4%) of the infectious disease fellows

converted. The expected conversion rate

from previous surveys was 2.3%. In

addition, the pulmonary disease fellows

were grouped according to tuberculin

skin status. Skin test status was

evaluated for its relationship to the

number of bronchoscopies performed

and the pattern of mask usage. No

correlations were found with these

factors and tuberculin skin status at the

end of the fellowship. The authors

suggested that the lack of correlation

between mask usage during

bronchoscopies and skin test conversion

implies that masks worn by physicians

may be inadequate. While little

information was presented to evaluate

this suggestion, the study does suggest

that high-hazard procedures such as

bronchoscopies that induce coughing,

performed under uncontrolled

conditions, present a risk for TB

transmission.

Pearson et al. (1992) conducted a

case-control study to investigate the

factors associated with the development

of MDR–TB among patients at a New
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54179

York City hospital (Ex. 5–24). As a part

of this study, tuberculin skin test

conversion rates were compared among

health care workers assigned to wards

where patients with TB were frequently

admitted (e.g., HIV unit, general medical

ward, respiratory therapy) or rarely

admitted (operating room, orthopedic

ward, outpatient clinic, psychiatry

ward). In addition, infection control

procedures and ventilation systems

were evaluated.

Of 79 health care workers who were

previously negative, 12 (15%) had

newly positive skin tests. Those health

care workers who were assigned to

wards where patients with TB were

frequently admitted were more likely to

have skin test conversions (i.e., 11 of 32)

than health care workers assigned to

wards where patients with TB were

rarely admitted (i.e., 1 of 47).

Evaluations of the infection control

procedures and ventilation systems

revealed that patients who were

receiving isolation precautions for

suspected or confirmed TB were

allowed to go to common areas if they

wore a surgical mask. However, many of

the patients did not keep their masks on

when out of their rooms. In addition,

neither the isolation rooms nor rooms

used for cough-inducing procedures

were under negative pressure, thus

allowing contaminated air to exhaust to

the adjacent corridors.

Edlin et al. (1992) (Ex. 5–9)

investigated an outbreak of MDR–TB in

a New York hospital among patients

with acquired immunodeficiency

syndrome (AIDS). This study compared

the exposure period of AIDS patients

diagnosed with MDR–TB to the

exposure period of AIDS patients with

drug-susceptible TB. The date of

diagnosis was defined as the date the

sputum sample was collected from

which tuberculosis bacteria were grown

in culture. Patients were assumed to be

infectious two weeks before and two

weeks after the date of diagnosis. The

period of exposure was the period in

which the patient may have been

infected with TB. Because of the rapid

progression from infection to disease,

the exposure period was defined as 6

months preceding the date of diagnosis,

excluding the last two weeks.

The patients with MDR–TB were

found to be more likely to have been

hospitalized during their exposure

periods. Those who were hospitalized

were more likely to have been on the

same ward and on the same day as a

patient with infectious TB and were

more likely to have been near a room

housing an infectious patient.

Examination of the infectious patients’

rooms revealed that only 1 of 16 rooms

had negative pressure. Based on this

evidence, the authors concluded that

the observed cases of MDR-TB were a

likely result of infections acquired in

the hospital (i.e., primary TB) rather

than as a result of the reactivation of

infections acquired in the past. The

authors attributed these nosocomial

infections to the lack of adherence to

recommended infection control

procedures.

While the primary focus of this study

was to investigate the transmission of

TB among patients, the increased

likelihood of nosocomial infections

among patients in the hospital would

seem equally likely to apply to health

care workers working in the same

environment. A survey of tuberculin

skin test conversions revealed an 18%

conversion rate for health care workers

who previously had negative skin tests

and were present during this outbreak of

MDR-TB. Although no statistics were

reported, the authors stated that the

pattern of skin test conversions

suggested an ongoing risk over time

rather than a recent increase during the

outbreak period.

Based on an earlier 1990 report from

the CDC (Ex. 5–22), Beck-Sague et al.

1992 (Ex. 5–21) conducted a casecontrol study to investigate an outbreak

of MDR–TB among the staff and patients

in a HIV ward and clinic of a Miami

hospital. As part of the overall study the

authors compared the skin test

conversion rates of health care workers

in the HIV ward and clinic to the skin

test conversion rates of health care

workers in the thoracic surgery ward

where TB patients were rarely seen. In

addition, the authors also evaluated the

relationship between the presence of

patients with infectious MDR–TB and

patients with infectious drugsusceptible TB on the HIV ward and the

risk of skin test conversion among the

HIV ward health care workers. Infection

control procedures in the HIV ward and

clinic were also examined.

All patients with suspected or

confirmed TB were placed in isolation.

However, some patients whose

complaints were not primarily

pulmonary and whose chest X-rays were

not highly suggestive of TB were not

initially suspected of TB and were not

placed in isolation. Patients who were

admitted to isolation rooms were

allowed to leave TB isolation 7 days

after the initiation of chemotherapy

regardless of clinical or bacteriologic

response. Thus, in some instances,

patients with MDR–TB were allowed to

leave isolation while they were still

infectious, before drug resistance was

recognized. In addition, patients in

isolation rooms sometimes left the doors

open, left their rooms, and/or removed

their masks while outside their rooms.

Patients with TB who were readmitted

to the HIV ward and who were receiving

anti-TB drugs were not admitted to

isolation. In some cases, these patients

were later found to have infectious

MDR–TB.

An environmental assessment of the

ventilation revealed that among 23

rooms tested with smoke tubes, 6 had

positive pressure and many of the rooms

under negative pressure varied from

negative to positive depending on the

fan setting and whether the bathroom

door was open. Aerosolized

pentamidine administration rooms were

also found to have positive pressure

relative to adjacent treatment areas. In

addition, the sputum induction rooms

were found to recirculate air back to the

HIV clinic.

Skin test conversions were evaluated

for all health care workers (i.e., nurses

and clerical staff) who tested negative

on the tuberculin skin test before the

outbreak period, March 1988 through

April 1990. Health care workers on the

HIV ward and in the HIV clinic

exhibited a significantly higher rate of

skin test conversion than health care

workers on the thoracic surgery ward

(e.g., 13/39 vs. 0/15). Ten of the

conversions occurred among the 28

health care workers in the HIV ward.

Among these health care workers, the

authors reported a significant

correlation between the risk of infection

in health care workers and the number

of days that patients with infectious

MDR–TB were hospitalized on the HIV

ward. No correlation was observed

between the risk of infection among

health care workers on the HIV ward

and the number of days that patients

with infectious drug-susceptible TB

were hospitalized on the ward.

Based on skin test conversions and

the evaluation of infection control

practices in the HIV ward and clinic, the

authors concluded that the health care

workers most likely were infected by

patients on the HIV ward with MDR–

TB. The factors most likely contributing

to this increased risk of infection

included: (1) The prolonged

infectiousness and greater number of

days that patients with infectious MDR–

TB were hospitalized, (2) the delayed

recognition of TB and failure to suspect

infectious TB in patients receiving what

proved to be ineffective anti-TB

treatment, (3) the inadequate duration

of, and lapses in, isolation precautions

on the HIV ward, and (4) the lack of

negative pressure ventilation in

isolation and treatment rooms. While

the evidence in this study primarily

points to the transmission of MDR–TB
54180 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

from patients to health care workers,

many of the problems identified with

infection control procedures and

ventilation would also increase the risk

of acquiring drug-susceptible TB.

In addition to MDR–TB outbreak

investigations in Miami, in 1993 the

CDC reported an outbreak in New York

City in which health care workers

became infected after being exposed to

patients with MDR–TB (Ex. 6–18). In

this investigation, for the period

December 1990 through March 1992, 32

patients were identified with MDR–TB.

Twenty-eight of these patients had

documented exposure to an

undiagnosed infectious MDR–TB

patient while all of them were in the

HIV ward of the hospital.

During November 1991, health care

workers who were assigned to the HIV

inpatient unit and who were also

previously negative on the tuberculin

skin test, were given an additional skin

test. Of 21 health care workers tested, 12

(57%) had converted to positive status

(7 nurses, 4 aides and 1 clerical worker).

None of the health care workers had

used respiratory protection.

An investigation of infection control

practices revealed that of 32 patients

with MDR–TB, 16 were not initially

suspected of TB and in these cases

isolation precautions either were not

used or were instituted late during the

patients’ hospitalization. In addition,

patients who were admitted to isolation

frequently left their rooms and when in

their room the doors were frequently left

open. Moreover, all rooms were found

to be under positive pressure relative to

the hall. Thus, similar to the findings in

Miami, the results of this study indicate

that the inability to properly isolate

individuals with MDR–TB and also the

use of inadequate respiratory protection

may increase the risk of infection among

health care workers.

Undiagnosed cases may also present a

significant source for occupational

transmission of TB. A case study by

Cantanzaro (Ex. 5–14) described an

outbreak of TB infection among hospital

staff at a San Diego hospital where the

hospital staff were exposed to a single

patient with undiagnosed TB. In this

case, a 64 year old man suffering from

generalized seizures was transferred

from a local jail to the emergency room

and later admitted to a four bed

intermediate care unit. While in the

intermediate care unit he was treated

with anticonvulsants but continued to

have seizures accompanied with

vomiting. He was therefore placed in

intensive care where he underwent a

variety of procedures including

bronchoscopies and endotracheal

intubation. During his stay, he received

frequent chest therapy and suctioning.

Three sputum samples were taken from

the patient for smears and cultures. All

AFB smears were negative. However,

two cultures were positive for

tuberculosis.

Despite the presence of positive

cultures the patient was not diagnosed

with active TB. The problem was not

recognized until a physician on staff

later developed symptoms of malaise

and slight cough and requested a

tuberculin skin test and was found to be

positive. Because the physician had

been tuberculin negative 8 months

earlier, a contact investigation was

initiated. As a part of this investigation,

all employees who previously had

negative tuberculin tests and who also

worked in the intermediate and

intensive care units where the patient

had been treated were given repeat skin

tests. Of 45 employees who previously

had negative tuberculin skin tests, 14

(31%) converted to positive status (6

physicians, 3 nurses, 2 respiratory

therapists and 1 clerk). Ten of these

conversions were among the 13

previously tuberculin negative staff

members who were present at the time

bronchoscopies were conducted (10/

13=76.9%). Four of the conversions

were among 32 susceptible staff

members who were not present at the

bronchoscopies (4/32=12.5%). The

author thus concluded that being

present during the bronchoscopy of the

patient was a major risk factor in

acquiring the TB infection. However,

the evidence did not show a significant

correlation between skin test conversion

and the type of exposure, i.e., close

(administered direct contact) versus

casual (in the room) contact. Thus,

people who were present in the room

during the bronchoscopy had an equal

risk of infection as those administering

direct patient care, presumably, as the

author suggests, because droplet nuclei

can disperse rapidly throughout the air

of a room.

Similarly, Kantor et al. (Ex. 5–18)

reported an outbreak of TB infection

among hospital staff exposed to a single

undiagnosed case of TB. The index case

in this investigation was a 50 year old

man who was admitted for lung cancer

and was receiving chemotherapy,

steroids and radiation treatment. After a

month of treatment, the patient

complained of a cough and chest pain

and was found to have emphysema

requiring additional drug treatment and

a chest tube. However, even after the

emphysema resolved, the patient

complained of weakness, loss of

appetite and fever. A sputum culture

and smear were conducted for

mycobacteria and found to be negative.

Lung X-rays were found to be irregular

but were attributed to the lung cancer.

Upon his death the autopsy revealed

extensive necrosis in the lung but

tuberculosis was not suspected. Thus,

no cultures for mycobacteria were

performed and no infection control

procedures were initiated. It was only

upon histological examination of tissue

samples one month later that the

presence of TB was confirmed. Five

months later one of the staff performing

the autopsy developed active TB. His

only history of exposure was to the

index case.

As a result, a contact investigation

was initiated for hospital personnel who

had shared air with the patient during

his stay, including the autopsy staff. Of

susceptible hospital staff (i.e., those not

previously found to react positive to the

tuberculin skin test), infection

developed in 9 of 56 (16%) exposed

employees (4 autopsy staff, 4 nursing

staff and 1 radiology staff). Only 3 of

333 unexposed personnel were found to

have converted to positive tuberculin

status at the hospital during the same

period of investigation, thus indicating

a 17.8 fold increase in the infection rate

for the exposed group.

Undiagnosed cases of TB at time of

autopsy were also indicated as the likely

cause for development of active TB

among staff and students in an autopsy

room in a Swedish hospital (Ex. 5–19).

In this study, three medical students

and one autopsy technician, who were

present during the autopsy of a patient

with previously undiagnosed

pulmonary TB, developed active TB.

Both the medical students and the

autopsy technician had previously

received the BCG vaccine but none had

any other known contact with a

tuberculosis subject. Thus, it was

concluded that the tuberculosis

infections were most likely to have been

transmitted during the autopsy. The

findings of this study further illustrate

the risks that undiagnosed cases of

active TB present to health care

workers. The lack of recognition of an

active case of TB often results in a

failure to initiate appropriate infection

control procedures and provide

appropriate personal protective

equipment. In addition, this study

illustrates that, while TB is most often

transmitted by individuals with

infectious pulmonary TB who generate

droplet nuclei when they cough or

speak, the autopsy procedures on

deceased individuals with pulmonary

TB may also aerosolize bacteria in the

lungs and generate droplet nuclei.

Exposure during autopsy procedures

was also suspected as a possible route

of TB transmission in an upstate New
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54181

York Medical Examiner’s Office (Ex. 7–

152). This Medical Examiner’s Office

conducted autopsies on deceased

inmates from upstate New York prisons.

In 1991, the same year that an outbreak

of MDR–TB occurred among inmates

from an upstate New York prison, the

Medical Examiner’s office conducted

autopsies on 8 inmates with TB, six of

whom had infectious MDR–TB at death

and who were also HIV positive and had

disseminated TB disease.

Skin tests were administered to

employees who had worked for at least

one month during 1991 at the Medical

Examiner’s Office. Among 15 employees

who had originally tested negative on a

baseline skin test, 2 were found to have

converted. These two employees

worked as morgue assistants and had

recent documented exposure to persons

with extensive disseminated MDR–TB.

No potential exposure to TB outside the

Medical Examiner’s Office could be

found.

The autopsy area of the office had a

separate ventilation system. However,

air was returned to a common air

plenum, allowing the air to mix between

the autopsy area and other areas of the

office. In addition, the autopsy room

was found to be at positive pressure

relative to the adjacent hallway.

Employees performing or assisting at

autopsies on persons known to be

infected with HIV were required to wear

plastic gowns, latex gloves and surgical

masks. Particulate respirators were not

required until November of 1991, after

the installation of germicidal UV lamps.

However, this was after the last MDR–

TB autopsy. This study suggests that the

conversion of these two morgue

assistants occurred as a result of

exposure to aerosolized M. tuberculosis

resulting from autopsy procedures,

either as a result of participation in an

autopsy in the autopsy area or from

exposure to air contaminated with

aerosolized M. tuberculosis that was

exhausted into other areas of the

Medical Examiner’s Office.

In addition to autopsy procedures,

other procedures, such as the irrigation

of abscesses at sites of extrapulmonary

TB, can result in the generation of

droplet nuclei. An outbreak

investigation in an Arkansas hospital

(Ex. 5–17) reported the transmission of

TB among hospital employees exposed

to a patient with a tuberculous abscess

of the hip and thigh. In this study, the

source case was a 67 year old man who

was admitted to the hospital with a

fever of unknown origin and progressive

hip pain. The patient did not present

any signs of pulmonary TB; however,

the examination of soft tissue swelling

in the hip area revealed an abscess that

required drainage and irrigation. Due to

the suspicion of TB, specimens for AFB

smear and culture were obtained and

the patient was placed in isolation.

While in isolation, drainage from the

abscess continued and irrigation of the

abscess cavity was initiated on an 8-

hour schedule. After four days, acid fast

bacilli were observed in the AFB smears

and TB therapy was begun. The patient

remained in isolation until his death

except for three days that he spent in

the Intensive Care Unit (ICU) due to

high fever.

An investigation of skin test surveys

among the hospital employees revealed

55 skin test conversions among 442

previously nonreactive employees and 5

conversions among 50 medical students.

In addition, 5 of the employees who had

conversions also had active TB,

including one who developed a

tuberculous finger lesion at the site of a

needle-stick injury incurred during the

incision and drainage of the patient’s

abscess. All the skin test converters,

except for two, recalled exposure to the

source case. Of the 442 susceptible

employees, 108 worked at least one day

on one of the floors where the patient

stayed (i.e., the surgical ward, the

medical floor of the patient’s room and

the ICU). Four (80%) of 5 surgical suite

employees who had direct contact with

the patient through their assistance with

the incision and irrigation of the

patient’s abscess had skin test

conversions. In addition, 28 (85%) of 33

employees on the general medical floor

and 6 (30%) of 20 ICU employees had

skin test conversions. All those

employees converting recalled exposure

to the patient, some of whom had no

direct contact with the patient.

Environmental studies revealed that

two of the areas in which the patient

stayed during his hospitalization did

not have negative pressure. The

isolation room was under positive

pressure relative to adjacent rooms and

the corridor. In addition, the patient’s

cubicle in the ICU had neutral pressure

relative to the rest of the ICU.

Employees in these two areas had skin

test conversions even in cases where

there was no direct patient contact. The

lack of negative pressure was thought to

have significantly contributed to the

dispersion of droplet nuclei generated

from the irrigation of the tuberculous

abscess. In the surgical ward, air was

directly exhausted to the outside.

However, all employees present in the

surgical ward when the patient was

being treated had direct contact with the

patient. There was no indication that

the surgical staff had taken any special

infection control precautions or had

worn any personal protective

equipment.

Thus, similar to other outbreak

investigations, the lack of appropriate

ventilation and respiratory protection

stand out as the key factors in the

transmission of TB to employees who

are exposed to individuals with

infectious TB. Moreover, this particular

case study demonstrates that certain

forms of extrapulmonary TB in

conjunction with aerosolizing

procedures, e.g., the irrigation of a

tuberculous abscess, have the potential

for presenting significant airborne

exposures to M. tuberculosis.

Other aerosolizing procedures have

also shown evidence of presenting

airborne exposures to M. tuberculosis.

For example, tissue processing was

associated with the skin conversion of

two pathologists working at a

community hospital in California (Ex.

6–27). In this case study, after autopsy,

a 62 year old man who had died from

bronchogenic carcinoma was discovered

to have a caseating lung lesion. A stain

revealed a heavy concentration of acidfast bacilli, which were identified in

culture as M. tuberculosis. As a result,

a contact investigation was initiated.

This investigation found twenty

employees who had contact with the

patient, including two pathologists and

a laboratory assistant. All were given a

tuberculin skin test and found to be

negative. However, after follow-up skin

testing three months later, the two

pathologists had converted. Other than

contact with the source case, the two

had no other obvious sources of

infection. One of the pathologists had

been present at the autopsy. Both

pathologists were present when the

frozen lung sections were prepared.

During this process, the lung tissue was

sprayed with a compressed gas coolant,

which created a heavy aerosol. Masks

were not routinely worn during this

tissue processing. The investigators

suspected that this aerosol promoted the

transmission of TB and was the likely

cause of the observed infections.

While much of the health effects

literature has focused on outbreaks of

TB or MDR–TB, a more recent study

investigated the status of infection

control programs among ‘‘non-outbreak’’

hospitals (Ex. 7–147). Investigators from

the Society of Health care Epidemiology

of America (SHEA) and the CDC

surveyed members of SHEA to assess

compliance in the respondents’

hospitals with the 1990 CDC Guidelines

for Preventing the Transmission of TB

in Health Care Facilities for the years

1989 to 1992. The survey included

questions on tuberculin skin testing

programs (e.g., frequency of testing,
54182 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

positivity at hire, and percent newly

converted), AFB isolation capabilities

(e.g., negative pressure, air changes per

hour, HEPA filtration) and respiratory

protection.

The survey showed that of the 210

hospitals represented by the SHEA

members’ survey results, 193 (98%)

admitted TB patients from 1989 to 1992,

40% of which had one or more patients

with MDR–TB. In addition, the

proportion of hospitals caring for drug

susceptible TB patients rose from 88%

to 92% and the proportion of hospitals

caring for MDR–TB patients rose from

5% to 30%. While the number of

hospitals caring for TB patients

increased, the majority of those

hospitals cared for a small number of

patients. In 1992, approximately 89% of

the hospitals reported 0 to 25 patients

per year, while approximately 5%

reported greater than 100 patients per

year.

Few hospitals reported routine

tuberculin skin testing for each of the

years surveyed. For example, while 109

(52%) of the responding hospitals

reported tuberculin skin test results for

at least one of the years from 1989 to

1992, only 63 (30%) reported results for

each of these years. When examining

the conversion rates over time from

1989 to 1992, the investigators limited

their analysis to the 63 hospitals

reporting skin test data for each of these

4 years. Among these hospitals the

median percentage of employees newly

converting to positive skin test status

remained constant over the 4 year

period at approximately 0.34% per year

(i.e., 3/1000 per year). However, when

including all hospitals in the analysis,

from 1989 to 1992, the number of

hospitals reporting conversion rates

increased from 63 to 109 and the

conversion rates increased from 0.26%

(i.e., 2/1000) to 0.50% (i.e., 5/1000).

With regard to AFB isolation

capabilities, 62% of 181 responding

hospitals reported that they had

isolation facilities consistent with the

1990 CDC TB Guidelines (i.e., singlepatient room, negative pressure, air

directly exhausted outside, and ≥6 air

changes per hour). Sixty-eight percent of

the reporting hospitals had isolation

facilities meeting the first three of these

recommendations. For respiratory

protection, the majority of health care

workers in the hospitals used surgical

masks. However, there was an increase

in the use of dust-mist or dust-mistfume respirators. The use of dust-mist

respirators increased from 1 to 13%

from 1989 to 1992 and the use of dustmist-fume respirators increased from 0

to 10% for the same period. The only

use of high efficiency particulate air

(HEPA) filter respirators was by

bronchoscopists and respiratory

therapists at 4 hospitals.

As a second phase of this

investigation, the survey responses were

analyzed to determine the efficacy of the

TB infection control programs among

the member hospitals participating in

the survey (Ex. 7–148). In this analysis,

the reported conversion rates were

compared to reported infection control

measures (i.e., AFB isolation

capabilities and respiratory protection).

For purposes of comparison, hospitals

were categorized as having either less

than or ≥6 TB patients, less than or ≥437

beds, and admitting or not admitting

MDR–TB patients.

Conversion rates were higher among

health care workers from hospitals with

≥437 beds than among health care

workers from smaller hospitals (0.9%

vs. 0.6%, p≤0.05). This difference was

more pronounced among ‘‘higher-risk’’

health care workers (i.e., health care

workers including bronchoscopists and

respiratory therapists). ‘‘Higher-risk’’

health care workers from hospitals with

437 or more beds had a 1.9% conversion

rate compared to a conversion rate of

0.2% for ‘‘higher-risk’’ health care

workers from smaller hospitals.

Similarly, health care workers from

hospitals where 6 or more TB patients

were admitted per year had higher

conversion rates than health care

workers from hospitals with fewer than

6 TB patients per year (e.g., 1.2% vs.

0.6%).

For hospitals with 6 or more TB

patients, conversion rates also varied

depending on the level of TB infection

control practices that were in place in

the hospital. For example, among

hospitals with 6 or more TB patients

and whose AFB isolation capabilities

included at least single-room

occupancy, negative pressure and

directly exhausted air, the conversion

rates among health care workers were

lower than the conversion rates among

health care workers at hospitals with 6

or more TB patients but which did not

have similar isolation capabilities

(0.62% vs. 1.83%, p=0.03). For

respiratory protection, however, no

differences in conversion rates were

observed among health care workers

wearing surgical masks (0.94%) and

health care workers using submicron

surgical masks, dust-mist respirators or

dust-mist-fume respirators (0.98%).

Very few survey respondents reported

use of HEPA filter respirators. For

example, only four hospitals reported

use of any HEPA respirators, and these

were not the predominant type of

respiratory protection used (Ex. 7–147).

Thus, it is not possible to evaluate the

efficacy of these particulate respirators

in reducing conversion rates from the

reported survey data.

For hospitals with fewer than 6 TB

patients or with fewer than 437 beds, no

differences in conversion rates were

reported among health care workers

from hospitals that had implemented

AFB isolation capabilities such as

single-room occupancy, negative

pressure, or directly exhausted air and

those hospitals that had not. The

investigators suggested that this finding

may support contentions that the

efficacy of TB infection control

measures vary depending on

characteristics of the hospital or

community exposure. However, given

the small sample size of the survey, as

well as the reduced potential for

exposure in hospitals with fewer than 6

TB patients per year, it would be

difficult to detect any differences in

conversion rates among health care

workers from hospitals with or without

certain levels of infection control.

Where more opportunity does exist for

exposure (e.g., hospitals with ≥6 TB

patients), this analysis does show that

the implementation of TB infection

control procedures can reduce the

transmission of TB among health care

workers.

Hospitals—Summary

In summary, the evidence clearly

shows that in hospital settings,

employees are at risk of occupational

exposure to TB. Various studies and TB

outbreak investigations have shown that

employees exposed to individuals with

infectious TB have converted to positive

tuberculin skin status and in some cases

have developed active disease. In these

reports, a primary factor in the

transmission of TB has been a failure to

promptly identify individuals with

infectious TB so that appropriate

infection control measures could be

initiated to prevent employee exposure.

In addition, another major factor

identified as contributing to

occupational exposures was the lack or

ineffective implementation of

appropriate exposure control methods

(e.g., lack of negative pressure in

isolation rooms, lack of appropriate

respiratory protection for exposed

employees, performance of high-hazard

procedures under uncontrolled

conditions). The lack of early

identification and appropriate control

measures resulted in the exposure and

subsequent infection of various hospital

employees. These employees included

not only health care providers

administering direct patient care to

individuals with infectious TB, but also

hospital staff providing support services
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54183

to the infectious individuals, hospital

staff working in adjacent areas of the

hospital using shared air, autopsy staff

and laboratory staff working with

infected culture and tissue samples.

Other Occupational Settings

While hospitals have been historically

recognized as the primary type of work

setting where TB presents an

occupational hazard, there are other

work settings where the transmission of

TB presents a hazard to workers. There

are a variety of occupational settings in

which workers can reasonably be

anticipated to encounter individuals

with active TB as a part of their job

duties. Several work settings have been

identified by the CDC where exposure to

TB presents an occupational hazard:

correctional facilities, long-term care

facilities for the elderly, homeless

shelters, drug treatment centers,

emergency medical services, homehealth care, and hospices. Similar to the

hospital setting, these work settings

have a higher number of individuals

with active TB than would be expected

for the general population. Many of the

clients of these work settings have many

characteristics (e.g., high prevalence of

TB infection, high prevalence of HIV

infection, intravenous drug use) that

place them at an increased risk of

developing active TB. These types of

work settings are also similar to

hospitals in that workers at these sites

may also provide medical services and

perform similar types of high-hazard

procedures that are typically done in a

hospital setting.

In addition to employees who provide

medical services in these other types of

work settings, there are other types of

workers (e.g., guards, admissions staff,

legal counsel for prisoners) who may

also be exposed to individuals with

infectious TB. Similar to hospitals, these

work settings have an overrepresentation of populations at high

risk for developing active TB, e.g.,

individuals infected with HIV,

intravenous drug users, elderly

individuals, and individuals with poor

nutritional status and who are medically

underserved. In addition to having a

higher percentage of individuals with

TB infection and a higher percentage of

individuals at an increased risk for

developing active TB, many of these

work settings also share environmental

factors that facilitate the transmission of

TB, such as overcrowding and

inadequate ventilation, which increases

the occupational hazard. The following

discussion describes some of the studies

available in the literature that have

examined the occupational transmission

of TB in other occupational settings

such as those listed above. Not all the

settings listed by the CDC as places

where TB transmission may be likely to

occur have been adequately studied and

thus can not be included in this

discussion. However, the discussion of

the following sectors clearly

demonstrates that the occupational

transmission of TB is not limited to the

hospital setting. Occupational settings

where there is an increased likelihood

of exposure to aerosolized M.

tuberculosis present the same types of

occupational hazards as have been

documented in the hospital setting.

Correctional Facilities

Many correctional facilities have a

higher incidence of TB cases than occur

in the general population. For example,

the CDC reported that the incidence of

TB among inmates of correctional

facilities was more than three times

higher than that for nonincarcerated

adults aged 15–64, based on a survey of

TB cases in 1984 and 1985 by 29 state

health departments (Ex. 3–33). In

particular, among inmates in the New

York correctional system, the TB

incidence increased from an annual

average of 15.4 per 100,000 during 1976

to 1978 to 105.5 per 100,000 in 1986

(Ex. 7–80) to 156.2/100,000 for 1990–

1991 (Ex. 7–137). Similarly, in 1987, the

incidence of TB among inmates in New

Jersey was 109.9 per 100,000

(approximately 11 times higher than the

general population in New Jersey) and

in California the incidence of TB among

inmates was 80.3 per 100,000

(approximately 6 times higher than that

for the general population for California)

(Ex. 3–33). In 1989, the CDC reported

that since 1985, eleven known outbreaks

of TB have been recognized in prisons

(Ex. 3–33).

The increased incidence of TB in

correctional facilities has been

attributed to several factors (Ex. 7–25).

One, correctional facilities have a higher

incidence of individuals who are at

greater risk for developing active TB.

For example, the population in prisons

and jails may be dominated by persons

from poor and minority groups, many of

whom may be intravenous drug users.

These particular groups may also suffer

from poor nutritional status and poor

health care, factors that place them at

increased risk of developing active

disease. Two, special types of

correctional facilities, such as holding

facilities associated with the

Immigration and Naturalization

Services, may have inmates/detainees

from countries with a high incidence of

TB. For foreign-born persons arriving in

the U.S., the case rate of TB in 1989 was

estimated to be 124 per 100,000,

compared to an overall TB case rate of

9.5 per 100,000 for the U.S. (Ex. 6–26).

In 1995, TB cases reported among the

foreign born accounted for 35.7% of the

total reported cases, marking a 63.3%

increase since 1986 (Ex. 6–34). Three,

many correctional facilities have a high

proportion of individuals who are

infected with HIV. The CDC reported

that in addition to the growing increase

in AIDS among prisoners, the incidence

of AIDS in prisons is markedly higher

than that for the U.S. general

population. In 1988, the incidence of

AIDS cases in the U.S. population was

13.7 per 100,000 compared to an

estimated aggregate incidence for state/

federal correctional systems of 75 cases

per 100,000 (Ex. 3–33). Individuals who

are infected with HIV or who have AIDS

are at an increased risk of developing

active TB due to their decreased

immune capacity. The likelihood of

pulmonary TB in individuals with HIV

infection is reflected in the CDC’s

Revised Classification System for HIV

infection (Ex. 6–30). In this revised

classification system, the AIDS

surveillance case definition was

expanded to include pulmonary TB.

Moreover, X-rays of individuals infected

with HIV who have TB often exhibit

radiographic irregularities that make the

diagnosis of active TB difficult (Exs. 7–

76, 7–77, 7–78, and 7–79). HIV-infected

individuals may have concurrent

pulmonary infections that confound the

radiographic diagnosis of pulmonary

TB. In addition, it may be difficult to

distinguish symptoms of TB from

Pneumocystis carinii pneumonia or

other opportunistic infections. This

difficulty in TB diagnosis can result in

true cases of active TB going

undiagnosed in this population.

Undiagnosed TB has been shown to be

an important cause of death in some

patients with HIV infection (Ex. 7–76).

Fourth, environmental conditions in

correctional facilities can aid in the

transmission of TB. For example, many

prisons are old, have inadequate

ventilation systems, and are

overcrowded. In addition, inmates are

frequently transferred both within and

between facilities, thus increasing the

potential for the spread of TB infection

among inmates and staff. This increased

potential for mobility among inmates

also enhances the likelihood that

inmates undergoing therapy for active

disease will either discontinue their

treatment or inadequately follow their

prescribed regime of treatment. The

inadequacy of their treatment may give

rise not only to relapses to an infectious

state of active disease, but also

potentially give rise to strains of MDR–
54184 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

TB. These strains of TB have a higher

incidence of fatal outcome and are

generally characterized by prolonged

periods of infectiousness during which

the risk of infection to others is

increased.

The high incidence of TB among the

inmate population presents an

occupational hazard to the staff in these

types of facilities. Recent outbreak

investigations by the CDC have

documented the transmission of TB to

exposed workers. In an investigation of

a state correctional facility in New York

for 1991 (Exs. 6–3 and 7–136), eleven

persons with TB were identified (10

inmates and one correctional facility

guard). Nine persons (8 inmates and the

guard) had MDR–TB. All eight inmates

were HIV positive. The guard was HIV

negative; however, he was also

immunocompromised as a result of

treatment for laryngeal cancer. Seven of

the inmates and the guard died from

MDR–TB. The eighth inmate was still

alive and receiving treatment for MDR–

TB 2 years after being diagnosed as

having the disease. DNA analysis

identified the strains of tuberculosis

bacteria from these individuals to be

identical.

The investigation revealed that the

source case was an inmate who had

been transferred from another prison

where he had been previously exposed

to MDR–TB. He arrived at the prison

with infectious TB but refused

evaluation by the infirmary staff. This

inmate was placed in the general prison

population where he stayed for 6

months until he was admitted to the

hospital where he later died. However,

before his hospitalization, he exposed

two inmates living in his cell block who

later developed MDR–TB. These two

inmates continued to work and live in

the prison until shortly before their final

hospitalization. The other inmates who

subsequently developed MDR–TB had

several potential routes of exposure:

social contact in the prison yard, contact

at work sites in the prison, and contact

at the prison infirmary where they

shared rooms with other inmates before

diagnosis with TB.

The guard who developed MDR–TB

had exposure to inmates while

transporting them to and from the

hospital. The primary exposure for this

guard apparently occurred when he was

detailed outside the inmates’ room

during their hospitalization for MDR–

TB. The inmates were hospitalized in an

isolation room with negative pressure.

However, upon investigation it was

discovered that the ventilation system

for the room had not been working

correctly and had allowed air to be

exhausted to the hospital corridors and

other patient rooms.

A contact investigation in the prison

was conducted to identify other inmates

who might have been exposed during

this outbreak of MDR–TB. Of those

inmates with previous negative

tuberculin skin tests and without active

disease (306), ninety-two (30%) had

documented skin test conversions.

There was no tuberculin skin test

program for prison staff; therefore,

conversions among prison employees

could not be evaluated.

The primary factors identified as

contributing to this outbreak were

deficiencies in identifying TB among

transferred inmates, laboratory delays,

and lapses in isolating inmates with

active TB within the facility. Inmates

with symptoms of active disease were

not sent for evaluation in some cases

until they became so ill they could not

care for themselves. Some of these

inmates were placed in the infirmary

with other inmates until their diagnosis

with TB. On other occasions, drug

susceptibility testing was not reported

until after an inmate’s death, which

means that appropriate patient

management was not initiated.

As a result of this outbreak, a

retrospective epidemiological

investigation was conducted to examine

the potential extent and spread of MDR–

TB throughout the New York State

prison system during the years 1990–

1991 (Ex. 7–137). This investigation

revealed that 69 cases of TB were

diagnosed in 1990 and another 102 were

diagnosed in 1991, resulting in a

combined incidence of 156.2 cases/

100,000 inmate years for 1990 and 1991

combined. Of the cases, 39 were

identified as being MDR–TB, 31 of

which were shown to be

epidemiologically linked. Thirty-three

of the individuals with MDR–TB never

received any treatment for MDR–TB, 3

were diagnosed at death, and 23 died

before drug susceptibility results were

known. These inmates were also

discovered to be highly mobile. The 39

inmates lived in 23 different prisons

while they were potentially infectious.

Twenty transfers were documented for

12 inmates with potentially infectious

MDR–TB (9 shortly before diagnosis,

one after diagnosis with TB but before

diagnosis with MDR–TB, and 2 after a

diagnosis of MDR–TB).

Several factors were identified as

contributing to the spread of MDR–TB

throughout the New York prison system:

delays in identifying and isolating

inmates, frequent transfers without

appropriate medical evaluation, lapses

in treatment, and delays in diagnosis

and susceptibility testing.

A similar investigation in a California

state correctional institution identified

three active cases of TB (two inmates

and one employee) during September

and October 1991 (Ex. 6–5). As a result,

an investigation was commenced to

determine whether transmission of TB

was ongoing in the institution. Eighteen

inmates with active TB were identified.

TB in 10 of these inmates was

recognized for the first time while they

were in the institution during 1991,

resulting in an annual incidence of TB

of 184 per 100,000, a rate greater than

10 times that for the state (17.4 per

100,000). Two of the 10 inmates had

negative tuberculin skin tests prior to

their entry into the institution. Three of

the cases were determined to have been

infectious during 1991.

A review of skin test data revealed

that for the 2944 inmates for whom skin

test results were available, 324 tested

positive for the first time while in the

prison system. Of these, 106 were

tuberculin negative before their entry

into the prison system, 96 of which

occurred in the previous two years.

The employee identified as having

active TB had worked as a counselor on

the prison’s HIV ward, where he

recalled exposure to one of the 3

infectious inmates. This employee could

recall no known exposures outside the

prison. Similarly, two other prison

employees had documented skin test

conversions while working at the

prison. Neither recalled exposures

outside the prison; one reported

exposure to an inmate with possible TB.

No information was provided in this

report as to whether any isolation

precautions were implemented at this

facility. However, the investigators

concluded that their findings suggested

the likelihood that transmission of TB

had occurred in the prison. Their

conclusion was based on the fact that a

substantial number of skin test

conversions were documented among

the inmates and that at least two

inmates with active TB became infected

while at the prison.

The transmission of TB was also

reported in another California prison

among prison infirmary physicians and

nurses and correctional officers (Ex. 6–

6). In this investigation, an inmate with

active MDR–TB spent 6 months during

1990–1991 in the infirmary. The

infirmary had no isolation rooms and

inmates’ cells were found to be under

positive pressure. Employees

occasionally recalled wearing surgical

masks when entering the rooms of TB

patients.

An analysis of available skin testing

data revealed that of the 21 infirmary

health care providers, only 10 had been
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54185

tested twice during the period from

1987 to 1990. Of these 10, two were

newly positive, one of whom had

recently converted in 1991 and had

spent 5 months in the preceding year

providing health care to the source case

in this investigation. Another health

care provider and a correctional officer

who worked in the infirmary also were

identified as having newly converted

while at the prison. There was no yearly

skin test screening, and thus their

conversions could have occurred at any

time between 1987 and 1991. However,

13 other inmates were diagnosed with

pulmonary TB during that same period.

An additional correctional officer who

did not work in the infirmary also was

found to have newly converted. His

reported exposure occurred at a

community hospital where he was

assigned to an inmate with infectious

TB. The officer was not provided with

any respiratory protection. The lack of

isolation precautions and the lack of

appropriate respiratory protection

suggest transmission of TB from

infectious inmates in the infirmary to

the prison staff, either as a result of

exposure to the source case or other

inmates with pulmonary TB who were

also treated in the prison infirmary.

Because of the lack of contact tracing or

routine annual screening of inmates or

staff, the full extent of transmission

from the source case or other TB cases

could not be determined.

Thus, similar to the evidence for the

hospital setting, the evidence on

correctional facilities shows that the

failure to promptly identify individuals

with infectious TB and provide

appropriate infection control measures

can result in the exposure and

subsequent infection of employees with

TB. These employees include the

correctional facility infirmary staff,

guards on duty at the facility, and

guards assigned to escort inmates during

transport to other facilities (e.g., outside

health care facilities and other

correctional facilities).

Homeless Shelters

Tuberculosis has also been recognized

as a health hazard among homeless

persons. The growth of the homeless

population in the United States since

the 1980s and the subsequent increase

in the number of shelters for the

homeless, furthers heightens the

concern about the potential for the

increased incidence and transmission of

TB among the homeless, especially in

crowded living conditions such as

homeless shelters.

A number of factors are present in

homeless shelters which increase the

potential for the transmission of TB

among the shelter residents and among

the shelter staff. A high prevalence of

TB infection and disease is common

among many homeless shelters. This is

not surprising, since the residents of

these facilities usually come from lower

socio-economic groups and often have

characteristics that place them at high

risk. Screening of selected clinics and

shelters for the homeless has shown that

the prevalence of TB infection ranges

from 18 to 51% and the prevalence of

clinically active disease ranges from 1.6

to 6.8% (Ex. 6–15). The CDC estimates

this to be 150 to 300 times the

nationwide prevalence rate (Ex. 6–17).

In addition to having a high

prevalence of individuals with TB

infection in the shelters, many of the

shelter residents possess characteristics

that impair their immunity and thus

place them at a greater risk of

developing active disease. For example,

homeless persons generally suffer from

poor nutrition, poor overall health

status and poor access to health care.

Many also suffer from alcoholism, drug

abuse and psychological stress.

Moreover, a significant portion of

homeless shelter residents are infected

with the HIV. In 1988, the Partnership

of the Homeless Inc. conducted a survey

of 45 of the nation’s largest cities and

estimated that there were between 5,000

and 8,000 homeless persons with AIDS

in New York City and approximately

20,000 nationwide (Ex. 7–55). Due to

these factors, homeless shelter residents

are at increased risk of developing

active disease. Thus, there is the

increased likelihood that these

individuals will be infectious as a result

of active disease and thereby present a

source of exposure for other homeless

persons and for shelter employees.

In addition to having factors which

increase their risk of developing active

TB disease, homeless persons also are a

very transient population. Because they

are transient, homeless persons are more

likely to discontinue or to erratically

adhere to the prescribed TB therapy.

Inadequately adhering to TB therapy

can result in relapses to an infectious

state of the disease or the development

of MDR–TB. Both outcomes result in

periods of infectiousness, during which

they present a source of exposure to

other residents and staff. In addition,

environmental factors at homeless

shelters, such as crowded living

conditions and poor ventilation,

facilitate the transmission of TB.

Outbreaks of TB among homeless

shelter residents have been reported.

For example, during 1990, 17

individuals with active pulmonary TB

were identified among residents of

homeless shelters in three Ohio cities:

Cincinnati, Columbus, and Toledo (Ex.

7–51). In Cincinnati, 11 individuals

with active TB were identified in a

shelter for homeless adults. The index

case was a man who had resided at the

shelter and later died from respiratory

failure. He was not diagnosed with TB

until his autopsy. Of these 11

individuals, of which the index case

was one, 7 were determined to be

infectious. There was no indication as to

whether any infection control measures

were in place in the shelter. DNA

analysis of 10 individual M. tuberculosis

isolates showed identical patterns. The

similarity among these DNA patterns

suggested that transmission of the TB

occurred in the shelter.

While the primary focus of this

investigation was on the active cases

reported among the residents in this

Cincinnati shelter, the risk of

transmission identified in this shelter

also would apply to the shelter staff.

Possible transmission of TB infection

from the infectious individuals to the

shelter staff might have been identified

through tuberculin skin test

conversions. However, no tuberculin

skin test information for the staff was

reported in this investigation.

Tuberculin skin testing results were

reported in the investigation of a

Columbus, Ohio shelter. In this

investigation, a resident of a Columbus

homeless shelter was identified with

infectious pulmonary TB at the local

hospital in March of 1990. The patient

also had resided in a shelter in Toledo.

As a result, a city-wide TB screening

was initiated from April to May 1990

among the residents and staff of the

city’s men’s shelters. Tuberculin skin

tests were conducted on 363 shelter

residents and 123 shelter employees.

Among 81 skin-tested residents of the

shelter in which the index case had

resided, 32 (40%) were positive

compared to 47 (22%) of 210 skin-tested

residents of other shelters in Columbus

who had positive skin test reactions.

Similarly, among 27 employees of the

shelter where the index case resided, 7

(26%) had positive skin test reactions

compared to 9 (11%) of 85 employees in

other men’s shelters. These skin test

results suggest an increased risk of

transmission of TB among residents and

employees of the homeless shelter

where the index case resided. However,

due to the lack of baseline skin test

information among these residents and

employees it is not possible to

determine when their conversion to

positive status occurred and whether

this index case was their source of

exposure. These results, however, do

indicate a high prevalence of TB

infection among homeless residents
54186 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

(e.g., 40% and 22%). Many of these

individuals are likely to have an

increased risk of developing active TB

and, as a result, they may present a

source of exposure to residents and

staff.

The transmission of TB has also been

observed among residents and staff of

several Boston homeless shelters (Exs.

7–75 and 6–25). From February 1984

through March 1985, 26 cases of TB

were confirmed among homeless

residents of three large shelters in

Boston. Nineteen of the 26 cases

occurred in 1984, thus giving an

incidence of approximately 317 per

100,000, 6 times the homeless case rate

of 50 per 100,000 reported for 1983 and

nearly 16 times the 1984 case rate of 19

per 100,000 for the rest of Boston (Ex.

6–25).

Of the 26 cases of TB reported, 15 had

MDR–TB. Phage typing of isolates from

13 of the individuals with drug-resistant

TB showed identical phage types, thus

suggesting a common source of

exposure. As a result of this outbreak, a

screening program was implemented in

November 1984 over a four-night

period. Of 362 people who received skin

tests, 187 returned for reading, 42 (22%)

were found to be positive and 3 were

recent converters. Screening also was

reported for the shelter staff at the three

homeless facilities. At the largest of the

three shelters, 17 of 85 (20%) staff

members had skin test conversions. In

the other two shelters, 3 of 15 (20%) and

3 of 18 (16%) staff members had skin

test conversions.

Whereas MDR–TB was primarily

involved in the outbreak in Boston, an

outbreak of drug-susceptible TB was

reported in a homeless shelter in

Seattle, Washington (Ex. 7–73). From

December 1986 to January 1987, seven

cases of TB from homeless residents

were reported to the Seattle Public

Health Department. The report of 7

individuals with active TB in one

month prompted an investigation,

including: (1) A mass screening to

detect undiagnosed cases, (2) phage

typing of isolates from shelter clients to

detect epidemiologically linked cases,

and (3) a case-control study to

investigate possible risk factors for the

acquisition of TB.

A review of the case registries

revealed that 9 individuals with active

TB had been reported from the homeless

shelter for the preceding year and four

cases in the year previous to that. As a

result of the mass screening in late

January 1987, an additional 6

individuals with active TB were

detected. Phage typing of 15 isolates

from the shelter-associated cases

revealed that 6 individuals with active

TB diagnosed around the time of the

outbreak were of the same phage type,

suggesting that there was a predominant

chain of infection, i.e., a single source

of infection. However, there also were

other phage types, suggesting several

sources of infection. Therefore, the

investigators suggested that there was

probably a mixture of primary and

reactivated cases.

In addition to the similarity of phage

types among TB cases, tuberculin skin

testing results suggested the ongoing

transmission of TB in the shelter. For

example, 10 shelter clients who were

previously tuberculin negative in May

1985 were re-tested in January 1987 and

3 (30%) had converted. In addition, 43

clients who were negative in January

1987 were re-tested in June 1987 or

February 1988 and 10 (23%) had

converted. Factors identified as

contributing to the outbreak were the

increased number of men with

undiagnosed infectious pulmonary TB,

the close proximity of beds in the

shelter, and a closed ventilation system

that provided extensive recirculation of

unfiltered air.

As a result of the outbreak, a control

plan was implemented. This plan

included repetitive mass screening,

repetitive skin testing, directly observed

therapy, preventive therapy and

modification of the ventilation system to

incorporate UV light disinfection in the

ventilation duct work. After the control

plan was in place, five additional

individuals with active TB were

observed over a 2-year follow-up period.

While the primary focus in this study

was on clients of the shelter rather than

the shelter staff, the risk factors present

in the shelter before implementation of

the control plan would have also

increased the likelihood for

transmission of TB to shelter employees

from infectious clients.

Thus, similar to correctional facilities,

homeless shelters have a number of risk

factors that facilitate and promote the

transmission of TB (e.g., high incidence

of infected residents with an increased

likelihood of developing active disease,

crowded living conditions and poor

ventilation). Also, similar to

correctional facilities, the evidence in

homeless shelters shows that the failure

to promptly identify homeless residents

with infectious TB and the lack of

appropriate TB control measures (e.g.,

lack of isolation precautions or prompt

transfer to facilities with adequate

isolation precautions) resulted in the

transmission of TB to shelter employees.

Long-Term Care Facilities for the Elderly

Long-term care facilities for the

elderly also represent a high-risk

population for the transmission of TB.

TB disease in persons over the age of 65

constitutes a large proportion of TB in

the United States. Many of these

individuals were infected in the past,

before the introduction of anti-TB drugs

and TB control programs when the

prevalence of TB disease was much

greater among the general population,

and have harbored latent infection over

their lifetimes. However, with

advancing age, these individuals’

immune function starts to decline,

placing them at increased risk of

developing active TB disease. In

addition, they may have underlying

disease or overall poor health status.

Moreover, residents are often clustered

together and group activities are often

encouraged. TB case rates are higher for

this age group than for any other. For

example, the CDC reports that in 1987,

the 6,150 cases of TB disease reported

for persons ≥65 years of age accounted

for 27% of the U.S. TB morbidity

although this group only represented

12% of the U.S. population (Ex. 6–14).

Because of the higher prevalence of

TB cases among this age group,

employees of facilities that provide

long-term care for the elderly are at

increased risk for the transmission of

TB. More elderly persons live in nursing

homes than in any other type of

residential institution. The CDC’s

National Center for Health Statistics

reports that elderly persons represent

88% of the nation’s approximately 1.7

million nursing home residents. As

noted by the CDC, the concentration of

such high-risk individuals in long-term

care facilities creates a high-risk

situation for the transmission of TB (Ex.

6–14).

In addition to having a higher

prevalence of active TB, the recognition

of TB in elderly individuals may be

difficult or delayed because of the

atypical radiographic appearance that

TB may have in elderly persons (Exs. 7–

59, 7–81, 7–82, and 7–83). In this

situation, individuals with active TB

may go undiagnosed, providing a source

of exposure to residents and staff.

While the increased incidence of TB

cases among the elderly in long-term

care facilities may be a result of the

activation of latent TB infections, the

transmission of TB infection to residents

and staff from infectious cases in the

facilities has been observed and

reported in the scientific literature.

For example, Stead et al. (1985)

examined the reactivity to the

tuberculin skin test among nursing

home residents in Arkansas (Ex. 7–59).

This study involved a cross-sectional

survey in which tuberculin skin tests

were given to all current nursing home
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54187

residents. In addition, all newlyadmitted nursing home residents were

skin tested. For the three year period

evaluated, 25,637 residents of the 223

nursing homes in Arkansas were tested.

Of 12,196 residents who were tested

within one month of entry, only 12

percent were tuberculin positive,

including those for whom a booster

effect was detected. However, among

the 13,441 residents for whom the first

test was delayed for more than a month,

20.8% were positive. In addition, the

results of retesting 9,937 persons who

were tuberculin negative showed an

annual conversion rate of approximately

5% in nursing homes in which an

infectious TB case had been recognized

in the last three years. In nursing homes

with no recognized cases, the authors

reported an annual conversion rate of

approximately 3.5%. The authors

concluded that their data supported the

contention that tuberculosis may be a

rather common nosocomial infection in

nursing homes and that new infections

with tuberculosis is an important risk

for nursing home residents and staff.

Brennen et al. (Ex. 5–12) described an

outbreak of TB that occurred in a

chronic care Veteran’s Administration

Medical Center in Pittsburgh. This

investigation was initiated as a result of

two skin test conversions identified

through the employee testing program.

One converter was a nurse working on

ward 1B (a locked ward for

neuropsychiatric patients) and the other

was a physician working in an adjacent

ward, 1U, who also had significant

exposure to ward 1B. The source of

infection in this investigation was

traced to two patients who had resided

on ward 1B and who had either a

delayed or undiagnosed case of TB. The

contact investigation revealed 8

additional conversions among patients,

4 in ward 1B and 4 in wards 2B and 4B

(units on the floor above 1B).

Because the source cases were

initially unidentified, no isolation

precautions were taken. Smoke tracer

studies revealed that air discharged

from the window air conditioning unit

of one of the source patients discharged

directly into the courtyard. Air from this

courtyard was the air intake source for

window air conditioning units in the

converters’ room on ward 2B and thus

was one of the possible sources of

exposure.

In addition to the contact

investigation on ward 1B and the

adjacent units, hospital-wide skin

testing results were evaluated. Of 395

employees tested, 110 (28%) were

positive. The prevalence in the

surrounding community was estimated

to be 8.8%. Of those employees initially

negative, 38 (12%) converted to positive

status. Included among these were

employees in nursing (18), medical (3),

dental (1), maintenance/engineering (3),

supply (1), dietary (9), and clerical (2)

services.

Occupational transmission of TB was

also reported in a nursing home in

Oklahoma (Ex. 6–28). In August 1978, a

68 year old female residing in the east

wing of the home was diagnosed with

pulmonary TB. She was subsequently

hospitalized. However, by that time she

had already had frequent contact with

other residents in the east wing. As a

result, a contact investigation, in which

all residents of the home were given

skin tests, was initiated.

The investigation revealed that the

reaction rate for residents in the east

wing (34/48, 71%) was significantly

higher than the reaction rates of

residents living in the north and front

wings (30/87, 34%). No baseline skin

test information was presented for the

residents to determine the level of

conversion. However, it was noted that

half of the nursing home residents were

former residents of a state institution for

the developmentally disabled. A 1970

tuberculin skin test survey of that

institution had shown a low rate of

positive reactions.

In addition to the nursing home

residents, nursing home employees

were also skin tested. Of the 91

employees tested, 61 (67%) were

negative and 30 (33%) were positive.

Similar to results observed among the

residents, positive reaction rates were

higher for employees who had ever

worked in the east wing (50%) than for

those who had never worked in the east

wing (23%). Retesting of the employees

3 months later revealed 3 conversions.

These results suggested that there may

have been occupational transmission of

TB in this facility.

Occupational transmission has also

been observed in a retrospective study

of residents and employees who lived or

worked in an Arkansas nursing home

between 1972 and 1981 (Ex. 7-83). In

this retrospective study, investigators

reviewed the skin testing and medical

chart data collected over a 10-year

period at an Arkansas nursing home.

Among the nursing home residents who

were admitted between 1972 and 1982,

32 of 226 residents (17%) who were

initially tuberculin negative upon

admittance became infected while in the

home, based on conversion to positive

after at least two previous negative tests.

Twenty-four (63%) of these conversions

were infected in 1975, following

exposure to one infectious resident.

This resident, who had negative skin

tests on three previous occasions during

his stay in the home, was not diagnosed

with TB until after he was hospitalized

because of fever, loss of weight and

productive cough. The remaining 37%

converted in the absence of a known

infectious case. Thus, the authors

suggested that nosocomial infections are

likely to result from persons

unsuspected of having TB.

Skin testing was also reviewed for

employees of the nursing home.

Questionnaires were completed by 108

full-time employees. Eleven of 68

employees with follow-up skin tests

converted to positive skin status during

the study period. Ten of the 11 (91%)

converters reported that they had been

in the nursing home in 1975, the same

year in which many of the residents

were also found to have converted from

a single infectious case. In addition,

employees working at least 10 years in

the home had a higher percentage of

conversions (9 of 22, 40%) than

employees working less than 10 years (2

of 46, 4.4%). Based on the results of this

study, the authors concluded that, in

addition to occurrence of TB cases from

the reactivation of latent infections

among the elderly, TB can also be

transmitted from one resident to another

resident or staff. Consequently, TB must

be considered as a potential nosocomial

infection in nursing homes.

Thus, long-term care facilities for the

elderly represent a high-risk situation

for the transmission of TB. These types

of facilities possess a number of

characteristics that increase the

likelihood that active disease may be

present among the facility residents and

may go undetected. Similar to other

high-risk settings, the evidence shows

that the primary factors in the

transmission of TB among residents and

staff have been the failure to promptly

identify residents with infectious TB

and initiate and adequately implement

appropriate exposure control measures.

Drug Treatment Centers

Another occupational setting that has

been identified as a high-risk

environment for the transmission of TB

is drug treatment centers. Similar to

other high-risk sites, drug treatment

centers have a higher prevalence of TB

infection than the general population.

For example, in 1989 the CDC funded

25 state and city health departments to

support tuberculin testing and

administration of preventive therapy in

conjunction with HIV counseling and

testing. In this project, 28,586 clients

from 114 drug treatment centers were

given tuberculin skin tests. Of those,

2,645 (9.7%) were positive (Ex. 6–8).

When persons with previously
54188 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

documented positive tests were

included, 4167 (13.3%) were positive.

There is also evidence to suggest that

drug dependence is a risk factor for TB

disease. For example, Reichman et al.

(Ex. 7–85) evaluated the prevalence of

TB disease among different drugdependent populations in New York: (1)

An in-hospital population, (2) a

population in a local drug treatment

center, and (3) a city-wide population in

methadone clinics. For the in-hospital

population of 1,283 patients discharged

with drug dependence, 48 (3.74%) had

active disease, for a prevalence rate of

3,740 per 100,000. In comparison, the

TB prevalence rate for the total inpatient

population was 584 per 100,000 and for

New York City as a whole was 86.7 per

100,000. Screening of clients at a local

drug treatment center in Harlem

revealed a TB prevalence of 3750 per

100,000 in the drug-dependent

population. Similarly, in the New York

methadone program, the city-wide TB

prevalence was 1,372 per 100,000. The

authors also reported that although

estimates of TB infection rates for both

drug-dependent and non-drug

dependent people were similar, the

prevalence of TB disease among the

drug-dependent was higher, thus

suggesting that drug dependency may be

a risk factor for disease.

Clients of drug treatment centers not

only have a high prevalence of TB

infection, a majority of them are

intravenous drug users. Of the estimated

645,000 clients discharged each year

from drug treatment centers,

approximately 265,000 are intravenous

drug users who either have or are at risk

for HIV infection. In the Northeastern

U.S., HIV seroprevalence rates of up to

49% have been reported (Ex. 6–8).

These individuals are at increased risk

of developing active TB disease.

To determine the risk of active TB

associated with HIV infection, Selwyn

et al. (Ex. 5–6) prospectively studied

520 intravenous drug users enrolled in

a methadone maintenance program. In

this study, 217 HIV seropositive and 303

seronegative intravenous drug users,

who had complete medical records

documenting their history of TB and

skin test status, were followed from June

1985 to January 1988. On admission to

the methadone program, and at yearly

intervals, all patients were given

tuberculin skin tests.

Forty-nine (23%) of the seropositive

patients and 62 (20%) of the

seronegative patients had positive

reactions to the skin test before entry

into the study. Among the patients who

initially had negative skin tests, 15 of

131 (11%) seropositive patients and 62

of 303 (13%) seronegative patients

converted to positive tuberculin status.

While the prevalence and incidence

rates of TB infection were similar for the

two groups of patients, seropositive

patients showed a higher incidence of

developing active disease. Active TB

developed in 8 of the seropositive

subjects with TB infection (4%),

whereas none of the seronegative

patients with TB infection developed

active TB during the study period.

Among individuals who are infected

with HIV or who have AIDS, TB disease

may be difficult to diagnosis because of

the atypical radiographic appearance

that TB may present in these

individuals. In these individuals, TB

may go undiagnosed and present an

unsuspected source of exposure. Clients

of drug treatment centers also may be

more likely to discontinue or

inadequately adhere to TB therapy

regimens in instances where they

develop active disease. As in other

instances, this increases the likelihood

of relapse to active disease or possibly

the development of MDR–TB, both of

which result in additional or even

prolonged periods of infectiousness

during which other clients or staff can

be exposed.

There is evidence showing the

transmission of TB in drug treatment

facilities among both the clients and the

staff. In a CDC case study (Ex. 5–6), a

Michigan man who was living in a

residential substance abuse treatment

facility and was undergoing therapy for

a previously diagnosed case of TB

disease, was discovered by the local

health department to have MDR–TB. As

a result, a contact investigation was

initiated at the drug treatment facility in

which he resided.

Of the 160 clients and staff who were

identified as potential contacts, 146

were tested and given tuberculin skin

tests in November. No health screening

program had been in place at the

facility. The following March repeat

skin tests were given. Of the 70 persons

who were initially tuberculin negative

and were still present in the facility, 15

(21%) had converted to positive status

(14 clients and 1 staff member). The

investigators noted that the number of

converters may have been

underestimated for two reasons. Many

of the clients were at risk for HIV

infection and thus may have been

anergic and not responded to the

tuberculin skin tests. In addition, nearly

half of the clients who were initially

negative were not available for repeat

skin testing.

Several factors may have contributed

to the observed conversions in this

facility. For example, no health

screening program was in place.

Therefore, individuals with TB would

go unidentified. In addition, the clients

were housed in a building with crowded

dormitories for sleeping. The only

ventilation in this building was

provided by opening windows and

doors. Thus, environmental conditions

were ideal for the transmission of TB.

Consequently, the high-risk

characteristics of clients who frequent

these centers (e.g., high prevalence of

infection and factors increasing the

likelihood of developing active disease)

and environmental characteristics of the

center (e.g., crowding and poor

ventilation), lead to drug treatment

centers being considered a high-risk

setting for the transmission of TB. The

available evidence shows that the

failure to promptly identify clients with

infectious TB and to initiate and

properly implement exposure control

methods (e.g., proper ventilation)

resulted in the infection of clients and

staff at these facilities.

Conclusion

The available evidence clearly

demonstrates that the transmission of

TB represents an occupational hazard in

work settings where employees can

reasonably be anticipated to have

contact with individuals with infectious

TB or air that may reasonably be

anticipated to contain aerosolized M.

tuberculosis as a part of their job duties.

Epidemiological studies, case reports,

and outbreak investigations have shown

that in various work settings where

there has been an increased likelihood

of encountering individuals with active

TB or where high-hazard procedures are

performed, employees have become

infected with TB and in some cases

developed active disease. While some

infections were a result of more direct

and more prolonged exposures, other

infections resulted from non-direct and

brief or intermittent exposures. Because

of the variability in the infectiousness of

individuals with active TB, one

exposure may be sufficient to initiate

infection.

Several factors, common to many of

these work settings, were identified as

contributing to the transmission of TB:

(1) Failure or delayed recognition of

individuals with active TB within the

facility, and (2) failure to initiate or

adequately implement appropriate

infection control measures (e.g.,

performance of high-hazard procedures

under uncontrolled conditions, lack of

negative pressure ventilation,

recirculation of unfiltered air, and lack

of appropriate respiratory protection).

Thus, in work settings where employees

can reasonably be anticipated to have

contact with individuals with infectious
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54189

TB or air that may contain aerosolized

M. tuberculosis and where appropriate

infection control programs are not in

place, employees are at increased risk of

becoming infected with TB.

Infection with TB is a material

impairment of the worker’s health. Even

though not all infections progress to

active disease, infection marks a

significant change in an individual’s

health status. Once infected, the

individual is infected for his or her

entire life and carries a lifetime risk of

developing active disease, a risk they

would not have had they not been

infected. In addition, many individuals

with infection undergo preventive

therapy to stop the progression of

infection to active disease. Preventive

therapy consists of very toxic drugs that

can cause serious adverse health effects

and, in some cases, may be fatal.

Although treatable, active disease is

also a serious adverse health effect.

Some TB cases, even though cured, may

result in long-term damage to the organ

that is infected. Individuals with active

disease may need to be hospitalized

while they are infectious and they must

take toxic drugs to stop the progressive

destruction of the infected tissue. These

drugs, as noted above, are toxic and may

have serious side effects. Moreover,

even with advancements in treating TB,

individuals still die from TB disease.

This problem is compounded by the

emergence of multidrug-resistant strains

of TB. In these cases, due to the inability

to find adequate drug regimens which

can treat the disease, individuals remain

infectious longer, allowing the disease

to progress further and cause more

progressive destruction of the infected

tissue. This increases the likelihood of

long-term damage and death.

V. Preliminary Risk Assessment for

Occupational Exposure to Tuberculosis

Introduction

The United States Supreme Court, in

the ‘‘benzene’’ decision (Industrial

Union Department, AFL–CIO v.

American Petroleum Institute, 448 U.S.

607 (1980)), has stated the OSH Act

requires that, prior to the issuance of a

new standard, a determination must be

made, based on substantial evidence in

the record considered as a whole, that

there is a significant health risk under

existing conditions and that issuance of

a new standard will significantly reduce

or eliminate that risk. The Court stated

that

‘‘before he can promulgate any permanent

health or safety standard, the Secretary is

required to make a threshold finding that a

place of employment is unsafe in the sense

that significant risks are present and can be

eliminated or lessened by a change in

practices’’ (448 U.S. 642).

The Court in the Cotton Dust case

(American Textile Manufacturers

Institute v. Donovan, 452 U.S. 490

(1981)), rejected the use of cost-benefit

analysis in setting OSHA health

standards. However, the Court

reaffirmed its previous position in the

‘‘benzene’’ case that a risk assessment is

not only appropriate, but also required

to identify significant health risk in

workers and to determine if a proposed

standard will achieve a reduction in that

risk. Although the Court did not require

OSHA to perform a quantitative risk

assessment in every case, the Court

implied, and OSHA as a matter of policy

agrees, that assessments should be put

into quantitative terms to the extent

possible. The following paragraphs

present an overall description of

OSHA’s preliminary quantitative risk

assessment for occupational exposure to

tuberculosis (TB).

An earlier version of this risk

assessment was reviewed by a group of

four experts in the fields of TB

epidemiology and mathematical

modeling. The reviewers were George

Comstock, MD, MPH, DPH, Alumni

Centennial Professor of Epidemiology,

The Johns Hopkins University; Neil

Graham MBBS, MD, MPH, Associate

Professor of Epidemiology, The Johns

Hopkins University; Bahjat Qaqish, MD,

PhD, Assistant Professor of Biostatistics,

University of North Carolina; and

Patricia M. Simone, MD, Chief, Program

Services Branch, Division of

Tuberculosis Elimination, CDC. The

reader is referred to the peer review

report in the docket for additional

details (Ex. 7–911). The revised version

of OSHA’s risk assessment, as published

in this proposed rule, includes OSHA’s

response to the reviewers’ comments as

well as updated risk estimates based on

recent purified protein derivative (PPD)

skin testing data made available to the

Agency since the peer review was

performed and is generally supported by

the reviewers or is consistent with

reviewers’ comments. (Note: PPD skin

test and tuberculin skin test (TST) are

synonymous terms.)

The CDC estimates that, once infected

with M. tuberculosis, an untreated

individual has a 10% lifetime

probability of developing active TB and

that approximately half of those cases

will develop within the first or second

year after infection occurs. Individuals

with active TB represent a pool from

which the disease may spread. Based on

data from the CDC, OSHA estimates that

every index case (i.e., a person with

infectious TB) results in at least 2 other

infections (Ex. 7–269). For some

percentage of active cases, a more severe

clinical course can develop which can

be attributed to various factors such as

the presence of MDR–TB, an allergic

response to treatment, or the synergistic

effects of other health conditions an

individual might have. Further, OSHA

estimates that for 7.78% of active TB

cases, TB is expected to be the cause of

death. Section 6(b)(5) of the OSH Act

states that,

The Secretary, in promulgating standards

dealing with toxic materials or harmful

physical agents under this subsection, shall

set the standard which most adequately

assures, to the extent feasible, on the basis of

the best available evidence, that no employee

will suffer material impairment of health or

functional capacity even if such employee

has regular exposure to the hazard dealt with

by such standard for the period of his

working life.

For this rulemaking, OSHA defines

TB infection as a ‘‘material impairment

of health’’, for several reasons. First,

once infected with TB, an individual

has a 10% lifetime likelihood of

developing active disease and

approximately 1% likelihood of

developing more serious complications

leading to death. Second, allergic

reaction and hepatic toxicity due to

chemoprophylaxis with isoniazid,

which is one of the drugs used in the

recommended course of preventive

treatment, pose a serious threat to a

large number of workers. Third,

defining infection with M. tuberculosis

as material impairment of health is

consistent with OSHA’s position in the

Bloodborne Pathogens standard and is

supported by CDC and several

stakeholders who participated in the

pre-proposal meetings, as well as Dr.

Neil Graham, one of the peer reviewers

of this risk assessment. In his comments

to OSHA, Dr. Graham stated,

The focus of OSHA on risk of TB infection

rather than TB disease is appropriate. TB

infection is a potentially adverse event,

particularly if exposure is from a MDR–TB

patient, or if the health-care or institutional

worker is HIV seropositive. In addition, a

skin test conversion will in most cases

mandate use of chemoprophylaxis for >6

months which is at least inconvenient and at

worst may involve adverse drug reactions.

(Ex. 7–271)

The approach taken in this risk

assessment is similar to the approach

OSHA took in its risk assessment for the

Bloodborne Pathogens standard. As

with bloodborne pathogens, the health

response (i.e., infection) associated with

exposure to the pathogenic agent does

not depend on a cumulative level of

exposure; instead, it is a function of

intensity and frequency of each
54190 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

exposure incident. However, unlike

hepatitis B, where the likelihood of

infection once an exposure incident

occurs is known with some degree of

certainty, the likelihood of becoming

infected with TB after an exposure

incident is not as well characterized.

With TB, the likelihood of infection

depends on the potency of an exposure

incident and the susceptibility of the

exposed individual (which is a function

of the person’s natural resistance to TB

and his or her health status). Further,

the potency of a given exposure incident

is highly dependent on several factors,

such as the concentration of droplet

nuclei in the air, the duration of

exposure, and the virulence of the

pathogen (e.g., pulmonary and laryngeal

TB are considered more infectious than

other types).

The Agency has sufficient data to

quantify the risk associated with

occupational exposure to TB among

health care workers in hospitals on a

state-by-state basis. In addition to

hospital employee data, OSHA has

obtained data on selected health care

employee groups from the TB Control

Office of the Washington State Health

Department. These groups include

workers employed in long-term health

care, home health care, and home care.

Small entities are encouraged to

comment and submit any data or studies

on TB infection rates relevant to their

business.

Because it is exposure to aerosolized

M. tuberculosis that places workers at

risk of infection, and not some factor

unique to the health care profession, the

Agency concluded that the experience

of these groups of health care workers

is representative of that of the other

‘‘high-risk’’ workers covered by this

proposal. This means that the risk

estimates calculated for these groups of

workers are appropriate to use as the

basis for describing the potential range

of risks for workers in other work

settings where workers can be expected

to come into close and frequent contact

with individuals with infectious TB (or

with other sources of aerosolized M.

tuberculosis) as an integral part of their

job duties. As discussed in section IV

(Health Effects), epidemiological

studies, case reports, and outbreak

investigations have shown that workers

in various work settings, including but

not limited to hospitals, have become

infected with tuberculosis as a result of

occupational exposure to aerosolized M.

tuberculosis when appropriate infection

control programs for tuberculosis were

not in place.

In this preliminary risk assessment,

OSHA presents risk estimates for TB

infections, cases of active disease, and

TB-related deaths (i.e., where TB is

considered the cause or a major

contributing cause of death) for workers

with occupational exposure to

tuberculosis.

A number of epidemiological studies

demonstrate an increased risk of TB

infection among health care workers in

hospitals and other work settings. A

brief review of a selection of these

studies is presented below, followed by

OSHA’s estimates of excess risk due to

occupational exposure. Finally, OSHA

presents a qualitative assessment of the

risk of TB infection caused by

occupational exposure to tuberculosis in

correctional facilities, homeless shelters,

drug treatment centers, medical

laboratories, and other high-risk work

groups.

Review of the Epidemiology of TB

Infection in Exposed Workers

There are several studies in the

published scientific literature

demonstrating the occupational

transmission of infectious TB. Reports

of TB outbreaks and epidemiologic

surveillance studies have shown that

health care and certain other workers

are, as a result of their job duties, at

significantly higher risk of becoming

infected than the average person.

OSHA conducted a thorough search of

the published literature and reviewed

all studies addressing occupational

exposure to tuberculosis and TB

infection in hospitals and other work

settings. All published studies show

positive results (i.e., workers exposed to

infectious individuals have a high

likelihood of becoming infected with

TB). Because there are so many studies,

OSHA selected a representative subset

of the more recent studies conducted in

the U.S. to include in this section. These

studies were chosen because they show

occupational exposure in various work

settings, under various working

conditions, and under various scientific

study designs.

OSHA’s summary of the studies is

presented in Table V–1(a) and Table V–

1(b). These studies represent a wide

range of occupational settings in

hospitals, ranging from TB and HIV

wards in high prevalence areas, such as

New York City and Miami, to hospitals

with no known TB patients located in

low prevalence areas such as the state

of Washington. The studies include

prospective studies of entire hospitals or

groups of hospitals, retrospective

surveys of well-controlled clinical

environments, such as an HIV ward in

a hospital, and case studies of singlesource infection (i.e., outbreak

investigations).

TABLE V–1(A).—OUTBREAK INVESTIGATIONS OF TB INFECTION

Authors/year Setting/source Risk of TB in health care workers Contributing factors

Catanzaro (1982) ........... Hospital intensive care unit/San

Diego/1 index case—7-day hospital

stay.

14/45 (31%) PPD conversions, 10/13

(77%) PPD conversions among

health care workers present at

bronchoscopy.

Poor ventilation. No report on respirator use.

Kantor et al. (1988) ........ VA hospital in Chicago autopsy

room/1 index case undiagnosed

until histology exam of autopsy tissue.

9/56 (16%) PPD conversions among

exposed workers vs. 3/333 (1%)

conversions among unexposed

(RR=17.8) 3 workers developed

active TB.

No mechanical ventilation on medical

ward (autopsy room): no isolation.

Autopsy room had 11 air changes/

hour and no air recirculation.

Beck-Sague (1992) ........ Jackson Memorial Hospital in Miami

MDR–TB in HIV/patients on HIV

ward and clinic during 1989–91.

13/39 (33%) PPD conversions on

HIV ward and clinic.

Some rooms had positive pressure.

Inadequate triage of patients with

suspected TB. Delay in use of isolation. Early discharge from isolation.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54191

TABLE V–1(B).—SURVEILLANCE STUDIES OF TB INFECTION IN EXPOSED HEALTH CARE WORKERS

Authors/year Setting/source Study period Population Risk of TB in health care

workers Comments

Price et al. (1987) ..... 19 Eastern North Carolina hospitals.1980–84 All Hospital workers ....... 1.80% annual PPD conversion rate.

29 Central North Carolina hospitals................. ........................................ 0.70% annual PPD conversion rate.

8 Western North Carolina hospitals................. ........................................ 0.61% annual PPD conversion rate.

Aitken et al. (1987) .... 64 hospitals in Washington State.1982–84 All Hospital workers ....... 0.1% PPD conversion

rate/in 3 years.

Strict adherence to CDC

guidelines.

Malasky et al. (1990) 14 urban hospitals in U.S (1) Physicians in training in

pulmonary medicine

and infectious disease.

11% PPD conversion/3

years among pulmonary fellows, 2.4%

PPD conversions/3

years among infectious

disease fellows.

Dooley et al. (1992) .. Hospital in Puerto Rico

TB in HIV-infected patients.

1989–90 Hospital workers (n=908) Prevalence study: 54/

109 (50%) nurses exposed to TB patients

had positive PPDs 35/

188 (19%) clerical

workers with no exposure to TB had positive PPDs (p<0.001).

Isolation rooms did not

have negative pressure. Recirculated air

was not filtered.

NIOSH ....................... Jackson Memorial Hospital, Miami.1989–92 Hospital workers in selected wards (n=607).60% annual PPD conversion among 263 exposed workers, 0.6%

annual PPD conversion among 344 unexposed workers.

Incomplete isolation facilities. Improper application of isolation procedures.

Cocchiarella et al.

(1996).

Cook County Hospital,

Chicago.

1991 Graduating physicians

with at least 1 year of

clinical work at CCH

(n=128).

18.8% 3-year PPD conversion rate for house

staff in internal medicine vs. 2.2% PPD

conversion rate for

house staff in other

specialties.

Residents were offered

limited respiratory protection during exposures. No protocol

available for early

identification of suspect TB cases. PPD

testing program incomplete. Inadequate isolation facilities.

1 Mid 1980’s (3 years).

Outbreak investigations describe

occupational exposure to tuberculosis

from single index patients or a welldefined group of patients. Such

investigations are more likely to

demonstrate an upper limit of

occupational risk in different settings,

usually under conditions of suboptimal

environmental and infection controls.

Although outbreak investigations

demonstrate the existence of

occupational risk under certain

conditions and the importance of the

early identification of suspect TB

patients quite well, these studies do not

provide information conducive to risk

assessment estimations. Limitations of

outbreak investigations include the

frequent absence of baseline PPD test

results, the difficulty of extrapolating

the results to non-outbreak conditions of

TB exposure, and, often, small sample

sizes. Table V–1(a) lists some of the

published outbreak investigations and

shows the risks posed to health care

workers by such outbreaks, as well as

the failures in control programs

contributing to these episodes.

Prospective and/or retrospective

surveillance studies are used to estimate

conversion rates from negative to

positive in PPD skin testing programs.

These conversion rates can be used to

estimate the excess incidence of TB

infection. Surveillance studies among

health care workers lend themselves to

a more systematic evaluation of the risk

of TB infection than outbreak

investigations, for several reasons. First,

these studies better reflect the risk of TB

experienced by workers under routine

conditions of exposure. Second, these

studies are usually based on a larger

group of workers and therefore yield

more precise and accurate estimates of

the actual risk of infection. However,

the extent to which results from

surveillance studies can be generalized

depends on a careful evaluation of the

study population. Some studies report

skin test conversion rates for all workers

in the hospital(s) under study. Such

studies often include large groups of

employees with little or no exposure to

TB. Results from such studies may

reflect an overall estimate of risk in that

environment, but may underestimate

the occupational risk of those with

frequent exposure.

Other surveillance studies report PPD

conversion rates of more narrowlydefined groups of workers, usually those

working in ‘‘high-risk’’ areas within a

hospital such as the HIV or TB wards.

Some of these studies have internal

control groups (i.e., they compare PPD

conversion rates between a group of

workers with extensive exposure to TB

and a group of workers with minimal or

no exposure to TB), thus making it

possible to more precisely quantify the

magnitude of excess risk due to

occupational exposure. However, these

studies are also limited in their

usefulness for risk assessment purposes.

They usually have small sample sizes,

making it more difficult to observe

statistically significant differences. More
54192 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

importantly, internal control groups

may overestimate background risk, and

thus underestimate excess occupational

risk, unless painstaking efforts are made

to eliminate from the control group

those individuals with the potential for

occupational exposure, a difficult task

in some hospital environments. Table

V–1(b) contains a selected list of

published surveillance studies.

In reviewing Table V–1(a) and Table

V–1(b), the reader should bear in mind

that these tables are not intended to

present an exhaustive list of

epidemiologic studies with TB

conversion rates in occupational

settings. Instead, these tables present

brief summaries of some of the

epidemiologic evidence of occupational

TB transmission found in the published

literature; they are intended to convey

the seriousness of the risk posed to

health care workers and to illustrate

how failures in control programs

contribute to this risk. Upon reviewing

these studies, a consistent pattern

emerges: these work settings are

associated with a high likelihood for

occupational exposure to tuberculosis,

and high rates of TB infection are being

observed among health care workers.

Quantitative Assessment of Risk

Data availability usually dictates the

direction and analytical approach

OSHA’s risk assessment can take. For

this rulemaking, three health endpoints

will be used: (1) TB infection, which is

‘‘material impairment of health’’ for this

proposed standard; (2) Active disease

following infection; and, (3) Risk of

death from active TB.

In order to account for regional

variability in TB prevalence and

therefore to account for expected

variability in the risk of TB infection in

different areas, the Agency chose to

develop occupational risk estimates on

a state-by-state basis. This approach was

criticized by Dr. Neil Graham as being

too broad and ’’* * * insufficient in

light of the tremendous variability

* * * that can occur within a state.’’

(Ex. 7–911). The Agency recognizes that

risk estimates on a county-by-county

basis would be preferable; however, the

unavailability of comprehensive county

data has prevented the Agency from

conducting such analysis.

The annual excess risk of TB infection

due to occupational exposure is defined

as a multiplicative function of the

background rate of infection and is

expressed as:

p = ERRo * Rb

where:

p is the annual excess risk due to

occupational exposure,

Rb is the background rate of TB

infection, and

ERRo is a multiplicative factor denoting

the excess relative risk due to

occupational exposure (ERRo).

Estimates of ERRo are derived from

surveillance studies of workers with

occupational exposure to TB. ERRo is

defined as the relative difference

between the overall exposed worker risk

and the background (population) risk

and is calculated as the difference

between overall worker and background

risk divided by the background risk.

The annual excess risk due to

occupational exposure is defined as a

function of the background risk because

of data limitations. If data on overall

worker risk were available for each

state, then the excess risk due to

occupational exposure would simply be

the difference between overall worker

risk and background risk. Instead, the

annual excess risk due to occupational

exposure (i.e., p) is estimated using a

multiplicative model because data on

overall worker risk (i.e., Rw) were

available only for the states of

Washington, and North Carolina and for

Jackson Memorial Hospital located in

Miami, Florida. Therefore, the annual

excess risk due to occupational

exposure in state i (pi) is expressed as:

p

R R

R i R wj bj

bj

= bi

( ) − ∗

where:

Rwj is the overall worker risk estimated

from surveillance studies (study j),

Rbj is the study control group risk (i.e.,

study background risk), and

Rbi is the background rate for state i.

When i=j (i.e., Washington State or

North Carolina), the excess risk due to

occupational exposure, is expressed as

the straight difference between overall

worker risk and background risk.

OSHA calculated estimates of ERRo

based on three occupational studies: the

Washington State study, the North

Carolina study, and the Jackson

Memorial Hospital study (Exs. 7–263, 7–

7, 7–108). These estimates were

expressed as percent change above each

study’s background. The derivation of

these estimates is described in section 2.

In order to estimate an overall range

of occupational risk of TB infection,

taking into account regional differences

in TB prevalence in the U.S., OSHA: (1)

Estimated background TB infection rates

by state (Rbi), and (2) applied estimates

of ERRo, derived from the occupational

studies, to the state background rates to

calculate estimates of excess risk due to

occupational exposure by state.

OSHA used a multiplicative function

of each state’s background infection rate

to estimate excess risk of TB infection

because the probability of occupational

infection can be viewed as a function of

the number of contacts and frequency of

contacts with infectious individuals.

Thus, estimates of expected relative

increase in risk above background due

to occupational exposure are calculated

for the three available studies and these

relative increases (i.e. ERRo) are

multiplied by background rates for each

state to derive estimates of excess

occupational risk by state. These state

estimates are then used to derive a

national estimate of occupational risk.

The CDC compiles and publishes

national statistics on the incidence of

active TB in the U.S. by state based on

reported cases. OSHA relied on these

data to estimate TB infection

background rates through the use of a

mathematical model because

information on TB infection is not being

collected nationwide by CDC. A more

detailed discussion on the methodology

and derivation of background risk

estimates by state is found in section 3,

and discussion on the estimation of

occupational risk estimates by state is

found in section 4 of this risk

assessment.

Because section 6(b)(5) of the OSH

Act requires OSHA to assess lifetime

risks, OSHA has converted the annual

excess risk due to occupational

exposure into an excess lifetime risk

based on a 45-year working lifetime.

The formula used to calculate lifetime

occupational risk estimates of the

probability of at least one occurrence of

TB infection due to occupational

exposure in 45 years is expressed as { 1–

(1–p)45 }, where p is the annual excess

risk due to occupational exposure. Two

assumptions are critical in defining

lifetime risk: (1) the exposure period is

45 years, and (2) the annual excess risk

remains constant. The implication of the

second assumption is that the worker’s

exposure profile and working

conditions, which may affect the level

and intensity of exposure, and the

virulence of the pathogen, remain

unchanged throughout a working

lifetime. The merit of this assumption

was questioned by Dr. Graham, because,

as he states ‘‘* * * patient contact may

vary greatly throughout a career for

many HCWs [health care workers].’’ and

‘‘ * * * physicians (and nurses) often

do not have extensive patient contact

until [their] mid-twenties, while other

workers increasingly retire early.’’ Dr.

Graham recommends that OSHA’s risk

assessment be adjusted to account for

variable exposure levels and variable

working lifetimes. Although accounting
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54193

for variable exposure levels could result

in more precise risk estimates, the

unavailability of comprehensive

information on lifetime TB exposure

scenarios by occupational group

prevented the Agency from developing

a more complex risk model.

OSHA has customarily assumed a 45

year working lifetime in setting health

standards. The Agency believes that this

assumption is reasonable and consistent

with the Act. The Act requires the

Secretary to set a standard for toxic

substances that would assure ‘‘no

employee * * * suffer material

impairment of health or functional

capacity even if such employee has

regular exposures to the hazard for the

period of his working lifetime.’’ 29

U.S.C. § 655(b)(5) (emphasis added).

The U.S. Court of Appeals for the

District of Columbia upheld the use of

a 45-year lifetime in the asbestos

standard against an assertion by the

Asbestos Information Association that

the average duration of employment was

five years. Building and Construction

Trades Department, AFL–CIO v. Brock,

838 F.2d 1258, 1264, 1265 (D.C. Cir.

1988). The Court said that OSHA’s

assumption ‘‘appears to conform to the

intent of Congress’’ as the standard must

protect even the rare employee who

would have 45 years of exposure. Id. at

1264. In addition, while working

lifetimes will vary, risk is significant for

some who work as little as one year and,

at any rate, individual and population

risks are likely to remain the same so

long as employees who leave one job are

replaced by others, and those who

change jobs remain within a covered

sector. Nevertheless, the Agency solicits

information regarding the likelihood of

exposure to active TB in the workplace

and duration of employment in various

occupational groups. Lifetime risk

estimates of TB infection by state are

described in section 4.

Lifetime risk estimates of developing

active TB are calculated from lifetime

risk estimates of TB infection assuming

that, once infected, there is a 10%

likelihood of progressing to active TB.

These estimates are discussed in section

4. Further, the number of deaths caused

by TB is calculated from the lifetime

estimates of active TB using OSHA’s

estimate of TB case fatality rate, also

discussed in section 4.

1. Definitions

For the purpose of estimating

incidence rates, TB infection rate is

defined as the annual probability of an

individual converting from negative to

positive in the tuberculin skin test.

Annual occupational risk is defined as

the annual excess risk of becoming

infected with TB due to occupational

exposure, and is estimated as a function

of the background risk. Lifetime

occupational risk is defined as the

excess probability of becoming infected

with TB due to exposure in the

workplace, at least once, in the course

of a 45-year working lifetime and is

estimated as { 1–(1–p)45 } where p is the

annual occupational risk of TB

infection.

2. Data Sources for Estimating

Occupational Risk

The quantitative data needed to

develop an overall national estimate of

risk for TB infection due to occupational

exposure are not available. The CDC

does not publish occupational data

associated with TB infection incidence

and active TB on a nationwide basis.

There has been some effort to include

occupational information on the TB

reporting forms, but only a limited

number of states are currently using the

new forms that capture occupational

information in a systematic way.

However, there are a number of

sources that permit the risk in

occupational settings to be reasonably

estimated and, with the aid of

mathematical models, to develop

estimates of excess relative occupational

risk (ERRo), which can then be

multiplied by the state-specific

background rates to yield estimates of

excess occupational risk. OSHA has

identified three data sources that are

suitable for assessing the excess risk of

TB infection in health care workers with

occupational exposure. These include:

(1) A 1994 survey of tuberculin skin

testing in all health care facilities in

Washington State; (2) A state-wide

survey of hospitals in North Carolina,

conducted in 1984–1985, which

addressed TB skin testing practices, TB

infection prevalence, and TB infection

incidence among hospital employees in

that state; and (3) the employee

tuberculin skin test conversion database

from Jackson Memorial Hospital in

Miami, Florida. In addition to these

hospital employee data, the Agency has

obtained data on selected other work

groups from the state of Washington.

These groups include workers employed

in long-term health care, home health

care, and home care.

On the issue of data availability for

this risk assessment, Dr. Graham agrees

with OSHA that there are no

comprehensive data available with

respect to occupational risk of TB

infection in health care and other

institutions in the U.S. Instead of

relying on two state specific studies, Dr.

Graham recommends, though with

serious reservations, the use of a review

study by Menzies et al. (Ex. 7–130). Dr.

Graham admits that the ‘‘validity of the

estimates in these reports [reviewed in

the Menzies et al. study] must be open

to serious question * * *’’ for the

following reasons, which were pointed

out by Dr. Graham: several of the studies

reviewed are very old and not relevant

to TB risk in the 1990s; four studies use

tine tests and self-reports of skin test

results, which are not useful for

estimation of risk of TB infection; the

studies were not consistent in the

inclusion of high and low risk workers;

two-step testing was not done; and the

participation rates were extremely low

or unreported in many of the studies

included in this review.

OSHA has chosen not to rely on the

Menzies et al. review study, because, in

addition to Dr. Graham’s reservations

(which the Agency shares), OSHA is

also concerned about the inclusion in

the Menzies et al. review article of

studies conducted outside the U.S.

Factors known to affect the

epidemiology of TB, such as

environmental conditions, socioeconomic status, and work practices, are

expected to differ greatly from one

country to another, and are not

controlled for in the statistical analyses

of these studies. For all of these reasons,

the Agency has chosen to rely solely on

U.S. studies for its quantitative risk

estimations.

Estimates of excess risk due to

occupational exposure are expressed as

the percent increase above background

based on relative risk estimates derived

from occupational studies. Internal

control groups provided estimates of

background risk for the Washington

state and Jackson Memorial data sets. In

the absence of a suitable internal control

group, the estimated annual state-wide

TB infection rate, as calculated in

Section 3, was used as the background

rate in the North Carolina study.

(a) Washington State Data: Initially,

OSHA relied on a three-year prospective

study, conducted between 1982 and

1984 in the state of Washington, to

derive an estimate of excess risk for TB

infection as a result of occupational

exposure (Ex. 7–42). OSHA received

several objections to the use of this

study. The study used hospitals with no

known TB cases as ‘‘controls’’ based on

the assumption that in those hospitals

the risk of TB infection to employees

may be the same as for the general

population. Dr. Qaqish noted that this

assumption is highly questionable and

that the use of such controls is not

appropriate. Dr. Graham and Dr. Qaqish

pointed out that the published results

did not include conversions identified

through contact investigations, which
54194 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

means that the conversion rate reported

in that study was likely to be an

underestimate of the true risk. In

addition, the commenters noted that the

study was designed to estimate the

effectiveness of the TB screening

program and may have produced skin

testing results biased toward the null;

the study is relatively old; and, the

study was conducted prior to the AIDS

epidemic and therefore the results may

not be relevant to the occupational risk

at present because the relationship

between HIV and TB is not reflected in

this study.

In an effort to respond to reviewers’

comments, the Agency chose to update

the analysis by relying on a data set of

tuberculin skin testing results from a

survey of the state’s tuberculin skin

testing program in 1994. This survey is

conducted by the TB Control Office in

the Washington State Health

Department and it covers all hospitals in

the state, as well as long-term care,

home health care, and home care

facilities. OSHA was given access to the

database for the 1994 survey as well as

data on conversions identified through

contact investigations for the same year

(Ex. 7–263). Table V–2 summarizes the

results of the 1994 survey. Of the 335

health care establishments in the state of

Washington, 273 responded to the

survey, for an overall response rate of

81.5%. Of those, 76 were hospitals, 142

were long-term care, 47 were home

health care, and 8 were home care

facilities. Hospitals had the highest

survey response rate (85%) and home

health care had the lowest (77%). Every

employee at risk for TB infection (i.e.,

who was known to be tuberculin skin

test negative at the start of the study

period) in the participating hospitals

and long-term care facilities was given

a tuberculin skin test, including

administrators, housekeepers, business

office staff, and all part-time employees.

Testing in home health care facilities

was generally confined to those nursing

staff who had direct client contact.

Employees in home care are those who

provide services to patients in home

health care and include food handlers,

cleaning aides, personal care-givers, and

some social workers.

TABLE V–2—WASHINGTON STATE 1994 SURVEY RESULTS

Type of facility Number of a

establishments

Number of

skin tests

Number of

conversions

Annual

rate of TB

conversion

Hospital ...................................................................................................................... 76 (85%) 39,290 50 1.27/1,000

Long-term Care ......................................................................................................... 142 (81%) 11,332 111 9.80/1,000

Home Health Care ..................................................................................................... 47 (77%) 2,172 11 5.06/1,000

Home Care ................................................................................................................ 8 (80%) 537 1 1.86/1,000

Total .................................................................................................................... 273 (81.5%) 53,331 173 3.24/1,000

a Numbers in parentheses are study response rates for each group.

The overall rate of skin test

conversion for workers in the health

care system in Washington State in 1994

was 3.24 per 1,000 employees tested.

This is greater than a 4-fold increase

from the estimated state-wide

background rate of 0.69 per 1,000 at

risk, as calculated in section 3. The

annual rate of TB conversion ranged

from 1.27 per 1,000 tested for hospital

employees to 9.80 per 1,000 tested for

long-term care employees.

The annual rate of 9.8 per 1,000 for

long-term care employees probably

reflects the high potential for exposure

to undiagnosed active TB in those

facilities. As a rule, long-term facilities

in Washington State do not have AFB

isolation rooms. Therefore, residents

with no obvious TB symptoms but who

might be infectious spend most of their

time in open spaces exposing other

residents and workers to infectious

droplet nuclei. However, once a resident

has been identified as a suspect TB

patient, that person is transferred to a

hospital until medically determined to

be non-infectious.

Also, since employees who were 35

years of age or younger were not given

a two-step test at hiring, and a high

percentage of employees are foreign

born and therefore most likely to have

been vaccinated during childhood with

the BCG vaccine, some of the

conversions observed might be late

boosting because of BCG. However, an

almost two-fold increase in risk for longterm care workers even as compared to

the significant excess risk among home

health care workers clearly indicates

that the risk of TB infection for workers

in long-term care is high and not likely

to be fully explained by late boosting.

Beginning in 1995, two-step testing has

been done on all new hires in

Washington State. Thus, tuberculin skin

testing data for 1995 are not expected to

be influenced by possible late boosting;

OSHA will place the 1995 data in the

rulemaking record as they become

available.

Hospital workers had the lowest

overall rate of conversion (overall rate of

1.27 per 1,000). This, in part, can be

attributed to the existence of extensive

TB control measures in that

environment in Washington State.

Compliance with the CDC Guidelines

and OSHA’s TB Compliance Directive is

quite high in Washington State because:

(a) There is a strong emphasis on early

identification of suspect TB patients; (b)

there is a strong emphasis on employee

training and regular tuberculin skin

testing (although on a less-frequent basis

than recommended in the Guidelines:

All employees are tested at hire and

annually thereafter); (c) the use of

respirators is expected when entering an

isolation room; and (d) all isolation

rooms are under negative pressure, have

UV lights, and exhaust to the outside. In

addition, conversion data in hospitals

are more likely to represent true TB

infections than in the other health care

settings, because hospitals are more

likely to re-test converters in an effort to

eliminate false-positive cases.

A more thorough analysis of the

hospital data is presented in table V–3.

Because the Washington State survey

was not designed to compare exposed

persons with matched controls who

have had no exposure, several

alternative definitions of an internal

control (unexposed) group were used in

analyzing this data set. Three different

analyses, shown in table V–3, produced

estimates of annual occupational

infection rates ranging from 0.4 to 0.6

per 1,000 above control (i.e., ranging

from a 47% to an 84% increase above

control). In order to minimize the

likelihood of contaminating the control

group with persons having significant

occupational exposure, OSHA defined

the control group as workers in

hospitals located in zero-TB counties

and with no known TB patients. This

analysis is summarized in table V–3 as

Definition 1. If potential for

occupational exposure is defined as
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54195

either working in a hospital in a county

that has active TB or in a hospital that

has had TB patients, then the annual

risk due to occupational exposure is

47% above background. The excess

annual risk due to occupational

exposure appears to be approximately

60% above background, if workers in

hospitals with a transfer-out policy for

TB patients are considered to be the

control group, shown as Definition 2 in

table V–3. A 60% increase above

background is not statistically

significantly different from a 47%

increase and therefore these two

‘‘control’’ groups can be viewed as

producing ‘‘statistically’’ equivalent

results. However, the Agency believes

that Definition 1 is more appropriate,

though the risk estimates are higher if

the control group is defined based on

Definition 2, because there is a higher

likelihood of potential for exposure to a

patient with undiagnosed TB under

Definition 2 conditions. Comparisons of

all hospital TST data to the state-wide

estimate of TB infection rate resulted in

an estimate of the annual excess

occupational risk of approximately 84%

above background, shown in table V–3

as Definition 3. Estimates of the annual

and lifetime occupational risk of TB

infection for the average health care

worker in hospitals by state,

extrapolated from this study and using

Definition 1 as the control group, are

presented and summarized in section 4.

TABLE V–3—WASHINGTON STATE DATA HOSPITAL PPD SKIN TESTING RESULTS

Definition of exposed and control groups Sample size

Number of

skin tests

given

Number of

conversions

observed

Average conversion rate

1 a

Overall conversion rate

2 b

Relative risk

Rate 1 Rate 2

Definition 1

Control: Hospitals in zero-TB counties and with

no-known TB patients ...................................... 16 1,142 1 0.477 0.8756 ............ ..............

Exposed: Hospitals in counties reporting TB or

having TB patients ........................................... 60 38,148 49 1.523 1.28447 3.19 1.47

Definition 2

Control: Hospitals that transfer out TB patients 35 3,645 3 0.498 0.823 ............ ..............

Exposed: Hospitals with isolation rooms ............ 41 35,645 47 1.989 1.3185 3.99 1.602

Definition 3

Control: State-wide estimates of annual risk of

infection ........................................................... .................... .................... .................... c0.69 c0.69 ............ ..............

Exposed: All PPD testing data ............................ 76 39,290 50 1.302 1.27 1.89 1.84

aRate 1 is estimated as the arithmetic average of hospital specific conversion rates.

bRate 2 is estimated as the ratio of the sum of all conversions reported divided by the total number of skin tests given within each group.

cSource: Table V–3(b), state-wide rate of infection.

Annual rates of excess risk due to

occupational exposure were estimated

for long-term care, home health care,

and home care and are presented in

Section 4. The same control group used

in the hospital data analysis, Definition

1 (i.e., 0.876/1,000 workers at risk) was

used to estimate the background risk

among workers in long-term care, health

care, and home care facilities and

settings. Using 0.876 as the background

infection rate for workers in these

settings (a) provided a level of

consistency among the Washington data

analyses, and (b) resulted in a lower

estimate of occupational risk for the

non-hospital health care workplaces

than would have resulted had the statewide background risk estimate (i.e.,

0.67/1,000 see Section 3) been used.

When industry-specific risk data are

used, there is approximately a 10-fold

increase in annual risk for workers in

long-term care, a 5-fold increase in

annual risk for workers in home health

care, and a 1-fold increase in annual risk

for workers in home care (see Section 4).

Estimates of the range of annual and

lifetime occupational risk for the

average health care worker in long-term

care, home health care, and home care

by state, extrapolated from the

Washington State study, are presented

in Section 4.

(b) North Carolina Study: A statewide survey of all hospitals in North

Carolina (NC) was conducted in 1984–

1985 (Ex. 7–7). The survey’s

questionnaire was designed to address

three main areas of concern affecting

hospital employees: (1) Tuberculin skin

testing practices; (2) TB infection

prevalence; and (3) TB infection

incidence. The incidence of new

infections among hospital personnel

was assessed over a five-year period by

reviewing tuberculin skin test

conversion data during calendar years

1980 through 1984 and was calculated

as the number of TB skin test

conversions divided by the number of

skin tests administered. (Since most

employees were only given annual

testing, the number of tests

administered is a very close estimate of

the total number of people tested within

a year and thus can be used as the

denominator in estimating infection

incidence.) Only 56 out of 167 hospitals

reported information on TB conversion

rates (34% response rate). The authors

estimated a state-wide TB infection rate

of 11.9 per 1,000 per year for hospital

employees in 1984 and a five-year mean

annual infection rate of 11.4 per 1,000,

with a range of 0-89 per 1000 employees

at risk for TB infection. An analysis of

the data by region (i.e., eastern, central,

western) showed that the eastern region

had consistently higher rates (with an

average infection rate of 18.0 per 1,000)

followed by the central region (7.0 per

1,000) and the western region (6.1 per

1000). Results of this study are shown

in table V–4.
54196 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

1Using the state-wide estimate of population risk

as the background estimate of risk for this study

most likely results in an underestimate of the true

excess risk due to occupational exposure, because

the true background estimate of risk for the western

region in North Carolina is expected to be less than

the state-wide estimate, which is influenced by the

large number of infections found in the eastern

region of that state.

TABLE V–4—SKIN TEST CONVERSION RATES a NORTH CAROLINA HOSPITAL PERSONNEL b

Region

Year

1980 1981 1992 1993 1984 5-year mean

Eastern .................................................................. 19.3

(7)

30.8

(10)

17.7

(11)

11.2

(12)

15.7

(18)

18.0

(19)

Central ................................................................... 3.0

(6)

3.7

(8)

7.2

(13)

6.6

(23)

10.0

(25)

7.0

(29)

Western ................................................................. 1.9

(2)

13.5

(4)

5.3

(4)

4.1

(4)

7.2

(8)

6.1

(8)

a Conversion rates are expressed as number of conversions per 1,000 workers tested.

b In parentheses is the number of hospitals included in the study.

Use of this study’s overall results for

risk estimates was criticized by the peer

reviewers because of design flaws in the

study (e.g., high non-response rate,

inconsistent skin testing practices, and

limited two-step testing) and, most

importantly, the presence of atypical

mycobacteria (contributing to false

positive results) in the eastern part of

the state. Based on further input from

Dr. Comstock, the Agency chose to rely

on the study results from the western

region only, because they are considered

to be more representative of the ‘‘true’’

risk of infection and are expected to be

less confounded by cross-reactions to

atypical mycobacteria. Further, the

Agency chose to rely on the conversion

rate estimated for 1984 because it was

the most recent data reported in the

study. Therefore, the western region

conversion rate of 7.2 per 1,000,

estimated based on responses to the

survey from eight hospitals in 1984, was

used as an overall worker conversion

rate. Further, the 1984 rate was adjusted

by the percent decrease of active TB

between 1984 and 1994 in North

Carolina so that the final worker

conversion rate for 1994 based on the

western region rates reported in this

study was estimated to be 5.98 (7.2 *

532/641 = 5.98) per 1,000 employees at

risk for TB infection.

The North Carolina study did not

have an internal control group to use as

the basis for estimating excess risk due

to occupational exposure because the

conversion rates presented in this study

were based on TST results for the entire

hospital employee population. In the

absence of an internal control group, the

Agency used the estimated state-wide

background rate of 1.20 per 1,000 as the

background rate of infection for the

western region in North Carolina (see

Section 3) to estimate excess risk due to

occupational exposure.1 Based on this

study, annual occupational risk is

approximately four times greater than

background [(5.98–1.2)/1.2 = 3.98].

Estimates of the annual and lifetime

occupational risk of TB infection based

on this study by state are presented in

Section 4.

(c) Jackson Memorial Hospital Study:

Jackson Memorial Hospital (JMH) is a

1500-bed general facility located in

Miami, Florida, employing more than

8,000 employees. It is considered one of

the busiest hospitals in the U.S. It is the

primary public hospital for Dade County

and the main teaching hospital for the

University of Miami School of

Medicine. JMH treats most of the TB

and HIV cases in Dade County and,

consequently, there is a higher

likelihood of occupational exposure to

TB in this facility than in the average

hospital in the U.S. From March 1988 to

September 1990, an outbreak of

multidrug-resistant TB (MDR–TB)

occurred among patients and an

increased number of TST conversions

was observed among health care

workers on the HIV ward. This

prompted a re-evaluation of the

hospital’s infection control practices

and the installation of engineering

controls to minimize exposure to TB. As

part of the evaluation of the outbreak,

NIOSH did a Health Hazard Evaluation

and issued a report (Ex. 7–108). In

addition, NIOSH conducted a

retrospective cohort study of JMH to

determine whether the risk of TB

infection was significantly greater for

health care workers who work on wards

having patients with infectious TB than

those who work on wards without TB

patients.

For the data analysis of this study,

‘‘potential for occupational exposure’’

was defined based on whether an

employee worked on a ward that had

records of 15 or more positive cultures

for pulmonary or laryngeal TB during

1988–1989. In other words, positive

culture was taken as a surrogate for

exposure to infectious TB. The authors

restricted the ‘‘exposed’’ group to

employees on wards with exposures to

pulmonary or laryngeal TB because they

intended to restrict the study to hospital

workers with exposure to patients with

the highest potential for being

infectious. There were 37 wards at JMH

that had submitted at least one positive

culture during 1988–1989. Seven wards

met the criteria of 15 or more and were

therefore included in the ‘‘exposed’’

group. These were the medical intensive

care unit, five medical wards, and the

emergency room. The ‘‘control’’ group

was defined as hospital workers

assigned to wards with no TB patients

(i.e., wards with no records of positive

cultures during 1988–89). The ‘‘control’’

wards were post-partum, labor and

delivery, newborn intensive care unit,

newborn intermediate care unit, and

well newborn unit. The results of this

analysis are presented in Table V–5.

TABLE V–5—SKIN TEST CONVERSION RATES FOR HOSPITAL PERSONNEL AT JACKSON MEMORIAL HOSPITAL a, b

Year Exposed

group

Control

group

Relative

risk

95%

confidence

interval

1989 .............................................................................................................................. 62.2

(13/209)

6.2

(2/324)

10.1 2.3—44.2
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54197

TABLE V–5—SKIN TEST CONVERSION RATES FOR HOSPITAL PERSONNEL AT JACKSON MEMORIAL HOSPITAL a, b—

Continued

Year Exposed

group

Control

group

Relative

risk

95%

confidence

interval

1990 .............................................................................................................................. 75.5

(16/212)

6.5

(2/309)

11.7 2.7—50.2

1991 .............................................................................................................................. 31.7

(6/189)

3.5

(1/282)

9.0 1.1—73.8

a Rates are expressed as number of conversions per 1,000 workers tested.

b Source: Ex. 7–108

Table V–5 shows a substantially

elevated risk for those workers with

potential exposure to patients with

infectious TB. The relative risk ranges

from 9 to 11.7 between 1989 and 1991

and is statistically significant for all of

those years. This suggests that the

excess risk due to occupational

exposure is approximately 8-fold above

background; this is an overall risk

estimate that reflects the occupational

risk of TB infection for JMH employees

with patient contact, because this

analysis included everyone tested in the

‘‘exposed’’ and ‘‘control’’ group,

regardless of his or her specific job

duties or length of patient contact.

An analysis of various occupational

groups within this cohort showed that

nurses and ward clerks in the

‘‘exposed’’ groups had the highest

conversion rates: 182 and 156

conversions per 1,000 workers tested,

respectively. Other studies have shown

that health care workers who provide

direct patient care are at greater risk for

infection than workers who do not

provide direct patient care. The high

risk seen in ward clerks was unexpected

since these workers are not involved in

direct patient care. However, in the

emergency room, the risk for TST

conversion for the ward clerks was

almost three times higher than for the

nurses, 222 and 83 per 1,000,

respectively. Ward clerks in the

emergency room are responsible for

clerical processing of patients after

triage, handling specimens for the

laboratory, and gathering clothing and

valuables from admitted patients.

During these interactions, there may

have been less strict adherence to

infection control measures, and this

could explain the high conversion rate.

OSHA used the results from the 1991

analysis of the data in the JMH study to

estimate occupational risk of TB

infection in hospital workers with a

relatively high likelihood of

occupational exposure, for the following

reasons: (a) 1991 represents the most

recent year for which conversion data

are available prior to the time when TB

infection control measures were fully

implemented at JMH; and (b) The higher

conversion rates reported for 1990 and

1989 (75.5 and 62.2 per 1,000

respectively) may be atypical, i.e., they

may to some extent reflect the effect of

the outbreak and not the long-term

occupational risk.

Based on the results of this study,

OSHA estimates that the annual excess

risk of TB infection due to occupational

exposure is 7.95 times greater than

background. Estimates of annual and

lifetime occupational risk of TB

infection for the average health care

worker in hospitals by state,

extrapolated from this study, are

presented and summarized in section 4.

3. Estimation of Background Risk of TB

Infection

OSHA’s methodology for estimating

population (background) TB infection

rates relies on the assumption that TB

infection occurring in an area can be

expressed as a numerical function of

active TB cases reported in the same

area. If the likelihood of observing any

infection in a population is minimal,

then the likelihood of observing active

disease diminishes. Conversely, the

presence of active TB implies the

presence of infection, since active

disease can only progress from

infection. Therefore, there is a

functional relationship linking TB

infections to active disease being

observed in a particular area during a

specified time period.

Peer reviewer comments on this

assumption varied. Neil Graham states

in his comment ‘‘Although factors such

as migration and distribution of the

population may influence this

relationship it seems probable that this

assumption is largely correct and

justifiable.’’ (Ex. 7–271). On the other

hand, Dr. Simone expresses concern

over this assumption and states ‘‘It is

not necessarily true that a change in

cases now reflects the risk of infection

now.’’ Dr. Qaqish demonstrates in his

comment that the net effect of assuming

a proportional relationship between the

number of active cases and the number

of new infections is to introduce a

possible bias into the estimate of

background risk of TB infection,

although such a bias could work in

either direction, i.e., toward increasing

or decreasing the estimate of risk. Dr.

Qaqish further states that in the absence

of more ‘‘relevant data,’’ it is not

possible to determine the actual net

effect in magnitude and direction of the

bias and ‘‘without obtaining additional

data, it would be impossible for the

Agency to improve on the accuracy of

the risk estimates * * * ’’ OSHA has

considered all of the reviewer comments

and is aware of the inherent uncertainty

and the potential for bias associated

with the use of this assumption;

however, in the absence of the

additional ‘‘relevant’’ data to which Dr.

Qaqish refers, the Agency believes this

approach to be justifiable.

In defining the model used to estimate

the annual infection rates occurring in

a geographical area based on data on

active disease cases reported for the

same area, infections progressing to

active disease are assigned to one of

three distinct groups: those occurring

this year, last year, and in previous

years.

BILLING CODE 4510–26–P
54198 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

2Using the prevalence of TB infection in 1992

(i.e., Pi(1992)) to approximate the quantity inside the

summation sign (i.e., everyone infected between

1919 and 1992 and alive in 1994) slightly

overestimates the quantity inside the summation

(i.e., Pi(1992) is slightly larger than the quantity it

approximates.) It includes a small number of people

BILLING CODE 4510–26–C

TB cases reported to CDC each year

are a combination of new and old

infections that have, for various reasons,

progressed to active disease. Until

recently, it was believed that most of the

active cases were the product of old

infections. However, with the use of

DNA fingerprinting techniques,

researchers have reported that a larger

percentage of active cases may be

attributed to new or recent infections.

Small et al. reported, in an article on

tracing TB through DNA fingerprinting,

that as many as 30% of the active cases

reviewed in the study may be the result

of recent infections (Ex. 7–196).

In this risk assessment, the Agency

assumes the lifetime risk that an

infection will progress to active TB to be

approximately 10%. This estimate is

supported by CDC and in her comment,

Dr. Simone states that: ‘‘The assumption

* * * is generally agreed upon.’’ Dr.

Comstock and Dr. Qaqish both

questioned the validity and accuracy of

CDC’s estimate. Their comments suggest

that the true lifetime rate of progression

from infection to active disease for

adults may be less than 10 percent.

However, as Dr. Graham points out, the

10% assumption is a widely accepted

‘‘rule of thumb’’ and is also in relative

agreement with data from the

unvaccinated control group of the

British Medical Research Council (MRC)

vaccination trial in adolescents (Ex. 7–

266).

In the MRC study, 1,338 adolescents’

skin tests converted following TB

exposure where the precise date of

conversion was known. Of these, 108

(8.1%) individuals developed active TB

during follow-up. Of these, 54%

developed active TB within one year

and 78% within 2 years. This results in

a risk of approximately 4% at one year,

6% at two years, and an overall risk of

8%. Given that the risk of TB

reactivation increases with age, the

lifetime risk is expected to be higher

than the 8% attained in this study and,

as Dr. Graham points out, a 10% overall

lifetime risk seems reasonable.

Based on Dr. Graham’s

recommendation to rely on the

progression rates from the MRC study,

OSHA changed the assumption on the

progression parameters from 2.5% (first

year), 2.5% (second year), and 5%

(remaining lifetime) to 4%, 2% and 4%,

respectively. Therefore the total 10%

progression from infection to active

disease is partitioned into 3 groups:

progression during the first year after

infection (40% of all infections that

eventually progress, for a net probability

of 4%), progression during the second

year (20% of all infections that

eventually progress, for a net probability

of 2%), and progression during all

subsequent years (the remaining 40% of

progressing infections). This last

probability (4%) is assumed to be

uniformly distributed across the

remaining lifespan.

TB rates vary considerably by

geographic area, socio-economic status,

and other factors. In an attempt to

account for some of those factors, to the

extent possible, background TB

infection rates have been estimated

separately for each state. The derivation

of background infection rates involves

several steps for which the process and

formulae are presented below.

Step 1: Background rate of TB

infection for state i in year j is defined

as:

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

where:

Bi(j) is the background TB infection rate

for state i in year j

Ii(j) is an estimate of the number of new

infections that occurred in state i in

year j

Xi(j) is the population at risk for TB

infection in state i in year j.

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

of new TB infections:

Let:

Ai(j) be the total number of adult TB

cases reported to CDC by state i in

year j.

A(j) be the total number of adult TB

cases reported to CDC by all states

in year j.

Pi(j) be the estimated prevalence of adult

TB infection in state i during year

j.

Ri be the ratio of the number of adult TB

cases reported in 1993 to the

number of adult cases reported in

1994 in state i.

The number of TB cases reported in

1994 can be expressed as a function of

TB infections expected to have

progressed to active disease, by the

following formula:

Ai(1994)=.04*Ii(1994)+.02*Ii(1993)+(.04/

73)*Ii(1992)*prob(alive in 1994)

+(.04/73)*Ii(1991)*prob(alive in 1994)

+....

+....

+(.04/73)*Ii(1919)*prob(alive in 1994)

This can be expressed as:

Ai(1994)=.04*Ii(1994)+.02*Ii(1993)+(.04/

73)*∑ [Ii(j)*prob(alive in 1994)],

where j ranges from 1919 to 1992. The

quantity inside the summation symbol

is the sum of all people who were

infected with TB between 1919 and

1992 and are still alive in 1994. This

summation can be approximated by the

prevalence of TB infection in 1992,

Pi(1992). Therefore, the number of active

TB cases reported in 1994 can be

expressed as:

Ai(1994)=.04*Ii(1994)+.02*Ii(1993)+(.04/

73)*Pi(1992) (2)

Further, if we assume that the number

of new infections is directly

proportional to the number of active

cases, then Ii(1993) can be expressed as

follows:

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

and (2) can be expressed as:

Ai(1994)=[(.02*(Ai(1993)/

Ai(1994))+.04]*Ii(1994)+(.04/73)*Pi(1992)

Ai(1994)=[(.02*Ri+.04]*Ii(1994)+(.04/

73)*Pi(1992) (4)

then solving for Ii(1994) becomes: 2
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54199

who were infected with TB and were alive as of

1992 and who were therefore included in the

prevalence figure, but who died before 1994, and,

technically, are not included in the summation.

This implies that, in equation (5), a slightly larger

number is being subtracted from Ai(1994) than should

be, resulting in an underestimate of the number of

new infections in 1994 and an underestimate of the

occupational risk.

Ii(1994)=[Ai(1994)¥.04/73*Pi(1992)]/

(.02*Ri+.04) (5)

Step 3: Estimation of Xi(1994):

Xi(1994), the population at risk for TB

infection in state i in 1994, is estimated

as follows:

Xi(1994)=Ni¥Pi(1993) (6)

Where:

Ni is the adult population for state i as

reported by U.S. Census in 1994.

Pi(1993) is the estimated number of

infected adults in state i in 1993

(i.e., prevalence of TB infection in

state i among adults).

To estimate the number of adults

currently at risk for TB infection in each

state, the number of already infected

adults (i.e., prevalence of TB infection Pi

in 1993) is subtracted from the adult

population in 1994.

Step 4: Estimation of population

currently infected as of 1993 by state,

Pi(1993):

The prevalence of TB infection in

each state is estimated as a function of

TB infection prevalence in the U.S. in

1993 and the percent TB case rate for

each state.

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

Where:

P(1993) is the prevalence of TB infections

in the U.S. in 1993 (Ex. 7–66) and

A(1993) is the total number of adult TB

cases reported in 1993.

Estimates of TB infection prevalence

in the U.S. were developed for OSHA by

Dr. Christopher Murray of the Harvard

Center for Population and Development

Studies and are presented in Table V–

6 (Ex. 7–267). The mathematical model

used by Dr. Murray to estimate TB

infection prevalence has been designed

to capture the transmission dynamics of

TB by modeling transfers between a

series of age-stratified compartments

using a system of differential equations.

The model adjusts for various

epidemiological factors known to

influence the course of active TB, such

as onset of infection (i.e., old vs. new

infections) and the impact of

immigration rates and the HIV

epidemic. However, it does not

differentiate among gender or race

categories. The model has been

successfully validated using actual

epidemiological data on active TB from

1965 to 1994. The estimates of TB

prevalence rates presented here are

specific for adults (i.e., older than 18

years of age), which make them more

appropriate for estimating risk of

transmission in an occupational setting.

TABLE V–6.—NATIONAL PREVALENCE OF TB INFECTION IN ADULTS (18+) a b

Year Expected Minimum Maximum

1992 ........................................................................................................................................ 6.87%

(12,978,461)

6.53%

(12,336,150)

7.22%

(13,639,663)

1993 ........................................................................................................................................ 6.64%

(12,667,062)

6.31%

(12,037,524)

6.97%

(13,296,599)

1994 ........................................................................................................................................ 6.47%

(12,449,445)

6.14%

(11,814,465)

6.79%

(13,065,182)

a Numbers in parentheses are population prevalence figures.

bEstimated for OSHA by Christopher Murray MD, PhD, Harvard University, Center for Population and Development Studies (Ex. 7–267).

To estimate the number of previously

infected adults in each state (Pi), the

estimated national TB prevalence figure

was multiplied by the active cases for

each state and divided by the total

number of active cases reported [see

equation (7)] (i.e., the national

prevalence estimate was apportioned

among the states based on each state’s

percent contribution to active TB

reported for 1993). To estimate the

number of adults at risk of TB infection,

(Xi), the number of already infected

adults was subtracted from the adult

population estimate for each state (see

equation (6)). The number of new

infections expected to have occurred in

1994 was estimated using equation (5).

The background rate of TB infection

for 1994 was then estimated by dividing

the number of new infections (Ii) by the

number of susceptible adults in each

state (Xi) (see equation (1)).

Results on estimated TB background

annual infection rates for each state are

presented in Table V–7(a)—Table V–

7(c). In Table V–7(a) TB infection rates

are based on an average value of TB

infection prevalence, as estimated by Dr.

Murray, in the U.S. (i.e., 12,667,062). In

Table V–7(b), infection rates are based

on the minimum value of TB infection

prevalence in the U.S. (i.e., 12,037,524).

In Table V–7(c), infection rates are

based on the maximum value of TB

infection prevalence in the U.S. (i.e.,

13,296,599). An overall range of

background annual TB infection rates

was constructed by combining all three

sets of infection rates and was estimated

to be between 0.194 and 3.542 per 1,000

individuals at risk of TB infection, with

a weighted average of 1.46 per 1,000

using state population size as weights.

TABLE V–7(a).—ESTIMATES OF ANNUAL BACKGROUND TB INFECTION RATES a

[Referent Year 1994]

State TB cases reported in 1994

Population

size a

Population

currently infected b

Population at

risk

Estimate of

new infections

Annual population rate of

TB infection

Ai Ni Pi(1993) Xi Ii Bi

Alabama (01) ............................................ 413 3,139 250,083 2,888,917 4,779 1.65

Alaska (02) ................................................ 78 414 27,787 386,213 1,182 3.06

Arizona (04) .............................................. 233 2,936 118,231 2,817,769 2,858 1.01

Arkansas (05) ............................................ 235 1,813 107,334 1,705,666 2,906 1.70

California (06) ........................................... 4,291 22,754 2,437,044 20,280,956 47,852 2.36
54200 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

TABLE V–7(a).—ESTIMATES OF ANNUAL BACKGROUND TB INFECTION RATES a—Continued

[Referent Year 1994]

State TB cases reported in 1994

Population

size a

Population

currently infected b

Population at

risk

Estimate of

new infections

Annual population rate of

TB infection

Ai Ni Pi(1993) Xi Ii Bi

Colorado (08) ............................................ 90 2,686 52,850 2,633,150 1,045 0.40

Connecticut (09) ........................................ 144 2,487 81,182 2,405,818 1,665 0.69

Delaware (10) ........................................... 51 531 26,152 504,848 671 1.33

D.C. (11) ................................................... 116 451 80,092 370,908 1,162 3.13

Florida (12) ................................................ 1,675 10,691 846,687 9,844,314 20,545 2.09

Georgia (13) .............................................. 676 5,162 396,646 4,765,354 7,082 1.49

Hawaii (15) ................................................ 234 875 132,942 742,058 25,890 3.49

Illinois (17) ................................................. 1,021 8,669 622,211 8,046,789 10,994 1.37

Indiana (18) ............................................... 201 4,279 129,673 4,149,327 2,083 0.50

Iowa (19) ................................................... 62 2,180 31,056 2,068,943 859 0.42

Kansas (20) ............................................... 77 1,864 37,049 1,826,951 1,065 0.58

Kentucky (21) ............................................ 316 2,857 203,227 2,653,773 3,273 1.23

Louisiana (22) ........................................... 412 3,080 185,792 2,894,208 5,582 1.93

Maine (23) ................................................. 31 934 14,712 919,289 419 0.46

Maryland (24) ............................................ 344 3,743 211,399 3,531,601 3,582 1.01

Massachusetts (25) ................................... 299 4,617 183,067 4,433,933 2,889 0.65

Michigan (26) ............................................ 438 6,971 246,269 6,724,731 5,036 0.75

Minnesota (27) .......................................... 127 3,326 68,105 3,257,895 1,413 0.43

Mississippi (28) ......................................... 262 1,913 141,659 1,771,341 3,120 1.76

Missouri (29) ............................................. 241 3,899 128,583 3,770,417 2,922 0.78

Montana (30) ............................................. 22 618 11,987 606,013 290 0.48

Nebraska (31) ........................................... 22 1,181 12,531 1,168,469 233 0.20

Nevada (32) .............................................. 111 1,181 50,670 1,130,330 1,514 1.34

New Hampshire (33) ................................. 17 845 13,076 831,924 182 0.22

New Jersey (34) ........................................ 764 5,973 456,579 5,516,421 8,150 1.48

New Mexico (35) ....................................... 78 1,156 35,415 1,120,585 944 0.84

New York (36) ........................................... 3,414 13,658 2,044,797 11,613,203 34,728 2.99

North Carolina (37) ................................... 532 5,314 298,574 5,015,426 6,000 1.20

North Dakota (38) ..................................... 10 466 3,813 426,186 132 0.29

Ohio (39) ................................................... 318 8,248 161,274 8,086,726 3,763 0.47

Oklahoma (40) .......................................... 231 2,378 101,886 2,276,114 3,064 1.35

Oregon (41) ............................................... 146 2,303 78,457 2,224,543 1,793 0.81

Pennsylvania (42) ..................................... 583 9,154 379,211 8,774,789 5,886 0.67

Rhode Island (44) ..................................... 47 757 31,601 725,399 495 0.68

South Carolina (45) ................................... 362 2,712 205,406 2,506,594 4,273 1.70

South Dakota (46) ..................................... 26 513 8,173 504,827 342 0.68

Tennessee (47) ......................................... 494 3,878 283,863 3,594,137 5,759 1.60

Texas (48) ................................................. 2,276 13,077 1,199,200 11,877,800 27,306 2.30

Utah (49) ................................................... 47 1,236 23,973 1,212,027 427 0.35

Vermont (50) ............................................. 10 434 2,724 431,276 160 0.37

Virginia (51) ............................................... 330 4,949 226,110 4,722,890 3,220 0.68

Washington (53) ........................................ 241 3,935 142,729 3,792,251 2,554 0.67

West Virginia (54) ..................................... 80 1,393 40,318 1,352,682 919 0.68

Wisconsin (55) .......................................... 104 3,735 50,126 3,684,874 1,307 0.35

Wyoming (56) ............................................ 12 339 3,814 335,186 188 0.56

aExpressed in thousands.

bBased on 6.64% rate of TB infection prevalence in the U.S. (expected)

TABLE V–7(b).—Estimates of Annual Background TB Infection Rates

[Referent Year 1994 a]

State TB cases reported in 1994

Population

size a

Population

currently infected b

Population at

risk

Estimate of

new infections

Annual population rate of

TB infection

Ai Ni Pi(1993) Xi Ii Bi

Alabama (01) ............................................ 413 3,139 237,654 2,901,346 4,871 1.68

Alaska (02) ................................................ 78 414 26,406 387,594 1,196 3.09

Arizona (04) .............................................. 233 2,936 112,355 2,823,645 2,913 1.03

Arkansas (05) ............................................ 235 1,813 102,000 1,711,000 2,967 1.73

California (06) ........................................... 4,291 22,754 2,350,136 20,403,864 48,956 2.40

Colorado (08) ............................................ 90 2,686 50,223 2,635,777 1,066 0.40

Connecticut (09) ........................................ 144 2,487 77,147 2,409,853 1,700 0.71

Delaware (10) ........................................... 51 531 24,853 506,147 681 1.34

D.C. (11) ................................................... 116 451 76,111 374,889 1,192 3.18
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TABLE V–7(b).—Estimates of Annual Background TB Infection Rates—Continued

[Referent Year 1994 a]

State TB cases reported in 1994

Population

size a

Population

currently infected b

Population at

risk

Estimate of

new infections

Annual population rate of

TB infection

Ai Ni Pi(1993) Xi Ii Bi

Florida (12) ................................................ 1,675 10,691 804,607 9,886,393 20,944 2.12

Georgia (13) .............................................. 676 5,162 376,933 4,785,067 7,275 1.52

Hawaii (15) ................................................ 234 875 126,335 748,665 2,652 3.54

Illinois (17) ................................................. 1,021 8,669 591,288 8,077,712 11,260 1.39

Indiana (18) ............................................... 201 4,279 123,228 4,155,772 2,136 0.51

Iowa (19) ................................................... 62 2,180 29,513 2,070,487 869 0.42

Kansas (20) ............................................... 77 1,864 35,208 1,828,792 1,079 0.59

Kentucky (21) ............................................ 316 2,857 193,126 2,663,874 3,357 1.26

Louisiana (22) ........................................... 412 3,080 176,558 2,903,442 5,667 1.95

Maine (23) ................................................. 31 934 13,980 920,020 425 0.46

Maryland (24) ............................................ 344 3,743 200,893 3,542,107 3,677 1.04

Massachusetts (25) ................................... 299 4,617 173,969 4,443,031 2,983 0.67

Michigan (26) , .......................................... 438 6,971 234,030 6,736,970 5,144 0.76

Minnesota (27) .......................................... 127 3,326 64,721 3,261,279 1,448 0.44

Mississippi (28) ......................................... 262 1,913 134,619 1,778,381 3,183 1.79

Missouri (29) ............................................. 241 3,899 122,193 3,776,807 2,978 0.79

Montana (30) ............................................. 22 618 11,391 606,609 294 0.48

Nebraska (31) ........................................... 22 1,181 11,909 1,169,091 240 0.21

Nevada (32) .............................................. 111 1,181 48,152 1,132,848 1,536 1.36

New Hampshire (33) ................................. 17 845 12,426 832,574 185 0.22

New Jersey (34) ........................................ 764 5,973 433,887 5,539,113 8,357 1.51

New Mexico (35) ....................................... 78 1,156 33,655 1,112,345 965 0.86

New York (36) ........................................... 3,414 13,658 1,943,173 11,714,827 35,735 3.05

North Carolina (37) ................................... 532 5,314 283,735 5,030,265 6,138 1.22

North Dakota (38) ..................................... 10 466 3,624 462,376 134 0.29

Ohio (39) ................................................... 318 8,248 153,259 8,094,741 3,845 0.48

Oklahoma (40) .......................................... 231 2,378 96,822 2,281,178 3,116 1.37

Oregon (41) ............................................... 146 2,303 74,558 2,228,442 1,825 0.82

Pennsylvania (42) ..................................... 583 9,154 360,365 8,793,635 6,047 0.69

Rhode Island (44) ..................................... 47 757 30,030 726,970 506 0.70

South Carolina (45) ................................... 362 2,712 195,197 2,516,803 4,356 1.73

South Dakota (46) ..................................... 26 513 7,766 505,234 350 0.69

Tennessee (47) ......................................... 494 3,878 269,756 3,608,244 5,875 1.63

Texas (48) ................................................. 2,276 13,077 1,139,601 11,937,399 27,853 2.33

Utah (49) ................................................... 47 1,236 22,782 1,213,218 446 0.37

Vermont (50) ............................................. 10 434 2,589 431,411 162 0.37

Virginia (51) ............................................... 330 4,949 214,873 4,734,127 3,311 0.70

Washington (53) ........................................ 241 3,935 135,654 3,799,346 2,621 0.69

West Virginia (54) ..................................... 80 1,393 38,315 1,354,685 941 0.69

Wisconsin (55) .......................................... 104 3,735 47,634 3,687,366 1,332 0.36

Wyoming (56) ............................................ 12 339 3,624 335,376 190 0.57

aExpressed in thousands.

bBased on a 6.31% rate of TB infection in the U.S.

TABLE V–7(c).—ESTIMATES OF ANNUAL BACKGROUND TB INFECTION RATES

[Referent Year 1994 a]

State TB cases reported in 1994

Population

size

Population

currently infected b

Population at

risk

Estimate of

new infections

Annual population rate of

TB infection,

Ai Ni Pi(1993) Xi Ii Bi

Alabama (01) ............................................ 413 3,139 262,512 2,876,488 4,685 1.63

Alaska (02) ................................................ 78 414 29,168 384,832 1,167 3.03

Arizona (04) .............................................. 233 2,936 124,107 2,811,893 2,801 1.00

Arkansas (05) ............................................ 235 1,813 112,669 1,700,332 2,843 1.67

California (06) ........................................... 4,291 22,754 2,595,951 20,158,049 46,720 2.32

Colorado (08) ............................................ 90 2,686 55,476 2,630,524 1,024 0.39

Connecticut (09) ........................................ 144 2,487 85,216 2,401,784 1,629 0.68

Delaware (10) ........................................... 51 531 27,452 503,508 661 1.31

D.C. ........................................................... 116 451 84,072 366,928 1,131 3.08

Florida (12) ................................................ 1,675 10,691 888,766 9,802,234 20,137 2.05

Georgia (13) .............................................. 676 5,162 416,359 4,745,641 6,884 1.45

Hawaii (15) ................................................ 234 875 139,539 735,451 2,526 3.43

Illinois (17) ................................................. 1,021 8,669 653,134 8,015,866 10,721 1.34
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TABLE V–7(c).—ESTIMATES OF ANNUAL BACKGROUND TB INFECTION RATES—Continued

[Referent Year 1994 a]

State TB cases reported in 1994

Population

size

Population

currently infected b

Population at

risk

Estimate of

new infections

Annual population rate of

TB infection,

Ai Ni Pi(1993) Xi Ii Bi

Indiana (18) ............................................... 201 4,279 136,117 4,142,883 2,029 0.49

Iowa (19) ................................................... 62 2,180 32,600 2,067,401 849 0.41

Kansas (20) ............................................... 77 1,864 38,891 1,825,109 1,052 0.58

Kentucky (21) ............................................ 316 2,857 213,327 2,643,673 3,187 1.21

Louisiana (22) ........................................... 412 3,080 195,025 2,884,975 5,496 1.91

Maine (23) ................................................. 31 934 15,442 918,558 413 0.45

Maryland (24) ............................................ 344 3,743 221,905 3,521,095 3,484 0.99

Massachusetts (25) ................................... 299 4,617 192,166 4,424,834 2,793 0.63

Michigan (26) ............................................ 438 6,971 258,508 6,712,492 4,925 0.73

Minnesota (27) .......................................... 127 3,326 71,490 3,254,510 1′,377 0.42

Mississippi (28) ......................................... 262 1,913 148,700 1,764,300 3,057 1.73

Missouri (29) ............................................. 241 3,899 134,973 3,764,027 2,865 0.76

Montana (30) ............................................. 22 618 12,582 605,418 286 0.48

Nebraska (31) ........................................... 22 1,181 13,154 1,167,846 227 0.20

Nevada (32) .............................................. 111 1,181 53,189 1,127,811 1,491 1.32

New Hampshire (33) ................................. 17 845 13,726 831,274 178 0.21

New Jersey (34) ........................................ 764 5,973 479,270 5,493,730 7,938 1.44

New Mexico (35) ....................................... 78 1,156 37,175 1,118,825 922 0.82

New York (36) ........................................... 3,414 13,658 2,146,421 11,511,421 33,696 2.92

North Carolina (37) ................................... 532 5,314 313,413 5,000,587 5,859 1.17

North Dakota (38) ..................................... 10 466 4,003 461,997 129 0.28

Ohio (39) ................................................... 318 8,248 169,289 8,078,711 3,678 0.46

Oklahoma (40) .......................................... 231 2,378 106,949 2,271,051 3,011 1.33

Oregon (41) ............................................... 146 2,303 82,357 2,220,643 1,760 0.80

Pennsylvania (42) ..................................... 583 9,154 398,057 8,755,943 5,722 0.66

Rhode Island (44) ..................................... 47 757 33,171 723,829 483 0.67

South Carolina (45) ................................... 362 2,712 215,614 2,496,386 4,188 1.68

South Dakota (46) ..................................... 26 513 8,579 504,421 334 0.67

Tennessee (47) ......................................... 494 3,878 297,971 3,580,029 5,641 1.58

Texas (48) ................................................. 2,276 13,077 1,258,799 11,818,201 26,746 2.26

Utah (49) ................................................... 47 1,236 25,165 1,210,835 408 0.34

Vermont (50) ............................................. 10 434 2,860 431,140 158 0.37

Virginia (51) ............................................... 330 4,949 237,347 4,711,653 3,126 0.66

Washington (53) ........................................ 241 3,935 149,843 3,785,157 2,485 0.66

West Virginia (54) ..................................... 80 1,393 42,322 1,350,679 896 0.66

Wisconsin (55) .......................................... 104 3,735 52,617 3,682,383 1,283 0.35

Wyoming (56) ............................................ 12 339 4,003 334,997 185 0.55

aExpressed in thousands.

bBased on 6.97% rate of TB infection prevalence in the U.S. (maximum estimate).

Step 5 Model validation:

An alternative, but less sophisticated,

way to estimate annual risk of infection,

if prevalence is known in a specific age

group, is to use the following formula:

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

(8)

Where:

P is the percent prevalence of infection

and

d is the average age of the population

(Ex. 7–265).

In order to validate the model used by

OSHA to estimate background infection

rates, estimates of TB infection

prevalence for 1994 were used to

calculate predicted infection rates using

equation (8). Based on Murray’s model,

TB infection prevalence is expected to

range from 6.31% to 6.97% in 1994

among adults (18+). Using these figures

and assuming the average age to be 45

years, formula (8) predicts that infection

rates can range from 1.45 to 1.61 per

1,000. These results are in close

agreement with OSHA’s weighted

average estimate of the national TB

infection rate, which is 1.46 per 1,000.

4. Occupational Risk Estimations

OSHA used the three different data

sources to obtain estimates of risk of TB

infection for health care employees: the

Washington State data, the North

Carolina study, and the NIOSH Health

Hazard Evaluation (HHE) from Jackson

Memorial Hospital (Exs. 7–263, 7–7, 7–

108). The Washington State data

represent workplaces located in low TB

prevalence areas, where TB infection

control measures and engineering

controls are required by state health

regulations. The North Carolina data

represent workplaces located in areas

with moderate TB prevalence and

inadequate TB infection control

programs. Finally, the Jackson Memorial

Hospital data are representative of

county hospitals serving high-risk

patients whose employees have a high

frequency of exposure to infectious TB.

These data sources provide information

on the magnitude of the expected excess

risk in three different environments, and

are used to provide a range of possible

values of excess risk.

Based on the Washington State data,

the annual risk is expected to be 1.5

times the background rate for hospital

employees, approximately 11 times the

background rate for long-term care

employees, 6 times the background rate

for home health care workers, and

double the background rate for home

care employees. Based on the North

Carolina data, the annual risk is
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54203

expected to be approximately 5 times

the background rate. Based on the

Jackson Memorial Hospital data, the

annual risk is expected to be

approximately 9 times the background.

Estimates of expected excess risk of

TB infection for workers with

occupational exposure by state are

calculated by applying the excess

relative risk ratios, derived from the

three occupational studies, to the

overall background rate of infection for

each state and are presented in table V–

8(a)—table V–8(c). A range of excess

risk of TB infection due to occupational

exposure is constructed by using the

minimum and maximum estimates of

excess risk among all states for each

data source. These results are presented

in table V–9 and table V–10 for workers

in hospitals and for workers in other

work settings, respectively.

BILLING CODE 4510–26–P
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BILLING CODE 4510–26–C
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TABLE V–9.—OCCUPATIONAL RISK ESTIMATES FOR HOSPITAL EMPLOYEES a

Source Overall risk/

(exposed)

Background

risk based on

study

Excess risk

based on

study

(percent)

Range of excess occupational

risk d

Annual Lifetime

Washington State 1994 data ............................................ 1.24/1000 0.88/1000 47 0.09–1.66 4.1–72.2

North Carolina Western Counties ..................................... b 5.98/1000 d 1.20/1000 398 0.77–14.1 34.2–472

Jackson Memorial (1991) ................................................. 31.7/1000 3.5/1000 795 1.54–28.2 67.1–723

aBackground TB infection rate ranges from 0.194 to 3.542 per 1,000 at risk for TB infection.

bAjusted for 1994, i.e., 5.98=7.2*(532/641)

cThe range reflects regional differences in TB prevalence as well as inherent uncertainty in the estimate of TB infection prevalence in the U.S.,

as estimated by Dr. Christopher Murray, and used in the internal calculations of annual background TB infection rate. dState-wide estimate of population risk for North Carolina, shown in Table V–3(a).

TABLE V–10.—OCCUPATIONAL RISK ESTIMATES FOR OTHER WORK SETTINGS a,b

Type Overall risk/

(exposed)

Background

risk Statewide c

Excess risk

based on

study

(percent)

Range of excess occupational

risk d

Annual Lifetime

Long-term Care ................................................................. 9.8/1000 0.8756/1000 1019 1.98–36.1 85–807

Home Health Care ............................................................ 5.06/1000 0.8756/1000 478 0.93–16.9 40.9–526

Home Care ....................................................................... 1.86/1000 0.8756/1000 112 0.22–3.97 9.7–164

aBackground TB infection rate ranges from 0.194 to 3.542 per 1,000 employees at risk of infection.

bBased on the Washington State data.

cBackground rate for this analysis is assumed to be the same as in the case-control analysis of the Washington State hospital data (i.e.

0.8756 per 1,000 employees). dThe range reflects regional differences in TB prevalence as well as inherent uncertainty in the estimate of TB infection prevalence in the U.S.,

as estimated by Dr. Christopher Murray, and used in the internal calculations of annual background TB infection rate.

Lifetime estimates of the excess risk of

TB infection were estimated based on

the annual excess risk by using the

formula {1–(1–p) 45}, where p is the

annual excess risk. Lifetime excess

estimates of TB infection are presented

in table V–9 and table V–10. Lifetime

risk estimates of developing active TB

are calculated from lifetime risk

estimates of TB infection assuming that,

once infected, there is a 10% likelihood

of progressing to active TB; these

estimates are presented in table V–11

and table V–12. Further, the risk of

death caused by TB is calculated from

the lifetime estimates of active TB using

OSHA’s estimate of the TB case fatality

rate (also presented in table V–11 and

table V–12). The methodology used to

estimate a TB case fatality rate is

presented below.

TABLE V–11.—LIFETIME OCCUPATIONAL RISK ESTIMATES FOR HOSPITAL EMPLOYEES a b c

Source TB infection d Active disease e Death caused

by TB

Washington State (1994) ......................................................................................................... 4.1–72.2 0.4–7.2 0.03–0.6

North Carolina Western Region ............................................................................................... 34.2–472 3.4–47.2 0.3–3.7

Jackson Memorial Hospital (Miami) ......................................................................................... 67.1–723 6.7–72.3 0.5–5.6

a Risk estimates reflect excess risk due to occupational exposure and are expressed per 1,000 employees at risk.

bEstimates of death caused by TB due to occupational exposure are derived based on an estimated TB case death rate of 77.85 per 1,000

TB cases and are estimated by multiplying the lifetime active disease rate by .07785. cThe ranges of risk presented in this TABLE reflect expected variance in the annual background TB infection rate by state. They are estimated

based on the assumption that the annual background TB infection rate ranges from 0.194 to 1.542 per 1,000 employees at risk. d Lifetime infection rate is estimated by (1–(1–p) 45), where p is the annual excess TB infection rate due to occupational exposure. e Lifetime active disease rate is estimated to be 10% of lifetime infection rate.

TABLE V–12—LIFETIME OCCUPATIONAL RISK ESTIMATES FOR EMPLOYEES IN OTHER WORK SETTINGS a b c

Work setting TB infection d Active disease e Death caused

by TB

Long-term Care ...................................................................................................................... 85–807 8.5–80.7 0.7–6.2

Home Health Care ................................................................................................................. 40.9–536 4.1–53.6 0.3–4.2

Home Care ............................................................................................................................. 9.7–164 1.0–16.4 0.1–1.3

a Risk estimates reflect excess risk due to occupational exposure and are expressed per 1,000 employees at risk of TB infection.

bEstimates of death caused by TB due to occupational exposure are derived based on an estimated TB case death rate of 77.85 per 1,000

cases and are estimated by multiplying the lifetime active disease rate by .07785. cThe ranges of risk presented in this TABLE reflect expected variance in the annual background TB infection rate by state. They are estimated

based on the assumption that the annual background TB infection rate ranges from 0.194 to 3.542 per 1,000 employees at risk. d Lifetime infection rate is estimated by (1–(1–p)45), where p is the annual excess TB infection rate due to occupational exposure. e Lifetime active disease rate is estimated to be 10% of lifetime infection rate.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54207

As outlined in the Health Effects

section, several possible outcomes are

possible following an infection.

Approximately 90% of all infections

never progress to active disease. An

estimated 10% of infections is expected

to progress to active disease; most of

these cases are successfully treated.

However, a percentage of active TB

cases develop further complications.

Approximately 7.8% of active TB cases

may take a more severe clinical course

and lead to death. The TB case fatality

rate was estimated using information on

reported deaths caused by TB from table

8–5 of the Vital Statistics for the U.S.

and cases of TB reported in CDC’s TB

Surveillance system for 1989 through

1991 (Exs. 7–270, 7–264). As shown in

table V–13, the TB case death rate

ranged from 69.94 to 89.18 per 1,000

with a 3-year average of 77.85 per 1,000

TB cases. The Agency used the 3-year

average (77.85 per 1,000) for its estimate

of deaths caused by TB. This estimate is

in close agreement with published

results from a retrospective cohort study

conducted in Los Angeles County on TB

cases in 1990 (Ex. 7–268). In this study,

all confirmed TB cases reported in the

county in 1990 were tracked and the

number of deaths where TB was the

direct or contributing cause was

ascertained. ‘‘Contributing cause’’ was

defined as a case of TB of such severity

that it would have caused the death of

the patient had the primary illness not

caused death earlier. Of the 1,724 cases

included in the study, TB was

considered the cause of death or the

contributing cause of death in 135 cases

(78.31 per 1,000).

TABLE V–13.—TB CASE DEATH RATES FOR ADULTS (18+)

Year Number of

deaths a

Number of TB

cases b

TB case death

rate c

1991 .............................................................................................................................................. 1,700 24,307 69.94

1990 .............................................................................................................................................. 1,796 23,795 75.48

1989 .............................................................................................................................................. 1,956 21,934 89.18

3-year Average ............................................................................................................................. 1,817 23,345 77.85

aSource: Vital Statistics for the U.S., Table 8–5, (age 20+).

bSource: CDC, TB surveillance system, (age 18+).

c Rate expressed per 1,000 TB cases. Any deaths caused by TB in persons 18 or 19 years of age are not included in the numerator.

National estimates of annual and

lifetime risk for TB infection, active

disease and death caused by TB due to

occupational exposure are computed as

weighted averages of the state estimates

and are presented in table V–14.

TABLE V–14.—AVERAGE OCCUPATIONAL RISK ESTIMATES a, b PER 1,000 WORKERS AT RISK

Work setting Annual TB infection

Lifetime TB infectionLifetime active

TB

Death caused

by TBc

Hospitals:

WA ........................................................................................................... 0.68 30 3.0 0.2

NC ........................................................................................................... 5.7 219 22.0 1.7

JM ............................................................................................................ 11.8 386 38.6 3.0

Long-term Care .............................................................................................. 14.6 448 44.8 3.5

Home Health Care .......................................................................................... 6.9 225 25.5 2.0

Home Care ..................................................................................................... 1.6 69 6.9 0.5

aWeighted by each state’s population in 1994.

b Risk estimates reflect excess risk due to occupational exposure and are expressed per 1,000 employees at risk.

c Number of deaths caused by TB due to occupational exposure are derived based on an estimated TB case death rate of 77.85 per 1,000

cases and are computed by multiplying the lifetime active disease rate by .07785.

(a) Risk Estimates for Hospital

Employees: Logistic regression analysis

of the Washington state hospital data

indicated an increase in annual risk

(47% above background) for employees

with potential exposure to TB. For this

particular analysis the control group

was defined as those hospitals with noknown TB patients that are located in

counties that did not report any active

TB cases in 1994. However, an

increased risk of 47% above background

in the annual infection rate is expected

to produce a range of 4 to 72 TB

infections per 1000 exposed workers in

a working lifetime, which could result

in as many as 7 cases of active TB and

approximately 1 death per 1,000

exposed workers.

Based on the survey of hospitals in

North Carolina’s western region, the

expected overall risk due to

occupational exposure is estimated to be

4 times the background rate. This results

in an expected range of lifetime risk

between 34 and 472 infections per 1,000

employees at risk for TB infection.

Lifetime estimates of active TB cases

resulting from these infections are

expected to range between 3 and 47,

resulting in as many as 4 deaths per

1,000 exposed employees at risk of TB

infection. As done previously, the North

Carolina study results were adjusted to

reflect 1994 TB disease trends.

Based on the data from Jackson

Memorial Hospital, the overall risk due

to occupational exposure is estimated to

be 8 times the background rate. This

results in an expected range of lifetime

risk between 67 and 723 infections per

1,000 employees at risk. Lifetime

estimates of the number of active TB

case per 100 exposed workers are

expected to range between 7 and 72,

resulting in as many as 6 deaths per

1,000 exposed employees at risk for TB

infection.

In summary, table V–9 and table V–

14 show that the annual occupational

risk of infection is expected to range:

(a) From .09 to 1.66 with a weighted

average of 0.68 per 1,000 for workplaces

located in relatively low TB prevalence

areas, and where TB infection measures

and engineering controls are required;

(b) From 0.77 to 14.1 with a weighted

average of 5.7 per 1,000 for workplaces

located in areas with moderate TB

prevalence and inadequate TB control

programs; and

(c) From 1.54 to 28 with a weighted

average of 11.8 per 1,000 for workplaces
54208 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

located in high TB prevalence areas,

serving high risk patients, with high

frequency of exposure to infectious TB.

Similarly, the lifetime occupational

risk is expected to range:

(a) From 4 to 72 with a weighted

average of 30 per 1,000 for workplaces

located in relatively low TB prevalence

areas, and where TB infection measures

and engineering controls are required;

(b) From 34 to 472 with a weighted

average of 219 per 1,000 for workplaces

located in areas with moderate TB

prevalence and inadequate TB control

programs; and

(c) From 67 to 723 with a weighted

average of 386 per 1,000 for workplaces

located in high TB prevalence areas,

serving high risk patients, with high

frequency of exposure to infectious TB.

Risk estimates derived from either

study (Washington State or North

Carolina) represent an overall rate of

occupational risk, because both studies

include PPD skin testing results from

the entire hospital employee

population, whereas the Jackson

Memorial study addresses the

occupational risk to workers where

exposure to infectious TB is highly

probable.

Although the exact compliance rate is

not known, hospitals in Washington

State have been required to implement

the CDC TB guidelines with respect to

engineering controls (requiring isolation

rooms with negative pressure) and

infection control measures (advocating

early patient identification, employee

training, respiratory protection, and PPD

testing).

Neither the facilities in North

Carolina nor Jackson Memorial had

engineering controls fully implemented

at the time these data were collected.

Early identification of suspect TB

patients has always been recommended

in North Carolina. However, engineering

controls in isolation rooms were either

not present or did not function properly

because of modifications in the physical

structure of the building (i.e., isolation

rooms had been subdivided using

partitions, air ducts had been redirected because of remodeling, etc.).

Tuberculin skin testing was very

inconsistent and sporadic. In addition,

employee training and use of respiratory

protection were not emphasized.

By 1991, Jackson Memorial had most

of the engineering controls in place in

the HIV ward (where the first outbreak

took place) and in selected areas with

high TB exposure, but not in the entire

hospital. However, the staff training

program was still being developed and

respiratory protection was not always

adequate. Although exposures had been

greatly reduced, ‘‘high risk’’ procedures

were still being performed in certain

areas of the hospital without adequate

engineering controls, such as the

Special Immunology clinic where HIV–

TB patients received pentamidine

treatments. Like the hospitals in the

North Carolina study, Jackson Memorial

represents a working environment that

serves a patient population known to

have high TB prevalence. In addition,

Jackson Memorial only tested

employees with patient contact in areas

where active TB had been detected.

(b) Risk Estimates for Workers in

Other Work Settings: In long-term care

facilities for the elderly there is also a

significantly increased likelihood that

employees will encounter individuals

with infectious TB. Persons over the age

of 65 constitute a large proportion of the

TB cases in the United States. In 1987,

CDC reported that persons aged 65 and

over accounted for 27% (6150) of the

reported cases of active TB in the U.S.,

although they account for only 12% of

the U.S. population. Many of these

individuals were infected in the past

and advancing age and decreasing

immunocompetence have caused them

to develop active disease. In 1990 the

CDC estimated that approximately 10

million people were infected with TB.

As the U.S. population steadily ages,

many of these latent infections may

progress to active disease. Because

elderly persons represent a large

proportion of the nation’s nursing home

residents and because the elderly

represent a large proportion of the active

cases of TB, there is an increased

likelihood that employees at long-term

care facilities for the elderly will

encounter individuals with infectious

TB.

Similarly, there are other

occupational settings that serve highrisk client populations and thus have an

increased likelihood of encountering

individuals with infectious TB. For

example, hospices, emergency medical

services, and home-health care services

provide services to client populations

similar to those in hospitals and thus

are likely to experience similar risks.

OSHA used information from the

1994 Washington state PPD skin testing

survey to estimate occupational risk for

workers in long-term care, home health

care, and home care. Annual estimates

of excess risk for TB infection are

presented in TABLE V–10 and lifetime

estimates for TB infection, active TB,

and death caused by occupational TB

are presented in TABLE V–12.

Based on the Washington State data,

the overall annual excess risk for TB

infection is estimated to be 10-fold over

background for workers in long-term

care. This results in an expected range

of lifetime risk of between 85 and 800

infections per 1,000 employees at risk

for TB infection. Lifetime estimates of

the number of active TB cases resulting

from these infections range from 9 to 81

and are projected to cause as many as

6 deaths per 1,000 exposed employees

at risk of TB infection. Similarly, the

overall annual excess risk of TB

infection for workers in home health

care is estimated to be approximately

500% above background. This results in

an expected range of lifetime risk of

between 41 and 536 infections per 1,000

employees at risk for TB infection.

Lifetime estimates of the number of

active TB cases range from 4 to 54 per

1,000, and are projected to cause as

many as 4 deaths per 1,000 exposed

employees at risk of TB infection.

Similarly, the overall annual excess risk

of TB infection for workers in home care

is estimated to be approximately 100%

above background. This results in an

expected range of lifetime risk of

between 10 and 164 infections per 1,000

employees at risk for TB infection.

Lifetime estimates of the number of

active TB cases range from 1 to 16, and

are expected to result in approximately

1 death per 1,000 exposed employees at

risk of TB infection.

Clearly, employees in all three groups

(long-term care for the elderly, home

health care, and home care) have higher

risks than hospital employees in

Washington. This could be attributed, in

part, to the lack of engineering controls

in these work settings. That respirators

may be used only intermittently may

also play a role. Although workers in

these three groups are encouraged by

local health authorities to use

respiratory protection while tending to

a suspect TB patient, the actual rate of

respirator usage is difficult to ascertain.

A third factor that may contribute to

higher risk in these work settings is

delayed identification of suspect TB

patients due to confounding symptoms

presented by the individuals. For

example, many long-term care residents

exhibit symptoms of persistent coughing

from decades of smoking. Consequently,

an individual in long-term care with a

persistent cough may be infectious for

several days before he or she is

identified as having suspected

infectious TB.

Qualitative Assessment of Risk for Other

Occupational Settings

The quantitative estimates of the risk

of TB infection discussed above are

based primarily upon data from

hospitals and selected other health care

settings. Data from hospitals and certain

health care settings were selected

because OSHA believes that these data
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54209

represent the best information available

to the Agency for purposes of

quantifying the occupational risks of TB

infection and disease. However, as

discussed above, it is their exposure to

aerosolized M. tuberculosis that places

these workers at risk of infection and

not factors unique to these particular

kinds of health care activities. Thus,

OSHA believes that the risk estimates

derived from hospitals and selected

other work settings can be used to

describe the potential range of risks for

other health care and other occupational

settings in which workers can

reasonably anticipate frequent and

substantial exposure to aerosolized M.

tuberculosis.

In order to extrapolate the

quantitative risk estimates calculated for

hospital employees and other selected

health care settings, OSHA, as a first

step, identified risk factors that place

employees at risk of exposure. Some

amount of exposure to TB could occur

in any workplace in the United States.

TB is an infectious disease that occurs

in the community and thus, individuals

may bring the disease into their own

workplace or to other businesses or

work settings that they may visit.

However, there are particular kinds of

work settings where risk factors are

present that substantially increase the

likelihood that employees will be

frequently exposed to aerosolized M.

tuberculosis. First among these factors is

the increased likelihood of exposure to

individuals with active, infectious TB.

Individuals who are infected with TB

have a higher risk of developing active

TB if they are (1) immunocompromised

(e.g., elderly, undergoing chemotherapy,

HIV positive), (2) intravenous drug

users, or (3) medically underserved and

of generally poor health status (Exs. 6–

93 and 7–50). Thus, in work settings in

which the client population is

composed of a high proportion of

individuals who are infected with TB,

are immunocompromised, are

intravenous drug users or are of poor

general health status, there is a greatly

increased likelihood that employees

will routinely encounter individuals

with infectious TB and be exposed to

aerosolized M. tuberculosis. A second

factor that places employees at high risk

of exposure to aerosolized M.

tuberculosis is the performance of highhazard procedures, i.e., procedures

performed on individuals with

suspected or confirmed infectious TB

where there is a high likelihood of the

generation of droplet nuclei. A third

factor that places employees at risk of

exposure is the environmental

conditions at the work setting. Work

settings that have overcrowded

conditions or poor ventilation will

facilitate the transmission of TB. Thus,

given that a case of infectious TB does

occur, the conditions at the work setting

itself may promote the transmission of

disease to employees who share

airspace with the individual(s) with

infectious TB.

The second step in extrapolating the

quantitative risks is to identify the types

of work settings which have some or all

of the risk factors outlined above. Once

these work settings have been

identified, OSHA believes that it is

reasonable to assume that the

quantitative risk estimates calculated for

hospitals and other selected health care

settings can be used to describe the risks

in the identified work settings.

Correctional Facilities

Employees in correctional facilities or

other facilities that house inmates or

detainees have an increased likelihood

of frequent exposure to individuals with

infectious TB. Many correctional

facilities have a higher incidence of TB

cases in comparison to the incidence in

the general population. In 1985, the

CDC estimated that the incidence of TB

among inmates of correctional facilities

was more than three times higher than

that for nonincarcerated adults aged 15–

64 (Ex. 3–33). In particular, in states

such as New Jersey, New York, and

California, the increased incidence of

annual TB cases in correctional facilities

ranged from 6 to 11 times greater than

that of the general population for their

respective states (Exs. 7–80 and 3–33).

A major factor in the increased

incidence of TB cases in correctional

facilities is the fact that the population

of correctional facilities is overrepresented by individuals who are at

greater risk of developing active disease,

e.g., persons from poor and minority

groups who may suffer from poor

nutritional status and poor health care,

intravenous drug users, and persons

infected with HIV. Similarly, certain

types of correctional facilities, such as

holding facilities associated with the

Immigration and Naturalization Service,

may have inmates/detainees from

countries with a high incidence of TB.

For foreign-born persons arriving in the

U.S., the case rate of TB in 1989 was

estimated to be 124 per 100,000,

compared to an overall TB case rate of

9.5 per 100,000 for the U.S. (Ex. 6–26).

Moreover, in the period from 1986 to

1989, 22% of all reported cases of TB

disease occurred in the foreign-born

population. Given the increased

prevalence of individuals at risk for

developing active TB, there is an

increased likelihood that employees

working in these facilities will

encounter individuals with infectious

TB. In addition, environmental factors

such as overcrowding and poor

ventilation facilitate the transmission of

TB. Thus, given that a case of infectious

TB does occur, the conditions in the

facility itself promote the transmission

of the disease to other inmates and

employees in the facility who share

airspace.

As discussed in the Health Effects

section, a number of outbreak

investigations (Exs. 6–5, 6–6) have

shown that where there has been

exposure to aerosolized M. tuberculosis

in correctional facilities, the failure to

promptly identify individuals with

infectious TB and provide appropriate

infection control measures has resulted

in employees being infected with TB.

These studies demonstrate that, as in

hospitals or health care settings, where

there is exposure to aerosolized TB

bacilli and where effective control

measures are not implemented, exposed

employees are at risk of infection. Thus,

estimates based on the risk observed

among employees in hospitals and in

selected other work settings that involve

an increased likelihood of exposure can

be appropriately applied to employees

in correctional facilities.

Recently, scientists at NIOSH have

completed a prospective study of the

incidence of TB infection among New

York State correctional facilities

employees (Ex. 7–288). This study is the

first prospective study of TB infection

among employees in correctional

facilities in an entire state. Other studies

have reported on contact investigations,

which seek to identify recent close

contacts with an index case and

determine who might subsequently have

been infected. Studies based on contact

investigations have the advantage of a

good definition of potential for exposure

and they serve to identify infected

persons for public health purposes. On

the other hand, prospective studies of

an entire working group have the

advantage of covering the entire

population potentially at risk, of

considering all inmate cases

simultaneously as potential sources of

infection, and, most importantly, of

permitting the calculation of incidence

rates and risk attributable to

occupational exposure.

Following an outbreak of active TB

among inmates that resulted in

transmission to employees in 1991, the

state of New York instituted a

mandatory annual tuberculin skin

testing program to detect TB infection

among employees. The authors used

data from the first two years of testing

to estimate the incidence of TB infection
54210 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

among 24,487 employees of the NY

Department of Corrections. Subjects

included in the study had to have two

sequential PPD skin tests, have a

negative test the first year, and have

complete demographic information. The

overall conversion rate was estimated to

be 1.9%. Preliminary results show that

after controlling for age, ethnicity,

gender, and residence in New York City,

corrections offices and medical

personnel, working in prisons with

inmate active TB cases, had odds ratios

of TB infection of 1.64 and 2.39,

respectively, compared to maintenance

and clerical personnel who had little

opportunity for prisoner contact. Based

on these results, the annual excess risk

due to occupational exposure is

estimated to be 1.22% and 2.64% for

corrections officers and medical

personnel, respectively. This translates

into lifetime occupational risks of 423

and 700 per 1,000 exposed employees,

respectively. In prisons with no known

inmate TB cases, there were no

significant differences in TB infection

rates among employees in different job

categories.

Homeless Shelters

Employees in homeless shelters also

have a significantly increased likelihood

of frequent exposure. A high prevalence

of TB infection and disease is common

in many homeless shelters. Screening in

selected shelters has shown the

prevalence of TB infection to range from

18 to 51% (Ex. 6–15). Many shelter

residents also possess characteristics

that impair their immunity and thus

place them at greater risk of developing

active disease. For example, homeless

persons often suffer from poor nutrition

and poor overall health status, and they

also have poor access to health care. In

addition, they may suffer from

alcoholism, drug abuse and infection

with HIV. Screening of selected shelters

has shown the prevalence of active TB

disease to range from 1.6 to 6.8% (Ex.

6–15). Thus, there is an increased

likelihood that employees at homeless

shelters will frequently encounter

individuals with infectious TB in the

course of their work.

In addition, as in the case for

correctional facilities, homeless shelters

also tend to be overcrowded and have

poor ventilation, factors that promote

the transmission of disease and place

shelter residents and employees at risk

of infection. Outbreaks reported among

homeless shelters (Exs. 7–51, 7–75, 7–

73, 6–25) also provide evidence that

where there is exposure to individuals

with infectious TB and effective

infection control measures are not

implemented, employees are at risk of

infection. It is reasonable to assume,

therefore, that risk estimates calculated

for hospital employees who have an

increased likelihood of exposure to

individuals with infectious TB can be

used to estimate the risks for homeless

shelter employees.

Facilities That Provide Treatment for

Drug Abuse

Employees in facilities that provide

treatment for drug abuse have an

increased likelihood of frequent

exposure to individuals with infectious

TB. Surveys of selected U.S. cities by

the CDC have shown the prevalence of

TB infection among the clients of drug

treatment centers to range from

approximately 10% to 13% (Ex. 6–8).

Clients of these centers are also

generally at higher risk of developing

active disease. The clients typically

come from medically underserved

populations and may suffer from poor

overall health status. As discussed in

the Health Effects section, drug

dependence has also been shown to be

a possible risk factor in the development

of active TB. Moreover, many of the

drug treatment center clients are

intravenous drug users and are infected

with HIV, placing these individuals at

an increased risk of developing active

TB. Given these risk factors for the

clients served at drug treatment centers,

there is an increased likelihood that

employees in these work settings will be

exposed frequently to individuals with

infectious TB.

Medical Laboratories

Medical laboratory work is a

recognized source of occupational

hazards. CDC considers workers in

medical laboratories that handle M.

tuberculosis to be at high risk for

occupational transmission of TB either

because of the volume of material

handled by routine diagnostic

laboratories or the high concentrations

of pathogenic agents often handled in

research laboratories.

Few surveys of laboratory-acquired

infections have been undertaken; most

reports are of small outbreaks in specific

laboratories. Sulkin and Pike’s study of

5,000 laboratories suggested that

brucellosis, tuberculosis, hepatitis, and

enteric diseases are among the most

common laboratory-acquired infections

(Ex. 7–289). In 1957, Reid noted that

British medical laboratory workers had

a risk of acquiring tuberculosis two to

nine times that of the general

population (Ex. 7–289). This result was

validated in 1971 by Harrington and

Channon in their study of medical

laboratories (Ex. 7–289). A retrospective

postal survey of approximately 21,000

medical laboratory workers in England

and Wales showed a five-times

increased risk of developing active TB

among these workers as compared with

the general population. Technicians

were at greater risk, especially if they

worked in anatomy departments. A

similar survey carried out in 1973 of

3,000 Scottish medical laboratory

workers corroborates the results from

England and Wales. Three cases, one

doctor and two technicians, were noted

in the 1973 survey, which resulted in an

overall incidence rate of 109 per

100,000 person-years. The general

population incidence rate for active TB

was 26 per 100,000 person-years, giving

a risk ratio of 4.2 (Ex. 7–289).

The studies reviewed in this section

indicate that workers in medical

laboratories with potential for exposure

to M. tuberculosis during the course of

their work have a several-fold (ranging

from 2- to 9-fold) increased risk of

developing active disease compared

with the risk to the general population.

Although these studies were conducted

over two decades ago, they represent the

most recent data available to the

Agency, and OSHA has no reason to

believe that the conditions giving rise to

the risk of infection at that time have

changed substantially in the interim.

The Agency is not aware of any more

current data on transmission rates in

medical laboratories. OSHA solicits

information on additional studies

addressing occupational exposure to

active TB in laboratories; such studies

would then be considered by OSHA in

the development of a final rule.

Other Work Settings and Activities

In addition to the information

available for correctional facilities,

homeless shelters, and facilities that

provide treatment for drug abuse, there

are other work settings and activities

where there is an increased likelihood

of frequent exposure to aerosolized M.

tuberculosis. For example, hospices

serve client populations similar to those

of hospitals and perform similar

services for these individuals.

Individuals who receive care in

hospices are likely to suffer from

medical conditions (e.g., HIV disease,

end-stage renal disease, certain cancers)

that increase their likelihood of

developing active TB disease once

infected. Thus, employees providing

hospice care have an increased

likelihood of being exposed to

aerosolized M. tuberculosis. CDC has

recommended that hospices follow the

same guidelines for controlling TB that

hospitals follow.

Emergency medical service employees

also have an increased likelihood of
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54211

encountering individuals with

infectious TB. Like hospices, emergency

medical services cater to the same high

risk client populations as hospitals.

Moreover, emergency medical services

are often used to transport individuals

identified with suspected or confirmed

infectious TB from various types of

health care settings to facilities with

isolation capabilities.

In addition, other types of services

(e.g., social services, legal counsel,

education) are provided to individuals

who have been identified as having

suspected or confirmed infectious TB

and have been placed in isolation or

confined to their homes. Employees

who provide social welfare services,

teaching, law enforcement or legal

services to those individuals who are in

AFB isolation are exposed to

aerosolized M. tuberculosis. In

particular, employees performing highhazard procedures are likely to generate

aerosolized M. tuberculosis by virtue of

the procedure itself. Thus, employees

providing these types of services also

have an increased likelihood of

exposure to aerosolized M. tuberculosis

and are therefore likely to experience

risks similar to those described above

for hospital workers.

Although they do not have contact

with individuals with infectious TB,

employees who repair and maintain

ventilation systems which carry air

contaminated with M. tuberculosis and

employees in laboratories who

manipulate tissue samples or cultures

contaminated with M. tuberculosis also

have an increased likelihood of being

exposed to aerosolized M. tuberculosis.

Like employees in the work settings

discussed above, these employees have

an increased risk of frequent exposure to

aerosolized M. tuberculosis.

Therefore, OSHA believes that the

quantitative risk estimates derived from

data observed among health care

workers in the hospital setting can be

generally used to describe the potential

range of risks for workers in other

occupational settings where there is a

reasonable anticipation of exposure to

aerosolized M. tuberculosis. The

reasonableness of this assumption is

supported by the overall weight of

evidence of the available health data. As

discussed in the Health Effects section,

epidemiological studies, case reports

and outbreak investigations have shown

that in correctional facilities, homeless

shelters, long-term care facilities for the

elderly, drug treatment centers, and

laboratories where appropriate TB

infection control programs have not

been implemented, employees have

become infected with TB as a result of

occupational exposure to individuals

with infectious TB or to other sources of

aerosolized M. tuberculosis. Thus,

although the data on employee

conversion rates in other work settings

cannot be used to directly quantify the

occupational risk of infection for those

work settings, there is strong evidence

that employees in various work settings

other than hospitals can reasonably be

anticipated to have exposure to

aerosolized M. tuberculosis and that TB

can be transmitted in these workplaces

when appropriate TB infection control

programs are not implemented.

VI. Significance of Risk

Section 6(b)(5) of the OSH Act vests

authority in the Secretary of Labor to

issue health standards. This section

provides, in part, that:

The Secretary, in promulgating standards

dealing with toxic materials or harmful

physical agents under this subsection, shall

set the standard which most adequately

assures, to the extent feasible, on the basis of

the best available evidence, that no employee

will suffer impairment of health or functional

capacity even if such employee has regular

exposure to the hazard dealt with by such

standard for the period of his working life.

OSHA’s overall analytical approach to

making a determination that workplace

exposure to certain hazardous

conditions presents a significant risk of

material impairment of health is a four

step process consistent with

interpretations of the OSH Act and

rational, objective policy formulation. In

the first step, a quantitative risk

assessment is performed where possible

and considered with other relevant

information to determine whether the

substance to be regulated poses a

significant risk to workers. In the second

step, OSHA considers which, if any, of

the regulatory alternatives being

considered will substantially reduce the

risk. In the third step, OSHA examines

the body of ‘‘best available evidence’’ on

the effects of the substance to be

regulated to set the most protective

requirements that are both

technologically and economically

feasible. In the fourth and final step,

OSHA considers the most cost-effective

way to achieve the objective.

In the Benzene decision, the Supreme

Court indicated when a reasonable

person might consider the risk

significant and take steps to decrease it.

The Court stated:

It is the Agency’s responsibility to

determine in the first instance what it

considers to be ‘‘significant’’ risk. Some risks

are plainly acceptable and others are plainly

unacceptable. If, for example, the odds are

one in a billion that a person will die from

cancer by taking a drink of chlorinated water,

the risk could not be considered significant.

On the other hand, if the odds are one in a

thousand that regular inhalation of gasoline

vapors that are 2% benzene will be fatal, a

reasonable person might well consider the

risk significant and take the appropriate steps

to decrease or eliminate it. (I.U.D. v. A.P.I.),

448 U.S. at 655).

The Court indicated that ‘‘while the

Agency must support its findings that a

certain level of risk exists with

substantial evidence, we recognize that

its determination that a particular level

of risk is ‘significant’ will be based

largely on policy considerations.’’ The

Court added that the significant risk

determination required by the OSH Act

is ‘‘not a mathematical straitjacket’’ and

that ‘‘OSHA is not required to support

its findings with anything approaching

scientific certainty.’’ The Court ruled

that ‘‘a reviewing court (is) to give

OSHA some leeway where its findings

must be made on the frontiers of

scientific knowledge and that the

Agency is free to use conservative

assumptions in interpreting the data

with respect to carcinogens, risking

error on the side of overprotection

rather than underprotection.’’ (448 U.S.

at 655, 656).

As a part of the overall significant risk

determination, OSHA considers a

number of factors. These include the

type of risk presented, the quality of the

underlying data, the reasonableness of

the risk assessments, and the statistical

significance of the findings.

The hazards presented by the

transmission of tuberculosis, such as

infection, active disease, and death are

very serious, as detailed above in the

section on health effects. If untreated,

40–60% of TB cases have been

estimated to result in death (Exs. 5–80,

7–50, 7–66). Fortunately, TB is a

treatable disease. The introduction of

antibiotic drugs for TB has helped to

reduce the mortality rate by 94% since

1953 (Ex. 5–80). However, TB is still a

fatal disease in some cases. From 1989–

1991 CDC reported 5,452 deaths among

adults from TB (see TABLE V–13, Risk

Assessment section). In addition, there

has been an increase in certain forms of

drug-resistant TB, such as MDR–TB, in

which the tuberculosis bacilli are

resistant to one or more of the front line

drugs such as isoniazid and rifampin,

two of the most effective anti-TB drugs.

The information available today is not

adequate to estimate the future course of

MDR–TB, but the reduction in the

potential of transmitting this deadly

form of the disease is itself another

benefit of this standard. The current

data indicate that among MDR–TB

cases, the risk of death is increased

compared to drug-susceptible forms of

the disease. A CDC investigation of 8
54212 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

outbreaks of MDR–TB revealed that

among 253 people infected with MDR–

TB, 75% died within a period 4 to 16

weeks after the time of diagnosis (Ex.

38–A). MDR–TB may be treated, but due

to the difficulty in finding adequate

therapy which will control the bacilli’s

growth, individuals with this form of

the disease may remain infectious for

longer periods of time, requiring longer

periods of hospitalization, additional

lost worktime, and an increased

likelihood of spreading TB infection to

others until treatment renders the

patient non-infectious. Because of the

difficulty in controlling these drugresistant forms of the disease with

antibiotics, progressive lung destruction

may progress to the point where it is

necessary to remove portions of the lung

to treat the advance of the disease.

The OSH Act directs the Agency to set

standards that will adequately assure, to

the extent feasible, that no employee

will suffer ‘‘material impairment of

health or functional capacity.’’ TB

infection represents a material

impairment of health that may lead to

active disease, tissue and organ damage,

and death. Although infected

individuals may not present any signs

or symptoms of active disease, being

infected with TB bacilli is a serious

threat to the health status of the infected

individual. Individuals who are infected

have a 10% chance of developing active

disease at some point in their life, a risk

they would not have had without being

infected. The risk of developing active

disease is even greater for individuals

who are immunocompromised, due to

any of a large number of factors. For

example, individuals infected with HIV

have been estimated as having an 8–

10% risk per year of developing active

disease (Ex. 4B).

In addition, since infected individuals

commonly undergo treatment with antiTB drugs to prevent the onset of active

disease, they face the additional risk of

serious side effects associated with the

highly toxic drugs used to treat TB.

Preventive treatment with isoniazid, one

of the drugs commonly used to treat TB

infection, has been shown in some cases

to result in death from hepatitis or has

damaged the infected person’s liver to

the extent that liver transplantation was

performed (Ex. 6–10). Thus, the health

hazards associated with TB infection

clearly constitute material impairment

of health.

Clinical illness, i.e., active disease,

also clearly constitutes material

impairment of health. Left untreated, 40

to 60 percent of active cases may lead

to death (Exs. 7–50, 7–66, 7–80).

Individuals with active disease may be

infectious for various periods of time

and often must be hospitalized. Active

disease is marked by a chronic and

progressive destruction of the tissues

and organs infected with the bacteria.

Active TB disease is usually found in

the lungs (i.e., pulmonary tuberculosis).

Long-term damage can result even when

cases of TB are cured; a common result

of TB is reduced lung function

(impaired breathing) due to lung

damage (Ex. 7–50, pp. 30–31).

Inflammatory responses caused by the

disease produce weakness, fever, chest

pain, cough, and, when blood vessels

are eroded, bloody sputum. Also, many

individuals have drenching night sweats

over the upper part of the body several

times a week. The intensity of the

disease varies, ranging from minimal

symptoms of disease to massive

involvement of many tissues, with

extensive cavitation and debilitating

constitutional and respiratory problems.

Long-term damage can also result from

extrapulmonary forms of active disease;

such damage may include mental

impairment from meningitis (infection

of membranes surrounding the brain

and spinal cord) and spinal deformity

and leg weakness due to infection of the

vertebrae (i.e., skeletal TB) (Ex. 7–50, p.

31). Active disease is treatable but it

must be treated with potent drugs that

have to be taken for long periods of

time. The drugs currently used to treat

active TB disease may be toxic to other

parts of the body. Commonly reported

side effects of anti-TB drugs include

hepatitis, peripheral neuropathy, optic

neuritis, ototoxicity and renal toxicity

(Ex. 7–93). Active disease resulting from

infection with MDR–TB is of even

greater concern due to the inability to

find adequate drug regimens. Although

OSHA has not been able to precisely

quantify the increase in incidence of

MDR–TB, the number of cases of MDR–

TB is clearly on the rise. In these cases,

individuals may remain infectious for

longer periods of time and may suffer

more long-term damage from the

chronic progression of the disease until

adequate therapy can be identified.

In this standard, OSHA has presented

quantitative estimates of the lifetime

risk of TB infection, active disease and

death from occupational exposure to M.

tuberculosis. Qualitative evidence of

occupational transmission is also

included in OSHA’s risk assessment.

In preparing its quantitative risk

assessment, OSHA began by seeking out

occupational data associated with TB

infection incidence in order to calculate

an estimate of risk for TB infection

attributable to occupational exposure for

all U.S. workers. Unfortunately, an

overall national estimate of risk for TB

infection attributable to occupational

exposure is not available. CDC, which

collects and publishes the number of

active TB cases reported nationwide

each year, does not publish

occupational data associated with the

incidence of TB infection and active TB

on a nationwide basis. There has been

some effort to include occupational

information on the TB reporting forms,

but only a limited number of states are

currently using the new forms and

capturing occupational information in a

systematic way. In the absence of a

national database, OSHA used two

statewide studies, from North Carolina

and Washington (Exs. 7–7, 7–263), and

data from an individual hospital,

Jackson Memorial Hospital (Ex. 7–108),

on conversion rates of TB infection for

workers in hospitals. The Washington

State database also contained

information on three additional

occupational groups: long-term care,

home health care and home care

employees. OSHA used these data to

model average TB infection rates and

estimate the range of expected risks in

the U.S. among workers with

occupational exposure to TB.

The conversion rates in the selected

studies were used to estimate the annual

excess relative risk due to occupational

exposure, which was expressed as the

percent increase of infection above each

study’s control group. In order to

estimate an overall range of

occupational risk of TB infection, taking

into account regional differences in TB

prevalence in the U.S. and indirectly

adjusting for factors such as socioeconomic status, which might influence

the rate of TB observed in different parts

of the country, OSHA: (1) Estimated

background rates of infection for each

state by assuming that the number of

new infections is functionally related to

the number of active cases reported by

the state each year (i.e., the distribution

of new infections is directly

proportional to the distribution of active

cases), and 2) applied estimates of the

annual excess relative risk, derived from

the occupational studies, to the state

background rates to calculate estimates

of excess risk due to occupational

exposure by state. Thus, the excess

occupational risk estimates are actually

calculated from the three available

studies, on a relative increase basis, and

these relative increases are multiplied

by background rates for each state to

derive estimates of excess occupational

risk by state. The state estimates are

then used to derive a national estimate

of annual occupational risk of TB

infection. Given an annual rate of

infection, the lifetime risk of infection

was calculated assuming that workers
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54213

are exposed for 45 years and that the

worker’s exposure profile and working

conditions remain constant throughout

his or her working lifetime. Lifetime

infection rates are then used to calculate

the lifetime risk of developing active

disease based on the estimate that 10%

of all infections result in active disease.

Given a number of active cases of TB,

the number of expected deaths can be

calculated based on the estimated

average TB case death rate (i.e., number

of TB deaths per number of active TB

cases averaged over 3 years as reported

by CDC).

OSHA estimates that the risk of

material impairment of health or

functional capacity, that is, the average

lifetime occupational risk of TB

infection for hospital workers ranges

from 30 to 386 infections per 1,000

workers who are occupationally

exposed to TB. These are different

national averages, each derived by

calculating the risk in each state and

weighting it by the state’s population.

The low end of this range is derived by

using the Washington State data, and is

likely to seriously underestimate the

true risk to which workers are exposed.

This is because the Washington data

represent occupational exposures

among employees in hospitals which

are located in areas of the country with

a low prevalence of active TB and

which have implemented TB controls

(e.g., early identification procedures,

annual skin testing, and negative

pressure in AFB isolation rooms). The

high end of this range is derived by

using the Jackson Memorial Hospital

study, and represents occupational risk

for workers in hospitals located in high

TB prevalence areas, serving high risk

patients, and with a high frequency of

exposure to infectious TB.

OSHA also used information from the

Washington State database to estimate

national average estimates of lifetime

risk for workers in long-term care (i.e.,

nursing homes), home health care, and

home care. The national average lifetime

risk of TB infection is estimated to be

448 per 1,000 for workers in long-term

care facilities, 225 per 1,000 for workers

in home health care (primarily nursing

staff), and 69 per 1,000 for workers in

home care. The higher likelihood of

occupational exposure in long-term care

facilities (early identification of suspect

TB cases is often difficult among the

elderly) and the presence of fewer

engineering controls in these facilities

may explain the high observed

occupational risk in that work setting.

The national average lifetime risk of

developing active disease ranges from

approximately 3 to 39 cases per 1,000

exposed employees for workers in

hospital settings. Similarly, the average

lifetime risk of active disease is

estimated to be approximately 45 per

1,000 for workers in long-term care, 26

per 1,000 in home health care, and 7 per

1,000 in home care. This range is based

on the estimate that 10% of infections

will progress to active disease over one’s

lifetime. This risk may be greater for

immunocompromised individuals.

The national average lifetime risk of

death from TB ranges from 0.2 to

approximately 3 deaths per 1,000

exposed employees for workers in

hospital settings. Similarly, the average

lifetime risk of death from TB is

estimated to be approximately 3.5 per

1,000 for workers in long-term care, 2

per 1,000 for workers in home health

care, and 0.5 per 1,000 in home care.

The lower range of the national lifetime

risk of deaths, 0.2 per 1,000, is based on

the Washington State hospital data

where the prevalence of TB is low and

infection control measures have been

implemented. Thus, this lower range of

risk underestimates the risk of death

from TB for other employees who work

in settings where infection control

measures, such as those outlined in this

proposed standard, have not been

implemented. The risk assessment data

show that where infection control

measures were not in place, the

estimated risk of death from TB was as

high as 6 deaths per 1,000 exposed

employees.

The quantitative risk estimates are

based primarily upon data from

hospitals and selected other work

settings. However, it is frequent

exposure to aerosolized M. tuberculosis

which places workers at substantially

increased risk of infection and not

factors unique to the health care

profession or any job category therein.

Qualitative evidence, such as that from

the epidemiological studies, case reports

and outbreak investigations reported for

various types of work settings, as

discussed earlier in the Health Effects

section, clearly demonstrates that

employees exposed to aerosolized M.

tuberculosis have become infected with

TB and have gone on to develop active

disease. These work settings share risk

factors that place employees at risk of

transmission. For example, these work

settings serve client populations that are

composed of a high prevalence of

individuals who are infected with TB,

are immunocompromised, are injecting

drug users or are medically underserved

and of poor general health status.

Therefore, there is an increased

likelihood that employees in these work

settings will encounter individuals with

active TB. In addition, high-hazard

procedures, such as bronchoscopies, are

performed in some of these work

settings, which greatly increases the

likelihood of generating aerosolized M.

tuberculosis. Moreover, some of the

work settings have environmental

conditions such as overcrowding and

poor ventilation, factors that facilitate

the transmission of disease. Therefore,

OSHA believes that the quantitative risk

estimates based on hospital data and

other selected health care settings can

be extrapolated to other occupational

settings where there is a similar

increased likelihood of exposure to

aerosolized M. tuberculosis.

Having specific data for non-health

care workers and workplace conditions

would add more precision to the

quantitative risk assessment, but that

level of detail is not possible with the

currently available information.

However, the Agency believes that such

a level of detail is not necessary to make

its findings of significant risk because

the risk of infection is based upon

occupational exposure to aerosolized M.

tuberculosis. Nevertheless, OSHA seeks

information on conversion rates and the

incidence of active disease among

employees in non-health care work

settings in order to give more precision

to its estimates of risk.

OSHA’s risk estimates for TB

infection are comparable to other risks

which OSHA has concluded are

significant, and are substantially higher

than the example presented by the

Supreme Court in the Benzene Decision.

After considering the magnitude of the

risk as shown by the quantitative and

qualitative data, OSHA preliminarily

concludes that the risk of material

impairment of health from TB infection

is significant.

OSHA also preliminarily concludes

that the proposed standard for

occupational exposure to TB will result

in a substantial reduction in that

significant risk. The risk of infection is

most efficiently reduced by

implementing TB exposure control

programs for the early identification and

isolation of individuals with suspected

or confirmed infectious TB. Engineering

controls to maintain negative pressure

in isolation rooms or areas where

infectious individuals are being isolated

will reduce the airborne spread of

aerosolized M. tuberculosis and

subsequent exposure of individuals,

substantially reducing the risk of

infection. In addition, for those

employees who must enter isolation

rooms or provide services to individuals

with infectious TB, respiratory

protection will reduce exposure to

aerosolized M. tuberculosis and thus

reduce the risk of infection.
54214 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

Several studies have shown that the

implementation of infection control

measures such as those outlined in this

proposed standard have resulted in a

reduction in the number of skin test

conversions among employees with

occupational exposure to TB. For

example, results of a survey conducted

by the Society of Healthcare

Epidemiology of America (SHEA) of its

member hospitals (Exs. 7–147 and 7–

148) revealed that among hospitals that

treated 6 or more patients with

infectious TB per year there were 68%

fewer tuberculin skin test conversions

in hospitals that had AFB isolation

rooms with one patient per room,

negative pressure, exhaust air directed

outside and six or more air changes per

hour, compared to hospitals that did not

have AFB isolation rooms with these

same characteristics. Similarly, an 88%

reduction in tuberculin skin test

conversions was observed in an Atlanta

hospital after the implementation of

infection control measures such as an

expanded respiratory isolation policy,

improved diagnostic and testing

procedures, the hiring of an infection

control coordinator, expanded

education of health care workers,

increased frequency of tuberculin skin

tests, implementation of negative

pressure, and use of submicron masks

for health care workers entering

isolation rooms (Ex. 7–173).

Improvements in infection control

measures in a Florida hospital after an

outbreak of MDR-TB reduced tuberculin

skin test conversions from 28% to 18%

to 0% over three years (Ex. 7–167).

These improvements included

improved early identification

procedures, restriction of high-hazard

procedures to AFB isolation rooms,

increased skin testing, expansion of

initial TB treatment regimens, and daily

inspection of negative pressure in AFB

isolation rooms. Thus, these

investigations show that the

implementation of infection control

measures such as those included under

OSHA’s proposed standard for TB can

result in substantial reductions in

infections among exposed employees. As discussed in further detail in the

following section of the Preamble to this

proposed standard, OSHA estimates that

full implementation of the proposed

standard for TB will result in avoiding

approximately 21,400 to 25,800 workrelated infections per year, 1,500 to

1,700 active cases of TB resulting from

these infections and 115 to 136 deaths

resulting from these active cases. In

addition, because the proposed standard

encourages the identification and

isolation of active TB cases in the client

populations served by workers in the

affected industries, there will also be

non-occupational TB infections that will

be averted. OSHA estimates that

implementation of the proposed

standard will result in avoiding

approximately 3,000 to 7,000 nonoccupational TB infections, 300 to 700

active cases of TB resulting from these

infections, and 23 to 54 deaths resulting

from these active cases. OSHA

preliminarily concludes that the

proposed standard for TB will

significantly reduce the risk of infection,

active disease and death from exposure

to TB and that the Agency is thus

carrying out the Congressional intent

and is not attempting to reduce

insignificant risks. Although the current OSHA

enforcement program, which is based on

the General Duty Clause of the Act,

Section 5(a)(1), and the application of

some general industry standards, such

as 29 CFR 1910.134, Respiratory

Protection, has reduced the risks of

occupational exposure to tuberculosis to

some extent, significant risks remain

and it is the Agency’s opinion that an

occupational health standard

promulgated under section 6(b) of the

Act will much more effectively reduce

these risks for the following reasons.

First, because of the standard’s

specificity, employers and employees

are given more guidance in reducing

exposure to tuberculosis. Second, it is

well known that a standard is more

protective of employee health than an

enforcement program based upon the

general duty clause and general

standards. Unlike the proposed

standard, the general duty clause

specifies no abatement methods and the

general industry standards do not set

forth abatement methods specifically

addressing occupational exposure to TB.

Third, the general duty clause imposes

heavy litigation burdens on OSHA

because the Agency must prove that a

hazard exists at a particular workplace

and that it is recognized by the industry

or the cited employer. Since the

proposed standard specifies both the

conditions that trigger the application of

the standard and the employer’s

abatement obligations, thereby

establishing the existence of the hazard,

no independent proof that the hazard

exists in the particular workplace need

be presented. The reduction in litigation

burdens will mean that the Labor

Department, as well as the employer,

will save time and money in the

investigation and litigation of

occupational TB cases. Finally, the

promulgation of this proposed standard

will result in increased protection for

employees in state-plan states which,

although not required to adopt general

duty clauses, must adopt standards at

least as effective as Federal OSHA

standard.

In summary, the institution of the

enforcement guidelines has been

fruitful, but it has not eliminated

significant risks among occupationally

exposed employees. Therefore, OSHA

preliminarily concludes that a standard

specifically addressing the risks of

tuberculosis is necessary to further

substantially reduce significant risk.

OSHA’s preliminary economic analysis

and regulatory flexibility analysis

indicate that the proposed standard is

both technologically and economically

feasible. OSHA’s analysis of the

technological and economic feasibility

is discussed in the following section of

the preamble.

VII. Summary of the Preliminary

Economic Analysis and Regulatory

Flexibility Analysis

OSHA is required by the

Occupational Safety and Health Act of

1970 and several court cases pertaining

to that Act to ensure that its rules are

technologically and economically

feasible for firms in the affected

industries. Executive Order (EO) 12866

and the Regulatory Flexibility Act (as

amended) also require Federal agencies

to estimate the costs, assess the benefits,

and analyze the impacts on the

regulated community of the regulations

they propose. The EO additionally

requires agencies to explain the need for

the rule and examine regulatory and

non-regulatory alternatives that might

achieve the objectives of the rule. The

Regulatory Flexibility Act requires

agencies to determine whether the

proposed rule will have a significant

economic impact on a substantial

number of small entities, including

small businesses and small government

entities and jurisdictions. For proposed

rules with such impacts, the agency

must prepare an Initial Regulatory

Flexibility Analysis that identifies those

impacts and evaluates alternatives that

will minimize such impacts on small

entities. OSHA finds that the proposed

rule is ‘‘significant’’ under Executive

Order 12866 and ‘‘major’’ under Section

804(2) of the Small Business Regulatory

Enforcement Fairness Act of 1996.

Accordingly, the Occupational Safety

and Health Administration (OSHA) has

prepared this Preliminary Economic and

Regulatory Flexibility Analysis (PERFA)

to support the Agency’s proposed

standard for occupational exposure to

tuberculosis (TB). The following is an

executive summary of that analysis. The

entire test of the PERFA can be found

in the rulemaking docket as Exhibit 13.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54215

The complete PERFA is composed of

various chapters that describe in detail

the information summarized in the

following section.

Statement of Need

TB is a communicable, potentially

lethal disease caused by the inhalation

of droplet nuclei containing the bacillus

Mycobacterium tuberculosis (M.

tuberculosis). Persons exposed to these

bacteria can respond in different ways:

by overcoming the challenge without

developing TB, by becoming infected

with TB, or by developing active TB

disease. Those who become infected

harbor the infection for life, and have a

10 percent chance of having their

infection progress to active disease at

some point in their life. Those with

active disease have the signs and

symptoms of TB (e.g., prolonged,

productive cough; fatigue; night sweats;

weight loss) and have about an 8

percent risk of dying from their disease.

TB has been a worldwide health

problem for centuries, causing millions

of deaths worldwide. In the United

States, however, there has been a

decline in the number of active TB cases

over the last four decades. Between

1953 and 1994, the number of active

cases declined from 83,304 to 24,361, an

annual rate of decline of 3.6 percent

over the period as a whole (Figure VII–

1). The 1988–1992 period, however, saw

the first substantial increase in the

number of active cases since 1953. A

number of outbreaks of this disease have

occurred among workers in health care

settings, as well as other work settings,

in recent years. To add to the

seriousness of the problem, some of

these outbreaks have involved the

transmission of multi-drug resistant

strains of M. tuberculosis, which are

often fatal. Very recently, i.e., after 1992,

this trend has reversed, and the number

of such cases appears once again to have

begun to decline. Nevertheless, TB

remains a major health problem, with

22,813 active cases reported in 1995.

Because active TB is endemic in many

U.S. populations—including groups in

both urban and rural areas—workers

who come into contact with diseased

individuals are at risk of contracting the

disease themselves.

BILLING CODE 4510–26–P
54216 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

BILLING CODE 4510–26–C
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54217

Many occupational groups, including

workers in health care, nursing homes,

homeless shelters, hospices,

correctional facilities, laboratories,

physicians’ offices, and other settings

are at risk of contracting TB on the job.

These workers are at risk because they

are exposed in the course of their work

to patients and others with active TB

disease, perform procedures that expose

them to airborne concentrations of M.

tuberculosis, or serve client populations

where the incidence of active disease is

unusually high.

The purpose of OSHA’s standard is to

reduce these risks in health care and

other work settings where active TB

cases are likely to be encountered by

employees. To accomplish this goal, the

proposed standard requires those

employers who are responsible for the

working conditions where such

encounters occur to implement a

program of infection prevention and

infection control that is designed to

prevent occupational infections in the

first place, and to identify and treat any

job-related infections that do occur. The

approach taken in the proposed

standard is similar to that adopted by

OSHA in its 1991 bloodborne pathogens

standard, which is given credit for

achieving a dramatic reduction in the

number of cases of hepatitis among

health care and other workers since it

was issued. OSHA predicts that, once

implemented, the proposed TB standard

will have similar results, achieving

reductions on the order of 70 to 90

percent in the number of TB infections,

active cases, and directly related deaths.

This Preliminary Economic and

Regulatory Flexibility Analysis includes

an introductory chapter that describes

the major provisions of the standard.

The proposal would apply to

occupational exposure to TB occurring

in, during, or through the provision of

services by:

• Hospitals.

• Nursing homes.

• Correctional facilities.

• Immigration detainment facilities.

• Law enforcement facilities.

• Hospices.

• Substance abuse treatment centers.

• Homeless shelters.

• Medical examiners’ offices.

• Home health care providers.

• Emergency medical services.

• Research and clinical laboratories

handling TB.

• Contract work on ventilation

systems or areas of buildings that may

contain aerosolized M. tuberculosis.

• Physicians performing certain high

hazard procedures.

• Social service workers providing

services to individuals identified as

having suspected or confirmed

infectious TB.

• Personnel service agencies when

providing workers to covered facilities.

• Attorneys visiting known or

suspected infectious TB patients.

The groups, industries, and work

settings covered by the standard have

been included in its scope for specific

reasons. For example, hospitals are

included because they treat patients

with active TB disease, while hospices,

certain laboratories, pulmonary and

certain other physicians, medical

examiners, and contract HVAC workers

are covered because employees in these

settings/jobs are exposed to aerosolized

M. tuberculosis during the performance

of high-hazard procedures, such as

bronchoscopies, sputum induction,

autopsies, and during work on

ventilation systems that may contain TB

bacteria. Other work settings, such as

homeless shelters and nursing homes,

are covered because their employees

serve a client population known to have

a high incidence of TB infection.

Another group of employees included

within the scope of the standard are

workers who must occasionally serve

patients with active TB who are being

treated in ‘‘isolation,’’ i.e., a room or

area specifically designed to contain the

TB microorganism and prevent its

spread to surrounding areas. Attorneys

and social workers are typical of this

group. Finally, the proposed standard

covers personnel service agencies that

provide temporary, seasonal, or

‘‘leased’’ personnel to hospitals and

other covered work settings.

OSHA estimates that the standard

would apply to approximately 102,000

establishments and provide protection

to more than 5 million workers

currently at risk of occupational

exposure to TB. More than half of these

workers—almost 4 million—work in the

two industries most affected by the

standard: hospitals and nursing homes.

Other covered industries with large

numbers of workers are home health

care, emergency medical services, and

correctional institutions.

Table VII–1 shows the number of

affected establishments and the

population at risk for each covered

industry. (Table VII–1 does not include

all sectors that might hypothetically be

covered by the standard. For example, a

chiropractor who engaged in high

hazard procedures would be covered by

the standard. However, this possibility

is sufficiently rare for this activity not

to have been included in this analysis.

OSHA solicits comments on any

affected job categories or industries it

may have omitted.) Because the

standard requires employers in the

covered industries to make an initial

determination that will identify which

job classifications, employees, and

activities within their workplace

involve occupational exposure to TB, its

requirements are narrowly targeted to

those workers most at risk. Thus, for

example, only approximately 57 percent

of hospital workers are potentially

affected by the standard; these workers

would include those working on

infectious disease floors or wards,

radiology units, autopsy suites, and in

other, similarly exposed locations.

TABLE VII–1.—NUMBER OF AFFECTED

ESTABLISHMENTS AND POPULATION

AT RISK, BY INDUSTRY

Industry

Number of

affected establishmentsPopulation

at risk

Hospitals ........... 5,749 2,663,996

Nursing Homes 20,254 1,200,034

Correctional Institutions ........ 2,079 268,432

Immigration Detainment ......... 12 990

Law Enforcement ............... 4,950 27,469

Hospices ........... 1,755 17,250

Homeless Shelters ................. 10,450 85,168

Substance

Abuse Treatment Centers 9,730 120,115

Medical Examiners .................. 100 2,000

Home Health

Care ............... 10,921 418,538

Emergency Medical Services .. 5,099 255,200

Laboratories ...... 851 11,108

Contract HVAC 300 2,500

Social Services 2,342 20,000

Physicians ......... 21,698 43,395

Pulmonary Physicians ............ 1,853 3,705

Personnel Services ................ 1,426 161,608

Attorneys ........... 2,306 4,611

Total ........... 101,875 5,306,119

Source: U.S. Department of Labor, OSHA,

Office of Regulatory Analysis.

Technological Feasibility

Chapter III of the analysis evaluates

the technological feasibility of the

proposed standard for affected

establishments. OSHA preliminarily

concludes that no provisions of the rule

pose technological feasibility problems

for any potentially affected entities. This

is the case because the standard

emphasizes administrative controls,

such as the early identification of

suspected or confirmed cases of TB and

employee information and training,

rather than engineering controls. In
54218 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

addition, the engineering controls that

are required, such as AFB isolation

rooms, biological safety cabinets, and

temporary AFB isolation facilities,

would be mandated only in those

situations where individuals with

suspected or confirmed infectious TB

are admitted and isolated, where high

hazard procedures are performed, and

in situations where individuals cannot

be placed into AFB isolation rooms

within five hours of being identified as

having suspected or confirmed

infectious TB. All of the engineering

controls required by the standard are

currently available and in widespread

use in many affected establishments.

Benefits of the Proposed Standard

Workers employed in the work

settings covered by the standard are at

significant risk of material impairment

of health as a result of exposure to M.

tuberculosis on the job. These workers

will be the primary beneficiaries of the

protection provided by the rule.

However, because TB is a

communicable disease, many other

individuals will also benefit from the

standard. Reducing the number of cases

of TB among workers who are regularly

in contact both with patients and

infected members of client populations

will reduce the incidence of TB

infections and active cases in these

client populations (since infected

individuals spend the most time with

other members of their group) and

among members of the families of

exposed workers. OSHA has expressed

the benefits of the standard in terms of

the numbers of TB infections, active

cases, and TB-related deaths averted by

the standard. In addition to reducing

morbidity and mortality among workers,

their families, and client populations,

the standard will also generate readily

quantifiable cost savings in the form of

lower medical costs, less lost

production, and reduced costs for

administering workers’ compensation

claims and other private and social

insurance system transactions.

OSHA’s estimates of the potential

benefits of the standard take into

account the extent of current industry

compliance with the provisions of the

proposed standard, i.e., the benefits

estimates do not include the benefits

that employers in affected sectors are

already garnering as a result of their

voluntary efforts to provide protections

to their TB-exposed employees. The

benefits assessment presented in

Chapter IV of the economic analysis is

based on OSHA’s Preliminary Risk

Assessment (see that section of the

preamble), which quantifies the

occupational risk of TB infection among

workers in hospitals, nursing homes,

home health care work settings, and

home care work settings. The estimates

of risk are based on the rate of

tuberculin skin test (TST) conversions

among these populations. TST

conversions are a widely used and welldocumented index of TB infection; rates

of conversion among the exposed

populations are then compared with

rates in unexposed or less-exposed

‘‘control’’ populations to obtain an

estimate of the ‘‘excess’’ risk associated

with occupational exposure. Table VII–

2 shows the results of OSHA’s estimates

of the risks confronting workers in

various work settings, based on

statistical analyses and studies in the

literature.

TABLE VII–2.—ESTIMATES OF OCCUPATIONAL RISK CONFRONTING WORKERS IN VARIOUS SETTINGS

Setting Location and date Excess risk

(percent)

Estimated

annual excess rate of

TB infection

per 1,000

workers

Hospital ............................................................................. North Carolina Western Region—1984–1985 ................ 398 5.7

Hospital ............................................................................. Washington State—1994 ................................................ 47 .68

Hospital ............................................................................. Jackson Memorial Hospital, Miami, Florida—1991 ........ 795 11.8

Nursing Homes ................................................................. Washington State—1994 ................................................ 1019 14.6

Home Health Care ........................................................... Washington State—1994 ................................................ 478 6.9

Home Care ....................................................................... Washington State—1994 ................................................ 112 1.6

Source: OSHA, Preliminary Assessment of Risk.

Where risk data of good quality were

available for a specific industry, OSHA

relied on that data. However, such data

were available only for the hospital,

nursing home, home health care, and

home care industries. Accordingly,

OSHA identified the best data to use to

characterize the occupational risk of TB

infection posed to workers in the other

work settings covered by the proposed

rule. After a careful review of the

available data, OSHA chose to rely on

data from western North Carolina that

looked at occupational risk in a total of

eight hospitals. These data were

selected because they derived from

hospitals that were relatively

‘‘uncontrolled,’’ i.e., that had not yet

implemented many of the controls that

would be required by the proposed

standard. Data from the other hospitals

shown in Table VII–2 were judged to be

less appropriate for the purpose of

extrapolation because Washington State

hospitals are already generally in

compliance with the requirements of the

proposed rule and Jackson Memorial

Hospital had recently experienced an

outbreak of multi-drug resistant TB

among its patients at the time the risk

data were gathered. OSHA believes that

using occupational risk data from

hospitals to characterize the risk in

other occupational settings for which

risk data are unavailable is appropriate

because employees in these other

settings serve client populations that

have a high incidence of active TB

cases, perform high-hazard procedures,

or visit hospitalized TB patients. The

use of a hospital-based risk estimate

results in a lower estimate of risk than

would be the case if OSHA had used

risk data from nursing homes or home

health care to characterize the risk in

other settings, but a higher risk than if

OSHA had used risk data from the home

care industry to do so.

To predict the effectiveness of the

proposed standard, OSHA evaluated the

reduction in occupational risk that

various control measures required by

the standard can be expected to achieve.

Effectiveness is measured as the percent

reduction in TST conversions and in the

TB infections, active cases, and deaths

represented by those conversions. Based

on a thorough review of the available

literature on the effectiveness of control

programs that have actually been

implemented in a number of hospitals,

OSHA believes that the proposed

standard, once implemented, would
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54219

reduce TB infections among

occupationally exposed hospital

workers by 90 percent, and would

decrease such infections in the other

work settings covered by the standard

by 70 to 90 percent. OSHA also

estimated the effectiveness and medical

surveillance and follow-up in

preventing infections from advancing to

active cases of TB. OSHA found that

such measures reduced the probability

of an infection advancing to an active

case by 35 to 47 percent, depending on

the frequency of testing.

Using these effectiveness data, taking

account of the current levels of

compliance in various workplaces, and

relying on the estimates of excess risk

presented in OSHA’s Preliminary Risk

Assessment, OSHA predicts that the

proposed standard will avert about

21,000 to 26,000 work-related TB

infections per year, 1,500 to 1,750 active

disease cases resulting directly from

these infections, and 115 to 136 deaths

directly related to the same infections.

Preventing this number of infections

among workers will, in turn, prevent

about 3,000 to 7,000 infections, 300 to

700 active cases, and 23 to 54 deaths

among the families, friends, clients, and

contacts of these workers. In addition,

the standard will annually generate cost

savings of $89 to $116 million dollars in

avoided medical costs, lost production

caused by absence from work and other

factors, and insurance administration

costs. Table VII–3 shows the benefits of

the proposed standard.

TABLE VII–3.—SUMMARY OF BENEFITS ASSOCIATED WITH THE PROPOSED STANDARD

Type of benefit Work-related Transmissions from work-related

sources Total number averted

Infections Avoided ..................................... 21,380–25,769 ............................ 2,954–6,978 ................................ 24,334–32,747.

Active Cases Avoided ............................... 1,477–1,744 ................................ 295–698 ...................................... 1,772–2,442.

Deaths Avoided ......................................... 115–136 ...................................... 23–54 .......................................... 138–190.

Cost Savings ............................................. $80,721,000–$95,393,000 .......... $8,614,000–$20,381,000 ............ $89,335,000–$115,774,000.

Source: Office of Regulatory Analysis, OSHA, DOL.

Chapter V of the economic analysis

projects the costs employers in the

various industries covered by the

standard are estimated to incur to

achieve compliance with the rule’s

requirements. OSHA estimated costs for

each covered industry and for each

provision of the standard. These costs

take account of the baseline levels of

compliance prevailing in each industry

at the present time and are presented as

annualized costs discounted at 7

percent. Annualized costs are the sum

of annualized initial costs and recurring

annual costs. For example, a temporary

AFB isolation room costing $4,095 with

annual maintenance costs of $50 would

have annualized costs of $633 ($583 +

$50).

The total estimated costs of

compliance for the standard as a whole

are $245 million per year. The most

costly provisions of the standard are

those requiring medical surveillance

and training for occupationally exposed

employees. Together, these two

provisions account for 60 percent of the

costs of compliance. The two industries

projected to incur the highest costs are

hospitals and nursing homes. Together,

the costs incurred by these two

industries are estimated to be $138

million per year. Tables VII–4 and

VII–5 summarize the annualized costs of

compliance, by provision and industry,

respectively.

TABLE VII–4.—TOTAL ANNUALIZED COSTS, BY PROVISION

Provision

Total

annualized

cost

Exposure Control ................................................................................................................................................................................. $12,858,183

Work Practice Controls ........................................................................................................................................................................ 9,740,559

Transfers ....................................................................................................................................................................................... 9,740,559

Engineering Controls ........................................................................................................................................................................... 22,529,248

AFB Isolation Rooms .................................................................................................................................................................... 7,547,912

Temporary AFB Isolation .............................................................................................................................................................. 10,792,678

Laboratories .................................................................................................................................................................................. 780,270

Autopsies ...................................................................................................................................................................................... 2,903,077

Daily Testing of Negative Pressure .............................................................................................................................................. 505,310

Respiratory Protection ......................................................................................................................................................................... 45,771,276

Respirators .................................................................................................................................................................................... 32,225,228

Respirator Program ...................................................................................................................................................................... 1,670,677

Fit Testing ..................................................................................................................................................................................... 8,905,821

Evaluation of Program .................................................................................................................................................................. 2,969,549

Medical Surveillance ............................................................................................................................................................................ 94,901,455

Medical History/Physical Exam .................................................................................................................................................... 62,974,255

Tuberculin Skin Testing (TST) ...................................................................................................................................................... 21,907,252

Medical Management/Follow-up ................................................................................................................................................... 4,773,377

Medical Removal .......................................................................................................................................................................... 5,246,570

Communication of Hazards ................................................................................................................................................................. 52,268,172

Signs and Labels .......................................................................................................................................................................... 58,284

Training ......................................................................................................................................................................................... 52,209,888

Recordkeeping ..................................................................................................................................................................................... 7,228,533

Engineering Control Maintenance ................................................................................................................................................ 20,052

Medical .......................................................................................................................................................................................... 6,785,014

Training ......................................................................................................................................................................................... 423,467
54220 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

TABLE VII–4.—TOTAL ANNUALIZED COSTS, BY PROVISION—Continued

Provision

Total

annualized

cost

Total ....................................................................................................................................................................................... 245,297,426

Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.

TABLE VII–5.—SUMMARY OF COMPLIANCE COSTS, BY INDUSTRY

Provision

Total

annualized

cost

Hospitals .............................................................................................................................................................................................. $61,819,637

Nursing Homes .................................................................................................................................................................................... 76,500,314

Correctional Institutions ....................................................................................................................................................................... 20,187,666

Immigration Detainment ....................................................................................................................................................................... 145,378

Law Enforcement ................................................................................................................................................................................. 6,708,174

Hospices .............................................................................................................................................................................................. 2,237,959

Homeless Shelters ............................................................................................................................................................................... 11,287,278

Substance Abuse Treatment Centers ................................................................................................................................................. 12,751,545

Medical Examiners ............................................................................................................................................................................... 557,811

Home Health Care ............................................................................................................................................................................... 16,448,605

Emergency Medical Services .............................................................................................................................................................. 4,981,780

Laboratories ......................................................................................................................................................................................... 1,696,383

Contract HVAC .................................................................................................................................................................................... 396,197

Social Services .................................................................................................................................................................................... 3,063,444

Physicians ............................................................................................................................................................................................ 5,663,949

Pulmonary Physicians .......................................................................................................................................................................... 930,775

Personnel Services .............................................................................................................................................................................. 18,363,135

Attorneys .............................................................................................................................................................................................. 1,557,398

Total .............................................................................................................................................................................................. 245,297,426

Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.

Chapter VI assesses the economic

impacts of the proposed standard on the

industries affected by the proposed

standard and also analyzes the impacts

on the small businesses within each of

these industries. OSHA preliminarily

concludes that the standard is

economically feasible for affected firms.

On average, annualized compliance

costs for all entities amount only to 0.06

percent of revenues and only 1.8

percent of profits. For all industries,

costs as a percentage of revenues are

less than 1 percent. For two industries,

costs as a percentage of profits exceed

5 percent; these industries are substance

abuse treatment centers and personnel

services. OSHA does not believe,

however, that these profit impacts will

actually be incurred by facilities in

these two sectors. Only 18.5 percent of

substance abuse treatment centers

operate on a for-profit basis. If substance

abuse treatment centers can increase

their revenues by as little as 0.34

percent, they can completely offset their

compliance costs. The revenue increases

or reductions in services needed to

achieve cost passthrough are not

expected to represent significant

impacts for these facilities. The

situation for personnel service firms is

similar; these firms would have to

increase the prices charged to their

customers by as little as 0.56 percent to

completely offset the costs of

compliance. It is likely that these

agencies will be able to pass such a

small increase in costs through to their

customers, i.e., to facilities purchasing

personnel services. Table VII–6 shows

compliance costs as a percentage of

revenues, by industry.

TABLE VII–6.—SCREENING ANALYSIS TO IDENTIFY POTENTIAL ECONOMIC IMPACTS ON AFFECTED ENTITIES

Industry

Number of

affected establishments

Percent of

for-profit establishments in industryCost as a

percentage

of revenues

Hospitals ................................................................................................................................................... 5,749 15.5 0.02

Nursing Homes ......................................................................................................................................... 20,254 71.4 0.16

Correctional Institutions ............................................................................................................................ 2,079 0.0 0.10

Immigration Detainment ........................................................................................................................... 12 0.0 0.16

Law Enforcement ..................................................................................................................................... 4,950 0.0 0.03

Hospices ................................................................................................................................................... 1,755 12.0 0.09

Homeless Shelters ................................................................................................................................... 10,450 0.0 0.64

Substance Abuse Treatment Centers ...................................................................................................... 9,730 18.5 0.34

Medical Examiners ................................................................................................................................... 100 0.0 0.28

Home Health Care ................................................................................................................................... 10,921 40.6 0.11

Emergency Medical Services ................................................................................................................... 5,099 14.5 0.11
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54221

3The Regulatory Flexibility Act states that a

Regulatory Flexibility Analysis need not contain all

of the above elements in toto if these elements are

presented elsewhere in the documentation and

analysis of the rule. The Regulatory Flexibility

Analysis should, however, summarize where these

elements can be found elsewhere in the rulemaking

record.

TABLE VII–6.—SCREENING ANALYSIS TO IDENTIFY POTENTIAL ECONOMIC IMPACTS ON AFFECTED ENTITIES—Continued

Industry

Number of

affected establishments

Percent of

for-profit establishments in industryCost as a

percentage

of revenues

Laboratories .............................................................................................................................................. 851 100.0 0.13

Contract HVAC ......................................................................................................................................... 300 100.0 0.17

Social Services ......................................................................................................................................... 2,342 0.0 0.27

Physicians ................................................................................................................................................ 21,698 95.0 0.03

Pulmonary Physicians .............................................................................................................................. 1,853 95.0 0.06

Personnel Services .................................................................................................................................. 1,426 100.0 0.56

Attorneys .................................................................................................................................................. 2,306 89.8 0.10

Total .................................................................................................................................................. 101,875 48.7 0.06

Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.

OSHA has preliminarily concluded

that the proposed standard will have a

significant impact on a substantial

number of small entities and has

therefore, as required by the Regulatory

Flexibility Act Amendments of 1996,

conducted an Initial Regulatory

Flexibility Analysis (IRFA). This

analysis has identified significant

impacts on the small entity portion of

the hospital, nursing home, correctional

institution, homeless shelter, substance

abuse treatment center, contract HVAC,

and personnel services industries.

For the purposes of this analysis,

OSHA defines small for-profit entities

using the Small Business

Administration’s (SBA’s) Table of Size

Standards. For businesses affected by

the proposed standard, the SBA

classifies entities with annual revenues

of less than $5 million as small for all

industries, with the exception of

contract HVAC firms, for which entities

with less than $7 million in annual

revenues are classified as small.

A small not-for-profit entity is defined

as any nonprofit enterprise that is

independently owned and operated and

is not dominant in its field. Based on

this definition, all not-for-profit entities

affected by the proposed standard are

considered small.

Many of the affected industries

consist almost entirely of public sector

facilities, such as correctional facilities,

immigration detainment facilities, law

enforcement facilities, medical

examiners’ offices, and social service

organizations. Several other affected

industries include some governmentowned facilities, such as hospitals,

nursing homes, and emergency medical

services. Under the Regulatory

Flexibility Act, ‘‘small governmental

jurisdiction’’ refers to governments of

cities, counties, towns, townships,

villages, school districts, or special

districts with populations of less than

50,000. For most of the affected

industries, information on the number

of such entities was not readily

available. Where data were unavailable,

the number of small publicly-owned

entities was estimated based on the

average number of people served per

employee in each industry, from which

OSHA estimated the average

employment size of establishments

serving populations of less than 50,000.

These entities are considered small for

the purposes of this analysis. OSHA

requests information on size standards

for public-sector entities.

OSHA requests comment on these

definitions and estimates of the number

of small entities. The complete IRFA is

presented in Chapter VI of the economic

analysis, and is also presented here.

Initial Regulatory Flexibility Analysis

The Regulatory Flexibility Act, as

amended in 1996, requires that an

Initial Regulatory Flexibility Analysis

contain the following elements:

(1) A description of the reasons why

action by the agency is being

considered;

(2) A succinct statement of the

objectives of, and legal basis for, the

proposed rule;

(3) A description of, and, where

feasible, an estimate of the number of

small entities to which the proposed

rule will apply;

(4) A description of the projected

reporting, recordkeeping and other

compliance requirements of the

proposed rule, including an estimate of

the classes of small entities that will be

subject to the requirement and the type

of professional skills necessary for

preparation of the report or record; and

(5) An identification, to the extent

practicable, of all relevant Federal rules

that may duplicate, overlap or conflict

with the proposed rule.

In addition, a regulatory flexibility

analysis must contain a description of

any significant alternatives to the

proposed rule that accomplish the

stated objectives of applicable statutes

(in this case the OSH Act) and that

minimize any significant economic

impact of the proposed rule on small

entities.3 This section of the analysis

closes with a review of the

recommendations of the SBREFA Panel

concerning this proposed rule and

discusses how OSHA has responded to

these recommendations.

Reasons for the Proposed Rule

From 1985 to 1994, the number of

active TB cases in the United States

increased by 9.4 percent, reversing a 30-

year downward trend. Although the

number of cases reported to the CDC has

declined over the past few years, TB

remains a serious problem in the United

States. In 1994, 24,361 active TB cases

were reported to the Centers for Disease

Control and Prevention (CDC), and TB

was reported to have caused 1,590

deaths in that year alone (Ex. 7–283).

Transmission of M. tuberculosis is a

recognized risk in several work settings.

A number of outbreaks of this dreaded

disease have occurred among workers in

health care settings, as well as other

work settings, in recent years. To add to

the seriousness of the problem, some of

these outbreaks have involved the

transmission of multidrug-resistant

strains of M. tuberculosis, a form of the

disease that is often fatal.

Objectives of the Proposed Rule

The objective of this proposal is to

reduce the risk of occupational exposure

to M. tuberculosis in exposed working

populations through the use of

engineering controls, work practice

controls, respiratory protection, medical
54222 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

surveillance, training, signs and labels,

and recordkeeping. Implementation of

these measures has been shown to

minimize or eliminate occupational

exposure to M. tuberculosis, and thus to

reduce the risk of TB infection among

workers. The legal authority for this

proposed standard is the Occupational

Safety and Health Act, 29 U.S.C. 655(b).

Description of the Number of Small

Entities

The proposed rule would cover

80,400 establishments operated by

67,116 small entities, as defined above.

Of the 67,116 small entities, about 49

percent (32,605 entities) are for-profit

small entities, 20 percent (13,622

entities) are publicly-owned, and 31

percent (20,889 entities) are not-forprofit. About 79 percent of the total

number of affected establishments are

operated by small entities. The

proposed rule covers 48,804

establishments operated by 48,044 very

small entities, defined as entities of all

kinds employing fewer than 20 workers.

Almost 48 percent of the affected

establishments are operated by very

small entities.

Description of Proposed Reporting,

Recordkeeping and Other Compliance

Requirements

Avoiding a One-Size-Fits-All

Standard. Occupational TB occurs in a

wide variety of settings, which means

that the risk varies substantially, and

control measures differ, from one

facility to another. OSHA’s proposed TB

standard has been tailored to recognize

these differences. With respect to the

background risk of exposure, the OSHA

standard distinguishes between work

settings in counties that have had no

cases of TB in one of the past two years

and fewer than 6 cases in the other of

the past two years, work settings in

counties with one or more cases of TB

in both of the past two years or that

have had 6 or more cases of TB in one

of the past two years, and work settings

that have encountered 6 or more cases

of TB in the past 12 months. In addition,

the OSHA standard treats different types

of exposure to TB differently. For

example, the standard has different

requirements for employers who own

facilities that treat TB patients,

employers whose client populations

have high TB rates, employers whose

employees (such as attorneys and social

service providers) visit patients who

have been identified as having

suspected or confirmed cases of TB,

employers whose employees engage in

various high hazard procedures,

employers whose employees provide

maintenance for ventilation systems

serving confirmed or suspected TB

patients, and employers who provide

personnel to treat patients in their own

homes. In part because of these many

distinctions, the SBREFA Panel found

that the regulation was difficult for

many employers to understand (Ex. 12).

To make the tailoring of the standard to

specific situations easier to see, OSHA

has developed tables showing which

provisions of the standard are most

likely to apply to employers in different

circumstances and in various affected

sectors (see the Scope paragraph

discussion in Section X of the Preamble,

‘‘Summary and Explanation’’). In

addition, OSHA intends to provide

extensive outreach when the standard is

published in final form. OSHA solicits

comments on other ways to avoid a

‘‘one-size-fits-all’’ standard while at the

same time making the standard easier to

follow. For example, would developing

a flow chart and/or expert system that

asks employers a series of questions and

then directs employers to applicable

requirements be an aid to affected small

entities?

Description of the Proposed Standard.

The proposed rule would require that

employers develop and implement

exposure control plans; institute work

practice and engineering controls;

provide respiratory protection in

various situations; provide medical

surveillance (e.g., tuberculin skin

testing, medical histories, medical

management, medical follow-up,

medical removal); and communicate

hazards through the use of signs, labels,

and training. These proposed

requirements are discussed in greater

detail in the Introduction (Chapter I) of

this analysis.

The proposed standard would also

require that employers establish and

maintain medical, training, illness/

injury, and engineering control

maintenance and performance

monitoring records. All establishments

affected by the proposed rule would be

affected by these proposed

requirements. However, only

establishments with engineering

controls would be required to maintain

records of the maintenance and

monitoring of engineering controls.

In estimating the cost of establishing

and maintaining medical records, OSHA

used the wage rate of a clerical worker

with some knowledge of medical

recordkeeping as the base wage.

However, the knowledge required to

perform such duties can be acquired by

most clerical workers with little effort.

All recordkeeping requirements

included in the proposed rule could

therefore be performed by the existing

staff in any of the covered industries. A

detailed description of the proposed

requirements appears in the

Introduction and in the Costs of

Compliance chapters of this analysis.

Relevant Federal Rules That May

Duplicate, Overlap, or Conflict With the

Proposed Rule

On October 28, 1994, the Centers for

Disease Control and Prevention (CDC) of

the U.S. Department of Health and

Human Services published ‘‘Guidelines

for Preventing the Transmission of

Mycobacterium tuberculosis in HealthCare Facilities,’’ which recommends

that facilities adopt many of the

requirements included in this proposed

standard. CDC has also published

guidelines for the prevention of

transmission of TB in homeless shelters,

long-term care facilities for the elderly,

and correctional institutions. OSHA has

consulted with CDC in developing the

proposed standard, and the basic

elements of the standard correspond to

the basic elements in the CDC

guidelines. However, the CDC

publication is only recommendatory

and is therefore not enforceable.

OSHA’s studies (see chapters IV and V)

show that few facilities are following all

elements of these guidelines. Further,

many portions of the CDC guidelines are

written in language that does not lend

itself to enforcement even if the

guidelines were made mandatory. For

example, portions of the CDC guidelines

for health care facilities suggest that the

employer ‘‘consider’’ adopting certain

controls. A fuller discussion of the

similarities and differences between

OSHA’s proposed rule and the CDC’s

recommendations is provided in Section

III of the Preamble, which describes the

events leading to the proposed standard.

Although the U.S. Public Health Service

has overall responsibility for the control

of TB in the U.S. population, OSHA is

the only agency specifically mandated

to address the problem of TB

transmission in occupational settings.

The Health Care Financing

Administration (HCFA) of the U.S.

Department of Health and Human

Services requires that facilities undergo

an initial accreditation inspection prior

to receiving Medicare and Medicaid

funding. Such facilities include

hospitals, nursing homes and other

long-term care facilities, and clinical

laboratories. Hospitals are reinspected

annually, nursing homes every 15

months, and laboratories every two

years. One of the requirements of such

accreditation is the implementation of

an infection control program. However,

unlike the OSHA proposed rule, HCFA’s

requirements do not specify the

elements that must be included in such
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54223

a program. HCFA may cite facilities

with poor results for specific program

deficiencies but does not have the

authority to cite facilities for failing to

include specific elements in their

infection control programs, unless those

program elements are specifically

required by an OSHA standard. This

means that in the absence of an OSHA

TB standard, HCFA could not require

implementation of specific controls. The

proposed rule does not in any way

conflict with HCFA requirements.

Further, the existing HCFA

requirements have not ensured that

health care facilities adopt the elements

of an effective infection control and

have not prevented outbreaks of TB in

this workforce.

One small entity representative to the

SBREFA Panel suggested that the OSHA

regulation might conflict with state and

local requirements for skin testing and

for tracing contacts of active cases of TB

(Ex. 12). OSHA has considered this

suggestion and believes there is no

conflict. Some states do have rules

covering TB testing and contact tracing,

but most states do not. In 1993, only 18

states had requirements for TB

screening of employees in medical

facilities, and only 23 states had testing

requirements for nursing home

employees. Further, these requirements

are sometimes not as stringent as those

OSHA is proposing; for example, some

states require only an initial skin test.

Although 49 states require the

investigation of reported cases of TB,

only 29 states require contact tracing by

health departments. In states where

local health departments provide

contact tracing, such contact tracing

would constitute compliance with

OSHA’s requirements for contact tracing

by employers. Employers merely need

to assure that contact tracing takes

place; they need not do the contact

tracing themselves if others are available

to do this job for them. Thus, there is

no conflict between the OSHA standard

and existing state requirements, nor do

existing state laws obviate the need for

a standard that requires TB testing of

exposed employees and the

investigation of reported TB exposures.

However, OSHA solicits comment on

the interaction of state rules regarding

testing and tracing and the proposed

standard.

One small entity representative was

concerned with how medical removal

protection and worker compensation

programs would interact (Ex. 12).

Medical removal protection requires

that workers receive full salaries, full

benefits, and no loss of job position or

seniority while the employee is unable

to work, or unable to work at his/her

usual position, as a result of incurring

an occupational case of TB. The purpose

of medical removal protection is to

assure that workers provide timely and

accurate information to their employers

concerning their medical symptoms. In

the absence of medical removal

protection, workers have financial and

job security incentives to avoid

reporting symptoms. OSHA counts any

payments workers receive from workers’

compensation toward the goal of

assuring medical removal protection;

that is, employers may deduct from the

amount they pay out to the worker any

monies paid to the ill worker by

workers’ compensation. Workers’

compensation is not an adequate

substitute for medical removal

protection because workers’

compensation does not fully replace lost

wages and provides no guarantee of

maintenance of seniority, job security,

current position, or non-wage benefits.

Medical removal protection requires the

employer to provide any of these

elements that are not a part of workers’

compensation. Thus, the employer of a

worker already receiving workers’

compensation would need to provide an

additional salary increment in order to

restore the employee’s full salary and

would need to provide the worker his or

her full non-wage benefits.

One small entity representative

expressed concern over a possible

conflict between the proposed rule and

Federal Confidentiality Regulations

covering chemically abusive or

dependent clients participating in

licensed and federally-funded programs

[Ex. 12]. These regulations prohibit

disclosing information regarding the

identification of a patient as a substance

abuser without the patient’s consent.

This representative noted that, without

patient consent, a disclosure may be

made only to medical personnel to meet

a situation that has been declared a

medical emergency by the Surgeon

General. This small entity representative

was referring to Public Health

regulations: Confidentiality of Alcohol

and Drug Abuse Patient Records, 42

CFR 2, and a similar state statute:

Confidentiality of Records, Minnesota

Statute 254A.09. Both the Federal

Confidentiality Regulations and the

state statute cover records that would

identify a patient as an alcoholic or drug

abuser or concern his or her prognosis,

diagnosis, treatment, attendance, status

or physical whereabouts. No

requirements of the standard would

require the disclosure of records of this

kind. These are not the kinds of records

that are relevant to determining whether

an individual has suspect or confirmed

infectious TB. In addition, a medical

referral for the client who is exhibiting

signs and symptoms of TB can be made

without revealing any of the prohibited

confidential information. Moreover, in

the case of an exposure incident, the

identity of the individual with

suspected or confirmed infectious TB

need not be told to employees. Records

maintained by employers on their

employees are not covered by the

regulations or statute, but would be

subject to the same confidentiality

requirements that govern all medical

records. The identification and

notification requirements in the

proposed TB standard are the minimum

necessary to prevent transmission of TB

to employees. The contagious nature of

the disease mandates early detection

and early monitoring of individuals who

have had an exposure incident.

One small entity representative to the

SBREFA Panel expressed concern over

possible interactions between the

proposed standard and the Family and

Medical Leave Act (FMLA) (Ex. 12). The

Family and Medical Leave Act does not

provide for leave with pay, and does not

guarantee the continuation of any

benefits other than health insurance.

Further, the Family and Medical Leave

Act covers a more limited timeframe (12

weeks) than the proposed standard’s

medical removal protection provisions

(18 months). Thus, the only overlap

between the proposed standard and the

FMLA would occur in the area of health

insurance benefits in the first 12 weeks

of the worker’s absence from work.

Since the standard would specifically

allow the employer to deduct from

medical removal protection benefits any

benefits paid to the worker from other

sources, employers would not pay for

the same benefits twice.

One small entity representative felt

that the Americans with Disabilities Act

(ADA) may offer protection to the

‘‘worker who becomes ill as a result of

an occupational exposure or who cannot

work because of an inability to wear a

PR [respirator].’’ (Ex. 12) The ADA

prohibits employers of 15 or more

employees from discriminating, because

of the disability, against a qualified

individual with a disability with regard

to terms, conditions and privileges of

employment. An employer must

provide reasonable accommodation for

known physical or mental limitations

for a qualified individual with a

disability, unless accommodation can be

shown to impose undue hardship on the

employer. OSHA representatives noted

that there is no conflict between an

OSHA standard and the ADA

requirements prohibiting

discrimination. The ADA says that:
54224 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

Nothing in this Act shall be construed to

invalidate or limit the remedies, rights and

procedures of any Federal law * * * that

provides greater or equal protection for the

rights of individuals with disabilities that are

afforded by this Act. 42 U.S.C.A. 12201(b).

Further, the ADA would not provide the

same protections as medical removal

protection. In order for an employee to

take advantage of the provisions of the

ADA, certain conditions must be met.

For example, the employee must work

for a covered employer and be a

qualified individual with a disability,

i.e., one who can perform his or her job

with or without reasonable

accommodation. Thus, while the ADA

may offer some protection to an

employee who has or is suspected of

having infectious TB or who cannot

work because he or she cannot wear a

respirator, the protection proposed to be

provided by the OSHA standard for TB

is more comprehensive and will lead to

greater participation in the entire

medical surveillance program. The

OSHA proposed standard, in paragraph

(g)(5)(ii), would provide to the employee

with suspected or confirmed infectious

TB:

* * * his or her total normal earnings,

seniority, and all other employee rights and

benefits, including the employee’s right to

his or her former job status * * * until the

employee is determined to be noninfectious

or for a maximum of 18 months, whichever

comes first.

For each employee who must be

removed for his or her job because he

or she cannot wear a respirator

(paragraph (g)(5)(iii)), the employer is

required to:

transfer the employee to comparable work for

which the employee is qualified or can be

trained in a short period (up to 6 months),

where the use of respiratory protection is not

required [and] * * * maintain the total

normal earnings, seniority, and all other

employee rights and benefits. If there is no

such work available, the employer shall

maintain the employee’s total normal

earnings, seniority, and all other employee

rights and benefits until such work becomes

available or for a maximum of 18 months,

whichever comes first.

OSHA’s MRP provisions provide each

employee, who must be medically

removed, with the level of protection

that is needed to assure that the

employee promptly reports his or her

symptoms of TB (which makes the

workplace safer for all employees) and

reports his or her difficulty with

wearing a respirator (which makes the

workplace safer for that employee).

Significant Alternatives to the Rule

Considered by OSHA

This section first considers

alternatives that OSHA was urged to

consider by the SBREFA Panel and then

turns to other alternatives considered by

the Agency.

Alternatives Suggested by SBREFA

Panel Members

Small entity representatives and

SBREFA Panel members suggested a

wide variety of possible clarifications

and alternatives to the regulation. In

response to these suggestions, OSHA

has made a number of changes to the

regulation, clarified the meaning of

many sections of the rule, provided

additional analysis, and added tables to

the Preamble designed to clarify the

requirements of the rule in various

situations. A full discussion of OSHA’s

responses to all of the SBREFA Panel

recommendations is given in the next

section. This section only presents

alternative approaches to the proposed

rule and a discussion of the extent to

which OSHA has adopted these

alternative approaches. OSHA

welcomes comments on these and other

alternatives and on ways OSHA could

adopt additional aspects of these

alternative approaches and still meet the

requirements of the OSH Act,

particularly that Act’s requirement to

control significant risk to the extent

feasible.

Less Stringent Trigger Mechanisms for

the More Burdensome Portions of the

Standard, Including Raising the ZeroCase Per County Per Year Trigger

OSHA has re-examined each

provision of the proposed standard to

ensure that it is necessary and

appropriate to reduce risk. In the draft

of the proposal reviewed by the Panel,

OSHA required that a facility would

only be eligible for the reduced TB

control program requirements of

Appendix A if the facility did not treat

TB patients and if there had been no

cases of TB in the county or the facility

in the previous year. In its review,

OSHA found that applying the

standard’s Appendix A requirements to

facilities in counties with no TB cases

in one of the last two years and fewer

than 6 TB cases in the other of the last

two years would not substantially

increase the risk to employees in

facilities located in such counties. This

change from the trigger OSHA originally

considered increases the number of

counties qualifying for the Appendix A

program from 43 percent to 55 percent

of all U.S. counties.

Consider Allowing Portability of

Training

The draft proposal reviewed by the

SBREFA Panel required that all new

employees be provided complete

training. OSHA has examined its

training provisions and decided that the

non-site-specific components of

training, such as training in the

difference between tuberculosis

infection and disease, can be transferred

between employers without reducing

the protection such training affords

employees.

Do Not Require Annual Retraining

The draft proposal reviewed by the

SBREFA Panel required annual

retraining of all employees. OSHA

believes that some method of assuring

continuing competency is necessary,

and that one-time training will not

provide such assurance. However, the

proposal now would allow employers to

develop methods of assuring the

competency of their employees, such as

asking them questions about

procedures, controls, etc., as an

alternative to retraining. This change in

the regulation will result in cost savings

of $20 million per year.

Cooperative Initiatives, Such as

Expanding OSHA’s Current Cooperative

Initiative With JCAHO

Some Panel members felt that

cooperative initiatives could substitute

for regulation in some areas. As noted

above, however, in the absence of an

OSHA standard, HCFA (and accrediting

associations working with HCFA, such

as JCAHO) does not have the authority

to enforce specific infection control

requirements. As a result, a cooperative

initiative alone would leave employees

exposed to TB in hospitals, who account

for 13 percent of the active cases of TB

projected to be prevented by the

standard, without any new initiative

designed to prevent these active cases of

TB. If this approach were extended to

nursing homes, and all nursing homes

chose to be accredited, then 70 percent

of the active cases of TB projected to be

prevented by the standard would be

denied coverage. Thus, OSHA does not

feel that cooperative initiatives, even

with accrediting organizations, can

substitute for regulation.

Others suggested that OSHA could

turn over enforcement of any TB

regulation to HCFA, JCAHO or another

accrediting or standards organization. In

the eyes of its proponents, the

suggestion that others could enforce

OSHA’s regulation has several major

advantages. First, it would assure

regular and more frequent inspections at

health care facilities and nursing homes

than OSHA alone could provide.

Second, it would require health care

facilities and nursing homes to deal

only with a single inspection for

infection control procedures, rather than
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54225

inspections by two different federal

agencies. Third, these organizations may

have greater penalty powers than

OSHA, in that denial of HCFA

acceptance or of accreditation can result

in a health care facility losing

significant funding or even being

required to close.

For several reasons, providing

exclusive HCFA enforcement of OSHA’s

TB requirements is an unsound

approach. First, OSHA inspectors

already inspect health care facilities,

just as they inspect any other facility

covered by the OSH Act, for possible

violations of any OSHA requirement,

e.g., safety as well as health

requirements. The need for these OSHA

inspections would not change even if

HCFA or accrediting agencies enforced

OSHA’s TB requirements. Second,

OSHA does not believe that it is legally

appropriate under the OSH Act to tell

its inspectors that, when they inspect

health care facilities, they must ignore

violations of the Agency’s occupational

exposure to TB requirements. Third,

OSHA also cannot legally ignore

employee complaints relating to

occupational exposure to TB. For all of

these reasons, OSHA believes that

exclusive enforcement of the rule by

HCFA or by agencies, such as JCAHO,

that are authorized to provide

accreditation, is not an appropriate or

legally defensible approach.

However, OSHA does favor

expanding its cooperative agreements,

such as the current agreement with

JCAHO, in any ways that both agencies

agree would be beneficial, and OSHA is

currently pursuing this option. On

August 5, 1996, OSHA and JCAHO

announced a 3-year partnership to

promote health and safety for healthcare

workers. This partnership will help

health care facilities to meet

accreditation expectations and OSHA

compliance requirements. The

initiatives of this partnership will

include cataloging and evaluating

duplicative compliance activities;

undertaking cross-education and

training of JCAHO and OSHA staff on

corresponding requirements that relate

to the management of worker safety and

health; and developing a series of

collaborative publications and user

education programs.

A Federal-State Government Public

Health Partnership to Develop

Guidelines in Various Industry Sectors

The CDC is already charged with

developing guidelines for the control of

TB, and has already issued guidelines

for correctional institutions,

laboratories, health care facilities, longterm care facilities for the elderly, and

homeless shelters. In fact, OSHA has

made extensive use of these guidelines

in developing its proposed occupational

exposure to TB standard. OSHA feels

that the CDC guidelines alone have not

served adequately to protect TB-exposed

workers, however. OSHA research

indicates that the CDC guidelines are

not being followed in most facilities,

and believes that this is the reason that

occupational exposure to TB remains

such a serious problem in this country.

In Chapter VII of the analysis, OSHA

shows that these guidelines are not

being followed and explains why many

employers have little economic

incentive to implement these

guidelines.

Performance Standards Developed With

the Assistance of Federal, State, and

Local Government, and Labor and

Industry

OSHA feels that its standard is a

performance oriented standard that has

benefited from both CDC’s expertise and

from many stakeholder meetings (which

include representatives of other federal,

state and local government agencies,

labor, and industry) and the SBREFA

Panel Process.

OSHA’s proposed standard is

performance oriented in a variety of

ways. For example, OSHA does not

specify procedures by which facilities

must achieve AFB isolation, but instead

allows any workable design. Similarly,

OSHA sets performance criteria for

respirators, but does not specify the

types of respirators that must be used.

OSHA does specify procedures for

identification of suspect cases, but

allows any method that assures that

persons with the appropriate symptoms

are identified as suspect cases.

However, OSHA did not consider it

appropriate to specify performance in

terms of rates of TB cases or TB skin test

conversions. Such an approach is not

preventive, in that application of proper

procedures would only occur after TB

infection had occurred. Furthermore,

most smaller facilities do not have

enough TST conversions for statistically

meaningful trends to be established.

OSHA requests comments on this issue.

Some proponents of this approach

feel that OSHA’s proposed standard

may not reflect the best ideas for

controlling occupational exposure to TB

and argue that stakeholder meetings

would be a useful way of developing a

better approach. OSHA held five

stakeholder meetings involving

representatives from more than thirty

interested organizations. Furthermore,

the CDC has made use of the best

expertise in the country in developing

its guidelines, and OSHA has adopted

most elements of these guidelines and

will hold public hearings on the

standard at which interested parties can

present their views. OSHA welcomes

comments about alternative approaches

to reducing occupational exposure to

TB, particularly suggestions concerning

more performance oriented approaches,

but feels that this proposal is the result

of an extensive review of the literature

and of input from stakeholders on the

available prevention and control

methods and should be issued as a

proposal at this time to prompt further

discussion and exchange of information.

OSHA is particularly interested in

alternative methods of identifying

suspected cases of TB and in whether

the proposed requirements would

preclude or impede programs that

employers have found to be effective.

Separate Approaches for Health and

Non-Health Industries The Approach for

Health Industries Should Be Keyed to

Existing Industry Standards and That

for Non-Health Industries to Guidelines

This suggested alternative

incorporates several concepts. First, it

assumes that the health and non-health

care sectors should be given separate

treatment because of differences in

existing regulations and expertise.

OSHA agrees that sectors that differ in

relevant ways should be given different

treatment, and the standard therefore

has provided for different approaches to

different sectors. For example, OSHA’s

standard does treat facilities that treat

TB patients differently from the way it

treats those that transfer TB patients out

of their facilities, and treats employers

whose employees are routinely in

contact with client populations with

high rates of infectious TB (such as

homeless shelters and drug abuse

treatment centers) differently from

employers whose employees only come

into contact with infectious TB cases on

an occasional basis (such as attorneys

and social workers).

Second, this alternative posits that the

health care sector is already subject to

an extensive regulatory system with

respect to occupational exposure to TB.

Although some states have laws on

contact tracing and skin testing, and

HCFA inspects infection control

systems in hospitals and long-term care

facilities for the elderly, there are no

existing enforceable standards aimed

specifically at occupational exposure to

TB. Thus OSHA’s proposed provisions

with respect to preventive measures

have no equivalent in existing

regulations, and only a limited number

of states require skin testing of the kind

OSHA’s proposed standard requires.

OSHA (and CDC) believes that these
54226 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

provisions are essential to any program

to control occupational exposure to TB.

Third, proponents of this alternative

believe that the non-health care sectors,

particularly those engaged in charitable

work such as homeless shelters, are

better approached through guidelines

than regulations. OSHA believes that

there is relatively little need to develop

guidelines for non-healthcare sectors,

such as correctional institutions and

homeless shelters, because such

guidelines already exist and have not

been implemented in many, if not most,

facilities. Some proponents of this

approach believe that the failure of nonhealth care sectors to implement

existing guidelines is due to the absence

of outreach and information. OSHA is

not substituting a system of regulation

for a system of outreach. OSHA intends

to continue a program of outreach on

occupational TB, and hopes that

facilities in all sectors will adopt

appropriate policies before the

regulation is finalized. However, given

that even in the relatively

knowledgeable health care sector,

implementation of the CDC guidelines

has been limited, it is unlikely that

outreach alone can assure the full

implementation of suitable measures for

control of occupational exposure to TB.

Different Levels of Requirements for

Different Industries, Depending on

Their Expertise, Resources, and Risk

OSHA’s proposed standard recognizes

three levels of risk and provides

separate treatment for employers

engaged in different kinds of activities,

where those differences are relevant to

the purposes of the standard. This

subject is discussed in the next sections.

Such tailoring, however, must be

consistent with the mandate of the

Occupational Safety and Health Act to

reduce significant risk to the full extent

feasible. OSHA has preliminarily found

all of the standard’s provisions to be

technologically and economically

feasible, within the meaning of the Act,

for facilities in all affected industries.

(The special potential problems of

homeless shelters and substance abuse

treatment centers are discussed further

below.) The statutory requirement to

eliminate significant risk to the extent

feasible means that if inadequate

resources and expertise would make any

provision of the proposed standard

infeasible, then OSHA would have to

consider alternative approaches.

However, it also means that the

resources and expertise that are feasible

for an employer to acquire must be

employed if they will reduce significant

risk.

Separate Standards for Each Affected

Industry

Proponents of this alternative had two

goals: first, to assure that OSHA gave

full consideration to the circumstances

of each affected industry, and second, to

make the standard easier to follow for

affected small entities. With respect to

the first goal, OSHA has recognized a

wide variety of distinctions in risk of

exposure and practice among affected

employers. Some of these differences

follow industry lines. Accordingly, the

proposed standard includes special

provisions for laboratories and home

health care providers. However, most of

the relevant differences among

employers do not strictly follow

industry lines, and attempts to write

separate standards for different

industries would not significantly

reduce the complexity of the regulation.

For example, all industries need to

realize that different requirements are

applicable for each of three types of risk

of exposure. Similarly, the applicability

of certain requirements depends on

whether TB patients are treated onsite

and on whether certain hazardous

procedures are performed. While, for

example, the typical nursing home

would not treat TB patients or perform

high hazard procedures on site, some

might, and thus these provisions would

need to be included in an industry

standard written for nursing homes.

OSHA’s proposed standard carefully

distinguishes a variety of activities that

may occur in different industries and

has different requirements for each

activity. Although this makes the

standard somewhat more complex, this

approach is essential to avoid a ‘‘one

size fits all’’ standard. In addition, as

presented in the discussion of the scope

in the Summary and Explanation of the

Preamble, OSHA has developed charts

showing the requirements of the

proposed standard that are applicable to

each industry. OSHA welcomes any

suggestions on ways to make the

standard easier to understand, or on

ways to adapt the standard to the

situation of specific industries while

reducing significant risk.

Revise the Proposed Standard for

Consistency With CDC Guidelines

The issue of how the CDC Guidelines

fit into a regulatory scheme to prevent

or reduce occupational exposure to TB

has been considered by OSHA and other

reviewers. OSHA’s view is embodied in

the proposed standard, in which the

Agency has attempted to translate the

CDC’s recommendations into

enforceable regulatory language that can

be applied to a variety of occupational

settings where the risk of transmission

of TB is significant. The Agency

believes that, in addition to the basic

difference between a ‘‘guideline’’ and a

‘‘regulation,’’ there are only three

general areas where the proposed

standard differs substantially from the

CDC Guidelines for health care

facilities: the use of site-specific risk

assessment, the frequency of skin testing

in certain situations, and the required

use of respiratory protection around

unmasked individuals with suspected

or confirmed infectious TB. Several

small entity representatives, along with

some SBREFA Panel members, have

suggested that the Agency consider

allowing employers to follow the CDC

Guidelines as an additional option to

comply with the OSHA standard.

Both the OMB and SBA Panel

representatives believe that for at least

some of the work sites OSHA has

proposed to cover, the CDC Guidelines

currently provide an adequate measure

of protection. They believe it would be

burdensome for employers who are

already in compliance with the

Guidelines to have to become familiar

with the OSHA proposal and to

implement its provisions. These

employers have already invested in a TB

prevention and response program

consistent with the Guidelines. In other

words, the employers have conducted

their risk assessments, implemented the

suggested provisions and trained their

workers to comply. Moreover, these

reviewers point out that where the

Guidelines have allowed for discretion

on the part of the employer as, for

example, where an employer may first

consider the symptoms specified in the

several CDC Guidelines’ definition of

‘‘suspected infectious TB’’ before

adopting a definition for his or her own

work site, prevention of the

transmission will more easily be

achieved because the employer is

allowed to tailor the requirements to

actual conditions in his or her

workplace. To assure that the

employer’s adoption of the CDC

Guidelines is effective, these reviewers

recommended that the employer assert

or certify that he or she is in compliance

and, if challenged in an OSHA

inspection, prove the efficacy of his or

her program through a performance

measure, such as skin test conversion

rates. These reviewers believe that this

approach will result in a more efficient

use of scarce health resources.

OSHA agrees that the various CDC

Guidelines are the most important

sources for setting an occupational

health standard that will reduce or

prevent the spread of TB. However,

although certain facilities adhere to the
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54227

Guidelines, OSHA’s research has shown

that most facilities have not fully

implemented the CDC

recommendations. TB remains an

occupational hazard, and OSHA has

preliminarily concluded that the risk of

transmission of TB to employees is

significant. OSHA believes there are a

number of reasons why the Guidelines

cannot take the place of an OSHA

standard. First, the Guidelines are not

written in language that can be

enforced. For example, the Guidelines

suggest, recommend and set forth what

an employer could or should do, not

what he or she must do. Unless the

Guidelines are converted to regulations,

an employer may adhere to some

applicable recommendations while not

implementing others, which could

result in uneven and inadequate

employee protection. OSHA standards

are written in mandatory language,

letting employers and employees know

what they have to do in order to be in

compliance with the regulation. This

permits an employer, an employee or a

compliance officer to determine easily

whether an entity is in compliance with

a standard. Second, the establishmentspecific risk assessment approach of the

Guidelines imposes a tremendous

paperwork burden on covered entities

and requires a level of professional

expertise in risk assessment that few

entities outside of large hospitals

possess. OSHA believes that

recommendations or regulations that

necessitate this level of expertise could

make it difficult to determine if an

entity is in compliance. Third, OSHA

knows of no objective criterion that

could be reliably used as a measure of

proof of an effective program.

Tuberculin skin testing has been

suggested as a means of proving

compliance with the CDC Guidelines,

e.g., zero conversions would be

accepted as proof that an entity was

complying with the Guidelines.

However, the use of conversions as a

compliance measurement has two

problems. First, skin test conversions

are not necessarily indicative of

implementation of the Guidelines’

recommendations. For example, an

entity may have implemented very few

of the Guidelines’ recommendations, yet

been fortunate enough to experience no

conversions. Therefore, compliance

with the Guidelines’ recommendations

has not been achieved even though

there have been no employee

conversions. Furthermore, while an

increase in the number of conversions

indicates employee exposure, a lack of

conversions does not necessarily mean

that employees are not being exposed.

For example, some employees have

already skin-tested positive, not all

exposures result in conversions, and

many entities will not have enough

TST-negative employees to generate

sufficient statistical power to accurately

determine an increased conversion rate.

With regard to this last point, the CDC

states:

A low number of HCWs in a specific area

may result in a greatly increased rate of

conversion for that area, although the actual

risk may not be significantly greater than that

for other areas. Testing for statistical

significance (e.g., Fisher’s exact test or chi

square test) may assist interpretation;

however, lack of statistical significance may

not rule out a problem (i.e., if the number of

HCWs tested is low, there may not be

adequate statistical power to detect a

significant difference). Thus, interpretation of

individual situations is necessary. (Ex. 4B)

Second, OSHA believes that reliance on

number of TST conversions as a

performance measure is reactive rather

than proactive, because it emphasizes

the identification of employees who

have already incurred a status change as

a result of an exposure instead of

averting exposures.

OSHA believes that compliance with

the proposed standard by all affected

facilities within the covered sectors is

the way to assure that employees will be

protected from occupational

transmission of TB. The Agency

believes that compliance will not be

difficult for employers who have

already implemented the Guidelines,

because many of the elements of the

Guidelines have been incorporated into

the proposed standard. Also, employers

who are not in compliance with the

Guidelines will find that the standard

gives them clear instructions on what to

do. In addition, the structure of OSHA’s

proposed TB standard is similar to that

of the Bloodborne Pathogens standard

(BBP). Since the vast majority of

workplaces that will be covered by the

TB standard are subject to BBP,

becoming familiar with and

implementing the requirements of the

TB standard should not be difficult.

Another issue raised in the review

process was what would happen if, after

the OSHA standard was promulgated,

the CDC issued a new guideline that

was different from the OSHA standard

on an item addressed by the standard.

OSHA believes this is already addressed

by OSHA’s citation policy, in particular,

the policy for De Minimis Violations,

which states that violations of standards

which have no direct or immediate

relationship to safety or health are not

to be included in citations. An example

of a de minimis violation occurs when

an employer complies with a proposed

OSHA standard or a consensus standard

rather than with the OSHA standard in

effect at the time of the inspection and

the employer’s action clearly provides

equal or greater employee protection

[OSHA Field Inspection Reference

Manual, Instruction CPL 2.103,

September 26, 1994]. In cases where an

employer is complying with another

provision, such as a consensus standard,

the Agency looks at the consensus

standard to make sure the consensus

standard is at least as protective as the

OSHA standard. Because CDC

Guidelines reflect the views of many of

the country’s leading experts and

practitioners in public health measures

to prevent the spread of TB, the updated

CDC Guidelines can be assumed to

provide equal or greater protection

against occupational transmission of TB

to employees. Because these guidelines

carry great authority, the De Minimis

Violation policy would not only be a

defense, but would be accorded such

deference that OSHA would incur a

heavy burden in showing that an

updated CDC guideline on an item

addressed by the OSHA TB standard did

not provide equal or greater protection

against occupational transmission of TB

to employees. In order to ensure that the

new CDC Guidelines would be

communicated to the OSHA Regions

and others who would need to know,

OSHA will issue a Memorandum for

Regional Administrators that will

address how the new Guideline could

be implemented in the work place,

include a copy of the new Guideline,

and instruct the Regional Administrator

to contact area offices and the OSHA

state designees. In addition, the

Memorandum would be posted on the

OSHA Computer Information Service

(OCIS) and OSHA CD–ROM, which are

accessible to the public.

OSHA seeks comment on all issues

related to the CDC Guidelines,

particularly whether they could be

implemented in lieu of an OSHA

standard and, if so, how compliance and

efficacy could be determined.

Change the Approach to the

Identification of Suspect Cases for

Homeless Shelters or Substance Abuse

Treatment centers

The SBREFA Panel found that ‘‘Given

the current definition of suspect cases,

it is not clear that homeless shelters can

comply fully with the standard.

Accordingly, OSHA should reexamine

the definition of suspect cases and/or

reexamine its approach to homeless

shelters.’’ The SBREFA Panel also noted

that this same finding might be relevant

to substance abuse treatment centers.

The Panel arrived at this finding as a
54228 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

result of statements made by small

entity representatives from the homeless

shelter sector. Small entity

representatives concerned with

homeless shelters had serious problems

with OSHA’s definition of a suspect

case and questioned the feasibility of

screening the homeless by using

questions about symptoms. Mr. Wayne

Anderson of the National Health Care

for the Homeless Council argued that

OSHA’s definition of a suspect case

would result in the identification of

most of the homeless as suspect cases

during the winter months. Major

Dalberg of the Salvation Army found

OSHA’s definition of a suspect case

confusing and ambiguous, and stated

that it would cover a substantial portion

of the homeless. All three small entity

representatives from this sector

questioned whether the standard’s

screening procedures were workable in

the homeless shelter context. They

asserted that the homeless might avoid

screening questions, be unable to

answer them, learn how to lie in

response to such questions, or choose to

remain on the street rather than be

transferred to a hospital. The small

entity representatives for this sector felt

that this portion of the standard should

be abandoned. Because substance abuse

treatment centers serve a similar

clientele, the Panel was concerned that

the same problems might apply to

substance abuse treatment centers.

To address this issue, and other issues

related to the feasibility of the proposed

standard for homeless shelters, OSHA

has decided to hold special sessions

during the public hearings on the

proposed standard and to study these

issues further through an onsite survey

of a number of homeless shelters. The

study will address the following issues:

• Percentage of homeless persons that

would be identified by OSHA’s

definition of a suspected infectious TB

case. (Breakdown of which symptoms

are particularly common so a better

definition might be designed.)

• Turnover among the homeless who

use shelters.

• Employee turnover in homeless

shelters.

• Trends in number of homeless

persons served in shelters.

• Criteria currently used by some

homeless shelters to identify suspected

infectious TB cases.

• Current practices used in homeless

shelters to address the TB hazard

(baseline compliance with the draft

proposed standard).

—Methods of isolation.

—How suspected TB cases are handled.

• Feasibility of having hospitals

provide cards to the homeless indicating

TB skin test status.

• Number of TB skin test conversions

and active cases among the homeless

and homeless shelter employees.

• Types of benefits offered to

homeless shelter employees (e.g., health

insurance).

• Economic feasibility:

—Costs of running a shelter.

—Revenue sources.

—How costs are accommodated as the

number of homeless persons served

increases.

—Opportunities for cost pass-through.

• Number, location and types (e.g.,

family-oriented, walk-in, all-male) of

homeless shelters.

• Number or proportion of homeless

shelter workers who are unpaid

volunteers.

The study will also address the issue

of volunteers. The OSH Act applies to

employees, not bona fide volunteers;

however, OSHA understands that some

states may, as a matter of state law,

require facilities to provide volunteers

with the protections established by

OSHA standards. Thus, OSHA’s study

will address the following issues:

• Economic impacts, in such states, of

covering volunteers (e.g., how costs

would be handled, cost pass-through

opportunities).

• Protections currently offered to

volunteers.

The results of the study will be made

available for comment in the public

record.

OSHA does not feel that the same

problems apply to substance abuse

treatment centers, even if a high

percentage of clients might be defined

as suspect cases. Inpatient substance

abuse treatment centers routinely

provide some form of entrance physical:

this would be an appropriate time to

screen for suspect cases and provide for

their referral.

Outpatient substance abuse treatment

centers do not provide any form of

shelter for patients, and thus could

readily refer suspect cases to a hospital

without either denying them shelter or

having to pay for the referral. Such a

facility could simply insist that suspect

cases not return without data showing

that they had been to a doctor and did

not have TB. Since outpatient facilities

handle a known population, such an

approach might involve high initial

referrals, but could thereafter settle into

a system that checked for suspect cases

on entry to the program.

OSHA estimates that the proposed

standard will result in a reduction of 28

to 33 active disease cases and 2 to 3

deaths per year in the homeless shelter

sector. A standard requiring skin testing

and follow-up treatment alone would

have only one third the benefits (such

an approach would reduce the number

of active disease cases to only 10 per

year and the number of lives saved to

1 per year). The annual costs of the

proposed standard for homeless shelters

are estimated to be $11,287,278, or

approximately $1,080 per shelter per

year.

OSHA solicits comments on all of the

issues listed above to be covered by its

study of homeless shelters, and solicits

comment on the feasibility of the

standard for substance abuse treatment

centers, and particularly on the extent to

which substance abuse treatment

centers already provide for medical

examinations prior to entry into their

programs.

Other Alternatives Considered by OSHA

OSHA considered several additional

alternatives but has preliminarily

concluded that the proposed rule will

better carry out the objectives of the

OSH Act, while minimizing the

economic impact on affected

establishments, and especially on small

establishments. OSHA requests

comment on the validity of this

preliminary conclusion. First, OSHA

considered making all of the proposed

requirements applicable to every

establishment in the covered industries.

The prevalence of TB, however, varies

by geographical areas and by the

populations served by facilities in

different industries. OSHA therefore

believes it will be possible to reduce

significant risk without imposing the

full regulatory requirements on each

covered employer. Second, OSHA

considered proposing requirements

similar to the CDC’s guidelines, which

recommend that risk assessments be

conducted to determine the level of risk

in each facility and that the controls

implemented vary in accordance with

the level of risk in each facility. This

would require that employers conduct

risk assessments by evaluating factors,

such as the number of suspected or

confirmed TB cases among patients and

employees, employee tuberculin skin

testing results, and the amount of TB in

the community. The CDC

recommendations include five levels of

risk (i.e., minimal, very-low, low,

intermediate, and high), and the

recommended controls vary by the level

of risk. However, adopting such a

requirement in the OSHA standard

would impose a large cost and a heavy

paperwork burden on affected facilities.

To avoid imposing unnecessary

burdens on facilities where the risk of
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54229

occupational exposure to M.

tuberculosis may be lower, OSHA is

proposing to exempt facilities from

certain requirements (i.e., respiratory

protection, annual medical histories,

and annual skin tests) if the facility

transfers, instead of admits, individuals

with suspected or confirmed infectious

TB and can additionally demonstrate

that there have been (1) no reported

confirmed infectious TB cases in the

county within one of the last two 12-

month reporting periods; (2) fewer than

6 infectious cases of TB in the other 12-

month reporting period; and (3) no

infectious cases of TB encountered

within their employees’ work settings

within the past 12 months.

OSHA also considered proposing a

requirement that facilities implement

engineering controls in all intake areas

in which early identification procedures

are performed, if the facility had

encountered six or more individuals

with confirmed infectious TB in the past

12 months. The engineering controls

considered were single-pass ventilation,

filtration of air through the use of HEPA

filters installed as part of the ventilation

system, or stand-alone auxiliary HEPA

filtration units. However, areas where

early identification procedures are

performed vary widely in size and

configuration, making it difficult to

assess the effectiveness of such controls

in reducing the risk of occupational

exposure to M. tuberculosis in a

particular setting. Given the high cost of

such controls and the lack of data on

their effectiveness, OSHA is not

proposing such a requirement. However,

the Agency requests comment on the

potential effectiveness of such controls

in intake areas.

Another alternative considered was to

propose that each occupationally

exposed employee be provided with a

baseline medical examination,

including a physical examination that

emphasized the pulmonary system and

an evaluation for the signs and

symptoms of active TB disease and

factors affecting immunocompetence.

However, requiring a baseline physical

examination for all exposed employees

would impose a heavy cost burden on

affected establishments, and OSHA

could find no evidence that providing a

baseline physical examination would

accomplish more than a baseline and

annual medical history and tuberculin

skin test in identifying or reducing

occupationally induced TB infections.

Thus, OSHA is proposing to require

physical examinations only when they

are deemed necessary by the physician

or other licensed health care

professional, as appropriate.

OSHA also considered providing

medical management and follow-up to

each employee who had been exposed

to air originating from an area where an

individual with suspected or confirmed

infectious TB was present. However,

stakeholders contacted prior to the

issuance of this proposal stated that a

requirement for medical management

and follow-up would impose an

unnecessary burden on affected

establishments for those cases that were

suspected but were subsequently ruled

out. In response to stakeholders’

comments, the Agency is proposing that

medical management and follow-up be

provided only when an employee is

actually exposed to an individual with

confirmed infectious TB or to air

containing aerosolized M. tuberculosis

without the benefit of the applicable

exposure control measures (e.g.,

respiratory protection) that would be

required under the proposed rule.

Another alternative considered was to

require tuberculin skin tests every six

months for all employees assigned to

wear respirators. However, to reduce the

burden on facilities that do not

encounter many infectious TB cases,

OSHA is not requiring 6-month skin

testing for workers assigned to wear

respirators and who work in the intake

areas of facilities where fewer than six

confirmed infectious TB cases are

encountered each year.

Rejecting these regulatory alternatives

has reduced the estimated costs of the

proposed rule by a minimum of $100

million.

The RFA emphasizes the importance

of performance-based standards for

small businesses. OSHA considers the

proposed standard to be highly

performance oriented. The proposed

standard emphasizes the early

identification and isolation of

individuals with suspected or

confirmed infectious TB. Affected

employers have been allowed wide

discretion in the selection of procedures

they use to achieve this. Without early

identification and isolation, prevention

of the spread of TB from patients and

clients to workers is virtually

impossible. OSHA has also limited

requirements for work settings located

in a county that, in the past 2 years, has

had zero cases of confirmed infectious

TB reported in one year and fewer than

6 cases of confirmed infectious TB

reported in the other year. OSHA

welcomes comment on other ways that

the standard can be made more

performance oriented.

Another approach considered is

compliance date phase-ins for small

businesses. OSHA is proposing to

extend the standard’s compliance

deadlines for engineering controls and

has considered extending the

compliance deadlines for the other

proposed requirements; however, since

these other requirements are not capitalintensive for most affected facilities,

such an extension would do little to

reduce the burden on small entities and

would only result in a delay in the

protection of workers provided by

compliance with the proposed rule.

OSHA solicits comment on the effects of

extending phase-in dates for the other

proposed requirements, particularly

those for respirators, for small entities.

After considering all of the above

alternatives and adopting those that

were consistent with the mandate

imposed by the OSH Act, OSHA has

developed a proposed rule that will

minimize the burden on affected

employers, while maintaining the

necessary level of worker protection.

OSHA’s Response to SBREFA Panel

Recommendations

Table VII–7 lists the SBREFA Panel

Recommendations and OSHA’s

response to these recommendations.

The complete SBREFA Panel Report is

available for comment in the record as

Exhibit 12 of Docket H–371.

TABLE VII–7.—OSHA’S RESPONSES TO SBREFA PANEL RECOMMENDATIONS

Panel recommendation OSHA response

OSHA should define the terms ‘‘establishment,’’ ‘‘firm’’ and ‘‘facility’’ in

the IRFA.

These terms are now defined in Chapter VI of the PEA.

OSHA should consider analyzing additional size classes of firms .......... OSHA now uses the SBA definitions of small entities and also analyzes entities with fewer than 20 employees in the IRFA.

OSHA should clarify and more carefully explain the requirements and

engage in extensive outreach efforts to assure that the regulated

community understands the regulation.

OSHA has provided tables illustrating requirements for groups of affected firms, added many clarifications to the Preamble and regulatory text, and plans extensive outreach upon publication of the final

standard (see Preamble Section IX).
54230 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

TABLE VII–7.—OSHA’S RESPONSES TO SBREFA PANEL RECOMMENDATIONS—Continued

Panel recommendation OSHA response

OSHA should reexamine the definition of a suspect case and/or reexamine its approach to homeless shelters.OSHA will conduct a special study of homeless shelters. This study is

discussed in the IRFA. OSHA will also designate certain hearing

dates for persons who wish to testify on homeless shelter issues.

OSHA should reconsider applying the standard to substance abuse

centers.

OSHA has explained in the IRFA why it thinks that its treatment of

substance abuse treatment centers is feasible and has solicited

comment on this issue in the Issues Section of the Preamble.

OSHA should more carefully address the economic impacts on facilities

that rely on Medicaid/Medicare or charitable funding.

OSHA has added a discussion of this issue to Chapter VI of the PEA.

OSHA’s preamble and IRFA should explain OSHA’s role and authority

as compared to other voluntary and regulatory organizations; preamble should explain ongoing cooperative efforts; solicit comments

on conflicts and ways of better coordinating with other organizations.

OSHA has added a preamble discussion of why OSHA regulates occupational exposure to TB, why other organizations are unable to do

so effectively, and how OSHA has worked with other organizations.

OSHA solicits comments on possible conflicts and better methods of

coordination.

OSHA should examine additional alternatives, such as revising the proposed standard for greater consistency with CDC guidelines.OSHA has added a discussion of additional alternatives suggested by

SBREFA Panel members to the IRFA and has solicited comment on

these alternatives in the Preamble.

OSHA should clarify that employers would only be required by the

standard to determine the TB status of their county once per year,

rather than monthly.

OSHA has clarified this issue in the Preamble.

OSHA should reexamine the standard and the economic analysis to

ensure that the issues of part-time, multi-employer, and off-site workers have been adequately addressed. OSHA should also specifically

address the issue of portability of training. OSHA should clarify the

term ‘‘accessibility’’ in the context of employers with off-site employees.

OSHA has modified the standard to allow portability of non-site specific

elements of training and to allow portability of skin tests. For off-site

workers, OSHA has clarified in the Preamble that the standard may

be made available at the primary workplace facility, provided there is

a mechanism for immediate availability of information during the

workshift.

OSHA should clarify exactly what is required for temporary AFB isolation.The Summary and Explanation Section of the Preamble describes temporary AFB isolation, and OSHA’s assumptions concerning the costs

of such units are given in Chapter V of the PEA.

OSHA should clarify that engineering control provisions do not apply to

home health care.

OSHA has clarified the point in Section IX of the Preamble.

OSHA should explain the differences in protection provided by surgical

masks and respirators.

OSHA has explained this difference in Section IX of the Preamble.

OSHA should explain the reasons for its detailed respiratory protection

program, why it considers manufacturers’ instruction inadequate as a

substitute for a respirator program, and why annual respirator program evaluation is necessary.

OSHA has discussed this issue in the Summary and Explanation Section of the Preamble.

OSHA should explain its intent to fold many aspects of respiratory protection provisions for occupational exposure to TB into the upcoming

respirator standard.

OSHA has discussed this issue in the Summary and Explanation Section of the Preamble.

OSHA should explain the number of employees required to have medical surveillance in homeless shelters, the elements of a written medical opinion, and the importance of two-step skin testing.OSHA provides an estimate of the number of employees requiring

medical surveillance in Chapter V of the PEA. The regulation lists

the elements of a medical opinion. The Preamble explains the importance of two-step skin testing.

OSHA should explain its basis for believing that two-step skin testing is

appropriate for employees who have had BCG vaccinations.

OSHA has discussed this issue in the Summary and Explanation Section of the Preamble.

OSHA should clarify the interaction of workers’ compensation and medical removal protection and examine more carefully the costs and impacts of medical removal protection on small firms that actually have

an employee with a serious and costly active case of TB.

OSHA has addressed this interaction in both the Preamble and the

IRFA, and has provided a special discussion in Chapter VI of the

PEA on the economic impacts of the medical removal protection provision on small firms. OSHA has solicited comment on this issue.

OSHA should examine the potential cost savings associated with a provision that allows training to be ‘‘portable’’ (assuming the training is

equivalent to that required by the standard). OSHA should clarify that

posting a copy of the standard will be considered an adequate

means of providing employees with the standard. OSHA should clarify its performance-oriented interpretations of the training requirements in the Preamble, and OSHA should examine the need for annual retraining for all employees.

OSHA has modified the proposed regulation to allow portability of nonsite specific training and to allow employers to demonstrate employee competence rather than provide annual retraining. OSHA has

clarified in the Preamble that posting a copy of the standard will be

considered an adequate means of providing employees with the

standard. OSHA has clarified in the preamble that the training is performance oriented and need not include training in topics not relevant to an employee’s duties.

OSHA should clarify how the identification, referral, and notification requirements of the proposed standard can be met without breaching

federal and state confidentiality regulations and statutes.

OSHA has added a discussion of this issue to the IRFA and the Preamble.

OSHA should include a discussion of the interaction between medical

removal protection provisions and the Americans with Disabilities Act

and the Family and Medical Leave Act.

OSHA has added a discussion of this issue to the IRFA and the preamble.

OSHA should solicit comment and request data on industry turnover

rates in the Summary of the Preliminary Economic Analysis in the

Preamble.

OSHA has solicited comment on this issue.

OSHA should reexamine its estimate of the number of hospices and

adopt the most accurate figure.

OSHA has reexamined the issue of the number of hospices and retained its original estimate. OSHA has clarified that this estimate includes only free-standing hospices. Hospices that are parts of nursing homes and hospitals are included in estimates for those sectors.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54231

TABLE VII–7.—OSHA’S RESPONSES TO SBREFA PANEL RECOMMENDATIONS—Continued

Panel recommendation OSHA response

OSHA should clarify why family practice physicians were not included

in the analysis, and solicit comment on the extent to which family

practitioners conduct the kind of hazardous procedures that would

place them within the scope of the rule.

OSHA has added physicians who conduct high hazard procedures to

its economic analysis and has sought comment on whether family

practitioners commonly conduct such procedures.

OSHA should consider estimating the effects of the rule on volunteers

and should include a discussion explaining that the proposed rule

does not apply to volunteers, although some states may choose to

apply it to these categories of individuals.

OSHA has explained in the Preamble that the standard does not apply

to bona fide volunteers. OSHA has solicited comments on states or

localities that elect to extend OSHA requirements to volunteers and

on the number of affected volunteers. OSHA will further examine the

issue of the number of potentially affected volunteers in homeless

shelters in its homeless shelter study.

OSHA should solicit comment on the number of small government jurisdictions affected by the draft proposed standard.OSHA has solicited comments on this issue in the Preamble.

OSHA should include a discussion of tribal governments in its analysis

and solicit comment on this issue.

OSHA has provided an estimate of the number of affected tribal facilities and has sought comment from tribal governments in the Preamble.

OSHA should remind small entities that OSHA’s risk assessment will

be part of the public record and is subject to comment, and that

small entities may submit any appropriate additional literature or

studies that OSHA should consider in determining the risk of occupational TB.

OSHA has solicited comments on several specific aspects of the risk

assessment and benefits analysis, and on these analyses as a

whole.

OSHA should discuss the annualization of costs in greater detail in the

economic analysis.

Chapter V of the PEA and the summary of the PEA in the Preamble

now discuss the annualization of costs.

OSHA should clarify its position on the costs and durability of various

respirators that can be used to comply with the standard, and should

seek additional comment on the costs and durability of respirators.

OSHA has reanalyzed the costs of respirators in hospitals, and has

added a discussion of the uncertainties concerning the costs and durability of respirators to the PEA. OSHA has solicited comments on

these issues in the Preamble.

OSHA should perform further analyses to identify the marginal costs of

medical removal protection above and beyond worker compensation,

should further assess the probability that employers will actually incur

costs for medical removal protection if they have an employee with

an active case of TB, and should incorporate the results of this reexamination into its determination of feasibility.

OSHA specifically addresses this issue in Chapter VI of the PEA and

has sought comment on this issue.

OSHA should reassess whether affected facilities have reasonable access to facilities with AFB isolation rooms, solicit comments on this

issue, and incorporate the results of this reexamination into its determination of feasibility.

OSHA has further examined this issue, and found that affected facilities do have reasonable access to AFB isolation rooms; however,

OSHA is seeking comments on whether some affected facilities may

not have adequate local access to facilities with AFB isolation.

OSHA should reexamine its analysis of the economic impacts of the

proposed rule on firms, such as emergency medical services firms,

that operate under the constraint of being unable to charge some of

their clients.

OSHA has discussed this issue in Chapter VI of the PEA.

VIII. Unfunded Mandates Analysis

The proposed TB standard has been

reviewed in accordance with the

Unfunded Mandates Reform Act of 1995

(UMRA) (2 U.S.C. 1501 et seq.) and

Executive Order 12875. OSHA estimates

that compliance with the proposed

standard will require expenditures of

more than $100 million each year by

employers in the private sector.

Therefore, the proposed TB standard

establishes a federal private sector

mandate and is a significant regulatory

action within the meaning of Section

202 of UMRA (2 U.S.C. 1532). OSHA

has included this statement to address

the anticipated effects of the proposed

TB standard pursuant to Section 202.

OSHA standards do not apply to state

and local governments except in states

that have voluntarily elected to adopt an

OSHA State Plan. Consequently, the

proposed TB standard does not meet the

definition of a ‘‘federal

intergovernmental mandate’’ (Section

421(5) of UMRA (2 USC 658 (5)). In

sum, the proposed TB standard does not

impose unfunded mandates on state,

local, and tribal governments.

The remainder of this section

summarizes OSHA’s findings as

required by Section 202 of UMRA (2

U.S.C. 1532):

This standard is proposed under

Section 6(b) of the OSH Act. The

proposed standard has annualized costs

estimated at $245 million and would

save an estimated 138 to 190 lives per

year as a result of TB infections avoided.

An estimated 1,772 to 2,442 active TB

cases will be averted annually as a

result of the proposed rule. Compliance

will also result in an estimated 24,333

to 32,719 infections averted. The

proposed standard will impose no more

than minimal costs on state, local or

tribal governments. OSHA pays 50

percent of State plan costs but does not

provide funding for state, local or tribal

governments to comply with its rules.

OSHA does not anticipate any

disproportionate budgetary effects upon

any particular region of the nation or

particular state, local, or tribal

governments, or urban or rural or other

types of communities. Chapters V and

VI of the economic analysis provide

detailed analyses of the costs and

impacts of the proposed standard on

particular segments of the private sector.

OSHA has analyzed the economic

impacts of the standard on the affected

industries and found that compliance

costs are, on average, only 0.18 percent

of sales, and that few, if any, facility

closures or job losses are anticipated in

the affected industries. As a result,

impacts on the national economy would

be too small to be measurable by

economic models. OSHA requests

information on state and local

government issues.

Pursuant to Section 205 of the UMRA

(2 U.S.C. 1535), and having considered

a variety of alternatives outlined in the

Preamble and in the Regulatory

Flexibility Analysis above, the Agency

preliminarily concludes that the
54232 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

proposed rule is the most cost-effective

alternative for implementation of

OSHA’s statutory objective of reducing

significant risk among employees to the

extent feasible. OSHA solicits comment

on these issues.

IX. Environmental Impacts

The provisions of this proposed

standard have been reviewed in

accordance with the requirements of the

National Environmental Policy Act

(NEPA) of 1969 [42 U.S.C. 432, et seq.],

the Council on Environmental Quality

(CEQ) NEPA regulations [40 CFR Part

1500], and OSHA’s DOL NEPA

Procedures [29 CFR Part 11]. As a result

of this review, OSHA has preliminarily

determined that this proposed standard

will have no significant effect on air,

water, or soil quality, plant or animal

life, use of land, or other aspects of the

environment.

X. Summary and Explanation of the

Standard

Based on currently available data in

the record, OSHA has preliminarily

concluded that the requirements set

forth in this proposed standard are those

that are necessary and appropriate to

provide adequate protection to

employees exposed to tuberculosis (TB).

In the development of this proposed

standard, OSHA has carefully

considered the numerous reference

works, journal articles, and other data

collected by OSHA since the initiation

of this proceeding. In particular, OSHA

has carefully considered the

recommendations given in the

document, ‘‘Guidelines for Preventing

the Transmission of Mycobacterium

tuberculosis in Health-Care Facilities’’

published by the Centers for Disease

Control and Prevention beginning on

page 54242 in the Federal Register of

October 28, 1994 (Ex. 4B). OSHA also

held a series of informal stakeholder

meetings during the development of the

proposal and considered the major

points raised by the stakeholders during

these meetings (Ex. 10). In addition, the

proposal has undergone the Panel

review process required by the Small

Business Regulatory Enforcement

Fairness Act (SBREFA)(5 U.S.C. Chapter

8) (Exs. 11 and 12). All of the

information developed to assist the

small entity representatives involved in

the SBREFA panel process, the

comments of these representatives, and

the Panel’s findings and

recommendations to OSHA have been

placed in the rulemaking record (Exs. 11

and 12).

Upon publication of the final

standard, the Agency will undertake a

number of compliance assistance

activities that will be particularly

beneficial to small entities. Past

compliance assistance activities have

included: publication of booklets

summarizing the provisions of the

standard; development of a compliance

directive that answers compliancerelated questions about the standard;

development of compliance guides

directed at assisting small businesses in

complying with the standard;

designation of certain OSHA employees

in each Regional office with the

responsibility of answering questions

from the public about the standard;

development of training materials; and

provision of speakers and information

for meetings and workshops of affected

parties (particularly small business

entities). OSHA anticipates initiating

similar activities upon publication of

the final standard for occupational

exposure to tuberculosis.

Paragraph (a) Scope

Tuberculosis is a well-recognized

occupational hazard (Ex. 4B). As

discussed in the Health Effects section

above, there are numerous

epidemiological studies, case reports,

and outbreak investigations that provide

evidence to show that employees who

are exposed to aerosolized M.

tuberculosis have become infected with

TB and in some cases have developed

active TB disease. Of particular concern

is the emergence of strains of multidrugresistant TB. MDR–TB presents an

additional hazard because individuals

with MDR–TB may be infectious for

weeks or months until an effective drug

regimen can be successfully

implemented and the patient rendered

noninfectious. This in turn increases the

likelihood that employees who must

provide health care or other services to

these individuals will be exposed. The

risk of death from infections with MDR–

TB is markedly increased. Outbreaks

involving strains of MDR–TB have had

mortality rates as high as 75% with

death occurring 4 to 16 weeks after the

diagnosis of disease (Ex. 3–38A).

Most of the TB outbreaks investigated

occurred in large metropolitan areas.

However, a recent study has shown that

MDR–TB spread from New York City to

patients in Florida and Nevada and

health care workers in Atlanta, Georgia

and Miami, Florida and to staff and

patients in a nursing home in Denver,

Colorado (Ex. 7–259). In addition, a

growing percentage of TB cases are

occurring among the foreign born. CDC

reported that in 1995 the number and

proportion of cases among the foreignborn had increased 63% since 1986 (Ex.

6–34). These two pieces of information

taken together clearly illustrate the

relationship between population

mobility and the spread of TB disease.

Thus, TB is a nationwide problem.

Although the total number of cases

declined to its pre-1985 levels after a

resurgence from 1985 to 1994, the rate

of active TB cases reported in 1995 (i.e.,

8.7/100,000) is still two and one half

times greater than the target rate of 3.5

active cases per 100,000 population for

the year 2000 proposed by the Advisory

Committee on the Elimination of

Tuberculosis (Ex. 6–19). In addition,

there is substantial variability from year

to year in the increases and decreases in

the number of cases reported by each

state. In 1995, all fifty states reported

cases of TB, and fifteen of these reported

increases over 1994 (Ex. 6–34). At the

county level, approximately 57% of

counties in the U.S. reported one or

more cases of active TB, with 17% of

the counties in the U.S. reporting 5 or

more cases (Ex. 7–262). In addition,

approximately 91% of the U.S.

population resides in the counties that

reported one or more cases of active TB.

Thus, while 43% of the counties in the

U.S. reported no cases of active TB, 10%

of the U.S. population resides in those

counties. The nationwide prevalence of

TB infection in the U.S. population in

1994 (age 18 years an older) is

approximately 6.5 percent.

The recent resurgences in the number

of reported cases of active TB have

brought to attention a number of

problems in existing TB control plans.

The problem is most apparent in health

care facilities such as hospitals, but it

also extends to other work settings

where the population served is at

increased risk for tuberculosis, such as

shelters for the homeless, correctional

institutions and settings where highhazard procedures are performed.

There are a number of factors that

make occupational exposure to

tuberculosis an important concern at the

present time. One factor is that the

results from OSHA’s quantitative risk

assessment show a high potential for TB

infection for employees who work in

close proximity to individuals with

infectious TB. A second factor is that

the cases of tuberculosis are not

distributed evenly throughout the entire

population. There is a relatively high

prevalence of tuberculosis infection and

disease in certain populations, such as

residents of nursing homes and inmates

of correctional institutions. A third

factor is the rise of MDR-TB. These

factors increase the risk for workers who

have occupational exposure.

Occupational exposure occurs through

contact with air that may contain

aerosolized M. tuberculosis as a result of

the performance of an employee’s
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54233

duties. Most often this occurs when an

employee is working in the same

environment with an individual with

infectious TB. It could also occur when

repairing air systems that may be

carrying aerosolized M. tuberculosis.

Individuals with infectious

tuberculosis expel airborne particles

called droplet nuclei when they cough,

sneeze, or speak. These droplet nuclei

contain the organism that causes

tuberculosis, M. tuberculosis. Normal air

currents can keep these droplet nuclei

airborne for long periods of time and

spread them throughout a building (Ex.

5–5). When employees breathe the air

that contains M. tuberculosis, they are at

risk for TB infection which may result

in illness and, in some cases, death.

Employees also may be exposed when

laboratory procedures produce aerosols

of M. tuberculosis. There is an extensive

discussion of the scientific literature

related to occupational transmission in

Section IV, Health Effects, which will

not be repeated here.

Because the CDC does not consider

fomites, e.g., objects such as clothing or

silverware, to present a hazard for

transmission of M. tuberculosis, this

standard is designed to eliminate or

reduce airborne exposures only. Even

though it is well established that

exposure to TB contaminated air is the

route of exposure related to the

development of disease, it is not known

what levels of contamination in the air

cause the disease. Unlike toxic

chemicals, a Permissible Exposure Limit

(PEL) for air concentration of TB cannot

be determined. As described in the

Health Effects section of this preamble,

it is known that a number of factors

contribute to the probability of

infection. For example, exposures of

relatively short duration, such as a day

or two, can result in infection of the

employee. OSHA has used these

findings to show that certain types of

work, in certain industries, can result in

significant risk of TB infection. For

these reasons, OSHA is defining the

scope of the standard by listing the

locations and services where this

proposed standard would apply.

Employers with employees working at

those locations, and employers whose

employees provide the listed services,

are covered by the standard. The

proposed standard applies to

occupational exposures to tuberculosis

that occur in certain specified

workplaces, such as a hospital, or as the

result of providing services, such as

emergency medical treatment.

Paragraphs (a)(1) through (10) of the

proposal describe the various work

settings and services that are covered

under the scope of the standard.

Paragraph (a)(1) states that the

standard applies to occupational

exposure to TB occurring in hospitals.

The record contains many examples of

occupational exposures with resultant

TB infection and disease that have

occurred in hospitals (e.g., Exs. 5–11; 5–

15; 7–43; 7–45). Recent outbreaks

involving multidrug-resistant strains of

M. tuberculosis have compounded the

long recognized risk of TB in such

settings.

Hospitals not only provide medical

care for persons with diagnosed

tuberculosis, they also provide medical

care for individuals who may be at

increased risk for TB. For example,

hospitals provide isolation for

individuals with suspected or

confirmed infectious TB and contain

rooms or areas where high-hazard

procedures on individuals with

infectious TB are performed that place

employees at risk of exposure. In

addition, the client population

encountered in hospitals is generally at

higher risk of developing active TB.

Individuals with HIV disease, for

example, are at increased risk for

developing disease when they have

been infected with M. tuberculosis. In

addition, medically underserved

populations with an increased

prevalence of tuberculosis (e.g.,

homeless persons) may seek acute care

in the emergency rooms of hospitals.

Employees who are at risk for

occupational exposure and potential

infection and disease include all

employees who have direct contact with

persons with infectious tuberculosis.

These may include but are not limited

to physicians, nurses, aides, dental

workers, medical technicians, workers

in laboratories and autopsy suites, and

emergency medical service personnel

(Ex. 4B). They may also include persons

not involved in direct patient care but

who have occupational exposure as a

result of providing other services such

as dietary, housekeeping, and

maintenance staff.

Paragraph (a)(2) covers occupational

exposure occurring in long-term care

facilities for the elderly. Persons aged 65

and older constitute a large repository of

M. tuberculosis infection in the United

States (Ex. 6–14). Many of these

individuals were infected many decades

ago when TB was a much more common

disease. Some of the TB occurring in

this age group arises from preexisting

infection of long duration and other

cases may be the result of recent

infections. In addition, elderly persons

residing in nursing homes are at greater

risk than elderly persons living in the

community. In its 1990 guidelines,

‘‘Prevention and Control of Tuberculosis

in Facilities Providing Long-term Care

to the Elderly,’’ the CDC cited 1984–

1985 data indicating a TB case rate of

39.2 per 100,000 population, a rate that

was twice that of elderly persons living

in the community (Ex. 6–14). The same

document stated that CDC had found

that the increased risk for nursing home

employees was three times higher than

the rate expected for employed adults of

similar age, race, and sex. Examples of

employees in long-term care facilities

who may have occupational exposure

include, but are not limited to,

registered nurses, licensed practical

nurses, nursing assistants, and auxiliary

personnel. OSHA has not included

other long-term care facilities under the

scope of the standard. The Agency

requests comment and supporting data

on whether it is appropriate to expand

the scope of the standard to include

other long-term care facilities that may

provide health care or other services to

individuals who may be at an increased

risk of developing infectious TB,

thereby presenting a potential source of

exposure to employees working in those

facilities. An example of another longterm care facility is a psychiatric

hospital.

Paragraph (a)(3) covers occupational

exposure occurring in correctional

facilities and other facilities that house

inmates or detainees. Facilities such as

prisons, jails and detainment centers

operated by the Immigration and

Naturalization Service (INS) would be

included in the scope of the standard.

The CDC considers TB to be a ‘‘major’’

problem in correctional institutions,

with cases occurring at a frequency

three times that of the general

population (Ex. 7–25). In addition to a

number of outbreaks that have occurred,

the overall incidence of tuberculosis in

the prison population is increasing. This

can be attributed to, (1) the overrepresentation of populations at high

risk for TB in prisons and jails, and (2)

environmental factors that promote the

transmission of TB. Compared to the

general population, inmates have a

higher prevalence of TB infection. The

population of correctional facilities is

also characterized as having a high

prevalence of individuals with HIV

infection and intravenous drug users,

factors that place these inmates at a

higher risk of developing active TB. In

addition, many prisons and jails are old,

overcrowded, and have inadequate

ventilation. Inmates may be moved

frequently within a facility and between

facilities, increasing the number of

persons, both inmates and employees,

exposed to an infected individual and

making contact tracing difficult.
54234 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

Medical records and treatment

information may not follow the inmate

in a timely manner, which may, in turn,

lead to inadequate drug therapy.

Detention facilities, such as those

operated by the INS, may house persons

who are entering this country from

countries with a prevalence of TB many

times that of the U.S. population (Ex. 6–

26). In addition, there may be a

substantial number of individuals in

these facilities currently awaiting

deportation who have an additional

increased risk of TB because they have

been previously incarcerated in

correctional institutions. In 1995, CDC

reported that approximately 36% of the

total reported cases of active TB were

among the foreign-born (Ex. 6–34). This

marks a 63% increase since 1986. In

addition, among those persons whose

records contained information on date

of arrival to the U.S., approximately

30% developed active TB within one

year of entering the country and

approximately 53% developed active

TB within 5 years of entering the

country. Employees who may have

occupational exposure in these facilities

include, but are not limited to,

correctional officers, physicians,

dentists, nurses, and other health care

workers.

Paragraph (a)(4) covers occupational

exposure occurring in hospices. CDC

identified hospices as one of the

inpatient health care facilities to which

its 1994 TB guidelines apply. CDC’s

Guidelines recommend that individuals

with suspected or confirmed infectious

TB be managed in the same manner

using similar methods of infection

control as recommended for hospitals.

Hospices serve the same high-risk

populations that hospitals serve. In

addition, individuals receiving hospice

care may be at increased risk for

tuberculosis if they are members of a

high risk group, which includes groups

whose members have a medical

condition that increases the likelihood

of developing active tuberculosis (e.g.,

HIV disease, end stage renal disease,

certain carcinomas). Employees who

may have occupational exposure

include, but are not limited to,

physicians, nurses, aides, social

workers, and other health care workers.

Occupational exposure occurring in

shelters for the homeless is covered

under paragraph (a)(5). Residents of

shelters for the homeless comprise a

population that is also at increased risk

for tuberculosis. Members of this

population are more likely to have risk

factors that are associated with TB than

the general population although the

exact prevalence of TB in this

population is unknown. The data

quoted in CDC’s 1992 document

‘‘Prevention and Control of Tuberculosis

Among Homeless Persons’’ indicated a

prevalence of clinically active

tuberculosis among homeless adults

ranging from 1.6% to 6.8% (Ex. 6–15).

The prevalence of latent tuberculosis

ranged from 18% to 51% and there was

a point prevalence of active TB of 968

cases/100,000 homeless adults (Ex. 6–

15). Similar to the population in

correctional facilities, residents of

homeless shelters have a high

prevalence of HIV infection and

intravenous drug use, factors that

increase the likelihood that their

infections will progress to active TB. In

addition, environmental factors such as

overcrowding and poor ventilation

promote the transmission of disease.

Examples of employees who may have

occupational exposure include, but are

not limited to, intake workers and

health care workers who have contact

with residents of homeless shelters.

Paragraph (a)(6) covers occupational

exposure occurring in facilities that

provide treatment for drug abuse. Based

on tuberculin skin testing reported in

1993, 13.3% of the clients of drug

treatment facilities had evidence of TB

infection (Ex.6–8). Many of these

persons have a history of intravenousdrug use and either have or are at risk

for HIV infection. These persons are at

increased risk for developing active TB

and transmitting the disease to others.

Many of these individuals may

discontinue treatment prematurely even

if they are diagnosed and started on

effective drug treatment. In addition, the

CDC reported that studies in some areas

have shown that over 20% of selected

inner city intravenous drug user

populations have tuberculous infection

(Ex. 3–37). The CDC thus concluded

that drug center clients and staff are at

risk of becoming infected. Employees in

drug treatment facilities who may have

occupational exposure include, but are

not limited to, counselors, nurses,

physicians and other staff.

Work settings where occupational

exposure occurs as a result of the

performance of high-hazard procedures,

which, for the purposes of this standard,

are certain procedures performed on

individuals with suspected or

confirmed infectious TB, are also

covered under the scope of the standard

as stated under paragraph (a)(7). Highhazard procedures are procedures that

are cough-inducing or aerosolgenerating that are likely to result in

droplet nuclei being expelled into the

air. A definition and discussion of highhazard procedures can be found under

paragraph (j), Definitions, of this

Summary and Explanation. Health care

workers and other employees who are

either performing or assisting with these

procedures or are in the general vicinity

are at an increased risk of inhaling

droplet nuclei and therefore have

occupational exposure. The 1994 CDC

guidelines recommend in Section G,

‘‘Cough-Inducing and AerosolGenerating Procedures’’ that special

precautions be taken when these

procedures are performed (Ex. 4B).

Health care workers, such as physicians,

nurses, technicians and others who

perform or assist in the performance of

high-hazard procedures have

occupational exposure. Other

employees who may be in the room or

area when such procedures are

performed would be expected to have

occupational exposure as well.

Paragraph (a)(8) applies to

occupational exposure that occurs in

laboratories that handle specimens that

may contain M. tuberculosis, process or

maintain those specimens or the

resulting cultures, or perform any

related activity that may result in the

aerosolization of M. tuberculosis. M.

tuberculosis is a proven hazard to

laboratory personnel (Exs. 7–68, 7–72,

7–142, 7–143). Aerosols present the

greatest hazard in laboratories. Tubercle

bacilli may be present in sputum, gastric

lavage fluids, cerebrospinal fluid, urine,

and in lesions from a variety of tissues.

In addition, the bacilli are grown in

culture to increase their concentration

beyond what would normally be found

in the sample for purposes of

identification and susceptibility testing.

The bacilli may survive in heat-fixed

smears and may be aerosolized in the

preparation of frozen sections and

during manipulation of liquid cultures.

CDC/NIH’s manual ‘‘Biosafety in

Microbiological and Biomedical

Laboratories’’ recommends Biosafety

Level 2 or 3 for such laboratories

depending on the procedures being

performed (Ex. 7–72). Employees who

may have occupational exposure

include a wide variety of laboratorians.

Examples include, but are not limited

to, medical technologists, laboratory

technicians, physicians, and research

scientists.

Occupational exposure incurred by

temporary or contract employees is also

covered under the Scope to the extent

that the occupational exposure occurs in

one of the work settings listed under

paragraphs (a)(1) through (a)(8). For

example, if a nurse working for a

temporary employment service were

hired by a hospital to work on a TB

ward, that temporary nurse would be

covered under the scope of the standard.

Physicians who are employees (e.g., of

an independent corporation) yet who
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54235

practice and are exposed in a covered

facility, such as a hospital, are also

covered by the standard. Similarly, in

any of the work settings listed under

paragraph (a)(1), temporary or contract

personnel who incur occupational

exposure to TB as a result of their

temporary or contract work would be

covered by the standard. The

occupational exposure experienced by

these employees would be expected to

be similar to that of other employees

performing the same tasks and

procedures in the work setting that has

contracted for their services. A note has

been added to the proposed standard to

make clear that these types of

employees are covered under the scope.

This note also clarifies that repair,

replacement, or maintenance personnel,

working in any of the work settings

covered under paragraphs (a)(1) through

(a)(8), who service air systems or

equipment or who renovate, repair or

maintain areas of buildings that may

reasonably be anticipated to contain

aerosolized M. tuberculosis are also

covered under the scope of the standard.

The standard requires the use of

engineering controls, such as isolation

rooms, to reduce the concentration of

droplet nuclei and therefore reduce the

likelihood of TB infection and

subsequent illness. The ventilation

systems that exhaust air from isolation

rooms may reasonably be anticipated to

contain aerosolized M. tuberculosis.

Maintenance and other workers who are

responsible for the servicing and repair

of ventilation systems that handle air

that may contain aerosolized M.

tuberculosis are at risk for occupational

exposure when, as the result of

performing their duties, they are

exposed to TB contaminated air moving

through the ventilation system.

Examples of employees who may have

occupational exposure include heating,

ventilation, and air conditioning

(HVAC) maintenance personnel.

In addition, there may be employees

who are responsible for renovating,

repairing, or maintaining areas of

buildings where exposure to aerosolized

M. tuberculosis may occur other than

those associated with the ventilation

systems. Maintenance staff who need to

repair fixtures in an isolation room, or

contractor personnel hired to provide

housekeeping in isolation rooms or

areas, are examples of such employees

who would also be covered under the

standard. OSHA expects that such

exposures would occur only rarely. In

many circumstances, minor nonemergency maintenance activities could

be performed by health care personnel

required to enter the isolation rooms or

areas for other reasons, such as to care

for a patient. However, there may be

activities that necessitate the expertise

of certain maintenance employees

which could place those employees at

risk of occupational exposure. Those

employees would therefore be covered

under the scope of the standard.

Paragraph (a)(9) applies to

occupational exposure occurring during

the provision of social work, social

welfare services, teaching, law

enforcement or legal services, where the

services are provided in the facilities

included in paragraphs (a)(1) through

(a)(8), or in residences, to individuals

who are in AFB isolation, or are

segregated or otherwise confined due to

having suspected or confirmed

infectious tuberculosis. This paragraph

is intended to cover those types of

employees who must provide services to

individuals who have been identified

beforehand as having suspected or

confirmed infectious tuberculosis and

who have either been isolated or

segregated in isolation rooms or areas or

have been confined in their homes. For

example, certain social workers may

need to enter AFB isolation rooms or

areas or visit homes of people who have

suspected or confirmed infectious

tuberculosis for the purposes of

collecting information or providing

discharge planning. While OSHA

believes that it would be preferable to

collect such information over the

telephone in order to prevent

occupational exposure, the Agency

realizes that there may be situations

where direct contact with these isolated

or confined individuals may be

necessary. In these limited situations,

these employees would be covered

under the scope of the standard. There

may also be situations where teachers

may be providing tutoring to

individuals isolated with suspected or

confirmed infectious tuberculosis.

Again, OSHA believes that such

situations would be limited and that

most educational instruction could be

delayed until an individual was

determined to be noninfectious.

However, where teachers must provide

instruction to individuals identified as

having suspected or confirmed

infectious TB, those teachers would be

covered under the scope of the standard.

In addition, certain law enforcement

officers might have to be in contact with

individuals who have been identified as

having suspected or confirmed

infectious tuberculosis. For example,

they may have to transfer such an

individual from a correctional or

detainment facility to a hospital for

diagnosis or treatment. Because these

workers must be in direct contact with

the individual during transport, perhaps

for long periods of time and probably in

an enclosed vehicle, such employees

could incur significant occupational

exposure. Paragraph (a)(9) would assure

that such employees would be covered

under the standard. Similarly, there may

be occasions where attorneys must

consult with clients or inmates who

have been isolated or segregated because

they have been identified as having

suspected or confirmed infectious

tuberculosis. Such attorneys would be

covered under the standard in the

limited situations where these

consultations cannot be done by phone

or delayed until the individual has been

determined to be noninfectious. Under

paragraph (a)(9), OSHA has specified

certain employee groups that it believes

would have to enter AFB isolation

rooms or areas or homes where

individuals are confined due to

suspected or confirmed infectious TB,

in order to provide services which may

result in occupational exposure. OSHA

requests comments and data as to

whether there are other employee

groups that may incur occupational

exposure and thus need protection

under this paragraph.

Paragraph (a)(10) applies to

occupational exposure occurring during

the provision of emergency medical

services, home health care, and homebased hospice care. Emergency medical

service employees may provide

emergency treatment and transportation

for individuals with suspected or

confirmed tuberculosis. For example, in

addition to serving the same high-risk

client population as hospitals,

emergency medical services are often

used to transport individuals who have

been identified as having either

suspected or confirmed infectious

tuberculosis from a facility with

inadequate isolation capabilities to

another facility better equipped to

isolate these individuals. Proximity to

the patient and time spent within an

ambulance or other emergency vehicle

affects the likelihood of occupational

exposure as the result of breathing

droplet nuclei generated when the

patient coughs or speaks. Examples of

employees who may have occupational

exposure include but are not limited to

emergency medical technicians,

paramedics, and, in some localities, fire

fighters.

The 1994 CDC guidelines identify

health care workers who provide

medical services in the homes of

patients with suspected or confirmed

infectious tuberculosis as being at risk

and recommend precautions to be used

in these settings (Ex. 4B). Employees

who provide home-based care serve a
54236 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

client population similar to that of

hospitals (e.g., individuals who may be

immunocompromised). Employees such

as nurses and aides who provide care to

these individuals would be expected to

have occupational exposure.

OSHA is also proposing that certain

limited construction activities be

included under the scope of the

standard; however, the Agency believes

that the proposed standard would have

little impact on this sector. The standard

would apply to construction operations

occurring in the work settings covered

by the scope of the standard where there

is a reasonable anticipation of exposure

to aerosolized M. tuberculosis, e.g.,

while rebuilding an HVAC system that

would connect to an existing one that is

in use. The standard is not intended to

cover employees involved in other

construction operations where they

would not have occupational exposure

to air which may reasonably be

anticipated to contain aerosolized M.

tuberculosis (e.g., a crane operator

constructing a new wing of a hospital).

The standard would apply only to

construction employees who would

incur occupational exposure to

tuberculosis. Such a case might arise

during maintenance operations on an air

system that carries air that may

reasonably be anticipated to contain

aerosolized M. tuberculosis or during

renovation, repair, or alteration of areas

of buildings that may reasonably be

anticipated to contain aerosolized M.

tuberculosis. The probability of

exposure to M. tuberculosis during these

activities may be high and it is

necessary, therefore, for employees

performing the work to wear respirators,

receive medical surveillance and be

protected by the other provisions of the

proposed TB standard. Employees of

such contractors are subject to the same

levels of TB exposure and need the

same protection as other exposed

employees. Therefore, OSHA proposes

to cover these employees under the TB

standard and has included construction

within the standard’s scope.

Thus, although the impact of the

standard will be limited, OSHA believes

that construction should not be

exempted from the proposed standard.

OSHA believes that a loophole would be

opened in the enforcement of the

standard if construction were exempted.

The distinction between maintenance

and construction is often an ambiguous

one. If construction were excluded,

contractors, such as HVAC contractors,

might argue that their work is

‘‘construction’’ and that they are not

covered by the standard. By covering

construction, this ambiguity does not

arise. This approach is consistent with

that taken in other standards (e.g.,

Ethylene Oxide, 29 CFR 1910.1047;

Benzene, 29 CFR 1910.1028).

Several of the sectors covered by the

proposed standard may be utilizing

volunteers for assistance in the

workplace. Under the OSH Act, OSHA

is mandated to protect employees

against workplace hazards.

Consequently, volunteers are not

covered by OSHA standards because

they are not employees. However,

employers should be aware that simply

labeling a person as a volunteer is not

determinative of whether an employer/

employee relationship exists, if the

person is compensated for his or her

services. Some states or localities may

decide to extend the protections of

OSHA standards to volunteers;

however, such action is the independent

decision of these jurisdictions and is not

a requirement of the OSH Act.

In addition, the proposed standard

applies in situations when an employer

has part-time employees, or where

employees of other employers are

working in a covered facility. These

employees are covered by the standard

in the same manner as other employees

who have occupational exposure to

tuberculosis. For example, they would

be provided with the same protections

as full-time on-site employees, such as

being included in the exposure

determination, being trained, being

provided with medical surveillance, and

being issued respiratory protection if

necessary. With regard to employers

who provide employees to other

employers (e.g., personnel providers,

temporary help agencies, nurse

registries), a shared responsibility for

worker protection exists between the

provider and the client or ‘‘host’’

employer. The safety and health rights

of temporary or ‘‘leased’’ or contracted

employees are the same as the rights of

those who are employed directly by the

host employer. The host employer is

generally responsible for safety and

health measures taken to address

hazards that are an integral part of the

workplace the host employer controls.

Where other employers are involved,

contractors or other ‘‘providers,’’ a joint

employer-employee relationship may

exist in which both (or more) employers

share responsibility for the safety and

health of the employees. OSHA’s

concern is to assure that workers receive

full protection under this standard. Who

provides which protections to the

various employees may be specified as

a matter of contract or employment

agreement existing between the client/

host and the contractor/provider. In a

typical arrangement, for example, the

provider employer might provide the

generic training required by the

standard and assure that proper followup medical evaluation occurs after an

exposure incident. Host employers

would typically control potential

exposure conditions and fulfill other

requirements of the standard, such as

site-specific training and respiratory

protection.

While the proposed standard covers a

number of different work settings, as

described above, OSHA recognizes that

many different types of activities occur

in these different settings. Thus, not all

provisions of the proposed standard

would apply in each work setting. The

provisions that are required will vary to

some degree, depending on the type of

activities done in the work setting. In

order to give employers guidance as to

what provisions would be applicable in

their work setting, OSHA has developed

a series of charts of the requirements

that are most likely to be applicable for

the affected industries.

The following charts outline

provisions that would be required for

employers covered under the scope of

the proposed TB standard. (Employers

who qualify for the limited program as

outlined under Paragraph (b),

Application, should consult Appendix

A for applicable provisions.) The charts

are categorized either by the types of

infection control activities that may be

common among different work settings

(e.g., early identification and transfer of

individuals with suspected or

confirmed infectious TB) or by a

particular occupational work group

(e.g., emergency medical services, home

health care). These charts are designed

to give employers a guide to the

regulatory text by outlining the

provisions of the proposed standard that

are applicable for various types of work

settings. These charts summarize the

general responsibilities of a particular

required provision. The regulatory text

should be consulted for more specific

details on particular provisions.

In addition, it should also be kept in

mind that even though these charts are

categorized by the type of activities

occurring at a worksite, the categories

do not necessarily always follow

industry lines (i.e., an employer under

a specific industry sector may not

always fall under a particular category

outlined in the following charts). The

charts are not designed to serve as a

stand alone check list for any one

industry sector. Due to the varying

activities that may take place in work

settings encompassed by an industry

sector, the charts may not account for

every applicable provision in every

work setting. The charts are intended to

provide general guidance as to what
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54237

OSHA anticipates to be applicable

provisions. Therefore, it is important

that employers evaluate the types of

activities occurring in settings where

their employees work to determine

which of the provisions of the proposed

standard would be applicable. In order

to give employers guidance, OSHA has

listed some of the types of industry

sectors that the Agency assumes are

likely to fall under a particular category,

given OSHA’s current understanding of

the activities commonly occurring in

these work settings.

OSHA requests comments on these

assumptions and on the charts, and

particularly, on how the charts can be

made more user friendly and be better

organized to help serve as a guide for

employers trying to comply with the

standard. The following charts are

included:

Chart 1: What Would Be Required in

Work Settings Where Individuals

with Suspected or Confirmed

Infectious TB are Admitted or

Provided Medical Services?

Chart 2: What Would Be Required in

Work Settings Where Early

Identification and Transfer

Procedures are Used for Individuals

with Suspected or Confirmed

Infectious TB?

Chart 3: What Would Be Required for

Employers with Employees Who

Provide Services to Individuals

Who Have Been Isolated or

Otherwise Confined Due to Having

Suspected or Confirmed Infectious

TB or Who Work in Areas Where

the Air Has Been Identified As

Reasonably Anticipated to Contain

Aerosolized M. tuberculosis?

Chart 4: What Would Be Required for

Home Health Care and Home-Based

Hospice Care?

Chart 5: What Would Be Required for

Emergency Medical Services?

Chart 6: What Would Be Required for

Clinical and Research Laboratories?

Chart 7: What Would Be Required for

Personnel Services?

Chart 1: What Would Be Required in

Work Settings Where Individuals

with Suspected or Confirmed

Infectious TB Are Admitted or

Provided Medical Services?

OSHA anticipates that Hospitals will

be the primary type of facility falling

under this category. In general,

individuals requiring isolation are

transferred to hospitals that have

isolation capabilities. In addition,

medical services such as diagnostic

testing for evaluating TB disease are

performed in a hospital setting. This

category also covers work settings where

high-hazard procedures are performed,

e.g., medical examiners’ offices.

(Laboratories are covered in a later

chart). However, there may be other

work settings such as correctional

facilities or long-term care facilities for

the elderly that provide isolation or

perform high-hazard procedures on

individuals with suspected or

confirmed infectious TB. In these cases,

employers at these facilities would be

required to comply with the provisions

outlined in this chart.

What Would Be Required in Work Settings Where Individuals With Suspected or Confirmed Infectious TB Are Admitted or Provided Medical

Services?

(c) Exposure Control

(c)(1) Exposure Determination

(c)(2)(i) Written Exposure Control Plan including:

(A) the exposure determination

(B) procedures for providing information to occupationally exposed employees about individuals with suspected or confirmed infectious TB or air that may reasonably be anticipated to contain aerosolized M. tuberculosis

(C) procedures for reporting exposure incidents

(c)(2)(iii):

(A) procedures for prompt identification of individuals with suspected or confirmed infectious TB

(B) procedures for isolating and managing the care of individuals with suspected or confirmed infectious TB (e.g., minimizing the time

and number of employees entering an isolation room)

(C) a list of high-hazard procedures

(D) a schedule for inspection, maintenance, and performance monitoring of engineering controls

(c)(2)(iv) If the employer operates an onsite laboratory, the plan must include a determination as to whether the facility should operate at

Biosafety Level 2 or 3 containment and document the need for controlled access, anterooms, sealed windows, directional airflow, measures to prevent the recirculation of lab exhaust air, filtration of exhaust air and thimble exhaust connections.

(c)(2)(vi) Document the number of confirmed cases of TB if claiming reduced responsibilities under paragraph (g)(3)(iii)(D)

(c)(2)(vii) The exposure control plan must be:

(A) accessible

(B) reviewed annually and updated whenever necessary

(C) available for copying by the Assistant Secretary and Director upon request

(d) Work Practices and Engineering Controls

All provisions of paragraph (d) are applicable

(e) Clinical and Research Laboratories

If the facility operates an onsite laboratory, the additional provisions under paragraph (e) must be followed (See Chart 6 for Clinical and

Research Laboratories)

(f) Respiratory Protection

(f)(1)(i) Provide respirators to employees who:

(A) enter isolation rooms or areas in use for TB isolation

(B) are present during the performance of procedures or services for an individual with suspected or confirmed infectious TB who is

not masked

(C) transport an unmasked individual with suspected or confirmed infectious TB within the facility

(D) repair, replace, or maintain air systems or equipment that may reasonably be anticipated to contain aerosolized M. tuberculosis

(E) work in an area where an unmasked individual with suspected or confirmed infectious TB has been segregated or otherwise confined

(f)(1)(iii) Provide respirators at no cost and assure that the employee uses the respirator in accordance with this standard

(f)(1)(iv) Assure that the employee dons the respirator before entering any of the work settings or performing any of the tasks identified in

paragraph (f)(1)(i) (A) through (E) and uses it until leaving the work setting or the task has been completed

All remaining provisions of paragraph (f) are applicable, i.e., (f)(2)–(f)(8)

(g) Medical Surveillance

All provisions of paragraph (g) are applicable

(h) Communication of Hazards and Training
54238 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

What Would Be Required in Work Settings Where Individuals With Suspected or Confirmed Infectious TB Are Admitted or Provided Medical

Services?

(h)(1)(i) Label air systems that may reasonably be anticipated to contain aerosolized M. tuberculosis ‘‘Contaminated Air—Respiratory Protection Required’’

(h)(1)(ii) If the employer operates an onsite laboratory, label clinical and research laboratory wastes with the biohazard symbol

(h)(2)(i) Post signs at entrances to:

(A) isolation rooms or areas

(B) areas where procedures or services are being performed on an individual with suspected or confirmed infectious TB

(C) clinical and research laboratories where M. tuberculosis is present if the employer operates an onsite laboratory

(h)(2)(ii) Ventilate isolation rooms or areas vacated by individuals with suspected or confirmed infectious TB, in accordance with Appendix

C, unless those individuals are medically determined to be noninfectious

(h)(2)(iii) Signs must be readily visible and have a stop sign with the legend ‘‘No Admittance Without Wearing a Type N95 or More Protective Respirator’’

(h)(2)(iv) Signs at the entrances to clinical or research laboratories (for employers who operate onsite laboratories) and autopsy suites

where procedures are being performed that may generate aerosolized M. tuberculosis

(h)(3) Information and Training

All elements are applicable

(i) Recordkeeping

All recordkeeping is applicable

Chart 2: What Would Be Required in Work Settings Where Early Identification and Transfer Procedures Are Used

for Individuals With Suspected or Confirmed Infectious TB ?

OSHA anticipates that the types of establishments falling under this category are likely to be long term care facilities

for the elderly, correctional facilities, immigration detainment facilities, hospices, homeless shelters, substance abuse

treatment centers, and hospitals that do not admit individuals with suspected or confirmed infectious TB. In these

work settings, employers will use the signs and symptoms of active TB as well as any other available information

(e.g., tuberculin skin test status) to identify individuals with suspected or confirmed infectious TB. These individuals

will then be transferred to facilities with appropriate isolation capabilities. Therefore, facilities that transfer do not

need to have engineering controls. Temporary engineering controls will only be necessary in limited situations where

transfer cannot be accomplished within 5 hours.

What Would Be Required in Work Settings Where Early Identification and Transfer Procedures Are Used for Individuals With Suspected or

Confirmed Infectious TB?

(c) Exposure Control

(c)(1) Exposure Determination

(c)(2)(i) Written Exposure Control Plan including:

(A) the exposure determination

(B) procedures for providing information to occupationally exposed employees about individuals with suspected or confirmed infectious TB or air that may reasonably be anticipated to contain aerosolized M. tuberculosis

(C) procedures for reporting exposure incidents

(c)(2)(ii) Employers who transfer individuals with suspected or confirmed infectious TB must include in the plan: procedures for prompt

identification, masking or segregation, and transfer of such individuals

(c)(2)(vi) Document the number of confirmed cases of TB if claiming reduced responsibilities under paragraph (g)(3)(iii)(D)

(c)(2)(vii) The exposure control plan must be:

(A) accessible

(B) reviewed annually and updated whenever necessary

(C) available for copying by the Assistant Secretary and Director upon request

(d) Work Practices and Engineering Controls

(d)(1) Use work practices and engineering controls to eliminate or minimize employee exposure to M. tuberculosis

(d)(2) Implement the work practices in the Exposure Control Plan

(d)(3) Identify individuals with suspected or confirmed infectious TB and:

(i) mask or segregate the individual until transfer can be accomplished

(ii) place the individual in temporary isolation if transfer cannot be accomplished within 5 hours from the time of identification

(d)(5) Engineering controls (i.e., negative pressure, direct exhaust or HEPA filtration, etc.) shall be used when temporary isolation is used

(d)(6) Provide information about TB hazards to any contractor who provides temporary or contract employees who will incur occupational

exposure

(f) Respiratory Protection

(f)(1)(i) Provide respirators to employees who:

(A) enter a temporary isolation room or area

(E) work in an area where an unmasked individual with suspected or confirmed infectious TB has been segregated or otherwise confined and is awaiting transfer

(f)(1)(iii) Provide respirators at no cost and assure that the employee uses the respirator in accordance with this standard

(f)(1)(iv) Assure that the employee dons the respirator before entering the work setting and uses it until leaving the work setting

All remaining provisions of paragraph (f) are applicable, i.e., (f)(2)–(f)(8)

(g) Medical Surveillance

All provisions of paragraph (g) are applicable

(h) Communication of Hazards and Training

(h)(1)(i) Label air systems that may reasonably be anticipated to contain aerosolized M. tuberculosis ‘‘Contaminated Air—Respiratory Protection Required’’ if temporary isolation is used

(h)(2)(i)(A) Post signs at entrances to temporary isolation rooms or areas

(h)(2)(ii) Ventilate temporary isolation rooms or areas vacated by individuals with suspected or confirmed infectious TB in accordance with

Appendix C, unless those individuals are medically determined to be noninfectious

(h)(2)(iii) Signs used for temporary isolation must be readily visible and have a stop sign with the legend ‘‘No Admittance Without Wearing

a Type N95 or More Protective Respirator’’
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54239

What Would Be Required in Work Settings Where Early Identification and Transfer Procedures Are Used for Individuals With Suspected or

Confirmed Infectious TB?

(h)(3) Information and Training

All elements are applicable

(i) Recordkeeping

All recordkeeping is applicable

Chart 3: What Would Be Required for Employers With Employees Who Provide Services to Individuals Isolated or

Otherwise Confined Due to Having Suspected or Confirmed Infectious TB or Who Work in Areas Identified

as Reasonably Anticipated to Contain Aerosolized M. tuberculosis?

OSHA anticipates that the type of

employees falling under this category

will be workers providing social work

services, social welfare services,

teaching, law enforcement or legal

services to individuals who are in

isolation or confined to their homes due

to having suspected or confirmed

infectious TB. Also included in this

category are maintenance employees

such as contract HVAC maintenance

employees who work on air systems that

have been identified as carrying air that

may reasonably be anticipated to

contain aerosolized M. tuberculosis.

Employers in these situations will not

need to perform early identification

procedures since the identification of

individuals with suspected or

confirmed infectious TB has already

been accomplished. Similarly, air

systems will already be labeled as

containing ‘‘Contaminated Air’’.

What Would Be Required for Employers with Employees Who Provide Services to Individuals Isolated or Otherwise Confined Due to Having

Suspected or Confirmed Infectious TB or Who Work in Areas Identified as Reasonably Anticipated to Contain Aerosolized M. tuberculosis?

(c) Exposure Control

(c)(1) Exposure Determination

(c)(2)(i) Written Exposure Control Plan including:

(A) the exposure determination

(B) procedures for providing information to occupationally exposed employees about individuals with suspected or confirmed infectious TB or air that may reasonably be anticipated to contain aerosolized M. tuberculosis

(C) procedures for reporting exposure incidents

(c)(2)(vii) The exposure control plan must be:

(A) accessible

(B) reviewed annually and updated whenever necessary

(C) available for copying by the Assistant Secretary and Director upon request

(d) Work Practices and Engineering Controls

(d)(1) Use work practices to eliminate or minimize employee exposure to M. tuberculosis

(d)(2) Implement the work practices in the Exposure Control Plan

(d)(6) Provide information about TB hazards to any contractor who provides temporary or contract employees who will incur occupational

exposure

(f) Respiratory Protection

(f)(1)(i) Provide respirators to employees who:

(A) enter isolation rooms or areas

(D) repair, replace or maintain air systems or equipment that may reasonably be anticipated to contain aerosolized M. tuberculosis

(F) work in a residence where an individual with suspected or confirmed infectious TB is known to be present

(f)(1)(iii) Provide respirators at no cost and assure that the employee uses the respirator in accordance with this standard

(f)(1)(iv) Assure that the employee dons the respirator before entering the work setting and uses it until leaving the work setting

All remaining provisions of paragraph (f) are applicable, i.e., (f)(2)—(f)(8)

(g) Medical Surveillance

All provisions of paragraph (g) are applicable

(h) Communication of Hazards and Training

(h)(3) Information and Training

All elements are applicable

(i) Recordkeeping

All recordkeeping, except for engineering controls records, is applicable

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

In general, most of the provisions of

the proposed standard would be

applicable for employers providing

home health care or home-based

hospice care. However, OSHA realizes

that home health care providers do not

have control over the home

environment and therefore, the standard

would not require these employers to

provide or maintain engineering

controls in the homes of their clients.

OSHA also realizes that some

individuals with infectious TB may be

sent home instead of being admitted to

the hospital; OSHA would not expect

employers to transfer such individuals

out of their home. However, individuals

with suspected or confirmed infectious

TB need to be identified so that home

health care providers can take

appropriate precautions to protect

themselves while in the home.

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

(c) Exposure Control

(c)(1) Exposure Determination

(c)(2)(i) Written Exposure Control Plan including:
54240 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

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

(A) the exposure determination

(B) procedures for providing information to occupationally exposed employees about individuals with suspected or confirmed infectious TB or air that may reasonably be anticipated to contain aerosolized M. tuberculosis

(C) procedures for reporting exposure incidents

(c)(2)(v) Employers who provide home health care or home-based hospice care must include procedures for prompt ID of individuals with

suspected or confirmed infectious TB, procedures for minimizing exposure to such individuals, a list of high-hazard procedures performed, if any, and procedures for delaying elective high-hazard procedures or surgery until the individual is noninfectious

(c)(2)(vii) The exposure control plan must be:

(A) accessible

(B) reviewed annually and updated whenever necessary

(C) available for copying by the Assistant Secretary and Director upon request

(d) Work Practices and Engineering Controls

(d)(1) Use work practices to eliminate or minimize employee exposure to M. tuberculosis

(d)(2) Implement the work practices in the Exposure Control Plan

(d)(3) Identify individuals with suspected of confirmed infectious TB

(d)(6) Provide information about TB hazards to any contractor who provides temporary or contract employees who will incur occupational

exposure

(f) Respiratory Protection

(f)(1)(i) Provide respirators to employees who:

(F) work in a residence where an individual with suspected or confirmed infectious TB is known to be present

(f)(1)(iii) Provide respirators at no cost and assure that the employee uses the respirator in accordance with this standard

(f)(1)(iv) Assure that the employee dons the respirator before entering the work setting and uses it until leaving the work setting

All remaining provisions of paragraph (f) are applicable, i.e., (f)(2)–(f)(8)

(g) Medical Surveillance

All provisions of paragraph (g) are applicable

(h) Communication of Hazards and Training

(h)(3) Information and Training

All elements are applicable except those related to the use of engineering controls

(i) Recordkeeping

All recordkeeping, except for engineering controls records, is applicable

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

Similar to Home Health Care or Home-Based Hospice Care, employers providing emergency medical services do

not have control over many of the work settings in which they may provide services. Thus, OSHA would not require

these employers to provide or maintain engineering controls. In addition, while these types of employers are likely

to be transferring individuals with infectious TB, it is not their responsibility to initiate the transfer of an individual

identified as having suspected or confirmed infectious TB to a facility with appropriate isolation capabilities. However,

where it is feasible to do so, such individuals need to be identified so that emergency medical service employees

can take precautions to protect themselves.

What Would Be Required for Emergency Medical Services?

(c) Exposure Control

(c)(1) Exposure Determination

(c)(2)(i) Written Exposure Control Plan including:

(A) the exposure determination

(B) procedures for providing information to occupationally exposed employees about individuals with suspected or confirmed infectious TB or air that may reasonably be anticipated to contain aerosolized M. tuberculosis

(C) procedures for reporting exposure incidents

(c)(2)(iii):

(A) Procedures for prompt identification of individuals with suspected or confirmed infectious TB

(B)(4) Procedure or policy for using properly-fitted masks on individuals with suspected or confirmed infectious TB

(C) A list of high-hazard procedures

(c)(2)(vii) The exposure control plan must be:

(A) accessible

(B) reviewed annually and updated whenever necessary

(C) available for copying by the Assistant Secretary and Director upon request

(d) Work Practices and Engineering Controls

(d)(1) Use work practices to eliminate or minimize employee exposure to M. tuberculosis

(d)(2) Implement the work practices in the Exposure Control Plan

(d)(3) Identify individuals with suspected or confirmed infectious TB

(d)(6) Provide information about TB hazards to any contractor who provides temporary or contract employees who will incur occupational

exposure

(f) Respiratory Protection

(f)(1)(i) Provide respirators to employees who:

(A) enter an isolation room or area

(B) are present during the performance of procedures or services for an individual with suspected or confirmed infectious TB who is

not masked

(C) transport an individual with suspected or confirmed infectious TB in an enclosed vehicle or who transport an unmasked individual

with suspected or confirmed infectious TB within the facility

(F) work in a residence where an individual with suspected or confirmed infectious TB is known to be present

(f)(1)(iii) Provide respirators at no cost and assure that the employee uses the respirator in accordance with this standard

(f)(1)(iv) Assure that the employee dons the respirator before entering the work setting and uses it until leaving the work setting
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54241

What Would Be Required for Emergency Medical Services?

All remaining provisions of paragraph (f) are applicable, i.e., (f)(2)–(f)(8)

(g) Medical Surveillance

All provisions of paragraph (g) are applicable

(h) Communication of Hazards and Training

(h)(3) Information and Training

All elements are applicable except those related to the use of engineering controls

(i) Recordkeeping

All recordkeeping, except for engineering controls records, is applicable

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

Employers in clinical and research laboratories that handle specimens that may contain M. tuberculosis or process

or maintain the resulting cultures or perform activities that may result in the aerosolization of M. tuberculosis must

follow most of the provisions of the proposed standard. In addition, a special paragraph has been added to address

the unique hazards of the lab environment. Clinical and research labs are not responsible for developing or implementing

procedures for the early ID of individuals with suspected or confirmed infectious TB or the transfer of those individuals.

What Would Be Required for Clinical and Research Laboratories?

(c) Exposure Control

(c)(1) Exposure Determination

(c)(2)(i) Written Exposure Control Plan including:

(A) the exposure determination

(B) procedures for providing information to occupationally exposed employees about individuals with suspected or confirmed infectious TB or air that may reasonably be anticipated to contain aerosolized M. tuberculosis

(C) procedures for reporting exposure incidents

(c)(2)(iv) Employers who operate a laboratory must include a determination as to whether the facility should operate a laboratory at Biosafety Level 2 or 3 containment and document the need for controlled access, anterooms, sealed windows, directional airflow, measures to prevent the recirculation of lab exhaust air, filtration of exhaust and thimble exhaust connections

(c)(2)(vii) The exposure control plan must be:

(A) accessible

(B) reviewed annually and updated whenever necessary

(C) available for copying by the Assistant Secretary and Director upon request

(d) Work Practices and Engineering Controls

(d)(1) Use work practices and engineering controls to eliminate or minimize employee exposure to M. tuberculosis

(d)(2) Implement the work practices in the Exposure Control Plan

(d)(6) Provide information about TB hazards to any contractor who provides temporary or contract employees who will incur occupational

exposure

(e) Clinical and Research Laboratories

All provisions of paragraph (e) are applicable

(f) Respiratory Protection

(f)(1)(ii) For research laboratories, provide respirators to employees who are present when aerosols of M. tuberculosis cannot be safely

contained

(f)(1)(iii) Provide respirators at no cost and assure that the employee uses the respirator in accordance with this standard

(f)(1)(iv) Assure that the employee dons the respirator before performing the tasks under (f)(1)(ii) and uses it until completing the tasks

All remaining provisions of paragraph (f) are applicable, i.e., (f)(2)–(f)(8)

(g) Medical Surveillance

All provisions of paragraph (g) are applicable

(h) Communication of Hazards and Training

(h)(1)(i) Labels:

(h)(1)(i) Label air systems that may reasonably be anticipated to contain aerosolized M. tuberculosis ‘‘Contaminated Air—Respiratory

Protection Required’’

(h)(1)(ii) Label clinical and research laboratory wastes with the biohazard symbol

(h)(2) Signs:

(h)(2)(i)(C) Post signs at entrances to clinical and research laboratories where M. tuberculosis is present

(h)(2)(iv) Include on the sign the biohazard symbol, the name and telephone number of the laboratory director or other designated responsible person, the infectious agent designation M. tuberculosis, and special requirements for entering the laboratory

(h)(3) Information and Training

All elements are applicable

(i) Recordkeeping

All recordkeeping is applicable

Chart 7: What Would Be Required for Personnel Services?

This category covers employers who provide temporary employees to any of the other employers covered under

the scope of the standard (e.g., temporary nurses hired to work at a hospital, temporary lab technicians working in

a clinical laboratory). Employees in these situations are covered by the standard in the same manner as other employees

who have occupational exposure to tuberculosis. A shared responsibility for worker protection exists between the personnel

service employer and the client (or ‘‘host’’) employer. These matters may be specified as a matter of contract or employment

agreement existing between the personnel service employer and the host employer. In this chart OSHA has assumed

that a typical contract or employment agreement exists between the two employers with the personnel provider accepting

responsibility for the general requirements and the host employer being responsible for site-specific measures. Therefore,

the personnel service provider is shown complying with non-site specific provisions such as exposure determination,

medical surveillance, and non-site specific employee training. The host employer would comply with more site-specific
54242 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

provisions such as procedures for early ID, engineering controls and site-specific employee training. In addition, the

chart assumes that the personnel service provider has accepted the responsibility for respiratory protection. OSHA requires

that workers in these situations receive full protection under the standard.

What Would Be Required for Personnel Services?

(c) Exposure Control

(c)(1) Exposure Determination

(c)(2)(i) Written Exposure Control Plan including:

(A) the exposure determination

(B) procedures for providing information to occupationally exposed employees about individuals with suspected or confirmed infectious TB or air that may reasonably be anticipated to contain aerosolized M. tuberculosis

(C) procedures for reporting exposure incidents

(c)(2)(vii) The exposure control plan must be:

(A) accessible

(B) reviewed annually and updated whenever necessary

(C) available for copying by the Assistant Secretary and Director upon request

(d) Work Practices and Engineering Controls

(d)(1) Use work practices to eliminate or minimize employee exposure to M. tuberculosis

(d)(2) Implement the work practices in the Exposure Control Plan

(f) Respiratory Protection

All provisions of paragraph (f) are applicable

(g) Medical Surveillance

All provisions of paragraph (g) are applicable except those related to conducting site-specific follow-up investigations after an exposure incident or skin test conversion

(h) Communication of Hazards and Training

(h)(3) Information and Training

All elements are applicable except those training elements which are site-specific

(i) Recordkeeping

All recordkeeping, except for engineering control records, is applicable

OSHA’s preliminary conclusion is

that all employees who have

occupational exposure to aerosolized M.

tuberculosis, as a result of performing

their duties, are at risk of infection.

Under paragraph (a) the Agency has

listed those facilities, work settings and

services where it believes that

significant occupational exposure is

most likely to occur. OSHA requests

comment and supporting data as to

whether there are other work settings or

services where significant occupational

exposures can be reasonably

anticipated.

Paragraph (b) Application

As discussed above, OSHA has

preliminarily determined that there are

elevated risks of TB infection associated

with certain types of work settings and

services. However, the Agency realizes

that there may be employers covered

under the scope of the standard who

have work settings in counties where

the risk of TB infection is low. Some

geographical areas in the U.S. have not

reported cases of TB to CDC and

facilities in these areas have not

encountered any individuals with

confirmed infectious TB in their work

settings within the recent past.

In consideration of the lessened

likelihood of employee exposure in

these work settings, OSHA is proposing

that some employers be permitted to

qualify for a more limited program.

Paragraph (b), Application, states that

an employer covered under paragraph

(a), Scope, other than the operator of a

laboratory, may choose to comply only

with the provisions of Appendix A if

the Exposure Control Plan demonstrates

that his or her facility or work setting:

(1) does not admit or provide medical

services to individuals with suspected

or confirmed infectious TB; (2) has not

encountered a case of confirmed

infectious TB in the past 12 months; and

(3) is located in a county that, in the

past 2 years, has had no cases of

confirmed infectious TB reported in one

year and fewer than 6 cases of

confirmed infectious TB reported in the

other year. Thus, in the past two year

period, the number of reported TB cases

must be 0 for at least one of the two

years. (It may even be zero for both

years). In the other year, the number of

cases must be no greater than 5. For

example, if in the first year of the

preceding two-year period the number

of reported cases was 0, but in the

second year there were 4 reported cases

of confirmed infectious TB in the

county, an employer would still qualify

for the limited program under paragraph

(b), provided that none of the cases were

encountered in his or her employees’

work setting. However, for the employer

in this scenario to continue to qualify

for the limited program, the number of

cases reported in the third year would

have to return to zero. Similarly,

employers would not qualify for the

limited program if the number of cases

of confirmed infectious TB reported in

the county was greater than zero in both

of the preceding two years or if 6 or

more cases were reported in one of the

preceding two years.

OSHA has taken this approach

because the number of TB cases

fluctuates widely and different locations

and geographical areas may be affected

at different times. For example, many

counties report no cases in one year or

even in two consecutive years, or report

a few cases in one year but then have

no cases in the following year. From

1992 to 1994 (Ex.7–262), 55.3 percent of

the counties in the U.S., representing

12.9 percent of the population, reported

no confirmed cases of TB in one year of

the preceding two-year period and fewer

than 6 cases in the other year. OSHA

believes that the approach described

above is appropriate given these

fluctuations and that it reduces the

burden on employers who rarely

encounter TB cases by allowing them to

qualify for the limited program. OSHA

initially considered allowing employers

to qualify for the limited program only

if there had been no cases of confirmed

infectious TB reported in the county in

the preceding one-year period. This

would have meant that an employer

would be required to comply with the

full program if even a single case was

reported in the county in any year.

OSHA requests comment on the

approach taken in the proposed rule and

the appropriateness of the ‘‘zerocounty’’ trigger used in the standard.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54243

Although OSHA believes that the risk

of incurring TB is substantially reduced

in facilities located in counties

qualifying for the limited program, the

risk of infection continues because all

counties have residents who are

infected and who may therefore develop

active TB and transmit it. In addition,

the mobility of the U.S. population

means that it is easy to carry the disease

from higher risk areas to lower risk

areas. Thus, OSHA believes that certain

TB exposure control provisions, i.e.,

those reflected in the limited program

required by the standard, need to be in

place in all work settings where cases of

TB could be encountered.

Under the limited program, employers

are responsible for (1) preparing a

written exposure control plan with

certain minimal elements, (2) providing

a baseline skin test and medical history,

(3) making medical management and

follow-up available after an exposure

incident, (4) providing medical removal

protection if necessary, (5) providing

information and training to employees

with potential occupational exposure,

and (6) complying with pertinent

recordkeeping requirements. The

specific paragraphs of the proposed

standard that would apply in these

situations are outlined in Appendix A.

OSHA believes that these provisions

are the minimum requirements

necessary for employee protection, even

in work settings where no TB has

recently been reported in the county

and no individuals with confirmed

infectious TB have been encountered

within the work setting during the past

12 months. OSHA’s reasoning is that,

although no cases of confirmed

infectious TB have been reported for the

preceding two years, there is

considerable fluctuation among counties

from one year to the next, as explained

above. In addition, as discussed in the

preliminary risk assessment section of

the preamble, there is a high prevalence

of TB infection nationwide,

approximately 6.5 percent. Infections

may become active after a latency

period of years. Therefore, the absence

of a reported active case in the

immediate past does not mean that

active cases will not be manifested in

the current or subsequent years. For

these reasons, it is necessary for covered

facilities to maintain, at a minimum, a

TB program that incorporates the basic

TB exposure control provisions that will

protect employees from exposures.

A primary element of the limited

program is a written exposure control

plan. The exposure control plan

includes an exposure determination to

identify those employees who would

incur occupational exposure if an

individual with infectious TB were

encountered in the work setting. The

exposure control plan would also have

to contain procedures and policies for

the early identification and masking of

individuals with suspected or

confirmed infectious TB and procedures

for transferring those individuals to

other facilities. This would assure that

if an individual with suspected or

confirmed infectious TB were to enter

the workplace, he or she would be

promptly identified and transferred to a

facility with AFB isolation capabilities.

In addition, while awaiting transfer,

these individuals could be masked to

the extent that it is feasible (e.g., in the

case of a non-combative individual) in

order to prevent transmission. Similarly,

the exposure control plan must include

procedures for reporting exposure

incidents should they occur. Employees

need to know what steps to take if an

exposure occurs so that appropriate

follow-up can be initiated for the

medical management of the exposed

employee and investigation of the

incident.

In order to qualify for the limited

program pursuant to paragraph (b), the

employer must include in his or her

exposure control plan the number of TB

cases reported in the county and the

number of individuals with confirmed

infectious TB who have been

encountered within the work setting. An

employer is required by the standard to

check and document the number of

confirmed infectious TB cases in the

county once a year. Typically, county

health departments collect this

information for reporting purposes and

report it both on a monthly and an

annual basis. Obtaining the annual

count from the county health

department would meet the

requirements of the proposed rule.

County case counts must be recorded for

the two most recent annual reporting

periods, i.e., the two preceding years.

This count must be reflected in the

employer’s Exposure Control Plan, as

described below in paragraph (c),

Exposure Control Plan, of this Summary

and Explanation. The count of cases and

the notation in the Plan can be kept in

any media, e.g., paper or electronic.

In addition to an abbreviated

exposure control plan, the limited

program would include some of the

basic elements of medical surveillance,

i.e., baseline skin tests and medical

histories for employees identified under

the exposure determination and medical

management and follow-up for those

employees who have had an exposure

incident. Baseline skin tests and

histories will help to assure that true

conversions are appropriately identified

should an exposure incident occur.

Medical management and follow-up

provisions will assure that exposed

employees receive the proper medical

evaluation after an exposure incident

and that the incident is properly

investigated so that it will not occur

again. Under this limited program, no

periodic medical surveillance would be

required.

Where necessary, the employer is also

required to provide medical removal

and protection (MRP) of benefits for

those employees who develop active

TB. OSHA anticipates that the need to

provide MRP would be a rare event

because little active TB has been

reported in many of these counties. In

addition, if employees are properly

trained to identify suspected and

confirmed infectious TB and to

promptly transfer those individuals, few

occupational exposures should occur,

thus minimizing the likelihood that

employees will become infected.

Therefore, training is an important

element of the limited program.

Training is a key element in assuring

that employees know how to identify

individuals with suspected or

confirmed infectious TB and the

necessary steps to take if such an

individual is encountered.

Certain minimal records must also be

kept by the employer. Medical records

for documenting baseline skin tests and

any potential medical evaluations made

as a result of an exposure incident, as

well as records for training and records

for OSHA illnesses and injuries, would

have to be kept. Keeping records should

not be burdensome for the employer

since it is likely that only a minimal

number of employees would be

identified by the exposure

determination as having potential

occupational exposure (e.g., intake

workers in admitting areas or emergency

departments); only such employees

need medical surveillance or training.

The elements of the limited program

outlined under this paragraph closely

track the recommendations of the CDC

for facilities designated as having

‘‘minimal risk’’ under the CDC’s TB

Guidelines for Health Care Facilities

(Ex. 4B). Under these guidelines, CDC

considers facilities to have ‘‘minimal

risk’’ if there is no TB in the community

and no TB in the facility. CDC’s

recommendations for such facilities

include a written TB control plan,

procedures for early identification and

prompt transfer of individuals with

suspected or confirmed infectious TB,

and employee training. CDC does not

specifically recommend baseline skin

testing. However, CDC’s guidelines do

say that baseline testing would be
54244 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

advisable in these facilities so that, if an

unexpected exposure does occur,

conversions can be distinguished from

positive skin test results caused by

previous exposures. CDC also

recommends that a risk assessment be

conducted by such facilities each year.

In the case of a ‘‘minimal risk’’ facility,

as defined by CDC, this would

essentially involve checking on the

number of reported cases of TB in the

community and within the facility,

which is essentially what OSHA

requires under the exposure control

plan as documentation to qualify for the

limited program available under

paragraph (b).

Paragraph (c) Exposure Control

Employees incur risk each time they

are exposed to aerosolized M.

tuberculosis. A worker can become

infected from a single exposure

incident, and thus it is necessary to

prevent exposure incidents whenever

possible. The goal of this proposed

standard is to reduce the significant risk

of infection by minimizing or

eliminating occupational exposure to

aerosolized M. tuberculosis.

One purpose of paragraph (c),

Exposure Control, is to identify the tasks

and procedures where occupational

exposure may occur and to identify

those employees whose duties include

these tasks and procedures. An

additional purpose of the paragraph is

to develop and document, in an

exposure control plan, policies and

procedures for eliminating or

minimizing occupational exposure, e.g.,

developing procedures for identifying

individuals with suspected or

confirmed TB, for appropriately

isolating and minimizing employee

contact with those individuals, and for

reporting exposure incidents.

Paragraph (c)(1) requires each

employer who has an employee with

occupational exposure to prepare an

exposure determination that identifies

those employees who have occupational

exposure to aerosolized M. tuberculosis.

As discussed under paragraph (j),

Definitions, ‘‘occupational exposure’’

means ‘‘reasonably anticipated contact

that results from the performance of an

employee’s duties, with an individual

with suspected or confirmed infectious

TB or air that may contain aerosolized

M. tuberculosis.’’ Thus, the exposure

determination needs to include, in

addition to those employees who have

direct contact with individuals with

suspected or confirmed infectious TB

and employees who perform procedures

that may aerosolize M. tuberculosis,

those employees who can reasonably be

anticipated as part of their job duties to

be exposed to air that may contain

aerosolized M. tuberculosis.

For example, while an admissions

clerk in a homeless shelter will not

perform medical procedures on a client

with suspected infectious tuberculosis,

the clerk may reasonably be anticipated

to encounter and share the same

airspace with such an individual.

Therefore, the admissions clerk would

be included in the Exposure Control

Plan and would be covered by this

standard.

Exposure determination is a key

provision of exposure control because

the employer must know which tasks or

procedures involve occupational

exposure in order to determine what

measures can be taken to eliminate or

minimize exposure incidents. In

addition, an exposure determination is

necessary in order to ascertain which

employees are to be provided with

respiratory protection, medical

surveillance, and training.

Each employer is required to consider

the duties, tasks, and procedures of all

employees in each job classification in

each work area where occupational

exposure occurs when making the

exposure determination. OSHA believes

that it is appropriate to allow the

employer to identify and document job

classifications where all or some

employees have occupational exposure

as a basis for the required exposure

determination. By identifying the job

classification, each employee included

in the description will know that he or

she is within the scope of the standard.

Listing of every employee’s name is not

required, however, because that may be

burdensome for employers who have

many employees with occupational

exposure.

The term ‘‘job classification’’ is used

generically. During the development of

the Bloodborne Pathogens standard,

commenters used several terms (e.g.,

‘‘job category’’, ‘‘job responsibility’’,

‘‘job title’’, ‘‘position description’’) to

identify and document employees at

risk in the exposure determination.

OSHA sought to use a term that would

encompass all of these terms. Therefore,

as in the Bloodborne Pathogens

standard, OSHA has chosen to use the

term ‘‘job classification’’ because it has

the broadest application to facilities of

all sizes that use formal and less formal

designations to classify employees.

Thus, the standard would allow

employers to use existing job titles, job

descriptions, or other designations to

identify those job classifications in

which occupational exposure occurs.

OSHA solicits comment on whether this

term needs further defining in this

paragraph or in paragraph (j),

Definitions.

The standard does not require that

every task and procedure that could

result in occupational exposure be listed

in the exposure control plan, but instead

gives the employer a choice in how to

document the exposure determination.

Paragraph (c)(1)(i) states that the

exposure determination shall contain:

(A) A list of the job classifications in which

all employees have occupational exposure;

and

(B) A list of the job classifications in which

some employees have occupational exposure,

and a list of all tasks and procedures (or

groups of closely related tasks and

procedures) that these employees perform

and that involve occupational exposure.

This means that the employer may

choose to extend ‘‘blanket’’ coverage to

those job classifications where

essentially all employees have

occupational exposure [the paragraph

(c)(1)(i)(A) option]. In this case, the

employer would not have to list all tasks

and procedures for those employees in

the exposure control plan, since all of

these employees would be covered by

the standard. For example, if a hospital

determines that all employees within

the job classification ‘‘respiratory

therapist’’ have duties or

responsibilities that involve tasks and

procedures where occupational

exposure occurs, the job classification

‘‘respiratory therapist’’ can simply be

listed in the exposure determination in

accordance with paragraph (c)(1)(i)(A)

and no subsequent listing of those tasks

and procedures is required. Similarly,

the job classification of ‘‘homeless

shelter admissions clerk’’ in the

previous example could be included

under the ‘‘blanket’’ job classification

list in paragraph (c)(1)(i)(A).

On the other hand, the employer may

determine that job classifications exist

in which only some employees have

occupational exposure. The employer

may determine that it is not necessary

to include all employees in such job

classifications under the standard since

only a portion of them have

occupational exposure. In these

situations [paragraph (c)(1)(i)(B)], the

employer must list the job classification

as well as the tasks and procedures or

groups of closely related tasks and

procedures performed by employees

within that job classification that result

in occupational exposure. For example,

within the job classification ‘‘laboratory

technician,’’ there may be some

employees who experience occupational

exposure (e.g., laboratory technicians

who perform microbiological

procedures on M. tuberculosis cultures),

while others would not be expected to
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54245

have such exposure (e.g., laboratory

technicians who work in clinical

chemistry). In such a case, the employer

may not wish to extend coverage to all

employees in the job classification

‘‘laboratory technician’’. Consequently,

the job classification ‘‘laboratory

technician’’ would be listed in the

exposure determination along with the

tasks and procedures in which

occupational exposure occurs. This

approach would inform employees

within the job classification ‘‘laboratory

technician’’ about those tasks that they

perform that involve occupational

exposure and that employees

performing those tasks and procedures

triggers their inclusion in the scope of

the standard. However, it would not be

necessary for the employer to list each

procedure performed by a ‘‘laboratory

technician’’. For example, performing

sputum smears, culturing the bacteria in

the sputum, and conducting drugsusceptibility testing on the culture all

involve manipulation of specimens that

could contain M. tuberculosis.

Therefore, these tasks could be grouped

under the designation ‘‘manipulation of

specimens that may contain M.

tuberculosis.’’

Although the standard permits the

exposure determination to list job

classifications, grouping job

classifications according to location

would not be sufficient to meet the

requirement for identifying job

classifications with occupational

exposure. For example, identifying job

classifications by using the ‘‘Emergency

Department’’ would not fulfill this

requirement because it does not identify

the specific employee job classifications

that have occupational exposure. An

employer who has determined that

employees in the ‘‘Emergency

Department’’ warrant coverage under

the standard would have to list the job

classifications that involve occupational

exposure and identify the tasks and

procedures that result in occupational

exposure. OSHA believes that merely

grouping employees by location, e.g.,

designating all employees who work in

the Emergency Department, may

exclude employees who have

occupational exposure since such a

grouping could overlook employees

who may occasionally enter the

Emergency Department but are not

routinely assigned there. OSHA seeks

comment about the protectiveness of

permitting exposure determinations to

be made by location within a work

setting in certain specific instances

where the employer believes such a

delineation is useful and will not

misclassify employees and specifically

requests examples of regulatory

language that could achieve these

objectives.

Paragraph (c)(1)(ii) requires that the

exposure determination be made

without regard to the use of respiratory

protection. It has been OSHA’s longstanding position that the determination

of occupational exposure be made

without regard to the use of personal

protective equipment such as

respirators. The reason for this is that

several conditions must be met for

respiratory protection to effectively

lessen exposures. First, the employee

must be trained to use the equipment

properly. Second, respiratory protection

must be used each time the task

requiring such protection is performed.

Third, respiratory protection must fit

properly. If even one of these conditions

is not fully met, protection cannot be

assured. Therefore, all tasks that entail

occupational exposure need to be

included in the exposure determination,

regardless of the use of respiratory

protection. This approach is consistent

with other OSHA standards (e.g.,

Bloodborne Pathogens, 29 CFR

1910.1030; Formaldehyde, 29 CFR

1910.1048; Cadmium, 29 CFR

1910.1027) and is essential to designing

an appropriate exposure control

program. Utilizing this approach assures

that workers who perform tasks

requiring respiratory protection will

receive the training, medical

surveillance, and other provisions of

this standard that will enhance their

safety should respiratory protection fail.

Paragraph (c)(2) requires that each

employer covered under the scope of

the standard establish a written

exposure control plan. The exposure

control plan is a key provision of the

standard because it requires the

employer to identify the employees who

receive training, respiratory protection

and medical surveillance and to develop

a number of policies and procedures

that will eliminate or minimize

employees’ exposure to sources of

aerosolized M. tuberculosis. However,

because not all employers’ work settings

are the same, not all employers’

exposure control plans will need to

contain the same elements. The goal of

the exposure control plan is to address

the type of exposure that occurs in a

given work setting, as identified under

the exposure determination, and then to

develop procedures and policies to

minimize or eliminate that exposure.

Thus, the size and complexity of the

exposure control plan will be relative to

the types of exposure encountered in

the employer’s work setting. For

example, social service employees who

must provide services to individuals

who are in AFB isolation are covered

under the scope of the standard. The

employer in this case would only have

to include certain minimal elements in

his or her exposure control plan. This

employer would not have to include

elements for identifying individuals

with suspected or confirmed infectious

TB since these individuals will already

have been identified by someone else.

Similarly, the exposure control plan of

such employers would not have to

include procedures for isolating or

managing the care of individuals with

infectious TB. On the other hand,

hospitals that admit or provide medical

services to individuals with suspected

or confirmed infectious TB would be

required to have a more extensive

exposure control plan since the

employer in this case would be

responsible for identifying, isolating and

possibly performing high-hazard

procedures on individuals with

suspected or confirmed infectious TB.

Under paragraph (c)(2)(i), the

proposed standard requires that the

exposure control plan be written. There

are several reasons for having the plan

in writing. First, because exposure

control must be practiced by everyone—

employee and employer—it is

imperative that an employee be able to

find out what provisions are in place in

his or her workplace. In addition, the

exposure determination gives an

employee who may be unfamiliar with

the job a ready reference for ascertaining

which job classifications, tasks, and

procedures entail occupational

exposure. Second, the exposure control

plan also serves as an on-site adjunct to

the overall infection control plan for the

work setting and reinforces the

employer’s training program. Employees

will be trained about the various

procedures developed by the employer

to eliminate and minimize exposure.

Having the procedures written and

available at the work site will provide

a ready reference for employees and will

serve as an adjunct to their training.

Third, having the plan in writing is also

important for enforcement purposes. By

reviewing the exposure control plan, an

OSHA compliance officer will be able to

become familiar with the employer’s

determination of tasks and procedures

with occupational exposure, the job

classifications whose duties include

those identified tasks, and the policies

and procedures the employer uses to

minimize occupational exposure along

with any revisions to the exposure

control plan.

OSHA realizes that many workplaces

covered under the scope of the proposed

standard may already have

comprehensive infection control plans
54246 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

that may include many of the measures

required by the proposed standard. It is

not OSHA’s intent for employers to

duplicate current infection control plans

solely for the purpose of complying

with the standard. Therefore, the

exposure control plan may be

comprised of existing documents that

are part of a larger infection control

plan. However, all elements of the

exposure control plan for TB required

by the proposed standard must be

included. In addition, the plan must be

in some manner a cohesive entity by

itself or a guidance document must exist

that states the overall policy goals and

directs the reader to the location of the

separate documents that are being used

to fulfill the requirements of the

standard.

While there will be differences in the

elements of employers’ exposure control

plans, each employer covered under the

scope of the standard must have certain

minimal elements in his or her plan.

Paragraphs (c)(2)(i)(A) through

(c)(2)(i)(C) contain the minimal

elements that must be included in the

exposure control plans of every

employer covered under the scope of

the standard. Paragraph (c)(2)(i)(A)

requires that the exposure control plan

must include the exposure

determination required under paragraph

(c)(1). As discussed above, the exposure

determination is necessary to identify

those employees who have occupational

exposure so that the employer can

determine which employees are to be

given respiratory protection, medical

surveillance and training.

Paragraph (c)(2)(i)(B) requires that the

employer develop procedures for

informing occupationally exposed

employees about suspected or

confirmed infectious TB cases and about

air that may reasonably be anticipated to

contain aerosolized M. tuberculosis in

order that the employees can take

proper precautions against M.

tuberculosis exposure. Once individuals

with suspected or confirmed infectious

tuberculosis have been identified, it is

necessary to convey this information to

employees who may be exposed so that

they may take the steps necessary to

eliminate or minimize their exposure.

When patient confidentiality may be a

concern, it is not necessary to use an

individual’s name to satisfy this

provision. For example, lists do not

need to be made of all patients in the

hospital with active TB. Information

may be conveyed to employees by

simply labeling the isolation room with

the warning sign required under

paragraph (h)(2)(iii) while the room is in

use for TB isolation. Labeling the room

will inform the employees that the

individual in the room is in respiratory

isolation and the employee must stay

out of the room or don the appropriate

respiratory protection before entering.

Another scenario in which such

notification is necessary would be when

such an individual must be transported

to another facility in an ambulance. In

this case, the employees who will be

present in the ambulance would have to

be notified so that they could utilize

proper precautions during the transport.

Paragraph (c)(2)(i)(C) requires that the

employer include in the exposure

control plan procedures for reporting

exposure incidents, including

identification of the person to whom the

incident is to be reported, and the

procedures the employer will use for

evaluating the circumstances

surrounding exposure incidents as

required by paragraph (g)(4)(iv). Under

paragraph (j), Definitions, an exposure

incident * * * is defined as

* * * an event in which an employee has

been exposed to an individual with

confirmed infectious TB or to air containing

aerosolized M. tuberculosis without the

benefit of all applicable exposure control

measures required by this section.

In the event that unprotected

employees are exposed to aerosolized

M. tuberculosis, it is necessary that this

exposure incident be reported to the

employer as soon as feasible in order to

promptly initiate proper medical

management and follow-up of the

exposed employee. In addition, quick

reporting of exposure incidents permits

the employer to investigate the

circumstances surrounding such

incidents while pertinent conditions

remain relatively unchanged and are

fresh in the employee’s memory.

Procedures need to be in place

describing how the exposure incident is

to be investigated. Having investigation

procedures in place beforehand will

help to assure that such investigations

are able to be done promptly and in a

consistent and thorough manner from

case to case. This will assist the

employer in complying with the

requirement of paragraph (g)(4)(iv) that

directs the employer to investigate and

document the circumstances

surrounding the exposure incident to

determine if changes can be instituted

that will prevent similar occurrences in

the future.

Paragraph (c)(2)(ii) applies to

employers who transfer individuals

with suspected or confirmed infectious

TB to a facility with AFB isolation

capabilities. This would apply to

employers who operate a facility from

which an individual with suspected or

confirmed infectious TB is transferred

and would not apply to employers

whose employees provide certain

services such as social welfare services

to individuals who have been isolated

and in settings where home health care

and home hospice care is provided.

The standard does not require any

employer to transfer individuals with

suspected or confirmed infectious TB.

Transfer is an option that employers

have that relieves the employer of many

provisions of the standard, such as AFB

isolation rooms. If an employer chooses

to use the transfer option, the employer

must include the procedure for

implementing the transfer in the

exposure control plan.

Paragraph (c)(2)(ii) requires employers

who transfer individuals with suspected

or confirmed infectious TB to develop

exposure control plan procedures that

address the following: (1) prompt

identification of individuals with

suspected or confirmed infectious TB;

(2) masking or segregation of

individuals with suspected or

confirmed infectious TB; and (3)

transfer of such individuals to a facility

with AFB isolation capabilities.

One of the most important steps in

preventing TB transmission is the early

detection of individuals who may have

infectious TB (Exs. 3–33, 3–34, 3–35,

4B). It is essential that individuals with

suspected or confirmed infectious TB be

identified as soon as possible so that

employees who must have contact with

them will be warned early and be able

to use appropriate infection control

practices to protect themselves from

exposure. Obviously, the sooner this is

done, the less occupational exposure

there will be and the less likely that TB

will be transmitted. In addition, early

identification of individuals with

suspected or confirmed infectious TB

will allow for the timely transfer and

initiation of effective treatment of those

individuals for whom the diagnosis of

TB is likely. By promptly administering

effective treatment, these individuals

can be rendered noninfectious, thus

decreasing the time they are infectious

and their potential for exposing

employees and other people.

OSHA is proposing that employers

develop a procedure for the prompt

identification of individuals with

suspected or confirmed infectious TB as

part of the exposure control plan. In

order to assure prompt identification, it

is necessary for the employer to have

procedures in place regarding how this

identification will be made. CDC has

recommended that identification

procedures be based on the prevalence

and characteristics of TB in the

population served by the specific

facility (Ex. 4B). For example,
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54247

individuals who come from

communities with a high prevalence of

TB and exhibit certain signs of TB may

be more highly suspected as having

infectious TB than individuals from

communities with a low prevalence of

TB. OSHA, therefore, expects that the

procedures may be different depending

upon the local conditions.

The procedure needs to contain the

following:

Methodology—The employer must

describe how he or she will make the

determination that an individual should

be considered as having suspected or

confirmed infectious TB. There are

several ways of doing this. The

employer can use information provided

by a physician or other health care

provider in advance of an individual’s

admission to the employer’s facility that

the individual has been diagnosed with

suspected or confirmed infectious TB. If

this is not available the employer must

determine whether an individual should

be considered as having suspected

infectious TB. OSHA defines suspected

infectious TB as:

* * * a potential disease state in which an

individual is known, or with reasonable

diligence should be known, by the employer

to have one or more of the following

conditions, unless the individual’s condition

has been medically determined to result from

a cause other than TB: (1) to be infected with

M. Tuberculosis and to have the signs or

symptoms of TB; (2) to have a positive acidfast bacilli (AFB) smear; or (3) to have a

persistent cough lasting 3 or more weeks and

two or more symptoms of TB, e.g., bloody

sputum, night sweats, anorexia, weight loss

and fever. An individual with suspected

infectious TB has neither confirmed

infectious TB nor has he or she been

medically determined to be noninfectious.

Although the definition specifies the

criteria the employer must incorporate

in his or her plan, the employer will

still need to exercise judgment in

determining whether an individual

meets one or more prongs of the

definition. Of course, an employer, such

as one who operates a facility in an area

of particularly high TB prevalence, is

free to use more stringent (i.e.,

additional) criteria for considering an

individual to have suspected infectious

TB in his or her particular work setting.

In situations where a medical

diagnosis is not available either before

or at the time of admission, an employer

must collect the information he or she

needs to make the determination. This

can be accomplished in two ways. The

employer can have an employee

administer a medical history

questionnaire to individuals seeking

services from the facility. Another way

to obtain information to make this

determination is by having an employee

observe the individual to ascertain his

or her health status, looking for the

signs, and asking about the symptoms

included in OSHA’s definition that may

indicate infectious TB. Many employers

will use both questionnaires and

observation. The employee collecting

the information will have to be trained

on how to conduct the investigation

effectively and with respect for the

privacy of the individual.

Responsibilities—The employer must

designate responsibilities for

determining whether an individual

should be considered as having

suspected or confirmed infectious TB.

However, all employees need to be

given clear instructions regarding their

roles in the prompt identification of

suspected or confirmed infectious TB

cases. For example, the health care

workers who are the first points of

contact in ambulatory care settings and

emergency rooms in hospitals could be

involved with the initial screening of

patients. They may be given several

questions to ask a patient, which would

be used as information to begin the

determination. The next actions would

depend upon the responses, and the

authority of the health care workers.

Some employees, for example, would

only report answers to questions or their

observation of signs of infectious TB in

the client population to someone more

knowledgeable. Other employees would

be making determinations. The hospital

would probably have a different

procedure that would be used before or

at admission to the hospital for

scheduled services. The same hospital

might have still another procedure

designating responsibility to other

employees for identifying patients who

develop TB while in the hospital. The

Exposure Control Plan must designate

those employees who make the

determination as to whether an

individual has suspected or confirmed

infectious TB. An employer should

consider such designation(s) carefully

because, regardless of who determines

that an individual has suspected

infectious TB, it is the employer who is

responsible for ensuring that the

employee knows and uses the proper

criteria.

The identification procedures will

likely vary among establishments,

depending upon the type of work done

in the facility. For example, facilities

that provide long-term care for the

elderly will likely have a different

procedure from hospitals that have an

open admissions policy. OSHA also

expects that the methods different

employers use may vary depending on

whether the employer is in an area of

high or low TB prevalence. This

approach is consistent with CDC

recommendations.

Promptness—Prompt identification of

an individual with suspected or

confirmed infectious TB is important

because it allows isolation before the

disease is spread through the facility.

CDC recommends that procedures be in

place for prompt identification.

However, OSHA expects that the

determination will be made as soon as

reasonably practical since an employer

cannot always make such a

determination immediately. For many

situations, such as those occurring in a

hospice, the employer will have

information regarding an individual’s

health status prior to admitting the

individual to the facility. The employer

can use this information to determine

whether the individual should be

considered as having suspected or

confirmed infectious TB. In a long-term

health care facility, the employer needs

to be continually aware of each

resident’s health status because it can

change rapidly. Information regarding

the signs or symptoms suspected

infectious TB needs to be reported and

processed as soon as possible.

Effectiveness—OSHA believes that an

effective procedure, when implemented,

will identify individuals as having

suspected or confirmed infectious TB.

OSHA believes that many employers

affected by this proposed standard

currently use effective procedures and

find them to be practical. However,

OSHA also recognizes that it will not be

possible to ensure that the identification

procedure will promptly detect all

individuals with infectious TB each

time. In homeless shelters, for example,

the clients may withhold information

requested in a questionnaire because

they believe that such information may

persuade the shelter to refuse to admit

them. Therefore, homeless shelters may

have to place greater reliance on

observation of the residents for the

cluster of signs and symptoms

associated with infectious TB. Although

this standard would require that

homeless shelter workers and others be

trained to look for signs in individuals,

it is unlikely that all cases will be

identified. However, if the employer

finds that individuals with suspected

and confirmed infectious TB are not

being identified, the employer must

investigate in order to determine what

procedures need to be modified. During

an inspection, an OSHA compliance

officer will review the adequacy of the

procedures, and although a citation

would not be issued solely on the basis

of failure to identify an individual with

suspected infectious TB because no

identification system is fool-proof,
54248 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

failure to identify a number of

individuals with undetected suspected

or confirmed infectious TB would be

good evidence that the procedures or

their implementation need to be

investigated and improved and could

result in a citation.

The employer must also include in

the exposure control plan procedures

for transferring individuals with

suspected or confirmed infectious TB to

facilities with AFB isolation

capabilities. The procedures must

address how those transfers are to take

place in order that the transfers may be

conducted promptly and with minimal

exposure to employees. Specifically,

they will include where the cases are to

be transferred, how the transfer will

occur, and what precautions employees

are to take while individuals with

suspected or confirmed TB are awaiting

transfer.

As the note to paragraph (c)(2)(ii)

states, an employer’s duties regarding

transfer of an individual with suspected

or confirmed infectious TB will vary

with the type of facility the employer

operates and the work performed by his

or her employees. For example, the

transfer responsibilities of hospitals,

long-term care for the elderly,

correctional facilities, and hospices may

include contacting the receiving facility,

providing transport, and taking other

steps to ensure the individual can get to

the receiving facility. These types of

facilities often exercise custodial care

over such individuals and, hence, have

more responsibility for assuring

completion of the transfer. Conversely,

the responsibilities a homeless shelter

or a facility that offers drug treatment

for drug abuse, but that does not have

custody over individuals, may only

include providing information about the

receiving facility, contacting the facility,

and providing directions to the facility.

An employer who provides home health

care or home-based hospice care has no

obligation to transfer an individual from

his or her home to a receiving facility.

Transferring an individual with

suspected or confirmed infectious TB

protects employees within the facility

by making sure the source of

occupational exposure is removed and,

of course, benefits the individual in that

he or she receives help in locating and

getting to a receiving facility with the

capability for appropriately managing

their care.

Paragraph (c)(2)(iii) outlines the

additional elements required of

employers who have work settings

where individuals with suspected or

confirmed infectious TB are admitted or

provided with medical services.

Paragraph (c)(2)(iii)(A) requires that

their exposure control plans include

procedures for the prompt identification

of individuals with suspected or

confirmed infectious TB. As discussed

above, the early identification of

individuals with infectious TB will help

to assure that employees who must have

contact with those individuals will be

warned early and be able to use

appropriate infection control practices

to protect themselves from exposure. In

addition, for employers who have

facilities where individuals with

suspected or confirmed infectious TB

are admitted and provided medical

services, prompt identification is

essential so that isolation precautions

and effective treatment can be initiated

as soon as possible, thereby reducing

exposure to employees and other

people.

Paragraph (c)(2)(iii)(B) requires that

the employer develop procedures for

isolating and managing the care of

individuals with suspected or

confirmed infectious TB. Having

isolation procedures in place will help

to assure that employees are aware of

the steps to take in the event that

individuals with suspected or

confirmed infectious TB are identified.

If employees know the proper

procedures to follow, they will be better

equipped to initiate isolation promptly,

thereby reducing the likelihood that

individuals with infectious TB will

infect others. This provision is in

accordance with the most recent CDC

guidelines, which also recommend the

procedures include:

(1) The indications for isolation, (2) who is

authorized to initiate and discontinue

isolation, (3) isolation practices, (4)

monitoring of isolation, (5) management of

patients who will not comply with isolation

practices, and (6) criteria for discontinuing

isolation. (Ex. 4B)

While OSHA allows the employer to

determine what criteria should be

included in the procedures to isolate,

the Agency believes that it is prudent

for the employer also to consider the

elements listed in the CDC guidelines.

Paragraph (c)(2)(iii)(B) also requires

that the employer develop policies and

procedures for managing the care of

individuals with suspected or

confirmed infectious TB once they have

been placed in isolation. The exposure

control plan must include procedures

and polices addressing: (1)

Minimization of the time an individual

with suspected or confirmed infectious

TB remains outside of an AFB isolation

room or area, (2) minimization of

employee exposure in AFB isolation

rooms or areas, (3) delay of elective

transport or relocation of individuals

with infectious TB within the facility

and, to the extent feasible, performance

of services or procedures for such

individuals in an AFB isolation room or

area, (4) masking of individuals with

infectious TB or use of portable

containment engineering controls

during transport outside of AFB

isolation rooms and return of the

individual to an AFB isolation room or

area as soon as is practical after

completion of the service or procedure,

and (5) delay of elective high-hazard

procedures and elective surgery until an

individual with suspected or confirmed

infectious TB is determined to be

noninfectious.

It is important to minimize, to the

extent feasible, exposure of employees

to aerosolized M. tuberculosis even

while maintaining a high quality of

health care and other required services.

Developing policies and procedures

addressing the items listed above will

help to assure that this overall goal is

met. For example, there may be times

when an individual with suspected or

confirmed infectious TB must leave the

isolation room or area (e.g., when

certain equipment necessary for

providing care to the patient cannot be

brought into the room). On these

occasions having policies in place that

minimize the time those individuals

must be outside the isolation room or

area will help to reduce the likelihood

that droplet nuclei are spread. For

example, if a particular procedure must

be performed outside of the isolation

room, time could be minimized by

taking the individual directly to the

procedure area, performing the

procedure upon arrival, and returning

the individual to isolation immediately

after completion of the procedure. In

addition, if a procedure is to be

performed outside of the isolation room,

a time could be chosen when the

procedure area is not being used by

others.

The exposure control plan must also

contain procedures for minimizing

employee exposure in AFB isolation

rooms or areas. For example, policies

addressing minimizing both the number

of employees and time that such

employees spend in isolation rooms can

reduce exposure. This can be

accomplished in a variety of ways. For

example, in order to minimize the

number of employees entering an

isolation room, certain tasks or

procedures that might normally be done

by several different employees could be

done by one person. A nurse coming

into the room to administer daily TB

treatment could also bring in the

patient’s breakfast at the same time

rather than have a hospital dietician

deliver the meal. In addition, the
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54249

employer must address minimization of

time that employees spend in an

isolation room or area. For example,

rather than conducting an entire

discharge planning interview with an

individual in person, the employee may

be able to collect and convey a large part

of the information over the phone with

the individual. Personal contact could

be limited to just the time needed to

obtain items requiring direct interaction,

such as the individual’s signature.

Policies are to be included that

address the masking of individuals with

infectious TB during transport outside

of AFB isolation rooms or areas.

Masking of individuals may be

accomplished, for example, through the

use of surgical masks or valveless

respirators. A barrier such as a surgical

mask, when placed over the mouth of an

individual who is coughing, will reduce

the formation of droplet nuclei because

the mask will collect and contain the

droplets as they are discharged before

they have time to evaporate and form

droplet nuclei. A respirator that does

not have an exhalation valve can also be

used to capture droplets being

discharged. An exhalation valve would

permit droplets to pass through and

discharge into the air, where they could

evaporate and form droplet nuclei.

However, while surgical masks prevent

the formation of droplet nuclei, they do

not prevent exposure to droplet nuclei.

As the document ‘‘Biosafety Precautions

for Airborne Pathogens’’ states:

There is no reciprocity between the means

of prevention of the actual formation of

droplet nuclei (coughing into a tissue) and

the means of prevention of exposure (barriers

to breathing in the droplet nuclei). Once a

droplet nucleus has been allowed to form, its

small size can penetrate the fiber of a tissue

or a surgical mask. Thus these products do

not represent adequate physical barriers to

the aerosol transmission of droplet nuclei.

The appropriate barrier is a well fitted

respirator that does not allow leakage of air

around the edges and blocks passage of

microorganisms in the filter media (fibers or

pores) through which air is inspired.

Although a simple surgical mask applied to

a tuberculosis patient who must be

transported outside the isolation room will

prevent the dispersal of organisms as droplet

nuclei, such a mask does not provide

adequate protection to the individual who

must breathe air containing droplet nuclei.

(Ex. 7–134)

Since masking of an individual with

suspected or confirmed infectious TB

will reduce the number of droplet

nuclei expelled into the air, the

employer is required to develop policies

addressing the masking of such

individuals during transport outside of

an AFB isolation room.

It is not OSHA’s intent to dictate

patient management practices, nor will

it be the Compliance Officer’s

responsibility to determine the

correctness of certain patient

management policies. However, the

Agency believes that the employer must

consider the above situations and

develop policies that address them,

keeping in mind the goal of minimizing

employee exposure. This provision is in

accordance with CDC recommendations

(Ex. 4B).

The exposure control plan must also

contain policies for the delay of elective

transport or relocation within the

facility of individuals with suspected or

confirmed infectious TB outside of an

AFB isolation room or area. For

example, delaying the transfer of an

inmate with suspected or confirmed

infectious TB from one prison to

another, where possible, until the

inmate has been determined to be

noninfectious, will reduce not only the

number of employees exposed, but will

also minimize the exposure of other

inmates, thereby decreasing the risk of

transmission of disease.

Similarly, the exposure control plan is

to include policies for the delay of

elective high-hazard procedures until an

individual with suspected or confirmed

infectious TB has been determined to be

noninfectious. Elective high-hazard

procedures (e.g., pulmonary function

testing) or elective surgery (e.g.,

noncritical dental procedures) might be

easily delayed, without compromising

care, until an individual with infectious

TB has been determined to be

noninfectious.

Paragraph (c)(2)(iii)(C) requires the

employer to list all high-hazard

procedures performed in the workplace.

As discussed in paragraph (j),

Definitions, high-hazard procedures are

defined as ‘‘* * * those procedures

performed on an individual with

suspected or confirmed infectious

tuberculosis in which the potential for

being exposed to M. tuberculosis is

increased due to the reasonably

anticipated generation of aerosolized M.

tuberculosis * * *’’ Under paragraph

(d)(4) of Work Practice and Engineering

Controls, the proposed standard

requires that all employers assure that

high-hazard procedures are conducted

in an AFB isolation room or area. Thus,

listing the high-hazard procedures will

serve to identify those procedures that

require special ventilation

considerations (e.g., maintaining

negative pressure and properly

exhausting contaminated air). This will

assist employees in determining which

procedures must be performed using

such engineering controls and,

consequently, will help minimize

employee exposure.

For employers who have work

settings where TB cases are isolated,

paragraph (c)(2)(iii)(D) requires the

employer to develop a schedule for the

inspection, maintenance, and

performance monitoring of engineering

controls. Engineering controls required

by the proposed standard play an

essential role in reducing employee

exposures to M. tuberculosis. Thus, it is

necessary that these controls be

appropriately maintained, inspected

and monitored in order to assure that

they are functioning properly. Since

engineering controls are mechanical

systems, they are prone to occasional

lapses in performance caused by

occurrences such as clogged filters,

slipping or broken drive belts, burnedout motors, obstructed ducts, and so

forth. Since these situations cannot be

predicted, it is necessary to regularly

inspect engineering controls for proper

functioning. Hence, a schedule must be

developed for such activities. In

addition, employees who are

responsible for the maintenance will

have a record that they can check to see

when certain engineering controls need

to be inspected, maintained or

monitored. In general, OSHA has left

the time frame for these activities up to

the employer, except as required under

paragraphs (d)(5)(ii) and (d)(5)(iii), since

the employer is familiar with the

characteristics of the workplace that

could affect the performance of these

controls (e.g., dusty conditions, high

heat and humidity, seasonal variations).

For facilities with clinical or research

laboratories, Paragraph (c)(2)(iv)

requires that the exposure control plan

contain a determination from the

director of the laboratory as to whether

the laboratory facility should operate at

Biosafety Level 2 or 3 containment

according to CDC/NIH

recommendations. Under paragraph (e),

Clinical and Research Laboratories, the

proposed standard requires a number of

provisions to eliminate or minimize

exposure in clinical and research

laboratory settings. These provisions are

based on CDC/NIH recommendations

(Ex. 7–72) for laboratory procedures

performed under Biosafety Levels 2 and

3 for an infectious agent such as M.

tuberculosis. However, as noted in the

CDC/NIH recommendations, the

selection of a biosafety level depends on

a number of factors and it may be

necessary to adapt the biosafety level

based upon such factors. For example,

the CDC/NIH recommendations state

that:
54250 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

Occasions will arise when the laboratory

director should select a biosafety level higher

than that recommended. For example, a

higher biosafety level may be indicated by

the unique nature of the proposed activity

(e.g., the need for special containment for

experimentally generated aerosols for

inhalation studies) or by the proximity of the

laboratory to areas of special concern (e.g., a

diagnostic laboratory located near patient

care areas). Similarly, a recommended

biosafety level may be adapted to compensate

for the absence of certain recommended

safeguards. For example, in those situations

where Biosafety Level 3 is recommended,

acceptable safety may be achieved for routine

or repetitive operations (e.g., diagnostic

procedures involving the propagation of an

agent for identification, typing and

susceptibility testing) in laboratories where

facilities satisfy Biosafety Level 2

recommendations, provided the

recommended Standard Biological Practices,

Special Practices, and Safety Equipment for

Biosafety Level 3 are rigorously followed.

(Ex. 7–72, pg. 70)

OSHA agrees that it is appropriate

that such decisions be made by the

laboratory director and would allow

such adaptations to the CDC/NIH

recommendations. However, regardless

of adaptations, OSHA requires the

laboratory director to determine and

document the need for controlled

access, anterooms, sealed windows,

directional airflow, preventing

recirculation of laboratory exhaust air,

filtration of exhaust air before discharge

outside, and thimble exhaust

connections for biological safety

cabinets. These determinations, along

with any adaptations to the CDC/NIH

biosafety level, must be made a part of

the exposure control plan. The

documentation will provide information

to the laboratory employees of

adaptations to and changes in

recommended biosafety levels.

For employers who provide home

health care or home-based hospice care,

paragraph (c)(2)(v) specifies the

elements that are to be included in the

exposure control plan. In home health

care and home-based hospice care

situations, individuals are in their

private homes receiving health care and

other services and thus the employer

has limited control over the work site in

which he or she provides those services.

In addition, employers providing such

home-based care will not be transferring

individuals identified as having

suspected or confirmed infectious TB

from their homes to facilities with

isolation capabilities, nor will the

employer be initiating isolation

precautions in the home. In recognition

of the uniqueness of home-based work

settings, OSHA has limited the elements

of the exposure control plan for an

employer who provides home health

care and home-based hospice care. The

elements included under this paragraph

are intended to address the type of

activities that are likely to occur in the

home health care work setting. Under

this paragraph the employer must

include procedures for prompt

identification of individuals with

suspected or confirmed infectious TB

and for minimizing employee exposure

to such individuals. As discussed above,

in order for employees to take proper

precautions in protecting themselves

from exposure to TB, it is essential that

there be procedures to identity

potentially infectious individuals. In

many cases the home health care

employer may already know that the

individual has been identified as having

suspected or confirmed infectious TB

and has been confined to their home.

However, in other cases, an individual

may be suffering from other

immunocompromised conditions and

may develop active TB. Because

employees in home health care and

home-based hospice care may be

providing services to individuals at risk

of developing active TB, it is necessary

that there be procedures in place for

identifying those individuals. In

addition, the exposure control plan

must include procedures for minimizing

employee exposure. Such procedures

might include minimizing the time

spent in the home by combining tasks

to limit the number of entries or by

minimizing the number of employees

who must enter the home along with the

time they spend there. Paragraph

(c)(2)(v) also requires that the exposure

control plan include a list of highhazard procedures, if any, performed in

the workplace and procedures for

delaying elective high-hazard

procedures until the individual is

noninfectious. Listing the high-hazard

procedures will serve to identify those

procedures that may require special

considerations. In the home setting, this

would not include the use of AFB

isolation precautions. To the extent

possible the employer should also

include procedures for when these types

of procedures can be delayed. This will

decrease the exposure of employees to

aerosolized M. tuberculosis that might

be generated performing these

procedures.

Paragraph (c)(2)(vi) stipulates that the

employer must document the number of

confirmed infectious tuberculosis cases

encountered in the work setting in the

past 12 months in the Exposure Control

Plan whenever the employer is using

this information to claim reduced

responsibilities related to paragraph (b),

Application, and paragraph (g)(3)(iii)(D),

Medical Surveillance, of the standard.

Under paragraph (b), employers are

relieved from implementing certain

provisions of the standard if they do not

admit or provide medical services to

individuals with suspected or

confirmed infectious TB and they can

demonstrate that, in the past 2 years,

there have been no cases of confirmed

infectious TB reported in the local

county in one or both years and, if any

cases have occurred in one of the past

2 years, fewer than 6 confirmed

infectious cases were reported in that

year. Furthermore, employers desiring

to follow the limited program must

demonstrate that no such cases have

been encountered in his or her

employees’ work setting in the past 12

months. Under paragraph (g)(3)(iii)(D) of

Medical Surveillance, employees with

negative TB skin tests are to be provided

with a TB skin test every 6 months if the

employee works in an intake area where

early identification procedures are

performed in facilities where six or

more individuals with confirmed

infectious TB have been encountered in

the past 12 months. However, if the

employer can document that fewer than

6 individuals with confirmed infectious

TB have been encountered in the

facility, the employee in the intake area

would only have to be provided with a

TB skin test annually. The count of the

number of confirmed infectious TB

cases in the exposure control plan

would serve to document that fewer

than 6 individuals with confirmed

infectious TB had been encountered in

the past 12 months, thus relieving the

employer of the burden of providing

skin tests every 6 months for those

affected employees.

Paragraph (c)(2)(vii)(A) requires that a

copy of the exposure control plan be

accessible to employees. The reason for

this is to assure that an employee can

get and consult the exposure control

plan within a reasonable time, place and

manner. Having access to the plan

encourages employees to develop a

complete understanding of the plan and

its application, so that the program can

be carried out by both employer and

employees. Having the plan available

also serves as an on-site adjunct to the

overall infection control program and

may reinforce the training programs.

For fixed work sites and primary

workplace facilities, the plan must be

maintained on-site at all times. For

those situations where an employee(s)

travels between work sites or where the

employee’s work is carried out at more

than one geographical location, the plan

may be maintained at the primary

workplace facility. To ensure access, the

plan should be in a central location
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54251

where an employee may see it whenever

he or she wishes. However, in order to

allow flexibility, OSHA is not specifying

where the plan must be kept. The

employer is permitted to determine

where the plan is kept provided that the

employee can access a copy of the plan

at the workplace, within the workshift.

For example, if the plan is maintained

on a computer, access to the computer

or hard copy must be available to the

employee. Likewise, if the plan is

comprised of several separate policy

documents, copies of all documents

must be accessible in addition to any

general policy statement or guiding

document that may exist.

Paragraph (c)(2)(vii)(B) requires that

the exposure control plan be reviewed

at least annually and updated whenever

necessary to reflect new or modified

tasks, procedures, or engineering

controls that affect occupational

exposure and to include new or revised

employee positions with occupational

exposure. An example of such a

situation would be when an employer in

a facility that had previously transferred

individuals with suspected or

confirmed infectious TB decided that

such individuals would be admitted and

provided medical services. The purpose

of this requirement is to assure that all

new tasks and procedures are evaluated

in order to determine whether they

could result in occupational exposure.

New and revised job classifications

must be added to the lists of job

classifications and tasks and procedures

identified in (c)(1)(i) of this section in

order to assure full coverage of

occupationally exposed employees. The

updating must occur as soon as feasible

and may not be postponed until the

annual review.

Paragraph (c)(2)(vii)(C) requires that

the exposure control plan be made

available to the Assistant Secretary and

the Director upon request for

examination and copying. The purpose

of this requirement is to allow the

OSHA representative to review an

employer’s plan, including the exposure

determination of employees at risk for

occupational exposure. Although the

Assistant Secretary or the Director could

request the plan at any time, it will

usually be requested by an OSHA

compliance safety and health officer

(CSHO) during the course of a

workplace inspection. The CSHO needs

to examine the plan in order to see what

procedures and program planning for

the control of occupational exposures

have been instituted and whether they

meet the requirements of the standard.

Paragraph (d) Work Practices and

Engineering Controls

It is generally acknowledged that

protection of the employee is most

effectively attained by elimination or

minimization of the hazard at its source,

which engineering controls and work

practices are both designed to do.

Industrial hygiene principles also teach

that control methods that depend upon

the vagaries of human behavior are

inherently less reliable than wellmaintained mechanical methods. For

these reasons, OSHA has preferred

engineering and work practice controls

and has required, under paragraph

(d)(1), that they be used to eliminate or

minimize employee exposure to M.

tuberculosis. Nevertheless, OSHA

recognizes that situations may exist in

which neither of these control methods

is feasible and that, in these

circumstances, employee protection

must be achieved through the use of

personal protective equipment,

primarily respirators. In other

situations, personal protective

equipment may have to be utilized in

conjunction with engineering controls

and/or work practices to obtain a further

reduction in employee exposure.

Engineering controls serve to reduce

employee exposure in the workplace by

either removing the hazard or isolating

the worker from exposure. These

controls include process or equipment

redesign, process or equipment

enclosure (e.g., biosafety cabinets), and

employee isolation. In general,

engineering controls act on the source of

the hazard and eliminate or reduce

employee exposure without reliance on

the employee to take self-protective

action.

In comparison, work practice controls

reduce the likelihood of exposure

through alteration of the manner in

which a task is performed (e.g., closing

the door of an AFB isolation room

immediately upon entering or exiting).

Although work practice controls also act

on the source of the hazard, the

protection they provide is based upon

employer and employee behavior rather

than installation of a physical device. In

many instances these two control

methodologies work in tandem, because

it is often necessary to employ work

practice controls to assure effective

operation of engineering controls. Under

the provisions of the preceding

paragraph, Exposure Control Plan, the

employer is required to develop a

number of work practices relative to

controlling occupational exposure to

TB. In paragraph (d)(2), these work

practices are required to be

implemented in the work setting.

In developing the methods of

compliance section for this proposal,

OSHA carefully considered the work

environments that have the potential for

producing occupational exposures.

Since the source of the hazard is

frequently a living person, typical

methods of reducing or eliminating the

hazard at the source may not always be

feasible. For example, in an industrial

operation a process may be entirely

enclosed and operated or monitored by

an employee at a remote location, a

situation that would rarely, if ever,

occur in the work settings covered by

this standard. The Agency believes,

therefore, that prevention of exposures

to M. tuberculosis will often require use

of a combination of control methods to

achieve adequate protection of

employees. Paragraph (d)(1) requires

work practices and engineering controls

to be used to eliminate or minimize

employee exposures.

Not all facilities will have the

capabilities to admit or provide medical

services to individuals with suspected

or confirmed infectious tuberculosis.

Consequently, these facilities will have

to transfer such individuals to another

facility where isolation rooms or areas

are available. Paragraph (d)(3) requires

that individuals with suspected or

confirmed infectious TB must be

identified and, except in settings where

home health care or home-based

hospice care is provided, shall be: (i)

masked or segregated in such a manner

that contact with employees who are not

wearing respiratory protection is

eliminated or minimized until transfer

or placement in an AFB isolation room

or area can be accomplished; and (ii)

placed in an AFB isolation room or area

or transferred to a facility with AFB

isolation rooms or areas within 5 hours

from the time of identification, or

temporarily placed in AFB isolation

within 5 hours until placement or

transfer can be accomplished.

Masking or segregation of individuals

with suspected or confirmed infectious

TB while those individuals are awaiting

placement in isolation or transfer to

another facility is done to assure that

employee exposure is minimized to the

extent feasible. This provision, drawn

from CDC recommendations (Ex. 4B), is

aimed at minimizing the exposure of

employees in areas where individuals

are first identified as having suspected

or confirmed infectious TB. Although

CDC recommends masking such

individuals, OSHA presents a choice of

masking or segregation because the

Agency believes that this practice is

directly involved with the medical

management of such individuals. It is

OSHA’s mission to protect employees
54252 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

from occupational exposure to

tuberculosis and it is not the Agency’s

intent to dictate medical practice

relative to individuals with suspected or

confirmed infectious TB. Therefore,

where the employer has chosen not to

mask individuals with suspected or

confirmed infectious TB when they are

not in isolation rooms or areas or when

such individuals cannot be masked (e.g.,

because they are combative), the

employer must segregate these

individuals in a manner such that

contact with employees who are not

wearing respiratory protection is

eliminated or minimized. Segregation

could be accomplished, for example, by

having the individual wait in an area

out of the main traffic of a waiting room

or intake area or in a vacant

examination room that is not needed for

patient/client consultations. The time

that a facility can permit an individual

to await placement or transfer is limited

to 5 hours. After that the individual

must be placed in isolation.

The primary purposes of AFB

isolation rooms or areas are to (1) isolate

patients who are likely to have

infectious TB from unprotected

employees, (2) prevent escape of droplet

nuclei from the room, thus preventing

entry of M. tuberculosis into the corridor

and other areas of the facility where

unprotected employees may be exposed,

and (3) provide an environment that

will promote reduction of the

concentration of droplet nuclei through

various engineering controls (Ex. 4B).

All of these will reduce employee

exposure. Indeed, placement of

individuals with suspected or

confirmed infectious TB in an AFB

isolation room is the most effective way

to prevent or lessen transmission.

OSHA has proposed that individuals

with suspected or confirmed infectious

TB be isolated or transferred within 5

hours from the time of being identified

as a suspected or confirmed case. The

Agency realizes that the time it will take

to isolate or transfer an individual once

he or she is identified as having

suspected or confirmed infectious TB

may vary and that circumstances may

arise that cause delays in initiating

isolation (e.g., all isolation rooms may

be occupied by other patients).

However, OSHA is also concerned about

the amount of time an individual, who

has been identified as having suspected

or confirmed infectious TB, should be

permitted to stay in non-isolation areas.

Individuals who must wait for extended

periods of time before placement in AFB

isolation or transfer may present a risk

of exposure to employees working in

these areas even though these

individuals may be masked. A study by

Moran et. al. shows that emergency

departments that made a presumptive

diagnosis of TB were able to initiate

isolation in an average of 5 hours from

the time of patient registration (Ex. 7–

251). Patient registration usually

precedes identification. The standard

requires that procedures be in place for

prompt identification of individuals

with suspected or confirmed infectious

TB. In view of this requirement and the

fact that the study was based on time

elapsed from patient registration to

isolation, which included the time the

patient waited to be medically observed,

the Agency has preliminarily concluded

that five hours from the time of being

identified is a reasonable cutoff point

for transfer or placement in isolation.

The Agency’s concern regarding

permitting identified individuals to wait

for extended periods, even though they

are masked, before they are transferred

or isolated is not unfounded. The

American Thoracic Society, in its

document Control Of Tuberculosis In

The United States, states:

* * *Patients unable to cooperate in

covering coughs and sneezes can wear

ordinary surgical masks for short periods, for

example, while being transported within

institutions. For longer periods, masks on

patients are stigmatizing, uncomfortable, and

probably ineffective. (Ex. 5–80) (emphasis

added)

Consequently, a cutoff point of 5 hours

has been proposed as the maximum

amount of time individuals who have

been identified with suspected or

confirmed infectious TB may await

transfer or placement into AFB

isolation. As discussed under the

Exposure Control Plan, paragraph (c),

employers are required to have

procedures in place for isolating or

transferring individuals identified with

suspected or confirmed infectious TB so

that AFB isolation can be executed

expeditiously. Five hours would appear

to be a reasonable amount of time to

carry out these procedures. OSHA

believes that longer periods of time are

likely to pose too great a risk of

exposure to employees in the vicinity.

The longer an individual with suspected

or confirmed infectious TB remains

outside of AFB isolation, the greater the

risk of transmission.

It should be noted that the 5-hour

cutoff is the amount of time allotted per

facility to accomplish AFB isolation or

transfer of these individuals. More

specifically, if an individual spent 4

hours awaiting transfer at an identifying

facility, the receiving facility would still

be allowed 5 hours to accomplish

isolation, not just the one hour

remaining since initial identification of

the individual. The intent of the

proposed facility-based 5-hour period is

to allow the receiving facility adequate

time to accomplish isolation and to

recognize that the receiving facility

should not be held responsible for

circumstances beyond the facility’s

control (e.g., the time the individual

waited before arrival at the receiving

facility).

If placement or transfer cannot be

completed within five hours, it must be

done as soon as possible thereafter. In

addition, the employer must assure in

such a case that his or her facility has

AFB isolation rooms or areas for the

isolation of the individual until

placement or transfer can be

accomplished. More specifically, it is

not necessary to construct a dedicated

AFB isolation room or area to isolate

such individuals while awaiting transfer

or placement within the facility. The

definition of ‘‘AFB isolation room or

area’’ states that this may be a room,

area, booth, tent, or other enclosure that

is maintained at negative pressure to

adjacent areas in order to control the

spread of aerosolized M. tuberculosis.

For example, such isolation might be

achieved by placing a portable standalone HEPA filtration unit (vented to the

outside) in an unused examination

room. Another method is the use of a

rigid enclosure on casters with a

ventilation unit to achieve negative

pressure, a window kit to safely exhaust

the enclosure’s air to the outside, and a

digital pressure monitor to assure

maintenance of negative pressure within

the enclosure. As is the case with any

AFB isolation room or area, the means

used to isolate an individual awaiting

placement or transfer must achieve

negative pressure and have its air safely

discharged to the outside. OSHA seeks

comment regarding the 5-hour limit on

placement or transfer and measures that

can be used for AFB isolation in those

situations when transfer or placement

cannot be accomplished within that

time.

Paragraph (d)(4) stipulates that highhazard procedures must be conducted

in AFB isolation rooms or areas. Highhazard procedures as defined in

paragraph (b), Definitions, are

procedures performed on an individual

with suspected or confirmed infectious

TB in which the probability of M.

tuberculosis being expelled into the air

is increased. These procedures include,

but are not limited to, endotracheal

intubation and suctioning, diagnostic

sputum induction, aerosol treatments

(including pentamidine therapy),

pulmonary function testing, and

bronchoscopy. These procedures also

include autopsy, clinical, surgical, and

laboratory procedures that may
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54253

aerosolize M. tuberculosis. In view of

the increased probability of droplet

nuclei generation associated with these

procedures, all high-hazard procedures

are required to be performed in rooms,

areas, or booths that meet AFB isolation

criteria (e.g., negative pressure) in order

to contain the droplet nuclei and

eliminate or minimize employee

exposure. Other procedures that may

generate aerosols (e.g., irrigation of

tuberculous abscesses, homogenizing or

lyophilizing infectious tissue), are also

covered by this provision. (See

paragraph (e) of this proposal for

requirements for microbiological

practices and containment equipment in

laboratories.)

Paragraph (d)(5) requires that

engineering controls be used in facilities

that admit or provide medical services

or AFB isolation to individuals with

suspected or confirmed infectious TB

except in settings where home health

care or home-based hospice care is

being provided. For example,

engineering controls must be used in

isolation rooms or areas, areas where

high hazard procedures are performed,

and autopsy rooms where M.

tuberculosis may be aerosolized. This

provision specifically excepts settings

where home health care or home-based

hospice care is being provided. In such

situations, the employer is not in

control of the employee’s work setting

because the setting is the private home

of the individual being provided with

care. In view of this, an employer

providing home health care or homebased hospice care would not be

required to implement engineering

controls in the individual’s home.

In conjunction with this provision,

paragraph (d)(5)(i) requires that negative

pressure be maintained in AFB isolation

rooms or areas. The purpose of this

provision is to prevent the escape of

aerosolized M. tuberculosis from a room

and into the corridors and other areas of

the facility where unprotected

employees may be exposed. In order for

air to flow from one area to another,

there must be a difference in the

pressure between the two areas. Air will

flow from the higher pressure to the

lower pressure area. The lower pressure

area is at ‘‘negative pressure’’ relative to

the higher pressure area. The level of

negative pressure achieved will depend

on the physical configuration of the

area, including the air flow path and

flow openings. A pressure differential of

0.001 inch of water and an inward air

velocity of 100 feet per minute (fpm) are

minimum acceptable levels. The

pressure difference necessary to achieve

and maintain negative pressure in a

room is very small and may be difficult

to measure accurately. Negative

pressure can be achieved by balancing

the room supply and exhaust flows to

set the exhaust flow to a value of 10%

[but no less than 50 cubic feet per

minute (cfm)] greater than the supply

(Ex. 4B).

As stated above, the negative pressure

principle plays an important role in

controlling the spread of M. tuberculosis

to other areas of the facility where

unprotected workers may be exposed. In

isolation rooms and areas, and in areas

where high hazard procedures

(including autopsies) are performed,

engineering controls creating negative

pressure will prevent the escape of

droplet nuclei from the room, thus

preventing dispersion of M. tuberculosis

into the corridor and other areas of the

facility where unprotected employees

may be working.

In addition, negative pressure fulfills

the secondary purpose of general

ventilation by reducing the

concentration of contaminants in the

air. General ventilation maintains air

quality by two processes, dilution and

removal of airborne contaminants.

Dilution reduces the concentration of

contaminants in a room by supplying air

that does not contain those

contaminants. The supply air mixes

with and then displaces some of the

contaminated room air, which is

subsequently removed from the room by

the exhaust system. This process

reduces the concentration of droplet

nuclei in the room air and the risk of TB

transmission.

OSHA is not proposing to allow the

use of ultraviolet germicidal irradiation

(UVGI) in place of ventilation for

controlling aerosolized M. tuberculosis.

Although the germicidal properties of

certain wavelengths of ultraviolet light

(UV–C) are generally recognized, the

Agency has not included UVGI as a

primary engineering control in the

proposed standard. With regard to the

use of UVGI, CDC states:

Because the clinical effectiveness of UV

systems varies, and because of the risk for

transmission of M. tuberculosis if a system

malfunctions or is maintained improperly,

UVGI is not recommended for the following

specific applications: 1. Duct systems using

UVGI are not recommended as a substitute

for HEPA filters if air from isolation rooms

must be recirculated to other areas of a

facility. 2. UVGI alone is not recommended

as a substitute for HEPA filtration or local

exhaust of air to the outside from booths,

tents, or hoods used for cough-inducing

procedures. 3. UVGI is not a substitute for

negative pressure. (Ex. 4B)

The CDC goes on to discuss a number

of factors that affect the effectiveness of

UVGI and UV lamps in killing airborne

tubercle bacilli. These factors include

the intensity of UVGI, the duration of

irradiation of the organism, the relative

humidity of the environment, the age of

the UV lamp, and the amount of dust on

the lamp’s surface (Ex. 4B). In light of

this information, the Agency does not

believe that UVGI can reliably and

uniformly control airborne tubercle

bacilli. Consequently, UVGI is not

acceptable as a primary engineering

control. However, some employers may

choose to use UVGI as a supplement to

ventilation or HEPA filtration. In

recognition of this, OSHA has included

information regarding UVGI safety and

health concerns in Appendix D of this

section.

Paragraph (d)(5)(ii) requires that in

those areas where negative pressure is

required (i.e., AFB isolation rooms or

areas), maintenance of negative pressure

must be qualitatively demonstrated (e.g.,

by smoke trails) daily while in use for

tuberculosis isolation. In Supplement 3

of its 1994 guidelines, CDC states:

TB isolation rooms should be checked

daily for negative pressure while being used

for TB isolation. (Ex. 4B)

The principle and advantages of

negative pressure have been discussed

above. Proper maintenance of negative

pressure will prevent the contaminated

air from escaping from the room or area

and exposing unprotected employees.

One means of qualitatively

demonstrating negative pressure is

through the use of smoke trail testing

(see Appendix G of this section). Other

methods include flutter strips or

continuous monitoring devices. With

regard to the safety and effectiveness of

these methods, the CDC states:

The concern over the use of smoke tubes

is unfounded. Controlled tests by NIOSH

have shown that the quantity of smoke that

is released is so minute that it is not

measurable in the air. The location of the

patient and the length of time the patient is

exposed dilute the smoke to several orders of

magnitude below an 8-hour exposure limit. It

is not practical and often not effective to use

flutter strips or continuous monitoring

devices as alternatives to indicate directional

air movement. The air flow (due usually to

the small clearance area under the door) is

insufficient to move the flutter strip.

Likewise, low negative pressure, which will

satisfactorily provide adequate directional air

flow into the isolation room, may not be

readable on continuous monitoring devices.

Devices must be capable of reading 0.001

inch of water, the established minimum, to

be effective. (Ex. 4B)

In light of this information, employers

should be aware that when choosing a

method other than smoke trails to

demonstrate maintenance of negative

pressure, the method chosen should be
54254 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

reviewed carefully in order to assure

that the intended test can be effectively

conducted.

Paragraph (d)(5)(iii) stipulates that

engineering controls must be

maintained, and inspected and

performance monitored for filter loading

and leakage every six months, whenever

filters are changed, and more often if

necessary to maintain effectiveness. The

primary intent of this provision is to

assure that engineering controls are

maintained in such a manner that they

continue to function effectively. As

discussed previously, a number of

factors can affect the functioning of

engineering controls, such as frozen

bearings, broken belts, and burned out

motors. It is the employer’s

responsibility to maintain engineering

controls in proper working condition.

That is, if a belt breaks on a fan motor,

it is not appropriate to delay repairs

until the six-month inspection. This

provision does, however, stipulate a

maximum time period of six months

between inspections and performance

monitoring of engineering controls and

HEPA filters in air systems carrying air

that may reasonably be anticipated to

contain aerosolized M. tuberculosis. The

employer’s maintenance schedule may

specify more frequent inspection,

maintenance, and performance

monitoring based upon conditions

found in that particular work site. For

example, the employer, being more

familiar with his or her own work

setting, may have knowledge that the

work environment is very dusty, thus

necessitating a more frequent period for

changing the filters. When filters are

changed, performance monitoring must

be conducted to assure that the filter has

been correctly installed and is

functioning properly. In view of the

importance of these systems in reducing

the concentration of droplet nuclei and

thereby the risk of TB transmission,

OSHA believes that six months is the

longest period that these systems should

be allowed to operate without

inspection and performance monitoring.

This maximum six-month period of

time between consecutive inspections

and performance monitoring of HEPA

filters is supported by CDC (Ex. 4B).

Paragraph (d)(5)(iv) requires that air

from AFB isolation rooms or areas must

be exhausted directly outside, away

from intake vents and employees. If the

air from these areas cannot be exhausted

in such a manner or must be

recirculated, it must pass through HEPA

filters before discharge or recirculation.

In order for the air to be safely

discharged, exhaust ducts must not be

located near areas that may be

populated (e.g., sidewalks or windows

that may be opened). In addition,

ventilation system exhaust discharges

must be designed to prevent re-entry of

exhaust air. Wind blowing over a

building creates a highly turbulent

recirculation zone, which can cause reentry of the exhaust into the building.

Exhaust flow needs to be discharged

above the zone. When exhaust air

cannot be safely discharged, it must

pass through HEPA filters to remove

droplet nuclei, thereby precluding reentry of potentially contaminated air or

exposure of individuals who may have

to pass through the exhaust airstream.

The employer should be aware that

exhausting of this air may also fall

under federal, state and local

regulations concerning environmental

discharges.

This provision also states that if a

portion of this air is recirculated, it must

pass through a properly designed,

installed, and maintained HEPA filter

before discharge back into general

facility ventilation. HEPA filters clean

air through the physical removal of

particulates from the airstream. These

filters have a minimum removal

efficiency of 99.97% for particles ≥ 0.3

microns in diameter. Droplet nuclei of

M. tuberculosis range in size from 1

micron to 5 microns in diameter.

Therefore, HEPA filtration can be

expected to remove most droplet nuclei

from the air. It should be noted that

whenever feasible, exhaust air from the

AFB isolation rooms or areas must be

exhausted to the outside. In its 1994

guidelines, CDC states:

Air from TB isolation rooms and treatment

rooms used to treat patients who have

confirmed or suspected infectious TB should

be exhausted to the outside in accordance

with applicable Federal, state, and local

regulations. The air should not be

recirculated into the general ventilation. In

some instances, recirculation of air into the

general ventilation system from such rooms

is unavoidable (i.e., in existing facilities in

which the ventilation system or facility

configuration makes venting the exhaust to

the outside impossible). In such cases, HEPA

filters should be installed on the exhaust

duct leading from the room to the general

ventilation system to remove infectious

organisms and particulates the size of droplet

nuclei from the air before it is returned to the

general ventilation system (Section II.F;

Suppl. 3). Air from TB isolation rooms and

treatment rooms in new or renovated

facilities should not be recirculated into the

general ventilation system. (Ex. 4B)

The Agency agrees with CDC that

exhaust air should be vented to the

outside. However, OSHA recognizes

that there may be instances where

outside discharge may not be feasible

and has, therefore, permitted

recirculation with HEPA filtration of the

recirculated air, in such instances.

Paragraph (d)(5)(v) states that ducts

carrying air that may reasonably be

anticipated to contain aerosolized M.

tuberculosis must be maintained under

negative pressure for their entire length

before in-duct HEPA filtration or until

the ducts exit the building for discharge.

Ducts maintained under negative

pressure will contain exhaust air within

the system. Air will not escape to the

outside as it would under positive

pressure even if there are leaks in the

ducts. The purpose of this provision is

to prevent escape of air that may contain

aerosolized M. tuberculosis into areas

where occupational exposure is not

anticipated and unprotected employees

may be exposed.

Paragraph (d)(5)(vi) requires that,

while in use for TB isolation, doors and

windows of AFB isolation rooms or

areas must be kept closed except when

doors are opened for the purpose of

entering or exiting and when windows

are part of the ventilation system being

used to achieve negative pressure. For

example, the window may be serving as

the exit for the exhaust from an in-room

HEPA filtration unit. As stated above,

AFB isolation rooms and areas are to be

maintained under negative pressure

while in use for TB isolation. Negative

pressure in a room can be altered by

small changes in the ventilation system

operation, or by the opening and closing

of the isolation room doors or windows.

In order to assure that the ventilation

system functions as intended, it is

essential that, once an operating

configuration has been established,

doors and windows be opened only

when necessary.

Paragraph (d)(5)(vii) stipulates that

when an AFB isolation room or area is

vacated by an individual with suspected

or confirmed infectious TB, the room or

area must be ventilated for an

appropriate period of time, according to

current CDC recommendations for a

removal efficiency of 99.9%, before

permitting employees to enter without

respiratory protection (see Appendix C

of this section). The time required for

removing airborne particles from an

enclosed space depends on several

factors. These include the number of air

changes per hour (which is determined,

in part, by the number of cubic feet of

air in the room or booth), the rate at

which air is entering the room or booth

at the intake source versus the rate at

which it is being exhausted, the location

of the ventilation inlet and outlet, and

the physical configuration of the room

or booth. The times needed to achieve

a given removal efficiency (i.e., 90%,

99%, and 99.9%) presented in
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54255

Appendix C of this section assume

perfect air mixing within a space.

However, perfect mixing of air normally

does not occur because a number of

factors, such as room configuration, may

influence the movement of air. Because

perfect air mixing is not likely to occur,

the necessary time required for a

specific removal efficiency, as presented

in Appendix C of this section, may be

underestimated. In order to compensate

for this shortcoming, OSHA has

proposed that the most conservative

(i.e., protective) removal efficiency, i.e.,

99.9%, be used to determine the

appropriate amount of time an AFB

isolation room or area must be

ventilated before permitting employees

to enter without respiratory protection.

Using this conservative approach will

help to assure that an appropriate time

has passed before unprotected

employees enter the area, even in

situations where perfect air mixing has

not occurred. Ventilation of the room

would not be necessary if the room was

previously occupied by an individual

with suspected infectious tuberculosis

and that individual was medically

determined to be noninfectious, since

there would be no droplet nuclei

present.

Paragraph (d)(6) requires that the

employer must inform any outside

contractor who provides temporary or

contract employees who may incur

occupational exposure of the hazard, so

that the contractor can institute

precautions to protect his or her

employees. OSHA is concerned that the

contractor be aware of the existence of

TB hazards so that appropriate actions

can be undertaken to prevent the

contractor’s employees from being

unwittingly exposed. By conveying such

information to the contractor,

accountability for these employees is

established. If the contractor is aware of

the hazards, then it is the responsibility

of the contractor to institute procedures

to protect his or her employees from

occupational exposure to M.

tuberculosis.

Paragraph (e) Clinical and Research

Laboratories

This paragraph addresses

requirements that must be met by

clinical and research laboratories

engaged in the culture, production,

concentration, experimentation, and

manipulation of M. tuberculosis. These

requirements apply in addition to the

other requirements of the standard.

The risks associated with direct and

routine work with pathogens have long

been recognized:

Microbiology laboratories are special, often

unique, work environments that may pose

special infectious disease risks to persons in

or near them. Personnel have contracted

infections in the laboratory throughout the

history of microbiology. (Ex. 7–72)

Clinical and research laboratories

working with M. tuberculosis are no

exception, and the risks associated with

work in such facilities warrant

additional protective measures.

Prior to 1984, no single code of

practice, standards, guidelines or other

publication providing detailed

descriptions of techniques or equipment

for laboratory activities involving

pathogens was available. In that year,

the CDC and the National Institutes of

Health (NIH) published guidelines

entitled ‘‘Biosafety in Microbiological

and Biomedical Laboratories’’. These

biosafety guidelines were based on

combinations of standard and special

practices, equipment, and facilities

recommended for use when working

with various infectious agents in

laboratory settings. The most current

revision of these guidelines is dated

1993. (Ex. 7–72)

The biosafety guidelines are not

limited to M. tuberculosis, which is the

subject of this standard. They are

applicable to work with any infectious

agent. The basic format for the biosafety

guidelines categorizes infectious agents

and laboratory activities into four

classes or levels denoted as Biosafety

Levels 1 through 4. These biosafety

levels (BSL) are comprised of

combinations of laboratory practices

and techniques, safety equipment, and

laboratory facilities appropriate for the

operations performed and the hazard

posed. The Guidelines indicate the BSL

to be used when working with various

infectious agents and infected animals.

There is a risk to employees working

with materials containing M.

tuberculosis. When the concentration of

this bacterium is increased as the result

of growing it in cell culture or through

artificial concentration, then the risk of

transmission to employees increases if

the bacteria are not contained.

Therefore, the proposed standard

requires the employer to implement a

number of provisions specifically

related to these laboratory work settings.

The requirements in paragraph (e),

including those regarding biosafety

cabinets, are derived primarily from the

CDC/NIH recommendations found in

‘‘Biosafety in Microbiological and

Biomedical Laboratories’’ (Ex. 7–72).

Only those provisions that relate to the

health and safety of employees are

required by the standard. The

provisions in paragraph (e) are a

minimal program, and OSHA

anticipates that employers affected by

this paragraph will continue to follow

any other appropriate portions of the

above recommendations in addition to

the requirements of this standard. In

addition, the employer is responsible for

following this entire standard (e.g.

training employees, medical

surveillance).

Paragraph (e) applies to two types of

facilities that OSHA has designated as

‘‘clinical laboratories’’ and ‘‘research

laboratories.’’ For the purpose of this

standard a clinical laboratory is a

laboratory or area of a facility that

conducts routine and repetitive

operations for the diagnosis of TB, such

as preparing acid-fast smears and

culturing sputa or other clinical

specimens for identification, typing or

susceptibility testing. A research

laboratory is a laboratory that

propagates and manipulates cultures of

M. tuberculosis in large volumes or high

concentrations that exceed those used

for the identification and typing

activities common to clinical

laboratories.

The proposed standard requires, in

paragraphs (e)(2)(i)(A) through (D), that

both clinical and research laboratories

follow several standard microbiological

practices. All procedures are to be

performed in a manner that minimizes

the creation of aerosols. In view of the

mode of transmission of M. tuberculosis,

that is, through inhalation of airborne

organisms, this provision is extremely

important in eliminating or minimizing

employee exposure. It is the

responsibility of the employer to

evaluate laboratory tasks and institute

the measures necessary to minimize the

creation of aerosols.

OSHA also proposes to adopt the

good laboratory and infection control

practice of prohibiting pipetting or

suctioning by mouth. The use of cotton

plugs or other barriers does little to

reduce the hazards of mouth pipetting.

Even a technician who is skilled in

mouth pipetting may inadvertently suck

fluids containing M. tuberculosis into

the mouth. In addition to producing M.

tuberculosis-containing aerosols when

the fluid is expelled, these fluids may

also contain bloodborne pathogens that

would have contacted the employee’s

mucous membranes (i.e., the mouth) as

well as any blisters, cuts, or other

lesions in the mouth or on the lips.

Work surfaces and laboratory

equipment must be decontaminated at

the end of each shift and after any spill

of viable material. This is recognized as

good laboratory practice in minimizing

the spread of contamination.

Finally, the proposed standard

requires that all cultures, stocks, and

other wastes contaminated with M.

tuberculosis be decontaminated before
54256 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

disposal by a decontamination method,

such as autoclaving, known to

effectively destroy M. tuberculosis.

Materials to be decontaminated outside

of the immediate laboratory are to be

placed in a durable leakproof container,

closed to prevent leakage for transport

from the laboratory, and labeled or color

coded in accordance with paragraph

(h)(1)(ii) of this section.

Decontamination before disposal helps

assure that other employees are not

inadvertently exposed to the bacterium.

Although the proposed standard

requires proper containerization of

laboratory wastes, it includes no such

requirement for wastes originating from

the provision of care or services to

individuals with suspected or

confirmed infectious TB (e.g., facial

tissues that the individual has used).

The reason for this is that items, such

as facial tissues, capture and contain the

liquids generated by the individual.

Once captured, the liquid is not readily

aerosolized. In their guidelines, the CDC

states:

Disposable items contaminated with

respiratory secretions are not associated with

transmission of M. tuberculosis. (Ex. 4B)

In the laboratory, however, the liquids

containing M. tuberculosis are generally

not captured or contained on an item

but exist as an individual specimen or

culture. Also, in some instances, the

bacilli have been concentrated. The

possibility, therefore, for formation of

droplet nuclei from these wastes is

increased. Consequently, it is necessary

to properly containerize and label

laboratory wastes to assist in preventing

droplet nuclei formation and possible

infection. Proper containerization and

labeling of wastes to be decontaminated

outside a laboratory not only help

prevent employee exposure but also

warn employees who come in contact

with this waste of the hazard within the

container.

Paragraphs (e)(2)(ii)(A) through (E)

describe special practices to be followed

in clinical and research laboratories,

such as limiting access to the laboratory

to authorized personnel, preparing and

maintaining a biosafety manual,

properly containerizing materials

contaminated with M. tuberculosis,

immediately containerizing and

cleaning up all spills potentially

contaminated with M. tuberculosis, and

posting a sign with the universal

biohazard symbol on access doors when

materials containing or animals infected

with M. tuberculosis are present.

Limiting access to these laboratories

assures that unauthorized individuals

are not placed at risk, and that they do

not distract or otherwise interfere with

the activity of the authorized

employees. This provision works in

concert with the requirement for signs

in paragraph (h)(2)(iv) and ensures that

only employees who meet the special

requirements set forth by the laboratory

director, which will include training,

personal protective equipment, and

other requirements, could enter the area.

The requirement for a biosafety

manual helps assure that any additional

procedures are developed to address

situations that are unique to a particular

facility and to provide appropriate

protection to exposed employees. The

manual must be reviewed as necessary

and at least annually. The manual must

also be updated as necessary to reflect

changes in the work setting. The phrase

‘‘as necessary’’ has been used to indicate

that updating of the manual to reflect

work setting changes is to be done as

soon as possible and is not to be

postponed until the annual review.

Employees are required to read the

biosafety manual’s sections on potential

hazards and practices and procedures.

The requirement that contaminated

material removed from the work area be

placed in a container that prevents

leakage during collection, handling,

processing, storage, transport, or

shipping is to assure that there are no

accidental spills or other contamination

that may place other employees at risk.

Paragraph (e)(2)(ii)(D) requires that

spills be cleaned up immediately by

employees trained and equipped to

work with potentially concentrated M.

tuberculosis. Because M. tuberculosis

can become aerosolized during cleanup

procedures, the task cannot be done by

someone who is not skilled and

properly equipped. In addition,

exposure incidents must be reported so

that the post-exposure management and

follow-up required by paragraph (g) can

be initiated and the circumstances

surrounding the exposure incidents can

be investigated.

Paragraph (e)(2)(ii)(E) requires that,

when materials or animals infected with

M. tuberculosis are present in the

laboratory, a hazard warning sign, in

accordance with paragraph (h)(2)(iv) of

Communication of Hazards and

Training, incorporating the universal

biohazard symbol, shall be posted on all

laboratory and animal room access

doors. Because M. tuberculosis is

present in the materials listed above, it

is necessary to warn individuals who

may enter this area of the hazards that

are present so that they can take proper

precautions to guard themselves against

exposure.

The requirements of paragraph

(e)(2)(iii)(A) stipulate that whenever

activities with the potential for

generating aerosols of M. tuberculosis

are conducted, and whenever high

concentrations or volumes of M.

tuberculosis are used, a certified Class 2

biological safety cabinet must be used.

Such materials may be centrifuged in

the open laboratory, i.e., outside of a

biosafety cabinet, if sealed rotor heads

or centrifuge safety cups are used. These

requirements protect employees from

exposure during the performance of

procedures by assuring that aerosolized

M. tuberculosis will be contained and

kept away from the worker’s breathing

zone.

Paragraph (e)(2)(iii)(B) requires that

biological safety cabinets shall be

certified when they are installed,

annually thereafter, whenever they are

moved, and whenever filters are

changed. Biological safety cabinets must

be certified to ensure that they will

provide the proper protection. The

National Sanitation Foundation (NSF)

Standard 49 describes design,

construction, and performance criteria

for biosafety cabinets. (Ex. 7–135)

Moreover, this NSF standard is subject

to periodic review by the NSF in order

to keep the requirements consistent

with new technology. OSHA has

incorporated the current NSF Standard

49 performance criteria into the OSHA

standard. For example, Standard 49

states:

* * * that each cabinet be tested and

performance evaluated on site, assuring that

all physical containment criteria are met at

the time of installation, prior to use, and

periodically thereafter. (Ex. 7–135)

NSF Standard 49 also calls for

recertification of cabinets at least

annually, when HEPA filters are

changed, and after maintenance repairs

or relocation of a cabinet. Therefore,

OSHA believes that the requirements in

the proposed standard are appropriate

and that cabinets that are certified by

the manufacturer as Class 2 or 3 will

provide adequate protection to

employees.

Paragraph (e)(2)(iv) requires that a

method for decontamination of wastes

contaminated with M. tuberculosis (e.g.,

autoclave, chemical disinfection,

incinerator, or other approved

decontamination system known to

effectively destroy M. tuberculosis) must

be available within or as near as feasible

to the work area. The availability of

such methods of decontamination is

required for inactivating or destroying

M. tuberculosis in or on a variety of

media, including culture fluids, plastic

ware, and equipment. These materials

must be decontaminated to prevent

potential aerosolization of M.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54257

tuberculosis and inadvertent exposure

of employees outside of the laboratory.

Research laboratories working with M.

tuberculosis are held to several

additional requirements. Paragraph

(e)(3)(i)(A) requires that research

facilities keep laboratory doors closed

when working with M. tuberculosis.

Paragraph (e)(3)(i)(B) requires that

access to the work area be limited to

persons who comply with specified

entry and exit requirements. These

provisions are adopted from the CDC/

NIH recommendations for ‘‘Biosafety in

Microbiological and Biomedical

Laboratories’’ (Ex. 7–72). In addition,

paragraph (e)(3)(i)(C) requires that

respiratory protection shall be worn in

research laboratories when aerosols

cannot be safely contained (e.g., when

aerosols are generated outside a

biological safety cabinet). As stated

previously, research laboratories are

working with larger volumes and higher

concentrations of M. tuberculosis than

clinical laboratories. As such, the risk to

employees from aerosolized bacilli is

increased, necessitating that these

employees be protected whenever

lapses in containment occur. An

example of when aerosols would be

generated would be when a flask

containing M. tuberculosis is dropped

and broken outside of the biosafety

cabinet. Another example would be

centrifugation of M. tuberculosiscontaining cultures in an open

centrifuge without aerosol-proof

centrifuge safety containers, or utilizing

such containers but then opening them

outside of the biosafety cabinet (Ex. 7–

134).

Paragraph (e)(3)(ii) requires employers

to ensure that employees manipulating

cultures and clinical or environmental

materials that may generate M.

tuberculosis-containing aerosols,

challenging animals with M.

tuberculosis aerosols, harvesting tissues

or fluids from infected animals, or

performing necropsies on infected

animals use the appropriate

containment equipment and/or devices

when performing these activities. Such

equipment and devices include Class 2

or 3 biosafety cabinets, or appropriate

combinations of personal protective

equipment and physical containment

devices (such as respirators, centrifuge

safety cups, sealed centrifuge rotors, and

containment caging for animals). This

requirement, like the others in this

paragraph, is intended to ensure that

employees are protected during the

performance of these potentially highhazard procedures.

Research laboratories are also held to

additional requirements with regard to

facility construction. Paragraph

(e)(3)(iii)(A) requires that the laboratory

be separated from areas that are open to

unrestricted traffic flow within the

building. Passage through two sets of

self-closing doors is the requirement for

entry into the work area from access

corridors or other contiguous areas. This

type of entrance reduces the likelihood

of untrained employees accidentally

entering the work area, since such entry

necessitates deliberate action on the part

of the individual.

Paragraph (e)(3)(iii)(B) requires that

windows in the laboratory be closed and

sealed. This helps assure containment of

any aerosols and helps maintain proper

operation of biosafety cabinets through

minimization of cross drafts.

Paragraph (e)(3)(iii)(C) requires that a

ducted exhaust air ventilation system

shall be provided which creates

directional airflow that draws air from

clean areas into the laboratory toward

contaminated areas. The proper

direction of the airflow shall be verified

(i.e., into the work area) by the employer

at least every six months. The exhaust

air shall not be recirculated to any other

area of the building, shall be discharged

to the outside, and shall be dispersed

away from occupied areas and air

intakes. The requirement that research

laboratories have verified directional

airflow into the work area is to assure

that air is drawn into the laboratory

toward contaminated areas to assist in

maintaining containment of aerosols

within the laboratory.

Paragraph (e)(3)(iii)(D) requires that

the HEPA-filtered exhaust from Class 2

or 3 biosafety cabinets is to be

discharged to the outside of the building

or through the building exhaust system.

If it is discharged through the building

exhaust system, it must be connected to

this system in a manner that avoids any

interference with the air balance of the

cabinets or the building exhaust system.

This is required to assure that biosafety

cabinets and the building exhaust

system continue to function as

intended.

Paragraph (e)(3)(iii)(E) requires that

continuous flow centrifuges or other

equipment that may produce aerosols

must be contained in devices that

exhaust air through a HEPA filter before

discharge into the laboratory. This

assures that any aerosols which may

contain M. tuberculosis are effectively

filtered from the exhaust air before

discharge into the laboratory, thereby

protecting employees against

inadvertent exposure.

All of the requirements discussed

above were derived directly from the

CDC/NIH’s ‘‘Biosafety in

Microbiological and Biomedical

Laboratories.’’ OSHA requests comment

on the applicability and OSHA’s

application of CDC/NIH’s guidelines for

their use in laboratories which handle

M. tuberculosis.

Paragraph (f) Respiratory Protection

Respirators serve as supplemental

protection to reduce employee

exposures when engineering and work

practice controls are not sufficient to

provide adequate protection against

airborne contaminants.

At the opening of the public hearings

for the revision of OSHA’s General

Industry Respiratory Standard, 29 CFR

1910.134, the Agency stated that all

aspects of respirator use for protection

against tuberculosis would be addressed

in the rulemaking for Occupational

Exposure to Tuberculosis.

Consequently, the respiratory protection

portion of this proposal contains all of

the respiratory protection provisions

that have been preliminarily determined

to be applicable to respirator use for TB.

In the past, OSHA standards have

referred to the Respirator Standard (29

CFR 1910.134) for the general

requirements for respirator use (e.g.,

written respiratory protection program;

respirator maintenance) and have

included only the respirator provisions

specific to the hazard addressed by the

standard. OSHA’s approach in this

proposal, however, is to include

provisions relative to all aspects of

respirator use for tuberculosis. This will

provide interested parties with the

opportunity to review and comment on

these aspects. To assure consistency

across OSHA respiratory protection

standards, however, OSHA is

considering including in the final TB

rule cross-referencing to the general

requirements of the Respiratory

Protection Standard (29 CFR 1910.134)

and retaining in the final TB rule only

those provisions specific to respirator

use for TB. OSHA seeks comment on

this intended approach in the final

standard for TB.

Paragraph (f)(1)(i) states that each

employer must provide a respirator to

each employee who: (A) enters an AFB

isolation room or area in use for TB

isolation; (B) is present during

performance of procedures or services

for an individual with suspected or

confirmed infectious TB who is not

masked; (C) transports an individual

with suspected or confirmed infectious

TB in an enclosed vehicle or who

transports an individual with suspected

or confirmed infectious TB within the

facility whenever that individual is not

masked; (D) repairs, replaces, or

maintains air systems or equipment that

may reasonably be anticipated to

contain aerosolized M. tuberculosis; (E)
54258 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

is working in an area where an

unmasked individual with suspected or

confirmed infectious TB has been

segregated or otherwise confined (e.g.,

while awaiting transfer), and (F) is

working in a residence where an

individual with suspected or confirmed

infectious TB is known to be present. In

addition, paragraph (f)(1)(ii) requires

that each employer who operates a

research laboratory provide a respirator

to each employee who is present when

aerosols of M. tuberculosis cannot be

safely contained.

In discussing the use of respiratory

protection in their guidelines, CDC

states:

Personal respiratory protection should be

used by (a) persons entering rooms where

patients with known or suspected infectious

TB are being isolated, (b) persons present

during cough-inducing or aerosol-generating

procedures performed on such patients, and

(c) persons in other settings where

administrative and engineering controls are

not likely to protect them from inhaling

infectious airborne droplet nuclei. These

other settings include transporting patients

who may have infectious TB in emergency

transport vehicles and providing urgent

surgical or dental care to patients who may

have infectious TB before a determination

has been made that the patient is

noninfectious. (Ex. 4B)

The guidelines also state that respiratory

protection should be worn by personnel

who are performing maintenance and

testing procedures on HEPA filtration

systems (Ex. 4B). Furthermore, the CDC/

NIH document ‘‘Biosafety in

Microbiological and Biomedical

Laboratories’’ recommends that

respiratory protection be worn

whenever aerosols of organisms such as

M. tuberculosis cannot be safely

contained (Ex. 7–72). Consequently,

employees who may need to wear

respirators could include not only

health care providers but also

employees such as housekeepers,

dietary personnel, laboratory

technicians, employees in intake areas,

maintenance personnel, social workers,

and so forth. It is the employer’s

responsibility to determine which

occupationally exposed employees

would be covered under this provision

and, therefore, would need to wear a

respirator.

With regard to utilization of

respiratory protection when entering an

AFB isolation room or area, the reader

is referred to the definition of ‘‘AFB

isolation room or area’’ in paragraph (j),

Definitions. This definition clarifies that

the requirement refers not only to

situations such as entering a patient

room occupied by an individual with

suspected or confirmed infectious TB

but also refers to entering any area

where high-hazard procedures are being

performed and entering an autopsy

room where M. tuberculosis may be

aerosolized.

Paragraph (f)(1)(i)(B) requires

respirator use when an employee is

present during performance of

procedures or services for an unmasked

individual with suspected or confirmed

infectious TB. This provision is

intended to cover those situations in

which a procedure or service is

performed outside of an AFB isolation

room or area. For example, a facility

may not have a portable X-ray and may,

therefore, perform this procedure in a

standard X-ray room. If the individual is

not masked in such a situation, all

employees present (i.e., the X-ray

technician and any other employees in

the room) must utilize respiratory

protection.

As stated previously under discussion

of Scope, employees rendering

emergency medical services may spend

time in very close proximity to

individuals with suspected or

confirmed infectious TB within an

enclosed vehicle. Even though the

individual may be masked, droplet

nuclei that escape capture in the mask

are contained within the vehicle,

thereby increasing the likelihood that

employees will breathe droplet nuclei

generated when the patient coughs or

speaks. In addition, under paragraph

(f)(1)(i)(D), employees who repair,

replace, on maintain air systems or

equipment that may reasonably be

anticipated to contain aerosolized M.

tuberculosis are at risk of occupational

exposure as a result of exposure to air

that could contain aerosolized bacilli.

Therefore, respirator use would be

required in this situation.

As discussed under Scope,

aerosolized M. tuberculosis is a

recognized hazard to laboratory

personnel. When aerosols of M.

tuberculosis cannot be safely contained,

such as during a spill, the employer is

required to provide a respirator to each

employee who is present during this

time. This is consistent with CDC/NIH

recommendations regarding respirator

use in research laboratories (Ex. 7–72).

Unlike some other airborne

contaminants, the quantity of M.

tuberculosis that, when inhaled, will

result in infection (i.e., infectious dose)

has not been determined conclusively.

The number of droplet nuclei expelled

into a room by an infectious individual

or aerosol-producing procedure and the

concentration of droplet nuclei in a

room or area are unknown.

Consequently, there is no basis to judge

the effectiveness of other control

measures present even though they may

be operating as intended. OSHA

therefore agrees with the CDC that, in

the above situations, other controls that

may be in place cannot be assumed to

adequately protect employees against

exposure to airborne TB droplet nuclei

and therefore that the use of respiratory

protection is necessary.

While OSHA agrees with and has

adopted most of the CDC’s

recommendations regarding when

respiratory protection is necessary, the

Agency has extended respirator use to

two additional situations. More

specifically, when an individual with

suspected or confirmed infectious TB is

not masked and is transported within a

facility, the employee transporting the

individual must wear a respirator.

While CDC recommends masking

individuals with suspected or

confirmed infectious TB prior to

transporting them, there may be special

circumstances in which the individual

may not be masked (e.g., individual is

combative and will not wear a mask).

The employee transporting the

individual would most likely spend an

extended period of time in close

proximity to the individual, either

walking beside or behind (e.g., pushing

a wheelchair) the individual. The

employee would, therefore, be walking

directly through the airspace into which

the individual would be expelling

droplet nuclei, receiving exposure each

time the individual coughed, resulting

in multiple relatively concentrated

exposures. In view of this, the latter

portion of paragraph (f)(1)(i)(C)

addresses the Agency’s belief that it is

necessary and justified that respiratory

protection be worn by the employee to

protect against occupational exposure if

the individual is not masked.

The second situation, under

paragraph (f)(1)(i)(E), requires respirator

use by an employee when working in an

area where an unmasked individual

with suspected or confirmed infectious

TB has been segregated or otherwise

confined, for example while awaiting

transfer. As discussed above, it is

assumed that such individuals would

normally be masked. Here again,

however, there may be circumstances

that preclude the individual from being

masked (e.g., the individual is

combative). Therefore, employees who

must work in the area where these

unmasked individuals are located,

whether working directly with the

individual or performing other duties,

must wear a respirator to protect against

possible tuberculosis infection.

Paragraph (f)(1)(i)(F) requires that a

respirator be worn by an employee who

is working in a residence where an

individual with suspected or confirmed
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54259

infectious TB is known to be present. In

this situation, whether the individual is

masked or unmasked does not trigger

respirator use since the individual has

been releasing droplet nuclei into the

residence airspace. The CDC refers to

this type of situation in its discussion of

the provision of home health care and

states:

Health care workers who provide medical

services in the homes of patients who have

suspected or confirmed infectious TB should

instruct such patients to cover their mouths

and noses with a tissue when coughing or

sneezing. Until such patients are no longer

infectious, HCWs should wear respiratory

protection when entering these patients’

homes. (Ex. 4B)

In addition to home health care and

home-based hospice care workers, other

employees, such as social workers who

are entering these residences, would

come under this provision. It is the

Agency’s intent that a respirator be used

by an employee in these situations for

the time that the employee is in the

residence and that respirator use

continue until the individual is

noninfectious.

The proposed standard, in paragraphs

(f)(1)(iii) and (f)(1)(iv), places several

general responsibilities upon the

employer regarding respiratory

protection. Paragraph (f)(1)(iii) states

that where respirators are required by

the standard, the employer shall provide

them at no cost to the employee and

assure that they are used in accordance

with the requirements of the standard.

Paragraph (f)(1)(iv) stipulates further

that the employer must assure that the

employee dons a respirator before

entering the work settings or performing

the tasks set forth in paragraphs (f)(1)i

and (f)(1)(ii) above and uses it until

leaving the work setting or completing

the task, regardless of other control

measures in place.

It has been OSHA’s long-standing

policy to hold the employer responsible

for controlling exposure to hazards in

his or her workplace and to fulfill this

responsibility at no cost to the

employee. Therefore, the financial

burden for purchasing and providing

personal protective equipment,

including respirators, rests upon the

employer just as it does for all other

control measures (e.g., engineering

controls). OSHA believes that in order

to assure that employees are adequately

protected, the employer has the

responsibility not only to provide

respiratory protection, but also to assure

that it is utilized when necessary.

Furthermore, respiratory protection

must be donned prior to entering the

above work settings or performing the

tasks, for the period of time that the

employee remains in these work

settings, and must not be removed until

the employee leaves the work setting or

completes the tasks. In this way, the

employee is protected for the entire

period of occupational exposure.

It is not OSHA’s intent that each

employee be monitored constantly for

compliance; however, the Agency does

believe that the employer has the power

to assure that employees follow specific

rules. For example, most employers

have requirements that they require

employees to follow, such as reporting

to work on time, working a minimum

number of hours per day, notifying the

employer when the individual is unable

to report for work, and taking certain

precautions to prevent nosocomial

infections. Following these

requirements is not left to the

employee’s discretion, and employers

generally have some process to ensure

conformance with these procedures.

Therefore, the Agency believes that the

employer has not only the

responsibility, but also the ability, to

assure that respiratory protection is

used in accordance with the

requirements of this section.

Paragraph (f)(2)(i) requires that each

employer who has any employee whose

occupational exposure is based on

entering any of the work settings or

performing any of the tasks described in

paragraph (f)(1) must establish and

implement a written respiratory

protection program that assures that

respirators are properly selected, fitted,

used, and maintained. The program

must include the following elements:

(A) Procedures for selecting respirators

for use in the work setting; (B) a

determination of each employee’s

ability to wear a respirator, as required

under paragraph (g)(3)(ii), Medical

Surveillance, for each employee

required to wear a respirator; (C)

procedures for the proper use of

respirators; (D) fit testing procedures for

tight-fitting respirators; (E) procedures

and schedules for cleaning, disinfecting,

storing, inspecting, repairing, or

otherwise maintaining respirators; (F)

training of employees to assure the

proper use and maintenance of the

respirators as required under paragraph

(h), Communication of Hazards and

Training; and (G) procedures for

periodically evaluating the effectiveness

of the program. Written standard

operating procedures are essential to an

effective respiratory protection program.

Developing and writing down standard

operating procedures require employers

to think through how all of the

requirements pertaining to respirators

will be met in their workplace. In

addition, this provision assures that the

employer establishes standardized

procedures for selecting, using, and

maintaining respirators in the

workplace. OSHA’s long-standing

position has been that a systematic

respiratory protection program is

necessary to provide for consistency in

protection. Guidance that has been

developed by an outside party (e.g., a

respirator manufacturer) on the general

use of a particular respirator would not

address the site-specific aspects of the

employer’s work setting and would not

be an appropriate substitute for a

respiratory protection program.

Paragraph (f)(2)(ii) requires the

employer to designate a person qualified

by appropriate training or experience to

be responsible for the administration of

the respiratory protection program and

for conducting the required periodic

evaluations of its effectiveness. To

assure that the integrity of the

respiratory protection program is

maintained through the continuous

oversight of one responsible individual,

OSHA is proposing that a qualified

person be designated as responsible for

the administration of the program. That

individual can work with a committee

or assign responsibility for portions of

the program to other personnel, but the

overall responsibility for the operation

of the program remains with the

designated person. This approach

ensures coordination of all facets of the

program. The level of training or

experience necessary for a designated

person has been left performance

oriented since this will vary with the

complexity of the respirator program.

However, the person chosen would

need to have sufficient knowledge of

respiratory protection and the

workplace to properly supervise the

program.

Employers are required, in paragraph

(f)(2)(iii), to review and update the

written program as necessary to reflect

current workplace conditions and

respirator use. Reviewing and updating

will assure that the program addresses

current conditions. The reason OSHA

has not set a schedule for reviewing the

program is because conditions may

change frequently in some work settings

while remaining relatively stable in

others. Thus, the employer determines

the frequency of the review. However,

when an employer is aware of changes

in the workplace or respirator use which

could necessitate changes in the written

program, it is not appropriate to delay

revising the written program. OSHA’s

use of the phrase ‘‘as necessary’’ in the

requirement is intended to assure that

such changes are incorporated into the

written program expeditiously. As the

workplace situation or respirator use
54260 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

changes, the program is to be revised. In

addition, paragraph (f)(2)(iv) requires

that employers, upon request, make the

written respiratory protection program

available to affected employees, their

designated representatives, the Assistant

Secretary, and the Director. This

provision also requires that a copy of

the program be submitted to the

Assistant Secretary and/or the Director,

if requested.

Paragraph (f)(3) sets out the respirator

characteristics that must be satisfied in

order to provide employees with a

respirator that will protect them against

aerosolized M. tuberculosis. These

criteria are presented in performanceoriented language to provide flexibility

in choice of respirators and have been

drawn from CDC recommendations (Ex.

4B). CDC has based these criteria on

currently available information relative

to respirators that includes:

* * * (a) data on the effectiveness of

respiratory protection against noninfectious

hazardous material in workplaces other than

health-care settings and on an interpretation

of how these data can be applied to

respiratory protection against M.

tuberculosis; (b) data on the efficiency of

respirator filters in filtering biological

aerosols; (c) data on face-seal leakage; and (d)

data on the characteristics of respirators that

were used in conjunction with administrative

and engineering controls in outbreak settings

where transmission to HCWs and patients

was terminated (Ex. 4B).

The CDC Guidelines go on to state:

Available data suggest that infectious

droplet nuclei range in size from 1 [micron]

to 5 [microns]; therefore, respirators used in

health-care settings should be able to

efficiently filter the smallest particle in this

range. Fifty liters per minute is a reasonable

estimate of the highest airflow rate an HCW

is likely to achieve during breathing, even

while performing strenuous work activities

(Ex. 4B).

In their 1994 TB guidelines, the CDC

states:

Respiratory protective devices used in

health-care settings for protection against M.

tuberculosis should meet the following

standard performance criteria:

1. The ability to filter particles 1 um in size

in the unloaded state with a filter efficiency

of ≤ 95% (i.e., filter leakage of ≤ 5%), given

flow rates of up to 50 L per minute.

2. The ability to be qualitatively or

quantitatively fit tested in a reliable way to

obtain a face-seal leakage of ≤ 10%.

3. The ability to fit different facial sizes

and characteristics of HCWs [health care

workers], which can usually be met by

making the respirators available in at least

three sizes.

4. The ability to be checked for facepiece

fit, in accordance with standards established

by the Occupational Safety and Health

Administration (OSHA) and good industrial

hygiene practice, by HCWs each time they

put on their respirators. (Ex. 4B)

The various respirator provisions that

OSHA is proposing rely heavily on the

CDC’s aforementioned respirator

performance criteria. The second, third,

and fourth CDC criteria are addressed by

paragraphs (f)(3)(i) (A) and (B) and

paragraph (f)(5)(ii). Paragraph (f)(3)(i)

requires the employer to select and

provide properly fitted negative

pressure or more protective respirators.

Negative pressure respirators must be

capable of being: (A) Qualitatively or

quantitatively fit tested in a reliable way

to verify a face-seal leakage of no more

than 10%; and (B) fit checked by the

employee each time the respirator is

donned. Paragraph (f)(5)(ii) requires that

employers assure that each employee

who must wear a tight-fitting respirator

is fit tested and passes the fit test. All

of these provisions deal with the ability

of the respirator to achieve a good face

seal with a particular employee.

Good face fit is critical in assuring

proper performance of respiratory

protection. When an employee inhales

through a respirator that does not fit

properly, contaminated workplace air

can enter the respirator through gaps

and leaks in the seal between the face

and the facepiece. OSHA is requiring

the employer to provide each employee

who must wear a respirator with one

that fits. To do so, the employer will

have to consider the facial sizes and

characteristics in his or her workplace.

It is not necessary for the employer to

have respirators of different sizes of

characteristics unless the employees

need them. In other words, an employer

may need only one or two styles and

sizes. However, in workplaces where

employees have different facial sizes

and characteristics, obtaining proper

respirator fit for each employee may

require the fit testing of different mask

sizes, possibly from several

manufacturers. Proper respirator fit

reduces inhalation leakage through the

face-to-facepiece seal to a minimum.

Once a respirator has been selected

based on its ability to achieve an

adequate face-to-facepiece seal, the

employee must be able to check that the

respirator is properly seated and sealed

to his or her face each time it is donned.

The respirator, therefore, must be able to

be fit checked by the employee. This is

a procedure in which the employee

covers the filter surface of the respirator

and inhales (negative fit check) and

exhales (positive fit check). If the

respirator has an exhalation valve, this

valve must be covered during the

positive fit check. A respirator that is

properly sealed will firmly adhere to the

wearer’s face upon inhalation due to the

negative pressure created inside the

mask. Upon exhalation, the mask

should lift slightly off of the wearer’s

face to allow air to escape around the

face seal. Employers should be aware

that a problem could exist with fit

checking some disposable negative

pressure respirators. That is, it is

difficult to cover the entire filter surface,

thereby hindering the employee’s ability

to perform a proper fit check. At least

one respirator manufacturer has

developed a ‘‘fit-check cup’’ that covers

the filter surface of their disposable

respirator, thereby permitting the user to

more easily perform a fit check.

Reusable elastomeric facepiece

respirators utilize filter cartridges that

can be covered for performing a fit

check.

CDC’s first criteria, regarding filter

efficiency, is addressed under paragraph

(f)(3)(ii) of the standard. This provision

requires the employer to select a

respirator that will function effectively

in the conditions of the work setting. In

addition to meeting the criteria in

paragraph (f)(3)(i) above, the respirator

shall be, at a minimum, either a High

Efficiency Particulate Air (HEPA)

respirator selected from among those

jointly approved as acceptable by the

Mine Safety and Health Administration

(MSHA) and by the National Institute

for Occupational Safety and Health

(NIOSH) under the provisions of 30 CFR

part 11, or an N95 respirator certified by

NIOSH under the provisions of 42 CFR

part 84.

NIOSH and MSHA are the

government agencies charged with

testing and certifying respiratory

protective devices. It has always been

OSHA’s policy that respiratory

protection must be certified by these

agencies before being deemed

acceptable. Until recently, HEPA

respirators were the only NIOSH

certified negative pressure respirators

that met the CDC’s filter efficiency

criteria. However, on July 10, 1995,

NIOSH’s original respirator certification

procedures for air-purifying particulate

respirators, 30 CFR part 11, were

replaced by revised procedures, 42 CFR

part 84 (Ex. 7–261). Under the new

procedures, all nonpowered airpurifying particulate respirators are

challenged with a 0.3 micron particle

(the most penetrating size) at a flow rate

of 85 liters per minute. At the

conclusion of the test, those respirators

that pass are placed into one of nine

classes of filters (three levels of filter

efficiency, with three categories of

resistance to filter efficiency

degradation). The three levels of filter

efficiency are 99.97%, 99%, and 95%.

The three categories of resistance to

filter efficiency degradation are labeled

N (not resistant to oil), R (resistant to
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54261

oil), and P (oil proof). Given these

categories, a type N95 respirator would

meet or exceed the filter efficiency

performance criteria set forth in the CDC

guidelines which state that a respirator

appropriate for use in protecting against

transmission of tuberculosis must be

able to filter particles 1 micron in size

in the unloaded state with a filter

efficiency of ≥95%, given flow rates up

to 50 liters per minute (Ex. 4B). The

underlying reasoning for the

acceptability of type N95 respirators is

that their filter efficiency of 95% for a

0.3 micron particle will exceed 95%

filtering efficiency for a particle three

times as large (i.e., 1 micron). Also, the

Agency assumes that oil aerosols are not

likely to be found in the work settings

covered by the standard, and therefore,

that the use of a category N respirator

would be sufficient. However, if oil

aerosols are present, the employer

would be expected to consider this

when selecting the category of respirator

to be used in his or her workplace.

OSHA is permitting the employer to

select either a HEPA respirator certified

under 30 CFR part 11 or a respirator

certified under 42 CFR part 84, since

particulate respirators certified under

both of these regulations are currently

on the market. HEPA respirators are the

only nonpowered particulate respirators

certified under 30 CFR part 11 that meet

the CDC guidelines filtration criteria.

However, applications for certification

of nonpowered particulate respirators

under 30 CFR part 11 are no longer

being accepted by NIOSH. Therefore,

dwindling stocks of HEPA respirators

certified under that regulation will

eventually lead to their unavailability,

and employers will of necessity be

selecting respirators from those

approved under 42 CFR part 84.

Paragraph (f)(4)(i) states that the

employer shall not permit any respirator

that depends on a tight face-to-facepiece

seal for effectiveness to be worn by

employees having any conditions that

prevent such a seal. Examples of these

conditions include, but are not limited

to, facial hair that comes between the

sealing surface of the facepiece and the

face or facial hair that interferes with

valve function, absence of normally

worn dentures, facial scars, or headgear

that projects under the facepiece seal.

Paragraph (f)(4)(ii) requires the

employer to assure that each employee

who wears corrective glasses or goggles

wears them in such a manner that they

do not interfere with the seal of the

facepiece to the face of the wearer.

Tight-fitting facepiece respirators rely

on a good face-to-facepiece seal in order

to achieve effective protection.

Therefore, the employer must not allow

employees to wear such respirators with

conditions that prevent such a seal.

Several studies support the prohibition

of facial hair that comes between the

sealing surface of the facepiece and the

face (Exs. 7–243, 7-242, 7–182). A study

by Skretvedt and Loschiavo found that

bearded subjects wearing half-mask

respirators had a median face seal

leakage 246 times greater than clean

shaven subjects. They go on to state:

Even though a number of bearded

individuals did obtain fit factors above

OSHA’s minimum requirement for half-mask

respirators, they all failed the qualitative fit

test. No relationship was found between the

length, shape, density and texture of beards

and the amount of face seal leakage.

Therefore, the only way to identify bearded

negative-pressure respirator wearers

obtaining fit factors above OSHA’s minimum

requirements would be by performing a

quantitative fit test on them. However, even

if quantitative fit tests are performed on all

bearded individuals, another problem must

be faced. The drop in the fit factor

experienced when a beard is present is of

such magnitude that no confidence can be

placed in the protection the respirator will

provide in the workplace or in future

donnings. All respirator users experience

variability from one donning to the next. This

fit variability from donning to donning

occurs due to changes in strap tension,

positioning on the face, and a host of other

variables. Donning-to-donning fit variability

for bearded individuals will be even greater

since additional variables will be introduced.

A beard is a dynamically changing thing. The

hair length constantly changes as well as the

orientation of the hair in the sealing surface.

Beards also accumulate moisture, natural

oils, and debris from the workplace. Even

though a percentage of bearded respirator

wearers obtain fit factors slightly above

OSHA’s minimum requirements, the

tremendous drop in fit factor resulting from

the presence of a beard is such that the safety

factor necessary to accommodate the

variability of fit no longer exists. In summary,

although bearded individuals may be able to

achieve fit factors above OSHA’s minimum

requirements during a specific quantitative

fit test, the drop in protection caused by a

beard coupled with the large fit variability

from donning to donning makes it quite

likely that the individual will not obtain the

minimum required protection in the

workplace. (Ex. 7–243)

Therefore, while a bearded respirator

wearer may be able to obtain a

satisfactory fit on a particular occasion,

one cannot assume that the individual

can reliably be expected to achieve that

same protection level each time the

respirator is used. Beards grow and

change daily. Each time a respirator is

donned there is fit variability. Such

variability in face seal is greatly

increased for bearded workers. This

large variability in fit means that a

reliable seal cannot be reasonably

expected. This provision should not be

construed as a blanket prohibition on

beards among respirator wearers. There

are other types of respiratory equipment

such as hoods, helmets and suits that

can be worn by employees with beards,

since they do not rely upon a tight

facepiece fit. In addition, this provision

refers to facial hair that interferes with

the facepiece seal rather than simply

growth of beard or sideburns. It is the

interference with the facepiece seal that

is the concern, not the presence of facial

hair. Other conditions such as the

absence of normally worn dentures,

facial scarring and cosmetic surgery

change the geometry of the face, thereby

changing the ability of the respirator

wearer to achieve a facepiece seal.

Facepiece seal may also be

compromised when headgear, temple

pieces and nose pieces of glasses, the

edges of goggles and so forth project

underneath the respirator’s sealing

surface. Both of the above provisions are

intended to eliminate or minimize

conditions that jeopardize face-tofacepiece seal and could permit leakage

of outside air into the facepiece.

Paragraph (f)(4)(iii) states that

disposable respirators must be

discarded when excessive resistance,

physical damage, or any other condition

renders the respirator unsuitable for use.

It is not expected that the filter media

of respiratory protective devices would

become occluded with particulates in

the work settings covered by this

standard. However, if excessive

resistance is noted, the respirator must

be discarded. Also, such respirators

must be structurally sound in order to

provide a proper face seal and maintain

their effectiveness. Whenever physical

damage occurs (e.g., the respirator is

crumpled or torn; the flexible face seal

is damaged; a head strap is broken),

effective functioning cannot be assured

and the respirator must be replaced. In

addition, other conditions may render

the respirator unsuitable for use (e.g.,

the respirator may become

contaminated with blood), thereby

requiring discard.

In view of the types of activities

carried out and the environmental

conditions encountered in the work

settings covered by this standard, OSHA

is proposing to allow the multiple use

of disposable respirators. However, this

action should in no way be construed as

setting a precedent for the use of

disposable respirators in any other

OSHA standards or in how OSHA views

multiple use of disposable respirators in

other work settings. OSHA requests

comment on the approach taken in this

proposal toward the reuse of disposable

respirators.
54262 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

Paragraph (f)(4)(iv) requires the

employer to assure that each employee,

upon donning a tight-fitting respirator,

performs a facepiece fit check prior to

entering a work area where respirators

are required. In performing the fit check,

the procedures in Appendix B or other

procedures recommended by the

respirator manufacturer that provide

equivalent protection to the procedures

in Appendix B must be used. This

provision is supported by a recent study

by Meyers et al. that concluded:

* * * for wearers of respirators that have

been properly fit by a recognized fit test,

conducting fit checks according to the

manufacturer’s instructions can be a useful

tool for more consistently maintaining the

quality of respirator donning. (Ex. 7–233)

The use of such seal checks are a way

of helping to assure that attention is

paid to obtaining an adequate facepiece

seal each time a respirator is used.

The standard requires, under

paragraph (f)(4)(v), that respirators be

immediately repaired, or discarded and

replaced when they are no longer in

proper working condition. Examples of

these changes in condition would be

that a strap has broken, the respirator

has lost its shape, or the face seal can

no longer be maintained. As discussed

above, respirators must be in good

working condition in order to function

effectively. Therefore, it is imperative

that they not be used if they have been

impaired in any way. The respirator

manufacturers can supply replacement

parts for damaged portions of their

elastomeric respirators. Disposable

respirators cannot be repaired and must

be discarded when damaged.

Paragraph (f)(4)(vi) stipulates that the

employer shall permit each employee to

leave the respirator use area as soon as

practical to: (A) change the filter

elements or replace the respirator

whenever the ability of the respirator to

function effectively is compromised or

the employee detects a change in

breathing resistance; or (B) wash his or

her face and respirator facepiece as

necessary to prevent skin irritation

associated with respirator use. This

provision encourages and facilitates the

proper use of respirators by employees

by authorizing employees to take

specific actions to assure the effective

functioning of their respirators. This

provision is consistent with

requirements in other health standards

(e.g., Lead, 29 CFR 1910.1025;

Cadmium, 29 CFR 1910.1027).

Considering the health problems that

may be exacerbated with respirator use

and their associated detrimental effects

on an employee, the proposal states in

paragraph (f)(4)(vii) that each employee

required to wear a respirator under this

section shall be evaluated in accordance

with paragraph (g), Medical

Surveillance, of this section to

determine whether any health

conditions exist that could affect the

employee’s ability to wear a respirator.

In addition, paragraph (f)(4)(viii) states

that no employee shall be assigned a

task requiring the use of a respirator if,

based upon the employee’s most recent

evaluation, the physician or other

licensed health care professional, as

appropriate, determines that the

employee will be unable to continue to

function adequately while wearing a

respirator. If the physician or other

licensed health care professional, as

appropriate, determines that the

employee’s job activities must be

limited, or that the employee must be

removed from the employee’s current

job because of the employee’s inability

to wear a respirator, the limitation or

removal shall be in accordance with

paragraph (g)(5)(iii) under Medical

Removal Protection of this section.

Common health problems that could

interfere with respirator use include

claustrophobia (an intolerance of feeling

enclosed and a subjective feeling of

breathing difficulty), chronic rhinitis,

nasal allergies that would necessitate

frequent removal of the respirator to

deal with nasal discharges, and chronic

sinusitis. In addition, difficulties with

the use of respirators may arise in

employees with respiratory or cardiac

diseases. Respiratory diseases include

chronic obstructive pulmonary disease,

emphysema, asthma, and moderate to

severe pneumoconiosis. Cardiac or

cardiorespiratory diseases that may

affect respirator wear include any type

of congestive heart disease, other

ischemic heart diseases, and

hypertension.

As discussed further under paragraph

(g)(5)(iv), Medical Surveillance, of this

section, employees who are removed

from work due to the inability to wear

a respirator are afforded certain medical

removal protection relative to retention

of earnings, seniority, rights and

benefits. The Agency believes that these

provisions will encourage all

employees, including those

experiencing difficulty with respirator

use, to participate in the Medical

Surveillance Program and will minimize

an employee’s fear of losing his or her

job due to the possible inability to wear

a respirator.

Paragraph (f)(5)(i) requires the

employer to perform either quantitative

or qualitative face fit tests in accordance

with the procedures outlined in

Appendix B of this section.

Quantitative fit testing is an

assessment of the adequacy of respirator

fit by numerically measuring the

amount of leakage into the facepiece.

One method of accomplishing this

assessment utilizes a procedure

whereby the level of penetration of a

test agent of a known concentration is

measured inside the facepiece of the

respirator. In this quantitative fit test

procedure, the respirator is worn in a

stable test atmosphere containing a

suitable challenge agent. The adequacy

of fit is determined by measuring the

actual levels of the challenge agent, both

outside and inside the facepiece of the

respirator. This provides a quantitative

assessment of the fit (the fit factor). Fit

testing allows the employer to continue

testing different facepieces until a

properly fitting respirator is identified

and selected for the employee.

Quantitative fit testing requires the use

of moderately sophisticated testing

equipment and is more expensive to

perform than qualitative fit testing,

which may reduce its availability in

some work sites. Also, testing services

may not be available in all parts of the

country to provide quantitative fit

testing services for small businesses.

Qualitative fit testing does not

provide a numerical measure of the

quality of the fit but simply determines

whether a respirator fits or not. The

outcome of the test is simply a pass or

fail result. Qualitative fit testing

involves the detection of a gas, vapor, or

aerosol challenge agent through

subjective means such as odor, taste, or

nasal irritation. If the challenge agent’s

presence is detected, the respirator fit is

considered to be inadequate. Qualitative

fit testing is more subjective than

quantitative testing because it depends

on the individual’s ability to detect the

test agent.

OSHA believes that while quantitative

fit testing has some advantages,

qualitative fit testing conducted in

accordance with the protocols described

in Appendix B of this section can

generally accomplish the intent of the

standard, which is to assure that each

employee is assigned and wears a

respirator that provides a proper fit.

Paragraph (f)(5)(ii) states that the

employer shall assure that each

employee who must wear tight-fitting

respirator passes a fit test: (A) at the

time of initial fitting; (B) whenever

changes occur in the employee’s facial

characteristics that affect the fit of the

respirator; (C) whenever a different size

or make of respirator is used; and (D) at

least annually thereafter unless the

annual determination required under

paragraph (g)(3)(ii)(A), Medical

Surveillance, indicates that the annual
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54263

fit test of the employee is not necessary.

This frequency of fit testing is necessary

to assure that factors that may affect the

proper fit of a respirator are detected

and necessary adjustments are

performed to assure the integrity of the

faceseal. For example, the fit of

respirators is not standardized among

manufacturers. Fit testing would be

required, therefore, whenever a different

size or make of respirator is used. In

addition, a change in an employee’s

facial structure can compromise a

respirator’s faceseal. Examples of such

changes include loss of weight, cosmetic

surgery, facial scarring, and the

installation of dentures or the absence of

dentures that are normally worn by the

individual. Therefore, fit testing is

required when any facial changes, such

as those mentioned above, occur.

Requiring annual fit testing, unless

the annual determination by the

physician or other licensed health care

professional indicates that the annual fit

test is not necessary, assures that factors

that could affect respirator fit are

detected and the employee’s respirator

is adjusted or replaced as necessary. It

is OSHA’s intent in this provision that

each employee be evaluated annually

for respirator fit. This can be

accomplished through either an actual

fit test or through a person-to-person

evaluation consisting of a questionnaire

and personal observation by the

evaluator carried out under paragraph

(g)(3)(ii)(A), Medical Surveillance, of

this section. It should be noted that an

annual determination of respirator fit is

required, either through fit testing or the

person-to-person evaluation. The

employer may use the determination of

the need for the annual fit test in lieu

of an annual fit test if that determination

indicates that a fit test is not necessary.

One of the criteria that must be

satisfied when selecting respirators is a

faceseal leakage of 10% or less. OSHA

considers any respirator that passes a

qualitative fit test to meet this criteria.

However, quantitative fit testing

necessitates that a particular numerical

value be achieved. Therefore, paragraph

(f)(5)(iii) requires that when quantitative

fit testing is performed, the employer

shall not permit an employee to wear a

tight-fitting respirator unless a

minimum fit factor of one hundred (100)

is obtained in the test chamber. This

value corresponds to a faceseal leakage

of 10% or less.

In order to assure that continuing

protection is achieved by reusable and

powered air purifying respiratory

protective devices, it is necessary to

establish and implement proper

maintenance and care procedures. A lax

attitude toward this part of the

respiratory protection program will

negate successful selection and fit

because the devices will not deliver the

assumed protection unless they are kept

in proper working order. A basic

program for assuring proper respirator

function would contain procedures for

cleaning, inspection, repair, and

replacement of respirators used in the

workplace.

Paragraph (f)(6)(i) requires that the

employer clean and disinfect the

respirators using the manufacturer’s

recommended procedures at the

following intervals: (A) as necessary for

respirators issued for the exclusive use

of an employee; and (B) after each use

for respirators issued to more than one

employee. Respirators that are not

cleaned and disinfected can cause skin

irritation and dermatitis. When more

than one employee uses the same

respirator, cleaning and disinfecting

after each use provides the additional

benefit of minimizing the respirator’s

role as a vehicle for spreading infections

(e.g., skin, respiratory) between

employees.

In order to assure continued respirator

reliability, they must be inspected on a

regular basis. Therefore, paragraph

(f)(6)(ii) requires that respirators be

inspected before each use and during

cleaning after each use. As stipulated in

paragraph (f)(6)(iii), such inspections

must include: (A) a check of respirator

function, tightness of connections and

condition of the facepiece, head straps,

valves, connecting tube, and cartridges,

canisters, or filters; and (B) a check of

the rubber or elastomer parts for

pliability and signs of deterioration. In

this way, the employer can assure that

the respirator is functioning as

intended, is able to be adjusted by the

user, will not allow leakage through

cracks or breaks in the respirator, and is

pliable enough to achieve a proper

faceseal.

The standard also contains provisions

regarding those respirators that are

found to be deficient upon inspection.

Paragraph (f)(6)(iv) states that

respirators that fail to pass inspection

must be removed from service and

repaired or adjusted in accordance with

the following: (A) repairs or adjustments

to respirators are only to be made with

NIOSH-approved parts designed for the

respirator by the respirator

manufacturer and by persons

appropriately trained to perform such

operations; (B) only repairs of the type

and extent covered by the

manufacturer’s recommendations may

be performed; and (C) reducing or

admission valves or regulators shall be

returned to the manufacturer or given to

an appropriately trained technician for

adjustment or repair. It is self-evident

that repairs to respirators should only be

performed by trained individuals, using

parts designed for the specific respirator

under repair (not all respirator designs

are identical), and that the individual

should not attempt repairs that he or she

is not qualified to undertake or which

are not recommended by the

manufacturer.

Another important aspect of assuring

appropriate respirator function is proper

storage. Therefore, paragraph (f)(6)(v)

stipulates that the employer assure that

respirators are stored in a manner that

protects them from contamination,

damage, dust, sunlight, extreme

temperatures, excessive moisture,

damaging chemicals and that prevents

deformation of the facepiece or

exhalation valve. Proper storage, of both

new respirators and those already in

service, assists in maintaining

appropriate respirator function by

minimizing conditions that may cause

deterioration of the respirator or filter,

interfere with filter efficiency, change

faceseal geometry, and prevent sealing

of valves against inhalation of

contaminated air.

As discussed previously, OSHA

accepts those respirators certified by

MSHA and NIOSH. Therefore,

paragraph (f)(7)(i) requires that filters,

cartridges, and canisters used in the

workplace are properly labeled and

color-coded with the NIOSH approval

label as required by 30 CFR part 11 or

42 CFR part 84, whichever is applicable,

before they are placed into service. The

employer must assure that the existing

NIOSH approval label on a filter,

cartridge, or canister is not intentionally

removed, obscured, or defaced while it

is in service in the workplace, as

required by paragraph (f)(7)(ii) of this

section.

Paragraph (f)(8) requires the employer

to review the overall respiratory

protection program at least annually,

and conduct inspections of the

workplace as necessary to assure that

the provisions of the program are being

properly implemented for all affected

employees. The reason an employer

must conduct an annual review and

inspections as necessary is because

respirators are utilized as supplemental

and, in some instances, sole protection

to prevent transmission of infectious

TB. Therefore, it is of primary

importance to assure proper

implementation of the program. The

review of the program must include an

assessment of each element required

under paragraph (f)(2) of this section.

Once the respiratory protection program

is implemented, the employer retains

responsibility for detecting and
54264 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

addressing problems that arise. While

the written respiratory protection

program is required to be reviewed and

updated under paragraph (f)(2)(iii) of

the standard, the overall review requires

that the employer evaluate actual

implementation in the workplace.

Consequently, this provision stipulates

inspections of the workplace and an

assessment of each element required

under paragraph (f)(2) of this section to

assure proper implementation of the

program.

OSHA believes that the proposed

provisions regarding respirators are both

appropriate and justified. OSHA seeks

comments and data on all aspects of the

proposed respirator requirements.

Paragraph (g) Medical Surveillance

(1) General

The purpose of this section is early

detection and prevention of disease

through employee medical histories and

physical examinations, TB skin testing,

medical management and follow-up of

exposure incidents and skin test

conversions, and medical removal of

employees with suspected or confirmed

infectious TB. These requirements are

designed to ensure early detection of TB

infections and disease by providing

appropriate medical examinations to

enable identification of infection or

disease and to minimize the spread of

TB to other employees in the workplace.

Additionally, there are requirements in

this section to assure that employees

required to wear respiratory protection

are evaluated to determine their ability

to wear a respirator and advised about

the need for annual fit testing. The

needs of employees who have health

conditions that might require special

attention are also addressed (e.g., anergy

testing, more frequent screening, or

further medical examinations to

diagnose TB).

Paragraph (g)(1) calls for medical

surveillance to be provided for each

employee who has occupational

exposure, as defined in this standard.

Occupational exposure may result in TB

infection and the subsequent

development of TB disease. Paragraphs

(c)(1)(i, ii), (exposure determination)

require the employer to identify

employees with occupational exposure

in the facility. These employees must be

offered medical surveillance.

OSHA believes that early detection

and management of exposed employees

helps prevent severe illness and death.

According to CDC’s 1994 edition of the

Core Curriculum on Tuberculosis (Ex.

7–93), approximately ten percent of the

persons infected will develop active TB

disease at some point in their lives (Exs.

4B, 7–50, 7–93). Five per cent of those

infected develop disease within the first

two years following infection and

another five percent develop disease

later in their lives. Immunosuppressed

persons are at a considerably greater risk

of developing active disease following a

TB infection. For example, individuals

infected with HIV and TB have been

estimated to have a 8–10% risk per year

of developing active disease (Ex. 7–50).

However, according to the American

Thoracic Society:

Clinical trials have shown that daily

isoniazid preventive therapy for 12 months

will reduce the risk of developing

tuberculosis in infected persons by about 70

percent and in over 90 percent of patients

who are compliant in taking the medications.

(Ex. 5–80)

Most infected people have a positive

reaction to the TB skin test within 2–10

weeks after exposure. Consequently,

early detection of newly infected

workers is critical as it permits early

initiation of appropriate therapy and

results in a decrease in morbidity and

mortality.

Paragraph (g)(1)(ii) requires that

information about the signs and

symptoms of pulmonary tuberculosis

disease, a medical history, a physical

examination, TB skin testing, medical

management and follow-up, and if

indicated, other related tests and

procedures and medical removal

protection if the employee develops

infectious TB, be provided to each

employee in work settings described in

paragraph (a) Scope who sustains an

‘‘exposure incident.’’ This provision is

applicable when the employee has not

been categorized as having occupational

exposure in the employer’s Exposure

Control Plan. OSHA recognizes that

there may be times when employees

who are not ‘‘reasonably anticipated’’ to

have occupational exposure to TB may

be exposed, (e.g., if engineering controls

break down or an individual with

infectious tuberculosis is unidentified

during intake procedures). Employees

exposed under such circumstances

incur the risk of TB infection and

subsequent disease (Ex. 7–93) as a result

of their work duties. OSHA includes

this provision so that these employees

are provided protection.

Paragraph (g)(1)(iii)(A) requires the

employer to provide all medical

surveillance at no cost to the employee.

This is consistent with OSHA policy.

Providing services at no cost to the

employee is an important factor in

successful workplace health and safety

programs because it encourages

employee participation in medical

surveillance programs.

Paragraph (g)(1)(iii)(B) requires that

all medical surveillance be provided at

a reasonable time and place for the

employee. Convenience of these

procedures increases the likelihood of

employee participation in the program.

This helps assure that employees

receive the full benefits provided by the

standard. OSHA recognizes the need for

this provision and has included it in

other standards (e.g., Ethylene Oxide, 29

CFR 1910.1047; Asbestos, 29 CFR

1910.1001; and Bloodborne Pathogens

29 CFR 1910.1030).

Paragraph (g)(1)(iii)(C) states that all

medical surveillance is required to be

performed by or under the supervision

of a physician or other licensed health

care professional, as appropriate. OSHA

has included in paragraph (j)

Definitions, a description of the licensed

health care professional. Such an

individual is a physician or other health

care professional who holds a license

enabling her or him to independently

provide or be delegated the

responsibilities to provide some or all of

the health care services required by this

paragraph. In several states, nurse

practitioners may be licensed to

independently perform or supervise the

evaluations and procedures required by

this paragraph. In such cases, the

requirements of this standard can be

accomplished by those practitioners. In

addition, where registered nurses are

licensed to perform or supervise some of

the requirements of this standard, those

requirements can be accomplished by

those professionals.

Paragraph (g)(1)(iii)(D) requires that

medical surveillance procedures be

provided according to recommendations

of the CDC, current at the time these

procedures are performed, except as

specified by this paragraph (g). In other

words, employers must comply with

paragraph (g), and with the most current

CDC recommendations in providing

medical surveillance. OSHA has set

forth what an employer must do to

prevent or minimize occupational

exposure in the employer’s workplace.

However, CDC, an agency of the U.S.

Public Health Service (USPHS), follows

the epidemiology of M. tuberculosis and

periodically revises and updates its

guidelines and recommendations to

reflect changes in the diagnosis and

treatment of TB. OSHA believes that in

addition to meeting the requirements of

paragraph (g), it is appropriate to follow

CDC recommendations, which address

screening, medical evaluations, TB skin

test procedures and follow-up (e.g., the

administration and interpretation of

skin tests).

OSHA recognizes the dynamic nature

of medical knowledge relating to
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54265

tuberculosis and notes that CDC

recommendations current at the time of

the standard’s publication may differ

from recommendations at some future

time when an employee evaluation

takes place. Knowledge about

tuberculosis is expanding. For example,

the medical response to HIV/AIDS as

related to tuberculosis continues to

evolve. These are the reasons why

OSHA has not simply required the

employer to comply with a particular

CDC guideline. OSHA believes that

incorporating the CDC

recommendations into the standard by

reference enhances the quality of

medical surveillance. This assures that

employees are provided the most

current and effective evaluation and

treatment. Furthermore, the CDC

recommendations provide consistency

with regularly updated medical science

and health care practice. A similar

provision was included in the

Bloodborne Pathogens standard 29 CFR

1910.1030 and met with widespread

acceptance from the regulated

community. The CDC recommendations

cover the specific details of the medical

protocols.

Paragraph (g)(1)(iv) requires that all

laboratory tests be performed by an

accredited laboratory. Accreditation by

a national accrediting body or its state

equivalent means that the laboratory has

participated in a recognized quality

assurance program. (For an explanation

of ‘‘accredited laboratory’’ see paragraph

(j) Definitions below). This accreditation

process is required to assure a measure

of quality control so that employees

receive accurate information concerning

their laboratory tests. The accreditation

requirement assures long-term stability

and consistency among laboratory test

procedures and interpretations of

results. OSHA recognizes the need for

this requirement and has included it in

other standards (e.g., Benzene, 29 CFR

1910.1028; Bloodborne Pathogens, 29

CFR 1910.1030).

(2) Explanation of Terms

This paragraph explains the terms

used in paragraph (g) Medical

Surveillance. Paragraphs (g)(2)(i) to

(g)(2)(vii) include explanations of the

‘‘medical history’’, the ‘‘physical

examination (with emphasis on the

pulmonary system, signs and symptoms

of infectious tuberculosis, and factors

affecting immunocompetence)’’, ‘‘TB

skin testing’’, the ‘‘face-to-face

determination of ability to wear a

respirator and need to be re-fit tested’’,

‘‘medical management and follow-up’’,

‘‘other related procedures or tests

determined to be necessary’’, and

‘‘Medical Removal Protection’’. The

applications section, paragraph (g)(3),

describes what must be provided and at

what time.

Paragraph (g)(2)(i) describes a medical

history, during which the examiner

questions the employee in order to

gather information on the employee’s

pulmonary system, TB exposure,

vaccination, testing and disease status

and factors affecting

immunocompetence. A medical history

questionnaire may be used as a starting

point for this discussion. OSHA believes

that a medical history is essential for

interpreting the TB skin test results,

which are also required by this

paragraph (g). The CDC Core

Curriculum states:

TB skin testing is a useful tool, but is not

perfect. Several factors can affect the skin test

reaction: for example, infection with

mycobacteria other than M. tuberculosis and

vaccination with BCG. These factors can lead

to false-positive reactions * * * Other

factors, such as anergy, can lead to falsenegative reactions. (Ex. 7–93).

Therefore, the medical history is used

to assist in interpreting the TB skin test

results. The medical history also

provides information regarding the

employee’s potential for increased risk

if exposed to tuberculosis. Based on this

information, discussions between the

employee and the examiner regarding

the employee’s increased risk can assist

the employee in decision-making.

Paragraph (g)(2)(ii) describes the

physical examination. The physical

examination is to emphasize the

pulmonary system, signs and symptoms

of active TB disease, and factors

affecting immunocompetence. Such an

examination assists the examiner in

detecting evidence of active disease

(e.g., rales), differentiating TB disease

from other causes of cough or other

signs/symptoms associated with TB

disease, and ascertaining whether signs

are present that are compatible with an

immunocompromising health condition.

The physical examination is also

required when an employee has signs or

symptoms of TB or after a TB skin test

conversion and at other times, if

indicated.

That the pulmonary system is

emphasized in both the medical history

and physical examination assures that

the employee is evaluated with specific

attention to the most common site of

infectious TB. Although extrapulmonary

tuberculosis can occur (e.g., in bone,

meninges of the brain, and draining

abscesses), it is not usually a source of

infection for others. The language ‘‘with

emphasis on the pulmonary system’’ is

used to indicate that while the history

and physical examinations evaluate the

health of the patient as a whole,

particular emphasis should be placed on

the pulmonary system.

Paragraph (g)(2)(iii) explains the

required TB skin testing. TB skin testing

is the cornerstone for early detection of

TB transmission among exposed

workers. The American Thoracic

Society notes that:

Although currently available TB skin tests

are substantially less than 100% sensitive

and specific for detection of infection with

M. tuberculosis, no better diagnostic methods

have yet been devised. (Ex. 5–4)

The TB skin test is an important tool

that is useful in identifying employees

who may be eligible for appropriate,

early treatment; initiating contact

investigations; and evaluating the

effectiveness of the facility’s control

program. The requirement for TB skin

testing is supported by AHA (Exs. 7–61,

7–29 ), APIC (Ex. 7–30), AIHA (Ex. 7–

170) and the CDC 1994 Core Curriculum

which states, ‘‘TB screening should be

done in groups for which rates of TB are

substantially higher than the general

population.’’ [Ex. 7–93]. In this

document, CDC specifically mentions

screening for health care workers, staff

of long term care facilities, correctional

facilities, hospices, drug treatment

centers, and nursing homes.

Paragraph (g)(2)(iii) describes the

requirement for TB skin testing. TB skin

testing, which only applies to

employees whose TB skin test status is

not known to be positive, includes

anergy testing if indicated, and consists

of an initial 2-step protocol for each

employee who has not been previously

skin tested and/or for whom a negative

test in the past 12 months cannot be

documented. If the employer has

documentation that the employee has

had a negative TB skin test within the

past 12 months, that test may be used

to fulfill the skin testing portion of the

initial medical surveillance

requirements. For example, if an

employer has a new or existing

employee for whom: (1) a TB skin test

has not previously been performed, or

(2) a negative skin test result within the

past 12 months that cannot be

documented, the employer is required

to provide an initial two-step skin test

for the employee. Conversely, if the

employer can document a negative skin

test result from a test performed on the

employee within the past 12 months,

that test can be used to fulfill the initial

skin testing requirement of this section.

Subsequent periodic retesting of the

employee is to be performed in

accordance with paragraph (g)(3), as

discussed below.

It is important for the employer to

determine the current TB skin test status
54266 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

of employees prior to their initial

assignment to a job with occupational

exposure. This ‘‘baseline’’ status can

then be used to evaluate changes in the

employees’ TB skin test.

In their 1992 guidelines, the

American Thoracic Society

recommended the following:

Individuals at high risk for TB should have

a TB skin test at least once to assess their

need for preventive therapy and to alert the

health care providers of those with positive

skin tests of this medical problem. In

institutional settings, baseline information on

the TB skin test status of staff and residents

is a means of identifying candidates for

preventive therapy as well as determining

whether transmission of TB is occurring in

the facility. For this reason, TB skin testing

upon employment or upon entry should be

mandatory for staff and residents * * * (Ex.

5–80)

Previous BCG vaccination is not a

contraindication for skin testing. In its

1994 guidelines, the CDC states:

During the pre-employment physical or

when applying for hospital privileges, HCWs

who have the potential for exposure to M.

tuberculosis [sic], including those with a

history of BCG vaccination, should have

baseline PPD skin testing performed * * *

BCG vaccination may produce a PPD

reaction that cannot be distinguished reliably

from a reaction caused by infection with M.

tuberculosis. For a person who was

vaccinated with BCG, the probability that a

PPD test reaction results from infection with

M. tuberculosis increases (a) as the size of the

reaction increases, (b) when the person is a

contact of a person with TB, (c) when the

person’s country of origin has a high

prevalence of TB, and (d) as the length of

time between vaccination and PPD testing

increases. For example, a PPD test reaction of

≥10 mm probably can be attributed to M.

tuberculosis in an adult who was vaccinated

with BCG as a child and who is from a

country with a high prevalence of TB. (Ex.

4B)

CDC does not state that BCG vaccination

negates the need for baseline and

periodic skin testing but does state that

skin tests on vaccinated individuals

need to be interpreted carefully. OSHA’s

proposed rule is consistent with the

CDC Guidelines on this point. PPD

testing is thus not contraindicated for

BCG vaccinated employees; however,

such prior vaccination does mean that

other factors, such as the age of the

employee and the extent of induration,

must be considered in interpreting the

results.

The purpose of performing a two-step

test is to correctly identify the baseline

TB skin test status of those employees

who are infected with TB but whose

sensitivity to the tuberculin testing

material may have waned over the

years. This procedure enhances the

proper interpretation of subsequent

positive TB skin test results and is based

upon current CDC and American

Thoracic Society recommendations

(Exs. 5–80, 6–15, 7–52, 7–93, 7–169).

Two-step testing requires an employee

to be tested initially and, if the test

results are negative, to be tested again

within 1–3 weeks. This second test

stimulates or ‘‘boosts’’ the body’s

response to the testing material and

results in a more valid reaction. For

example, an employee who has not been

recently tested but who is infected with

TB from an earlier exposure may fail to

respond to this current test because his

or her immune response has waned over

time. However, a second test of this

employee will produce a positive TB

skin test that more accurately reflects

his or her true TB skin test status. Thus,

the initial use of a two-step testing

procedure ensures that the baseline TB

skin test is an accurate reflection of the

employee’s TB status and will reduce

the likelihood of misinterpreting a

‘‘boosted’’ reaction on subsequent tests

as a conversion. Two-step testing is also

appropriate for individuals who have

been BCG vaccinated, since these

individuals can exhibit a boosted

reaction. Therefore, two-step testing of

BCG vaccinated individuals can be used

to determine their baseline status,

although the skin test results must be

interpreted in light of their previous

BCG vaccination.

The two-step testing procedure does

not identify those persons who are truly

anergic and, therefore, are not capable of

mounting a typical immune response to

the test material. Evaluation of adequate

immune response, when determined to

be necessary by the physician or other

licensed health care professional, as

appropriate, is determined through

anergy testing, and this is provided for

in the explanation of TB skin testing in

paragraph (g)(2)(iii).

The CDC recommendations are the

guiding documents for TB skin test

protocols. By referring the employer to

these recommendations in Paragraph

(g)(1)(iii)(D), OSHA allows for future

changes in protocols and procedures

that result from continuing research.

Consistent with the CDC guidelines

(Exs. 3–33, 3–35, 3–32, 6–15), the

American Thoracic Society

recommends:

The Mantoux test with 5 Tuberculin Units

(TU) of PPD may be used as a diagnostic aid

to detect tuberculous infection and to

determine the prevalence of infection in

groups of people. (Ex. 5–4)

Proper administration of a TB skin

test results in a reaction described as a

classic example of a delayed (cellular)

hypersensitivity reaction. This reaction

indicates infection with mycobacterium,

most commonly M. tuberculosis. The

reaction characteristically begins in 5–6

hours, is maximal at 48–72 hours, and

subsides over a period of days (Ex. 5–

4).

Proper administration and

interpretation of the test is critical and

can be complex. In 1990, the American

Thoracic Society revised the criteria for

interpreting the TB skin test (Ex. 5–4).

Information such as the health status of

the tested employee, history of BCG

vaccination, recent close contact with

persons with active TB, chest x-ray

results, and other factors must be

considered when interpreting the TB

skin test results. CDC has established

criteria for a TB skin test conversion;

that is, when an employee’s TB skin test

results change from negative to positive,

indicating a recent TB infection (Ex. 4–

B).

Because of the complexity in properly

administering and interpreting TB skin

tests, it is essential that only trained

individuals perform this function. For

this reason, TB skin testing is to be

administered and interpreted by or

under the supervision of a physician or

other licensed health care professional

as appropriate and according to CDC

recommendations. This language allows

employers to chose from a variety of

health care professionals who can

administer and interpret TB skin tests.

OSHA is aware that in some worksites,

employees have been allowed to read

and interpret their own skin test results.

A surveillance system that allows selfreading and interpretation of TB skin

tests can be problematic. With regard to

interpretation of TB skin test results, the

American Thoracic Society states:

Intelligent interpretation of skin test results

requires a knowledge of the antigen used

(tuberculin), the immunologic basis for the

reaction to the antigen, the technique(s) of

administering and reading the test, and the

results of epidemiologic and clinical

experience with the test. (Ex. 5–4)

In its 1994 Core Curriculum on

Tuberculosis (Ex. 7–93), CDC describes

the complexities of interpreting the

induration resulting from TB skin

testing. A number of factors can affect

the size of a TB skin test induration

relative to whether or not the test

should be interpreted as being positive.

For example, induration of 5 mm or

more is classified as positive for persons

with known or suspected HIV infection,

while an induration must be 10 mm to

be classified as positive in persons who

are foreign-born in high prevalence

countries. An induration of 15 mm or

more is classified as positive in certain

other situations. In addition, TB skin
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54267

testing can result in both false positive

and false negative results.

Clearly, interpreting TB skin test

results requires professional expertise

and must be performed by or under the

supervision of a physician or other

licensed health care professional, as

appropriate, by an individual with

training and experience in performing

the test and interpreting the result.

Proper use of the TB skin test as a

medical surveillance tool will require

two visits to the health care

professional: one to receive the test and

one to read/interpret the test results.

However, considering the critical

importance of this element, OSHA

believes that allowing employees to read

and interpret their own tests or allowing

their peers to do so (unless they meet

the criteria discussed above)

compromises the quality and accuracy

of the testing procedure.

Paragraph (g)(2)(iv) describes the

determination of each employee’s

ability to wear a respirator and of his or

her need for re-fit testing for employees

required to wear a respirator. This faceto-face determination includes a verbal

exchange between the employee and the

examiner regarding the employee’s

health factors such as illness or injuries,

that may impact his or her ability to

wear a respirator (e.g. vascular or heart

disease, asthma, claustrophobia, facial

structure defects, certain skin

conditions, etc.) (Ex.7–64). Based on

this history and the observation of the

employee, the need for further testing or

physical examinations for the ability to

wear a respirator can be determined. In

addition, assessment of the need for refit testing is to be performed, which

assures that the examiner consider

whether re-fit testing is needed. OSHA

has included a note stating that the

determination of the need for re-fit

testing may only be performed after the

required initial fit test of the employee

and cannot be used in lieu of any other

required fit tests, as, for example, when

a different size or make of respirator is

used.

Paragraph (g)(2)(v) explains that

medical management and follow-up

include diagnosis, and, where

appropriate, prophylaxis and treatment

related to TB infection and disease. The

employer must provide medical

management and follow-up for

occupationally exposed employees with

skin test conversions [paragraph

(g)(3)(i)(D)], or those who undergo an

exposure incident whether or not they

are categorized as occupationally

exposed [paragraphs (g)(1)(ii) and

(g)(3)(i)(C)]. In addition, any time an

occupationally exposed employee

develops signs and symptoms of

infectious tuberculosis, medical

management and follow-up are required

[paragraph (g)(3)(i)(B)]. John E.

McGowan addressed follow-up in the

1995 article entitled ‘‘Nosocomial

Tuberculosis: New Progress in Control

and Prevention,’’ published in Clinical

Infectious Diseases. He states,

If the PPD skin testing program for health

care workers is to be useful, several steps are

crucial. * * * The institution also must

make sure that the occupational health

service undertakes careful follow-up of

workers found to have positive TB skin tests

or tuberculosis disease. This follow-up

should include counseling, careful

monitoring of therapy (when prescribed)

until its completion and evaluation of fitness

to return to work. (Ex. 7–248).

Paragraph (g)(2)(vi) explains that

other related tests and procedures are

any TB-related tests and procedures

determined to be necessary by the

physician or other licensed health care

professional, as appropriate. These

procedures or tests could include chest

radiographs, sputum smears, or other

testing determined to be necessary to

make an assessment, a diagnosis, or

medically manage the employee. An

example of a program that integrates

testing and examinations was given at

the 1994 meeting of the Society for

Occupational and Environmental

Health, by Carol Murdzak who

presented the University of Manitoba’s

Medical Surveillance program. Her

presentation, entitled ‘‘Conducting a

Medical Surveillance Program to

Prevent and Control Transmission of TB

in a Health Care Institution’’

demonstrates the use of skin testing and

general review of health status for

employee surveillance. Results of TB

skin testing and the review of health

status determine the need for chest x-ray

and further medical evaluation in this

program (Ex.7–169).

(3) Application

Medical examinations in the form of

medical histories, physical

examinations, TB skin testing and other

related tests and procedures are

necessary in order to promptly identify

and treat employees with infectious

tuberculosis.

Paragraph (g)(3), Application,

specifies what an employer must

provide. In each situation set forth in

paragraph (g)(3), the employer must

provide medical examinations, tests and

procedures as specified. Some of the

provisions are offered only ‘‘if

indicated,’’ which means that the

physician or other licensed health care

professional, as appropriate, has

determined that further tests or

procedures are needed. For example, an

employee who has no history of illness

or being immunocompromised and

whose TB skin test is negative at the

time of initial assignment is not

required to be offered a physical

examination unless the examiner

determines that a physical examination

is indicated. However, if at the time of

annual skin test, the employee has a

skin test conversion, a physical

examination is required.

Paragraph (g)(3)(i)(A) requires that,

before the time an employee is initially

assigned to a job with occupational

exposure (or within 60 days from the

effective date of the standard for

employees already assigned to jobs with

occupational exposure), the employee

be provided with a medical history, TB

skin testing, and, if indicated, a physical

examination and other related tests and

procedures.

OSHA requires the initial medical

history to assist in assessing the

employee’s health. This information

will provide a baseline health status that

can be used to evaluate (1) whether the

employee has a pre-existing condition

that may be exacerbated by occupational

exposure to TB and (2) any future health

conditions that may arise that are

relevant to occupational exposure to TB.

OSHA does not believe that an initial

physical examination for all

occupationally exposed employees is

necessarily warranted. However, the

Agency does believe that a physical

examination, if determined to be

indicated by the examiner based on the

medical history and TB skin test results,

is useful and effective.

The note to paragraph (g)(3)(i)(A)

specifies that if an employee has had a

medical examination within the twelve

(12) months preceding the effective date

of the standard and the employer has

documentation of that examination,

only the medical surveillance

provisions required by the standard that

were not included in the examination

need to be provided. The Agency

realizes that employees may have

received at least some of the elements of

the required medical surveillance

provisions shortly before the effective

date of the standard. In these situations,

a full TB examination would not need

to be repeated.

In addition, the proposed standard

allows the baseline TB skin testing

status of an employee to be established

by documentation of a TB skin test that

was administered within the previous

12 months. For example, if an employee

has a written record of a TB skin test

within the last 12 months, that

information can be used to document

the employee’s baseline TB skin test

status and another TB skin test at the
54268 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

time of the initial medical examination

is not necessary. When utilizing results

from a previous medical examination

and skin test to fulfill the initial medical

surveillance requirements, the employer

must use the date(s) of the previous

medical exam and skin test to determine

the date(s) of the employee’s next

medical examination and skin test. In

no case shall the interval between the

previous examination and skin test and

the next examination and skin test

exceed 12 months. These provisions are

designed to avoid unnecessary testing of

employees and do not compromise the

quality of the medical surveillance.

Information (e.g., medical history)

obtained from a medical examination in

the past 12 months is unlikely to change

within this span of time. However, this

may not be the case with regard to

previous skin testing results. While

OSHA is proposing to accept a skin test

performed within the past 12 months as

a substitute for performing an initial

baseline skin test, an employer utilizing

a new employee’s negative skin testing

result obtained more than 3 months

prior to beginning the new job may be

uncertain as to the source and time of

infection if the employee tests positive

at his or her next skin test. More

specifically, conversion normally occurs

within 3 months of infection. Therefore,

an employee would have been negative

at his or her last skin test, e.g., 7 months

previously, and have been infected just

after the skin test and subsequently

converted. In such a case, an employer

may rely on the previous negative skin

test as the baseline does not need to test

the new employee until 5 months later

(i.e., annual skin test frequency), at

which time the employee would test

positive and be identified as a converter.

In this situation, the new employer

would not be able to determine if the

employee’s conversion had occurred as

a result of exposure occurring previous

to hire or from exposure in his or her

current work setting. Regardless of the

source of the conversions, the employer

would be required by the standard to

initiate medical management and a

follow-up investigation, which might

also entail skin testing other employees

in the worksite to determine if other

conversions had taken place, a step that

would not be necessary if the employee

had been correctly identified as positive

upon entry into the workplace. In view

of this, employers may choose to

perform an initial baseline skin test on

each new employee before the employee

enters the work setting.

Once an employee is on the job,

paragraph (g)(3)(i)(A) requires

employers to periodically retest

employees who have negative TB skin

tests in order to identify those

employees whose skin test status

changes, indicating that they have been

infected. Because the baseline TB skin

test provides only a ‘‘snapshot’’ of the

TB skin test status of the employee and

because exposure and subsequent

infection can occur at any time, periodic

testing is necessary. The American

Thoracic Society recommends:

* * * follow-up skin-testing should be

conducted on at least an annual basis among

the staffs of TB clinics, health care facilities

caring for patients with HIV infection,

mycobacteriology laboratories, shelters for

the homeless, nursing homes, substanceabuse treatment centers, dialysis units, and

correctional institutions. (Ex. 5–80)

When TB exposure results in infection,

early identification allows employees to

have options regarding prophylactic

treatment, thereby reducing the

likelihood that the infection will

progress to disease.

OSHA recognizes the importance of

periodic testing to monitor the status of

employee’s skin test results. In their

1994 Guidelines for Preventing the

Transmission of Tuberculosis in HealthCare Facilities, the CDC recommends

that the frequency of PPD skin testing of

employees be based upon the individual

facility’s risk assessment in conjunction

with the criteria put forth by the CDC

(Ex. 4B). For situations that meet certain

CDC criteria, CDC recommends that

employees receive a repeat TB skin test

every 3 months, six months or annually,

depending upon the risk assessment.

OSHA’s proposed standard does not

require a risk assessment of the type

described by CDC and would extend

coverage to worksites other than

‘‘health-care facilities’’ as described in

the CDC document (Ex. 4B).

Consequently, OSHA is proposing that

repeat TB skin test be performed every

6 months or annually, depending upon

the exposure determination. This testing

frequency is expected to be both

practical and effective in early

identification of skin test conversions in

the various worksites described in the

Scope. The requirements for more

frequent TB skin tests (e.g., 3 months

after an exposure incident, or if deemed

necessary by a licensed health care

professional) ensures that employees’

health is not compromised.

An exemption to this annual testing is

permitted for an employer who can

demonstrate that his or her facility or

work setting: (1) Does not admit or

provide medical services to individuals

with suspected or confirmed infectious

TB, (2) has had no cases of confirmed

infectious TB in the past 12 months, and

(3) is located in a county that, in the

past two years, has had 0 cases of

confirmed infectious TB reported in one

year and fewer than 6 cases of

confirmed infectious TB reported in the

other year. In these settings only a

baseline TB skin test is required. This is

discussed earlier under paragraph b,

application.

Paragraph (g)(3)(i)(B) requires that,

when an employee has signs or

symptoms of TB, either observed or selfreported, the employee be provided a

medical history, physical examination,

TB skin testing, medical management

and follow-up, and other related tests

and procedures determined to be

necessary. CDC states that the presence

of signs or symptoms of tuberculosis in

the employee requires prompt medical

evaluation (Ex. 7–52, 7–93), and such

evaluation provides an opportunity for

initiating drug therapy. Furthermore,

identifying those with infectious

pulmonary TB disease enables the

employer to remove them from the

workplace, preventing exposure of other

employees.

Paragraph (g)(3)(i)(C) requires that

when an employee incurs an exposure

incident, a medical history, TB skin

testing, medical management and

follow-up, and, if indicated, a physical

examination and other related tests and

procedures be provided. Evaluation and

follow-up after each exposure incident

help detect any resultant infections, as

well as prevent infection in other

employees, benefitting the health of all

employees.

Following exposure, infected workers

will usually develop a positive response

to a TB skin test (Exs. 7–50, 7–93, 5–4).

In certain cases, workers may also

display signs or symptoms compatible

with tuberculosis disease such as

complaints of persistent cough (over 3

weeks in duration), bloody sputum,

night sweats, weight loss, loss of

appetite or fever. Use of the TB skin test

has been recognized as a tool in the

early identification of infection and for

disease surveillance and follow-up. In

paragraph (g)(3)(i)(C), the proposed

standard also requires employers to

provide testing for employees as soon as

feasible after an exposure incident,

unless a negative TB skin test has been

documented within the preceding 3

months. If this baseline skin test is

negative, another TB skin test shall be

repeated 3 months after the exposure

incident.

In order to accurately determine if an

exposure incident has resulted in

infection, the employer must first know

the baseline skin test status of the

affected employee(s) at the time of the

exposure incident. Typically, skin test

conversion can be documented

approximately 2–10 weeks following
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54269

infection (Ex. 7–52). Consequently, it

can be reasonably assumed that a

negative TB skin test within the three

months prior to the incident is

sufficiently indicative of the employee’s

status at the time of the exposure

incident.

For those employees who do not have

a documented negative skin test within

the past three months, the employer

must determine their TB skin test status

as soon as feasible after the exposure

incident. The requirement of ‘‘as soon as

feasible’’ in the provision puts the

employer under the obligation of

performing the TB skin test quickly, i.e.,

before infection resulting from the

exposure would be manifested as a

conversion. This assures that a true

indication of the employee’s skin test

status at the time of the incident is

obtained.

The purpose of the initial TB skin test

following an exposure incident is to

establish the TB skin test status of the

employee(s) at the time of the incident.

From this baseline, changes in TB skin

test status can be identified. This initial

test would not detect infection resulting

from the exposure, since there would

not have been sufficient time for

conversion to occur. Hence, the

employer is required to provide a repeat

TB skin test three months after the

exposure incident to determine if

infection has occurred. This

requirement reflects current CDC

recommendations (Ex. 4B).

Paragraph (g)(3)(i)(D) requires that

when an employee has a TB skin test

conversion, the employee receive a

medical history, a physical examination,

medical management and follow-up,

and other tests and procedures

determined to be necessary. This

provision assures that employees with

skin test conversions receive

appropriate evaluation for preventive

therapy and for infectious tuberculosis.

OSHA included the provision for early

identification of disease since, as the

CDC has stated in their guidelines,

infectious tuberculosis disease can be

prevented by the early treatment of

tuberculosis infection.

In paragraph (g)(3)(i)(E), the proposed

standard requires employers to provide

TB skin testing within 30 days prior to

termination of employment. The

rationale for this requirement is twofold. First, this requirement permits

employees whose employment is

terminated after an unrecognized

exposure incident, but before their next

regularly scheduled TB skin test, to

determine their current (exit) TB skin

test status. OSHA recognizes that in

some instances employees may be in the

process of converting from negative to

positive TB skin test results at the time

of the exit testing and that some of these

cases will be missed. Also missed will

be employees who decline testing or

who vacate their position immediately

or without notice. While such situations

are possible, the Agency believes that

these occurrences would be rare.

Secondly, by detecting recent

conversions, appropriate steps can be

taken by the employer to investigate the

cause of the exposure. This helps

prevent future exposures in those areas

or situations where the exiting

employee’s infection may have

occurred.

Paragraph (g)(3)(i)(F) requires that a

medical history, physical examination,

TB skin testing, determinations of the

employee’s ability to wear a respirator,

medical management and follow-up or

other related tests and procedures be

conducted at any other time determined

necessary by the physician or other

licensed health care professional, as

appropriate. This allows the physician

or other licensed health care

professional, as appropriate, to

recognize the individual differences in

employees’ medical status and response

to TB infection and increase the

frequency or content of examination as

needed. Some workers who have certain

health conditions may need more

frequent evaluation (Ex. 4B). For

example, individuals who have a

condition that may interfere with an

accurate interpretation of TB skin test

results (e.g., the development of test

anergy in an employee who is on

chemotherapy for cancer treatment),

may warrant more frequent evaluations

because of the high risk for rapid

progression to TB disease if he or she

becomes infected. (Ex. 4B)

Paragraph (g)(3)(ii) sets forth

provisions regarding employees who

wear respirators. Paragraph (g)(3)(ii)(A)

requires that a face-to-face

determination of the employee’s ability

to wear the respirator be accomplished

before initial assignment to a job with

occupational exposure (or within 60

days of the effective date of the

standard) and at least annually

thereafter. As discussed above under

explanation of terms, this is a verbal

exchange to assess health factors that

could affect the employee’s ability to

wear a respirator. An initial

determination is made before

assignment to a job requiring respirator

use to assure that the employee’s health

factors have been properly evaluated

prior to incurring exposure to M.

tuberculosis. This determination must

also be made annually to assure that no

health conditions have arisen that might

limit an employee’s ability to wear a

respirator.

Such conditions may arise and be

noted prior to the annual determination.

For example, the employee may

experience unusual difficulty while

being fitted or while using the

respirator. In these situations, it is not

appropriate to wait until the annual

determination. Therefore, paragraph

(g)(3)(ii)(B) requires that a face-to-face

determination of the employee’s ability

to wear a respirator, including relevant

components of a medical history and, if

indicated, a physical examination and

other related tests and procedures, be

provided whenever the employee

experiences unusual difficulty while

being fitted or while using a respirator.

Paragraph (g)(3)(iii) requires

employers to provide TB skin tests

every 6 months for each employee who

enters AFB isolation rooms or areas,

performs or is present during the

performance of high-hazard procedures,

transports or is present during the

transport of an individual with

suspected or confirmed infectious TB in

enclosed vehicles, or works in intake

areas where early identification is

performed in facilities where 6 or more

individuals with confirmed infectious

TB have been encountered within the

past 12 months. OSHA believes that

employees who perform these activities

are exposed more intensely and

frequently to individuals with suspected

or confirmed infectious tuberculosis and

should, therefore, be tested more

frequently.

(4) Additional Requirements

Paragraph (g)(4) (i) through (iv)

contain the additional requirements an

employer must meet. Paragraph (g)(4)(i)

requires that the physician or other

licensed health care professional, as

appropriate, verbally notifies the

employer and the employee as soon as

feasible if an employee is determined to

have suspected or confirmed infectious

tuberculosis. In this way an infectious

employee can be removed from the

workplace, thereby minimizing

occupational exposure for other

workers. Paragraph (g)(7)(i), Written

Opinion, allows 15 days before the

employer must provide the employee

with the written opinion of medical

evaluations from the physician or other

licensed health care professional, as

appropriate. In situations where an

employee is determined to be

potentially infectious, this time period

leads to unnecessary delays in removal

from the workplace and disease

treatment. Therefore, OSHA requires the

verbal notification to expedite treatment
54270 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

and prevent spread of disease to other

employees.

The proposed standard, in paragraph

(g)(4)(ii), requires the employer to notify

each employee who has had an

exposure incident when the employer

identifies an individual with confirmed

infectious TB who was previously

unidentified. For example, if a newly

admitted patient undergoes diagnostic

and therapeutic evaluation for

suspected pulmonary malignancy, and

the diagnosis of infectious tuberculosis

is not made until several days after

hospitalization, all hospital staff who

have had exposure must be identified

and provided TB skin test and followup. OSHA intends to assure that

employees are provided with

opportunities for early detection of

tuberculosis infection. These provisions

are consistent with the general purpose

of tuberculosis medical surveillance as

recommended by the CDC, and they are

included to assist all employees in

receiving the full benefits provided by

the standard.

Determination of the drug

susceptibility of the M. tuberculosis

isolate from the source of an exposure

incident resulting in a TB skin test

conversion is required by paragraph

(g)(4)(iii) unless the employer can

establish that such a determination is

infeasible. Information regarding drug

susceptibility assists the examiner in

deciding the most effective treatment

therapy for the exposed employee,

particularly if the source is a drug

resistant strain of M. tuberculosis. Drug

susceptibility testing of the source

isolate is recommended by CDC (Ex.

4B). OSHA includes the provision

regarding infeasibility because certain

TB skin test conversions may involve

unknown exposure sources. This can

make identification of the isolate and

therefore drug susceptibility testing

infeasible or even impossible. It is the

responsibility of the employer to

establish that this is infeasible, if such

is the case. Employers must make a

good faith effort to identify M.

tuberculosis isolates and obtain the drug

susceptibility testing.

Paragraph (g)(4)(iv) requires the

employer to investigate and document

the circumstances surrounding an

exposure incident or TB skin test

conversion and to determine if changes

can be instituted that will prevent

similar occurrences in the future.

The provision assures that employers

obtain feedback regarding the

circumstances of employee exposures

and use the information to eliminate or

decrease specific circumstances leading

to exposure. For example, exposure

incident investigation shows that an

employee was exposed to tuberculosis

as a result of recirculation of air

containing infectious droplet nuclei.

Further investigation shows inadequate

local or general ventilation in the

workplace. The employer can now

repair the ventilation system and

prevent future exposure incidents.

Another example of corrective measures

may be including a stronger training

emphasis on certain procedures where

proper work practices might have

decreased the likelihood of transmission

of tuberculosis. Employers can obtain

further guidance regarding

investigations for TB skin test

conversions and exposure incidents in

health care workers by reading the 1994

CDC guidelines.

(5) Medical Removal Protection

Paragraph (g)(5)(i) requires that

employees with suspected or confirmed

infectious tuberculosis be removed from

the workplace until determined to be

non-infectious according to current CDC

recommendations. Infectious TB is

contagious and removal is essential for

the protection of other workers. An

employee’s ‘‘infectiousness’’ is

determined by the physician or other

licensed health care professional, as

appropriate, who informs the employer

as required in paragraphs (g)(4)(i) and

(g)(7) of this section.

Paragraph (g)(5)(ii) states that for

employees removed from the workplace

under paragraph (g)(5)(i), the employer

shall maintain the total normal earnings,

seniority, and all other employee rights

and benefits, including the right to

former job status, as if the employee had

not been removed from the job or

otherwise been medically limited until

the employee is determined to be

noninfectious or for a maximum of 18

months, whichever comes first.

Paragraph (g)(5)(iii) provides medical

removal protection for employees

removed from the workplace under

paragraph (f)(4)(viii) of Respiratory

Protection. The provision requires the

employer to transfer the employee to

comparable work for which the

employee is qualified or can be trained

in a short period (up to 6 months),

where the use of respiratory protection

is not required. OSHA requires that if no

such work is available, the employer

shall maintain the employee’s total

normal earnings, seniority, and all other

employee rights and benefits until such

work becomes available or for 18

months, whichever comes first.

The requirement referring to the

employee’s right to return to his or her

former job is not intended to expand

upon or restrict any rights an employee

has or would have had, to a specific job

classification or position under the

terms of a collective bargaining

agreement. Where the employer

removes an employee from exposure to

tuberculosis, the employee is entitled to

full medical removal protection benefits

as provided for under the standard.

The medical removal requirement is

an indispensable part of this standard.

The medical removal protection helps

assure that affected employees

participate in medical surveillance and

seek appropriate care. If employees fear

losing their jobs as a result of their

medical condition they may attempt to

hide the illness, thereby infecting many

more workers and other people and

jeopardizing their own health. The

requirement for medical removal

assures that an infectious employee will

not be terminated, laid off, or

transferred to another job (possibly at a

lower pay grade) upon returning to

work. Consequently, this protection

should reduce reluctance on the part of

the employee to participate in medical

surveillance. The employee’s health will

be protected and the health of coworkers and others who come into

contact with that employee will be

protected, also.

OSHA believes that the cost of

protecting worker health to the extent

feasible is an appropriate cost of doing

business since employers are obligated

by the OSH Act to provide safe and

healthful places of employment.

Consequently, the costs of medical

removal, like the costs of respirators and

engineering controls, are borne by

employers rather than individual

workers.

If a removed employee files a claim

for workers’ compensation payments for

a tuberculosis-related disability, then

the employer must continue to provide

medical removal protection benefits

pending disposition of the claim. To the

extent that an award is made to the

employee for earnings lost during the

period of removal, the employer’s

medical removal protection obligation

may be reduced by such amount. The

employer’s obligation to provide

medical removal protection benefits to a

removed employee may be reduced to

the extent that the employee receives

compensation for earnings lost during

the period of removal either from a

publicly or employer-funded

compensation program, or receives

income from employment with another

employer which was made possible by

virtue of the employee’s removal.

Medical removal should not be

viewed as an alternative to primary

control (prevention) of workers’

exposure to tuberculosis; rather, it

should be used as a secondary means of
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54271

protection, where other methods of

control have failed to protect. The

stipulation of an 18 month time period

of protection is consistent with other

OSHA standards (e.g., Cadmium, 29

CFR 1910.1027; Lead in Construction,

29 CFR 1926.62). The provision of

medical removal and the costs

associated with the program may

indirectly provide employers with

economic incentives to comply with

other provisions of the standard. It can

be expected that the costs of medical

removal will decrease as employer

compliance with other provisions of the

standard increases.

(6) Information Provided to Physician or

Other Licensed Health Care

Professionals

Paragraph (g)(6)(i) requires the

employer to assure that the health care

professionals responsible for the

medical surveillance receive a copy of

this regulation. OSHA believes it is the

employer’s responsibility to inform the

health care professionals responsible for

medical surveillance of the

requirements of this standard. This will

help assure that these individuals are

aware of and implement the

requirements. This provision is

included in other OSHA standards (e.g.,

Benzene, 29 CFR 1910.1028; Bloodborne

Pathogens, 29 CFR 1910.1030).

Paragraph (g)(6)(ii) requires the

employer to assure that the physician or

other licensed health care professional,

as appropriate, evaluating an employee

after an exposure incident receives: (A)

A description of the exposed employee’s

duties as they related to the exposure

incident; (B) a description of the

circumstances under which the

exposure incident occurred; (C) the

employee’s diagnostic test results,

including drug susceptibility pattern, or

other information relating to the source

of exposure that could assist in the

medical management of the employee;

and (D) all of the employee’s medical

records relevant to the medical

evaluation of the employee, including

TB skin test results. Since the

individual responsible for medical

surveillance may not necessarily be the

person evaluating an employee after an

exposure incident, it is necessary to also

provide a copy of this standard to the

evaluating physician or other

appropriate licensed health care

professional, as required by paragraph

(g)(6)(i). In this way, the evaluator will

also be informed of and implement the

standard’s requirements. All of the

above information is essential to followup evaluation, and helps assure that an

accurate determination can be made

regarding appropriate medical treatment

of the exposed employee. This provision

is consistent with other OSHA

standards (e.g., Bloodborne Pathogens,

29 CFR 1910.1030, Benzene, 29 CFR

1910.1028).

(7) Written Opinion

Paragraph (g)(7)(i) states that the

employer shall obtain and provide the

employee with a copy of the written

opinion of the physician or other

licensed health care professional, as

appropriate, within 15 days of the

completion of all medical evaluations

required by this section. The purpose of

requiring the employer to obtain a

written opinion is to assure that the

employer is provided with

documentation that the medical

evaluation of the employee (1) has taken

place and that the employee has been

informed of the results; (2) has included

an evaluation of the employee’s need for

medical removal or work restriction; (3)

describes the employee’s TB skin test

status so that the employer can assess

action needed to prevent further

exposure; and (4) informs the employer

of the employee’s infectivity status so

that the employer can take action to

prevent the employee from becoming a

source of infection for other employees.

The employer has a right to know the

information contained in the written

opinion and may retain the original

written opinion, but must provide a

copy to the employee. The 15 day

provision assures that the employee is

informed in a timely manner regarding

information received by the employer

and is consistent with other OSHA

standards (e.g., Formaldehyde, 29 CFR

1910.1048; Benzene, 29 CFR 1910.1028;

Bloodborne Pathogens, 29 CFR

1910.1030).

In addition, the written opinion is

required to assure the employer that the

employee has been provided with

information about any medical

conditions resulting from exposure to

tuberculosis which require further

evaluation or treatment.

OSHA believes it is important that

employers know if their employees have

had evaluations for tuberculosis

infection or exposure incidents, and that

physicians or other appropriate licensed

health care professionals, acting as

agents for the employer, have provided

the employer with written

documentation that these evaluations

occurred. However, paragraph (g)(7)(ii)

limits the information the employer is

provided in order to protect the privacy

of the employee. The requirement for a

written opinion after a medical

evaluation has been included in other

OSHA standards (e.g., Occupational

Exposures to Hazardous Chemicals in

Laboratories, 29 CFR 1910.1450;

Formaldehyde, 29 CFR 1910.1048;

Bloodborne Pathogens, 29 CFR

1910.1030).

Paragraph (g)(7)(ii)(E) requires the

written opinion to state any

recommendations for medical removal

or work restrictions and the employee’s

ability to wear a respirator. This

recommendation must be in accordance

with paragraphs (g)(5)(i) and (f)(5)(viii)

of this section. Including this

information in the written opinion

assures that the employer is provided

with written documentation of the need

for removal of an employee with

infectious tuberculosis from the

workplace. The provision also assures

that the employer is aware of any work

restrictions on the employee and the

employee’s ability or inability to wear a

respirator. This information enables the

employer to take appropriate steps in

managing the employee’s duties upon

return to the workplace. OSHA

recognizes the need for this provision

and has included it in other standards

(e.g., Lead in Construction, 29 CFR

1926.62).

Paragraph (g)(7)(iii) states that all

other findings or diagnoses shall remain

confidential and shall not be included

in the written report. OSHA believes

that all health care professionals have

an obligation to view medical

information gathered or learned during

tuberculosis medical surveillance or

post-exposure evaluation as confidential

medical information. As stated

previously, the maintenance of

confidentiality encourages participation

in medical surveillance by allaying

employee concern that medical

conditions unrelated to tuberculosis

exposure will be communicated to the

employer. OSHA also recognizes that

successful medical surveillance and

medical management and follow-up

programs must guarantee this

confidentiality, the specific

requirements on confidentiality can be

found in applicable state and federal

laws and regulations that cover medical

privacy and confidentiality. Finally,

OSHA recognizes the need for this

provision and has included it in other

standards (e.g., Bloodborne Pathogens,

29 CFR 1910.1030).

Paragraph (h) Communication of

Hazards and Training

Paragraph (h), Communication of

Hazards and Training, addresses the

issues of transmitting information to

employees about the hazards of

tuberculosis through the use of labels,

signs, and information and training.

These provisions apply to all operations

that come under the coverage of
54272 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

paragraph (a), Scope, of this section.

Although OSHA has an existing

standard, Hazard Communication (29

CFR 1910.1200), which requires an

employer to inform employees about the

hazards of chemical substances they are

exposed to occupationally, that standard

does not apply to biological hazards

such as TB. Consequently, it is OSHA’s

intent in this paragraph to assure that

employees will receive adequate

warning through labels, signs, and

training so that the employee

understands the hazard and can take

steps to eliminate or minimize his or her

exposure to tuberculosis.

Paragraphs (h)(1) and (h)(2) of the

proposed standard for tuberculosis

provide the specific labeling and sign

requirements that are to be used to warn

employees of hazards to which they are

exposed. The requirements for labels

and signs are consistent with section

6(b)(7) of the OSH Act, which prescribes

the use of labels or other appropriate

forms of warning to apprise employees

of occupational hazards. As noted in

paragraphs (c)(2)(v), (d)(3), and (d)(5)

above, settings where home health care

and home-based hospice care are

provided are not required to have

engineering controls and, therefore, the

signs and labeling would not be

required in these cases.

Labels

Paragraph (h)(1)(i) requires that air

systems that may reasonably be

anticipated to contain aerosolized M.

tuberculosis must be labeled at all

points where ducts are accessed prior to

a HEPA filter and at duct access points,

fans, and discharge outlets of non-HEPA

filtered direct discharge systems. The

label must state ‘‘Contaminated Air—

Respiratory Protection Required.’’ The

provision for labeling of air ducts that

may reasonably be anticipated to

contain aerosolized M. tuberculosis,

with the proposed hazard warning, is

supported by the CDC in its discussion

of HEPA filter systems. This discussion

states:

Appropriate respiratory protection should

be worn while performing maintenance and

testing procedures. In addition, filter housing

and ducts leading to the housing should be

labeled clearly with the words

‘‘Contaminated Air’’ (or a similar warning).

(Ex. 4B)

The intent of this provision is to

assure that employees who may be

accessing these systems for the purposes

of activities such as maintenance,

replacement of filters, and connection of

additional ductwork are warned of the

presence of air that may contain

aerosolized M. tuberculosis so that

appropriate precautions can be taken.

Consequently, labels are to be placed at

all points where these systems are

accessed.

In situations where air that may

reasonably be anticipated to contain

aerosolized M. tuberculosis is

discharged directly to the outside, the

exhaust outlets are also to be labeled.

This is especially important since these

outlets will most likely be at a remote

location from the contaminated air

source. Employees working in these

locations would have no warning of the

hazard if these ducts were not labeled.

In addition, a number of exhaust outlets

from a variety of sources may be present

in an area (e.g., a hospital roof). In such

situations, labeling also serves to

distinguish contaminated air exhaust

outlets from others in the vicinity.

The proposed provision does not

require that a symbol (e.g., ‘‘STOP’’

sign) be included on the duct labels.

OSHA believes that, in many situations,

the label will be stenciled onto the duct,

similar to the labeling used on other

piping and duct labels currently being

employed in some of these facilities. In

addition, the group of workers accessing

ducts will likely be a well-defined,

skilled group that can be trained to

recognize the text’s warning. However,

OSHA seeks comment on whether a

symbol on duct labels is necessary and

any information regarding the current

use of such symbols.

Paragraph (h)(1)(ii) requires that

clinical and research laboratory wastes

that are contaminated with M.

tuberculosis and are to be

decontaminated outside of the

immediate laboratory must be labeled

with the biohazard symbol or placed in

a red container(s). This provision is

intended to assure that employees are

adequately warned that these containers

require special handling. In addition,

the label or color-coding serves as notice

that certain precautions may be

necessary should materials in the

container be released (e.g., a spill). This

provision closely follows the

recommendations outlined in the CDCNIH publication ‘‘Biosafety in

Microbiological and Biomedical

Laboratories’’ (Ex. 7–72) and is in

accordance with the labeling

requirements of paragraph (e)(2)(i)(D),

Clinical and Research Laboratories, of

this section.

Signs

Paragraph (h)(2) contains the

provisions relative to the posting of

warning signs in areas where employees

may be exposed to droplet nuclei or

other aerosols of M. tuberculosis. More

specifically, paragraph (h)(2)(i)(A)

requires that signs be posted at the

entrances to rooms or areas used to

isolate an individual with suspected or

confirmed infectious TB. The term

‘‘rooms or areas’’ is used in order to

expand the requirement beyond the

AFB isolation room or area. Throughout

the course of a day various employees

may enter such rooms or areas in order

to carry out their duties. These

employees can include physicians,

nurses, respiratory therapists,

housekeepers, and dietary workers.

Posting a sign at the entrance of those

rooms or areas where an individual with

suspected or confirmed infectious TB is

isolated serves to warn employees that

entry into the room or area requires that

certain precautions be taken. In

addition, the employer may have

implemented a program to minimize the

number of employees who enter such

rooms or areas. In this case, the sign

serves as notice that entry may not be

permitted for a particular employee or

group of employees. As an additional

public health benefit, such signs will

also provide warning to visitors or

family members who may be entering

the area and are unaware of the hazard.

Paragraph (h)(2)(i)(B) requires that

signs be posted at the entrances to areas

where procedures or services are being

performed on an individual with

suspected or confirmed infectious TB.

Although it is critically important to

provide appropriate warning to

employees who may inadvertently enter

an isolation room, other areas of the

facility are of concern as well. Special

treatment areas, such as bronchoscopy

suites, respiratory therapy areas where

cough-inducing procedures are

performed, or radiology examination

rooms may, at one time or another, be

occupied by an individual with

suspected or confirmed infectious TB.

When individuals with suspected or

confirmed tuberculosis are occupying

these areas, the area must have signs

placed at the entrances in order to warn

employees of the hazard.

The risk of exposure to aerosolized M.

tuberculosis also exists in clinical and

research laboratories where specimens,

cultures, and stocks containing the

bacilli are present. Therefore, paragraph

(h)(2)(i)(C) requires that a sign be posted

at the entrance to laboratories where M.

tuberculosis is present. Posting of such

a sign is consistent with the

recommendations of the CDC/NIH

publication ‘‘Biosafety in

Microbiological and Biomedical

Laboratories’’ (Ex. 7–72) and is in

accordance with the sign posting

requirement of paragraph (e)(2)(ii)(E),

Clinical and Research Laboratories, of

this section.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54273

Even though a suspected or confirmed

infectious individual is no longer

present in a room or area, the droplet

nuclei generated by that individual may

continue to drift in the air.

Consequently, the air in the room or

area presents a risk of TB infection until

the droplet nuclei are removed. With

this in mind, paragraph (h)(2)(ii)

requires that when an AFB isolation

room or area is vacated by an individual

with suspected or confirmed infectious

TB, unless the individual has been

medically determined to be

noninfectious, the sign shall remain

posted at the entrance until the room or

area has been ventilated according to

CDC recommendations for a removal

efficiency of 99.9%, to prevent entry

without the use of respiratory protection

[The rationale for specifying this

removal efficiency has been discussed

previously under paragraph (d), Work

Practices and Engineering Controls].

This provision is supported by the

CDC’s current recommendations for

tuberculosis control (Ex. 4B).

The CDC has published guidelines

regarding the length of time for such

sanitation of the room air based upon

the air exchanges per hour (see

Appendix C of this section). Requiring

that the sign remain posted until the

room or area is adequately ventilated

will assure that unprotected employees

do not inadvertently enter while an

infection risk is still present.

Until such time as the room or area

has been adequately ventilated,

employees entering the area must wear

respiratory protection. This paragraph is

designed to address the situations where

employees will be entering or using a

room or area previously occupied by an

individual with suspected or confirmed

infectious TB before the room or area

has been satisfactorily ventilated. For

example, when an infectious

tuberculosis patient is discharged from

a facility and the room is needed for an

incoming new patient, certain

housekeeping and maintenance

functions need to be done between

patient occupancies. Employees who

must perform the tasks required to

prepare the room for the next patient

must wear respiratory protection until

such time as the room has been

adequately ventilated, based upon the

CDC criteria. Obviously, if the room was

previously occupied by an individual

with suspected infectious TB and that

individual is medically determined to

be noninfectious, it would not be

necessary to ventilate the room to

remove M. tuberculosis nor to continue

to post a sign at the entrance to the room

since there would be no tuberculosis

bacilli present.

OSHA has given much consideration

to what sign should be required for

posting outside of isolation rooms or

areas and for areas where procedures or

services are performed on individuals

with suspected or confirmed infectious

TB. The purpose of the sign is to convey

a uniform warning along with the

necessary precautions to be used for the

particular situation.

The sign recommended by the CDC in

1983 in their ‘‘CDC Guidelines for

Isolation Precautions in Hospitals’’ (Ex.

7–112) read ‘‘AFB Isolation’’ and then

listed the requirements for entry.

However, the instructions on the CDC

sign are different from OSHA’s

requirements. For example, the sign

instructed workers that ‘‘Masks are

indicated only when patient is coughing

and does not reliably cover mouth’’, a

recommendation that is currently

outdated and no longer recommended

by CDC. The document contained

another sign for ‘‘Respiratory Isolation’’

but this sign was designed for use with

a number of respiratory hazards

(rubella, meningococcal meningitis,

chickenpox) that are not addressed in

OSHA’s proposed standard. Neither the

1990 CDC tuberculosis guidelines (Ex.

3–32) nor the 1994 CDC tuberculosis

guidelines (Ex. 4B) provided help with

this issue. OSHA also considered using

a sign having the words ‘‘AFB Isolation’’

however, there is some concern that

‘‘AFB Isolation’’ could compromise

patient confidentiality. For example,

that sign outside of a treatment area or

isolation room would allow members of

the public or employees with no ‘‘need

to know’’ to discern the potential

diagnosis of the individual being

isolated.

In addition, OSHA was unable to find

uniform recommendations about signs

in sources outside of the CDC. A

number of facilities use signs to warn

employees of the hazard of TB, but these

signs vary widely and often had been

developed for a particular facility. Thus,

facilities that were using TB warning

signs did not appear to be universally

applying a specific sign.

The Agency does not believe,

however, that development of a sign

should be left to individual employers

since this could lead to a variety of signs

that may not provide adequate warning

of the hazard. In the work settings

covered by the proposal, there are many

employees who move from facility to

facility or even from industry to

industry. In fact, a substantial number,

like contract nurses, will work in

several facilities at one time. A

universal sign will enable these

employees to recognize the hazard

wherever it occurs and then take proper

precautions. The issue of whether

OSHA should specify colors that must

be included on the sign was raised at TB

stakeholder meetings. OSHA realizes

there is a part of the population,

perhaps as high as 10% of all men, that

is color blind and that at some work

sites some colors have been employed

that are different from the red that

OSHA proposes be used. However,

stakeholders, particularly those whose

jobs took them to several different work

sites, urged OSHA to require a

standardized sign and, of those who

considered the issue, there was general

agreement that the red on the familiar

‘‘stop’’ sign was appropriate. OSHA has

preliminarily concluded that the colors

required provide needed warning even

though not all employees (e.g., those

who are color blind) may benefit from

them, and that the colors chosen are

consistent with conventions on health

signage. The Agency has developed a

sign that it believes will provide

appropriate warning and be easily

recognizable. Failing to find either a

guideline recommendation or a

generally accepted community standard

regarding what sign should be placed at

the entrances to these areas, OSHA

looked to generic, broad-based sources

for symbols which would be easily

identifiable, understandable to workers

who were not able to read well or are

non-English speaking, and simple to

construct.

In paragraph (h)(2)(iii), therefore,

OSHA is proposing that a ‘‘STOP’’ sign

with the accompanying legend, ‘‘No

Admittance Without Wearing A Type

N95 Or More Protective Respirator’’,

meets these criteria. The sign is easily

recognizable, requires a simple color

scheme, and should be understandable

to employees with minimal training.

OSHA is seeking information on the

effectiveness of the proposed sign to

warn workers of the presence of a

hazard, as well as information on other

signs that may be more effective. Please

be specific when providing information,

keeping in mind the wide variety of

work sites where signs will be needed.

Where an alternative is being proposed,

please enclose a model or drawing as

well as the rationale for believing that

it will be more effective than OSHA’s

proposed sign.

Paragraph (h)(2)(iv) requires that signs

at the entrances of clinical or research

laboratories and autopsy suites where

procedures are being performed that

may generate aerosolized M.

tuberculosis include the biohazard

symbol, name and telephone number of

the laboratory director or other

designated responsible person, the

infectious agent designation
54274 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

‘‘Mycobacterium tuberculosis’’, and

special requirements for entering the

laboratory or autopsy suite. This

provision has been taken directly from

the CDC/NIH publication ‘‘Biosafety in

Microbiological and Biomedical

Laboratories’’ (Ex. 7–72). As previously

discussed, the purpose for this sign is to

warn employees of the potential TB

hazard and inform them of precautions

that must be taken to prevent exposure.

Information and Training

It is OSHA’s position that employees

must understand the nature of the

hazards in their workplace and the

procedures to follow in order to

eliminate or minimize their risks of

exposure to these hazards. (Exs. 4–B, 7–

169, 7–170, 7–61, 7–64) In the case of

M. tuberculosis, employee exposures

may result in a TB infection, which may

ultimately result in disease and even

death. The provisions in paragraph

(h)(3) of this proposed standard set forth

the training that each employer must

provide to his or her employees. OSHA

believes that effective training is a

critical element in any occupational

safety and health program. In this

proposed standard, the employer would

be required to provide training for each

employee covered by the scope of the

standard.

Paragraph (h)(3)(i) requires that

employers assure that each employee

with occupational exposure participates

in training, which must be provided at

no cost to the employee and be made

available at a reasonable time and place.

Since appropriate training is considered

to be critical in assuring employee

protection, the employer is responsible

for making sure that each employee

with occupational exposure participates

in the training program. Having the

employee pay in some manner for all or

part of the training or requiring the

employee to attend training at an

unreasonable time and place would be

a disincentive to participation. If

training cannot feasibly be provided

during work hours, employees are to be

paid for training scheduled outside of

normal working hours.

In view of the importance of training,

OSHA is proposing that it be provided

at several particular points in time. (Exs.

7–169; 4–B) More specifically,

paragraph (h)(3)(ii) requires that training

be provided: (A) before initial

assignment to tasks where occupational

exposure may occur, for those

employees without previous

occupational exposure; (B) within 60

days after the effective date of the final

standard, for those employees who have

occupational exposure at the time of the

standard’s promulgation; and (C) at least

annually thereafter, unless the employer

can demonstrate that the employee has

the specific knowledge and skills

required under paragraph (h)(3)(vii).

The employer must provide re-training

to an employee in any of the topic(s) in

paragraph (h)(3)(vii) in which that

employee cannot demonstrate the

necessary knowledge and/or skill. This

approach to training frequency assures

that employees entering jobs with

occupational exposure will be fully

trained before exposure occurs. In

addition, employees who are already

working in jobs with occupational

exposure at the time of the standard’s

promulgation will receive training and

must become knowledgeable in all of

the required aspects of the standard

(e.g., employer’s exposure control plan,

medical surveillance program, warning

signs and labels) within a short period

of time.

Annual re-training reinforces the

initial training and provides an

opportunity to present new information

that was not available at the time of

initial training. The Agency recognizes

that, as a result of training previously

provided by the employer, employees

may possess some of the knowledge and

skills listed in the training topics in

paragraph (h)(3)(vii). Consequently,

OSHA is proposing that re-training be

provided annually unless the employer

can demonstrate that the employee has

the specific knowledge and skills

required by this paragraph. The

employer must provide re-training to an

employee in any topic(s) in paragraph

(h)(3)(vii) in which the employee cannot

demonstrate specific knowledge and

skills.

An employee with occupational

exposure to TB who moves to a job with

another employer that also involves

occupational exposure to TB would not

need to meet all of the initial training

requirements. In such instances, the

Agency has determined that the

employee’s prior training in the general

topics required by the standard (e.g., the

general epidemiology of tuberculosis,

the difference between tuberculosis

infection and tuberculosis disease)

would remain relevant in the new work

setting and that the new employer need

not re-train in these topics. However,

the employee would not possess

knowledge of the topics required by the

standard that are specific to the new

employer’s particular work setting (e.g.,

the new employer’s exposure control

plan and respiratory protection program

and the means by which the employee

could access the written plans for

review). OSHA is proposing to permit

limited ‘‘portability’’ of training, as

noted in the standard. This note states

that training in the general topics listed

in paragraph (h)(3)(vii) that has been

provided in the past 12 months by a

previous employer may be transferred to

an employee’s new employer. However,

the new employer must provide training

in the site-specific topics listed in

paragraph (h)(3)(vii) in accordance with

the requirements of paragraph (h) (e.g.,

at no cost to the employee and at a

reasonable time and place).

OSHA is aware that some employers

have already established training for

their occupationally exposed

employees. (Ex. 7–169) In light of this,

paragraph (h)(3)(iii) of the proposed

standard requires only that limited

training be conducted for those

employees who already have received

training on tuberculosis in the year

preceding the effective date of the

standard. The additional training would

only have to address those provisions of

the standard not previously covered in

the earlier training.

The requirement for annual training

within one year of the employee’s

previous training, in paragraph

(h)(3)(iv), assures that each employee

receives training within 12 calendar

months of his or her last training.

Annual training is not based on a

calendar year; that is, training will not

be permitted to be provided to an

employee in January of one year and in

December of the following year,

essentially a 23-month span between

training sessions. Employers may

establish schedules for training around

this requirement.

Also, paragraph (h)(3)(v) stipulates

that the employer must provide

additional training whenever changes in

the occupational environment, such as

modification of tasks or procedures or

institution of new tasks or procedures,

affect the employee’s occupational

exposure to M. tuberculosis. This

provision will assure that employees

remain apprised of any new exposure

hazards and the precautions necessary

to protect themselves from exposure.

This additional training does not need

to entail a complete reiteration of the

annual training, but may be limited to

addressing the new sources of potential

exposure.

The proposed standard requires that

training material be used that is

appropriate in content and vocabulary

to the educational level, literacy and

language of employees. Employees must

be able to comprehend the information

being conveyed in order for it to be

useful. Therefore, the employer has the

responsibility for assuring that the

training is provided in an

understandable manner to the audience

being addressed. This provision would
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54275

assure that employees, regardless of

their educational or cultural

background, will receive adequate

training.

Paragraph (h)(3)(vii) of the proposed

standard contains the specific elements

that would comprise a minimum

training program. (Exs. 4–B; 7–169; 7–

64) The provisions for employee

training are performance oriented,

stating the categories of information to

be transmitted to employees and not the

specific ways that this is to be

accomplished. This assures that

important information is communicated

to employees about the nature of this

occupational hazard while allowing

employers the most flexible approach to

providing training. OSHA has set forth

the objectives to be met and the intent

of training. The specifics of how the

employer assures that employees are

made aware of the hazards in their

workplace and how they can help to

protect themselves are left up to the

employer who is best qualified to tailor

the training to the TB hazards in his or

her workplace.

The proposed standard would require

the employer to explain a number of

particular topics in the training

session(s). Paragraph (h)(3)(vii)(A)

requires the employer to provide an

explanation of the contents of this

standard and the location of an

accessible copy of the regulatory text

and appendices to this standard. This

enables the employee to have access to

the standard and to become familiar

with its provisions. It is not necessary

for the employer to provide each

employee with a copy of the standard;

it is sufficient for the employer simply

to make a copy accessible. For example,

a copy of the standard could be posted

in a location where it could be readily

and easily viewed by employees.

An important element in the training

involves an overview of the

epidemiology of tuberculosis, the

pathogenesis of the disease and an

explanation of various aspects of risk to

employees. (Ex. 4B) More specifically,

paragraph (h)(3)(vii)(B) requires that the

training include an explanation of: the

general epidemiology of tuberculosis,

including multidrug-resistant TB and

the potential for exposure in the facility;

the signs and symptoms of TB,

including the difference between TB

infection and TB disease; the modes of

transmission of tuberculosis, including

the possibility of reinfection in persons

with a positive tuberculin skin test; and

the personal health conditions that

increase an employee’s risk of

developing TB disease if infected.

Since the employer can tailor the

training to the needs of his or her

employees, the training program will

likely be more technical for some

audiences and less technical for others.

The general goal of this paragraph is to

assure that each employee being trained

understands what tuberculosis is, how it

is spread, and possible risks that may

affect the employee.

Employees need to be able to

recognize symptoms associated with TB

disease. (Ex. 4B) The employee must

understand that certain symptoms (e.g.,

a persistent cough lasting 3 or more

weeks, bloody sputum, night sweats,

anorexia, weight loss, fever) may be

related to TB. In addition, information

on non-occupational risk factors that

place employees at increased risk of

developing tuberculosis disease

following an infection permits those

individuals at increased risk to make

informed decisions about their

employment situations.

Paragraph (h)(3)(vii)(C) requires an

explanation of the employer’s exposure

control plan and respiratory protection

program. Employees must also be

informed about what steps they need to

take to review the written plans, if they

so desire.

Paragraph (h)(3)(vii)(D) requires the

employer to train employees regarding

the tasks and other activities that may

involve occupational exposure to

tuberculosis. Employees must be made

aware of those job duties which may

expose them to tuberculosis. For

example, although certain health care

professionals may easily recognize the

hazard involved in transporting a

person with infectious TB, the staff of a

correctional facility may not. On the

other hand, some health care

professionals may not immediately

recognize that their mere presence in a

room where an individual with

suspected or confirmed infectious TB is

being X-rayed presents an exposure risk

and necessitates wearing a respirator.

All occupationally exposed employees

need training that will enable them to

recognize those activities that put them

at risk of exposure.

Paragraph (h)(3)(vii)(E) of this section

requires employers to train employees

regarding both the uses and limitations

of various control measures, specifically

those used at the employees’ worksite.

Exposed employees must be familiar

with the employer’s tuberculosis

policies and procedures in order for

them to be properly implemented.

Control of exposure frequently involves

using a variety or combination of

engineering controls, administrative

controls, work practice procedures and

personal protective equipment. To

assure that employees will be able to

identify and implement methods of

reducing occupational exposure to

tuberculosis, they must understand how

these controls are applied in their work

sites and the limitations thereof. With

this understanding, employees will be

more likely to use the appropriate

control for the situation at hand and to

use it correctly. For example, employees

must be able to recognize the labels and

signs used to identify rooms or areas

where suspected or confirmed

infectious individuals are present so

that they can take appropriate

precautions before entering.

Understanding of the limitations of

control measures will also enable

employees to recognize when

inappropriate or inadequate control

measures have been taken and increases

the likelihood that they will report such

situations.

Training must be relevant to the

specific site where the employee will be

working. Each employee must know, for

example, the procedures used in his or

her particular facility to identify

suspected infectious TB cases, where

respiratory protection is kept, and what

engineering controls are in place within

the facility. This training is particularly

important for workers who move

between several facilities in the course

of their work, for example, ‘‘leased’’

personnel, part-time employees,

‘‘moonlighters’’, or contractors.

The provision covering the selection,

types, proper use, location, removal and

handling of respiratory protection,

paragraph (h)(3)(vii)(F), is particularly

important because many of the

employees and employers proposed to

be covered by the tuberculosis standard

may not be accustomed to the use,

selection, and upkeep of respiratory

protection. Consequently, training on

aspects such as the necessity for

respiratory protection, the appropriate

type of respiratory protection, where to

obtain it, and its proper use, fit, and the

general upkeep is necessary to assure

the effectiveness of respirator use. (Ex.

7–64)

OSHA believes that employees who

have a clear understanding of the

medical surveillance program (its

purpose, methodology, and the

significance of the results of

examinations and tests), will be much

more likely to participate in that

program. Therefore, paragraph

(h)(3)(vii)(G) requires that the training

include an explanation of the

employer’s medical surveillance

program, including the purpose of

tuberculin skin testing, the importance

of a positive or negative skin test result,

anergy testing, and the importance of

participation in the program. This

increased participation by trained
54276 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

employees helps the employee to

identify changes in his or her personal

health status and also aids the employer

in assessing the effectiveness of his or

her TB control program.

Each employee must understand the

actions to be taken if an occupational

exposure occurs as well as what is

available to them regarding appropriate

medical treatment, prophylaxis, and

post exposure follow-up in order for the

employee to lessen the chance of

developing active disease. Therefore,

paragraph (h)(3)(vii)(H) would require

an explanation of the procedures to

follow if an exposure incident occurs,

including the method of reporting the

incident, an explanation of the medical

management and follow-up that the

employer is required to provide, and the

benefits and risks of drug prophylaxis.

In addition, the employee must be

provided with an explanation of the

procedures to follow if the employee

develops signs or symptoms of

tuberculosis disease [paragraph

(h)(3)(vii)(I)]. In this way, an employee

who notes the signs or symptoms of

personal disease development will be

aware of the appropriate steps to take,

thereby speeding initiation of medical

evaluation. Quick evaluation protects

the employee, co-workers, and the

public.

In paragraph (h)(3)(viii), the proposed

standard mandates that the person

conducting the training must be

knowledgeable in the subject matter as

it relates to the specific workplace being

addressed. OSHA believes that a variety

of persons are capable of providing

effective training to employees. OSHA

has approached this section of the

proposed standard in much the same

way as the trainer requirements were

addressed in the standard for

Occupational Exposure to Bloodborne

Pathogens. That is, a knowledgeable

trainer is one who is able to demonstrate

expertise in the area of the occupational

hazard of tuberculosis and is familiar

with the manner in which the elements

of the training program relate to the

particular workplace.

A number of resources are available

through the Centers for Disease Control

and Prevention and professional

organizations such as the American

Lung Association and the American

Thoracic Society that can be used to

educate trainers and prepare them for

this task. In addition, specialized

training courses in the area of

tuberculosis control can also assist in

educating trainers (Ex. 7–189).

In addition to general knowledge of

the subject matter, it is important that

the trainer be able to instruct the

participants in site-specific features of

the Exposure Control Plan that will

reduce their risk in the particular

facility. This benefits not only

employees within the facility but also

provides temporary employees with the

information needed to protect

themselves against exposure while

working in the facility. For example,

workers who have received general

training by their employer (e.g., a

personnel staffing agency) will also

receive training about the facility where

they will actually perform their duties

(e.g., a specific hospital).

An important component of an

effective learning experience is the

opportunity for the learner to interact

with the trainer for the purposes of

asking questions and obtaining

clarification. Paragraph (h)(3)(ix) would

require that the employer provide

employees with this opportunity as part

of the training program. The trainer

must be available at the time that the

training takes place. OSHA would

expect that in most instances, the

individual who would provide answers

to the employee’s question would be

physically present when the employee

is trained. The Agency does recognize,

however, that there may be some

instances where this is not possible. In

these cases, it would be acceptable for

the employee to ask questions by

telephone.

An employer would not be expected

to train employees in site-specific topics

that are not applicable to the employer’s

work setting. For example, if a facility

was not required by the standard to

utilize engineering controls, the

employer would not be responsible for

training his or her employees about the

various aspects of engineering controls.

OSHA believes that the information

and training requirements incorporated

into this proposed standard are needed

to inform employees about the hazard of

tuberculosis and to provide employees

with an understanding of the degree to

which they can minimize the health

hazard. Training is essential to an

effective overall hazard communication

program and serves to explain and

reinforce the information presented to

employees on signs and labels. These

forms of information and warning will

be meaningful only when employees

understand the information presented

and are aware of the actions to be taken

to avoid or minimize exposure.

OSHA seeks comment on the

proposed content of the training

program and requests that model TB

training programs be submitted to the

docket, particularly those designed for

audiences whose participants may have

language difficulties or have no health

care background, and those that have

been judged to be successful in

communicating information to

employees. It is OSHA’s intent, upon

publication of the final standard, to

include information on training

programs in compliance guides to be

developed for small entities.

Paragraph (i) Recordkeeping

This proposed standard requires

employers to keep records related to TB,

including medical surveillance and

training records for all employees with

occupational exposure and engineering

control maintenance and monitoring

records. OSHA has made a preliminary

determination that, in this context,

medical and training records are

necessary to assure that employees

receive appropriate information on

hazards and effective prevention and

treatment measures, as well as to aid in

the general development of information

on the occupational transmission of TB.

Specifically, OSHA believes that

maintenance of medical records is

essential because documentation is

necessary to ensure proper evaluation of

an employee’s infection status and for

prompt and proper healthcare

management following an exposure

incident. OSHA has also preliminarily

determined that maintenance and

monitoring records for engineering

controls are necessary for two reasons:

to enable the employer to know that the

control methods remain in good

working order so as to assure their

effectiveness and to aid the Agency in

enforcement of the standard.

In paragraph (i)(1), OSHA proposes to

require employers to establish and

maintain a medical record in

accordance with 29 CFR 1910.1020 for

each employee with occupational

exposure to TB. The record must

include: (A) The name, social security

number, and job classification of the

employee; (B) A copy of all results of

examinations, medical testing,

including the employee’s tuberculin

skin test status; and follow-up

procedures required by paragraph (g);

(C) The employer’s copy of the

physician’s or other licensed health care

professional’s written opinion as

required by paragraph (g)(7); and (D) A

copy of the information provided to the

physician or other health care

professional required by paragraph

(g)(6). The information that must be

included in the medical record is

necessary for the proper evaluation of

the employee’s infection status and

management of occupational exposure

incidents. This record will aid OSHA in

enforcing the standard and the

information therein, when analyzed,

will further the development of health
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54277

data on the causes and prevention of

occupational transmission of TB.

Similar provisions for collection and

retention of such information have been

included in other OSHA health

standards including, most recently,

Bloodborne Pathogens (29 CFR

1910.1030) and Cadmium (29 CFR

1910.1027).

In paragraph (i)(1)(iii), OSHA is

proposing to require that the employee

medical records be kept confidential

and not be disclosed or reported to

anyone without the employee’s express

written consent except as required by

section i or as may be required by law.

In nearly every health standard

rulemaking, employees have told the

Agency that keeping medical records

confidential is extremely important to

them. Employees stated that, without

assurance of confidentiality, they would

be reluctant to participate in medical

surveillance, a predicament that would

be detrimental to their health and could

affect health and safety conditions in

the workplace. During the Bloodborne

Pathogens rulemaking, confidentiality of

medical records was a major issue due

to the nature of the diseases addressed.

Of particular concern was keeping the

medical records from being disclosed to

the employer. It was explained in the

Bloodborne Pathogens standard and is

applicable here that such confidentiality

can be accomplished by having the

records kept by the physician or other

licensed health care provider at the

expense of the employer. In those cases

where the employer is the health care

provider, the records can be maintained

separately from other employee records

so that disclosure can be strictly limited

to the physician or other licensed health

care professional and his or her staff

who are responsible for the medical

management of the employee. It was

pointed out in the preamble to the

Bloodborne Pathogens standard, and

bears repeating here, that the

confidentiality provisions in the

proposed standard are reiterations of

existing standards of conduct in the

health care professions and that the

OSHA requirements do not abridge,

enlarge or alter existing ethical or

statutory codes (56 FR 64170). This

section of the proposal requires that

medical records be disclosed to the

Assistant Secretary or the Director (of

NIOSH) and as may be required by law,

which means that this proposed

standard would not prevent employers

from reporting TB cases to federal, state,

or municipal health departments where

that reporting is required by law.

Paragraph (i)(1)(iv) proposes to

require that medical records be

maintained in accordance with 29 CFR

1910.1020 for at least the duration of

employment plus 30 years. The Access

to Medical Records Standard contains

an exception to the 30-year requirement

that provides that the medical records of

an employee who has worked less than

one year must be maintained throughout

his or her employment, but need not be

retained afterwards as long as they are

given to the employee upon termination

of employment. Maintaining the records

for the duration of employment serves

several purposes: the records can

provide valuable information to the

employee’s healthcare provider; the

records enable the employer to know

that employees are benefitting from

regular surveillance and timely

intervention following occupational

exposure to TB; analysis and

aggregation of the records can provide

insight into the causes and

consequences of occupational exposure

to TB; and, the records will aid in the

enforcement of the standard. Requiring

the records to be kept 30 years beyond

employment is necessary because TB

can have a long incubation period, with

disease often appearing only many years

after initial infection. This retention

time is also consistent with other OSHA

health standards (See for example

Benzene, 29 CFR 1910.1028; Bloodborne

Pathogens, 29 CFR 1910.1030; Ethylene

Oxide, 29 CFR 1910.1047).

In paragraph (i)(2), OSHA proposes to

require employers to record TB

infection and disease in accordance

with 29 CFR 1904, Recording and

Reporting Occupational Injuries and

Illnesses, and 29 CFR 1960, the

equivalent requirement for Federal

Agency programs. This should not be an

unfamiliar requirement to employers

because occupational TB infections and

disease must be reported in accordance

with 29 CFR 1904 and 29 CFR 1960, as

directed by current OSHA enforcement

policy (Ex. 7–1).

In paragraph (i)(3), OSHA proposes to

require training records, which include:

(A) The dates of the training sessions;

(B) The contents or a summary of the

training sessions; (C) The names and

qualifications of persons conducting the

training; and (D) The name and job

classification of all persons attending

the training sessions. This requirement

is consistent with other OSHA

standards, particularly Bloodborne

Pathogens, and it represents the

minimum amount of information an

employer, an employee, or an OSHA

compliance officer would need in order

to determine when and what training

had been provided, who administered it

and who attended. Additionally, such a

record is an invaluable aid to the

employer when evaluating his or her

training program.

OSHA proposes, in paragraph (i)(3)(ii)

to require that training records be

maintained for three years beyond the

date the training occurred. The Agency

anticipates that employers will not have

difficulty maintaining the records for

three years because the information to

be included is not extensive and many

employers are already keeping training

records three years as required by other

OSHA standards (e.g., Bloodborne

Pathogens, 29 CFR 1910.1030).

Moreover, these records are not required

to be kept confidential and so may

become part of an employee’s personnel

file or part of a larger file, at the

discretion of the employer.

In paragraph (i)(4), OSHA proposes to

require engineering control maintenance

and monitoring records be kept that

include: (A) Date; (B) Equipment

identification; (C) Task performed; and

(D) Sign-off. The performance

monitoring records must include: (A)

Date and time; (B) Location; (C)

Parameter measured; (D) Results of

Monitoring; and (E) Sign-off. Only two

of these items will require more than a

few words or numbers to record; the two

items that require more extensive

information are the maintenance task

performed and the results of the

performance monitoring. Where the

employer has not already developed a

method for recording the task

performed, the maintenance person can

list the tasks or use a previously

prepared check-list. The results of

performance monitoring can be

recorded in the same way or another

way that meets the needs of the

particular workplace so long as it

includes all of the information required

by the paragraph. OSHA believes that

the information in these records is the

usual data that are generated by persons

maintaining and servicing equipment so

that the status of the equipment and its

effectiveness can be known for a given

time. The information is also useful in

determining when further servicing is

needed.

Proposed paragraph (i)(4)(iii) requires

engineering control maintenance and

monitoring records to be maintained for

three years. The three year period is a

reasonable period of time and it will

enable the employer to develop and

sustain a proper maintenance program

and to track the effectiveness of the

controls. Moreover, the records will aid

the OSHA compliance officer in

enforcing the standard’s requirements

for engineering controls.

Availability of medical records is

specified in section 8(c) of the Act. In

paragraph (i)(5) of this standard, OSHA
54278 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

proposes to restrict the availability of

employee medical records while making

employee training records and

engineering control and monitoring

records generally available upon

request. Medical records must be

provided to the subject employee, to

anyone having written consent from the

employee, to the Director and to the

Assistant Secretary in accordance with

29 CFR 1910.1020, which sets forth the

procedures that will protect the privacy

concerns of the employees. This

paragraph does not affect existing legal

and ethical obligations concerning

maintenance and confidentiality of

employee medical records. An

employer’s access is governed by

existing federal, state and local laws and

regulation. This standard, like

Bloodborne Pathogens (29 CFR

1910.1030) and other OSHA standards,

limits employer access to confidential

information while allowing the

employer access to the information

needed to make appropriate decisions

relative to his or her medical

surveillance program. For example,

paragraph (g)(7)(ii) limits the

information that can be included in the

physician’s or other licensed health care

professional’s written opinion and

paragraph (g)(7)(iii) requires that other

medical diagnoses or findings be kept

confidential. There is no language in

this proposed standard that grants an

employer access to the confidential

information in an employee’s medical

file. OSHA illness and injury records are

accessible under 29 CFR 1904 and 29

CFR 1960, as appropriate, to the facility.

In this proposal, as in OSHA’s other

health standards, training records and

engineering control maintenance and

monitoring records are to be provided

upon request to the employees, their

representatives, the Director and the

Assistant Secretary. Employers should

not have difficulty complying with this

provision because most will have

experience with such recordkeeping

from other standards. There are no

confidentiality issues raised by these

records.

In paragraph (i)(6), an employer who

goes out of business is required to

transfer medical records as set forth in

29 CFR 1910.1020(h) and 29 CFR 1904,

which address the transfer of medical

records. Specifically, medical records

must be transferred to a successor

employer who must accept them and

keep them in accordance with the

requirements of 29 CFR 1910.1020. In

the event the employer ceases to do

business and there is no successor

employer, the employer is required to

notify the Director, at least three months

prior to disposal of the records, and

transmit them to the Director if required

by the Director to do so. This is

consistent with other health standards

and ensures that a successor employer

(and the employees) can benefit from

the information contained in the

records. The reason the records are

transferred (if requested) to the Director

of NIOSH is that NIOSH has a vested

interest in maintaining records of

occupational injuries and illnesses and

is in an excellent position to decide how

the records can be best used to be of

value to the exposed employee,

subsequent employees in the field and

OSHA. At NIOSH, the records remain

confidential as required by 29 CFR

1910.1020(e). Thus, only the employee

or his or her representative with the

permission of the employee retains

access to the medical records transferred

to NIOSH.

Paragraph (j) Definitions

Acid-Fast Bacilli (AFB) means

bacteria that retain certain dyes after

being washed in an acid solution. Most

acid-fast organisms are mycobacteria.

Smears of sputum samples and other

clinical specimens may be stained with

dyes to detect acid-fast mycobacteria

such as M. tuberculosis. However, AFB

smear tests cannot distinguish one type

of mycobacteria from another.

Therefore, as noted by CDC, when AFB

are seen on a stained smear of sputum

or other clinical specimens, a diagnosis

of TB should be suspected; however, the

diagnosis of TB is not confirmed until

a culture is grown and identified as M.

tuberculosis (Ex. 4B).

Accredited Laboratory for purposes of

this standard means a laboratory that

has participated in a quality assurance

program leading to a certification of

competence administered by a

governmental or private organization

that tests and certifies laboratories.

Under the medical surveillance

provisions of the proposed standard,

paragraph (g)(1)(iv) requires that all

laboratory tests required by the standard

be conducted by an accredited

laboratory. This definition makes clear

OSHA’s intent about the type of

laboratory that would be required to

conduct these types of tests.

The term AFB Isolation Room or Area

refers specifically to the rooms or areas

where individuals with suspected or

confirmed infectious TB are isolated.

For purposes of this standard this term

includes, but is not limited to, rooms,

areas, booths, tents or other enclosures

that are maintained at negative pressure

relative to adjacent areas in order to

control the spread of aerosolized M.

tuberculosis. Such rooms or areas are

able to contain droplet nuclei through

unidirectional airflow into the room

(i.e., negative pressure). A definition of

negative pressure is presented below

and a more detailed explanation can be

found in the Summary and Explanation

of paragraph (d), Work Practices and

Engineering Controls.

Air purifying respirator means a

respirator that is designed to remove air

contaminants from the ambient air or air

surrounding the respirator. Air

purifying respirators remove particular

contaminants (e.g., particulates, organic

vapors, acid gases) from the ambient air

by drawing the air through appropriate

filters, cartridges, of canisters.

Anergy means the inability of a

person to react to skin test antigens

(even if the person is infected with the

organism(s)tested because of

immunosuppression. More specifically,

an anergic individual’s immune system

has become so compromised that it is

unable to mount a sufficient reaction to

the test organism. Because of their

inability to respond immunologically,

persons with anergy will have a

negative tuberculin skin test even if they

are infected with M. tuberculosis.

Therefore, as noted by the CDC, it may

be necessary to consider other

epidemiologic factors (e.g., the

proportion of other persons with the

same level of exposure who have

positive tuberculin skin test results and

the intensity or duration of exposure to

infectious TB patients that the anergic

person experienced) when making a

determination as to whether that anergic

individual has been infected with M.

tuberculosis (Ex. 4B). As discussed

under paragraph (g)(2)(iii), Medical

Surveillance, tuberculin skin testing is

to include anergy testing when the

physician or other licensed health care

professional, as appropriate, determines

such testing is necessary. Knowing

which individuals are anergic will help

to determine those situations where

information other than skin test status

will need to be ascertained and

considered in order to assess the

likelihood of infection for exposed

employees.

Assistant Secretary means the

Assistant Secretary of Labor for

Occupational Safety and Health, or

designated representative, and is a

definition consistent across all OSHA

standards.

BCG (Bacille Calmette-Guerin)

vaccine means a tuberculosis vaccine

used in many parts of the world.

Because of its variable efficacy and its

impact upon tuberculin skin tests (i.e.,

making skin test interpretation more

difficult), routine BCG vaccination is

not currently recommended in the
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54279

United States (Ex. 7–50). However,

many foreign countries still use BCG as

part of their tuberculosis control

programs, especially for infants (Ex. 7–

72). Since individuals vaccinated with

BCG may have a tuberculin skin test

that cannot be distinguished reliably

from a reaction caused by infection with

M. tuberculosis, it is helpful to know

whether an individual has been

vaccinated with BCG and when such

vaccination occurred. Thus, under the

medical surveillance provisions of the

proposed standard, the medical history

is to include a history of BCG

vaccination.

Cartridge or canister means a

container with a filter, sorbent, or

catalyst, or a combination of these

items, that removes specific air

contaminants from the air drawn

through the container. With respect to

this standard, respirators would be

equipped with cartridges or canisters

containing particulate filters.

Clinical laboratory has been defined

for purposes of this standard as a facility

or an area of a facility that conducts

routine and repetitive operations for the

diagnosis of TB, such as preparing acidfast smears and culturing sputa or other

clinical specimens for identification,

typing or susceptibility testing. This

definition is meant to apply to

laboratories where routine diagnostic

tests for TB are conducted as compared

to research laboratories where M.

tuberculosis may be cultured in large

volumes or concentrated for research or

commercial production. Clinical

laboratories may be located within

facilities such as hospitals or clinics, or

they may be freestanding facilities.

Confirmed infectious tuberculosis

(TB) means a disease state that has been

diagnosed by positive identification of

M. tuberculosis from body fluid or tissue

through positive culture, positive gene

probe, or positive polymerase chain

reaction (PCR); and the individual is

capable of transmitting the disease to

another person. The disease state may

be manifested as pulmonary or laryngeal

TB or extrapulmonary TB if the infected

tissue is exposed and could generate

droplet nuclei.

As discussed under the definition for

AFB, a positive AFB smear indicates

only that an individual has an

identifiable mycobacterium. The three

methods listed here provide positive

confirmation of M. tuberculosis. In

addition, the definition states that the

disease state must be capable of being

transmitted to another person (i.e.,

infectious). This provision of the

definition is to differentiate this state of

the disease from other active forms of

TB disease where the individual is not

infectious. For example, an individual

may contract active TB disease and

become infectious. After adequate drug

therapy has been initiated the

individual may become noninfectious,

at which point he or she cannot transmit

the disease to other individuals.

However, the individual, while no

longer infectious, still has active disease

and must continue treatment for several

months because living bacilli are still in

his or her body. The definition also

states that the disease may be

manifested as pulmonary or laryngeal

TB or extrapulmonary TB if the infected

tissue is exposed and could generate

droplet nuclei. In most cases, it is the

pulmonary or laryngeal forms of

infectious TB that present a risk of

infection for other individuals. This is

due to the fact that tuberculosis bacilli

in the pulmonary or laryngeal tracts

may be easily dispelled when infectious

individuals cough or speak. Other body

sites infected with the bacilli, i.e.,

extrapulmonary TB, do not present an

infection hazard in most cases because

the bacilli are not capable of being

dispelled outside the body. However, in

some situations, such as a lesion or an

abscess where the infected tissue is

exposed, there may be a risk of

transmission of disease when certain

procedures are performed (e.g., tissue

irrigation) that could generate droplet

nuclei containing the bacilli.

Conversion means a change in

tuberculin skin test results from

negative to positive, based upon current

Centers for Disease Control and

Prevention (CDC) guidelines. Under

paragraph (g), the employer is required

to provide medical management and

follow-up to employees who have

converted to positive tuberculin skin

test status (e.g., providing preventive

therapy, if appropriate, and conducting

follow-up investigations of

circumstances surrounding the

conversion). Since a number of specific

actions are required of the employer as

a result of a conversion, it is necessary

that conversions be correctly identified.

An important part of this identification

is the interpretation as to whether an

employee has a positive skin test

response. As such, this definition states

that the interpretation of the positive

reaction should be based upon current

CDC guidelines (Ex. 4B). It is not

OSHA’s intent to define what should

constitute a positive reaction, but rather

to assure that such determinations are

made using currently accepted public

health guidelines.

Director means the Director of the

National Institute for Occupational

Safety and Health, U.S. Department of

Health and Human Services, or

designated representative. Similar to the

definition for Assistant Secretary, the

definition for Director is consistent

across OSHA standards.

Disposable respirator means a

respiratory protective device that cannot

be resupplied with an unused filter or

cartridge and that is to be discarded in

its entirety after its useful service life

has been reached. In general, the

facepiece of these respirators is

constructed from the particular filter

media of interest (e.g., particulate filter).

Exposure incident for purposes of this

standard means an event in which an

employee has been exposed to an

individual with confirmed infectious TB

or to air containing aerosolized M.

tuberculosis without the benefit of all of

the applicable exposure control

measures required by this section. This

definition is limited to those situations

involving exposure to an individual

with confirmed infectious TB or air

originating from an area where a source

of aerosolized M. tuberculosis is present;

it does not include exposure to

individuals with suspected infectious

TB. OSHA has limited the definition in

this way because several provisions in

the proposed standard are triggered by

the occurrence of an exposure incident.

For example, under paragraph (g),

Medical Surveillance, the employer is

required to provide additional

tuberculin skin testing to each affected

employee and to investigate and

document the circumstances

surrounding each exposure incident to

determine if changes can be instituted to

prevent similar occurrences in the

future. OSHA believes that it would be

burdensome and unnecessary for the

employer to conduct follow-up

investigations for those occurrences

where an employee’s exposure is to an

individual suspected of having

infectious TB but for whom infectious

disease is subsequently ruled out.

An example of an exposure incident

is an employee entering an AFB

isolation room or area occupied by an

individual with confirmed infectious TB

without the employee wearing

appropriate personal respiratory

protection equipment. This occurrence

would not be defined under the

standard as an exposure incident if the

individual in the AFB isolation room

had only suspected infectious TB. If the

individual in AFB isolation room was

later confirmed to have infectious TB,

the employee entering the isolation

room without appropriate respiratory

equipment would then be considered to

have had an exposure incident and the

required medical management and

follow-up provisions for an exposure
54280 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

incident under paragraph (g), Medical

Surveillance, would be required.

Another example of an exposure

incident is a failure of engineering

controls, e.g., the ventilation system in

an AFB isolation room housing an

individual with confirmed infectious TB

malfunctioned, negative pressure was

lost, and air containing M. tuberculosis

was dispelled into the hall corridor,

exposing unprotected employees.

Although OSHA would consider this

type of loss of negative pressure in an

AFB isolation room to be an exposure

incident, the Agency does not intend

that each opening of the door to an AFB

isolation room be considered an

exposure incident, even though some

loss of negative pressure may result

when the door to an AFB isolation room

is opened. As a practical matter, OSHA

believes it would be infeasible to

consider every instance that a door to an

isolation was opened as an exposure

incident. In addition, these losses of

negative pressure are generally small, if

doors are kept open only briefly for

purposes of entry and exit and are kept

closed at all other times while the room

is in operation for TB isolation as

required under the Work Practices and

Engineering Controls paragraph

(d)(5)(vi).

There is a significant difference in the

meaning of the terms ‘‘exposure

incident’’ and ‘‘occupational exposure’’

as they are used in this standard. This

difference is discussed further under the

definition of ‘‘occupational exposure’’.

Filter means a component used in

respirators to remove solid or liquid

aerosols from the inspired air. The filter

is the medium that captures the aerosol,

preventing it from passing through to

the respirator wearer.

Fit factor is a quantitative measure of

the fit of a particular respirator on a

particular individual. Fit factor is

derived from the ratio of the

concentration of a challenge agent (or

air pressure) outside of the respirator to

the concentration of the test agent (or air

pressure) inside the respirator.

High Efficiency Particulate Air

(HEPA) Filter means a specialized filter

that is capable of removing 99.97

percent of particles greater than or equal

to 0.3 micrometer in diameter.

High-hazard procedures are those

procedures performed on an individual

with suspected or confirmed infectious

tuberculosis in which the potential for

being exposed to M. tuberculosis is

increased due to the induction of

coughing or the generation of

aerosolized M. tuberculosis. Such

procedures include, but are not limited

to, sputum induction, bronchoscopy,

endotracheal intubation or suctioning,

aerosolized administration of

pentamidine or other medications, and

pulmonary function testing. They also

include autopsy, clinical, surgical and

laboratory procedures that may

aerosolize M. tuberculosis. The

procedures listed above present a high

hazard because they are performed on

individuals with suspected or

confirmed infectious TB or on

specimens or deceased individuals

where M. tuberculosis may be present.

For example, some of the procedures

listed above, such as bronchoscopies

and pentamidine administration, cause

people to cough. For individuals with

pulmonary TB, coughing will increase

the likelihood that they will generate

aerosols with a high concentration of

droplet nuclei. In addition, certain

autopsy procedures, such as cutting into

a lung containing M. tuberculosis, and

certain laboratory procedures, such as

processing infected tissue samples with

pressurized freezants, can generate

aerosols containing droplet nuclei. In

the absence of M. tuberculosis, these

procedures would not be high-hazard.

For example, endotracheal intubation

on an individual who does not have

suspected or confirmed infectious TB

would not be considered a high-hazard

procedure.

M. tuberculosis means Mycobacterium

tuberculosis, the scientific name of the

bacillus that causes tuberculosis.

Negative Pressure means the relative

air pressure difference between two

areas. A room that is under negative

pressure has lower pressure than

adjacent areas, which keeps air from

flowing out of the room and into

adjacent rooms or areas. Paragraph

(d)(5)(i) of Work Practices and

Engineering Controls requires that

negative pressure be maintained in all

AFB isolation rooms or areas, and

paragraph (d)(4) requires that all highhazard procedures be performed in such

rooms or areas. Maintaining negative

pressure in such rooms or areas helps to

assure that droplet nuclei are contained

and not spread to other areas of the

facility where unprotected employees

may be exposed. A further discussion of

this principle can be found in the

Summary and Explanation of paragraph

(d), Work Practices and Engineering

Controls.

Negative pressure respirator means a

respirator in which the air pressure

inside the facepiece is negative during

inhalation with respect to the ambient

air pressure outside the respirator. In a

negative pressure respirator, the

wearer’s inhalation creates a drop in

pressure inside the facepiece,

consequently drawing outside air

through the filter and into the respirator.

Occupational exposure is one of the

key terms upon which the proposed

standard rests. It contains the criteria

that trigger application of the standard

for employees in work settings covered

under the scope of the standard as listed

in paragraphs (a)(1) through (a)(8) and

for employees providing the care and

services listed in paragraphs (a)(9) and

(a)(10). Although a variety of work

settings and several specific types of

work are covered within the scope of

the standard, it is only employees who

have ‘‘occupational exposure’’ in those

work settings and who are providing the

particular services that must be given

the protection mandated by the

standard. The exception to this is that

an employer covered under paragraph

(a), scope, must provide medical

management and follow-up to other

employees who have an exposure

incident.

For purposes of this standard,

occupational exposure means

reasonably anticipated contact, which

results from the performance of an

employee’s duties, with an individual

with suspected or confirmed infectious

TB or air that may contain aerosolized

M. tuberculosis. An example of

reasonably anticipated contact between

an employee and an individual with

suspected or confirmed infectious TB

would be an admissions clerk working

in a homeless shelter. In view of the

high incidence of TB among the

homeless, it can reasonably be

anticipated that an employee screening

people for admission into the shelter

would have contact with a person with

infectious TB during the performance of

his or her job duties. Another, more

obvious, example would be a

bronchoscopist in a hospital that

provides care for individuals with

suspected or confirmed infectious TB.

Others could include some physicians,

nurses, paramedics and emergency

medical technicians, health aides,

prison guards, and intake workers in the

facilities listed in paragraph (a) of this

section. An example of an employee

who would not be reasonably

anticipated to have occupational

exposure is an worker, in a covered

facility, whose duties were limited to

working in an area where suspected or

confirmed TB patients or clients do not

go and where the air would not contain

aerosolized Mycobacterium

tuberculosis. The risk of exposure for

this employee is comparable to the

exposure potential by the general

population.

The term occupational exposure is

used differently than the term exposure

incident in the proposed standard.

Occupational exposure is used to define
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54281

a condition of the employee’s work and

to identify which employees are affected

in a way that can reasonably be

anticipated, due to their job duties, to

involve potential exposure to

aerosolized M. tuberculosis, i.e., contact

with an individual with suspected or

confirmed infectious TB or with air that

may contain aerosolized M.

tuberculosis. The intent of the standard

is to prevent exposure to aerosolized M.

tuberculosis; therefore, certain proactive

measures are required by the standard,

e.g., training and medical surveillance,

when occupational exposure is present.

In order to provide these measures, it is

necessary to identify which employees

may be exposed before exposure occurs.

The definition of ‘‘occupational

exposure’’ is the basis for making this

identification.

An exposure incident, on the other

hand, is a discrete event in which it is

known that an employee has had

contact with aerosolized M.

tuberculosis, i.e., with an individual

with confirmed infectious TB or air

containing aerosolized M. tuberculosis.

The term ‘‘exposure incident’’ is used to

define those occasions when certain

reactive measures are required by the

standard, such as medical management

and follow-up. It is exposure to an

individual with confirmed infectious TB

that matters, since it is not necessary to

take reactive measures after being

exposed to an individual with suspected

infectious TB if that individual has

subsequently been determined not to

have infectious TB.

Physician or Other Licensed Health

Care Professional means an individual

whose legally permitted scope of

practice (i.e., license, registration, or

certification) allows her or him to

independently perform or be delegated

to perform some or all of the health care

services required by paragraph (g) of

this section. Paragraph (g) requires that

all medical evaluations and procedures

and medical management and follow-up

be performed by or under the

supervision of a physician or other

licensed health care professional, as

appropriate. OSHA is aware that a

variety of health care professionals are

licensed by their respective states to

legally perform different medical

provisions required under this proposed

standard. This definition clarifies that it

is not OSHA’s intent to dictate the

specific type of health care professional

to perform the activities required by the

medical surveillance paragraph. OSHA’s

intent is merely that these activities be

performed by persons who are legally

permitted to independently perform or

be delegated to perform some or all of

the health care services required under

the medical surveillance provisions of

the standard. Employers wishing to use

the services of a variety of health care

providers must be familiar with the

licensing laws of their state to ensure

that the activities being performed are

within the scope of that health care

provider’s licensure.

Powered air-purifying respirator

(PAPR) means an air-purifying

respirator that uses a blower to deliver

air through the air-purifying element to

the wearer’s breathing zone. A PAPR

uses a blower to draw ambient air

through a filter and provide this filtered

air, under pressure, to the facepiece of

the wearer.

Qualitative fit test means a pass/fail

fit test to assess the adequacy of

respirator fit that relies on the respirator

wearer’s response. Generally, this

assessment of adequacy of respirator fit

is made by determining whether an

individual wearing the respirator can

detect the odor, taste, or irritation of a

challenge agent introduced into the

vicinity of the wearer’s breathing zone.

Quantitative fit test means an

assessment of the adequacy of respirator

fit by numerically measuring the

amount of leakage into the respirator.

Leakage can be assessed through means

such as measuring the concentration of

a challenge agent (or air pressure)

outside of the respirator versus the

concentration of the agent (or air

pressure) inside the respirator. The ratio

of the two measurements is an index of

the leakage of the seal between the

respirator facepiece and the wearer’s

face.

Research laboratory is defined as a

laboratory that propagates and

manipulates cultures of M. tuberculosis

in large volumes or high concentrations

that are in excess of those used for

identification and typing activities

common to clinical laboratories. The

purpose of this definition is to

distinguish research laboratories from

clinical laboratories. Under paragraph

(e) of the proposed standard, research

laboratories are required to meet

additional provisions beyond those

required for clinical laboratories (e.g.,

use of a hazard warning sign

incorporating the biohazard symbol

when materials containing M.

tuberculosis are present in the

laboratory and use of two sets of selfclosing doors for entry into the work

area from access corridors). These

additional requirements are proposed

due to the higher degree of hazard that

may be present in research laboratories

as a result of the presence of research

materials that may contain M.

tuberculosis in larger volumes and

higher concentrations than would

normally be found in diagnostic

specimens or cultures in clinical

laboratories.

Respirator means a device worn by an

individual and intended to provide the

wearer with respiratory protection

against inhalation of airborne

contaminants. While the term

‘‘respirator’’ may be used in medical

situations to refer to a device that

provides breathing assistance to an

individual who is experiencing

breathing difficulty, this section utilizes

this term only in reference to the type

of protective device defined above.

Suspected infectious tuberculosis

means a potential disease state in which

an individual is known, or with

reasonable diligence should be known,

by the employer to have one or more of

the following conditions, unless the

individual’s condition has been

medically determined to result from a

cause other than TB: (1) to be infected

with M. tuberculosis and to have the

signs or symptoms of TB; (2) to have a

positive acid-fast bacilli (AFB) smear; or

(3) to have a persistent cough lasting 3

or more weeks and two or more

symptoms of active TB (e.g., bloody

sputum, night sweats, weight loss, fever,

anorexia). An individual with suspected

infectious TB has neither confirmed

infectious TB nor has he or she been

medically determined to be

noninfectious.

Suspected infectious TB is another

key term in the proposed standard. The

presence of a person with suspected

infectious TB triggers and is associated

with a number of the provisions

required of employers. Applying the

criteria associated with suspected

infectious TB is the first step in the

early identification of individuals with

infectious TB and is therefore a key

factor in the elimination and

minimization of occupational

transmission of TB. Therefore, for

purposes of implementing the standard

it is important that what constitutes

‘‘suspected infectious TB’’ is clear.

The first criterion in identifying an

individual as having suspected

infectious TB is the presence of TB

infection and the signs and symptoms of

active TB. Under the second criterion,

an individual would be suspected of

having infectious TB if that individual

had a positive AFB smear. The third

criterion is based primarily on

observation of an individual. The CDC

states that:

* * * A diagnosis of TB may be

considered for any patient who has a

persistent cough (i.e., a cough lasting for ≥ 3

weeks) or other signs or symptoms

compatible with active TB (e.g., bloody

sputum, night sweats, weight loss, anorexia
54282 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

or fever). * * * Diagnostic measures for

identifying TB should be conducted for

patients in whom active TB is being

considered. These measures include

obtaining a medical history and performing

a physical examination, PPD skin test, chest

radiograph, and microscopic examination

and culture of sputum or other appropriate

specimens. (Ex. 4B)

OSHA has relied on the CDC’s list of

symptoms, but does not agree that

employers need only ‘‘consider’’ a TB

diagnosis when any of the symptoms

appear. The Agency believes that

requiring employers merely to consider

a TB diagnosis under these

circumstances may allow too many

individuals with infectious TB to slip

through this screen and remain

unidentified. In addition, the CDC

recommendations do not identify the

minimum number of signs or symptoms

that should trigger employer concern.

The problem with the CDC’s approach

is that the signs and symptoms are so

general that they would be difficult to

apply in many of the occupational

exposure circumstances covered by the

standard. For example, if OSHA

required employers to identify each

individual with even one of the signs or

symptoms of TB as having suspected

infectious TB, too many individuals

would be likely to be identified, thereby

wasting valuable health care resources.

For these reasons, OSHA has proposed

that employers be required to determine

that an individual has suspected

infectious TB when the individual has

a prolonged cough and at least two of

the other signs or symptoms of

infectious TB. The Agency believes that

requiring the employer to identify

individuals as suspect cases when they

have only a prolonged cough, which is

the primary mode of transmission, and

at least 2 other signs or symptoms

strikes the appropriate balance between

over inclusion and under inclusion, i.e.,

between considering almost every

individual in poor health as a suspect

case and missing individuals who

should be suspected of having

infectious TB. OSHA believes that

setting forth these more definitive

criteria will meet the needs of the many

employers covered by this standard who

will not have skilled medical persons

making initial determinations about

whether or not an individual has

suspected infectious TB. Employer who

are in a position to make medical

determinations are permitted by the

standard to rule out infectious TB by

determining that a given individual’s

signs and symptoms are the result of a

cause other than TB.

That an employer knows or with

reasonable diligence should know that

an individual meets one or more of

these criteria means that an employer

must utilize the means at his or her

disposal to gather relevant information

about the individual. For example, the

employer may have access to the

medical records of the individual or

may question an individual who has

signs or symptoms of TB in order to

obtain information about the individual,

such as skin test status, AFB smear

status, and so forth. How much

questioning the employer might do

depends on the work setting. For

example, a hospital will have intake

procedures that include asking

questions, as will most homeless

shelters and other fixed work sites. In

other work settings, such as the many

places in which emergency medical

services and home health care are

provided to unidentified individuals

with infectious TB, the employer’s

obligation will be to respond when an

employee notices signs or symptoms

compatible with TB. In many of these

instances, it is the training employees

receive in identifying individuals with

suspected TB that will be the most

important factor.

In addition, as noted above, an

individual who meets one or more of

the above criteria but whose condition

has been medically determined to result

from a cause other than TB need not be

considered to have suspected infectious

TB. For example, a physician or other

licensed health care professional, as

appropriate, could determine that the

signs and symptoms exhibited by the

individual were the result, for example,

of pneumonia and not TB.

Tight-fitting respirator means a

respiratory inlet covering that is

designed to form a complete seal with

the face. A half-facepiece covers the

nose and mouth while a full facepiece

covers the nose, mouth, and eyes.

Tuberculosis (TB) means a disease

caused by M. tuberculosis.

Tuberculosis infection means a

condition in which living M.

tuberculosis bacilli are present in the

body, without producing clinically

active disease. Although the infected

individual has a positive tuberculin skin

test reaction, the individual may have

no symptoms related to the infection

and may not be capable of transmitting

the disease.

Tuberculosis disease is a condition in

which living M. tuberculosis bacilli are

present in the body, producing clinical

illness. The individual may or may not

be infectious.

Tuberculin skin test means a method

used to evaluate the likelihood that a

person is infected with M. tuberculosis.

The method utilizes an intradermal

injection of tuberculin antigen with

subsequent measurement of reaction

induration. It is also referred to as a PPD

skin test.

Two-step testing is a baseline skin

testing procedure used to differentiate

between a boosted skin test reaction and

a skin test reaction that signifies a new

infection. If the initial skin test is

negative, a second skin test is

administered 1 to 3 weeks later. If the

second skin test is positive, the reaction

is probably due to boosting. If the

second skin test is negative, the

individual is considered to be not

infected. A subsequent positive skin test

in this individual would thus indicate a

new infection. Boosting is discussed in

more detail in connection with the

Medical Surveillance paragraph.

Paragraph (k) Dates

As proposed, the final rule would

become effective ninety (90) days after

publication in the Federal Register.

This will allow time for public

distribution and give employers time to

familiarize themselves with the

standard. The various provisions have

phased-in effective dates.

The employer’s initial duty under the

standard is the exposure determination

and establishment of the written

Exposure Control Plan required by

paragraph (c) of this section. The plan

would need to be completed 30 days

after the effective date.

Thirty days later, 60 days after the

effective date, paragraphs (h)(3),

Information and Training, (g) Medical

Surveillance, and (i) Recordkeeping

would take effect.

Ninety (90) days after the effective

date, the work practice procedures and

engineering controls required by

paragraph (d) (in work settings other

than those noted below), the respiratory

protection required by paragraph (f),

and the labels and signs required by

paragraphs (h) (1) and (2) would take

effect. The work practices that are

directly related to the engineering

controls would have to be implemented

as soon as the engineering controls were

functional. Finally, the requirements for

clinical and research laboratories

contained in paragraph (e) would also

take effect 90 days after the effective

date.

For businesses with fewer than 20

employees, the engineering controls

required by paragraph (d) of this section

would take effect 270 days after the

effective date. As noted above, the work

practices directly related to the

engineering controls being installed in

accordance with paragraph (d) of this

section must be implemented as soon as

the engineering controls are
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54283

implemented. Since engineering

controls may necessitate more extensive

planning than is required to comply

with other provisions of the standard,

OSHA is proposing an extended phasein for the smallest employers.

Since many employers have many of

these provisions already in effect

through current infection control plans,

OSHA believes that these dates provide

adequate time for compliance.

Nevertheless, OSHA seeks comment on

the appropriateness of the dates for

compliance with the various provisions

of the standard.

XI. Public Participation—Notice of

Hearing

Interested persons are invited to

submit written data, views, and

arguments with respect to this proposed

standard. These comments must be

postmarked on or before December 16,

1997, and submitted in quadruplicate to

the Docket Officer, Docket No. H–371,

Room N2625, U.S. Department of Labor,

200 Constitution Avenue NW.,

Washington, DC 20210. Comments

limited to 10 pages or less also may be

transmitted by facsimile to (202) 219–

5046, provided the original and three

copies are sent to the Docket Officer

thereafter.

Written submissions must clearly

identify the provisions of the proposal

that are being addressed and the

position taken with respect to each

issue. The data, views, and arguments

that are submitted will be available for

public inspection and copying at the

above address. All timely written

submissions will be made a part of the

record of the proceeding.

Pursuant to section 6(b)(3) of the Act,

an opportunity to submit oral testimony

concerning the issues raised by the

proposed standard will be provided at

an informal public hearing scheduled to

begin at 10:00 A.M. on February 3, 1998,

in Washington, DC in the Auditorium of

the Frances Perkins Building, U.S.

Department of Labor, 200 Constitution

Avenue, NW., Washington, DC 20210.

Notice of Intention to Appear

All persons desiring to participate at

the hearings must file in quadruplicate

a notice of intention to appear

postmarked on or before December 16,

1997 addressed to the Docket Officer,

Docket No. H–371, Room N–2625, U.S.

Department of Labor, 200 Constitution

Avenue, NW., Washington, DC 20210;

telephone (202) 219–7894. The Notice of

Intention to Appear also may be

transmitted by facsimile to (202) 219–

5046, provided the original and 3 copies

of the notice are sent to the above

address thereafter.

The Notices of Intention to Appear,

which will be available for inspection

and copying at the OSHA Docket Office,

must contain the following information:

(1) The name, address, and telephone

number of each person to appear;

(2) The hearing site that the party is

requesting to attend;

(3) The capacity in which the person

will appear;

(4) The approximate amount of time

requested for the presentation;

(5) The specific issues that will be

addressed;

(6) A detailed statement of the

position that will be taken with respect

to each issue addressed;

(7) Whether the party intends to

submit documentary evidence, and if so,

a brief summary of that evidence; and

(8) Whether the party wishes to testify

on the days set aside to focus on

homeless shelters.

Filing of Testimony and Evidence Before

Hearings

Any party requesting more than 10

minutes for a presentation at the

hearing, or who will submit

documentary evidence, must provide in

quadruplicate the complete text of the

testimony, including any documentary

evidence to be presented at the hearing

to the Docket Officer at the above

address. This material must be

postmarked by December 31, 1997 and

will be available for inspection and

copying at the OSHA Docket Office.

Each such submission will be reviewed

in light of the amount of time requested

in the Notice of Intention to Appear. In

those instances where the information

contained in the submission does not

justify the amount of time requested, a

more appropriate amount of time will be

allocated and the participant will be

notified of that fact.

Any party who has not substantially

complied with this requirement may be

limited to a 10-minute presentation.

Any party who has not filed a Notice of

Intention to Appear may be allowed to

testify, as time permits, at the discretion

of the Administrative Law Judge.

OSHA emphasizes that the hearing is

open to the public, and that interested

persons are welcome to attend.

However, only persons who have filed

proper notices of intention to appear

will be entitled to ask questions and

otherwise participate fully in the

proceeding.

Conduct and Nature of Hearings

The hearings will commence at 10:00

a.m. on February 3, 1998. At that time

any procedural matters relating to the

proceeding will be resolved.

The nature of an informal hearing is

established in the legislative history of

section 6 of the Act and is reflected by

the OSHA hearing regulations (see 29

CFR 1911.15 (a)). Although the

presiding officer is an Administrative

Law Judge and questioning by interested

persons is allowed on crucial issues, the

proceeding shall remain informal and

legislative in type. The essential intent

is to provide an opportunity for effective

oral presentations that can proceed

expeditiously in the absence of rigid

procedures that would impede or

protract the rulemaking process.

Additionally, since the hearing is

primarily for information gathering and

clarification, it is an informal

administrative proceeding, rather than

an adjudicative one. The technical rules

of evidence, for example, do not apply.

The regulations that govern hearings

and the pre-hearing guidelines to be

issued for this hearing will ensure

fairness and due process and also

facilitate the development of a clear,

accurate and complete record. Those

rules and guidelines will be interpreted

in a manner that furthers that

development. Thus, questions of

relevance, procedure and participation

generally will be decided so as to favor

development of the record.

The hearing will be conducted in

accordance with 29 CFR Part 1911. The

hearing will be presided over by an

Administrative Law Judge who makes

no recommendation on the merits of

OSHA’s proposal. The responsibility of

the Administrative Law Judge is to

ensure that the hearing proceeds at a

reasonable pace and in an orderly

manner. The Administrative Law Judge,

therefore, will have all the powers

necessary and appropriate to conduct a

full and fair informal hearing as

provided in 29 CFR Part 1911 and the

prehearing guidelines, including the

powers:

(1) To regulate the course of the

proceedings;

(2) To dispose of procedural requests,

objections, and comparable matters;

(3) To confine the presentation to the

matters pertinent to the issues raised;

(4) To regulate the conduct of those

present at the hearing by appropriate

means;

(5) At the Judge’s discretion, to

question and permit the questioning of

any witness and to limit the time for

questioning; and

(6) At the Judges’s discretion, to keep

the record open for a reasonable, stated

time to written information and

additional data, views and arguments

from any person who has participated in

the oral proceeding.
54284 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

Information on Homeless Shelter Issues

for the Public Hearing

OSHA seeks to gather additional

information related to homeless shelters

during the written comment period and

the public hearing. OSHA recognizes

the unique service provided by

homeless shelters, yet is also aware that

shelters serve a client population that

has been identified as possessing a high

prevalence of active TB. OSHA is

seeking information on all aspects of TB

and employee protection against

occupational transmission of TB in

homeless shelters (e.g., means

successfully being used by shelters to

achieve early identification of shelter

clients with suspected or confirmed

infectious TB; successful programs

currently being used to protect

employees against occupational

transmission of TB).

The Agency intends to designate a

special session during the Washington,

D.C. hearing to focus on the issues

surrounding homeless shelters. We

encourage hearing participants whose

primary testimony will involve

homeless shelters to indicate this in

their Notice of Intention to Appear;

OSHA will attempt to schedule these

participants on the day(s) of the hearing

set aside to focus on homeless shelters.

Other participants whose testimony will

not be primarily on homeless shelter

issues but who wish to address the topic

of homeless shelters will be scheduled

another day, but they may enter a

separate statement in the record during

this period. In any case, participants are

free to discuss homeless shelters or any

other issue related to this proposed

standard whenever they present their

testimony.

Certification of Record and Final

Determination After Hearing

Following the close of the posthearing

comment period, the presiding

Administrative Law Judge will certify

the record to the Assistant Secretary of

Labor for Occupational Safety and

Health. The Administrative Law Judge

does not make or recommend any

decisions as to the content of the final

standard.

The proposed standard will be

reviewed in light of all testimony and

written submissions received as part of

the record, and a standard will be issued

based on the entire record of the

proceeding, including the written

comments and data received from the

public.

List of Subjects

29 CFR Part 1910

Health professionals, Occupational

safety and health, Reporting and

recordkeeping requirements,

Tuberculosis.

XII. Authority and Signature

This document was prepared under

the direction of Greg Watchman, Acting

Assistant Secretary of Labor, 200

Constitution Avenue, N.W.,

Washington, D.C., 20210.

It is issued under sections 4, 6, and 8

of the Occupational Safety and Health

Act of 1970 (29 U.S.C. 653, 655, 657),

Secretary of Labor’s Order 1–90 (55 FR

9033) and 29 CFR Part 1911.

Signed at Washington, DC, this 15th day of

September, 1997.

Greg Watchman,

Acting Assistant Secretary of Labor.

XIII. The Proposed Standard

General Industry

Part 1910 of Title 29 of the Code of

Federal Regulations is proposed to be

amended as follows:

PART 1910—[AMENDED]

Subpart Z—[Amended]

1. The general authority citation for

Subpart Z of 29 CFR Part 1910

continues to read as follows and a new

citation for § 1910.1035 is added:

Authority: Secs. 6 and 8, Occupational

Safety and Health Act, 29 U.S.C. 655, 657,

Secretary of Labor’s Orders Nos. 12–71 (36

FR 8754), 8–76 (41 FR 25059), or 9–83 (48

FR 35736), as applicable; and 29 CFR Part

1911.

* * * * *

Section 1910.1035 also issued under 29

U.S.C. 653.

* * * * *

2. Section 1910.1035 is added to read

as follows:

§ 1910.1035 Tuberculosis

(a) Scope. This section applies to

occupational exposure to tuberculosis

(TB) occurring:

(1) In hospitals;

(2) In long term care facilities for the

elderly;

(3) In correctional facilities and other

facilities that house inmates or

detainees;

(4) In hospices;

(5) In shelters for the homeless;

(6) In facilities that offer treatment for

drug abuse;

(7) In facilities where high-hazard

procedures (as defined by this section)

are performed;

(8) In laboratories that handle

specimens that may contain M.

tuberculosis, or process or maintain the

resulting cultures, or perform related

activity that may result in the

aerosolization of M. tuberculosis;

Note to paragraph (a)(8): Occupational

exposure incurred in any of the work settings

listed in paragraphs (a)(1) through (a)(8) of

this section by temporary or contract

employees or by personnel who service or

repair air systems or equipment or who

renovate, repair, or maintain areas of

buildings that may reasonably be anticipated

to contain aerosolized M. tuberculosis is

covered by this section.

(9) During the provision of social

work, social welfare services, teaching,

law enforcement or legal services if the

services are provided in any of the work

settings listed in paragraphs (a)(1)

through (a)(8) of this section, or in

residences, to individuals who are in

AFB isolation or are segregated or

otherwise confined due to having

suspected or confirmed infectious TB.

(10) During the provision of

emergency medical services, home

health care and home-based hospice

care.

(b) Application. An employer covered

under paragraph (a) of this section,

Scope (other than the operator of a

laboratory), may choose to comply only

with the provisions of appendix A to

this section if the Exposure Control Plan

demonstrates that his or her facility or

work setting: (1) Does not admit or

provide medical services to individuals

with suspected or confirmed infectious

TB; and

(2) Has had no case of confirmed

infectious TB in the past 12 months; and

(3) Is located in a county that, in the

past 2 years, has had 0 cases of

confirmed infectious TB reported in one

year and fewer than 6 cases of

confirmed infectious TB reported in the

other year.

(c) Exposure control—(1) Exposure

determination. (i) Each employer who

has any employee with occupational

exposure shall prepare an exposure

determination that contains the

following:

(A) A list of the job classifications in

which all employees have occupational

exposure; and

(B) A list of the job classifications in

which some employees have

occupational exposure, and a list of all

tasks and procedures (or groups of

closely related tasks and procedures)

that these employees perform and that

involve occupational exposure.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54285

(ii) The exposure determination shall

be made without regard to the use of

respiratory protection.

(2) Exposure Control Plan. (i) Each

employer who has any employee with

occupational exposure shall establish a

written Exposure Control Plan that must

include:

(A) The exposure determination

required by paragraph (c)(1) of this

section;

(B) Procedures for providing

information about individuals with

suspected or confirmed infectious TB or

about air that may reasonably be

anticipated to contain aerosolized M.

tuberculosis to occupationally exposed

employees who need this information in

order to take proper precautions; and

(C) Procedures for reporting an

exposure incident, including procedures

specifying the individual to whom the

incident is to be reported, and

procedures for evaluating the

circumstances surrounding the exposure

incident.

(ii) Each employer who transfers

individuals with suspected or

confirmed infectious TB to a facility

with AFB isolation capabilities shall

include in the Exposure Control Plan

procedures for prompt identification,

masking or segregation, and transfer of

such individuals.

Note to paragraph (c)(2)(ii): An employer’s

duties regarding transfer will vary with the

type of facility the employer operates and the

work performed by his or her employees. For

example, the transfer responsibilities of

hospitals, long-term care facilities for the

elderly, correctional facilities, and hospices

may include contacting the receiving facility,

providing transport, and taking other steps to

ensure that the individual with suspected or

confirmed infectious TB reaches the

receiving facility. By contrast, the

responsibilities of facilities that do not

maintain custody over individuals, such as

homeless shelters or facilities that offer

treatment for drug abuse, might only include

providing information about the receiving

facility, contacting the facility, and providing

directions to the facility.

(iii) Each employer in whose facility

individuals with suspected or

confirmed infectious TB are admitted or

provided medical services shall include

each of the following provisions in the

Exposure Control Plan:

(A) Procedures for prompt

identification of individuals with

suspected or confirmed infectious TB;

(B) Procedures for isolating and

managing the care of individuals with

suspected or confirmed infectious TB,

including:

(1) Minimizing the time an individual

with suspected or confirmed infectious

TB remains outside of an AFB isolation

room or area (e.g., in an emergency

room);

(2) Minimizing employee exposure in

AFB isolation rooms or areas by

combining tasks to limit the number of

entries into the room or area and by

minimizing the number of employees

who must enter and minimizing the

time they spend in the room or area;

(3) Delaying elective transport or

relocation within the facility of an

individual with suspected or confirmed

infectious TB. Procedures are to be

established to assure that, to the extent

feasible, services and procedures for

individuals with suspected or

confirmed infectious TB are brought

into or conducted in an AFB isolation

room or area;

(4) Using properly-fitted masks (e.g.,

surgical masks, valveless respirators) on

individuals with suspected or

confirmed infectious TB or transporting

such individuals in portable

containment engineering controls when

relocation or transport outside of AFB

isolation rooms or areas is unavoidable.

Procedures are to be established to

assure that the individual is returned to

an AFB isolation room or area as soon

as is practical after completion of the

service or procedure;

(5) Delaying elective high-hazard

procedures or surgery until an

individual with suspected or confirmed

infectious TB is determined to be

noninfectious;

(C) A list of all high-hazard

procedures, if any, performed in the

work setting; and

(D) A schedule for inspection,

maintenance, and performance

monitoring of engineering controls (see

appendix E to this section).

(iv) Each employer who operates a

laboratory shall include in the Exposure

Control Plan a determination from the

director of the laboratory as to whether

the facility should operate at Biosafety

Level 2 or 3 containment according to

current CDC recommendations (CDC/

NIH Biosafety in Microbiological and

Biomedical Laboratories). The

laboratory director shall determine and

document the need for:

(A) Controlled access;

(B) Anterooms;

(C) Sealed windows;

(D) Directional airflow;

(E) Measures to prevent recirculation

of laboratory exhaust air;

(F) Filtration of exhaust air before

discharge outside; and

(G) Thimble exhaust connections for

biological safety cabinets.

(v) Each employer who provides

home health care or home-based

hospice care shall include in the

Exposure Control Plan procedures for

prompt identification of individuals

with suspected or confirmed infectious

TB and procedures for minimizing

employee exposure to such individuals;

a list of the high-hazard procedures, if

any, performed in the work setting; and

procedures for delaying elective highhazard procedures or surgery until the

individual is noninfectious.

(vi) Each employer who claims

reduced responsibilities related to

paragraph (b), Application, or paragraph

(g)(3)(iii)(D), Medical Surveillance, of

this section shall document in the

Exposure Control Plan the number of

individuals with confirmed infectious

tuberculosis encountered in the work

setting in the past 12 months.

(vii) The Exposure Control Plan shall

be:

(A) Accessible to employees in

accordance with 29 CFR 1910.20(e);

(B) Reviewed at least annually and

updated whenever necessary to reflect

new or modified tasks, procedures, or

engineering controls that affect

occupational exposure and to reflect

new or revised employee job

classifications with occupational

exposure; and

(C) Made available for examination

and copying to the Assistant Secretary

and/or the Director upon request.

(d) Work Practices and Engineering

Controls. (1) Work practices and

engineering controls shall be used to

eliminate or minimize employee

exposures to M. tuberculosis.

(2) The work practices in the

Exposure Control Plan shall be

implemented.

(3) Individuals with suspected or

confirmed infectious TB shall be

identified, and except in settings where

home health care or home-based

hospice care is being provided, shall be:

(i) Masked or segregated in such a

manner that contact with employees

who are not wearing respiratory

protection is eliminated or minimized

until transfer or placement in an AFB

isolation room or area can be

accomplished; and

(ii) Placed in an AFB isolation room

or area or transferred to a facility with

AFB isolation rooms or areas within 5

hours from the time of identification, or

temporarily placed in AFB isolation

within 5 hours until placement or

transfer can be accomplished as soon as

possible thereafter.

(4) High-hazard procedures shall be

conducted in an AFB isolation room or

area.

(5) Engineering controls shall be used

in facilities that admit or provide

medical services or AFB isolation to

individuals with suspected or

confirmed infectious TB except in
54286 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

settings where home health care or

home-based hospice care is being

provided.

(i) Negative pressure shall be

maintained in AFB isolation rooms or

areas.

(ii) Negative pressure shall be

qualitatively demonstrated (e.g., by

smoke trails) daily while a room or area

is in use for TB isolation (see appendix

G to this section).

(iii) Engineering controls shall be

maintained, and inspected and

performance monitored for filter loading

and leakage every 6 months, whenever

filters are changed, and more often if

necessary to maintain effectiveness (see

appendix E to this section).

(iv) Air from AFB isolation rooms or

areas shall be exhausted directly

outside, away from intake vents,

employees, and the general public. Air

that cannot be exhausted in such a

manner or must be recirculated must

pass through HEPA filters before

discharge or recirculation.

(v) Ducts carrying air that may

reasonably be anticipated to contain

aerosolized M. tuberculosis shall be

maintained under negative pressure for

their entire length before in-duct HEPA

filtration or until the ducts exit the

building for discharge.

(vi) Doors and windows of AFB

isolation rooms or areas shall be kept

closed while in use for TB isolation,

except when doors are opened for

entering or exiting and when windows

are part of the ventilation system being

used to achieve negative pressure.

(vii) When an AFB isolation room or

area is vacated by an individual with

suspected or confirmed infectious TB,

the room or area shall be ventilated

according to current CDC

recommendations for a removal

efficiency of 99.9% before permitting

employees to enter without respiratory

protection (see appendix C to this

section).

(6) The employer shall provide

information about the TB hazard to any

contractor who provides temporary or

contract employees who may incur

occupational exposure so that the

contractor can institute precautions to

protect his or her employees.

(e) Clinical and Research

Laboratories. (1) This paragraph applies

to clinical and research laboratories that

engage in the culture, production,

concentration, experimentation, or

manipulation of M. tuberculosis. The

requirements in this paragraph apply in

addition to the other requirements of the

standard.

(2) Clinical and research laboratories

shall meet the following criteria:

(i) Standard microbiological practices.

(A) Procedures shall be performed in

a manner that minimizes the creation of

aerosols.

(B) Mouth pipetting shall be

prohibited.

(C) Work surfaces and laboratory

equipment shall be decontaminated at

the end of each shift and after any spill

of viable material.

(D) Cultures, stocks and other wastes

contaminated with M. tuberculosis shall

be decontaminated before disposal by a

decontamination method, such as

autoclaving, known to effectively

destroy M. tuberculosis. Materials to be

decontaminated outside of the

immediate laboratory shall be placed in

a durable, leakproof container, closed

and sealed for transport from the

laboratory and labeled or color-coded in

accordance with paragraph (h)(1)(ii) of

this section.

(ii) Special practices. (A) Access to

the laboratory shall be limited by the

laboratory director when work with M.

tuberculosis is in progress.

(B) A biosafety manual that includes

procedures for spill management shall

be adopted. The employer shall review

the manual as necessary and at least

annually. The employer shall update the

biosafety manual as necessary to reflect

changes in the work setting. Employees

shall be advised of potential hazards,

shall be required to read instructions on

practices and procedures, and shall be

required to follow them.

(C) Cultures, tissues, or specimens of

body fluids contaminated with M.

tuberculosis shall be placed in a

container that prevents leakage during

collection, handling, processing,

storage, transport, or shipping.

(D) All spills shall be immediately

contained and cleaned up by employees

who are properly trained and equipped

to work with potentially concentrated

M. tuberculosis. A spill or accident that

results in an exposure incident shall be

reported immediately to the laboratory

director or other designated person.

(E) When materials containing or

animals infected with M. tuberculosis

are present in the laboratory or

containment module, a hazard warning

sign, in accordance with paragraph

(h)(2)(iv), incorporating the universal

biohazard symbol, shall be posted on all

laboratory and animal room access

doors.

(iii) Containment equipment. (A)

Certified biological safety cabinets

(Class 2) shall be used whenever

procedures with a potential for

generating aerosols of M. tuberculosis

are conducted or whenever high

concentrations or large volumes of M.

tuberculosis are used. Such materials

may be centrifuged in the open

laboratory if sealed rotor heads or

centrifuge safety cups are used, and if

these rotors or safety cups are opened in

a biological safety cabinet.

(B) Biological safety cabinets shall be

certified when installed, annually

thereafter, whenever they are moved,

and whenever filters are changed.

(iv) Laboratory facilities. A method for

decontamination of wastes

contaminated with M. tuberculosis (e.g.,

autoclave, chemical disinfection,

incinerator, or other decontamination

system known to effectively destroy M.

tuberculosis) shall be available within or

as near as feasible to the work area.

(3) Research laboratories shall meet

the following additional criteria:

(i) Special practices. (A) Laboratory

doors shall be kept closed when work

involving M. tuberculosis is in progress.

(B) Access to the work area shall be

limited to authorized persons. Written

policies and procedures shall be

established so that only persons who

have been advised of the potential

biohazard, who meet any specific entry

requirements, and who comply with all

entry and exit procedures shall be

allowed to enter the work areas and

animal rooms.

(C) Respiratory protection shall be

worn when aerosols cannot be safely

contained (e.g., when aerosols are

generated outside of a biological safety

cabinet).

(ii) Containment equipment. Certified

biological safety cabinets (Class 2 or 3)

or appropriate combinations of personal

protection or physical containment

devices, such as respirators, centrifuge

safety cups, sealed centrifuge rotors, and

containment caging for animals, shall be

used for manipulations of cultures and

those clinical or environmental

materials that may be a source of

aerosols containing M. tuberculosis;

aerosol challenge of animals with M.

tuberculosis; harvesting of tissues or

fluids from animals infected with M.

tuberculosis; or the necropsy of animals

infected with M. tuberculosis.

(iii) Laboratory facilities. (A) The

laboratory shall be separated from areas

that are open to unrestricted traffic flow

within the building. Passage through

two sets of self-closing doors shall be

required for entry into the work area

from access corridors or other

contiguous areas.

(B) Windows in the laboratory shall

be closed and sealed.

(C) A ducted exhaust air ventilation

system shall be provided. This system

shall create directional airflow that

draws air from ‘‘clean’’ areas into the

laboratory toward ‘‘contaminated’’

areas. The employer shall verify the

proper direction of the airflow (i.e., into
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54287

the work area) at least every six months.

The exhaust air shall not be recirculated

to any other area of the building, shall

be discharged to the outside, and shall

be dispersed away from occupied areas

and air intakes.

(D) The high efficiency particulate air

(HEPA)-filtered exhaust air from Class 2

or Class 3 biological safety cabinets

shall be discharged directly to the

outside or through the building exhaust

system. If the HEPA-filtered exhaust air

from Class 2 or 3 biological safety

cabinets is to be discharged to the

outside through the building exhaust air

system, it shall be connected to this

system in a manner (e.g., thimble units)

that avoids any interference with the air

balance of the cabinets or building

exhaust system.

(E) Continuous flow centrifuges or

other equipment that may produce

aerosols shall be contained in devices

that exhaust air through HEPA filters

before discharge into the laboratory.

(f) Respiratory Protection—(1)

General. (i) Each employer shall provide

a respirator to each employee who:

(A) Enters an AFB isolation room or

area in use for TB isolation;

(B) Is present during the performance

of procedures or services for an

individual with suspected or confirmed

infectious TB who is not masked;

(C) Transports an individual with

suspected or confirmed infectious TB in

an enclosed vehicle (e.g., ambulance,

helicopter) or who transports an

individual with suspected or confirmed

infectious TB within the facility when

that individual is not masked;

(D) Repairs, replaces, or maintains air

systems or equipment that may

reasonably be anticipated to contain

aerosolized M. tuberculosis;

(E) Is working in an area where an

unmasked individual with suspected or

confirmed infectious TB has been

segregated or otherwise confined (e.g.,

while awaiting transfer); or

(F) Is working in a residence where an

individual with suspected or confirmed

infectious TB is known to be present.

(ii) Each employer who operates a

research laboratory shall provide a

respirator to each employee who is

present when aerosols of M. tuberculosis

cannot be safely contained (e.g., when

aerosols are generated outside of a

biological safety cabinet).

(iii) The employer shall provide the

respirator at no cost to the employee

and shall assure that the employee uses

the respirator in accordance with the

requirements of this section.

(iv) The employer shall assure that the

employee dons the respirator before

entering any of the work settings or

performing any of the tasks set forth in

paragraphs (f)(1)(i) and (f)(1)(ii) of this

section and uses it until leaving the

work setting or completing the task,

regardless of other control measures in

place.

(2) Respiratory Protection Program. (i)

Each employer who has any employee

whose occupational exposure is based

on entering any of the work settings or

performing any of the tasks described in

paragraph (f)(1) of this section shall

establish and implement a written

respiratory protection program that

assures respirators are properly selected,

fitted, used, and maintained. The

program shall include the following

elements:

(A) Procedures for selecting the

appropriate respirators for use in the

work setting;

(B) A determination of each

employee’s ability to wear a respirator,

as required under paragraph (g)(3)(ii) of

this section, Medical Surveillance, for

each employee required to wear a

respirator;

(C) Procedures for the proper use of

respirators;

(D) Fit testing procedures for tightfitting respirators;

(E) Procedures and schedules for

cleaning, disinfecting, storing,

inspecting, repairing, or otherwise

maintaining respirators;

(F) Training of employees to assure

the proper use and maintenance of the

respirator, as required under paragraph

(h) of this section, Communication of

Hazards and Training; and

(G) Procedures for periodically

evaluating the effectiveness of the

program.

(ii) The employer shall designate a

person qualified by appropriate training

or experience to be responsible for the

administration of the respiratory

protection program and for conducting

the periodic evaluations of its

effectiveness.

(iii) The employer shall review and

update the written program as necessary

to reflect current workplace conditions

and respirator use.

(iv) The employer shall, upon request,

make the written respiratory protection

program available to affected

employees, their designated

representatives, the Assistant Secretary,

and the Director. A copy of the program

shall be submitted to the Assistant

Secretary and/or the Director, if

requested.

(3) Respirator Selection. (i) The

employer shall select and provide

properly fitted negative pressure or

more protective respirators. Negative

pressure respirators shall be capable of

being:

(A) Qualitatively or quantitatively fit

tested in a reliable way to verify a faceseal leakage of no more than 10%; and

(B) Fit checked by the employee each

time the respirator is donned.

(ii) The employer shall select a

respirator that will function effectively

in the conditions of the work setting. In

addition to meeting the criteria in

paragraph (f)(3)(i) of this section, the

respirator shall be, at a minimum, either

a HEPA respirator selected from among

those jointly approved as acceptable by

the Mine Safety and Health

Administration and by the National

Institute for Occupational Safety and

Health (NIOSH) under the provisions of

30 CFR part 11, or an N95 respirator

certified by NIOSH under the provisions

of 42 CFR part 84.

(4) Respirator Use. (i) The employer

shall not permit any respirator that

depends on a tight face-to-facepiece seal

for effectiveness to be worn by

employees having any condition that

prevents such a seal. Examples of these

conditions include, but are not limited

to, facial hair that comes between the

sealing surface of the facepiece and the

face or if facial hair interferes with valve

function, absence of normally worn

dentures, facial scars, or headgear that

projects under the facepiece seal.

(ii) The employer shall assure that

each employee who wears corrective

glasses or goggles wears them in a

manner that does not interfere with the

seal of the facepiece to the face of the

wearer.

(iii) Disposable respirators shall be

discarded when excessive resistance,

physical damage, or any other condition

renders the respirator unsuitable for use.

(iv) The employer shall assure that

each employee, upon donning a tightfitting respirator, performs a facepiece

fit check prior to entering a work area

where respirators are required. The

procedures in appendix B to this section

or other procedures recommended by

the respirator manufacturer that provide

protection equivalent to that provided

by the procedures in appendix B shall

be used.

(v) Respirators shall be immediately

repaired, or discarded and replaced,

when they are no longer in proper

working condition.

(vi) The employer shall permit each

employee to leave the respirator use

area as soon as practical to:

(A) Change the filter elements or

replace the respirator whenever the

ability of the respirator to function

effectively is compromised or the

employee detects a change in breathing

resistance; or
54288 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

(B) Wash his or her face and respirator

facepiece as necessary to prevent skin

irritation associated with respirator use.

(vii) Each employee required to wear

a respirator under this section shall be

evaluated in accordance with paragraph

(g), Medical Surveillance, of this

section.

(viii) No employee shall be assigned

a task requiring the use of a respirator

if, based upon the employee’s most

recent evaluation, the physician or other

licensed health care professional, as

appropriate, determines that the

employee will be unable to function

adequately while wearing a respirator. If

the physician or other licensed health

care professional, as appropriate,

determines that the employee’s job

activities must be limited, or that the

employee must be removed from the

employee’s current job because of the

employee’s inability to wear a

respirator, the limitation or removal

shall be performed in accordance with

paragraph (g)(5)(iii) of this section.

(5) Fit Testing. (i) The employer shall

perform either quantitative or

qualitative face fit tests in accordance

with the procedures outlined in

appendix B to this section.

(ii) The employer shall assure that

each employee who must wear a tightfitting respirator passes a fit test:

(A) At the time of initial fitting;

(B) Whenever changes occur in the

employee’s facial characteristics which

affect the fit of the respirator;

(C) Whenever a different size or make

of respirator is used; and

(D) At least annually thereafter unless

the annual determination required

under paragraph (g)(3)(ii)(A), Medical

Surveillance, of this section indicates

that the annual fit test is not necessary.

(iii) When quantitative fit testing is

performed, the employer shall not

permit an employee to wear a tightfitting half-mask respirator unless a

minimum fit factor of one hundred (100)

is obtained in the test chamber.

(6) Maintenance and care of reusable

and powered air purifying respirators.

(i) Respirators shall be cleaned and

disinfected using the cleaning

procedures recommended by the

manufacturer at the following intervals:

(A) As necessary for respirators issued

for the exclusive use of an employee;

and

(B) After each use for respirators

issued to more than one employee.

(ii) Respirators shall be inspected

before each use and during cleaning

after each use;

(iii) Respirator inspections shall

include:

(A) A check of respirator function,

tightness of connections and the

condition of the facepiece, head straps,

valves, connecting tube, and cartridges,

canisters, or filters; and

(B) A check of the rubber or elastomer

parts for pliability and signs of

deterioration.

(iv) Respirators that fail to pass

inspection shall be removed from

service and shall be repaired or adjusted

in accordance with the following:

(A) Repairs or adjustments to

respirators are only to be made with

NIOSH-approved parts designed for the

respirator by the respirator

manufacturer, and conducted by

persons appropriately trained to

perform such operations;

(B) Only repairs of the type and extent

covered by the manufacturer’s

recommendations may be performed;

and

(C) Reducing or admission valves or

regulators shall be returned to the

manufacturer or given to an

appropriately trained technician for

adjustment or repair.

(v) Respirators shall be stored in a

manner that protects them from

contamination, damage, dust, sunlight,

extreme temperatures, excessive

moisture, and damaging chemicals and

prevents deformation of the facepiece or

exhalation valve.

(7) Identification of filters, cartridges,

and canisters. (i) Filters, cartridges, and

canisters used in the workplace shall be

properly labeled and color-coded with

the NIOSH approval label as required by

30 CFR part 11 or 42 CFR part 84,

whichever is applicable, before they are

placed into service.

(ii) The NIOSH approval label on a

filter, cartridge, or canister shall not be

intentionally removed, obscured, or

defaced while it is in service in the

workplace.

(8) Respiratory protection program

evaluation. The employer shall review

the overall respiratory protection

program at least annually, and shall

conduct inspections of the workplace as

necessary to assure that the provisions

of the program are being properly

implemented for all affected employees.

The review of the program shall include

an assessment of each element required

under paragraph (f)(2) of this section.

(g) Medical Surveillance—(1) General.

(i) Each employer who has any

employee with occupational exposure

shall provide the employee with

medical surveillance as described in

this paragraph.

(ii) Each employer covered under

paragraph (a), Scope, of this section

shall provide information about the

signs and symptoms of pulmonary TB,

a medical history, a physical

examination, TB skin testing, medical

management and follow-up and, if

indicated, other related tests and

procedures, and medical removal

protection if the employee develops

infectious TB, to any of his or her

employees who have an exposure

incident while working in a covered

work setting, even if such employee is

not categorized as having occupational

exposure.

(iii) Medical surveillance provisions,

including examinations, evaluations,

determinations, procedures, and

medical management and follow-up,

shall be:

(A) Provided at no cost to the

employee;

(B) Provided at a reasonable time and

place for the employee;

(C) Performed by or under the

supervision of a physician or other

licensed health care professional, as

appropriate; and

(D) Provided according to

recommendations of CDC current at the

time these evaluations and procedures

take place, except as specified by this

paragraph (g).

(iv) Laboratory tests shall be

conducted by an accredited laboratory.

(2) Explanation of Terms. This

paragraph explains the terms used in

paragraph (g).

(i) Medical history emphasizes the

pulmonary system, and includes

previous exposure to M. tuberculosis,

BCG vaccination, TB skin test results,

TB disease, prior and current preventive

or therapeutic treatment, current signs

or symptoms of active TB disease, and

factors affecting immunocompetence;

(ii) Physical examination emphasizes

the pulmonary system, signs and

symptoms of active TB disease, and

factors affecting immunocompetence;

(iii) TB skin testing, includes anergy

testing if indicated, and is only for

employees whose TB skin test status is

not known to be positive. An initial 2-

step protocol is to be used for each

employee who has not been previously

skin tested and/or for whom a negative

test cannot be documented within the

past 12 months. If the employer has

documentation that the employee has

had a negative TB skin test within the

past 12 months, that test may be utilized

to fulfill the skin testing portion of this

requirement. Periodic retesting shall be

performed in accordance with

paragraph (g)(3) of this section.

(iv) ‘‘Determination of the employee’s

ability to wear a respirator’’ is a face-toface assessment of the health factors

affecting respirator use and the need for

the annual fit test.

Note to paragraph (g)(2)(iv): A

determination of the need for the annual fit
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54289

test may only be performed after the required

initial fit test of the employee and cannot be

used in lieu of any other required fit tests, for

example, when a different size or make of

respirator is used.

(v) ‘‘Medical management and followup’’ include diagnosis, and, where

appropriate, prophylaxis and treatment

related to TB infection and disease.

(vi) Other related tests and

procedures include those associated

with TB infection and disease and

determined to be necessary by the

physician or other licensed health care

professional, as appropriate.

(vii) Medical Removal Protection is

the maintenance of earnings, seniority

and other benefits specified in

paragraph (g)(5) of this section for an

employee who has confirmed or

suspected infectious TB or is unable to

wear a respirator.

(3) Application. (i) Each employee

with occupational exposure shall be

provided with the following at the times

specified:

(A) Before initial assignment to a job

with occupational exposure or within

60 days of the effective date of this

standard and at least annually

thereafter: A medical history and TB

skin testing, and, if indicated, a physical

examination and other related tests and

procedures;

Note to paragraph (g)(3)(i)(A): If an

employee has had a medical examination

within the twelve (12) months preceding the

effective date of the standard and the

employer has the documented results of that

examination, only the medical surveillance

provisions required by the standard that were

not included in the examination need to be

provided. The date(s) of the previous medical

examination and skin test shall be used to

determine the date(s) of the employee’s next

medical examination and skin test but in no

case shall the interval between the previous

examination and skin test and the next

examination and skin test exceed 12 months.

(B) When the employee has signs or

symptoms of TB, either observed or selfreported: A medical history, a physical

examination, TB skin testing, medical

management and follow-up, and, if

indicated, other related tests and

procedures;

(C) When an employee undergoes an

exposure incident: A medical history,

TB skin testing as soon as feasible

(unless there is documented negative TB

skin testing within the past 3 months),

and if the result is negative, another

skin test 3 months later, medical

management and follow-up and, if

indicated, a physical examination and

other related tests and procedures;

(D) When the employee has a TB skin

test conversion: A medical history, a

physical examination, medical

management and follow-up, and, if

indicated, other related tests;

(E) Within 30 days of the termination

of employment: A TB skin test; and

(F) At any other time the physician or

other licensed health care professional,

as appropriate, deems it necessary: Any

or all the provisions of paragraph (g).

(ii) Each employee who must wear a

respirator shall be provided with the

following at the times specified:

(A) Before initial assignment to a job

with occupational exposure or within

60 days of the effective date of this

standard and at least annually

thereafter: A determination of the

employee’s ability to wear a respirator;

and

(B) When the wearer experiences

unusual difficulty while being fitted or

while using a respirator: A

determination of the employee’s ability

to wear a respirator, including relevant

components of a medical history, and, if

indicated, a physical examination and

other related tests and procedures.

(iii) An employee with negative TB

skin test status shall be provided with

a TB skin test every 6 months if the

employee in the course of his or her

duties:

(A) Enters an AFB isolation room or

area;

(B) Performs or is present during the

performance of high-hazard procedures;

(C) Transports or is present during the

transport of an individual with

suspected or confirmed infectious TB in

an enclosed vehicle; or

(D) Works in an intake area where

early identification procedures are

performed (e.g., emergency

departments, admitting areas) in

facilities where six (6) or more

individuals with confirmed infectious

TB have been encountered in the past

twelve months.

(4) Additional Requirements. (i) The

employer shall assure that when the

physician or other licensed health care

professional, as appropriate, determines

that an employee has suspected or

confirmed infectious TB, the physician

or other licensed health care

professional, as appropriate, shall notify

the employer and the employee as soon

as feasible.

(ii) When the employer first identifies

an individual with confirmed infectious

TB, the employer shall notify each

employee who has had an exposure

incident involving that individual of his

or her exposure to confirmed TB; and

(iii) When an exposure incident

results in a TB skin test conversion, the

employer shall assure that a

determination is made of the drug

susceptibility of the M. tuberculosis

isolate from the source, unless the

employer can demonstrate that such a

determination is not feasible.

(iv) When an exposure incident or a

TB skin test conversion occurs, the

employer shall investigate and

document the circumstances

surrounding the exposure incident or

conversion (e.g. failure of engineering

controls or work practices and events

leading to the exposure incident) to

determine if changes can be instituted to

prevent similar occurrences in the

future.

(5) Medical Removal Protection. (i)

Each employee with suspected or

confirmed infectious TB shall be

removed from the workplace until

determined to be noninfectious.

(ii) For each employee who is

removed from the workplace under

paragraph (g)(5)(i) of this section, the

employer shall maintain the total

normal earnings, seniority, and all other

employee rights and benefits, including

the employee’s right to his or her former

job status, as if the employee had not

been removed from the employee’s job

or otherwise medically limited until the

employee is determined to be

noninfectious or for a maximum of 18

months, whichever comes first.

(iii) For each employee who is

removed from his or her job under

paragraph (f)(4)(viii), Respiratory

Protection, of this section the employer

shall transfer the employee to

comparable work for which the

employee is qualified or can be trained

in a short period (up to 6 months),

where the use of respiratory protection

is not required. The employer shall

maintain the total normal earnings,

seniority, and all other employee rights

and benefits. If there is no such work

available, the employer shall maintain

the employee’s total normal earnings,

seniority, and all other employee rights

and benefits until such work becomes

available or for a maximum of 18

months, whichever comes first.

(iv) An employer’s obligation to

provide earnings, seniority and other

benefits to a removed employee may be

reduced to the extent that the employee

receives compensation for earnings lost

during the period of removal either from

a publicly or employer-funded

compensation program or from

employment with another employer

made possible by virtue of the

employee’s removal.

(6) Information Provided to Physician

or Other Licensed Health Care

Professionals. (i) Each employer shall

assure that all physicians or other

licensed health care professionals

responsible for making determinations

and performing procedures as part of

the medical surveillance program are
54290 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

provided a copy of this regulation and,

for those employees required to wear

respirators under this section,

information regarding the type of

respiratory protection used, a

description of the work effort required,

any special environmental conditions

(e.g., heat, confined space entry),

additional requirements for protective

clothing and equipment, and the

duration and frequency of usage of the

respirator.

(ii) Each employer shall assure that

the physician or other licensed health

care professional, as appropriate, who

evaluates an employee after an exposure

incident is provided the following

information:

(A) A description of the exposed

employee’s duties as they relate to the

exposure incident;

(B) Circumstances under which the

exposure incident occurred;

(C) Any diagnostic test results,

including drug susceptibility pattern or

other information relating to the source

of exposure which could assist in the

medical management of the employee;

and

(D) All of the employee’s medical

records relevant to the management of

the employee, including tuberculin skin

testing results.

(7) Written Opinion. (i) Each employer

shall obtain and provide the employee

with a copy of the written opinion of the

physician or other licensed health care

professional, as appropriate, within 15

days of the completion of all medical

evaluations required by this section.

(ii) The written opinion shall be

limited to the following information:

(A) The employee’s TB skin test

status;

(B) The employee’s infectivity status;

(C) A statement that the employee has

been informed of the results of the

medical evaluation;

(D) A statement that the employee has

been told about any medical conditions

resulting from exposure to TB that

require further evaluation or treatment;

(E) Recommendations for medical

removal or work restrictions and the

physician’s or other licensed health care

professional’s opinion regarding the

employee’s ability to wear a respirator.

(iii) All other findings or diagnoses

shall remain confidential and shall not

be included in the written report.

(h) Communication of Hazards and

Training—(1) Labels. (i) Air systems that

may reasonably be anticipated to

contain aerosolized M. tuberculosis

shall be labeled ‘‘Contaminated Air—

Respiratory Protection Required.’’ The

label shall be placed at all points where

ducts are accessed prior to a HEPA filter

and at duct access points, fans, and

discharge outlets of non-HEPA filtered

direct discharge systems.

(ii) Clinical and research laboratory

wastes that are contaminated with M.

tuberculosis and are to be

decontaminated outside of the

immediate laboratory shall be labeled

with the biohazard symbol or placed in

a red container(s).

(2) Signs. (i) Signs shall be posted at

the entrances to:

(A) Rooms or areas used to isolate an

individual with suspected or confirmed

infectious TB;

(B) Areas where procedures or

services are being performed on an

individual with suspected or confirmed

infectious TB; and

(C) Clinical and research laboratories

where M. tuberculosis is present.

(ii) When an AFB isolation room or

area is vacated by an individual with

suspected or confirmed infectious TB,

unless the individual has been

medically determined to be

noninfectious, the sign shall remain

posted at the entrance until the room or

area has been ventilated according to

CDC recommendations for a removal

efficiency of 99.9% (see Appendix C to

this section).

(iii) Signs for AFB isolation rooms or

areas, except as required in paragraph

(h)(2)(iv) of this section, shall be readily

observable and shall bear the following

legend with symbol and text in white on

a red background:

BILLING CODE 4510–26–P

BILLING CODE 4510–26–C

No Admittance Without Wearing a

Type N95 or More Protective Respirator

Note to paragraph (h)(2)(ii): Employers

may include additional information on signs

provided it does not interfere with

conveyance of this message.

(iv) Signs at the entrances of clinical

or research laboratories and autopsy

suites where procedures are being

performed that may generate aerosolized

M. tuberculosis shall include the

biohazard symbol, name and telephone

number of the laboratory director or

other designated responsible person, the

infectious agent designation

Mycobacterium tuberculosis, and

special requirements for entering the

laboratory or autopsy room.

(3) Information and Training. (i) Each

employer shall assure that each

employee with occupational exposure

participates in a training program,

which must be provided at no cost to

the employee and be made available at

a reasonable time and place.

(ii) Training shall be provided as

follows:

(A) Before initial assignment to tasks

where occupational exposure may

occur;

(B) Within 60 days after the effective

date of the standard; and

(C) At least annually thereafter, unless

the employer can demonstrate that the

employee has the specific knowledge

and skills required under paragraph

(h)(3)(vii) of this section. The employer

must provide re-training to the

employee in any topic(s) in which

specific knowledge and skills cannot be

demonstrated.

Note to paragraph (h)(3)(ii): Training in

the general topics under paragraph (h)(3)(vii)

of this section which has been provided in

the past 12 months by a previous employer

may be transferred to an employee’s new

employer. However, the new employer must

provide training in the site-specific topics

under paragraph (h)(3)(vii) in accordance

with the requirements of paragraph (h).

(iii) For employees who have received

training on TB in the year preceding the

effective date of the standard, only

training with respect to the provisions

of the standard that were not included

in such training need be provided. The

annual retraining shall be conducted

within one year from the date of the

training that occurred before the

effective date of the standard.

(iv) Annual training for each

employee shall be provided within one

calendar year of the employee’s

previous training.

(v) The employer shall provide

additional training when changes such

as modification of tasks or procedures or

institution of new tasks or procedures

affect the employee’s occupational

exposure. The additional training may

be limited to addressing the new or

modified exposures.

(vi) Material appropriate in content

and vocabulary to the educational level,

literacy, and language of employees

shall be used.

(vii) The training program shall

include an explanation of:

(A) The contents of this standard and

the location of an accessible copy of the

regulatory text of this standard;

(B) The general epidemiology of TB,

including Multidrug-Resistant TB

(MDR–TB), and the potential for

exposure within the facility; the signs

and symptoms of TB, including the

difference between tuberculosis
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54291

infection and tuberculosis disease; the

modes of transmission of tuberculosis,

including the possibility of reinfection

in persons with a positive tuberculin

skin test; and the personal health

conditions that increase the employee’s

risk of developing TB disease if infected

(e.g., HIV infection, prolonged

corticosteroid therapy, other

immunocompromising conditions);

(C) The employer’s exposure control

plan and respiratory protection program

and the means by which the employee

can review the written plans;

(D) The tasks and other activities that

may involve exposure to M.

tuberculosis;

(E) The use and limitations of

methods that will prevent or reduce

exposure, including appropriate

engineering controls, work practices,

respiratory protection, and site-specific

control measures;

(F) Why a respirator is necessary, and

the basis of selection of the respirators

used, the types of respirators used,

upkeep and storage of the respirators

used, and their location and proper use,

including procedures for inspection,

donning and removal, checking the fit

and seals, and wearing the respirator.

This instruction shall allow sufficient

practice to enable the employee to

become thoroughly familiar with and

effective in performing these tasks;

(G) The employer’s medical

surveillance program, including the

purpose of tuberculin skin testing, the

importance of a positive or negative skin

test result, anergy testing, and the

importance of participation in the

program;

(H) The procedures to follow if an

exposure incident occurs, including the

method of reporting the incident and

the medical management and follow-up

that the employer is required to provide,

and the benefits and risks of

prophylaxis; and

(I) The procedures to follow if the

employee develops signs or symptoms

of TB disease.

(viii) The person(s) conducting the

training shall be knowledgeable in the

subject matter covered by the elements

contained in the training program as it

relates to the workplace that the training

will address.

(ix) The employer shall provide

employees with an opportunity for

interactive questions and answers with

the person conducting the training

session.

(i) Recordkeeping—(1) Medical

Records. (i) Each employer shall

establish and maintain an accurate

record for each employee with

occupational exposure, in accordance

with 29 CFR 1910.1020.

(ii) This record shall include:

(A) The name, social security number,

and job classification of the employee;

(B) A copy of all results of

examinations; medical testing,

including the employee’s tuberculin

skin test status; and follow-up

procedures;

(C) The employer’s copy of the

physician’s or other licensed health care

professional’s written opinion; and

(D) A copy of the information

provided to the physician or other

licensed health care professional.

(iii) Confidentiality. The employer

shall assure that employee medical

records required by paragraph (i) are:

(A) Kept confidential; and

(B) Not disclosed or reported without

the employee’s express written consent

to any person within or outside the

workplace, except as required by this

section or as may be required by law.

(iv) The employer shall maintain the

records required by paragraph (i)(1) for

at least the duration of employment plus

30 years, in accordance with 29 CFR

1910.1020. The medical records of

employees who have worked for less

than one year for the employer need not

be retained beyond the term of

employment if they are provided to the

employee upon termination of

employment.

(2) OSHA Illness and Injury Records.

The employer shall record TB infection

or disease in accordance with 29 CFR

1904 and 29 CFR 1960, as applicable.

(3) Training Records. (i) Training

records shall include the following

information:

(A) The dates of the training sessions;

(B) The contents or a summary of the

training sessions;

(C) The names and qualifications of

persons conducting the training; and

(D) The name and job classification of

all persons attending the training

sessions.

(ii) Training records shall be

maintained for 3 years from the date on

which the training occurred.

(4) Engineering Control Maintenance

and Monitoring Records. (i) Engineering

control maintenance records shall

include the following information:

(A) Date;

(B) Equipment identification;

(C) Task performed; and

(D) Sign-off.

(ii) Performance monitoring records

shall include the following information:

(A) Date and time;

(B) Location;

(C) Parameter measured, including

units when appropriate;

(D) Results of monitoring; and

(E) Sign-off.

(iii) Engineering control maintenance

and monitoring records shall be

maintained for three years.

(5) Availability. (i) Employee medical

records required by paragraph (i)(1),

Recordkeeping, of this section shall be

provided upon request for the

examination and copying to the subject

employee, to anyone having the written

consent of the subject employee, to the

Director, and to the Assistant Secretary

in accordance with 29 CFR 1910.1020.

OSHA Illness and Injury Records shall

be accessible under the provisions of 29

CFR 1904 and 29 CFR 1960, as

applicable.

(ii) Employee training records

required by paragraph (i)(3),

Recordkeeping, of this section shall be

provided upon request for examination

and copying to employees, to their

representatives, to the Director, and to

the Assistant Secretary.

(iii) Engineering control maintenance

and monitoring records required by

paragraph (i)(4), Recordkeeping, of this

section shall be provided upon request

for examination and copying to

employees, their representatives, to the

Director, and to the Assistant Secretary.

(6) Transfer of Records. (i) The

employer shall comply with the

requirements involving transfer of

records set forth in 29 CFR 1910.1020(h)

and 29 CFR 1904 and 29 CFR 1960, as

applicable.

(ii) If the employer ceases to do

business and there is no successor

employer to receive and retain the

records for the prescribed period, the

employer shall notify the Director at

least three months before their disposal

and transmit them to the Director, if

required by the Director to do so, within

the three month period.

(j) Definitions. For the purposes of

this section, the following shall apply:

Acid-fast bacilli (AFB) means bacteria

that retain certain dyes after being

washed in an acid solution. Most acidfast organisms are mycobacteria.

Accredited laboratory means a

laboratory that has participated in a

quality assurance program leading to a

certification of competence

administered by a governmental or

private organization that tests and

certifies laboratories.

Air-purifying respirator means a

respirator that is designed to remove air

contaminants from the ambient air or air

surrounding the respirator.

AFB isolation room or area includes,

but is not limited to, rooms, areas,

booths, tents, or other enclosures that

are maintained at negative pressure to

adjacent areas in order to control the

spread of aerosolized M. tuberculosis.
54292 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

Anergy means the inability of a

person to react to skin test antigens

(even if the person is infected with the

organisms tested) because of

immunosuppression.

Assistant Secretary means the

Assistant Secretary of Labor for

Occupational Safety and Health, or

designated representative.

BCG (Bacille Calmette-Guerin)

vaccine is a tuberculosis vaccine.

Canister or cartridge means a

container with a filter, sorbent, or

catalyst, or a combination of these

items, that removes specific air

contaminants from the air drawn

through the container.

Clinical laboratory is a laboratory or

area of a facility that conducts routine

and repetitive operations for the

diagnosis of TB such as preparing acidfast smears and culturing sputa or other

clinical specimens for identification,

typing or susceptibility testing.

Confirmed infectious tuberculosis is a

disease state that has been diagnosed by

positive identification of M. tuberculosis

from body fluid or tissue through

positive culture, positive gene probe, or

positive polymerase chain reaction

(PCR). The disease state must be capable

of being transmitted to another

individual (e.g., pulmonary or laryngeal

TB or extrapulmonary TB where the

infected tissue is exposed and could

generate droplet nuclei).

Conversion means a change in

tuberculin skin test results from

negative to positive, based upon current

Centers for Disease Control and

Prevention (CDC) guidelines.

Director means the Director of the

National Institute for Occupational

Safety and Health, U.S. Department of

Health and Human Services, or

designated representative.

Disposable respirator means a

respiratory protective device that cannot

be resupplied with an unused filter or

cartridge and that is to be discarded in

its entirety after its useful service life

has been reached.

Exposure incident means an event in

which an employee has been exposed to

an individual with confirmed infectious

TB or to air containing aerosolized M.

tuberculosis without the benefit of

applicable exposure control measures

required by this section.

Filter means a component used in

respirators to remove solid or liquid

aerosols from the inspired air.

Fit factor means a quantitative

measure of the fit of a particular

respirator on a particular individual.

High efficiency particulate air (HEPA)

filter means a specialized filter that is

capable of removing 99.97% of particles

greater than or equal to 0.3 micrometer

in diameter.

High hazard procedures are

procedures performed on an individual

with suspected or confirmed infectious

tuberculosis in which the potential for

being exposed to M. tuberculosis is

increased due to the reasonably

anticipated generation of aerosolized M.

tuberculosis. Such procedures include,

but are not limited to, sputum

induction, bronchoscopy, endotracheal

intubation or suctioning, aerosolized

administration of pentamidine or other

medications, and pulmonary function

testing. They also include autopsy,

clinical, surgical and laboratory

procedures that may aerosolize M.

tuberculosis.

M. tuberculosis means Mycobacterium

tuberculosis, the scientific name of the

bacillus that causes tuberculosis.

Negative pressure means the relative

air pressure difference between two

areas. A room that is under negative

pressure has lower pressure than

adjacent areas, which keeps air from

flowing out of the room and into

adjacent rooms or areas.

Negative pressure respirator means a

respirator in which the air pressure

inside the facepiece is negative during

inhalation with respect to the ambient

air pressure outside the respirator.

Occupational exposure means

reasonably anticipated contact, that

results from the performance of an

employee’s duties, with an individual

with suspected or confirmed infectious

TB or air that may contain aerosolized

M. tuberculosis.

Physician or other licensed health

care professional means an individual

whose legally permitted scope of

practice (i.e., license, registration, or

certification) allows him or her to

independently provide or be delegated

the responsibility to provide some or all

of the health care services required by

paragraph (g) of this section.

Powered air-purifying respirator

(PAPR) means an air-purifying

respirator that uses a blower to deliver

air through the air-purifying element to

the wearer’s breathing zone.

Qualitative fit test means a pass/fail

fit test to assess the adequacy of

respirator fit that relies on the respirator

wearer’s response to a challenge agent.

Quantitative fit test means an

assessment of the adequacy of respirator

fit by numerically measuring the

amount of leakage into the respirator.

Research laboratory is a laboratory

that propagates and manipulates

cultures of M. tuberculosis in large

volumes or high concentrations that are

in excess of those used for identification

and typing activities common to clinical

laboratories.

Respirator means a device worn by an

individual and intended to provide the

wearer with respiratory protection

against inhalation of airborne

contaminants.

Suspected infectious tuberculosis

means a potential disease state in which

an individual is known, or with

reasonable diligence should be known,

by the employer to have one or more of

the following conditions, unless the

individual’s condition has been

medically determined to result from a

cause other than TB:

(1) To be infected with M.

tuberculosis and to have the signs or

symptoms of TB;

(2) To have a positive acid-fast bacilli

(AFB) smear; or

(3) To have a persistent cough lasting

3 or more weeks and two or more

symptoms of active TB (e.g., bloody

sputum, night sweats, weight loss, fever,

anorexia). An individual with suspected

infectious TB has neither confirmed

infectious TB nor has he or she been

medically determined to be

noninfectious.

Tight-fitting facepiece means a

respiratory inlet covering that is

designed to form a complete seal with

the face. A half-facepiece covers the

nose and mouth; a full facepiece covers

the nose, mouth, and eyes.

Tuberculosis (TB) means a disease

caused by M. tuberculosis.

Tuberculosis infection means a

condition in which living M.

tuberculosis bacilli are present in the

body without producing clinically

active disease. Although the infected

individual has a positive tuberculin skin

test reaction, he or she may have no

symptoms related to the infection and

may not be capable of transmitting the

disease.

Tuberculosis disease is a condition in

which living M. tuberculosis bacilli are

present in the body, producing clinical

illness. The individual may or may not

be infectious.

Tuberculin skin test means a method

used to evaluate the likelihood that a

person is infected with M. tuberculosis.

The method utilizes an intradermal

injection of tuberculin antigen with

subsequent measurement of the reaction

induration. It is also referred to as a PPD

skin test.

Two-step testing is a baseline skin

testing procedure used to identify a

boosted skin test reaction from that of a

new infection. The procedure involves

placing a second skin test 1 to 3 weeks

after an initial negative test. A positive

reaction on the second test indicates a

boosted reaction.
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54293

(k) Dates.—(1) Effective Date. The

standard shall become effective on

[insert date 90 days after publication of

final rule in the Federal Register].

(2) Start-up dates. (i) Exposure

control. The exposure control

provisions required by paragraph (c) of

this section shall take effect on [insert

date 30 days after effective date of final

rule].

(ii) The Information and Training

provisions required under paragraph

(h)(3), the Medical surveillance

provisions required by paragraph (g),

and the Recordkeeping provisions

required by paragraph (i) of this section

shall take effect on [insert date 60 days

after effective date of final rule].

(iii) Work practices and Engineering

controls. The work practice and

engineering control provisions required

by paragraph (d) of this section shall

take effect on [insert date 90 days after

effective date of final rule]. For

businesses with fewer than 20

employees, engineering controls

required by paragraph (d) of this section

shall take effect [insert 270 days after

effective date of final rule]. Work

practice controls that are directly related

to engineering controls being installed

in accordance with this paragraph shall

be implemented as soon as those

engineering controls are implemented.

(iv) Respiratory protection.

Respiratory protection provisions

required by paragraph (f) of this section

shall take effect on [insert date 90 days

after effective date of final rule].

(v) Labels and signs. The labels and

signs provisions required by paragraphs

(h)(1) and (h)(2) of this section shall take

effect on [insert date 90 days after

effective date of final rule].

(vi) Clinical and research laboratories.

The additional requirements for Clinical

and Research Laboratories contained in

paragraphs (e)(1) through (e)(3) shall

take effect on [insert date 90 days after

effective date of final rule].

Appendix A to § 1910.1035—Provisions

for Employers Claiming Reduced

Responsibilities Under Paragraph (b),

Application (Mandatory)

(c) Exposure Control

Paragraph (c)(1)(i & ii) Exposure

Determination

(c)(2)(i) Written Exposure Control Plan with

the following elements:

(c)(2)(i)(A) The exposure determination

(c)(2)(i)(B) Procedures for providing

information to employees about

individuals identified with suspected or

confirmed infectious TB or air that may

reasonably be anticipated to contain

aerosolized M. tuberculosis

(c)(2)(i)(C) Procedures for reporting an

exposure incident

(c)(2)(ii) Procedures for identifying,

masking or segregating and transferring

individuals with suspected or confirmed

infectious TB

(c)(2)(vi) Documentation of the number of

individuals with confirmed infectious

TB encountered in the past 12 months

(c)(2)(vii) (A–C) Accessible exposure

control plan, reviewed annually and

updated as necessary, and made

available to the Assistant Secretary and

Director

(d) Work Practice Procedures and

Engineering Controls

(d)(1) Use of work practices to eliminate or

minimize employee exposure

(d)(2) Implementation of the work practice

procedures in the exposure control plan

(d)(3)(i) Identification and masking or

segregating of individuals with

suspected or confirmed infectious TB

(d)(3)(ii) Temporary isolation of individuals

who cannot be transferred within 5

hours

(d)(5)(i–vii) Engineering controls if

temporary isolation is used

(d)(6) Provide information about TB

hazards to temporary or personnel who

may incur occupational exposure

(g) Medical Surveillance

(g)(1)(i–iv) Medical surveillance program

for each employee with occupational

exposure or who has an exposure

incident in one of the covered work

settings, at no cost, at a reasonable time,

by a physician or other licensed health

care professional, according to current

recommendations of the CDC and with

laboratory tests conducted by an

accredited laboratory

(g)(2)(i, ii, iii, v, vi & vii) Explanation of

terms: Medical history, Physical

examination, tuberculin skin testing,

medical management and follow-up,

medical removal protection, and other

related tests and procedures

(g)(3)(i)(A) Initial TB skin testing and

medical history (NOTE: Annual skin

testing and medical histories are not

required)

(g)(3)(i)(B) Medical history, TB skin testing

and follow-up for employees who

develop signs or symptoms of TB

(g)(3)(i)(C) Medical history, TB skin testing

and medical management and follow-up

of employees after an exposure incident

(g)(4)(i) Notification of employee and

employer as soon as feasible about

infectious TB disease status of the

employee

(g)(4)(ii) Notification of employees about

previously unidentified individuals with

infectious TB

(g)(4)(iii) Determination of drug

susceptibility of M. tuberculosis source

after an exposure incident

(g)(4)(iv) Investigations of exposure

incidents and TB skin test conversions

(g)(5)(i, ii & iv) Medical removal and

protection of benefits for individuals

with infectious TB

(g)(6)(i & ii) Information provided to the

physician or other licensed health care

professional

(g)(7)(i–iii) Physician or other licensed

health care professional’s written

opinion

(h) Communication of Hazards and Training

(h)(1)(i) If temporary isolation is used, label

air systems that may reasonably be

anticipated to contain aerosolized M.

tuberculosis

(h)(2)(i)(A) If temporary isolation is used,

post signs at entrance to temporary

isolation

(h)(2)(ii) When temporary isolation room or

area is vacated by an individual with

suspected or confirmed infectious TB,

ventilate for an appropriate period

(h)(2)(iii) Signs for temporary isolation

rooms or areas must have a stop sign

with the legend ‘‘No Admittance

Without Wearing a Type N95 or More

Protective Respirator’’

(h)(3)(i–viii) Annual training with specified

elements for employees with

occupational exposure

(i) Recordkeeping

(i)(1)(i–iv) Medical Records

(i)(2) OSHA Illness and Injury Records

(i)(3)(i & ii) Training Records

(i)(4)(i–iii) If temporary isolation is used,

engineering control maintenance records

(i)(5)(i & ii) Availability of medical and

training records

(i)(6)(i & ii) Transfer of records

(k) Dates

(k)(1) Effective date

(k)(2)(i, ii & iii) Start up dates for exposure

control, medical surveillance,

information and training, recordkeeping,

and work practices and engineering

controls

Appendix B to § 1910.1035—Fit Testing

Procedures (Mandatory)

Part I. Approved Fit Test Protocols

A. Fit Testing Procedures

The employer shall conduct fit testing

using the following procedures. These

provisions apply to both QLFT and QNFT.

1. The test subject shall be allowed to pick

the most acceptable respirator from a

selection of respirators of various sizes and

models.

2. Prior to the selection process, the test

subject shall be shown how to put on a

respirator, how it should be positioned on

the face, how to set strap tension and how

to determine an acceptable fit. A mirror shall

be available to assist the subject in evaluating

the fit and positioning the respirator. This

instruction may not constitute the subject’s

formal training on respirator use, as it is only

a review.

3. The test subject shall be informed that

he or she is being asked to select the

respirator that provides the most acceptable

fit. Each respirator represents a different size

and shape, and if fitted and used properly,

will provide adequate protection.

4. The test subject shall be instructed to

hold each chosen facepiece up to the face

and eliminate those that obviously do not

give an acceptable fit.

5. The more acceptable facepieces are

noted; the most acceptable mask is donned
54294 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

and worn at least five minutes to assess

acceptability. Assistance in assessing

acceptability can be given by discussing the

points in item 6 below. If the test subject is

not familiar with using a particular

respirator, the test subject shall be directed

to don the mask several times and to adjust

the straps each time to become adept at

setting proper tension on the straps.

6. Assessment of acceptability shall

include reviewing the following points with

the test subject and allowing the test subject

adequate time to determine the acceptability

of the respirator:

(a) Position of the mask on the nose,

(b) Room for eye protection,

(c) Room to talk;

(d) Position of mask on face and cheeks.

7. The following criteria shall be used to

help determine the adequacy of the respirator

fit:

(a) Chin properly placed;

(b) Adequate strap tension, not overly

tightened;

(c) Fit across nose bridge;

(d) Respirator of proper size to span

distance from nose to chin;

(e) Tendency of respirator to slip;

(f) Self-observation in mirror to evaluate fit

and respirator position.

8. The test subject shall conduct the

negative and positive pressure fit checks as

described in this appendix or other fit check

procedures recommended by the respirator

manufacturer providing equivalent

protection to the procedures in this

appendix. Before conducting the negative or

positive pressure fit checks, the subject shall

be told to seat the mask on the face by

moving the head from side-to-side and up

and down slowly while taking in a few slow

deep breaths. Another facepiece shall be

selected and retested if the test subject fails

the fit check tests.

9. The test shall not be conducted if there

is any hair growth between the skin and the

facepiece sealing surface, such as stubble

beard growth, beard, mustache or sideburns

that cross the respirator sealing surface. Any

type of apparel which interferes with a

satisfactory fit shall be altered or removed.

10. If a test subject exhibits difficulty in

breathing during the tests, she or he shall be

referred to a physician or other licensed

health care professional, as appropriate, to

determine whether the test subject can wear

a respirator while performing her or his

duties.

11. If the employee finds the fit of the

respirator unacceptable, the test subject shall

be given the opportunity to select a different

respirator and to be retested.

12. Exercise regimen. Prior to the

commencement of the fit test, the test subject

shall be given a description of the fit test and

the test subject’s responsibilities during the

test procedure. The description of the process

shall include a description of the test

exercises that the subject will be performing.

The respirator to be tested shall be worn for

at least 5 minutes before the start of the fit

test.

13. Test Exercises. The test subject shall

perform exercises, in the test environment,

while wearing any applicable safety

equipment that may be worn during actual

respirator use which could interfere with fit,

in the manner described below:

(a) Normal breathing. In a normal standing

position, without talking, the subject shall

breathe normally.

(b) Deep breathing. In a normal standing

position, the subject shall breathe slowly and

deeply, taking caution so as to not

hyperventilate.

(c) Turning head side to side. Standing in

place, the subject shall slowly turn his or her

head from side to side between the extreme

positions on each side. The head shall be

held at each extreme momentarily so the

subject can inhale at each side.

(d) Moving head up and down. Standing in

place, the subject shall slowly move his/her

head up and down. The subject shall be

instructed to inhale in the up position (i.e.,

when looking toward the ceiling).

(e) Talking. The subject shall talk out loud

slowly and loud enough so as to be heard

clearly by the test conductor. The subject can

read from a prepared text such as the

Rainbow Passage, count backward from 100,

or recite a memorized poem or song.

Rainbow Passage

When the sunlight strikes raindrops in the

air, they act like a prism and form a rainbow.

The rainbow is a division of white light into

many beautiful colors. These take the shape

of a long round arch, with its path high

above, and its two ends apparently beyond

the horizon. There is, according to legend, a

boiling pot of gold at one end. People look,

but no one ever finds it. When a man looks

for something beyond reach, his friends say

he is looking for the pot of gold at the end

of the rainbow.

(f) Grimace. The test subject shall grimace

by smiling or frowning. (Only for QNFT

testing, not performed for QLFT)

(g) Bending over. The test subject shall

bend at the waist as if he/she were to touch

his/her toes. Jogging in place shall be

substituted for this exercise in those test

environments such as shroud type QNFT

units which prohibit bending at the waist.

(h) Normal breathing. Same as exercise (a).

Each test exercise shall be performed for one

minute except for the grimace exercise which

shall be performed for 15 seconds.

The test subject shall be questioned by the

test conductor regarding the acceptability of

the respirator upon completion of the

protocol. If it has become unacceptable,

another model of respirator shall be tried.

B. Qualitative Fit Test (QLFT) Protocols

1. General

(a) The employer shall assign specific

individuals who shall assume full

responsibility for implementing the

respirator qualitative fit test program.

(b) The employer shall ensure that persons

administering QLFT are able to prepare test

solutions, calibrate equipment and perform

tests properly, recognize invalid tests, and

assure that test equipment is in proper

working order.

(c) The employer shall assure that QLFT

equipment is kept clean and well maintained

so as to operate within the parameters for

which it was designed.

2. Isoamyl Acetate Protocol

Note: This protocol is not appropriate, by

itself, for fit testing particulate respirators. If

chosen for use in fit testing particulate

respirators, the respirator must be equipped

with an organic vapor cartridge, provided the

employee will be using the same facepiece in

the work setting except that it will be

equipped with particulate filters.

(a) Odor threshold screening. The odor

threshold screening test, performed without

wearing a respirator, is intended to determine

if the individual tested can detect the odor

of isoamyl acetate.

(1) Three 1 liter glass jars with metal lids

are required.

(2) Odor free water (e.g. distilled or spring

water) at approximately 25 degrees C shall be

used for the solutions.

(3) The isoamyl acetate (IAA) (also known

at isopentyl acetate) stock solution is

prepared by adding 1 cc of pure IAA to 800

cc of odor free water in a 1 liter jar and

shaking for 30 seconds. A new solution shall

be prepared at least weekly.

(4) The screening test shall be conducted

in a room separate from the room used for

actual fit testing. The two rooms shall be well

ventilated to prevent the odor of IAA from

becoming evident in the general room air

where testing takes place.

(5) The odor test solution is prepared in a

second jar by placing 0.4 cc of the stock

solution into 500 cc of odor free water using

a clean dropper or pipette. The solution shall

be shaken for 30 seconds and allowed to

stand for two to three minutes so that the

IAA concentration above the liquid may

reach equilibrium. This solution shall be

used for only one day.

(6) A test blank shall be prepared in a third

jar by adding 500 cc of odor free water.

(7) The odor test and test blank jars shall

be labeled 1 and 2 for jar identification.

Labels shall be placed on the lids so they can

be periodically peeled off and switched to

maintain the integrity of the test.

(8) The following instruction shall be typed

on a card and placed on the table in front of

the two test jars (i.e., 1 and 2): The purpose

of this test is to determine if you can smell

banana oil at a low concentration. The two

bottles in front of you contain water. One of

these bottles also contains a small amount of

banana oil. Be sure the covers are on tight,

then shake each bottle for two seconds.

Unscrew the lid of each bottle, one at a time,

and sniff at the mouth of the bottle. Indicate

to the test conductor which bottle contains

banana oil.

(9) The mixtures used in the IAA odor

detection test shall be prepared in an area

separate from where the test is performed, in

order to prevent olfactory fatigue in the

subject.

(10) If the test subject is unable to correctly

identify the jar containing the odor test

solution, the IAA qualitative fit test shall not

be performed.

(11) If the test subject correctly identifies

the jar containing the odor test solution, the

test subject may proceed to respirator

selection and fit testing.

(b) Isoamyl acetate fit test. (1) The fit test

chamber shall be similar to a clear 55-gallon

drum liner suspended inverted over a 2-foot
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54295

diameter frame so that the top of the chamber

is about 6 inches above the test subject’s

head. The inside top center of the chamber

shall have a small hook attached.

(2) Each respirator used for the fitting and

fit testing shall be equipped with organic

vapor cartridges or offer protection against

organic vapors.

(3) After selecting, donning, and properly

adjusting a respirator, the test subject shall

wear it to the fit testing room. This room

shall be separate from the room used for odor

threshold screening and respirator selection,

and shall be well ventilated, as by an exhaust

fan or lab hood, to prevent the test medium

that is not contained will be removed from

the general room air.

(4) A copy of the test exercises and any

prepared text from which the subject is to

read shall be taped to the inside of the test

chamber.

(5) Upon entering the test chamber, the test

subject shall be given a 6-inch by 5-inch

piece of paper towel, or other porous,

absorbent, single-ply material, folded in half

and wetted with 0.75 cc of pure IAA. The test

subject shall hang the wet towel on the hook

at the top of the chamber.

(6) Allow two minutes for the IAA test

concentration to stabilize before starting the

fit test exercises. This would be an

appropriate time to talk with the test subject;

to explain the fit test, the importance of his/

her cooperation, and the purpose for the test

exercises; or to demonstrate some of the

exercises.

(7) If at any time during the test, the subject

detects the banana like odor of IAA, the test

is failed. The subject shall quickly exit from

the test chamber and leave the test area to

avoid olfactory fatigue.

(8) If the test is failed, the subject shall

return to the selection room and remove the

respirator. The test subject shall repeat the

odor sensitivity test, select and put on

another respirator, return to the test area and

again begin the fit test procedure described

in (1) through (7) above. The process

continues until a respirator that fits well has

been found. Should the odor sensitivity test

be failed, the subject shall wait about 5

minutes before retesting. Odor sensitivity

will usually have returned by this time.

(9) When the subject wearing the respirator

passes the test, its efficiency shall be

demonstrated for the subject by having the

subject break the face seal and take a breath

before exiting the chamber.

(10) When the test subject leaves the

chamber, the subject shall remove the

saturated towel and return it to the person

conducting the test, so there is no significant

IAA concentration buildup in the chamber

during subsequent tests. The used towels

shall be kept in a self sealing bag to keep the

test area from being contaminated.

3. Saccharin Solution Aerosol Protocol

The entire screening and testing procedure

shall be explained to the test subject prior to

the conduct of the screening test.

(a) Taste threshold screening. The

saccharin taste threshold screening,

performed without wearing a respirator, is

intended to determine whether the

individual being tested can detect the taste of

saccharin.

(1) During threshold screening as well as

during fit testing, subjects shall wear an

enclosure about the head and shoulders that

is approximately 12 inches in diameter by 14

inches tall with at least the front portion

clear and that allows free movements of the

head when a respirator is worn. An enclosure

substantially similar to the 3M hood

assembly, parts # FT 14 and # FT 15

combined, is adequate.

(2) The test enclosure shall have a 3⁄4-inch

hole in front of the test subject’s nose and

mouth area to accommodate the nebulizer

nozzle.

(3) The test subject shall don the test

enclosure. Throughout the threshold

screening test, the test subject shall breathe

through his/her slightly open mouth with

tongue extended.

(4) Using a nebulizer device such as the

DeVilbiss Model 40 Inhalation Medication

Nebulizer or equivalent, the test conductor

shall spray the threshold check solution into

the enclosure. This nebulizer shall be clearly

marked to distinguish it from the fit test

solution nebulizer.

(5) The threshold check solution consists of

0.83 grams of sodium saccharin USP in 100

ml of warm water. It can be prepared by

putting 1 ml of the fit test solution (see (b)(5)

below) in 100 ml of distilled water.

(6) To produce the aerosol, the nebulizer

bulb is firmly squeezed so that it collapses

completely, and is then released and allowed

to fully expand.

(7) Ten squeezes are repeated rapidly and

then the test subject is asked whether the

saccharin can be tasted.

(8) If the first response is negative, ten

more squeezes are repeated rapidly and the

test subject is again asked whether the

saccharin is tasted.

(9) If the second response is negative, ten

more squeezes are repeated rapidly and the

test subject is again asked whether the

saccharin is tasted.

(10) The test conductor will take note of

the number of squeezes required to solicit a

taste response.

(11) If the saccharin is not tasted after 30

squeezes (step 10), the test subject may not

perform the saccharin fit test.

(12) If a taste response is elicited, the test

subject shall be asked to take note of the taste

for reference in the fit test.

(13) Correct use of the nebulizer means that

approximately 1 ml of liquid is used at a time

in the nebulizer body.

(14) The nebulizer shall be thoroughly

rinsed in water, shaken dry, and refilled at

least each morning and afternoon or at least

every four hours.

(b) Saccharin solution aerosol fit test

procedure.

(1) The test subject may not eat, drink

(except plain water), smoke, or chew gum for

15 minutes before the test.

(2) The fit test uses the same enclosure

described in (a) above.

(3) The test subject shall don the enclosure

while wearing the respirator selected in

section I.A. above. The respirator shall be

properly adjusted and equipped with a

particulate filter(s).

(4) A second nebulizer device such as the

DeVilbiss Model 40 Inhalation Medication

Nebulizer or equivalent is used to spray the

fit test solution into the enclosure. This

nebulizer shall be clearly marked to

distinguish it from the screening test solution

nebulizer.

(5) The fit test solution is prepared by

adding 83 grams of sodium saccharin to 100

ml of warm water.

(6) As before, the test subject shall breathe

through the slightly open mouth with tongue

extended.

(7) The nebulizer is inserted into the hole

in the front of the enclosure and the fit test

solution is sprayed into the enclosure using

the same number of squeezes required to

elicit a taste response in the screening test.

A minimum of 10 squeezes is required.

(8) After generating the aerosol the test

subject shall be instructed to perform the

exercises in section I. A. 13 above.

(9) Every 30 seconds the aerosol

concentration shall be replenished using one

half the number of squeezes as initially.

(10) The test subject shall indicate to the

test conductor if at any time during the fit

test the taste of saccharin is detected.

(11) If the taste of saccharin is detected, the

fit is deemed unsatisfactory and a different

respirator shall be tried.

4. Bitrex (Denatonium benzoate) Solution

Aerosol Qualitative Fit Test Protocol

The Bitrex (Denatonium benzoate) solution

aerosol QLFT protocol uses the published

saccharin test protocol because of its current

acceptance and past validation. Bitrex is

routinely used as a taste aversion agent in

household liquids which children should not

be drinking and is endorsed by the American

Medical Association, the National Safety

Council, and the American Association of

Poison Control Centers. The entire screening

and testing procedure shall be explained to

the test subject prior to the conduct of the

screening test.

(a) Taste Threshold Screening. The Bitrex

taste threshold screening, performed without

wearing a respirator, is intended to determine

whether the individual being tested can

detect the taste of Bitrex.

(1) During threshold screening as well as

during fit testing, subjects shall wear an

enclosure about the head and shoulders that

is approximately 12 inches (30.5 cm) in

diameter by 14 inches (35.6 cm) tall. The

front portion of the enclosure shall be clear

from the respirator and allow free movement

of the head when a respirator is worn. An

enclosure substantially similar to the 3M

hood assembly, parts # 14 and # 15 combined,

is adequate.

(2) The test enclosure shall have a 3⁄4 inch

(1.9 cm) hole in front of the test subject’s

nose and mouth area to accommodate the

nebulizer nozzle.

(3) The test subject shall don the test

enclosure. Throughout the threshold

screening test, the test subject shall breathe

through his or her slightly open mouth with

tongue extended.

(4) Using a nebulizer device such as a

DeVilbiss Model 40 Inhalation Medication

Nebulizer or equivalent, the test conductor

shall spray the threshold check solution into

the enclosure. This nebulizer shall be clearly

marked to distinguish it from the fit test

solution nebulizer.
54296 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

(5) The threshold check solution consists of

13.5 milligrams of Bitrex in 100 ml of 5%

NaCl solution in distilled water.

(6) To produce the aerosol, the nebulizer

bulb is firmly squeezed so that the bulb

collapses completely, and is then released

and allowed to fully expand.

(7) Ten squeezes are repeated rapidly and

then the test subject is asked whether the

Bitrex can be tasted.

(8) If the first response is negative, ten

more squeezes are repeated rapidly and the

test subject is again asked whether the Bitrex

is tasted.

(9) If the second response is negative, ten

more squeezes are repeated rapidly and the

test subject is again asked whether the Bitrex

is tasted.

(10) The test conductor will take note of

the number of squeezes required to solicit a

taste response.

(11) If the Bitrex is not tasted after 30

squeezes (step 10), the test subject may not

perform the Bitrex fit test.

(12) If a taste response is elicited, the test

subject shall be asked to take note of the taste

for reference in the fit test.

(13) Correct use of the nebulizer means that

approximately 1 ml of liquid is used at a time

in the nebulizer body.

(14) The nebulizer shall be thoroughly

rinsed in water, shaken to dry, and refilled

at least each morning and afternoon or at

least every four hours.

(b) Bitrex solution aerosol fit test

procedure.

(1) The test subject may not eat, drink

(except plain water), smoke, or chew gum for

15 minutes before the test.

(2) The fit test uses the same enclosure

described in (a) above.

(3) The test subject shall don the enclosure

while wearing the respirator selected in

section I.A. of this appendix. The respirator

shall be properly adjusted and equipped with

a particulate filter(s).

(4) A second nebulizer device such as a

DeVilbiss Model 40 Inhalation Medication

Nebulizer or equivalent is used to spray the

fit test solution into the enclosure. This

nebulizer shall be clearly marked to

distinguish it from the screening test solution

nebulizer.

(5) The fit test solution is prepared by

adding 337.5 mg of Bitrex in 200 ml of a 5%

solution of NaCl in warm water.

(6) As before, the test subject shall breathe

through his or her slightly open mouth with

tongue extended.

(7) The nebulizer is inserted into the hole

in the front of the enclosure and the fit test

solution is sprayed into the enclosure using

the same number of squeezes required to

elicit a taste response in the screening test.

(8) After generating the aerosol the test

subject shall be instructed to perform the

exercises in section I.A.13 of this appendix.

(9) Every 30 seconds the aerosol

concentration shall be replenished using half

the number of squeezes as initially.

(10) The test subject shall indicate to the

test conductor if at any time during the fit

test the taste of Bitrex is detected.

(11) If the taste of Bitrex is detected, the

fit is deemed unsatisfactory and a different

respirator shall be tried.

5. Irritant Fume Protocol

(a) The respirator to be tested shall be

equipped with high-efficiency particulate

filters (i.e., HEPA, N100, R100, or P100) .

(b) No form of test enclosure or hood for

the test subject shall be used.

(c) The test subject shall be allowed to

smell a weak concentration of the irritant

smoke before the respirator is donned to

become familiar with its irritating properties.

(d) Break both ends of a ventilation smoke

tube containing stannic chloride. Attach one

end of the smoke tube to an aspirator squeeze

bulb and cover the other end with a short

piece of tubing to prevent potential injury

from the jagged end of the smoke tube.

(e) Advise the test subject that the smoke

can be irritating to the eyes and instruct the

subject to keep his or her eyes closed while

the test is performed.

(f) The test conductor shall direct the

stream of irritant smoke from the smoke tube

towards the face seal area of the test subject

beginning at least 12 inches from the

facepiece and gradually moving to within

one inch, moving around the whole

perimeter of the mask.

(g) The exercises identified in section I.A.

13 above shall be performed by the test

subject while the respirator seal is being

challenged by the smoke.

(h) Each test subject passing the smoke test

without evidence of a response (involuntary

cough) shall be given a sensitivity check of

the smoke from the same tube once the

respirator has been removed to determine

whether he or she reacts to the smoke.

Failure to evoke a response shall void the fit

test.

(i) The fit test shall be performed in a

location with exhaust ventilation sufficient to

prevent general contamination of the testing

area by the test agent.

C. Quantitative Fit Test (QNFT) Protocols

The following quantitative fit testing

procedures have been demonstrated to be

acceptable:

(1) Quantitative fit testing using a nonhazardous challenge aerosol (such as corn oil

or sodium chloride) generated in a test

chamber, and employing instrumentation to

quantify the fit of the respirator.

(2) Quantitative fit testing using ambient

aerosol as the challenge agent and

appropriate instrumentation (condensation

nuclei counter) to quantify the respirator fit.

(3) Quantitative fit testing using controlled

negative pressure and appropriate

instrumentation to measure the volumetric

leak rate of a facepiece to quantify the

respirator fit.

1. General

(a) The employer shall assign specific

individuals who shall assume full

responsibility for implementing the

respirator quantitative fit test program.

(b) The employer shall ensure that persons

administering QNFT are able to calibrate

equipment and perform tests properly,

recognize invalid tests, calculate fit factors

properly and assure that test equipment is in

proper working order.

(c) The employer shall assure that QNFT

equipment is kept clean, maintained and

calibrated according to the manufacturer’s

instructions so as to operate at the parameters

for which it was designed.

2. Generated Aerosol Protocol

(a) Apparatus. (1) Instrumentation. Aerosol

generation, dilution, and measurement

systems using particulates (corn oil or

sodium chloride) or gases or vapors as test

aerosols shall be used for quantitative fit

testing.

(2) Test chamber. The test chamber shall be

large enough to permit all test subjects to

perform freely all required exercises without

disturbing the challenge agent concentration

or the measurement apparatus. The test

chamber shall be equipped and constructed

so that the challenge agent is effectively

isolated from the ambient air, yet uniform in

concentration throughout the chamber.

(3) When testing air-purifying respirators,

the normal filter or cartridge element shall be

replaced with a high-efficiency particulate

filter (i.e., HEPA, N100, R100, P100) supplied

by the same manufacturer in the case of

particulate QNFT aerosols or a sorbent

offering contaminant penetration protection

equivalent to high-efficiency filters where the

QNFT test agent is a gas or vapor.

(4) The sampling instrument shall be

selected so that a computer record or strip

chart record may be made of the test showing

the rise and fall of the challenge agent

concentration with each inspiration and

expiration at fit factors of at least 2,000.

Integrators or computers that integrate the

amount of test agent penetration leakage into

the respirator for each exercise may be used,

provided a record of the readings is made.

(5) The combination of substitute airpurifying elements, challenge agent and

challenge agent concentration shall be such

that the test subject is not exposed in excess

of an established exposure limit for the

challenge agent at any time during the testing

process based upon the length of the

exposure and the exposure limit duration.

(6) The sampling port on the test specimen

respirator shall be placed and constructed so

that no leakage occurs around the port (e.g.

where the respirator is probed), a free air

flow is allowed into the sampling line at all

times and so that there is no interference

with the fit or performance of the respirator.

The in-mask sampling device (probe) shall be

designed and used so that the air sample is

drawn from the breathing zone of the test

subject, midway between the nose and mouth

and with the probe extending into the

facepiece cavity at least 1⁄4 inch.

(7) The test set-up shall permit the person

administering the test to observe the test

subject inside the chamber during the test.

(8) The equipment generating the challenge

atmosphere shall maintain the concentration

of challenge agent constant to within a 10

percent variation for the duration of the test.

(9) The time lag (interval between an event

and the recording of the event on the strip

chart or computer or integrator) shall be kept

to a minimum. There shall be a clear

association between the occurrence of an

event and its being recorded.

(10) The sampling line tubing for the test

chamber atmosphere and for the respirator

sampling port shall be of equal diameter and
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54297

of the same material. The length of the two

lines shall be equal.

(11) The exhaust flow from the test

chamber shall pass through an appropriate

filter (i.e., high efficiency or sorbent) before

release.

(12) When sodium chloride aerosol is used,

the relative humidity inside the test chamber

shall not exceed 50 percent.

(13) The limitations of instrument

detection shall be taken into account when

determining the fit factor.

(14) Test respirators shall be maintained in

proper working order and inspected for

deficiencies such as cracks, missing valves

and gaskets, etc.

(b) Procedural Requirements. (1) When

performing the initial positive or negative

pressure fit check, the sampling line shall be

crimped closed in order to avoid air pressure

leakage during either of these fit checks.

(2) An abbreviated screening QLFT test

may be utilized in order to quickly identify

poor fitting respirators which passed the

positive and/or negative pressure test and

thus reduce the amount of QNFT time. The

use of the CNC QNFT instrument in the

count mode is another method that can be

used to obtain a quick estimate of fit and

eliminate poor fitting respirators before going

on to perform a full QNFT.

(3) A reasonably stable challenge agent

concentration shall be measured in the test

chamber prior to testing. For canopy or

shower curtain type of test units the

determination of the challenge agent stability

may be established after the test subject has

entered the test environment.

(4) Immediately after the subject enters the

test chamber, the challenge agent

concentration inside the respirator shall be

measured to ensure that the peak penetration

does not exceed 5 percent for a half mask or

1 percent for a full facepiece respirator.

(5) A stable challenge concentration shall

be obtained prior to the actual start of testing.

(6) Respirator restraining straps shall not

be over tightened for testing. The straps shall

be adjusted by the wearer without assistance

from other persons to give a reasonable fit

typical of normal use.

(7) The test shall be terminated whenever

any single peak penetration exceeds 5

percent for half masks and 1 percent for full

facepiece respirators. The test subject shall be

refitted and retested.

(c) Calculation of fit factors. (1) The fit

factor shall be determined for the

quantitative fit test by taking the ratio of the

average chamber concentration to the

concentration measured inside the respirator

for each test exercise except the grimace

exercise.

(2) The average test chamber concentration

shall be calculated as the arithmetic average

of the concentration measured before and

after each test (i.e., 8 exercises) or the

arithmetic average of the concentration

measured before and after each exercise or

the true average measured continuously

during the respirator sample.

(3) The concentration of the challenge

agent inside the respirator shall be

determined by one of the following methods:

(i) Average peak penetration method,

which is the method of determining test

agent penetration into the respirator utilizing

a strip chart recorder, integrator, or

computer. The agent penetration is

determined by an average of the peak heights

on the graph or by computer integration, for

each exercise except the grimace exercise.

Integrators or computers that calculate the

actual test agent penetration into the

respirator for each exercise also meet the

requirements of the average peak penetration

method.

(ii) Maximum peak penetration method

means the method of determining test agent

penetration in the respirator as determined

by strip chart recordings of the test. The

highest peak penetration for a given exercise

is taken to be representative of average

penetration into the respirator for that

exercise.

(iii) Integration by calculation of the area

under the individual peak for each exercise

except the grimace exercise is another

method. This includes computerized

integration.

(iv) The calculation of the overall fit factor

using individual exercise fit factors involves

first converting the exercise fit factors to

penetration values, determining the average,

and then converting that result back to a fit

factor is also appropriate. This procedure is

described in the following equation:

Overall Fit Factor = Number of exercises

1/ff 1/ff 1/ff 1/ff 1/ff 1/ff 1/ff 1/ff 1 2 3 4 + + + + + + + 5 6 7 8

Where ff1, ff2, ff3, etc. are the fit factors for

exercise 1,2,3, etc.

(4) The test subject shall not be permitted

to wear a half mask or quarter facepiece

respirator unless a minimum fit factor of 100

is obtained, or a full facepiece respirator

unless a minimum fit factor of 500 is

obtained.

(5) Filters used for quantitative fit testing

shall be replaced whenever increased

breathing resistance is encountered, or when

the test agent has altered the integrity of the

filter media. Organic vapor cartridges/

canisters shall be replaced if there is any

indication of breakthrough by a test agent.

3. Ambient Aerosol Condensation Nuclei

Counter (CNC) Protocol

The ambient aerosol condensation nuclei

counter (CNC) quantitative fit testing

(PortacountTM) protocol quantitatively fit

tests respirators with the use of a probe. The

probed respirator is only used for

quantitative fit tests. A probed respirator has

a special sampling device, installed on the

respirator, that allows the probe to sample

the air from inside the mask. A probed

respirator is required for each make, model,

and size that is intended to be used and can

be obtained from the respirator manufacturer

or distributor. The CNC instrument

manufacturer TSI also provides probe

attachments (TSI sampling adapters) that

permit fit testing in an employee’s own

respirator. A minimum fit factor pass level of

100 is necessary for a half-mask respirator

and a minimum fit factor of at least 500 is

required for a full facepiece respirator. The

Agency does not recommend the use of

homemade sampling adapters. The entire

screening and testing procedure shall be

explained to the test subject prior to the

conduct of the screening test.

(a) Portacount Fit Test Requirements.

(1) Check the respirator to make sure the

respirator is fitted with a high efficiency filter

(i.e., HEPA, N100, R100, P100) and that the

sampling probe and line are properly

attached to the facepiece.

(2) Instruct the person to be tested to don

the respirator several minutes before the fit

test starts. This purges the particles inside

the respirator and permits the wearer to make

certain the respirator is comfortable. This

individual should have already been trained

on how to wear the respirator properly.

(3) Check the following conditions for the

adequacy of the respirator fit: Chin properly

placed; Adequate strap tension, not overly

tightened; Fit across nose bridge; Respirator

of proper size to span distance from nose to

chin; Tendencies for the respirator to slip;

Self-observation in a mirror to evaluate fit;

and respirator position.

(4) Have the person wearing the respirator

do a fit check. If leakage is detected,

determine the cause. If leakage is from a

poorly fitting facepiece, try another size of

the same type of respirator.

(5) Follow the instructions for operating

the Portacount and proceed with the test.

(b) Portacount Test Exercises—(1) Normal

breathing. In a normal standing position,

without talking, the subject shall breathe

normally for 1 minute.

(2) Deep breathing. In a normal standing

position, the subject shall breathe slowly and

deeply for 1 minute, taking caution so as not

to hyperventilate.

(3) Turning head side to side. Standing in

place, the subject shall slowly turn his or her

head from side to side between the extreme

positions on each side for 1 minute. The head

shall be held at each extreme momentarily so

the subject can inhale at each side.

(4) Moving head up and down. Standing in

place, the subject shall slowly move his or

her head up and down for 1 minute. The

subject shall be instructed to inhale in the up

position (i.e., when looking toward the

ceiling).

(5) Talking. The subject shall talk out loud

slowly and loud enough so as to be heard

clearly by the test conductor. The subject can

read from a prepared text such as the

Rainbow Passage, count backward from 100,

or recite a memorized poem or song for 1

minute.
54298 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

(6) Grimace. The test subject shall grimace

by smiling or frowning for 15 seconds.

(7) Bending Over. The test subject shall

bend at the waist as if he or she were to touch

his or her toes for 1 minute. Jogging in place

shall be substituted for this exercise in those

test environments such as shroud type QNFT

units that prohibit bending at the waist.

(8) Normal Breathing. Remove and re-don

the respirator within a one-minute period.

Then, in a normal standing position, without

talking, the subject shall breathe normally for

1 minute.

After the test exercises, the test subject

shall be questioned by the test conductor

regarding the acceptability of the respirator

upon completion of the protocol. If it has

become unacceptable, another model of

respirator shall be tried.

(c) Portacount Test Instrument. (1) The

Portacount will automatically stop and

calculate the overall fit factor for the entire

set of exercises. The overall fit factor is what

counts. The Pass or Fail message will

indicate whether or not the test was

successful. If the test was a Pass, the fit test

is over.

(2) A record of the test needs to be kept on

file assuming the fit test was successful. The

record must contain the test subject’s name;

overall fit factor; make, model and size of

respirator used, and date tested.

4. Controlled Negative Pressure (CNP)

Protocol

The CNP protocol provides an alternative

to aerosol fit test methods. The CNP fit test

method technology is based on exhausting air

from a temporarily sealed respirator

facepiece to generate and then maintain a

constant negative pressure inside the

facepiece. The rate of air exhaust is

controlled so that a constant negative

pressure is maintained in the respirator

during the fit test. The level of pressure is

selected to replicate the mean inspiratory

pressure that causes leakage into the

respirator under normal use conditions. With

pressure held constant, air flow out of the

respirator is equal to air flow into the

respirator. Therefore, measurement of the

exhaust stream that is required to hold the

pressure in the temporarily sealed respirator

constant yields a direct measure of leakage

air flow into the respirator.

The CNP fit test method measures leak

rates through the facepiece as a method for

determining the facepiece fit for negative

pressure respirators. The CNP instrument

manufacturer Dynatech Nevada also provides

attachments (sampling manifolds) that

replace the filter cartridges to permit fit

testing in an employee’s own respirator. To

perform the test, the test subject closes his or

her mouth and holds his or her breath, then

an air pump removes air from the respirator

facepiece at a pre-selected constant pressure.

The facepiece fit is expressed as the leak rate

through the facepiece, expressed as

milliliters per minute. The quality and

validity of the CNP fit tests are determined

by the degree to which the in-mask pressure

tracks the challenge pressure during the

system measurement time of approximately

five seconds. Instantaneous feedback in the

form of a real-time pressure trace of the inmask pressure is provided and used to

determine test validity and quality. A

minimum fit factor pass level of 100 is

necessary for a half-mask respirator and a

minimum fit factor of at least 500 is required

for a full facepiece respirator.

The entire screening and testing procedure

shall be explained to the test subject prior to

the conduct of the screening test.

(a) CNP Fit Test Requirements—(1) The

instrument shall have a non-adjustable

challenge pressure of 15.0 mm water

pressure.

(2) The CNP system defaults for challenge

pressure shall be tested at ¥0.58 inches of

water and the modeled inspiratory flow rate

shall be 53.8 liters per minute.

Note: CNP systems have built-in capability

to conduct fit testing that is specific to

unique work rate, mask, and gender

situations that might apply in a specific

workplace. Use of system default values,

which were selected to represent respirator

wear with medium cartridge resistance at a

low-moderate work rate, will allow inter-test

comparison of the respirator fit.

(3) The individual who conducts the CNP

fit testing shall be thoroughly trained to

perform the test.

(4) The respirator filter or cartridge needs

to be replaced with the CNP test manifold.

The inhalation valve downstream from the

manifold either needs to be temporarily

removed or propped open.

(5) The test subject shall be trained to hold

his or her breath for at least 20 seconds.

(6) The test subject shall don the test

respirator without any assistance from the

individual who conducts the CNP fit test.

(7) The QNFT protocol shall be followed

according to section I.C.1 except that the CNP

test exercises shall be used.

(b) CNP Test Exercises—(1) Normal

breathing. In a normal standing position,

without talking, the subject shall breathe

normally for 1 minute. After the normal

breathing exercise, the subject needs to hold

head straight ahead and hold his or her

breath for 10 seconds during the test

measurement.

(2) Deep breathing. In a normal standing

position, the subject shall breathe slowly and

deeply for 1 minute, taking caution not to

hyperventilate. After the deep breathing

exercise, the subject needs to hold head

straight ahead and hold his or her breath for

10 seconds during test measurement.

(3) Turning head side to side. Standing in

place, the subject shall slowly turn his or her

head from side to side between the extreme

positions on each side for 1 minute. The head

shall be held at each extreme momentarily so

the subject can inhale at each side. After the

turning head side to side exercise, the subject

needs to hold head full left and hold his or

her breath for 10 seconds during test

measurement. Next, the subject needs to hold

head full right and hold his or her breath for

10 seconds during test measurement.

(4) Moving head up and down. Standing in

place, the subject shall slowly move his or

her head up and down for 1 minute. The

subject shall be instructed to inhale in the up

position (i.e., when looking toward the

ceiling). After the moving head up and down

exercise, the subject needs to hold head full

up and hold his or her breath for 10 seconds

during test measurement. Next, the subject

needs to hold head full down and hold his

or her breath for 10 seconds during test

measurement.

(5) Talking. The subject shall talk out loud

slowly and loud enough so as to be heard

clearly by the test conductor. The subject can

read from a prepared text such as the

Rainbow Passage, count backward from 100,

or recite a memorized poem or song for 1

minute. After the talking exercise, the subject

needs to hold his or her head straight ahead

and hold his or her breath for 10 seconds

during the test measurement.

(6) Grimace. The test subject shall grimace

by smiling or frowning for 15 seconds. After

the grimace exercise, the subject needs to

hold his or her head straight ahead and hold

his or her breath for 10 seconds during the

test measurement.

(7) Bending Over. The test subject shall

bend at the waist as if he or she were to touch

his or her toes for 1 minute. Jogging in place

shall be substituted for this exercise in those

test environments such as shroud type QNFT

units that prohibit bending at the waist. After

the bending over exercise, the subject needs

to hold his or her head straight ahead and

hold his or her breath for 10 seconds during

the test measurement.

(8) Normal Breathing. Remove and re-don

the respirator within a one-minute period.

Then, in a normal standing position, without

talking, the subject shall breathe normally for

1 minute. After the normal breathing

exercise, the subject needs to hold his or her

head straight ahead and hold his or her

breath for 10 seconds during the test

measurement.

After the test exercises, the test subject

shall be questioned by the test conductor

regarding the acceptability of the respirator

upon completion of the protocol. If it has

become unacceptable, another model of a

respirator shall be tried.

(c) CNP Test Instrument.—(1) The test

instrument shall have an effective audio

warning device when the test subject fails to

hold his or her breath during the test. The

test shall be terminated whenever the test

subject failed to hold his or her breath. The

test subject may be refitted and retested.

(2) A record of the test needs to be kept on

file, assuming the fit test was successful. The

record must contain the test subject’s name;

overall fit factor; make, model and size of

respirator used, and date tested.

Part II. Facepiece Fit Checks

(Nonmandatory)

A. Positive pressure check. Close off the

exhalation valve and exhale gently into the

facepiece. The face fit is considered

satisfactory if a slight positive pressure can

be built up inside the facepiece without any

evidence of outward leakage of air at the seal.

For most respirators this method of leak

testing requires the wearer to first remove the

exhalation valve cover before closing off the

exhalation valve and then carefully replacing

it after the test.

B. Negative pressure check. Close off the

inlet opening of the canister or cartridge(s) by

covering with the palm of the hand(s) or by

replacing the filter seal(s), inhale gently so

that the facepiece collapses slightly, and hold
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54299

the breath for ten seconds. If the facepiece

remains in its slightly collapsed condition

and no inward leakage of air is detected, the

tightness of the respirator is considered

satisfactory.

Appendix C to § 1910.1035—Ventilation

Chart for Isolation Rooms or Areas

(Mandatory)

Under paragraph(d)(5)(vii), the proposed

standard requires that when an AFB isolation

room or area is vacated by an individual with

suspected or confirmed infectious TB, the

room or area shall be ventilated according to

current CDC recommendations for a removal

efficiency of 99.9% before permitting

employees to enter without respiratory

protection. The following appendix is an

excerpt of the CDC recommendations of the

air changes per hour (ACH) and time in

minutes required for removal efficiencies of

90%, 99% and 99.9% of airborne

contaminants (Ex.4B). This table specifies the

time necessary to ventilate an isolation room

or area, for a given air change per hour,

before allowing employees to enter without

respiratory protection.

Minutes required for a removal efficiency

of:

ACH 90% 99% 99.9%

1 138 276 414

2 69 138 207

3 46 92 138

4 35 69 104

5 28 55 83

6 23 46 69

7 20 39 59

8 17 35 52

9 15 31 46

10 14 28 41

11 13 25 38

12 12 23 35

13 11 21 32

14 10 20 30

15 9 18 28

16 9 17 26

17 8 16 24

18 8 15 23

19 7 15 22

20 7 14 21

25 6 11 17

30 5 9 14

35 4 8 12

40 3 7 10

45 3 6 9

50 3 6 8

This table has been adapted from the formula

for the rate of purging airborne contaminants.

(Ex. 5–100) Values have been derived from

the formula t1 = [In (C2 + C2) + (Q + V)] ×

60, with t1 = 0 and C1 + C2—(removal

efficiency + 100), and where:

t1 = initial timepoint

C1 = initial concentration of contaminants

C2 = final concentration of contaminants

Q = air flow rate (cubic feet per hour)

V = room volume (cubic feet)

Q + V = ACH

The times given assume perfect mixing of air

within the space (i.e., mixing factor = 1).

However, perfect mixing usually does not

occur, and the mixing factor could be as high

as 10 if air distribution is very poor (Ex. 5–

99). The required time is derived by

multiplying the appropriate time for the table

by the mixing factor that has been

determined for the booth or room. The factor

and required time should be included in the

operating instructions provided by the

manufacturer of the booth or enclosure, and

these instructions should be followed.

Appendix D to § 1910.1035—Ultraviolet

Radiation Safety and Health Provisions

(Nonmandatory)

This appendix sets forth non-mandatory

guidelines on safety and health provisions

concerning the use of ultraviolet germicidal

irradiation (UVGI). Because the effectiveness

of UVGI systems will vary, and the

interaction of factors such as humidity, UV

intensity, duration of exposure, lamp

placement, and air mixing have not been

adequately evaluated, employers may choose

to use UVGI systems as supplements to the

administrative, engineering, and work

practice controls required by this standard.

OSHA does not consider UVGI as a substitute

or replacement for:

(1) Negative pressure;

(2) Exhaust of contaminated air directly to

the outside away from intake vents and

employees;

(3) High efficiency particulate air (HEPA)

filtration of contaminated air before being

recirculated to the general facility or

exhausted directly outside (permitted only

when it cannot be safely discharged).

UVGI Systems

The intent of UVGI systems is to kill or

inactivate airborne microorganisms,

including M. tuberculosis. Two types of

systems are generally employed for this

purpose: duct irradiation systems, and upper

room air irradiation systems. (Floor level

UVGI systems are used in some laboratory

facilities, but are not specifically discussed in

this appendix.) UVGI systems utilize lowpressure mercury vapor lamps that emit

radiant energy predominantly at a

wavelength of 254 nanometers (nm).1 In duct

irradiation systems, one or more UV tubes are

positioned within a duct to irradiate air being

exhausted from a room or facility. In upper

room air irradiation systems, UV lamps are

suspended from a ceiling or mounted on a

wall. The lamps are positioned such that air

in the upper part of the room is irradiated.

The intent is to minimize the levels of UV

radiation in the lower part of the room where

the occupants are located. These systems rely

on air mixing to move the air from the lower

portion of the room to the upper portion of

the room where it can be irradiated.

Safety and Health Considerations

UV radiation at 254 nm is absorbed by the

outer surfaces of the eyes and skin.

Overexposure to UVGI can result in

photokeratitis (inflammation of the cornea)

and/or conjunctivitis (inflammation of the

conjunctiva).2 Keratoconjunctivitis is a

reversible condition but can be debilitating

while it runs its course. Because there is a

latency period before health effects are

observed, workers may not recognize this as

an occupational injury. Symptoms may

include a feeling of sand in the eyes, tearing,

and sensitivity to light. Overexposure of the

skin to UVGI also can result in erythema

(reddening). This effect is also reversible,

with recovery occurring within 2 to 3 days.

In 1992, the International Agency for

Research on Cancer (IARC) classified UV–C

radiation as ‘‘probably carcinogenic to

humans (Group 2A)’’.3 This classification

was based on studies suggesting that UV–C

radiation can induce skin cancers in animals,

DNA and chromosome damage in human

cells in vitro, and DNA damage in

mammalian skin cells in vivo. In the animal

studies, exposure to UV–B could not be

excluded; however, the observed effects were

greater than expected for UV–B alone.3

Laboratory studies have shown that UV

radiation can activate human

immunodeficiency virus (HIV) gene

promoters in human cells (genes in HIV that

prompt replication of the virus); however, the

implications of these findings for humans

exposed to UVGI are unknown.4,5,6,7,8,9

Occupational Exposure Criteria for

Ultraviolet Radiation

In 1972, the National Institute for

Occupational Safety and Health (NIOSH)

published a recommended exposure limit

(REL) for UV radiation to prevent adverse

effects on the eyes and skin.2 The NIOSH

REL for UV radiation is wavelength

dependent because different wavelengths of

ultraviolet radiation have differing abilities to

cause skin and eye effects. The American

Conference of Governmental Industrial

Hygienists (ACGIH) also has a Threshold

Limit Value for UV radiation that is

identical to the REL in this spectral region.10

It should be noted that photosensitive

individuals and those concomitantly exposed

to photosensitizing agents (including certain

medications) may not be protected by these

occupational exposure limits.10

The term relative spectral effectiveness is

used to compare UV sources with a source

producing UV radiation only at 270 nm, the

wavelength of maximum sensitivity for

corneal injury. For example, the relative

spectral effectiveness (Sλ) at 254 nm is 0.5;

therefore, twice as much energy is required

at 254 nm to produce the same biological

effect at 270 nm. Thus, at 254 nm, the NIOSH

REL is 0.006 joules per square centimeter (J/

cm2), and at 270 nm it is 0.003 J/cm2.

For germicidal lamps, proper use of the

REL (or TLV) requires that the measured

irradiance level (E) in microwatts per square

centimeter (μW/cm2) be multiplied by the

relative spectral effectiveness at 254 nm (0.5)

to obtain the effective irradiance (Eeff). The

maximum permissible exposure time (t) for

workers with unprotected eyes and skin can

then be read directly from Table 1 for

selected values of Eeff, or can be calculated

(in seconds) by dividing 0.003 J/cm2 (the

NIOSH REL at 270 nm) by Eeff in W/cm2. To

protect workers who are exposed to

germicidal UV radiation for eight hours per

day, the measured irradiance (E), should be

≤0.2 μW/cm2. This is calculated by using

Table 1 to obtain Eeff (0.1 μW/cm2), and then

dividing by Sλ (0.5).

Example: If the measured irradiance was

0.4 μW/cm2, then the maximum permissible

exposure time is 15,000 seconds, or

approximately 4 hours as shown below:
54300 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

E E S

W cm

W cm

t

J cm

E W cm

J cm

W cm

eff

eff

= ×

= ×

=

=

( )

= × −

λ

μ

μ

0 0 5

0 2

0 003

0 003

0 2 10

2

2

2

2

2

6 2

.4 / .

. /

(sec) . /

/

. /

. /

= 15,000 sec. (approx 4 hours)

TABLE 1—MAXIMUM PERMISSIBLE EXPOSURE TIMES FOR SELECTED VALUES OF Eeff.

Duration of exposure per day

Effective

irradiance

Eeff (μW/cm2)

8 hrs ........................................ 0.1

4 hrs ........................................ 0.2

2 hrs ........................................ 0.4

1 hr .......................................... 0.8

30 min ..................................... 1.7

15 min ..................................... 3.3

10 min ..................................... 5.0

5 min ....................................... 10.0

This table was adapted from a table in Criteria for a Recommended Standard . . . . Occupational Exposure to Ultraviolet Radiation.2

Maximum permissible exposure times refer to

workers with unprotected eyes and skin.

Measurement Equipment. A UV radiometer

can be used to measure the irradiance levels

in the room and to document lamp output.

Some UV measurement systems rely on the

use of a detector or probe which is most

sensitive at 254 nm, while others rely on the

use of a broad-band radiometer with an

actinic probe. The latter instrument has a

response that accounts for the wavelength

dependence of the REL, allowing direct

measurement of the effective irradiance

(Eeff).11 While both types of systems are

acceptable, persons performing the

measurements should be aware of the

differences so that the measurements

obtained are appropriately compared with

the recommended occupational exposure

limits. Equipment used to measure UV

radiation should be maintained and

calibrated on a regular schedule, as

recommended by the manufacturer.

UVGI Safety and Health Program

Employers should consult with persons

having expertise in industrial hygiene,

engineering, and/or health physics before

designing and installing UVGI systems. In

addition, the following guidelines should be

used to protect workers from overexposure to

UV radiation. These guidelines should be

incorporated into a UVGI safety and health

program. One person should be given

responsibility for managing the program.

(1) Exposure Monitoring

a. Upper Air Irradiation Systems. Before an

upper air UVGI system is activated in the

workplace, exposure monitoring should be

conducted to determine the levels of UV

radiation in the room. The UV radiation

levels will be affected by the position of the

lamp, fixture design (including presence and

position of baffles and louvers), tube type,

room dimensions, and presence of UV

absorbing or reflecting materials. At a

minimum, UV radiation measurements

should be made with the detector directly

facing the lamp at head or eye height (with

maximum levels recorded), to assess the

potential UV exposure to the eyes, the most

sensitive organ. Because workers typically

move around a room or area while

performing their duties, it is often not

possible to predict how long a worker will be

in a given location, nor is it practical to

attempt to control exposures administratively

by limiting the duration of exposure at a

given location. Therefore, the exposure

monitoring should be conducted in

representative locations to adequately assess

the range of potential worker exposures.

Worker exposures should be maintained

below the NIOSH REL 2 and ACGIH TLV 10

for ultraviolet radiation.

UV radiation measurements should be

made: (1) at the time of initial installation of

the UVGI system; (2) whenever new tubes are

installed; and (3) whenever modifications are

made to the UVGI system or to the room that

may affect worker exposures (i.e., adjustment

of fixture height, location, or position of

louvers; addition of UV absorbing or

reflecting materials; and changes in room

dimensions).

UV radiation measurements may also be

obtained to document the UV output of the

lamp for tube replacement or other purposes.

Because these types of measurements are

commonly done close to the source of the UV

output, the person obtaining the

measurements may be exposed to high levels

of UV radiation. UV radiation levels up to

840 μW/cm2 (420 μ/cm2 effective irradiance)

have been measured at a distance of four

inches from the face of a 30W tube that had

been in use several months.12 Using the

NIOSH REL, this exposure level would result

in a permissible exposure time of only 7

seconds for workers with unprotected eyes

and skin. Because of the high irradiance

levels, it would not be practical in this

situation to control UV exposures by limiting

exposure duration. Skin and eye protection

would be needed to protect the worker when

making UV measurements close to the

source.

b. Duct Irradiation Systems. Duct

irradiation systems frequently involve the

placement of several UV tubes within a

section of duct work. Thus, workers who

have contact with these lamps are potentially

exposed to high levels of UV radiation. This

presents a hazard for maintenance workers

and others who are responsible for

documenting the UV output of these lamps.

At one facility where a duct irradiation

system was used, UV radiation levels up to

950 μW/cm2 were measured at a distance of

approximately three feet from a bank of four

39W UV tubes.11 In this situation, the NIOSH

REL would be exceeded in about 6 seconds;

therefore, skin and eye protection would be

needed to prevent worker overexposures to

UV radiation. Most UV exposures resulting

from duct irradiation systems can be avoided

by inactivating the lamps before maintenance

work is done, and providing an access port

for viewing the lamps during preventive

maintenance inspections. These control

measures are discussed further in the Control

Methods section of this appendix.

(2) Control Measures

The following control measures should be

used to prevent or reduce UV exposures.

a. Engineering Controls. 1. In upper air

irradiation systems, the UV tubes in the

fixture should not be visible from any usual

location/position in the room. The fixtures

should contain baffles or louvers that are

appropriately positioned to direct the UV

irradiation to the upper air space. The baffles

and louvers should be constructed so that

they cannot be easily bent or deformed.

2. In upper air irradiation systems, all

highly UV reflecting material should be

removed, replaced, or covered. Reflectance

values for various materials have been

published.13 Etched aluminum and

chromium are examples of materials that

have high reflectance values (88 and 45%

reflectance, respectively) for 254 nm

radiation. Unpainted white wall plaster is

reported to have reflectance values of 40–

60%.13

3. UV-absorbing paints (such as those

containing titanium dioxide) can be used on

ceilings and walls to minimize reflectance of

UV in the occupied space, as needed.

4. The on/off switch for the UVGI lamps

should not be located on the same switch as

the general room lighting. In addition, these

switches should be positioned in such a

location that only authorized persons have

access to them and they should be locked to

ensure that they are not accidentally turned

on or off.

5. In duct irradiation systems, there should

be an access panel for conducting routine

maintenance, monitoring, and cleaning. This

access panel should have an interlock or

other device to ensure that the tubes are

deactivated whenever the panel is opened.

To prevent unnecessary UV exposures to

maintenance personnel, this port should

have a window for viewing the tubes during

routine inspections. Ordinary glass (not

quartz) and plastics (polycarbonate and

polymethylmethacrylate) are sufficient to

filter out the UV radiation.14

6. All UVGI systems should be inactivated

prior to maintenance activity in the affected

areas, such as when maintenance workers

replace lamps or when entering the upper air

space for room maintenance, renovation, or

repair work.

b. Personal Protective Equipment. UV

exposures should be maintained below

existing recommended levels. Despite the use

of the engineering controls listed above, there

may be situations when worker exposures

exceed the NIOSH REL, such as when UV

measurements are being made close to the

lamp source in order to document lamp

output, or when maintenance procedures

must be performed in areas where UVGI

systems are activated. In these and other

situations where the NIOSH REL is exceeded,

personal protective equipment is needed to

prevent worker overexposure to UV

radiation. This includes the use of UVabsorbing eyewear with side-shields, head,
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54301

neck, and face covering opaque to UV

radiation, gloves, and long-sleeved garments.

The weave of the fabric has been shown to

be the major factor affecting transmission of

UV radiation,15 thus, tightly woven fabrics

are recommended. UV-absorbing sunscreens

with solar-protection factors of 15 or higher

may help protect photosensitive persons.16

(3) Labeling

Warning labels should be placed on UV

lamp fixtures in upper air irradiation systems

and on access panels in duct irradiation

systems to alert workers and other room

occupants to this potential hazard. These

warning labels should be of sufficient size to

be visible to room occupants and should be

in the appropriate language(s). Examples of

warning labels are shown below:

BILLING CODE 4510–26–P

BILLING CODE 4510–26–C

(4) Training

All workers who have potential exposure

to UV radiation from UVGI systems should

be receiving training on the hazards, relevant

symptoms, and precautions concerning

exposure. This training should include

specific information on:

a. The rationale for use of UVGI and

general principles of operation, including its

limitations;

b. Control measures used to prevent or

reduce UV radiation exposure;

c. Health effects associated with

overexposure to UV radiation (including the

potential for additive exposure from other

UV sources, such as solar radiation and

welding);

d. Recognition of the symptoms of eye and

skin damage; and

e. Special precautions to be taken by

workers to prevent overexposure to UV

radiation (including the use of personal

protective equipment).

(5) Medical Recommendations

The worker’s medical history should be

obtained to determine if the worker suffers

from any condition that may be exacerbated

by exposure to UV radiation. Workers should

be advised that any eye or skin irritation that

develops after acute exposure to UV

radiation, or any skin lesion that appears on

skin repeatedly exposed to UV radiation

should be examined by a physician.

(6) Recordkeeping

The employer should maintain accurate

and complete records pertaining to the

following:

a. Exposure monitoring;

b. Instrument calibration;

c. Documentation of health effects;

d. Training;

e. Maintenance of UVGI systems, including

cleaning and replacement of tubes.

References

1. IES [1966]. Illuminating Engineering

Society (IES) lighting handbook, 4th ed., IES,

New York, 25–27.

2. NIOSH [1972]. Criteria for a

recommended standard . . . occupational

exposure to ultraviolet radiation. U.S.

Department of Health, Education, and

Welfare, Public Health Service, Health

Services and Mental Health Administration,

National Institute for Occupational Safety

and Health, Washington, DC, HSM–11009.

3. IARC [1992]. IARC monographs on the

evaluation of carcinogenic risks to humans:

solar and ultraviolet radiation. Vol. 55. Lyon,

France: World Health Organization,

International Agency for Research on Cancer.

4. Valerie K, Delers A, Bruck C, Thiriart C,

Rosenberg H, Debouck C, Rosenberg M

[1988]. Activation of human

immunodeficiency virus type 1 by DNA

damage in human cells. Nature 333:78–81.

5. Zmudzka BZ, Beer JZ [1990]. Activation

of human immunodeficiency virus by

ultraviolet radiation (yearly review).

Photochem and Photobiol, 52:1153–1162.

6. Wallace BM, Lasker JS [1992].

Awakenings . . . UV light and HIV gene

activation. Science, 257:1211–1212.

7. Valerie K, Rosenberg M [1990].

Chromatin structure implicated in activation

of HIV–1 gene expression by ultraviolet light.

The New Biologist, 2:712–718.

8. Stein B, Rahmsdorf HJ, Steffen A, Litfin

M, Herrlich P [1989]. UV-induced DNA

damage is an intermediate step in UVinduced expression of human

immunodeficiency virus type 1, collagenase,

C-fos, and metallathionein. Mol Cell Biol,

9:5169.

9. Clerici M, Shearer GM [1992]. UV light

exposure and HIV replication. Science, 11/

13/92:1070–1071.

10. ACGIH [1994]. 1994–1995 Threshold

limit values for chemical substances and

physical agents and biological exposure

indices. American Conference of

Governmental Industrial Hygienists,

Cincinnati, OH: ACGIH.

11. Murray WE [1990]. Ultraviolet

radiation exposures in a mycobacteriology

laboratory. Health Physics, 58(4):507–510.

12. NIOSH [1992]. Hazard evaluation and

technical assistance report: Onondaga County

Medical Examiner’s Office, Syracuse, New

York. Cincinnati, OH: U.S. Department of

Health and Human Services, Public Health

Service, Centers for Disease Control and

Prevention, National Institute for

Occupational Safety and Health, (NIOSH

Report No. HETA 92–171–2255).

13. Summer W [1962]. Ultra-violet and

infra-red engineering. New York: Interscience

Publishers, p 300.

14. Sliney DH, Wolbarsht ML [1982].

Safety with lasers and other optical sources.

3rd Printing. New York: Plenum Press.

15. Gies HP, Roy CR, Elliott G [1994].

Ultraviolet radiation protection factors for

clothing. Health Physics 67(2):131–139.

16. CDC [1994]. Guidelines for preventing

the transmission of tuberculosis in healthcare facilities, second edition. Atlanta, GA:

Centers for Disease Control and Prevention.

Appendix E to § 1910.1035—

Performance Monitoring Procedures for

HEPA Filters (Nonmandatory)

This appendix offers nonmandatory

guidance on design considerations and

performance monitoring of HEPA filters used

in air systems that carry air that may

reasonably be anticipated to contain

aerosolized M. tuberculosis (e.g.,

recirculation into building circulating air

system, exhausting outdoors near air intakes,

etc.).

Both OSHA and CDC recommend against

the recirculation of air that may reasonably

be anticipated to contain aerosolized M.

tuberculosis into the general circulating air

system of the building or other opportunities

where such air may become entrained into

the circulating air system (e.g., outdoor

exhausting near intakes, transfer to heat

wheels, etc.). When recirculation is

unavoidable, the air should be cleaned with

HEPA filtration. In order to assure effective

functioning of these systems, they should be

properly designed, installed, and maintained.

Design of HEPA Filtration Systems

The following elements should be

considered for incorporation into the design

of HEPA filtration systems:

1. Provide upstream prefiltering to reduce

dust that may plug the HEPA filter.

2. Provide worker-entry into housings for

visual examinations and probe scanning for

leaks of filter media and frame-to-filter

interfaces. In addition, adequate access

should be provided to allow for replacement

of the HEPA filters and pre-filters without

contaminating the work area by

unintentional jarring or dropping of the

filters.

3. Provide devices for measuring HEPA

filter loading (e.g., pressure differential

across a filter).

4. Provide appropriate mounting frames

and seals to minimize frame-to-filter leakage.

5. Specify filter media to match operating

criteria (e.g., face velocity, volumetric flow

rate, pressure drop, etc.).

6. Design upstream and downstream duct

to facilitate performance monitoring (e.g.,

good air mixing for uniform dispersal of

challenge aerosols, sectioning to allow

isolation of leaks, etc.).

7. HEPA filters must operate in dry

airstreams. Tests have shown that exposure
54302 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

to high humidity for a period of five hours

will result in a threefold increase in particle

penetration.

Maintenance of HEPA Filtration Systems

HEPA filtration systems are generally

passive systems without moving parts, so the

majority of filter maintenance activities are

associated with performance monitoring. In

terms of performance monitoring, HEPA

filters are to be monitored for filter loading

and for possible leakage every 6 months,

whenever filters are changed, and more often

if necessary to maintain effectiveness. Leaks

in HEPA filters can occur in the following

ways: (1) in the filter media, (2) in the bond

between media and frame, (3) in the frame

gasket, (4) in the support frame, and (5) in

between the frame and the wall.

Testing of HEPA filters after installation is

used to detect leaks associated with shipping

damage and with installation problems such

as handling damage, variations in gasket

thickness and poorly formed gasket corners.

Periodic testing detects deterioration of

components, relaxation of gaskets, clamping

devices, weld cracks or other leaks that may

develop during use. This deterioration will

take place even if the system is not on-line

and in use.

Monitoring for Filter Loading

HEPA filtration systems become loaded

with particulate matter through use.

Although this loading improves particulate

arrestance, it eventually increases the

pressure drop across the filter assembly.

Consequently, the flow capacity begins to

diminish and bypass leakage at the frame-tofilter interface increases. Therefore, these

filters need to be monitored and changed.

It is imperative that the differential

pressures across the HEPA filter remain

below the maximum operating resistance

level set by the manufacturer and stamped on

the filter label. Filter penetration by

contaminants can occur when HEPA filters

exceed the manufacturer’s maximum

resistance rating, making the system

ineffective.

The operating resistance level is

determined by measuring the pressure

differential across the filter through use of a

pressure sensing device. Measurements of

differential pressure across the HEPA filters

should be made when the prefilters have

been removed. These measurements should

be used to predict future HEPA filter

replacement or for determining the need for

immediate HEPA filter replacement.

Additional control measures can be used to

detect a differential pressure that exceeds the

maximum operating resistance which signals

the alarm’s set point (i.e., audible/visual

alarms or computerized error messages).

All pressure measurements should be

logged and retained in accordance with

paragraph (i)(4)(ii) of this standard.

Monitoring for In-service Filter Leakage

In CDC’s ‘‘Guidelines for Preventing the

Transmission of Mycobacterium tuberculosis

in Health-Care Facilities’’ [Ex. 4B], the dioctal phthalate (DOP) penetration test as

described in Chapter 25 of the 1992 Systems

Handbook from the American Society of

Heating, Refrigerating and Air-Conditioning

Engineers (ASHRAE) is offered as a method

of performance monitoring HEPA filters. The

basis of this well-recognized test is to

challenge a HEPA filter assembly with a

uniformly distributed cloud of 0.3 μm (mass

median diameter) DOP aerosol and measure

the DOP smoke upstream and downstream

with a light-scattering photometer.

Penetration ‘‘P’’ through the filter assembly is

the performance criterion typically specified

and is defined as:

P = 



 

 100  downstream concentration

upstream concentration

%

Penetration is related to filter efficiency

‘‘E’’ by the equation:

E=100(1–P)%

Therefore, an efficiency of 99.97% is

equivalent to P=0.0003.

Other Filter Testing Methods

There are many recognized HEPA filter

testing standards. Most of these standards

utilize DOP aerosol to challenge the HEPA

filters and provide penetration performance

data for 0.3 μm size particles. Since TB

droplet nuclei range in size from 1 to 5 μm,

the DOP aerosol challenge is indicative of

droplet nuclei penetration. Some

manufacturers may provide bench test data

for filtration efficiency versus particle size

which may be useful information when

selecting filters but may be difficult to

duplicate in the field for in-service testing.

These test standards include:

1. Standard UL 586, High-Efficiency,

Particulate, Air Filter Units as published by

Underwriters Laboratories, 1990 (Ex. 7–227).

This test is designed for bench testing at the

factory and does not include the frame-tofilter bypass leakage measured by in-service

testing. This test method uses a light beamphotocell combination (photometer) to

measure the density of the DOP smoke in the

air.

2. Standard ASTM F1471–92, Air Cleaning

Performance of a High-Efficiency Particulate

Air-Filter System, as published by the

American Society for Testing and Materials,

1993 (Ex. 7–222). This test can be used in the

field for in-service testing of HEPA filters.

This test method utilizes a laser aerosol

spectrometer which can count particles by

particle size.

3. Standard NSF–49, Appendix B, HEPA

Filter Leak Test for Biosafety Cabinets, as

published by the National Sanitation

Foundation (Ex. 7–226). This test is designed

for in-service HEPA filter testing and utilizes

a portable photometer probe which can be

passed over the filter frame perimeter to

check for bypass leaks.

Unfortunately, there are hazards associated

with exposure to DOP. The Material Safety

Data Sheet for DOP reports irritation, nausea

and numbness as symptoms associated with

DOP inhalation. Nausea, diarrhea,

reproductive effects, liver enlargement, and

cancer are effects associated with ingestion of

DOP. Therefore, performance testing that

does not utilize DOP should also be

considered.

Alternative methods are in use and being

developed that capitalize on recently

developed optical particle counters (e.g.,

lasers) that can count particles at specified

sizes. For example, the National

Environmental Balancing Bureau (NEBB)

publishes Procedural Standards for Certified

Testing of Clean rooms’ Section 8.3 presents

an Ambient Particle Aerosol Challenge

Method that utilizes new-generation optical

particle counters to measure upstream and

downstream concentrations of particles of a

specified size (Ex. 7–228). Only ambient air

is measured and no aerosol is generated. This

method may have merit for TB applications

because ambient air has a statistically

significant quantity of particles less than 3.0

μm, but at the same time, this high number

of particles may overload the instrument.

Because a dark DOP smoke is not required

to attenuate light as is the case with a

photometer, recently developed optical

particle counters offer the opportunity for an

alternative non-toxic challenge aerosol like

that described in the proposed Standard 52.2

Method of Testing General Ventilation AirCleaning Devices for Removal Efficiency by

Particle Size from the American Society of

Heating, Refrigerating and Air-Conditioning

Engineers. This non-toxic challenge aerosol

is based upon potassium chloride (KC)

particles which are generated in the 0.3 to 10

μm size range (Ex. 7–224).

Filter Testing Performance Criteria

The following should be considered when

setting performance testing criteria: (1)

Failure of a HEPA filter in a recirculating air

system can have serious consequences; (2)

HEPA filters are more efficient in removing

droplet nuclei than DOP due to the larger

particle size of droplet nuclei; (3) In-service

filter penetration testing should match

factory testing that is P≤ 0.0003 for 0.3μm

challenge particle; (4) The differential

pressure drop across a HEPA filter from dirt

loading should never exceed the maximum

operating resistance set by the manufacturer

and stamped on the filter label; (5)

Penetration should not exceed 0.0001 when

performing localized penetration scanning

with a photometer probe around filter frames

and across the filter face.

Appendix F to § 1910.1035—A Guide to

Writing an Exposure Control Plan (Nonmandatory)

A Guide to Writing an Exposure Control

Plan is a non-mandatory appendix developed

to assist employers in complying with

§ 1910.1035 Occupational Exposure to
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54303

Tuberculosis. This standard requires

employers to have a written Exposure

Control Plan (ECP) documenting procedures

they use to control exposure to Tuberculosis

(TB).

The following guide aids employers in

writing the required ECP by reviewing the

standard’s requirements and providing

examples of policy, narrative statements, and

a ‘‘fill-in-the-blank’’ sample ECP. Before

using this guide, employers will need to read

the standard. Once familiar with the

standard, they can use this appendix to

develop a program specific to their facility.

Employers are not required to use the

sample ECP included in this guide. They may

develop their own format and may include

the TB ECP in their overall infection control

plan. However, the ECP must include all

OSHA required information and all policies

and procedures in the plan must be

implemented whether the ECP is a separate

plan or included in another document. If the

TB elements are included in an overall

infection control plan, the employer must

develop an index referring the reader to their

locations within that plan. Since the

elements in the sample ECP are the minimum

necessary to meet the standard’s

requirements, employers may enhance the

sample with more comprehensive procedures

if they wish.

OSHA developed the guide to help

employers comply with the standard. The

information contained in this Guide to

Writing an Exposure Control Plan for

Occupational Exposure to Tuberculosis is not

considered to be a substitute for the OSH Act

or any provisions of the OSHA Standard. It

provides general guidance for a particular

standards-related topic and should not be

considered a legal authority for compliance

with OSHA requirements. The reader should

consult the OSHA standard in its entirety for

specific compliance requirements.

Employers who have additional questions

concerning this standard may contact the

nearest OSHA office.

How to Use This Guide

A Guide to Writing An Exposure Control

Plan has two components: Notes to the

Employer and a Sample Exposure Control

Plan. Notes to the Employer consists of

explanations for some of the standard’s ECP

requirements, guidance about writing an ECP

and information about practices common to

a variety of employers. Notes to the Employer

is organized to correspond chronologically to

the Sample Exposure Control Plan.

The Sample Exposure Control Plan

contains examples of policy statements and

procedures. It has a number of sections and

is organized in program development form.

Although it does not always follow the exact

sequence of the standard, all elements of the

standard are included. Each section of the

Sample ECP is cross-referenced to the

specific provisions of the standard using the

letter and numerical paragraph designation.

The Sample ECP has blank spaces to be

completed by the employer with site-specific

information.

The standard provides a tiered approach to

compliance. Not all provisions apply to all

facilities. This approach accommodates

facilities with varying factors. OSHA’s

sample ECP accommodates the difference

between these types of facilities.

(1) The first tier is employers (other than

the operators of a laboratory) that do not

admit or provide medical services to

individuals with suspected or confirmed

infectious TB, have had no cases of

confirmed TB in the past 12 months and are

located in counties that in the past two years

have had zero cases of confirmed infectious

TB in one year and fewer than 6 cases of

confirmed infectious TB in the other year.

Work settings in this tier have presented

minimal occupational exposure and therefore

may choose to comply with only a limited

number of provisions. (See Appendix A).

Required elements for these facilities are

underlined in the sample ECP. They include:

procedures for exposure determination,

prompt identification of individuals with

suspected or confirmed infectious TB,

exposure incident reporting, and procedures

for referring individuals with suspected or

confirmed TB to facilities with appropriate

isolation capabilities.

Employers who wish to have a minimal

exposure control plan as described in

Appendix A must document the number of

cases of tuberculosis reported in their county

in the previous twelve month reporting

period and the number of individuals with

confirmed tuberculosis encountered in the

facility in the previous twelve months.

(2) The second tier encompasses employers

who use early identification and transfer

procedures rather than admit individuals

with suspected or confirmed infectious TB.

They typically do not have AFB isolation

rooms or autopsy rooms or conduct highhazard procedures in their facility. These

facilities can omit the sections about AFB

isolation rooms and engineering controls

since these provisions do not apply to them

unless they have to use temporarily isolate

when it is not possible to transfer individuals

with suspected or confirmed infectious TB

within five hours. Paragraph (c)(2)(ii) lists the

requirements of the ECP for this type of

facility. In the sample ECP, certain sections

are starred (*) to assist facilities that transfer

individuals with suspected or confirmed

infectious TB within five hours of discovery.

These employers may omit the starred

sections when writing their ECP.

(3) The third tier covers employers who

admit and provide medical services to

individuals with suspected or confirmed

infectious TB. These employers are required

to have AFB isolation rooms and procedures

to protect employees working in or around

those rooms. In addition, they must have

maintenance schedules for engineering

controls as well as other protections.

Paragraph (c)(2)(iii) lists specific

requirements for these facilities. However, if

these employers transfer some individuals

with suspected or confirmed infectious TB as

well as admit and provide medical services

for those individuals, the facility must have

procedures for the transfer. The sample ECP

includes all required ECP elements thus

providing guidance to facilities that admit

and provide medical services.

Sample Exposure Control Plan Notes to the

Employer

Exposure Control Plan (c)(2)

Policies and Program Administration

The standard requires each employer to

have a written exposure control plan and to

review and update it annually. The Sample

Exposure Control Plan has examples of

statements reflecting the employer’s policy.

Blanks are provided for the employer to

designate the facility name.

Employers have limited ECP provisions

(see Appendix A) if they (1) do not admit or

provide medical services to individuals with

suspected or confirmed infectious TB, (2)

have had no case of confirmed infectious TB

in the past 12 months and (3) are located in

a county that, in the past 2 years, has had

zero cases of confirmed infectious TB

reported in one year and fewer than 6 cases

of confirmed infectious TB reported in the

other year. (Paragraph (b)). In addition, these

employers must determine the number of

reported cases in the county for the last

twelve month reporting period and record it

in the ECP. They must also document the

number of confirmed cases of TB in their

facilities. The numbers can be recorded in

this first section of the ECP.

The written ECP must be accessible to

employees, OSHA and NIOSH

representatives for viewing and copying as

necessary. (Paragraph (c)(2)(vii)) A sample

statement regarding the accessibility is

written below. OSHA does not require this

statement to be written. However, employers

may include this type of statement in their

ECP to clearly define the company’s/

organization’s policy.

Sample Statement: Employees and/or

OSHA or NIOSH representatives may view

the ECP at llll (location of ECP)llll

and may copy the plan as necessary.

Designating a specific person to be

responsible for maintaining the exposure

control plan is not a requirement of the

regulation. However, it is a common practice.

Sample Statement: llll (responsible

person/department) llll is responsible

for maintaining, reviewing and updating the

Exposure Control Plan (ECP).

Employee Exposure Determination

(Paragraph (c)(1)(i)(A))

In paragraph (c)(1)(i) & (ii), OSHA requires

employers to review job classifications in

their facilities and determine which

employees have occupational exposure to

infectious TB (Occupational exposure is

defined in paragraph (j) of the standard). All

TB exposure determinations must be made

without regard to the use of respiratory

protection.

There are two basic employee job

classifications for employers to consider: (1)

jobs in which all employees have

occupational exposure to infectious

tuberculosis because of the very nature of the

job such as respiratory therapists and nurses

who work on a pulmonary unit and (2) jobs

that result in occupational exposure to

tuberculosis when certain tasks or

procedures are performed; for example,

dietary personnel delivering meals to an

individual in AFB isolation or housekeeping

staff cleaning an AFB isolation room.
54304 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

All employees in the first job classification

are considered to have occupational exposure

to infectious TB, so specific job tasks for this

classification are not required to be defined.

In the second category, however, only some

employees may have occupational exposure

and , then, only when performing certain

tasks. Therefore, OSHA requires the

employer to define those tasks. Examples of

tasks in which employees may have

occupational exposure to TB include:

transporting patients; entering occupied

isolation areas to clean or deliver meals;

performing maintenance on HVAC systems

that exhaust air from occupied AFB isolation

rooms; and, performing suctioning and/or

aerosolized treatments on patients with

suspected/confirmed TB. Tasks may be listed

in closely related groups or as individual

tasks.

Not all employers have both types of job

classifications. Employers are not required to

complete both categories unless there are job

classifications that pertain to each.

Employee Notification of TB Hazards

(Paragraph (c)(2)(i)(B))

The standard requires that the employer

include procedures in the ECP ‘‘for providing

information about individuals with

suspected or confirmed infectious TB or

about air that may reasonably be anticipated

to contain aerosolized M. tuberculosis to

occupationally exposed employees who need

this information in order to take proper

precautions.’’

The employer must assure that employees

have enough information to take proper

precautions against exposure to TB.

However, the employer must also consider

the medical confidentiality of the infectious

individual and assure that this

confidentiality is maintained to the extent

possible and consistent with applicable laws.

Employers are expected to define

responsibilities and outline procedures used

to inform employees of TB hazards. OSHA

requires that an employer notify employees

by posting signs and labeling ventilation

ducts. (Paragraphs (h) (1) & (2))

The following sample statements provide

an abbreviated example of some procedures

that might be used in a health care facility.

These statements are not OSHA requirements

but examples.

Sample Statement: As soon as infectious

TB is suspected the nurse in charge of the

unit must be informed. The nurse in charge

of the unit also must assure that (1) the

individual is placed in an AFB isolation

room marked with a sign: ‘‘No Admittance

Without Wearing a Type N95 of More

Protective Respirator’’, (2) the nursing

supervisor and infection control specialist

are notified, (3) all staff working on the unit

are notified, and (4) proper equipment is

obtained.

If the individual with suspected or

confirmed infectious TB must be transferred

to be placed in an isolation room, all

procedures required by this ECP will be

utilized, such as masking the individual or if

that cannot be done, having the employee

don a respirator.

The nurse in charge of the unit

immediately notifies the facility engineer to

assure that (1) the engineering controls are

working properly and (2) all maintenance

and contract employees are informed of the

potential TB hazard. llll (maintenance

engineer) llll is to immediately check to

assure that all ducts carrying exhaust air from

the room occupied by the individual with

suspected or confirmed infectious TB are

labeled ‘‘Contaminated air—Respiratory

Protection Required’’.

Dietary, laboratory, and other test order

sheets are specially noted to indicate

‘‘Respiratory Isolation—No admittance

without an N95 or More Protective

Respirator.’’

In addition to informing their own

employees, host employers are required to

notify contractors of TB hazards. Some

contractors and contracting employees may

be required to enter or work in AFB isolation

areas or other areas in the facility where

occupational exposure is likely to occur or

where air systems may reasonably be

anticipated to contain aerosolized M.

tuberculosis. Since host employers know the

location of the hazards, they must inform the

contractor. (Paragraph (d)(6))

OSHA requires the employer to post signs

at the entrance to (1) rooms or areas used to

isolate individuals with suspected or

confirmed infectious TB, (2) areas where

procedures or services are being performed

on an individual with suspected or

confirmed infectious tuberculosis and (3)

clinical/research laboratories where M.

tuberculosis is present. (Paragraph (h)(2))

Signs must include a picture of a stop sign,

have a red background with white lettering

and say: ‘‘No Admittance Without Wearing a

N95 or More Protective Respirator.’’ The

employer may include additional language

provided the major message on the sign

remains clear. (Paragraph (h)(2)(iii))

After the room is vacated, the sign must

remain posted at the entrance until the room

or area is ventilated, using the USPHS

recommendations for removal efficiency of

99.9%, for the time necessary to permit entry

without the use of a respirator. See Appendix

C of the standard. (Paragraph (h)(2)(ii))

The room does not need to be ventilated

and the sign may be removed immediately if

both of the following criteria are met (1) the

room was occupied by an individual with

suspected infectious tuberculosis and (2) that

individual is medically determined to be

non-infectious. (Paragraph (h)(2)(ii))

If employers have engineering controls,

those controls must be labeled appropriately

and the labeling procedures must be noted in

the ECP. (Paragraph (h)(1))

The type of HVAC system in the facility

will determine where ducts are labeled.

Ducts that have HEPA filtration must be

labeled at all duct access points located prior

to the HEPA filter. HVAC systems that

exhaust air directly to the outside must be

labeled at all access points, fans and exhaust

outlets. (Paragraph (h)(1))

Signs at the entrance to clinical or research

laboratories and autopsy suites must include

the biohazard symbol, name of the laboratory

director or other designated responsible

person, M. tuberculosis, and special

requirements for entering the laboratory or

autopsy room. In addition, contaminated

laboratory wastes must be labeled with the

biohazard symbol or be placed in a red

container. (Paragraph (h)(2)(iv))

Although the standard does not require

noting this in the ECP, employers may want

to document where engineering controls are

located in their facility. If an employer

chooses to note this, sample verbiage may be:

Sample Statement: llll (list type of

engineering controls in place)

lllllllllllllllllllll

engineering controls are used in the

Bronchoscopy suite located on the third floor

of this building.

OR

There are no high-hazard procedures

performed in this facility. There are no

engineering controls in place.

Exposure Incident Reporting (Paragraph

(c)(2)(i)(C))

The employer must investigate

circumstances surrounding TB Skin Test

conversions and exposure incidents to

determine the cause and ways to make

changes to prevent similar occurrences.

(Paragraph (g)(4)(iv))

The procedures used to report and then to

evaluate the incident must be included in

this section of the ECP. In addition,

employees are required to report incidents to

a particular department or person. (Paragraph

(c)(2)(i)(C)) This information must be

included here, also.

Sample Statement: Exposure incidents are

to be reported to llll (name and

department)

. llllllllllllllllllll

The reporting procedures utilized at l

(organization’s name) l are:

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

Procedures for evaluating the circumstances

surrounding the exposure incident at lll

(organization’s name) llll are:

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

Prompt Identification of Individuals With

Suspected or Confirmed Infectious TB

(Paragraph (c)(2)(ii) & (iii)(A))

Each facility is required to establish

procedures for promptly identifying

individuals with suspected or confirmed

infectious TB. The standard considers

‘‘suspected or confirmed infectious TB’’ to

be:

‘‘A potential disease state in which an

individual is known or with reasonable

diligence should be known, by the employer

to have one or more of the following

conditions, unless the individual’s condition

has been medically determined to result from

a cause other than TB: (1) to be infected with

M. tuberculosis and to have signs and

symptoms of TB; (2) to have a positive acid

fast bacilla (AFB) smear; or (3) to have a

persistent cough lasting 3 or more weeks and

two or more symptoms of active TB (e.g.,

bloody sputum, night sweats, weight loss,

fever, anorexia)’’. (Paragraph (j))

This definition must be included in the

early identification criteria. Although not

mandated by OSHA, some employers add

high risk factors like IV drug use,
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54305

immunocompromised status, recent

immigration from Asia, Africa, Latin

America, etc.

Some employers use the 1994 CDC

Guidelines for Preventing the Transmission

of Mycobacterium Tuberculosis in HealthCare Facilities to assist in early identification

of TB (Ex. 4). These guidelines state, ‘‘TB is

not distributed evenly throughout all

segments of the U.S. population’’ and defines

groups known to have a higher prevalence of

TB infection. These high risk groups include

‘‘foreign born persons from Asia, Africa,

Latin America and the Caribbean; medically

under served populations(e.g. some AfricanAmericans, Hispanics, Asians, and Pacific

Islanders, American Indians, and Alaskan

Natives); homeless persons; current or former

correctional-facility inmates; alcoholics;

intravenous drug-users; and the elderly.’’

Persons with certain medical conditions have

a greater risk of progression from latent

infection to active disease. These medical

conditions are defined in the 1994 CDC

guidelines as: ‘‘HIV infection, silicosis,

diabetes mellitus, gastrectomy or jejuno-ileal

bypass, being greater than 10% below ideal

body weight, chronic renal failure or renal

dialysis, immuno-suppression due to drug

therapy and some malignancies.’’

There are several ways to conduct early

identification. Many employers use a

questionnaire to quickly assess the

individual’s health status at intake or

admission. Some employers located in

communities considered to have a high

incidence of TB or working with high risk

populations use chest x-rays. Since use of a

questionnaire is a common practice, OSHA

included one in the Sample ECP. This is not

mandatory but is a guide for those employers

who may wish to develop a questionnaire.

An example of a policy statement referring

to use of a questionnaire is:

Sample Statement: ll (organization’s

name) llll uses the attached

questionnaire to assess the individual’s

health status as related to suspected or

confirmed infectious TB. An individual who

has two or more of the symptoms of

Tuberculosis in addition to a prolonged

cough, a positive AFB smear or is known by

ll (organization’s name) llll or any of

its employees to be infected with M.

tuberculosis is categorized as having

suspected or confirmed infectious TB.

Employers Who Transfer (Paragraph (c)(2)(ii))

Procedures for Transfer of Individuals With

Suspected or Confirmed Tuberculosis

Employers that transfer rather than admit

and provide medical services must document

their procedures for isolating an individual

while awaiting transfer such as segregating

and masking the individual and procedures

used if the individual cannot be transferred

within 5 hours. This includes documenting

the type of equipment used (e.g. masks,

respirators).

In the remainder of the sample ECP,

employers who transfer suspected or

confirmed infectious TB within 5 hours of

identification may omit starred sections if

they do not have isolation rooms and

engineering controls.

Employers who do not admit or provide

medical services to individuals with

suspected or confirmed infectious TB, have

not encountered any individuals with

confirmed TB in their facility in the past

twelve months and who are located in

counties that in the past two years have had

zero cases of confirmed TB reported in one

year and fewer than 6 cases in the other year

and wish to claim reduced responsibilities

must be prepared to transfer such

individuals. Therefore, the standard requires

these facilities to have procedures for

transferring an individual with suspected or

confirmed infectious TB, if encountered.

(Appendix A)

Employers Who Admit and Provide Medical

Services (Paragraph(c)(2)(iii))

Procedures for Isolating and Managing Care

(Paragraph (c)(2)(iii)(B))

The employer must document procedures

for isolating individuals with suspected or

confirmed infectious TB such as using AFB

isolation rooms and procedures for managing

care to minimize employee exposure.

Procedures listed in the Sample ECP are

limited to the standard requirements.

Employers should add any other isolation

and segregation procedures used in their

facility to assure that their ECP reflects the

way they manage isolation and segregation.

Employers who transfer individuals with

suspected or confirmed infectious TB do not

need to include procedures for isolating and

managing care. However, as stated above,

they must list procedures for transferring the

individual and segregating and masking these

individuals while awaiting transfer. In

addition, employers who do not perform high

hazard procedures in their facilities do not

need to notate anything in the high hazard

section of the ECP. These employers may

wish to enhance their ECP by clarifying their

functions, however. A sample of a statement

to enhance and clarify is:

Sample Statement: (1) This facility

transfers individuals with suspected or

confirmed infectious TB within 5 hours of

identification, (2) high-hazard procedures are

not performed in this facility, (3) there are no

engineering controls for TB control at this

facility.

Again, the above statements are not OSHA

requirements.

Each employer who admits or provides

services to individuals with suspected or

confirmed infectious TB is required to

institute policies and procedures to address

the following issues. The procedures in the

Sample ECP are an abbreviated version of the

OSHA requirements. (Paragraph (c)(2)(iii)(B)

(1 through 5)):

• Minimizing the time the suspected/

confirmed infectious individual spends

outside the AFB isolation room.

• Minimizing the time of employee

exposure in AFB isolation rooms or areas by

combining as many tasks as possible into one

entry.

• Minimizing the number of workers

entering AFB isolation rooms.

• Using a properly fitted mask (e.g.

surgical mask or valveless respirator) on

individuals with suspected or confirmed

infectious TB or transporting these

individuals in portable containment

engineering control when transport or

relocation outside of AFB isolation rooms or

areas is unavoidable.

• Delaying of elective transport or

relocation.

• Providing services in an AFB isolation

room or area to the extent feasible (e.g.

portable x-ray).

• Assuring that the individual is returned

to the isolation room as soon as is practical

after the completion of the service or

procedure.

• Delaying elective high-hazard

procedures or elective surgery until the

individual with suspected or confirmed

infectious TB is determined to be noninfectious.

Some facilities may have extensive

procedures while others may have less

involved procedures. The extensiveness of

the procedures is determined by the type of

tasks and services provided the individual

with suspected or confirmed infectious TB in

that facility.

Whatever the procedures are, the employer

is expected to assure that the procedures

comply with the OSHA requirement and that

all procedures are implemented.

*High-Hazard Procedures (Paragraph

(c)(2)(iii)(C))

The ECP must contain a list of high-hazard

procedures performed in the facility.

(*)All high-hazard procedures that may

aerosolize M. tuberculosis must be performed

in an AFB isolation room, an AFB isolation

area, or in a special AFB containment booth.

Examples of high hazard procedures include

bronchoscopy, pulmonary function testing,

endoscopy and autopsy on an individual

with suspected or confirmed infectious TB.

*Engineering Controls Maintenance

Schedules and Records (Paragraph

(c)(2)(iii)(D))

Employers who have engineering controls

in any part of their facility must include a

maintenance and performance monitoring

schedule in this section of the ECP.

(Appendix E)

Sample Statement: Engineering controls

for infectious TB are inspected, maintained

and undergo performance monitoring

according to the following schedule:

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

Clinical and Research Laboratory Biosafety

Procedures Paragraph (c)(2)(iv))

OSHA requires that the facility’s laboratory

director determine and document the

biosafety level at which the laboratory

operates.

In addition, the laboratory director must

determine and document the need for (1)

controlled access, (2) anterooms, (3) sealed

windows, (4) directional airflow, (5)

preventing recirculation of laboratory

exhaust air, (6) filtration of exhaust air before

discharge to the outside and (7) thimble

exhaust connections for biological safety

cabinets.

The laboratory director must consult and

follow the guidelines found in the OSHA

regulation.
54306 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

Home Health Care or Home-Based Hospice

Care (Paragraph (c)(2)(v))

OSHA requires employers of Home Care or

Home-based Hospice care to include

procedures for prompt identification of

individuals with suspected or confirmed

infectious TB. In addition procedures to

minimize employee exposure to such

individuals and a list of any high-hazard

procedures performed in the home and

procedures for delaying elective high hazards

procedures or surgery until the individual is

non-infectious must be included in the ECP.

Sample Exposure Control Plan

Exposure Control Plan (Paragraph(c)(2))

Policies and Program Administration

(company name) maintains, reviews and

updates the Exposure Control Plan (ECP) at

least annually, and whenever necessary to

reflect new or modified tasks, procedures and

engineering controls * that affect

occupational exposure. The ECP is also

updated to reflect new or revised employee

positions with occupational exposure.

This facility has had llll cases of

confirmed TB in the last 12 months.

(Paragraph (c)(2)(vi))

(b) This facility is located in lllll

county which has reported cases of TB in the

last twelve month reporting period.

Employee Exposure Determination

(Paragraph (c)(2)(i)(A))

ALL employees in the following job

classifications have or may have

occupational exposure to TB

(Paragraph(c)(1)(i)(A)): JOB TITLE

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

Employees in the following job

classifications have or may have exposure to

TB when they are performing the listed tasks

and procedures (Paragraph (c)(1)(B)):

JOB TITLE TASKS/PROCEDURES

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

Employee Notification of TB Hazard

(Paragraph (c)(2)(i)(B))

(organization’s name ) uses the following

procedures to assure that all employees with

job tasks that offer potential for occupational

exposure are informed of the hazard and

take proper precautions against exposure to

TB.

(procedures described)

lllllllllllllllllllll

(*) llll (responsible person(s)/

department) llll maintains contact with

all outside contractors who provide

temporary or contract employees who may

incur occupational exposure. This allows the

contractor to institute precautions to protect

his or her employees. Theses contractors are

informed of the TB hazard and the facility’s

procedures for protecting themselves from

exposure.

(*) Signs are posted at the entrance to:

(*) 1) Rooms or areas used to isolate an

individual with suspected or confirmed

infectious TB,

(*) 2) Areas where procedures or services

are being performed on an individual with

suspected/confirmed infectious TB, and

(*) 3) clinical land research laboratories

where M. tuberculosis is present.

(*) All signs are red with white text stating

‘‘No Admittance Without a Type N95 of More

Protective Respirator’’ and have a picture of

a stop sign. (See attached sample).

(*) llll (organization’s name) llll

ensures that warning labels are placed on

AFB isolation room exhaust ducts and areas

where occupational exposure to TB is

expected.

(*) All systems carrying air that may be

contain aerosolized M. Tuberculosis are

labeled at all points where ducts are accessed

prior to HEPA filter, at fans and at the

discharge outlets of non-HEPA filtered direct

discharge systems. The label says:

‘‘Contaminated Air—Respiratory Protection

Required’’.

(*) ll (organization’s name) ll notifies

employees entering the laboratory and the

autopsy room of the occupational hazards by

using signs at the entrance to both these

locations. These signs indicate the name and

telephone number of the director of the

laboratory, infectious agent—M. tuberculosis,

and the special requirements for entering the

laboratory or autopsy room. The sign

displays the Biohazard symbol.

Exposure Incident Reporting (Paragraph

(c)(2)(i)(C))

All employees must report exposure

incidents immediately to (responsible

person(s)/department). ll (Organization’s

name) is responsible for investigating,

evaluating, and documenting the

circumstances surrounding the exposure

incident for instituting changes to prevent

similar occurrences.

The following procedures are used to

investigate/evaluate exposure incidents at

(organization’s name):

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

Prompt Identification of Individuals With

Suspected or Confirmed Infectious TB

(Paragraph (c)(2)(ii) and (iii)(A))

(Organization’s name) considers an

individual to be suspected of having

Infectious TB (unless the individual’s

condition has been medically determined to

result from a cause other than TB) if either

the company or any of its employees

determine(s)/learn(s)that the individual:

• has a persistent cough lasting 3 or more

weeks with 2 or more signs and symptoms of

active infectious TB (e.g., bloody sputum,

night sweats, weight loss, fever, anorexia),

• has a positive AFB smear,

Based on the criteria listed above,

(Organization’s name) utilizes the following

procedures for early detection of individuals

with suspected/confirmed infectious TB.

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

Employers Who Transfer (Paragraph(c)(2)(ii))

Procedures for Transfer of Individuals With

Suspected or Confirmed Infectious TB:

If/when an isolation room is not

available at our facility, the individual

is transferred within 5 hours of

identifying the infectivity to a facility

(name of facility) where isolation rooms

are available. The following procedures

for transfer of an individual with

suspected/confirmed infectious

tuberculosis are utilized:

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

While awaiting transfer, the individual is

masked or segregated to protect employees

who are without respiratory protection.

(organization’s name) uses the following

procedures/equipment when masking and

segregating an individual with suspected/

confirmed infectious TB:

lllllllllllllllllllll

lllllllllllllllllllll

If a situation arises and the individual is

not able to be transferred within 5 hours of

identifying the suspected or confirmed

infectious TB, the following procedures,

including AFB isolation, are instituted: (list

procedures used)

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

Employers Who Admit and Provide Medical

Services (Paragraph (c)(2)(iii))

Procedures to Isolate and Manage Care

(Paragraph(c)(2)(iii)(B))

(*) The following procedures are used to

isolate individuals with suspected or

confirmed infectious TB.

(*) All individuals with suspected or

confirmed infectious TB are placed in AFB

isolation rooms or areas.

(*) lll (organization’s name) lll

uses the following procedures to minimize

the time an individual with suspected or

confirmed infectious TB remains outside of

an AFB isolation room or area: lll (detail

responsibilities and steps)

lllllllllllllllllllll

lllllllllllllllllllll

(Paragraph(C)(2)(iii)(B)(1))

(*) Employee exposure in AFB isolation

rooms is minimized by combining tasks the

amount of time an employee spends in an

AFB isolation room is minimized by lll

(list procedures used)

lllllllllllllllllllll

lll (Paragraph (c)(2)(iii)(B)(2))

(*) ll (organization’s name) lll uses

the following procedures, minimizing the

number of workers entering AFB isolation

rooms:

lllllllllllllllllllll

lllllllllllllllllllll

(*) ll (organization’s name) lll

utilizes the following procedures to delay
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54307

transport or relocation within the facility

until the individual is considered noninfectious:

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

(Paragraph (c)(2)(iii)(B)(3))

(*) Services are provided in the patient’s

room whenever feasible such as portable xray and lll (list other services provided

in the patient’s room to minimize exposure)

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

(*) This facility uses llll (list the type

of engineering controls in use—properly

fitted masks or valveless respirators for the

for the patient to be masked or portable

containment devices)

lllllllllllllllllllll

on individuals with suspected or confirmed

infectious TB when it is necessary to

transport or relocate the individual.

(Paragraph (c)(2)(iii)(B)(4))

(*) The following procedures assure that

the individual is returned to the AFB

isolation room as soon as practical after

completion of the procedure lll (list of

procedures)

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

(*) Services that cannot be rendered in the

patient’s room are provided in and area that

meets the requirements for an AFB isolation

room.

(*) Elective high-hazard procedures and

surgery are delayed until the patient is noninfectious.(Paragraph(c)(2)(iii)(B)(5))

(*) HIGH-HAZARD PROCEDURES

(Paragraph(c)(2)(iii)(C))

(*) High-hazard procedures (where TB may

be aerosolized) require special precautions to

prevent/minimize occupational exposure to

infectious TB. The following high-hazard

procedures are performed at this facility:

lll (list procedures)

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

(*) Engineering Controls Maintenance

Schedules and Records (Paragraph

(c)(2)(iii)(D))

(*) The maintenance schedule for

engineering controls is as follows:

(*) Daily—Negative pressure areas are

qualitatively demonstrated by using smoke

trails.

(*) Whenever HEPA filters are changed, the

system is inspected and its performance

monitored in accordance with current

USPHS guidelines. HEPA filters are changed

every lll in this facility or whenever

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

(*) Every six months—HEPA filters in

contained air exhaust systems are inspected,

maintained and performance monitored in

accordance with current USPHS guidelines.

Clinical and/or Research Laboratories

(Paragraph (c)(2)(iv))

The llll (type of laboratory—clinical

or research) llll operates at biosafety

level llll as determined by llll

(name of laboratory director) llll for

llll (organization’s name) llll.

This is in accordance with CDC/NIOSH

Biosafety in Microbiological and Biomedical

Laboratories).

The following controls are in operation in

the laboratory at this facility llll (list

controlled access, anterooms, sealed

windows and other controls required in the

standard and determined necessary by the

laboratory director)

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

(c)(2)(v) HOME HEALTH CARE OR HOMEBASED HOSPICE

See the following sections of this sample

ECP for information regarding the ECP

requirements:

(1) (c)(2)(ii) & (iii)(A) for sample statements

regarding the Prompt identification of

individuals with suspected or confirmed

infectious TB.

(2) (c)(2)(iii) for sample statements re:

procedures for minimizing employee

exposure.

(3) (c)(2)(iii)(C) for a sample statement

regarding high hazard procedures.

The procedures in this Exposure Control

Plan minimize the occupational exposure to

TB. The procedures for isolating and

managing care are used until the individual

with suspected or confirmed infectious TB is

determined to be non-infectious or until the

diagnosis for TB is ruled out.

Evaluation

Early Detection of Tuberculosis

This questionnaire gives guidance in

identifying individuals who meet OSHA’s

definition of ‘‘suspected infectious

tuberculosis’’ so that appropriate controls can

be initiated.

The questionnaire has two parts: (1)

reviewing the individual’s TB history and (2)

assessing current symptoms.

INSTRUCTIONS:

• Record each answer with a check mark

• Add your comments as the evaluator at

the bottom of the page.

• Institute the facility’s exposure control

measures outlined in the facility’s Exposure

Control Plan, Respiratory Protection and

Medical Surveillance Program and refer the

individual for further evaluation if the

individual has:

(1) A persistent cough lasting 3 or more

weeks and two or more symptoms of active

TB.

(2) Had a positive TB test on mucous that

he/she coughed up.

(3) Been told that he/she had TB and was

treated, but never finished the medication.

TB HISTORY

(Part One)

Have you ever had a positive TB skin test?

Yes No Don’t Know

Have you ever had an abnormal chest x-ray?

Yes No Don’t Know

If yes, how long ago?

Have you recently had the mucous you

cough up tested for TB?

Yes No Don’t Know

If yes, were you told it was positive

Yes No Don’t Know

Have you ever been told you have Infectious

Tuberculous?

Yes No Don’t Know

If yes, how long ago?

Have you ever been treated with medication

for Infectious TB?

Yes No Don’t Know

If yes, how many medications?

One Two Over Two

Are you still taking TB medicine?

Yes No

Did you take all the TB medicine until the

health care professional told you that you

were finished?

Yes No

Do you live with or have you been in close

contact with someone who was recently diagnosed with TB? (e.g. shelter roommate,

close friend, relative)

Yes No Don’t Know

CURRENT SYMPTOMS

(Part Two)

Do you have a cough that has lasted longer

than three weeks?

Yes No

Do you cough up blood or mucous?

Yes No

Have you lost your appetite? Aren’t hungry?

Yes No

Have you lost weight (more than 10 pounds)

in the last two months? without trying to?

Yes No

Do you have night sweats (need to change

the sheets or your clothes because they

are wet)?

Yes No

Evaluator Comments:

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

Exposure Control Methods Implemented?

Yes No

Referred for Further Evaluation? Yes No

lllllllllllllllllllll

Evaluator’s Signature

lllllllllllllllllllll

Date
54308 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

Appendix G to § 1910.1035—Smoketrail Testing Method for Negative

Pressure Isolation Rooms or Areas

A. Test Method Description

The purpose of a negative pressure AFB

isolation room or area is to prevent TB

droplet nuclei from escaping the isolation

room or area and entering adjacent or

surrounding spaces (e.g., a corridor). One

method to check for negative room pressure

is to use smoke-trails to demonstrate that the

pressure differential is inducing airflow from

the corridor through the crack at the bottom

of the door (undercut) and into the isolation

room or area. When performing a smoke-trail

test, follow these recommendations where

applicable:

1. Test only with the isolation room or area

door shut. If not equipped with an anteroom,

it is assumed that there will be a loss of space

pressure control when the isolation or area

door is opened and closed. It is not necessary

to demonstrate direction of airflow when the

door is open.

2. If there is an anteroom, release smoke at

the inner door undercut, with both anteroom

doors shut.

3. In addition to a pedestrian entry, some

isolation rooms or areas are also accessed

through a wider wheeled-bed stretcher door.

Release smoke at all door entrances to

isolation rooms or areas.

4. So that the individual conducting the

test does not advertently force the smoke into

the isolation room or area, hold the smoke

bottle/tube parallel to the door so the smoke

is released perpendicular to the direction of

airflow through the door undercut.

5. Position the smoke bottle/tube tight to

the floor, centered in the middle of the door

jamb and approximately two inches out in

front of the door.

6. Release a puff of smoke and observe the

resulting direction of airflow. Repeat the test

at least once or until consistent results are

obtained.

7. Minimize momentum imparted to the

smoke by squeezing the bulb or bottle slowly.

This will also help minimize the volume of

smoke released.

8. Depending on the velocity of the air

through the door undercut, the smoke plume

will stay disorganized or it will form a

distinct streamline. In either case, the smoke

will directionally behave in one of three

ways. It will:

(a) Go through the door undercut into the

isolation room or area,

(b) Remain motionless, or

(c) Be blown back into the corridor.

Negative pressure requires that the smoke

be drawn into the isolation room or area

through the door undercut.

9. Release smoke from the corridor side of

the door only for occupied AFB isolation

rooms or areas. If the room is unoccupied,

also release smoke inside the isolation room

or area (same position as in Step No. 5) to

verify that released smoke remains contained

in the isolation room or area (i.e., the smoke

serves as a surrogate for TB droplet nuclei).

10. To assist in observing the smoke when

photography or videotaping is performed, it

is recommended that a dark surface be placed

on the floor to maximize the contrast. Be

aware that most autofocusing cameras cannot

focus on smoke.

B. Testing ‘‘As Used’’ Conditions

Testing of negative pressure AFB isolation

rooms or areas requires that the test reflect

as-used conditions. As-used means that the

isolation room or area shall remain the same

during testing conditions as it is when in use

for isolation. Consider the following use

variables that may affect space pressurization

and the performance of the negative pressure

AFB isolation room or area:

1. Patient toilet rooms are mechanically

exhausted to control odors. The position of

the toilet room door may affect the pressure

differential between the isolation room or

area and the corridor. Smoke-trail tests

should be performed both with the toilet

room door open and the toilet room door

closed. This will not be necessary if the toilet

room door is normally closed and controlled

to that position by a mechanical door closer.

2. An open window will adversely affect

the performance of a negative pressure AFB

isolation room or area. If the isolation room

or area is equipped with an operable

window, perform smoke-trail tests with the

window open and the window closed.

3. There may be corridor doors that isolate

the respiratory ward or wing from the rest of

the facility. These corridor doors are

provided in the initial design to facilitate

space pressurization schemes and/or

building life safety codes. Leaving the

corridor doors open to the rest of the facility

may cause pressure changes in the corridor

(e.g., proximity to an elevator lobby) and

affect the performance of the negative

pressure AFB isolation room or area. Perform

isolation room or area smoke-trail testing

with these corridor doors in their ‘‘as-used’’

position, which is either normally open or

normally closed.

4. Isolation rooms or areas may be

equipped with auxiliary, fan-powered,

recirculating, stand alone HEPA filtration or

UV units. These units must be running when

smoke-trail tests are performed.

5. Do not restrict corridor foot traffic while

performing smoke-trail tests.

6. Negative pressure is accomplished by

exhausting more air than is supplied to the

isolation room or area. Some HVAC systems

employ variable air volume (VAV) supply air

and sometimes VAV exhaust air. By varying

the supply air delivered to the space to

satisfy thermal requirements, these VAV

systems can adversely impact the

performance of a negative pressure isolation

room. If the isolation room or area or the

corridor is served by a VAV system, the

smoke test should be performed twice.

Perform the smoke test with the thermostat

set at the desired temperature and again with

the thermostat set at a lower or higher

temperature, depending upon the season,

thus simulating the full volumetric flowrate

range of the VAV system serving the area

being tested.

C. Smoke

Most smoke tubes, bottles and sticks use

titanium chloride (TiCl4) to produce a visible

fume. There is no OSHA PEL or ACGIH TLV

for this chemical, although it is a recognized

inhalation irritant. Health care professionals

may be concerned about releasing TiCl4

around pulmonary patients. The smoke

released at the door undercut makes only one

pass through the isolation room and is

exhausted directly outside. (Isolation room

air is typically not ‘‘recirculated.’’)

The CDC in the supplementary information

to the 1994 TB Guidelines has indicated that

‘‘The concern over the use of smoke is

unfounded.’’(Ex. 4B) Controlled tests by

NIOSH have shown that the quantity of

smoke released during the test is so minute

that it is not measurable in the air.

Nonirritating smoke tubes are available and

may be utilized.

[FR Doc. 97–27020 Filed 10–16–97; 8:45 am]

BILLING CODE 4510–26–P