[Federal Register Volume 68, Number 250 (Wednesday, December 31, 2003)]
[Proposed Rules]
[Pages 75768-75775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31845]



[[Page 75767]]

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Part III





Department of Labor





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Occupational Safety and Health Administration



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29 CFR Part 1910



Occupational Exposure to Tuberculosis; Proposed Rule; Termination of 
Rulemaking Respiratory Protection for M. Tuberculosis; Final Rule; 
Revocation

  Federal Register / Vol. 68, No. 250 / Wednesday, December 31, 2003 / 
Proposed Rules  

[[Page 75768]]


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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

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


Occupational Exposure to Tuberculosis

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

ACTION: Proposed rule; termination of rulemaking.

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SUMMARY: OSHA is withdrawing its 1997 proposed standard on Occupational 
Exposure to Tuberculosis (TB). Because of a broad range of Federal and 
community initiatives, the rate of TB has declined steadily and 
dramatically since OSHA began work on the proposal in 1993. Hospitals, 
which are the settings where workers are likely to have the highest 
risk of exposure to TB bacteria, have come into substantial compliance 
with Federal guidelines for preventing the transmission of TB. Overall 
reductions in TB mean that all workers are much less likely now to 
encounter infectious TB patients in the course of their jobs.
    In addition, an OSHA standard is unlikely to result in a meaningful 
reduction of disease transmission caused by contact with the most 
significant remaining source of occupational risk: exposure to 
individuals with undiagnosed and unsuspected TB. Particularly outside 
of hospitals, workers often will not identify suspect TB cases quickly 
enough to implement isolation procedures and other precautions before 
exposure occurs.
    OSHA recognizes, however, that continued vigilance is necessary to 
maintain the gains achieved so far. OSHA intends to provide guidance to 
workplaces with less medical expertise and fewer resources than 
hospitals, and to use cooperative relationships with employers, public 
health experts and other government agencies to promote TB control. 
OSHA will also continue to enforce the General Duty Clause of the OSH 
Act and relevant existing standards in situations where employers' 
failure to implement available precautions exposes workers to the 
hazard of TB infection.

DATES: This withdrawal is effective December 31, 2003.

FOR FURTHER INFORMATION CONTACT: George Shaw, OSHA Office of 
Communication, Room N-3647, U.S. Department of Labor, 200 Constitution 
Avenue, NW., Washington, DC 20210. Telephone: (202) 693-1999.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 25, 1993, the Coalition to Fight TB in the Workplace 
petitioned OSHA to promulgate both an Emergency Temporary Standard 
(ETS) under section 6(c) of the Occupational Safety and Health Act (OSH 
Act), and a permanent occupational health standard under section 6(b) 
of the Act to protect workers from occupational exposure to TB (Ex.1). 
29 U.S.C. 655(b), 655(c). Citing the resurgence of TB at that time and 
the emergence and increasing prevalence of multi-drug resistant TB 
(MDR-TB), the petition argued that a mandatory standard was needed to 
address the hazards associated with occupational exposure to TB. 
According to the petition, TB Guidelines developed by the Federal 
Centers for Disease Control and Prevention (CDC) were not an adequate 
response to this hazard because the guidelines were not mandatory and 
were not being implemented fully or rigorously in most workplaces. The 
petition also requested that, as an interim measure, OSHA immediately 
issue nationwide enforcement guidelines.
    On October 8, 1993, OSHA issued a directive governing enforcement 
activities to address occupational exposure to TB. (Ex. 7-1-A, updated 
February 9, 1996) The directive explained that, although OSHA had no 
standard directed specifically at occupational exposure to TB, some of 
its generally applicable standards provide protection from this hazard. 
For example, OSHA's Respiratory Protection Standard, 29 CFR 1910.134, 
requires employers to provide protection to workers exposed to airborne 
hazards. When this standard was revised in 1998, the earlier version 
was recodified as an interim standard governing respirators used to 
provide protection from TB. (29 CFR 1910.139; 63 FR 1152) (For the 
revocation of this rule, see the final rule published elsewhere in this 
separate part of the Federal Register) Another standard, 29 CFR 
1901.145, 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.

    OSHA compliance personnel were directed to evaluate employers' 
efforts to protect their workers from TB at health care facilities and 
other workplaces where CDC had identified a risk of occupational TB 
transmission, as well as to respond to complaints about inadequate TB 
control measures. The TB Directive is still in effect. OSHA has also 
implemented a number of National and Local 2002-2003 National Emphasis 
Program (NEP) for nursing and personal care facilities directed 
enforcement personnel to determine whether each facility where there 
was a suspect or confirmed TB case within the past six months had 
implemented appropriate infection control procedures, including 
isolation procedures and employee skin tests. OSHA conducted 1000 
inspections under the NEP this year.
    On January 26, 1994, OSHA responded to the rulemaking petition, 
saying that it was initiating rulemaking on a permanent standard, but 
would not issue an ETS. On October 17, 1997, OSHA published a Proposed 
Rule on Occupational Exposure to Tuberculosis (62 FR 54160). In the 
proposal, the Agency made a preliminary determination that workers in 
hospitals, nursing homes, hospices, correctional facilities, homeless 
shelters, and certain other work settings faced a significant risk of 
incurring TB infection through occupational exposure. The Agency also 
made a preliminary conclusion that use of established infection 
prevention and control measures could reduce or eliminate this 
significant risk. The protective measures OSHA proposed were based in 
large part on existing CDC guidelines, and included instituting 
procedures for the early identification and treatment of TB patients, 
isolating patients with infectious TB in rooms designed to protect 
others from contact with disease-causing microorganisms, requiring 
healthcare workers to use respirators to perform certain high-hazard 
procedures on infectious patients, training workers in TB recognition 
and control, and providing medical follow-up for occupationally exposed 
workers who become infected and information to their colleagues with 
similar exposures.
    OSHA accepted comments and held public hearings on the proposed 
standard in 1998. Additional comments on specific issues were also 
accepted in 1999 and 2002. (64 FR 32447 (June 17, 1999); 64 FR 34625 
(June 28, 1999); 67 FR 3465 (January 24, 2002); 67 FR 9934 (March 5, 
2002)) On the latter occasion, OSHA asked for comment on a revised risk 
assessment and peer reviews of that assessment, as well as on a 
National Academy of Sciences/Institute of Medicine (NAS/IOM) report,

[[Page 75769]]

``Tuberculosis in the Workplace,'' that Congress had commissioned in 
1999. (Exs. 184; 185; 186; 187)
    Rulemaking participants represented diverse constituencies, 
including public health organizations such as the CDC, the American 
Lung Association's American Thoracic Society, the Infectious Disease 
Society of America, the National TB Controller's Association, and state 
and local health departments; labor unions such as the American 
Federation of State, County, and Municipal Employees and the Service 
Employees International Union; safety and health professionals and 
employees working in hospitals, correctional facilities, TB clinics, 
nursing homes, drug treatment centers and homeless shelters; and 
professional and trade associations such as the Society of Healthcare 
Epidemiologists of America, the American Hospital Association and the 
Association for Professionals in Infection Control and Epidemiology. 
These groups have extensive experience in TB control, and provided a 
broad range of perspectives on the issues involved in the rulemaking.

II. Reasons for Withdrawal of the Proposed Standard

    OSHA has decided not to promulgate a standard addressing 
occupational exposure to TB because it does not believe a standard 
would substantially reduce the occupational risk of TB infection. Many 
commenters argued forcefully that the proposed rule was based on an 
overestimate of this risk. In addition, existing TB control efforts, 
initiated by the Federal government in concert with other public health 
agencies, have led to a dramatic decline in TB over the past decade, 
greatly reducing the risk of occupational exposure to TB. Because of 
these TB control efforts, effective infection control measures are 
already in place, particularly in hospitals, which is where the 
occupational risk of TB exposure would be most severe.
    Moreover, much of the current occupational transmission appears to 
occur when workers do not realize that a patient, client, or other 
contact has infectious TB. An OSHA standard is unlikely to be more 
effective than the CDC guidelines in eliminating this risk. OSHA 
believes that workers in many situations, particularly those with 
limited medical qualifications and resources, will not be able to 
identify or diagnose currently undiagnosed TB cases frequently and 
rapidly enough to prevent this transmission from occurring. Risk to 
workers encountering undiagnosed cases will be reduced most effectively 
by reducing even further the incidence of TB in the population as a 
whole, and therefore in their client populations. OSHA will use 
technical assistance, outreach, and cooperative activities to assist 
employers and their workers in implementing infection control measures. 
In addition, OSHA will continue to use its existing enforcement tools, 
as appropriate, with employers who are not taking adequate action to 
protect their workers from exposure to TB.
    TB in the United States has declined significantly since OSHA 
decided to propose a TB Standard.
    Until 1985, the number and rate of TB cases in the United States 
had declined steadily for more than 30 years. Unexpectedly, however, 
the incidence of TB started to increase in 1986. At the peak of this 
resurgence in 1992, CDC reported 26,673 TB cases (10.5 per 100,000 
population)--an increase of 20% over the number of cases, and of more 
than 12% over the case rate, reported in 1985. The situation was 
especially pronounced in states with historically high TB rates. In 
1992, when the rate of TB for the nation as a whole was 10.5 cases per 
100,000 population, New York, Florida, California, Texas and Illinois, 
had rates ranging from 10.9 to 25.2 per 100,000, and accounted for 58% 
of the total cases. In addition, by 1991 there had been a seven-fold 
increase in the percentage of multidrug-resistant TB (MDR-TB), TB that 
is resistant to both isoniazid and rifampin, the two major drug 
treatments for the disease. (Ex. 187, p. 13)
    The Federal agency with primary responsibility for responding to 
the TB crisis is the CDC. In 1989, CDC published its ``Strategic Plan 
for the Elimination of Tuberculosis in the United States.'' (Ex. 6-19, 
pp. 1-25) This plan, which had been under development since 1984, 
called for a comprehensive governmental and public health effort to 
address TB transmission. In 1992, it was supplemented by the CDC's 
National Action Plan to Combat Multidrug-Resistant Tuberculosis. (Ex. 
7-65) These plans provided the framework for the Federal response to 
the TB resurgence of the late 1980s and early 1990s.
    The plans prescribed a broad and multifaceted attack on TB, 
including infection control guidelines describing methods to reduce 
transmission in a number of settings; physician education programs and 
practice guidelines to ensure effective treatment; research into new 
and faster methods of identifying TB, particularly MDR-TB; the 
implementation and maintenance of community-based TB control programs, 
and the development of alternative TB treatments. (Ex. 187, pp. 17-23) 
As well as beginning work on its TB proposal, OSHA's contribution to 
this national effort included the enforcement activities described in 
its 1993 directive, as well as outreach and educational activities 
directed at employers with workers at risk of occupational exposure to 
TB. As a result of all of this coordinated activity, starting in 1993, 
the incidence of TB began to decline again.
    By 1996, as OSHA noted in the preamble to its 1997 proposal, both 
the number and the rate of TB cases were lower than they had been in 
1985, before the resurgence began. This decline has continued, and for 
2002 CDC reported 15,078 TB cases (5.2 per 100,000 population). These 
numbers represent a reduction of more than 50% in the rate of TB since 
the 1992 peak, and of 43.5% in the number of cases. (Table 1) The 
number of reported TB cases and the national TB case rate are now at 
their lowest levels since TB reporting began in 1953, with significant 
decreases occurring in the states where the resurgence was most severe. 
The most dramatic decline occurred in New York, which in 1992 had the 
highest TB rate in the Nation, 25.2 cases per 100,000 population. By 
2002, it had experienced a 70% decline in the case rate, to 7.5 per 
100,000. New York, California, Florida, Texas, and Illinois together 
account for fully 65% of the decrease in the number of cases since 
1992. The number of TB cases in these five states was reduced by about 
50% over this period, 7% more than the Nation as a whole. The number 
and percentage of MDR-TB cases have also declined dramatically over 
this period. In 2002, 138, or 1.3%, of culture-positive TB cases were 
resistant to isoniazid and rifampin, down from 468, or 2.7% reported in 
1993, a reduction of more than 70% in the number, and 50% in the 
percentage, of cases that are MDR-TB. (Centers for Disease Control and 
Prevention, Trends in Tuberculosis Morbidity, (United States, 1992-
2002), MMWR 2003; 52: 217-222).
    CDC has noted, however, that even though TB is declining in all 
demographic groups studied, there remains substantial variation in 
disease incidence among these groups. (MMWR 2003: 52: 217) In 2002, for 
the first time, more than half of all TB cases occurred in individuals 
who were born outside of the United States, and CDC believes that the 
majority of these cases are the result of infections also incurred 
outside of this country. This suggests that TB transmission in the U.S. 
may be even

[[Page 75770]]

less common than the numbers in Table 1 would indicate. Even among the 
U.S. born population, there are substantial disparities among racial, 
ethnic, and economic groups, with higher TB rates associated with lower 
socioeconomic status. (MMWR 2003: 52: 218) Well over half of all TB 
cases are in individuals who are not in the workforce, so the TB rates 
for workers are substantially lower than the overall population rates. 
(Ex. 187, pp. 153, 154 citing MMWR 2003: 52: 222)

                     Table 1.--U.S. Tuberculosis Cases and Case Rates per 100,000 Population
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                                                                                      Percent         Percent
                      Year                            Number           Rate       change  number   change  rate
----------------------------------------------------------------------------------------------------------------
1992............................................          26,673            10.5            +1.5            +1.0
1993............................................          25,287             9.8            -5.2            -6.7
1994............................................          24,361             9.4            -3.7            -4.1
1995............................................          22,860             8.7            -6.2            -7.4
1996............................................          21,337             8.0            -6.7            -8.0
1997............................................          19,851             7.4            -7.0            -7.5
1998............................................          18,361             6.8            -7.5            -8.1
1999............................................          17,531             6.4            -4.5            -5.9
2000............................................          16,377             5.8            -6.6            -9.4
2001............................................          15,989             5.6            -2.4            -3.4
2002............................................          15,078             5.2            -5.7           -7.1
----------------------------------------------------------------------------------------------------------------
From CDC: ``Reported Tuberculosis in the United States, 2001''; ``Trends in Tuberculosis Morbidity--U.S., 1992-
  2002.''

    The occupational risk of TB infection is lower than that reflected 
in OSHA's proposed standard.
    The proposed standard was based on OSHA's preliminary assessment 
that workers occupationally exposed to TB were at substantially greater 
risk of TB infection, and therefore of active TB disease and death, 
than was the general population. Both OSHA's preliminary risk 
assessment, and the revision released in 2000 were based in large part 
on published data on the number of workers in different health care and 
prison settings with skin tests indicating recent TB infection (the 
conversion rate), and on comparisons of those data to estimates of 
background conversion rates among comparable populations without 
occupational exposure. In order to determine the estimated background 
conversion rates, OSHA used calculations derived from the number of 
active TB cases reported to CDC in a given year. OSHA assumed that 
about 10% of infected individuals who do not undergo prophylactic 
treatment would eventually develop active TB, 40% of them in the first 
year after infection, 20% in the second year, and the remaining 40% 
distributed equally through the remainder of their lifetimes. The 
revised risk assessment estimated that, based on the existing frequency 
of prophylactic treatment, active TB would occur in only about 6.5% of 
infected individuals. OSHA also assumed that 7.8% of active TB cases 
would be fatal.
    As both OSHA's peer reviewers and many commenters pointed out, 
however, there are several uncertainties associated with these 
calculations, and the risk assessments likely overstated the 
occupational risk. (Exs. 185; 186; 187, p.153; 189-21; 189-20; 189-32; 
189-28; 189-25) First, for a number of reasons ranging from imprecise 
testing protocols to poor availability of appropriate study 
populations, data on conversion rates are of less than ideal 
reliability and estimates of increased risk among occupationally 
exposed workers are necessarily imprecise. Second, a number of 
participants pointed to data indicating that far less than 10% of 
infected individuals, possibly even less than 5%, will develop active 
TB. (Exs. 185; 187 pp. 152-153, 216-220) This most obviously affects 
OSHA's estimate of the number of occupationally-acquired infections 
that will develop into active TB. In addition, because background 
infection rates were derived in large part by applying this assumption 
about disease development to actual data on the number of active cases, 
the assumptions also affect the calculation of excess occupational risk 
of infection. If only half the assumed percentage of infected 
individuals develop active TB (5% instead of 10%), the number of TB 
infections leading to a given number of active TB cases (the background 
rate) would be twice as high as calculated, meaning that the excess 
risk of infection attributed to occupational exposure would be lower 
than originally assumed.
    Similarly, even though the fatality rate was not a major basis for 
OSHA's preliminary determination of significant risk, many participants 
criticized the assumption that 7.8% of TB cases would be fatal. The IOM 
report stated that, for healthcare workers who are not 
immunocompromised or infected with MDR-TB, the risk of death is 
negligible. (Ex. 187, pp. 154, 222). Several participants noted that 
the 7.8% mortality rate was derived from 1989 to 1991 data, and that 
the death rate for those years was much higher than it has been since; 
in fact, for 1999 and 2000, the death rate was 3%. (Exs. 187, p. 153; 
185, p.12; 189-13, p. 3; 189-22, p. 3; 189-25, p. 7; 189-28, p.3)
    In any event, whatever may have been the case when the proposal was 
issued in 1997, there is no dispute that occupational risk has declined 
as the incidence of TB in the population as a whole has declined. This 
is demonstrated by the fact that there has been a decline in TB among 
occupationally exposed workers that mirrors the decline in the 
population at large. The proposal noted that in the early 1990s, when 
the record shows that few employers were using infection control 
measures to protect their workers from exposure to TB, workplace 
exposures resulted in TB infections, disease and, in some cases death. 
(Exs. 187, pp. 95-96, 7-3; 5-16; 151-3; 151-15; 5-3; 7-136; 6-25) 
Healthcare workers represent the largest group of TB-exposed workers, 
and in the early years of TB recordkeeping, they were more likely than 
other workers to develop TB. (Exs. 187, pp. 105-107; 7-3; 5-16; 5-11; 
151-3; 151-15) As the Society for Healthcare Epidemiologists of America 
(SHEA) noted, more recent data indicate that healthcare workers 
``represent a small proportion of all cases and are not 
disproportionately represented in the TB caseload compared to their 
presence in the workforce'' (Ex. 183-15, p.1-2). IOM reported that for 
1998, although healthcare workers accounted for 9% of

[[Page 75771]]

the working population of the U.S., these workers accounted for only 8% 
of TB cases among the working population, which does not appear 
consistent with these workers being at much higher risk of infection 
than the rest of the population. Moreover, from 1994 to 1998, the TB 
rate for health care workers declined almost 20%, from 5.6 to 4.6 per 
100,000 population, while the rate for other workers remained steady at 
5.2 per 100,000. (Ex. 187, p.89)
    Because TB rates among healthcare workers vary demographically in a 
manner similar to rates among the general population, and because it is 
very difficult to determine whether any individual case was transmitted 
occupationally, many participants believed that much of the risk to 
these workers likely arises outside of work. For example, the 
Infectious Disease Society of America pointed to data ``suggest[ing] 
that community exposure was responsible for most conversions even at a 
hospital which cares for a large number of TB patients.'' (Ex. 183-1, 
p.2) IOM pointed out that foreign-born workers account for a very high 
percentage of TB cases in healthcare workers. (Ex. 187, p. 89) Many of 
these workers are from countries such as India and the Philippines, 
which have very high TB rates.
    Increased implementation of TB controls has reduced TB levels.
    The record contains virtually unanimous agreement on two crucial 
points. First, along with the spread of AIDS and an influx of 
immigrants from areas where TB is common, widespread complacency about 
TB and a consequent lack of resources focused on TB prevention 
contributed significantly to the 1985-1992 resurgence of the disease. 
(62 FR 54173, 54175; NY TR, p. 211) Second, the post-1992 decline in TB 
has resulted from public health and infection control measures taken as 
part of the intense Federally-coordinated response to the resurgence. 
(62 FR 54175, 54176; DC TR, pp. 767, 884) Primarily because of this 
CDC-coordinated anti-TB campaign, the public and occupational health 
communities better understand the factors creating risk of TB 
transmission and disease, are more knowledgeable about TB containment 
strategies, and are more aware of the importance of implementing those 
strategies. (Exs. 187, pp. 13-22, 82; 183-15, p. 1; TR NY p. 212)
    Prominent among these TB control strategies are the recommendations 
in several CDC guidelines for preventing the transmission of TB. CDC 
updated its TB guidelines for health care settings (first issued in 
1982) in 1990 and 1994. (Ex. 4B) The guidelines recommend measures such 
as early identification and isolation of individuals with infectious 
TB, prompt initiation of therapy for these individuals, the use of 
negative pressure ventilation in TB isolation rooms, the use of 
respiratory protection for health care workers performing high-hazard 
procedures or working in TB isolation rooms, and employee tuberculin 
skin testing and training. CDC issued additional guidelines for long 
term care facilities in 1990, for facilities dealing with homeless 
persons in 1992, and for correctional facilities in 1996, all locations 
where the resident populations have relatively high levels of 
infectious TB. (Exs. 3-35; 6-15; 7-284) As part of its outreach and 
compliance assistance efforts, OSHA notifies employers of these 
guidelines, and provides links to them on its own Web site.
    Because TB is an airborne hazard, the CDC guidelines have 
recommended that exposed workers wear respirators. OSHA requires the 
use of respirators certified by CDC's National Institute for 
Occupational Safety and Health (NIOSH). See 29 CFR 1910.134; 29 CFR 
1910.139 (1997)(to be revoked). In 1992, NIOSH recommended specific 
types of respirators for health care workers working around TB 
patients, and CDC's 1994 guidelines listed specific performance 
criteria that a respirator needed to meet to provide protection against 
TB. (Exs. 7-64; 4B) In 1995, NIOSH issued a new certification protocol 
for respirators, creating new classes of respirators that meet the CDC 
performance criteria. One new type of respirator is the N95, now the 
most frequently used respirator for TB protection. (Ex. 7-261)
    The record shows that compliance with CDC's TB guidelines has 
increased significantly since OSHA began work on a TB standard in 1993. 
Compliance is most extensive in hospitals. Hospitals are where the 
greatest risk of TB exposure occurs, because most TB cases are 
diagnosed and treated in a hospital setting, and this diagnosis and 
treatment often involves the use of cough-inducing procedures such as 
sputum induction and bronchoscopies that are likely to expose workers 
to high concentrations of infectious material. During the rulemaking, 
the American Hospital Association (AHA) relied on the results of 1992 
and 1996 surveys that it conducted in conjunction with CDC to show that 
``hospitals have made significant progress in implementing control 
measures to prevent transmission of TB consistent with the 1994 CDC 
guidelines.'' (Ex. 17-454) As shown in Table 2, by 1996, the vast 
majority of hospitals were using isolation rooms meeting CDC's 
criteria, providing appropriate respiratory protection, and performing 
periodic skin testing of potentially exposed workers.

 Table 2.--Comparison of Tuberculosis Control Measures for 103 Hospitals
 That Reported More Than Six Admissions of Patients With Tuberculosis in
 1992 CDC Survey and That Also Responded to 1996 CDC Survey (Ex. 187, p.
                                  111)
------------------------------------------------------------------------
                                  1992 number (%)      1996 number (%)
------------------------------------------------------------------------
Engineering Controls:
    [sbull] Isolation rooms     59/92 (64)           99/103 (96)
     meeting CDC criteria.
    [sbull] Routine check of    42/85 (49)           96/99 (97)
     negative air pressure.
    [sbull] Monthly check of    5/35 (14)            76/90 (84)
     negative air pressure.
Respiratory Protection \1\:
    [sbull] Nonfitted surgical  69/101 (68)          1/103 (1)
     mask.
    [sbull] Soft mask, molded   34/101 (34)          NA
     or fitted.
    [sbull] Particulate         8/101 (98)           40/103 (39)
     respirator.
    [sbull] N95...............  NA                   85/103 (83)
Tuberculin Skin Testing:
Testing by Worker Category:
    [sbull] Nurses............  103/103 (100)        103/103 (100)
    [sbull] Respiratory         102/103 (99)         103/103 (100)
     therapists.
    [sbull] House staff.......  65/81 (69)           65/73 (89)

[[Page 75772]]

 
    [sbull] Attending           43/86 (69)           65/94 (69)
     physicians.
    [sbull] Students..........  55/95 (58)           74/97 (76)
Testing Elements:
    [sbull] After exposure      98/101 (97)          102/103 (99)
     incident.
    [sbull] Two-step testing..  NA                   77/98 (79)
    [sbull] Maintain yearly     64/98 (65)           93/98 (95)
     reports.
------------------------------------------------------------------------
\1\ Numbers add to more than one hundred because facilities may use more
  than one type of mask.

    The record also shows increased compliance with TB control 
procedures in prisons and other correctional facilities. CDC published 
TB control guidelines for these facilities in June 1996, and surveys it 
conducted with National Institute of Justice between 1992 and 1997 
showed an increasing implementation of TB control measures in 
correctional facilities. The surveys examined the implementation of 
recommended control provisions in the Federal Bureau of Prisons 
facilities, all 50 state systems, and a number of large local jail 
systems. Results showed that 90% of facilities screened new employees 
for TB, and 75% of those included periodic tuberculin skin testing. The 
use of negative pressure isolation rooms increased from 30% in 1993 to 
nearly 98% in 1997 (for Federal and State systems) and 85% (for local 
jail systems). The use of directly observed therapy for inmates with 
active TB disease increased from 77% to 98% for Federal and State 
systems and 84% to 95% for local jail systems (Ex. 187, p. 113-114). 
Although an AFSCME report of a 1997 survey of correctional facilities 
where its members were employed showed ``a wide variation of adherence 
to CDC guidelines from departments that had instituted rigorous 
programs throughout prison systems to those that had done very 
little,'' the survey covered a ``very small, nonrandom set'' of 
facilities, and does not contradict the conclusion that compliance in 
correctional facilities is increasing. (Ex. 189-23, p. 4; 187 p. 116) 
The evidence in the record indicates that both hospitals and 
correctional facilities improved their TB control practices 
significantly over the 1990s.
    Taken together, survey results suggest, at a minimum, two 
conclusions. First, institutional departures from recommended 
tuberculosis control policies and procedures were common, if not the 
norm, in the late 1980s and early 1990s. Second, institutions--at least 
hospitals and correctional facilities--were taking tuberculosis control 
measures more seriously and reporting substantially higher rates of 
implementation of recommended measures in later years. (Ex. 187, p. 
116).
    Evidence about the use of infection control procedures in other 
types of settings also showed increasing levels of compliance, although 
generally not as high a level of compliance with CDC guidelines as was 
occurring in hospitals. (Ex. 187, pp. 114-117; DC TR, p. 676) AFSCME 
reported that, ``in non-hospital healthcare settings, [its] survey 
revealed inadequate to virtually non-existent TB control programs.'' 
(Ex. 189-23, p. 4) As noted above, however, IOM pointed out that this 
survey was of a ``very small, nonrandom set of respondents,'' only 23 
long-term care facilities, 28 mental health facilities, and 28 social 
service agencies, and that its results ``must be viewed with 
considerable caution.'' (Ex. 187, p. 116) In contrast to the AFSCME 
survey, a number of participants provided evidence that voluntary 
implementation of the CDC TB guidelines had increased dramatically 
since 1994, even outside of hospitals. For example, Barbara Hood, 
testifying on behalf of the California Association of Homes and 
Services for the Aging stated:

    * * * many health care employers have implemented key control 
measures as recommended in CDC's 1994 TB guidelines and have 
incorporated these recommendations in their policies and procedures. 
This has improved screening and surveillance protocols for both 
residents and staff. As a result, nursing facility providers have 
significantly reduced the level of TB in long-term care 
organizations. (LA TR, pp. 124-125)

AHCA also asserted that many nursing and long-term care facilities have 
protected their workers effectively by implementing many of the CDC 
recommendations, even though these facilities are not necessarily 
complying with all the provisions in OSHA's proposal. (Ex. 17-756)
    Particularly in nursing homes and other long-term care facilities, 
this trend has probably been accelerated by the need to comply with 
requirements for Medicare and Medicaid eligibility. A regulation that 
took effect in October 1992 requires each of these facilities ``to 
establish and maintain an infection control program * * * to help 
prevent the development and transmission of disease and infection.'' 
(42 CFR 483.65) IOM reports that, at least as of 2000, the guidelines 
used by state inspectors to determine compliance in nursing homes 
``specifically require that facilities demonstrate procedures for early 
detection and management of residents with signs and symptoms of 
infectious tuberculosis, screening of residents and workers for 
tuberculosis infection and disease, and evaluation of workers exposed 
to tuberculosis in the workplace.'' (Exs. 187, p. 58, n. 3; 17-756) 
Moreover, the Centers for Medicare and Medicaid Services (CMS) recently 
inaugurated a new Program of All-inclusive Care for the Elderly (PACE), 
which requires participants to ``follow accepted policies and standard 
procedures with respect to infection control, including at least the 
standard precautions developed by the Centers for Disease Control and 
Prevention.'' (42 CFR 460.74)
    The national efforts to reduce the incidence of TB in the general 
population have also protected workers by reducing the likelihood that 
they will encounter infectious TB at work. As the IOM points out, 
``Overall, fewer cases of tuberculosis and less multidrug-resistant 
disease means less risk for nurses, doctors, correctional officers, and 
others who work for organizations that serve people who have 
tuberculosis or who are at increased risk for the disease.'' (Ex. 187, 
p. 104) The Society of Healthcare Epidemiologists of America (SHEA) 
also credits the efforts of public health officials, government 
agencies, professional organizations and clinicians for ``clearly 
put[ting] the United States back on the road to TB

[[Page 75773]]

elimination.'' (Ex. 183-15, p. 1) The effectiveness of all of these 
measures is demonstrated by a decline in TB among occupationally 
exposed workers that has exceeded the decline in the population at 
large. (Exs. 7-147; 7-148; 7-149; 7-173; 7-167; 151-15; 18-49A; 181-3; 
18-53; 187, p. 89)
    An OSHA standard would not substantially reduce transmission of TB 
from undiagnosed sources.
    Finally, evidence in the rulemaking record indicates that, with the 
current level of compliance with CDC guidelines, the ``primary risk'' 
of occupational exposure to TB is from individuals with unsuspected and 
undiagnosed infectious TB. (Ex. 187, p. 2) One commenter, St. Joseph 
Mercy Hospital, called these exposures the ``Achilles heel'' of TB 
control efforts. (Ex. 17-881, p. 3) Although OSHA's proposed standard 
called for early identification and isolation of infectious TB 
patients, this early identification can be extremely difficult. (Exs. 
5-4; 5-18; 6-27; 7-76; 7-77; 7-78; 7-79; 5-12) An OSHA standard must 
substantially reduce a significant risk, and OSHA believes it is 
unlikely that employers will identify enough of the currently 
undiagnosed TB cases their workers come in contact with to reduce the 
remaining occupational risk of TB infection substantially. Industrial 
Union Department, AFL-CIO v. American Petroleum Institute, et al., 448 
U.S. 607, 642, 653 (1980).
    The record shows that there are a number of reasons that a client's 
or patient's infectious TB may not be recognized. (Exs. 17-11; 17-12; 
17-36; 17-458) In some situations, the infectious person may not 
manifest evident signs and symptoms of TB. And even after receiving 
training, a worker who is not expecting to see TB, which is especially 
likely in an area where the disease is uncommon, may not recognize the 
significance of TB signs and symptoms. In other cases, an exposed 
employee may lack the clinical expertise or resources to identify a 
patient or client as a suspect TB case and make a referral for 
diagnosis.
    Lack of recognition may also occur where a worker has contact with 
many patients or clients who have coughs or other possible TB symptoms. 
Also, workplaces such as drug treatment centers and homeless shelters 
operate with unique limitations, and rarely possess either the 
resources or the clinical expertise to identify and isolate TB cases in 
a timely manner. (Exs. 187, p. 132; 17-53; 17-76; 17-58; 17-12; DC TR, 
pp. 2019-2020, 2113, 2131; NY TR, pp. 610, 612; LA TR, pp. 598, 600, 
601, 617, 630) They are also less likely to be able to distinguish 
between active TB disease and other medical conditions with similar 
symptoms.
    As the Association for Professionals in Infection Control and 
Epidemiology (APIC) put it:

    Obviously, protecting workers against exposure to TB from 
patients is contingent upon suspecting that the patients have TB in 
the first place. Patients may initially enter a hospital for a 
different reason or show only vague symptoms of TB. Until diagnosed, 
these patients unwittingly expose probably dozens of individuals to 
their illness. (Ex. 17-671, p. 3)

APIC then reported on 17 outbreaks since 1960 where transmission to 
healthcare workers was reported, pointing out that 75.6% of the workers 
were infected by an undiagnosed and unsuspected TB patient. (Id.) The 
Home Health Services and Staffing Association (HHSSA) also asserted 
that 75% of TB transmissions from patients to healthcare workers are 
not preventable because, at the time of transmission, the patient's TB 
could not be readily identified or even suspected. (Ex. 17-673, p. 3) 
To the extent that these reports do not reflect advances made in 
infection control over the last decade, they may overstate the 
percentage of undiagnosable cases, but HHSSA's and APIC's conclusions 
about the significance of these cases are consistent with those of the 
IOM. Moreover, the case reports APIC submitted describe situations 
where transmissions have occurred, and OSHA's own review of these 
reports indicates that, even with a modern TB infection control 
program, a number of the source patients would still not have been 
diagnosed before healthcare workers were exposed to them.
    These reports also show that occupational exposures to undiagnosed 
TB and potential disease transmission can occur in all settings, 
including hospitals that have implemented the CDC Guidelines. The IOM 
pointed out that, in locations such as hospital emergency rooms, 
exposure may occur before infectious individuals are recognized and 
isolated, and that infectious individuals may remain asymptomatic for 
some time. (Ex. 187, p. 135) Consistent with CDC guidelines, the 
proposal called for treating contacts as having suspected infectious TB 
if they had both a persistent cough lasting at least three weeks, and 
at least two of the following additional symptoms: bloody sputum, night 
sweats, weight loss, fever, and anorexia. (62 FR 54292-3).
    First, for workers in residential settings such as nursing homes 
and correctional facilities, this criterion does not provide any 
protection in the first three weeks that a resident has symptoms and is 
not recognized as having TB. In some other settings, identification of 
infectious individuals depends on the self-reports of patients or 
clients to determine whether almost any of the symptoms are present. 
Several participants pointed out that, outside of health care settings, 
potentially infectious individuals who fear they will be denied a 
benefit (such as a shelter bed or substance abuse treatment), or be 
compelled to enter a coercive treatment situation, may feel a strong 
incentive not to respond honestly to questions about symptoms. ( Exs. 
18-22A, 18-57A; 183-15, p. 4; NY TR, p. 615; DC TR, pp. 2009; 2034; 
2069)
    Homeless shelters are a prime example of a population where many 
clients have the coughs, fevers, night sweats, weight loss, and other 
symptoms associated with TB. (NY TR, pp. 607-608; Chicago TR, pp. 710-
711, 768, 789) These non-hospital settings do not diagnose, treat, or 
isolate individuals with active TB disease; at most, they screen 
clients for symptoms of infectious disease and transfer or refer those 
with suspect symptoms to facilities with appropriate diagnostic and 
isolation capabilities. (Exs. 17-50; NY TR, p. 697; Chicago TR, pp. 
789-790; DC TR, pp. 1867-1868) They rarely possess any means to 
identify asymptomatic individuals. They often lack the resources even 
to provide all the services they believe their clients need, and may 
well resist transferring any of their limited resources to a TB 
screening program, particularly when, as noted above, the screening may 
engender fear or hostility in their clients. (Exs 18-22A, 18-57A; 17-
50; 183-15, p. 3, NY TR, p. 703; Chicago TR, pp. 701-702, 713; DC TR, 
pp. 1910, 2046, 2069)
    The bottom line is that no infection control regime, including that 
in OSHA's proposed standard, would have much effect on workplaces where 
the greatest source of exposure and risk is unsuspected and undiagnosed 
active TB disease.

The Need for an OSHA Standard

    The major issue in the rulemaking was whether, in light of the 
ongoing decline in the national incidence of TB, the steps that 
employers were already taking, and the difficulty in identifying many 
infectious TB patients, there is a current justification for an OSHA 
rule on occupational exposure to TB. Many participants argued that the 
rule would not result in a meaningful additional reduction in risk. 
According to these commenters, the problem addressed by

[[Page 75774]]

OSHA's proposed standard has already largely been solved. APIC 
testified, ``Clearly, the TB crisis that OSHA is attempting to address 
has passed.'' (DC TR, p. 722). This sentiment was echoed by other 
commenters, such as the American Medical Association, Infectious 
Disease Society of America, Home Health Service Staffing Association, 
American Health Care Association, Society of Healthcare Epidemiologists 
of America, American Association of Homes and Services for the Aging, 
who also questioned the need for an OSHA standard in an era of 
declining TB cases. (Exs.17-719; 183-1; 17-673; 18-61; 17-666; 17-673). 
The American Lung Association's American Thoracic Society, stated:

    The [proposed] OSHA * * * TB standard, is based heavily on the 
CDC's 1994 guidelines. * * * The CDC guidelines were an appropriate 
response at the time they were formulated but the proposed OSHA 
standard will be far out of proportion to the risk by the time it is 
implemented and increasingly inappropriate and burdensome with each 
passing year if the current epidemiologic trends continue. (DC TR, 
pp. 1035-36)

    In contrast, other commenters, such as the United Food and 
Commercial Workers Union and the Service Employees International Union 
(SEIU), argued that, because CDC's TB guidelines are not directly 
enforceable, there remain employers who have placed their workers at 
risk by failing to implement them fully. (DC TR, p. 676; Ex. 17-1089, 
p.1-2; DC TR, pp. 635-636). Some of these commenters, such as SEIU, 
pointed to the geographic variation in TB rates to support the argument 
that a standard is needed because not all employers are taking 
appropriate protective action. (Tr LA, pp. 245-246)
    In response to these arguments, OSHA acknowledges that a standard 
is often the most efficient way of assuring that employers reduce their 
employees' exposure to specific hazards. TB is primarily a public 
health hazard, however, and occupational exposure at this time is in 
large part a function of the prevalence of active TB in the population 
at large. There has been a decade-long decline in TB prevalence, 
resulting in large part from the Federal resources devoted to public 
health and infection control measures that were implemented without an 
OSHA standard in effect.
    OSHA believes this shows that, in the unique case of TB, there are 
powerful incentives for employers to continue to provide appropriate 
protection even without an OSHA TB standard. The ongoing Federal 
commitment to TB control provides them with a wealth of information and 
expert resources to assist in TB control efforts. Among other 
incentives, hospitals and nursing homes must have infection control 
plans to qualify for Medicaid and Medicare reimbursement, and are 
subject to annual reviews to verify their continuing compliance. (Ex 
17-756, 42 CFR 482.42; 42 CFR 483.65) Facilities participating in CMS's 
PACE program must comply with ``at least'' the CDC guidelines. (42 CFR 
460.74) The Joint Commission for the Accreditation of Healthcare 
Organizations (JCAHO), which many hospitals and nursing homes use to 
demonstrate qualification for Medicare and Medicaid reimbursement, also 
requires an infection control plan as a condition of accreditation. 
(Exs. 17-756; 187, p. 58; Chicago TR, p. 931) The record also shows, as 
does CDC's new TB elimination plan, that the sobering memory of the 
1985-1992 TB resurgence is not likely to fade anytime soon, and that 
the complacency that led to that resurgence is unlikely to recur. (Ex. 
187, p. 21; NY TR, p. 212)
    Nor does OSHA believe that the facts that there are pockets of TB 
prevalence and a few states where TB rates have increased require it to 
promulgate a standard. First, the states with the highest levels of TB 
during the resurgence are also states that have been aggressive in 
implementing control measures, and are among the states where the most 
significant recent declines have occurred. From 1992 to 2002, only 
three states reported an increase in their TB rates, and these 
increases represent only an additional 106 TB cases (which is less than 
1% of the total TB cases in the U.S). (Centers for Disease Control and 
Prevention, Trends in Tuberculosis Morbidity--United States, 1992-2002, 
MMWR 2003; 52: 217-222) These increases do not detract from the fact 
that, nationally, there are fewer TB cases and lower TB rates being 
reported each year. CDC's new plan for TB elimination, CDC's Response 
to Ending Neglect, directs resources specifically at localized areas 
and population groups who remain at higher risk for TB. (Centers for 
Disease Control and Prevention. CDC's Response to Ending Neglect: The 
Elimination of Tuberculosis in the United States. Atlanta, GA: U.S. 
Department of Health and Human Services, CDC; 2002) Even without a 
standard, OSHA can take appropriate enforcement action to address those 
situations where employers are not taking adequate steps to reduce 
their workers' TB exposure.
    OSHA has additionally concluded that, as a practical matter, early 
identification of infectious TB patients will not occur enough more 
often than it already does to justify adoption of a standard. The fact 
that TB symptoms are neither universal nor unique to TB could also make 
OSHA enforcement of an early identification provision highly 
problematic. As the proposal recognized, identification of suspect 
cases requires the exercise of judgment. (62 FR 54247) Unless an 
employer simply fails to implement any identification criteria at all, 
it would be very difficult to establish when a violation occurs. As 
noted above, however, the record shows that most affected workplaces 
with the expertise and other resources to do so have already adopted 
programs to control exposure, including early identification of 
infectious TB patients, and OSHA will continue to use its general duty 
clause to require others to follow suit.
    For employers without these resources, OSHA believes that providing 
assistance in exercising the judgment necessary for an effective early 
identification program can best be accomplished through outreach, 
consultation, and education efforts, and OSHA intends to provide this 
type of assistance. CDC's targeted guidelines already provide some 
guidance, and OSHA believes that the most effective approaches are 
likely to be the integrated ones that build on the CDC guidelines and 
target occupational TB transmission as part of a broader TB control 
program.
    As noted above, workers are exposed to TB when they serve patients 
or clients who have infectious disease, and one of the most 
straightforward ways to reduce that exposure is to reduce the number of 
such contacts that occur by reducing the rate of infectious TB in the 
patient or client population. As CDC's most recent prevalence data 
show, ongoing TB reduction efforts have been remarkably effective in 
achieving this goal.
    Nor is there any indication that this success is leading to the 
type of complacency and inattention that contributed to the last TB 
resurgence. CDC's new TB control plan takes full account of the 
``scientific, programmatic, and health-sector developments of the last 
decade.'' This plan is focused strongly on the current demographic and 
epidemiological profile of TB, with one of its major goals being to 
reduce the global burden of TB. In CDC's Response to Ending Neglect, 
CDC explained that ``the heavy impact of TB in foreign-born persons 
living in this country'' is a major factor tempering its recent success 
in TB control.'' (CDC; 2002, p. 13) Now that foreign-born residents 
account for more than half the

[[Page 75775]]

incidence of TB in the United States, reducing TB in this population is 
more critical than ever to controlling TB domestically. CDC is much 
better suited than OSHA, which has authority only over domestic 
workplaces and employers, to address this increasingly important aspect 
of TB control.
    OSHA believes its role in this process should be to continue with 
the initiatives that have already contributed to reducing the 
occupational risk of TB infection. OSHA will continue to provide both 
industry- and workplace-specific TB control information and guidance, 
through its website as well as targeted outreach activities. OSHA will 
also continue the successful enforcement policy, described in its TB 
Enforcement Directive and in several national, local and regional 
emphasis programs targeting TB risks, to make sure that employers 
protect their employees from TB infection. In fact, OSHA's experience 
in these programs has helped convince it of the high level of 
compliance with TB exposure safeguards. When appropriate, however, OSHA 
has cited these employers for violations of the general duty clause, 
the TB-specific respirator standard, or other applicable requirements. 
These citations, (32 of the general duty clause and 92 of the TB-
specific respirator standard since the proposal was issued), have 
provided protection to a broad range of workers, including ambulance 
drivers, physicians, therapists, lab personnel, health care social 
workers, emergency medical technicians, support personnel, and 
morticians. The availability of this enforcement mechanism, coupled 
with OSHA's ongoing monitoring of TB-control efforts, will help prevent 
the widespread complacency of the mid-1980s from recurring, and will 
allow an expeditious response to any backsliding that does occur.
    In summary, OSHA has concluded that the success of existing Federal 
and community programs to control TB has significantly diminished the 
need for a standard, and that promulgating a standard will not reduce 
the remaining occupational risk substantially. Under the leadership of 
the CDC, community, institutional, and occupational public health 
efforts, including OSHA's own continuing outreach and enforcement, have 
increased worker and employer awareness of the factors leading to TB 
infection and disease and led to an increased implementation of CDC's 
TB guidelines. OSHA also intends to continue to use its enforcement, 
outreach, and education resources to ensure that employers' TB control 
efforts remain effective.

Review Under Executive Order

    This document has been reviewed by OMB pursuant to E.O. 12866.

Authority and Signature

    This document was prepared under the direction of John L. Henshaw, 
Assistant Secretary of Labor for Occupational Safety and Health, U.S. 
Department of Labor, 200 Constitution Avenue, NW., Washington, DC, 
20210. It is issued pursuant to sections 4,6, and 8 of the Occupational 
and Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657), 
Secretary's Order 3-2000, and 29 CFR part 1911.

    Signed at Washington, DC, this 19th day of December, 2003.
John L. Henshaw,
Assistant Secretary of Labor.
[FR Doc. 03-31845 Filed 12-30-03; 8:45 am]
BILLING CODE 4510-26-P