[Federal Register Volume 68, Number 250 (Wednesday, December 31, 2003)]
[Rules and Regulations]
[Pages 75776-75780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31846]



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

[[Page 75776]]


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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. H-371]
RIN 1218-AA05


Respiratory Protection for M. Tuberculosis

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

ACTION: Final rule; revocation.

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SUMMARY: OSHA is revoking ``Respiratory Protection for M. 
Tuberculosis'' (29 CFR 1910.139) which is simply a recodification of 
OSHA's 1971 General Industry Respiratory Protection standard that was 
revised in 1998. At the time of the revision of the 1971 standard, OSHA 
decided that, because its proposed standard for occupational exposure 
to TB, published three months earlier, included a comprehensive 
respiratory protection provision, the Agency would allow compliance 
with the previous respirator standard for TB protection until 
completion of the TB rulemaking. Thus, pending conclusion of the TB 
rulemaking, OSHA redesignated the old Respiratory Protection Standard 
in a new section entitled ``Respiratory Protection for M. 
tuberculosis''. However, in a document published elsewhere in this 
separate part of the Federal Register, OSHA is today withdrawing its 
proposed TB standard. Because this withdrawal concludes the TB 
rulemaking, OSHA is revoking the redesignated Respiratory Protection 
Standard, and will begin applying the General Industry Respiratory 
Protection Standard (29 CFR 1910.134) to respiratory protection against 
TB.

DATES: This revocation 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 October 17, 1997, OSHA published its Notice of Proposed 
Rulemaking (NPRM) for Occupational Exposure to TB (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 were at significant risk of 
incurring TB infection while caring for their patients and clients or 
performing certain procedures. The Agency also preliminarily concluded 
that this significant risk can be minimized or eliminated using 
infection prevention and control measures that have been demonstrated 
to be highly effective in reducing or eliminating job-related TB 
infections. These measures included the use of respiratory protection 
when performing certain high-hazard procedures on infectious 
individuals.
    On January 8, 1998 OSHA revised its 1971 General Industry Standard 
for Respiratory Protection (63 FR 1152). Because the 1997 TB proposal 
included all of the respiratory protection provisions that OSHA 
believed would be applicable to respirator use for TB protection, the 
Agency did not require this use to comply with the new Sec.  1910.134 
during the rulemaking proceedings on the TB proposal. Instead, pending 
conclusion of the TB rulemaking, OSHA redesignated the old Sec.  
1910.134 as Sec.  1910.139, ``Respiratory protection for M. 
tuberculosis.''
    However, OSHA is today withdrawing its proposed TB standard (see 
Occupational Exposure to Tuberculosis; Proposed Rule; Withdrawal 
published elsewhere in this Federal Register), and with this document 
is revoking 29 CFR 1910.139.

II. Reasons for the Revocation of 29 CFR 1910.139

    OSHA is revoking 29 CFR 1910.139 because it was intended to apply 
only during the pendency of the TB rulemaking, and that rulemaking is 
being terminated. The standard being revoked is simply a recodification 
of OSHA's 1971 General Industry Respiratory Protection Standard, 29 CFR 
1910.134, which was revised in 1998. (63 FR 1152, (January 8, 1998)). 
At the time of the revision, OSHA decided that, because the TB proposal 
issued three months earlier included a self-contained respiratory 
protection provision, the Agency would allow compliance with the 
previous respirator standard for TB protection until completion of the 
TB rulemaking. (62 FR 54289); (63 FR 1180). To accomplish this, OSHA 
redesignated the old Sec.  1910.134 as Sec.  1910.139, ``Respiratory 
protection for M. tuberculosis.'' OSHA made clear in both rulemakings, 
however, that it intended the respiratory protection requirements 
ultimately made applicable to TB protection to be consistent with the 
revised Sec.  1910.134, and the TB proposal was itself consistent with 
that revision. (62 FR 54257, 54287-54288; 63 FR 1180). In fact, the 
relevant comments from the Respiratory Protection rulemaking were made 
part of the TB rulemaking. (Exs. 150-1 through 150-178). With this 
termination of the TB rulemaking, it is now appropriate for OSHA to 
begin applying the revised 29 CFR 1910.134 to respiratory protection 
against TB.
    Applying the General Industry Respiratory Protection standard to 
the use of respirators for TB protection is supported by the records in 
both the TB and respirator rulemaking proceedings. OSHA noted in the 
proposed TB rule that one option was to apply the general respirator 
standard to TB protection. (62 FR 54257). A number of participants in 
the TB rulemaking urged OSHA to take this course. (See, e.g., Exs. 17-
215; 17-271; 17-455; 17-570; 17-906; 17-1145). The proposed TB 
standard's respiratory protection requirements were largely consistent 
with those in the revised general industry standard. One of the hazards 
the latter standard was designed to address is the ``inhalation of 
bacteria * * * including tuberculosis.'' (63 FR 1159).
    The revised general industry standard reflects the Agency's 
evaluation of current knowledge and technology as they relate to 
effective respiratory protection programs. The revisions help to ensure 
that employers have sufficient guidance to select and maintain 
appropriate respiratory protection. Given the extensive rulemaking 
undertaken to establish these requirements, and the intensive review 
and consideration of all issues related to respiratory protection in 
that rulemaking, the Agency believes it is appropriate and necessary to 
ensure that employees exposed to TB have the same protections as 
employees exposed to other types of hazards in the workplace. All 
facilities that use respirators for any purpose other than TB 
protection are already required to comply with the revised respiratory 
protection standard. The revised standard has also been upheld in its 
entirety by the U.S. Court of Appeals for the Eleventh Circuit. AISI v. 
OSHA, 182 F.3d 1261, 1273 (11th Cir. 1999).
    The new requirements in the revised respiratory protection standard 
include updating the facility's respirator program, complying with 
amended medical evaluation requirements, annual fit testing of 
respirators, and some training and recordkeeping provisions. These 
provisions were also included in the TB proposal, and the only one that 
elicited significant comment was the requirement for annual fit 
testing.
    With regard to updating each facility's respiratory protection 
program,

[[Page 75777]]

Sec.  1910.139 provides the skeletal requirements for such a program, 
but does not elaborate on what would be required in each element. The 
revised respiratory protection rule provides employers with additional 
guidance on what constitutes an appropriate and effective program, 
giving employers a better road map to follow when relying on 
respiratory protection in the workplace. It is the Agency's view, 
supported by the Respiratory Protection rulemaking record, that an 
effective program requires a systematic approach to evaluating 
workplace conditions, selecting the appropriate respirator, ensuring 
the respirator fits, and maintaining the respirator properly. The 
revised standard specifies how this systematic approach is to be 
implemented in the workplace.
    Similarly, Sec.  1910.139 requires medical evaluation, but does not 
set forth the components of the evaluation, or how it is to be 
accomplished. The medical evaluation provisions of the revised Sec.  
1910.134 set forth the minimum requirements employers must implement to 
determine if employees are medically qualified to wear respirators in 
their places of work. The employer must provide a medical evaluation 
for each covered employee, performed by either a physician or another 
licensed health care professional. Information from the medical 
evaluation is to be used to determine the employee's eligibility to 
wear the respirator proposed for the employee. The employer must base 
the determination on the recommendation of the health care 
professional. Administration of the medical questionnaire in Sec.  
1910.134, Appendix C, is a further requirement.
    The medical evaluation provisions of revised Sec.  1910.134 are 
significantly better than the original standard. They ensure that the 
health care professional, the employee, and the employer are aware of 
the factors that must be considered in evaluating an employee's 
respiratory protection needs, and provide the tools to ensure 
appropriate decisions are made.
    With regard to employee training, Sec.  1910.139 states only that 
employees must be ``instructed and trained in the proper use of 
respirators and their limitations,'' with no provision for annual 
retraining. Revised Sec.  1910.134 requires employers to provide 
effective training to employees who are required to use respirators. 
The training must be comprehensive, understandable and recur at least 
annually. Employers must provide the training before their employees 
are required to use the respirator. Topics to be covered include why 
the respirator is necessary, what the limitations of the equipment are, 
how to use the respirator in emergencies, how to use and care for the 
equipment, and how to recognize the medical signs and symptoms that may 
limit or prevent the use of respirators. OSHA has determined that these 
more detailed requirements regarding employee training will help to 
ensure that the training provided is appropriate and effective, thus 
leading to a more effective workplace respiratory protection program.
    Section 1910.134 requires more recordkeeping than Sec.  1910.139. 
Section 1910.134 consolidates recordkeeping requirements with respect 
to medical evaluations, fit testing and the respirator program into one 
section of the standard. Commenters agreed that such consolidation of 
requirements would improve understanding of the standard's 
recordkeeping obligations (Exs. 54-267; 54-286).
    Both Sec.  1910.139 and Sec.  1910.134 recognize that fit testing 
is an important component of an effective respiratory protection 
program. Fit testing is necessary because a respirator that does not 
fit properly provides only the illusion of protection. While it has 
long been known that fit can affect respiratory protection 
significantly, particularly for these types of respirators that depend 
on filtering the contaminant (rather than providing a separate source 
of uncontaminated air), specific protocols for fit testing are a more 
recent development. The revised Sec.  1910.134 reflects this newer 
technology, and provides specific guidance on appropriate fit testing 
procedures. OSHA believes that following these types of procedures is 
necessary to ensure that respirators are really providing the 
protection needed.
    The frequency of fit testing was an issue in both the respiratory 
Protection and TB rulemakings, and it generated significant comment in 
both records. There was little dispute that some additional fit testing 
beyond the initial test is necessary because respirator fit can be 
affected by a number of factors, including the size and shape of a 
person's face, dental changes, changes in the types of movements 
required to perform work when wearing the respirator, and the presence 
of facial hair. As OSHA explained when it promulgated the annual 
retesting requirement in 29 CFR 1910.134, waiting more than a year 
between fit tests allows a substantial fraction of workers to lose the 
protection respirators provide (63 FR 1224). This is no less true when 
respirators are used for TB protection than it is when they are used 
for protection against other hazards.
    Consistent with current practice, CDC guidelines and NIOSH 
recommendations, and the selection criteria in Sec.  1910.134, OSHA 
anticipates that half-mask N95 air-purifying filtering facepiece 
respirators will be the primary type of respirator used for TB 
protection. This type of respirator has a securely-fitting facepiece 
that filters the air, preventing inhalation of contaminants. Effective 
protection requires a good face-to-facepiece seal in order to ensure 
that there are no gaps through which contaminated air can enter the 
facepiece and be breathed in by the worker. Thus in order to provide 
protection, the respirator must fit the employee well enough to prevent 
leakage from occurring. This is particularly important for a hazard 
such as TB that does not have any warning properties that would allow 
an employee to detect that it is being inhaled, e.g., there is no odor 
that might indicate a breakthrough.
    The proposed TB standard acknowledged these issues by proposing 
that fit testing be performed as follows. Each employee who would have 
been required to wear a tight-fitting respirator would have had to pass 
a fit test at the time of initial fitting of the respirator; whenever 
changes occurred in the employee's facial characteristics that affected 
the fit of the respirator; and whenever a different size or make of 
respirator was assigned for use by that employee. At a minimum, the 
proposal would have required fit tests to be conducted annually unless 
an annual medical evaluation (also required by the proposal) indicated 
that a fit test was not necessary. The revised respiratory protection 
standard imposes the same requirements, except that it does not require 
annual medical evaluations, and annual fit tests are required for all 
respirator users.
    Several commenters supported the proposed provision allowing a 
licensed health care professional to determine the need for an annual 
fit test during a face-to-face evaluation. (See, e.g., Exs. 17-671; 17-
454; 17-932.) However, others argued compellingly that there are no 
objective data demonstrating that it is possible to determine whether a 
respirator fits by examining a person's face. (See, e.g., Exs. 17-271; 
17-697; 18-60A; 17-455; 17-768; 17-920).
    A number of commenters argued that repeat fit testing should only 
be done when the respirator changes, or when there is a significant 
change in the employee's physical condition that may interfere with the 
facepiece seal (see, e.g., Exs. 150-56; 150-69; 150-125).

[[Page 75778]]

Some infection control professionals cited additional costs and a 
perceived lack of benefits from repeating fit testing on an annual 
basis. (See, e.g., Exs. 17-671-I; 17-671-X; 17-211; 17-464; 189-22; 
183-15; 183-13.) In particular, the Infectious Disease Society of 
America cited studies by Blumberg et al. that examined tuberculin skin 
test conversion rates before and after the implementation of expanded 
TB control measures at a large metropolitan hospital. (Exs. 189, p. 22; 
18-5300; 7-173.) The implementation of expanded controls, which 
included retrofitting rooms into negative-pressure isolation rooms, 
expanding respiratory isolation policies, 6-month skin testing of all 
health care workers, and the addition of NIOSH certified respiratory 
protection, led to a 90% reduction in skin test conversions. Because 
annual fit testing was not a part of the expanded infection control 
program, the IDSA asserted that these studies demonstrate that there is 
no benefit to annual fit testing.
    The fact that a single study of workers whose respirators were fit 
tested only once did not show excess TB infections does not overcome 
the evidence supporting OSHA's conclusion in the revised respiratory 
protection standard that ``annual fit testing * * * is appropriate to 
protect employee health'' (63 FR 1224). The studies by Blumberg, et al. 
were not designed to study the efficacy of fit testing but rather the 
efficacy of an overall expanded TB infection control program in which 
many different protective measures were implemented simultaneously. 
Thus, it is difficult, if not impossible, to determine the relative 
efficacy of any one measure. Moreover, not all exposed workers would 
have been infected even without respirators. In the absence of periodic 
fit testing, there is no way to determine which of the exposed workers 
were wearing properly fitting respirators. It is the fit of a 
respirator that determines its effectiveness, and the record contains 
no evidence indicating that factors affecting fit are different for TB-
exposed workers than they are for other workers.
    A large number of participants in both the respiratory protection 
and TB rulemakings supported annual fit testing (see, e.g., Exs. 150-
23; 150-24; 150-27; 150-45; 150-52; 150-53; 150-58; 150-74; 150-89; 
150-93; 150-96; 150-103; 150-117; 150-123; 150-45; 150-52; 150-141; 
Respiratory Protection Hearing TR, pp. 1573, 1610, 1653, 1674). These 
participants agreed that fit is not static, and that a one-time, 
initial fit test without a requirement for annual re-fitting does not 
ensure that the appropriate level of protection would continue to be 
provided over time. A number of participants in the TB rulemaking 
suggested that the respiratory protection standard be applied in its 
entirety for protection from TB exposures. For example, Health 
Evaluation Programs, Inc. indicated:

    Respirator fit testing is not a hazard-specific or industry 
specific activity. It is specific to tight-fitting respirators worn 
by people. OSHA recognized this when the new Respiratory Standard 29 
CFR 1910.134 was released on January 8, 1998. The fit testing 
provisions of this new standard replace those found in the various 
substance-specific OSHA standards. Likewise, there is no reason to 
make an exception for TB. The respirator either provides the level 
of fit it is rated for, or it does not. (Ex. 17-570)

    This commenter went on to state:

    OSHA's responsibility to base a final standard on the best 
respirator information available can best be served by incorporating 
what OSHA has already learned and decided regarding respirator fit 
testing frequency.

    Another commenter, Certified Industrial Hygienist David L. Spelce, 
noted the particular aspects of TB exposures that indicate fit testing 
is necessary to ensure proper fit for protective purposes, as well as 
reinforcing the training aspects of fit testing that help employees don 
respirators appropriately:

    Annual fit testing provides the opportunity for employees to 
receive feedback on how well they are donning their respirator. TB 
droplet nuclei have no warning properties such as taste, odor, or 
irritation. Employees cannot detect if TB droplet nuclei leak into 
their respirators. Qualitative fit test challenge agents are 
detectable by odor, taste, or irritation and provide instant 
feedback as to how well the respirator fits and if the respirator 
was properly donned. Quantitative fit tests also provide instant 
feedback to employees through instrumentation. Employees need fit 
testing annually as part of training to ensure they don the 
respirators correctly so that the respirator properly seals to their 
face. Fit testing is one of the respirator program elements that is 
essential to ensure the respirators issued to employees provide the 
protection factor assigned to that particular class of respirator. 
(Ex. 17-920)

    (See also Exs. 17-455; 17-591; 17-717; 18-53; 183-7).
    Some commenters who supported the concept of periodic fit testing 
suggested varying time intervals for that testing, either more or less 
frequent than annually. (Exs. 150-16; 150-55; 150-124; 54-290.) NIOSH, 
in addition to its support for applying all of the provisions of the 
revised Sec.  1910.134 to TB exposures, also supported periodic fit 
testing for those exposures. (Exs. 18-60A; 189-36.) NIOSH suggested 
that, in the absence of TB-specific data on the appropriate fit testing 
interval, the ``record for and the provisions of 29 CFR 1910.134 
[would] be the best guide.'' (Ex. 18-60A.)
    It should also be noted that the annual fit testing requirement of 
the revised respiratory protection standard was specifically challenged 
in court, and was upheld. The court concluded that the requirement is 
supported by substantial evidence in the record, even though ``some 
evidence'' indicated that such frequent retesting might not be 
necessary. 182 F.3d at 1273.
    In summary, OSHA believes that the provisions of revised Sec.  
1910.134 represent the Agency's assessment of the best information 
available at the time that rule was issued to ensure that respiratory 
protection in the workplace is effective. In order to extend similar 
protection to workers exposed to TB in the workplace, OSHA will apply 
all of the provisions of Sec.  1910.134, including annual fit testing 
to TB exposures. Because of the current widespread adherence to Sec.  
1910.134, and the ongoing nationwide decline in active TB, the Agency 
believes the rulemaking records for both the revised respiratory 
protection standard and the proposed TB standard support such an 
approach to respiratory protection.

III. Summary of the Final Economic Analysis and Regulatory Flexibility 
Certification

Introduction

    By including TB-related respirator use in Section 134, OSHA is 
imposing some new requirements on employers who require their employees 
to use respirators for this purpose. However, this action is not a 
significant rulemaking under Executive Order 12866, or a ``major rule'' 
under the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501) or 
Section 801 of the Small Business Regulatory Enforcement Fairness Act 
of 1996 (5 U.S.C. 601). Even though this action does not meet any of 
the criteria for an economically significant or major rule specified by 
the Executive Order or relevant statutes, as shown in the remainder of 
this summary of the Final Economic Analysis and Regulatory Flexibility 
Certification, it was reviewed by OMB pursuant to E.O. 12866. (The full 
analysis this summary relies upon has been entered into the docket as 
Ex. 192.)

Affected Establishments

    The scope of this action is limited to establishments in the health 
services industry (SIC 80) that follow the CDC guidelines and provide 
respiratory protection for employees potentially exposed to 
tuberculosis. These

[[Page 75779]]

establishments are primarily hospitals. To the extent that patients 
with active tuberculosis may be treated in other health services 
facilities, such as those that may be affiliated with nursing homes, 
correctional facilities, or substance abuse treatment facilities, these 
may also be potentially affected by this action.
    An estimated 6,500 establishments are potentially affected by this 
action. The employees who would be covered are those using respirators 
for protection against occupational exposure to TB. Unfortunately, 
there are no data showing exactly how many persons use respirators for 
the purpose of protecting against occupational exposure to 
tuberculosis. For the purposes of this analysis, OSHA is using a BLS 
estimate of the number of persons using filtering face piece 
respirators in the health care sector. This results in an estimate of 
638,000 affected employees. Using this estimate overestimates the 
number of respirator users using respirators for occupational exposure 
to TB by including respirator users in unaffected sectors and by 
including employees using respirators for reasons other than 
occupational exposure to TB. However, the estimate may exclude some 
employees who should be using respirators for occupational exposure to 
TB and are not doing so.
    An estimated 5,312 of the potentially affected establishments are 
small entities. Small entities were identified in accordance with the 
definitions established by the Small Business Administration, as 
specified in the Regulatory Flexibility Act. These small entities 
employ approximately 457,000 of the employees potentially affected by 
this action.

Benefits

    The employees covered by this action are those using respirators 
for protection against potential occupational exposure to tuberculosis. 
The reduction in risk achieved through compliance with the requirements 
of this action will result in reductions in the numbers of infections, 
active disease cases, and fatalities occurring among the covered 
workers. Although the employees working in establishments covered by 
this action will be the primary beneficiaries of the increased 
protection provided by the standard, many other individuals will also 
benefit from the standard because tuberculosis is a communicable 
disease.
    For the final respirator program standard, OSHA concluded based on 
the best available evidence that from 5 to 50 percent of employees 
would lack a proper fit without annual fit testing. OSHA further 
concluded that overall, moving from full compliance with the old 
standard to full compliance with the new standard would reduce 
exposures by 27 percent on average across all employees covered by the 
respirator protection program. OSHA estimates that this action will 
have similar effects in reducing the number of infections, active 
disease cases, and fatalities occurring among the covered workers.

Technological Feasibility

    In accordance with the provisions of the OSH Act, OSHA has reviewed 
the requirements of this action and has assessed their technological 
feasibility. As a result of this review, OSHA has determined that 
fulfilling the resulting requirements of this action is technologically 
feasible.
    Compliance with the requirements of the action can be achieved with 
methods and measures that have already been developed and implemented 
in many establishments already under the respirator protection 
standard. As established in the final respiratory protection standard, 
the standard's provisions in the respirator program standard require 
only technology that is currently and readily available and widely in 
use. There is no barrier to applying these technologies in a health 
care setting. In fact, the requirements added by this action are 
already applicable to and have already been implemented in many of the 
affected health care establishments to the extent that any use of 
respirator protection is occurring for purposes other than protection 
from occupational exposure to tuberculosis.

Costs of Compliance

    When OSHA promulgated its final respiratory protection standard in 
1998, all potentially affected establishments and employees, including 
those in the health services industry and those using respirators only 
for protection from tuberculosis, were included in the analysis of the 
costs of compliance and potential impacts. This was done because of 
uncertainty as to the extent to which respirators were being used for 
protection against occupational exposure to tuberculosis. Thus, the 
conclusions and determinations regarding impacts and feasibility 
associated with the provisions of the standard for these establishments 
have already been established by the evidence in the record and other 
documents and decisions associated with the rulemaking. Nevertheless, 
the final economic analysis for this action analyzes the full economic 
impacts of this action alone. Using the estimate of the number of 
respirator users provided by BLS, which probably overestimates the 
number of affected employees, the total annualized estimated costs for 
this action are $11.7 million, as shown in Table 1. The largest 
component of the costs is comprised of the requirements associated with 
employee fit-testing and training (which OSHA assumes will be done at 
the same time), which account for about 92 percent of the total costs, 
or $10.7 million. Costs associated with revising respirator programs 
and with the recordkeeping requirements have an estimated annualized 
cost of about $1 million. Given these costs, this action is not an 
economically significant rule with respect to E0 12866.

   Table 1.--Compliance Costs Associated With Revised Requirements For
                         Respiratory Protection
------------------------------------------------------------------------
                                                           Annualized
                     Type of cost                      incremental costs
------------------------------------------------------------------------
Respirator Program...................................           $325,000
Fit Testing And Training.............................         10,716,719
Recordkeeping........................................            638,000
                                                      ------------------
    Total............................................         11,679,719
------------------------------------------------------------------------

Economic Feasibility

    In order to assess the nature and magnitude of economic impacts, 
OSHA compares the estimated costs of compliance to industry revenues 
and profits. The estimated compliance costs represent less than 0.005 
percent of the revenues of the affected establishments in the hospital 
sector. The estimated compliance costs also represent about 0.08 
percent of profits among affected for-profit establishments. For these 
establishments, the costs of compliance with the OSHA action would also 
be economically feasible. The affected establishments face more 
significant increases in costs or reductions in revenues on a 
continuing basis, through changes in rent, labor costs, utility costs, 
and costs of other resources purchased, through changes in levels of 
donations and contributions provided, and through changes in government 
funding levels. Even if such costs cannot be passed on to consumers, 
changes in revenues or profits of this magnitude will not threaten the 
existence or competitive structure of an industry [the test for 
economic feasibility stated in United Steelworkers of America v. 
Marshall, 647 F.2d 1189, 1272 (D.C. Circuit 1980)].

Regulatory Flexibility Screening Analysis

    OSHA also analyzed the potential economic impacts of this action on

[[Page 75780]]

small entities (as defined in accordance with SBA criteria) and on very 
small establishments (those with fewer than 20 employees). For small 
entities as defined by SBA criteria, the costs represent 0.008 percent 
of revenues and 0.21 percent of profits (for those entities which are 
not nonprofits). For small entities with fewer than 20 employees, the 
cost also represents 0.008 percent of revenues and 0.21 percent of 
profits (for those entities which are not nonprofits). OSHA's 
Procedures define a significant impact as one in which the costs exceed 
1 percent of revenues or 5 percent of profits. OSHA therefore certifies 
that this final regulation will not have a significant impact on a 
substantial number of small entities.

Unfunded Mandates Analysis

    OSHA reviewed this action according to the Unfunded Mandates Reform 
Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.) and Executive Order 12875. 
As discussed above in the Final Economic Analysis and Regulatory 
Flexibility Certification of this preamble, the Agency has determined 
that this action imposes less than $100 million in costs in any given 
year on either private or public sector entities. As a result, this is 
not a major rule under UMRA. OSHA standards do not apply to state and 
local governments, except in states that have voluntarily elected to 
adopt a State Plan approved by the Agency. Consequently, this action 
does not meet the definition of a ``Federal intergovernmental mandate'' 
(see section 421(5) of the UMRA (2 U.S.C. 658(5))). In conclusion, this 
action does not mandate that state, local, and tribal governments adopt 
new, unfunded regulatory obligations.

Paperwork Review

    The paperwork burdens for this action were included in the final 
standard on Respiratory Protection, published January 8, 1998 (63 FR 
1152). The OMB control number is 1218-0019.

Environmental Impacts

    The provisions of this action 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 
determined that this action will have no significant adverse effect on 
air, water, or soil quality, plant or animal life, use of land, or 
other aspects of the environment.

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.

0
For the reasons set forth in the preamble, 29 CFR part 1910, Subpart I 
is amended as follows:

PART 1910--[AMENDED]

0
1. The authority citation for Subpart I of part 1910 is revised to read 
as follows:

    Authority: Sections 4, 6 and 8, Occupational Safety Act of 1970 
(29 U.S.C. 653, 655, 657); Secretary of Labor's Order 12-71 (36 FR 
8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-
96 (62 FR 111), or 5-2002 (67 FR 65008), as applicable. Sections 
1910.132, 1910.134, and 1910.138 also issued under 29 CFR part 1911. 
Sections 1910.133, 1910.135, and 1910.136 also issued under 20 CFR 
part 1911 and 5 U.S.C. 553.


Sec.  1910.139  [Removed]

0
2. Section 1910.139 is removed.

[FR Doc. 03-31846 Filed 12-30-03; 8:45 am]
BILLING CODE 4510-26-P