[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26600-26610]
[FR Doc No: 2023-09118]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2023-0004]

Traylor Bros., Inc.; Application for Modification of Permanent
Variance and Interim Order; Grant of Interim Order

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

ACTION: Notice; request for comments.

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SUMMARY: In this notice, OSHA announces an application for modification
of a permanent variance and for an interim order submitted by Traylor
Bros., Inc. (Traylor). The application seeks to modify a permanent
variance relating to work in compressed-air environments previously
granted to Traylor to add Traylor-Sundt Joint Venture (SUNDTJV) as an
additional employer and to add the Integrated Pipeline Tunnel Project.
Traylor also requests an interim order to be effective until OSHA
issues a final decision on the application. This notice presents the
agency's preliminary findings on Traylor's application and announces
the granting of an interim order. OSHA invites the public to submit
comments on the variance modification application to assist the agency
in determining whether to grant the applicant a modified permanent
variance based on the conditions specified in this application.

DATES: Submit comments, information, documents in response to this
notice, and request for a hearing on or before May 31, 2023. The
Interim Order described in this notice will become effective on May 1,
2023, and shall remain in effect until the completion of the Integrated
Pipeline Tunnel Project, the interim order is modified or revoked, or
OSHA makes a final decision on the application for a modified permanent
variance.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at: http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Instructions: All submissions must include the agency name and OSHA
docket number (OSHA-2023-0004). All comments, including any personal
information you provide, are placed in the public docket without
change, and may be made available online at http://www.regulations.gov.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office. All
documents in the docket (including this Federal Register notice) are
listed in the http://www.regulations.gov index; however, some
information (e.g., copyrighted material) is not publicly available to
read or download through the website. All submissions, including
copyrighted material, are available for inspection at the OSHA Docket
Office. Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY (877)
889-5627) for assistance in locating docket submissions.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor; telephone:
(202) 693-2110; email: [email protected].
    Copies of this Federal Register notice: Electronic copies of this
Federal Register notice are available at http://www.regulations.gov.
This Federal Register notice, as well as news releases and other
relevant information, also are available at OSHA's web page at http://www.osha.gov.
    Hearing Requests: According to 29 CFR 1905.15, hearing requests
must include: (1) a concise statement of facts detailing how the
proposed variance modification would affect the requesting party; (2) a
specification of any statement or representation in the variance
application that the commenter denies, and a concise summary of the
evidence offered in support of each denial; and (3) any views or
arguments on any issue of fact or law presented in the variance
application.

SUPPLEMENTARY INFORMATION:

I. Notice of Application

    This notice addresses Traylor's application by letter dated April
20, 2022, to modify the permanent variance granted to Traylor on March
11, 2016 (2016 Variance) (81 FR 12954), to include an additional
employer, the

Traylor-Sundt Joint Venture (SUNDTJV), which is a joint venture made up
of two construction companies, Traylor and Sundt Construction, Inc.
(Sundt). Traylor also requested an interim order while OSHA evaluates
the application (OSHA-2023-0004-0002). Because the joint venture
includes an additional employer not covered by the 2016 Variance, OSHA
will evaluate SUNDTJV's modification request as an application for a
new permanent variance.
    SUNDTJV was awarded the tunneling contract for the Integrated
Pipeline Tunnel Project in Dallas, Texas (OSHA-2023-0004-0001). The
Integrated Pipeline Tunnel Project includes two tunnels, the Cedar
Creek Tunnel, and the Hollywood Lake Tunnel, which require two separate
tunnel drives. This notice covers the Integrated Pipeline Tunnel
Project only and is not applicable to future tunneling projects by
Traylor, Sundt, or SUNDTJV.
    Specifically, this notice addresses the application by Traylor (the
applicant) for a permanent variance and interim order from the
provisions of the standard governing compressed air work that: (1)
prohibit compressed-air worker exposure to pressures exceeding 50
pounds per square inch (p.s.i.) except in an emergency (29 CFR
1926.803(e)(5)); \1\ (2) require the use of the decompression values
specified in decompression tables in Appendix A of the compressed-air
standard for construction (29 CFR 1926.803(f)(1)); and (3) require the
use of automated operational controls and a special decompression
chamber (29 CFR 1926.803(g)(1)(iii) and .803(g)(1)(xvii),
respectively).
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    \1\ The decompression tables in Appendix A of subpart S express
the maximum working pressures as pounds per square inch gauge
(p.s.i.g.), with a maximum working pressure of 50 p.s.i.g.
Therefore, throughout this notice, OSHA expresses the 50 p.s.i.
value specified by 29 CFR 1926.803(e)(5) as 50 p.s.i.g., consistent
with the terminology in Appendix A, Table 1 of subpart S.
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    OSHA has previously approved nearly identical provisions when
granting several other very similar variances, as discussed in more
detail in section II. OSHA preliminarily concludes that the variance is
appropriate, grants an interim order temporarily allowing the proposed
activity, and seeks comment on the variance application.

A. Background

    The variance application seeks a permanent variance for Traylor-
Sundt Joint Venture (SUNDTJV)'s work on the Integrated Pipeline Tunnel
Project. SUNDTJV is a contractor that works on complex tunnel projects
using innovations in tunnel-excavation methods. SUNDTJV's workers
engage in the construction of tunnels using advanced shielded
mechanical excavation techniques in conjunction with an earth pressure
balance tunnel boring machine (TBM). Using shielded mechanical
excavation techniques, in conjunction with precast concrete tunnel
liners and backfill grout, TBMs provide methods to achieve the face
pressures required to maintain a stabilized tunnel face through various
geologies and isolate that pressure to the forward section (the working
chamber) of the TBM.
    SUNDTJV asserts that it bores tunnels using TBM at levels below the
water table through soft soils consisting of clay, silt, and sand. TBMs
are capable of maintaining pressure at the tunnel face, and stabilizing
existing geological conditions, through the controlled use of a
mechanically driven cutter head, bulkheads within the shield, ground-
treatment foam, and a screw conveyor that moves excavated material from
the working chamber. The forward-most portion of the TBM is the working
chamber, and this chamber is the only pressurized segment of the TBM.
Within the shield, the working chamber consists of two sections: the
forward working chamber and the staging chamber. The forward working
chamber is immediately behind the cutter head and tunnel face. The
staging chamber is behind the forward working chamber and between the
man-lock door and the entry door to the forward working chamber.
    The TBM has twin man-locks located between the pressurized working
chamber and the non-pressurized portion of the machine. Each man-lock
has two compartments. This configuration allows workers to access the
man-locks for compression and decompression, and medical personnel to
access the man-locks if required in an emergency.
    SUNDTJV's Hyperbaric Operations Manual (HOM) for the Integrated
Pipeline Tunnel Project (OSHA-2023-0004-0003) indicates that the
maximum pressure to which it is likely to expose workers during project
interventions for the two tunnel drives (Cedar Creek Tunnel and
Hollywood Lake Tunnel) associated with the Integrated Pipeline Tunnel
Project is 58 p.s.i. Therefore, to work effectively, SUNDTJV must
perform hyperbaric interventions in compressed air at pressures nearly
15% higher than the maximum pressure specified by the existing OSHA
standard, 29 CFR 1926.803(e)(5), which states: ``No employee shall be
subjected to pressure exceeding 50 pounds per square inch except in
emergency'' (see footnote 1).
    SUNDTJV employs specially trained personnel for the construction of
the tunnel. To keep the machinery working effectively, SUNDTJV asserts
that these workers must periodically enter the excavation working
chamber of the TBM to perform hyperbaric interventions during which
workers would be exposed to air pressures up to 58 p.s.i., which
exceeds the maximum pressure specified by the existing OSHA standard at
29 CFR 1926.803(e)(5). These interventions consist of conducting
inspections or maintenance work on the cutter-head structure and
cutting tools of the TBM, such as changing replaceable cutting tools
and disposable wear bars, and, in rare cases, repairing structural
damage to the cutter head. These interventions are the only time that
workers are exposed to compressed air. Interventions in the working
chamber (the pressurized portion of the TBM) take place only after
halting tunnel excavation and preparing the machine and crew for an
intervention.
    During interventions, workers enter the working chamber through one
of the twin man-locks that open into the staging chamber. To reach the
forward part of the working chamber, workers pass through a door in a
bulkhead that separates the staging chamber from the forward working
chamber. The man-locks and the working chamber are designed to
accommodate three people, which is the maximum crew size allowed under
the proposed variance. When the required decompression times are
greater than work times, the twin man-locks allow for crew rotation.
During crew rotation, one crew can be compressing or decompressing
while the second crew is working. Therefore, the working crew always
has an unoccupied man-lock at its disposal.
    SUNDTJV asserts that these innovations in tunnel excavation have
greatly reduced worker exposure to hazards of pressurized air work
because they have eliminated the need to pressurize the entire tunnel
for the project and would thereby reduce the number of workers exposed,
as well as the total duration of exposure, to hyperbaric pressure
during tunnel construction. These advances in technology substantially
modified the methods used by the construction industry to excavate
subaqueous tunnels compared to caisson work.
    In addition to the reduced exposures resulting from the innovations
in tunnel-excavation methods, SUNDTJV asserts that innovations in
hyperbaric medicine and technology improve the

safety of decompression from hyperbaric exposures. These procedures,
however, would deviate from the decompression process that OSHA
requires for construction in 29 CFR 1926.803(e)(5) and (f)(1) and the
decompression tables in Appendix A of 29 CFR 1926, subpart S.
Nevertheless, according to SUNDTJV, their use of decompression
protocols incorporating oxygen is more efficient, effective, and safer
for tunnel workers than compliance with the decompression tables
specified by the existing OSHA standard.
    SUNDTJV therefore believes its workers will be at least as safe
under its proposed alternatives as they would be under OSHA's standard
because of the reduction in number of workers and duration of
hyperbaric exposures, better application of hyperbaric medicine, and
the development of a project-specific HOM that requires specialized
medical support and hyperbaric supervision to provide assistance to a
team of specially trained man-lock attendants and hyperbaric or
compressed-air workers (CAWs).
    Based on an initial review of the application for a permanent
variance and interim order for the construction of the Integrated
Pipeline Tunnel Project in Dallas, Texas, OSHA has preliminarily
determined that Traylor has proposed an alternative that would provide
a workplace at least as safe and healthful as that provided by the
standard.

II. The Variance Application

    Pursuant to the requirements of OSHA's variance regulations (29 CFR
part 1905), the applicant has certified that it notified its workers
\2\ of the variance modification application and request for interim
order by posting, at prominent locations where it normally posts
workplace notices, a summary of the application and information
specifying where the workers can examine a copy of the application.
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    \2\ See the definition of ``Affected employee or worker'' in
section V.D of this notice.
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A. OSHA History of Approval of Nearly Identical Variance Requests

    OSHA has previously approved several nearly identical variances
involving the same types of tunneling equipment used for similar
projects (tunnel construction variances). OSHA notes that it granted
seven subaqueous tunnel construction permanent variances from the same
provisions of OSHA's compressed-air standard (29 CFR 1926.803(e)(5),
(f)(1), (g)(1)(iii), and (g)(1)(xvii)) that are the subject of the
present application: (1) Impregilo, Healy, Parsons, Joint Venture (IHP
JV) for the completion of the Anacostia River Tunnel in Washington, DC
(80 FR 50652, August 20, 2015); (2) Traylor JV for the completion of
the Blue Plains Tunnel in Washington, DC (80 FR 16440, March 27, 2015);
(3) Tully/OHL USA Joint Venture for the completion of the New York
Economic Development Corporation's New York Siphon Tunnel project (79
FR 29809, May 23, 2014); (4) Salini-Impregilo/Healy Joint Venture for
the completion of the Northeast Boundary Tunnel in Washington, DC (85
FR 27767, May 11, 2020); (5) Traylor-Shea Joint Venture for the
completion of the Alexandria RiverRenew Tunnel Project in Alexandria,
Virginia and Washington, DC (88 FR 15090, March 10, 2023); and (6)
McNally/Kiewit Joint Venture for the completion of the Shoreline
Storage Tunnel Project in Cleveland, Ohio (88 FR 15080, September 25,
2022). OSHA also granted an interim order to Ballard Marine for the
Suffolk County Outfall Tunnel project in West Babylon, New York (86 FR
5253, January 19, 2021). The proposed alternate conditions in this
notice are nearly identical to the alternate conditions of the previous
permanent variances. OSHA is not aware of any injuries or other safety
issues that arose from work performed under these conditions in
accordance with the previous variances.

B. Variance From Paragraph (e)(5) of 29 CFR 1926.803, Prohibition of
Exposure to Pressure Greater Than 50 p.s.i.

    The applicant states that it may perform hyperbaric interventions
at pressures up to 58 p.s.i. in the working chamber of the TBM; this
pressure exceeds the pressure limit of 50 p.s.i. specified for
nonemergency purposes by 29 CFR 1926.803(e)(5). The TBM has twin man-
locks, with each man-lock having two compartments. This configuration
allows workers to access the man-locks for compression and
decompression, and medical personnel to access the man-locks if
required in an emergency.
    TBMs are capable of maintaining pressure at the tunnel face, and
stabilizing existing geological conditions, through the controlled use
of a mechanically driven cutter head, bulkheads within the shield,
ground-treatment foam, and a screw conveyor that moves excavated
material from the working chamber. As noted earlier, the forward-most
portion of the TBM is the working chamber, and this chamber is the only
pressurized segment of the TBM. Within the shield, the working chamber
consists of two sections: the staging chamber and the forward working
chamber. The staging chamber is the section of the working chamber
between the man-lock door and the entry door to the forward working
chamber. The forward working chamber is immediately behind the cutter
head and tunnel face.
    SUNDTJV will pressurize the working chamber to the level required
to maintain a stable tunnel face. Pressure in the staging chamber
ranges from atmospheric (no increased pressure) to a maximum pressure
equal to the pressure in the working chamber. The applicant asserts
that they may have to perform interventions at pressures up to 58
p.s.i.
    During interventions, workers enter the working chamber through one
of the twin man-locks that open into the staging chamber. To reach the
forward part of the working chamber, workers pass through a door in a
bulkhead that separates the staging chamber from the forward working
chamber. The maximum crew size allowed in the forward working chamber
is three. At certain hyperbaric pressures (i.e., when decompression
times are greater than work times), the twin man-locks allow for crew
rotation. During crew rotation, one crew can be compressing or
decompressing while the second crew is working. Therefore, the working
crew always has an unoccupied man-lock at its disposal.
    Further, the applicant has developed a project-specific HOM (OSHA-
2023-0004-0003) that describes in detail the hyperbaric procedures, the
required medical examination used during the tunnel-construction
project, the standard operating procedures and the emergency and
contingency procedures. The procedures include using experienced and
knowledgeable man-lock attendants who have the training and experience
necessary to recognize and treat decompression illnesses and injuries.
The attendants are under the direct supervision of the hyperbaric
supervisor (competent person experienced and trained in hyperbaric
operations, procedures and safety) and attending physician. In
addition, procedures include medical screening and review of
prospective CAWs. The purpose of this screening procedure is to vet
prospective CAWs with medical conditions (e.g., deep vein thrombosis,
poor vascular circulation, and muscle cramping) that could be
aggravated by sitting in a cramped space (e.g., a man-lock) for
extended periods or by exposure to elevated pressures and compressed
gas mixtures. A transportable recompression chamber (shuttle) is
available to extract workers from the hyperbaric working chamber

for emergency evacuation and medical treatment; the shuttle attaches to
the topside medical lock, which is a large recompression chamber. The
applicant believes that the procedures included in the HOM provide safe
work conditions when interventions are necessary, including
interventions above 50 p.s.i. or 50 p.s.i.g.
    OSHA comprehensively reviewed the project-specific HOM and
determined that the safety and health instructions and measures it
specifies are appropriate and adequately protect the safety and health
of the CAWs.

C. Variance From Paragraph (f)(1) of 29 CFR 1926.803, Requirement To
Use OSHA Decompression Tables

    OSHA's compressed-air standard for construction requires
decompression in accordance with the decompression tables in Appendix A
of 29 CFR 1926, subpart S (see 29 CFR 1926.803(f)(1)). As an
alternative to the OSHA decompression tables, the applicant proposes to
use newer decompression schedules (the 1992 French Decompression
Tables) that rely on staged decompression and supplement breathing air
used during decompression with air or oxygen (as appropriate).\3\ The
applicant asserts decompression protocols using the 1992 French
Decompression Tables for air or oxygen as specified by the Integrated
Pipeline Tunnel Project-specific HOM are safer for tunnel workers than
the decompression protocols specified in Appendix A of 29 CFR 1926,
subpart S. Accordingly, the applicant would commit to following the
decompression procedures described in that HOM, which would require it
to follow the 1992 French Decompression Tables to decompress CAWs after
they exit the hyperbaric conditions in the working chamber.
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    \3\ In 1992, the French Ministry of Labour replaced the 1974
French Decompression Tables with the 1992 French Decompression
Tables, which differ from OSHA's decompression tables in Appendix A
by using: (1) staged decompression as opposed to continuous (linear)
decompression; (2) decompression tables based on air or both air and
pure oxygen; and (3) emergency tables when unexpected exposure times
occur (up to 30 minutes above the maximum allowed working time).
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    Depending on the maximum working pressure and exposure times, the
1992 French Decompression Tables provide for air decompression with or
without oxygen. Traylor asserts that oxygen decompression has many
benefits, including (1) keeping the partial pressure of nitrogen in the
lungs as low as possible; (2) keeping external pressure as low as
possible to reduce the formation of bubbles in the blood; (3) removing
nitrogen from the lungs and arterial blood and increasing the rate of
nitrogen elimination; (4) improving the quality of breathing during
decompression stops so that workers are less tired and to prevent bone
necrosis; (5) reducing decompression time by about 33 percent as
compared to air decompression; and (6) reducing inflammation.
    In addition, the project-specific HOM requires a physician
certified in hyperbaric medicine, to manage the medical condition of
CAWs during hyperbaric exposures and decompression. A trained and
experienced man-lock attendant is also required to be present during
hyperbaric exposures and decompression. This man-lock attendant is to
operate the hyperbaric system to ensure compliance with the specified
decompression table. A hyperbaric supervisor, who is trained in
hyperbaric operations, procedures, and safety, directly oversees all
hyperbaric interventions and ensures that staff follow the procedures
delineated in the HOM or by the attending physician.

D. Variance From Paragraph (g)(1)(iii) of 29 CFR 1926.803,
Automatically Regulated Continuous Decompression

    The applicant is applying for a permanent variance from the OSHA
standard at 29 CFR 1926.803(g)(1)(iii), which requires automatic
controls to regulate decompression. As noted above, the applicant is
committed to conducting the staged decompression according to the 1992
French Decompression Tables under the direct control of the trained
man-lock attendant and under the oversight of the hyperbaric
supervisor.
    Breathing air under hyperbaric conditions increases the amount of
nitrogen gas dissolved in a CAW's tissues. The greater the hyperbaric
pressure under these conditions and the more time spent under the
increased pressure, the greater the amount of nitrogen gas dissolved in
the tissues. When the pressure decreases during decompression, tissues
release the dissolved nitrogen gas into the blood system, which then
carries the nitrogen gas to the lungs for elimination through
exhalation. Releasing hyperbaric pressure too rapidly during
decompression can increase the size of the bubbles formed by nitrogen
gas in the blood system, resulting in decompression illness (DCI),
commonly referred to as ``the bends.'' This description of the etiology
of DCI is consistent with current scientific theory and research on the
issue.
    The 1992 French Decompression Tables proposed for use by the
applicant provide for stops during worker decompression (i.e., staged
decompression) to control the release of nitrogen gas from tissues into
the blood system. Studies show that staged decompression, in
combination with other features of the 1992 French Decompression Tables
such as the use of oxygen, result in a lower incidence of DCI than the
use of automatically regulated continuous decompression.\4\ In
addition, the applicant asserts that staged decompression administered
in accordance with its HOM is at least as effective as an automatic
controller in regulating the decompression process because the HOM
includes a hyperbaric supervisor who directly supervises all hyperbaric
interventions and ensures that the man-lock attendant, who is a
competent person in the manual control of hyperbaric systems, follows
the schedule specified in the decompression tables, including stops.
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    \4\ See, e.g., Dr. Eric Kindwall, EP (1997), Compressed air
tunneling and caisson work decompression procedures: development,
problems, and solutions. Undersea and Hyperbaric Medicine, 24(4),
pp. 337-345. This article reported 60 treated cases of DCI among
4,168 exposures between 19 and 31 p.s.i.g. over a 51-week contract
period, for a DCI incidence of 1.44% for the decompression tables
specified by the OSHA standard. Dr. Kindwall notes that the use of
automatically regulated continuous decompression in the Washington
State safety standards for compressed-air work (from which OSHA
derived its decompression tables) was at the insistence of
contractors and the union, and against the advice of the expert who
calculated the decompression table and recommended using staged
decompression. Dr. Kindwall then states, ``Continuous decompression
is inefficient and wasteful. For example, if the last stage from 4
p.s.i.g. . . . to the surface took 1h, at least half the time is
spent at pressures less than 2 p.s.i.g. . . ., which provides less
and less meaningful bubble suppression. . . .'' In addition, Dr.
Kindwall addresses the continuous-decompression protocol in the OSHA
compressed-air standard for construction, noting that ``[a]side from
the tables for saturation diving to deep depths, no other widely
used or officially approved diving decompression tables use straight
line, continuous decompressions at varying rates. Stage
decompression is usually the rule, since it is simpler to control.''
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E. Variance From Paragraph (g)(1)(xvii) of 29 CFR 1926.803, Requirement
of Special Decompression Chamber

    The OSHA compressed-air standard for construction requires
employers to use a special decompression chamber of sufficient size to
accommodate all CAWs being decompressed at the end of the shift when
total decompression time exceeds 75 minutes (see 29 CFR
1926.803(g)(1)(xvii)). Use of the special decompression chamber enables
CAWs to move about and flex their joints to prevent neuromuscular
problems during decompression.
    Space limitations in the TBM do not allow for the installation and
use of an

additional special decompression lock or chamber. The applicant
proposes that it be permitted to rely on the man-locks and staging
chamber in lieu of adding a separate, special decompression chamber.
Because only a few workers out of the entire crew are exposed to
hyperbaric pressure, the man-locks (which, as noted earlier, connect
directly to the working chamber) and the staging chamber are of
sufficient size to accommodate all of the exposed workers during
decompression. The applicant uses the existing man-locks, each of which
adequately accommodates a three-member crew for this purpose when
decompression lasts up to 75 minutes. When decompression exceeds 75
minutes, crews can open the door connecting the two compartments in
each man-lock (during decompression stops) or exit the man-lock and
move into the staging chamber where additional space is available. The
applicant asserts that this alternative arrangement is as effective as
a special decompression chamber in that it has sufficient space for all
the CAWs at the end of a shift and enables the CAWs to move about and
flex their joints to prevent neuromuscular problems.

III. Agency Preliminary Determinations

    After reviewing the proposed alternatives, OSHA has preliminarily
determined that the applicant's proposed alternatives on the whole,
subject to the conditions in the request and imposed by this interim
order, provide measures that are as safe and healthful as those
required by the cited OSHA standards addressed in section II of this
notice.
    In addition, OSHA has preliminarily determined that each of the
following alternatives are at least as effective as the specified OSHA
requirements:

A. 29 CFR 1926.803(e)(5)

    SUNDTJV has developed, and proposed to implement, effective
alternative measures to the prohibition of using compressed air under
hyperbaric conditions exceeding 50 p.s.i. The proposed alternative
measures include use of engineering and administrative controls of the
hazards associated with work performed in compressed-air conditions
exceeding 50 p.s.i. while engaged in the construction of a subaqueous
tunnel using advance shielded mechanical-excavation techniques in
conjunction with the TBM. Prior to conducting interventions in the
TBM's pressurized working chamber, SUNDTJV halts tunnel excavation and
prepares the machine and crew to conduct the interventions.
Interventions involve inspection, maintenance, or repair of the
mechanical-excavation components located in the working chamber.

B. 29 CFR 1926.803(f)(1)

    SUNDJV has proposed to implement equally effective alternative
measures to the requirement in 29 CFR 1926.803(f)(1) for compliance
with OSHA's decompression tables. The project-specific HOM specifies
the procedures and personnel qualifications for performing work safely
during the compression and decompression phases of interventions. The
HOM also specifies the decompression tables the applicant proposes to
use (the 1992 French Decompression Tables). Depending on the maximum
working pressure and exposure times during the interventions, the
tables provide for decompression using air, pure oxygen, or a
combination of air and oxygen. The decompression tables also include
delays or stops for various time intervals at different pressure levels
during the transition to atmospheric pressure (i.e., staged
decompression). In all cases, a physician certified in hyperbaric
medicine will manage the medical condition of CAWs during
decompression. In addition, a trained and experienced man-lock
attendant, experienced in recognizing decompression sickness or
illnesses and injuries, will be present. Of key importance, a
hyperbaric supervisor, trained in hyperbaric operations, procedures,
and safety, will directly supervise all hyperbaric operations to ensure
compliance with the procedures delineated in the project-specific HOM
or by the attending physician.
    Prior to granting the seven previous permanent variances to IHP JV,
Traylor JV, Tully JV, Salini-Impregilo Joint Venture, Traylor-Shea JV
and McNally/Kiewit JV and Ballard, OSHA conducted a review of the
scientific literature and concluded that the alternative decompression
method (i.e., the 1992 French Decompression Tables) SUNDTJV proposed
would be at least as safe as the decompression tables specified by OSHA
when applied by trained medical personnel under the conditions that
would be imposed by the proposed variance.
    Some of the literature indicates that the alternative decompression
method may be safer, concluding that decompression performed in
accordance with these tables resulted in a lower occurrence of DCI than
decompression conducted in accordance with the decompression tables
specified by the standard. For example, H. L. Anderson studied the
occurrence of DCI at maximum hyperbaric pressures ranging from 4
p.s.i.g. to 43 p.s.i.g. during construction of the Great Belt Tunnel in
Denmark (1992-1996).\5\ This project used the 1992 French Decompression
Tables to decompress the workers during part of the construction.
Anderson observed 6 DCI cases out of 7,220 decompression events and
reported that switching to the 1992 French Decompression tables reduced
the DCI incidence to 0.08% compared to a previous incidence rate of
0.14%. The DCI incidence in the study by H. L. Andersen is
substantially less than the DCI incidence reported for the
decompression tables specified in Appendix A.
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    \5\ Anderson HL (2002). Decompression sickness during
construction of the Great Belt tunnel, Denmark. Undersea and
Hyperbaric Medicine, 29(3), pp. 172-188.
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    OSHA found no studies in which the DCI incidence reported for the
1992 French Decompression Tables were higher than the DCI incidence
reported for the OSHA decompression tables.\6\
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    \6\ Le P[eacute]chon JC, Barre P, Baud JP, Ollivier F (September
1996). Compressed air work--French Tables 1992--operational results.
JCLP Hyperbarie Paris, Centre Medical Subaquatique Interentreprise,
Marseille: Communication a l'EUBS, pp. 1-5 (see Ex. OSHA-2012-0036-
0005).
---------------------------------------------------------------------------

    OSHA's experience with the previous seven variances, which all
incorporated nearly identical decompression plans and did not result in
safety issues, also provide evidence that the alternative procedure as
a whole is at least as effective for this type of tunneling project as
compliance with OSHA's decompression tables. The experience of State
Plans \7\ that either granted variances (Nevada, Oregon and Washington)
\8\ or promulgated a new standard (California) \9\ for hyperbaric
exposures occurring during similar subaqueous tunnel-construction work,
provide additional evidence of the effectiveness of this alternative
procedure.
---------------------------------------------------------------------------

    \7\ Under section 18 of the OSH Act, Congress expressly provides
that States and U.S. territories may adopt, with Federal approval, a
plan for the development and enforcement of occupational safety and
health standards. OSHA refers to such States and territories as
``State Plan States'' Occupational safety and health standards
developed by State Plan States must be at least as effective in
providing safe and healthful employment and places of employment as
the Federal standards (29 U.S.C. 667).
    \8\ These state variances are available in the docket for the
2015 Traylor JV variance: Exs. OSHA-2012-0035-0006 (Nevada), OSHA-
2012-0035-0005 (Oregon), and OSHA-2012-0035-0004 (Washington).
    \9\ See California Code of Regulations, Title 8, Subchapter 7,
Group 26, Article 154, available at http://www.dir.ca.gov/title8/sb7g26a154.html.
---------------------------------------------------------------------------

C. 29 CFR 1926.803(g)(1)(iii)

    SUNDTJV developed, and proposed to implement, an equally effective

alternative to 29 CFR 1926.803(g)(1)(iii), which requires the use of
automatic controllers that continuously decrease pressure to achieve
decompression in accordance with the tables specified by the standard.
The applicant's alternative includes using the 1992 French
Decompression Tables for guiding staged decompression to achieve lower
occurrences of DCI, using a trained and competent attendant for
implementing appropriate hyperbaric entry and exit procedures, and
providing a competent hyperbaric supervisor and attending physician
certified in hyperbaric medicine to oversee all hyperbaric operations.
    In reaching this preliminary conclusion, OSHA again notes the
experience of previous nearly identical tunneling variances, the
experiences of State Plan States, and a review of the literature and
other information noted earlier.

D. 29 CFR 1926.803(g)(1)(xvii)

    SUNDTJV developed, and proposed to implement, an effective
alternative to the use of the special decompression chamber required by
29 CFR 1926.803(g)(1)(xvii). The TBM's man-lock and working chamber
appear to satisfy all of the conditions of the special decompression
chamber, including that they provide sufficient space for the maximum
crew of three CAWs to stand up and move around, and safely accommodate
decompression times up to 360 minutes. Therefore, again noting OSHA's
previous experience with nearly identical variances including the same
alternative, OSHA preliminarily determined that the TBM's man-lock and
working chamber function as effectively as the special decompression
chamber required by the standard.
    Pursuant to section 6(d) of the Occupational Safety and Health Act
of 1970 (29 U.S.C. 655), and based on the record discussed above, the
agency preliminarily finds that when the employer complies with the
conditions of the proposed modified variance, the working conditions of
the employer's workers would be at least as safe and healthful as if
the employer complied with the working conditions specified by
paragraphs (e)(5), (f)(1), (g)(1)(iii), and (g)(1)(xvii) of 29 CFR
1926.803.

IV. Grant of Interim Order, Proposal for Permanent Variance, and
Request for Comment

    OSHA hereby announces the preliminary decision to grant an interim
order to SUNDTJV for the Integrated Pipeline Tunnel Project in Dallas,
Texas. This interim order permits SUNDTJV's CAWs to perform
interventions in hyperbaric conditions not exceeding 58 p.s.i.g. during
the Integrated Pipeline Tunnel Project, subject to the conditions that
follow in this document. This interim order will remain in effect until
completion of the Integrated Pipeline Tunnel Project or until the
agency modifies or revokes the interim order or makes a final decision
on the application for a permanent variance. During the period starting
with the publication of this notice until completion of the Integrated
Pipeline Tunnel Project, or until the agency modifies or revokes the
interim order or makes a final decision on the application for a
permanent variance, SUNDTJV is required to comply fully with the
conditions of the interim order as an alternative to complying with the
following requirements of 29 CFR 1926.803 (hereafter, ``the standard'')
that:
    1. Prohibit exposure to pressure greater than 50 p.s.i. (29 CFR
1926.803(e)(5));
    2. Require the use of decompression values specified by the
decompression tables in Appendix A of the compressed-air standard (29
CFR 1926.803(f)(1));
    3. Require the use of automated operational controls (29 CFR
1926.803(g)(1)(iii)); and
    4. Require the use of a special decompression chamber (29 CFR
1926.803(g)(1)(xvii)).
    In order to avail itself of the interim order, SUNDTJV must: (1)
comply with the conditions listed in the interim order for the period
starting with the grant of the interim order and ending with SUNDTJV's
completion of the Integrated Pipeline Tunnel Project (or until the
agency modifies or revokes the interim order or makes a decision on its
application for a modified permanent variance); (2) comply fully with
all other applicable provisions of 29 CFR part 1926; and (3) provide a
copy of this Federal Register notice to all employees affected by the
proposed conditions, including the affected employees of other
employers, using the same means it used to inform these employees of
its application for a modified permanent variance.
    OSHA is also proposing that the same requirements (see above
section III, parts A through D) would apply to a permanent variance if
OSHA ultimately issues one for this project. OSHA requests comment on
those conditions as well as OSHA's preliminary determination that the
specified alternatives and conditions would provide a workplace as safe
and healthful as those required by the standard from which a variance
is sought. After reviewing comments, OSHA will publish in the Federal
Register the agency's final decision granting or denying a permanent
variance.

V. Description of the Specified Conditions of the Interim Order and the
Application for a Permanent Variance

    This section describes the alternative means of compliance with 29
CFR 1926.803(e)(5), (f)(1), (g)(1)(iii), and (g)(1)(xvii) and provides
additional detail regarding the proposed conditions that form the basis
of Traylor's application for an interim order and for a modified
permanent variance. The conditions are listed in section VI of this
notice. For brevity, the discussion that follows refers only to the
permanent variance, but the same conditions apply to the interim order.

Proposed Condition A: Scope

    The scope of the proposed permanent variance would limit coverage
to the work situations specified. Clearly defining the scope of the
proposed permanent variance provides Traylor, SUNDTJV's employees,
potential future applicants, other stakeholders, the public, and OSHA
with necessary information regarding the work situations in which the
proposed permanent variance would apply. To the extent that Traylor or
SUNDTJV exceeds the defined scope of this variance, it would be
required to comply with OSHA's standards.
    Pursuant to 29 CFR 1905.11, an employer (or class or group of
employers) \10\ may request a permanent variance for a specific
workplace or workplaces. If OSHA approves a permanent variance, it
would apply only to the specific employer(s) that submitted the
application and only to the specific workplace or workplaces designated
as part of the project. In this instance, if OSHA were to grant a
modified permanent variance, it would apply to only the applicant,
SUNDJV, and only the Integrated Pipeline Tunnel Project.
---------------------------------------------------------------------------

    \10\ A class or group of employers (such as members of a trade
alliance or association) may apply jointly for a variance provided
an authorized representative for each employer signs the application
and the application identifies each employer's affected facilities.
---------------------------------------------------------------------------

Proposed Condition B: Duration

    The interim order is only intended as a temporary measure pending
OSHA's decision on the permanent variance, so this condition specifies
the duration of the Order. If OSHA approves a permanent variance, it
would specify

the duration of the modified permanent variance as the remainder of the
Integrated Pipeline Tunnel Project.

Proposed Condition C: List of Abbreviations

    The proposed condition defines a number of abbreviations used in
the proposed modified permanent variance. OSHA believes that defining
these abbreviations serve to clarify and standardize their usage,
thereby enhancing the applicant's and its employees' understanding of
the conditions specified by the proposed permanent variance.

Proposed Condition D: Definitions

    The proposed condition defines a series of terms, mostly technical
terms, used in the proposed modified permanent variance to standardize
and clarify their meaning. OSHA believes that defining these terms
serves to enhance the applicant's and its employees' understanding of
the conditions specified by the proposed permanent variance.

Proposed Condition E: Safety and Health Practices

    This proposed condition requires the applicant to develop and
submit to OSHA a HOM specific to the Integrated Pipeline Tunnel Project
at least six months before using the TBM for tunneling operations. The
applicant must also submit, at least six months before using the TBM,
proof that the TBM's hyperbaric chambers have been designed,
fabricated, inspected, tested, marked, and stamped in accordance with
the requirements of ASME PVHO-1.2019 (or the most recent edition of
Safety Standards for Pressure Vessels for Human Occupancy). These
requirements ensure that the applicant develops hyperbaric safety and
health procedures suitable for the project.
    The submission of the HOM to OSHA, which SUNDTJV has already
completed, enables OSHA to determine whether the safety and health
instructions and measures it specifies are appropriate to the field
conditions of the tunnel (including expected geological conditions),
conform to the conditions of the variance, and adequately protect the
safety and health of the CAWs. It also facilitates OSHA's ability to
ensure that the applicant is complying with these instructions and
measures. The requirement for proof of compliance with ASME PVHO-1.2019
is intended to ensure that the equipment is structurally sound and
capable of performing to protect the safety of the employees exposed to
hyperbaric pressure.
    Additionally, the proposed condition includes a series of related
hazard prevention and control requirements and methods (e.g.,
decompression tables, job hazard analyses (JHA), operations and
inspections checklists, incident investigation, and recording and
notification to OSHA of recordable hyperbaric injuries and illnesses)
designed to ensure the continued effective functioning of the
hyperbaric equipment and operating system.

Proposed Condition F: Communication

    This proposed condition requires the applicant to develop and
implement an effective system of information sharing and communication.
Effective information sharing and communication are intended to ensure
that affected workers receive updated information regarding any safety-
related hazards and incidents, and corrective actions taken, prior to
the start of each shift. The proposed condition also requires the
applicant to ensure that reliable means of emergency communications are
available and maintained for affected workers and support personnel
during hyperbaric operations. Availability of such reliable means of
communications would enable affected workers and support personnel to
respond quickly and effectively to hazardous conditions or emergencies
that may develop during TBM operations.

Proposed Condition G: Worker Qualification and Training

    This proposed condition requires the applicant to develop and
implement an effective qualification and training program for affected
workers. The proposed condition specifies the factors that an affected
worker must know to perform safely during hyperbaric operations,
including how to enter, work in, and exit from hyperbaric conditions
under both normal and emergency conditions. Having well-trained and
qualified workers performing hyperbaric intervention work is intended
to ensure that they recognize, and respond appropriately to, hyperbaric
safety and health hazards. These qualification and training
requirements enable affected workers to cope effectively with
emergencies, as well as the discomfort and physiological effects of
hyperbaric exposure, thereby preventing worker injury, illness, and
fatalities.
    Paragraph (2)(e) of this proposed condition requires the applicant
to provide affected workers with information they can use to contact
the appropriate healthcare professionals if the workers believe they
are developing hyperbaric-related health effects. This requirement
provides for early intervention and treatment of DCI and other health
effects resulting from hyperbaric exposure, thereby reducing the
potential severity of these effects.

Proposed Condition H: Inspections, Tests, and Accident Prevention

    Proposed Condition H requires the applicant to develop, implement,
and operate a program of frequent and regular inspections of the TBM's
hyperbaric equipment and support systems, and associated work areas.
This condition would help to ensure the safe operation and physical
integrity of the equipment and work areas necessary to conduct
hyperbaric operations. The condition would also enhance worker safety
by reducing the risk of hyperbaric-related emergencies.
    Paragraph (3) of this proposed condition requires the applicant to
document tests, inspections, corrective actions, and repairs involving
the TBM, and maintain these documents at the jobsite for the duration
of the job. This requirement would provide the applicant with
information needed to schedule tests and inspections to ensure the
continued safe operation of the equipment and systems, and to determine
that the actions taken to correct defects in hyperbaric equipment and
systems were appropriate, prior to returning them to service.

Proposed Condition I: Compression and Decompression

    This proposed condition would require the applicant to consult with
the designated medical advisor regarding special compression or
decompression procedures appropriate for any unacclimated CAW and then
implement the procedures recommended by the medical consultant. This
proposed provision would ensure that the applicant consults with the
medical advisor, and involves the medical advisor in the evaluation,
development, and implementation of compression or decompression
protocols appropriate for any CAW requiring acclimation to the
hyperbaric conditions encountered during TBM operations. Accordingly,
CAWs requiring acclimation would have an opportunity to acclimate prior
to exposure to these hyperbaric conditions. OSHA believes this
condition would prevent or reduce adverse reactions among CAWs to the
effects of compression or decompression associated with the
intervention work they perform in the TBM.

Proposed Condition J: Recordkeeping

    Under OSHA's existing recordkeeping requirements in 29 CFR part
1904

regarding Recording and Reporting Occupational Injuries and Illnesses,
the employer must maintain a record of any recordable injury, illness,
or fatality (as defined by 29 CFR part 1904) resulting from exposure of
an employee to hyperbaric conditions by completing the OSHA Form 301
Incident Report and OSHA Form 300 Log of Work Related Injuries and
Illnesses. The applicant did not seek a variance from this standard and
therefore SUNDTJV must comply fully with those requirements.
    Examples of important information to include on the OSHA Form 301
Injury and Illness Incident Report (along with the corresponding
questions on the form) are:

Q14

     the task performed;
     the composition of the gas mixture (e.g., air or oxygen);
     an estimate of the CAW's workload;
     the maximum working pressure;
     temperature in the work and decompression environments;
     unusual occurrences, if any, during the task or
decompression

Q15

     time of symptom onset;
     duration between decompression and onset of symptoms

Q16

     type and duration of symptoms;
     a medical summary of the illness or injury

Q17

     duration of the hyperbaric intervention;
     possible contributing factors;
     the number of prior interventions completed by the injured
or ill CAW; and the pressure to which the CAW was exposed during those
interventions.\11\
---------------------------------------------------------------------------

    \11\ See 29 CFR 1904 Recording and Reporting Occupational
Injuries and Illnesses (http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9631); recordkeeping
forms and instructions (http://www.osha.gov/recordkeeping/RKform300pkg-fillable-enabled.pdf); and OSHA Recordkeeping Handbook
(http://www.osha.gov/recordkeeping/handbook/index.html).
---------------------------------------------------------------------------

    Proposed Condition J would add additional reporting
responsibilities, beyond those already required by the OSHA standard.
The applicant would be required to maintain records of specific factors
associated with each hyperbaric intervention. The information gathered
and recorded under this provision, in concert with the information
provided under proposed Condition K (using OSHA Form 301 Injury and
Illness Incident Report to investigate and record hyperbaric recordable
injuries as defined by 29 CFR 1904.4, 1904.7, 1904.8-1904.12), would
enable the applicant and OSHA to assess the effectiveness of the
permanent variance in preventing DCI and other hyperbaric-related
effects.

Proposed Condition K: Notifications

    Under the proposed condition, the applicant is required, within
specified periods of time, to notify OSHA of: (1) any recordable
injury, illness, in-patient hospitalization, amputation, loss of an
eye, or fatality that occurs as a result of hyperbaric exposures during
TBM operations within 8 hours; (2) provide OSHA a copy of the
hyperbaric exposures incident investigation report (using OSHA Form 301
Injury and Illness Incident Report) of these events within 24 hours of
the incident; (3) include on OSHA Form 301 Injury and Illness Incident
Report information on the hyperbaric conditions associated with the
recordable injury or illness, the root-cause determination, and
preventive and corrective actions identified and implemented; (4)
provide the certification along with the OSHA Form 310, that affected
workers were informed of the incident and the results of the incident
investigation; (5) notify OSHA's Office of Technical Programs and
Coordination Activities (OTPCA) and the OSHA Area Office in Dallas,
Texas within 15 working days should the applicant need to revise the
HOM to accommodate changes in its compressed-air operations that affect
SUNDTJV's ability to comply with the conditions of the proposed
modified permanent variance; and (6) provide OTPCA and the OSHA Area
Office in Dallas, Texas, at the end of the project, with a report
evaluating the effectiveness of the decompression tables within 30 days
of the completion of the Integrated Pipeline Tunnel Project.
    It should be noted that the requirement for completing and
submitting the hyperbaric exposure-related (recordable) incident
investigation report (OSHA 301 Injury and Illness Incident Report) is
more restrictive than the current recordkeeping requirement of
completing OSHA Form 301 Injury and Illness Incident Report within 7
calendar days of the incident (1904.29(b)(3)). This modified, more
stringent incident investigation and reporting requirement is
restricted to intervention-related hyperbaric (recordable) incidents
only. Providing rapid notification to OSHA is essential because time is
a critical element in OSHA's ability to determine the continued
effectiveness of the variance conditions in preventing hyperbaric
incidents, and the applicant's identification and implementation of
appropriate corrective and preventive actions.
    Further, these notification requirements also enable the applicant,
its employees, and OSHA to assess the effectiveness of the permanent
variance in providing the requisite level of safety to the applicant's
workers and, based on this assessment, whether to revise or revoke the
conditions of the proposed permanent variance. Timely notification
permits OSHA to take whatever action may be necessary and appropriate
to prevent possible further injuries and illnesses. Providing
notification to employees informs them of the precautions taken by the
applicant to prevent similar incidents in the future.
    Additionally, this proposed condition requires the applicant to
notify OSHA no later than seven (7) days of having knowledge that it
will cease to do business, have a new address or location for the main
office, or transfer the operations covered by the proposed permanent
variance to a successor company. In addition, the condition specifies
that the transfer of the permanent variance to a successor company must
be approved by OSHA. These requirements allow OSHA to communicate
effectively with the applicant regarding the status of the proposed
permanent variance, and expedite the agency's administration and
enforcement of the permanent variance. Stipulating that an applicant is
required to have OSHA's approval to transfer a variance to a successor
company provides assurance that the successor company has knowledge of,
and will comply with, the conditions specified by the proposed
permanent variance, thereby ensuring the safety of workers involved in
performing the operations covered by the proposed permanent variance.

VI. Specific Conditions of the Interim Order and the Proposed Permanent
Variance

    The following conditions apply to the interim order OSHA is
granting to SUNDTJV for the Integrated Pipeline Tunnel Project. These
conditions specify the alternative means of compliance with the
requirements of paragraphs 29 CFR 1926.803(e)(5), (f)(1), (g)(1)(iii),
and (g)(1)(xvii). In addition, these conditions are specific to the
alternative means of compliance with these requirements that OSHA is
proposing for SUNDTJV's permanent variance. To simplify the
presentation of the conditions, OSHA generally refers only to the
conditions of the proposed permanent variance, but the same

conditions apply to the interim order except where otherwise noted.\12\
---------------------------------------------------------------------------

    \12\ In these conditions, OSHA is using the future conditional
form of the verb (e.g., ``would''), which pertains to the
application for a permanent variance (designated as ``Permanent
Variance'') but the conditions are mandatory for purposes of the
interim order.
---------------------------------------------------------------------------

    The conditions would apply with respect to all employees of SUNDTJV
exposed to hyperbaric conditions. These conditions are outlined in this
section:

A. Scope

    The interim order applies, and the permanent variance would apply,
only when SUNDTJV stops the tunnel-boring work, pressurizes the working
chamber, and the CAWs either enter the working chamber to perform an
intervention (i.e., inspect, maintain, or repair the mechanical-
excavation components), or exit the working chamber after performing
interventions.
    The interim order and proposed permanent variance apply only to
work:
    1. That occurs in conjunction with construction of the Integrated
Pipeline Tunnel Project, a tunnel constructed using advanced shielded
mechanical-excavation techniques and involving operation of an TBM;
    2. In the TBM's forward section (the working chamber) and
associated hyperbaric chambers used to pressurize and decompress
employees entering and exiting the working chamber; and
    3. Performed in compliance with all applicable provisions of 29 CFR
part 1926 except for the requirements specified by 29 CFR
1926.803(e)(5), (f)(1), (g)(1)(iii), and (g)(1)(xvii).

B. Duration

    The interim order granted to Traylor will remain in effect until
SUNDTJV completes the Integrated Pipeline Tunnel Project, OSHA modifies
or revokes this interim order, or OSHA grants Traylor's request for a
permanent variance. The proposed permanent variance, if granted, would
remain in effect until the completion of SUNDTJV's Integrated Pipeline
Tunnel Project or until modified or revoked by OSHA pursuant to 29 CFR
1905.13(a)(2).

C. List of Abbreviations

    Abbreviations used throughout this proposed permanent variance
would include the following:

1. CAW--Compressed-air worker
2. CFR--Code of Federal Regulations
3. DCI--Decompression Illness
4. DMT--Diver Medical Technician
5. TBM--Earth Pressure Balanced Tunnel Boring Machine
6. HOM--Hyperbaric Operations Manual
7. JHA--Job hazard analysis
8. OSHA--Occupational Safety and Health Administration
9. OTPCA--Office of Technical Programs and Coordination Activities

D. Definitions

    The following definitions would apply to this proposed permanent
variance. These definitions would supplement the definitions in
SUNDTJV's project-specific HOM.
    1. Affected employee or worker--an employee or worker who is
affected by the conditions of this proposed modified permanent
variance, or any one of his or her authorized representatives. The term
``employee'' has the meaning defined and used under the Occupational
Safety and Health Act of 1970 (29 U.S.C. 651 et seq.).
    2. Atmospheric pressure--the pressure of air at sea level,
generally 14.7 pounds per square inch absolute (p.s.i.a)., 1 atmosphere
absolute, or 0 p.s.i.g.
    3. Compressed-air worker--an individual who is specially trained
and medically qualified to perform work in a pressurized environment
while breathing air at pressures not exceeding 58 p.s.i.g.
    4. Competent person--an individual who is capable of identifying
existing and predictable hazards in the surroundings or working
conditions that are unsanitary, hazardous, or dangerous to employees,
and who has authorization to take prompt corrective measures to
eliminate them.\13\
---------------------------------------------------------------------------

    \13\ Adapted from 29 CFR 1926.32(f).
---------------------------------------------------------------------------

    5. Decompression illness--an illness (also called decompression
sickness or ``the bends'') caused by gas bubbles appearing in body
compartments due to a reduction in ambient pressure. Examples of
symptoms of decompression illness include, but are not limited to:
joint pain (also known as the ``bends'' for agonizing pain or the
``niggles'' for slight pain); areas of bone destruction (termed
dysbaric osteonecrosis); skin disorders (such as cutis marmorata, which
causes a pink marbling of the skin); spinal cord and brain disorders
(such as stroke, paralysis, paresthesia, and bladder dysfunction);
cardiopulmonary disorders, such as shortness of breath; and arterial
gas embolism (gas bubbles in the arteries that block blood flow).\14\
---------------------------------------------------------------------------

    \14\ See Appendix 10 of ``A Guide to the Work in Compressed-Air
Regulations 1996,'' published by the United Kingdom Health and
Safety Executive available from NIOSH at http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-254/compReg1996.pdf.
---------------------------------------------------------------------------

    Note: Health effects associated with hyperbaric intervention, but
not considered symptoms of DCI, can include: barotrauma (direct damage
to air-containing cavities in the body such as ears, sinuses, and
lungs); nitrogen narcosis (reversible alteration in consciousness that
may occur in hyperbaric environments and is caused by the anesthetic
effect of certain gases at high pressure); and oxygen toxicity (a
central nervous system condition resulting from the harmful effects of
breathing molecular oxygen (O2) at elevated partial
pressures).
    6. Diver Medical Technician--Member of the dive team who is
experienced in first aid.
    7. Earth Pressure Balanced Tunnel Boring Machine--the machinery
used to excavate a tunnel.
    8. Hot work--any activity performed in a hazardous location that
may introduce an ignition source into a potentially flammable
atmosphere.\15\
---------------------------------------------------------------------------

    \15\ Also see 29 CFR 1926.1202 for examples of hot work.
---------------------------------------------------------------------------

    9. Hyperbaric--at a higher pressure than atmospheric pressure.
    10. Hyperbaric intervention--a term that describes the process of
stopping the TBM and preparing and executing work under hyperbaric
pressure in the working chamber for the purpose of inspecting,
replacing, or repairing cutting tools and/or the cutterhead structure.
    11. Hyperbaric Operations Manual--a detailed, project-specific
health and safety plan developed and implemented by SUNDTJV for working
in compressed air during the Integrated Pipeline Tunnel Project.
    12. Job hazard analysis--an evaluation of tasks or operations to
identify potential hazards and to determine the necessary controls.
    13. Man-lock--an enclosed space capable of pressurization, and used
for compressing or decompressing any employee or material when either
is passing into, or out of, a working chamber.
    14. Medical Advisor--medical professional experienced in the
physical requirements of compressed air work and the treatment of
decompression illness.
    15. Pressure--a force acting on a unit area. Usually expressed as
pounds per square inch (p.s.i.).
    16. p.s.i.a.--pounds per square inch absolute, or absolute
pressure, is the sum of the atmospheric pressure and gauge pressure. At
sea-level, atmospheric pressure is approximately 14.7 p.s.i.a. Adding
14.7 to a pressure expressed in units of p.s.i.g. will yield the
absolute pressure, expressed as p.s.i.a.
    17. p.s.i.g.--pounds per square inch gauge, a common unit of
pressure;

pressure expressed as p.s.i.g. corresponds to pressure relative to
atmospheric pressure. At sea-level, atmospheric pressure is
approximately 14.7 p.s.i.a Subtracting 14.7 from a pressure expressed
in units of p.s.i.a. yields the gauge pressure, expressed as p.s.i.g.
At sea level the gauge pressure is 0 psig.
    18. Qualified person--an individual who, by possession of a
recognized degree, certificate, or professional standing, or who, by
extensive knowledge, training, and experience, successfully
demonstrates an ability to solve or resolve problems relating to the
subject matter, the work, or the project.\16\
---------------------------------------------------------------------------

    \16\ Adapted from 29 CFR 1926.32(m).
---------------------------------------------------------------------------

    19. Working chamber--an enclosed space in the TBM in which CAWs
perform interventions, and which is accessible only through a man-lock.

E. Safety and Health Practices

    1. SUNDTJV would have to adhere to the project-specific HOM
submitted to OSHA as part of the application (see OSHA-2023-0004-0003).
The HOM provides the minimum requirements regarding expected safety and
health hazards (including anticipated geological conditions) and
hyperbaric exposures during the tunnel-construction project.
    2. SUNDTJV would have to demonstrate that the TBM on the project is
designed, fabricated, inspected, tested, marked, and stamped in
accordance with the requirements of ASME PVHO-1.2019 (or most recent
edition of Safety Standards for Pressure Vessels for Human Occupancy)
for the TBM's hyperbaric chambers.
    3. SUNDTJV would have to implement the safety and health
instructions included in the manufacturer's operations manuals for the
TBM, and the safety and health instructions provided by the
manufacturer for the operation of decompression equipment.
    4. SUNDTJV would have to ensure that there are no exposures to
pressures greater than 58 p.s.i.g.
    5. SUNDTJV would have to ensure that air or oxygen is the only
breathing gas in the working chamber.
    6. SUNDTJV would have to follow the 1992 French Decompression
Tables for air or oxygen decompression as specified in the HOM;
specifically, the extracted portions of the 1992 French Decompression
tables titled, ``French Regulation Air Standard Tables.''
    7. SUNDTJV would have to equip man-locks used by employees with an
air or oxygen delivery system, as specified by the HOM for the project.
SUNDTJV would be prohibited from storing in the tunnel any oxygen or
other compressed gases used in conjunction with hyperbaric work.
    8. Workers performing hot work under hyperbaric conditions would
have to use flame-retardant personal protective equipment and clothing.
    9. In hyperbaric work areas, SUNDTJV would have to maintain an
adequate fire-suppression system approved for hyperbaric work areas.
    10. SUNDTJV would have to develop and implement one or more Job
Hazard Analysis (JHA) for work in the hyperbaric work areas, and
review, periodically and as necessary (e.g., after making changes to a
planned intervention that affects its operation), the contents of the
JHAs with affected employees. The JHAs would have to include all the
job functions that the risk assessment \17\ indicates are essential to
prevent injury or illness.
---------------------------------------------------------------------------

    \17\ See ANSI/AIHA Z10-2012, American National Standard for
Occupational Health and Safety Management Systems, for reference.
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    11. SUNDTJV would have to develop a set of checklists to guide
compressed-air work and ensure that employees follow the procedures
required by the proposed modified permanent variance and this interim
order (including all procedures required by the HOM approved by OSHA
for the project, which this proposed variance would incorporate by
reference). The checklists would have to include all steps and
equipment functions that the risk assessment indicates are essential to
prevent injury or illness during compressed-air work.
    12. SUNDTJV would have to ensure that the safety and health
provisions of this project-specific HOM adequately protect the workers
of all contractors and subcontractors involved in hyperbaric operations
for the project to which the HOM applies.

F. Communication

    SUNDTJV would have to:
    1. Prior to beginning a shift, implement a system that informs
workers exposed to hyperbaric conditions of any hazardous occurrences
or conditions that might affect their safety, including hyperbaric
incidents, gas releases, equipment failures, earth or rock slides,
cave-ins, flooding, fires, or explosions.
    2. Provide a power-assisted means of communication among affected
workers and support personnel in hyperbaric conditions where unassisted
voice communication is inadequate.
    (a) Use an independent power supply for powered communication
systems, and these systems would have to operate such that use or
disruption of any one phone or signal location will not disrupt the
operation of the system from any other location.
    (b) Test communication systems at the start of each shift and as
necessary thereafter to ensure proper operation.

G. Worker Qualifications and Training

    SUNDTJV would have to:
    1. Ensure that each affected worker receives effective training on
how to safely enter, work in, exit from, and undertake emergency
evacuation or rescue from, hyperbaric conditions, and document this
training.
    2. Provide effective instruction on hyperbaric conditions, before
beginning hyperbaric operations, to each worker who performs work, or
controls the exposure of others, and document this instruction. The
instruction would need to include:
    (a) The physics and physiology of hyperbaric work;
    (b) Recognition of pressure-related injuries;
    (c) Information on the causes and recognition of the signs and
symptoms associated with decompression illness, and other hyperbaric
intervention-related health effects (e.g., barotrauma, nitrogen
narcosis, and oxygen toxicity);
    (d) How to avoid discomfort during compression and decompression;
    (e) Information the workers can use to contact the appropriate
healthcare professionals should the workers have concerns that they may
be experiencing adverse health effects from hyperbaric exposure; and
    (f) Procedures and requirements applicable to the employee in the
project-specific HOM.
    3. Repeat the instruction specified in paragraph (G) of this
proposed condition periodically and as necessary (e.g., after making
changes to its hyperbaric operations).
    4. When conducting training for its hyperbaric workers, make this
training available to OSHA personnel and notify the OTPCA at OSHA's
national office and OSHA's Dallas Area Office before the training takes
place.

H. Inspections, Tests, and Accident Prevention

    1. SUNDTJV would have to initiate and maintain a program of
frequent and regular inspections of the TBM's hyperbaric equipment and
support systems (such as temperature control, illumination,
ventilation, and fire-prevention and fire-suppression systems), and
hyperbaric work areas, as required under 29 CFR 1926.20(b)(2),
including:

    (a) Developing a set of checklists to be used by a competent person
in conducting weekly inspections of hyperbaric equipment and work
areas; and
    (b) Ensuring that a competent person conducts daily visual checks
and weekly inspections of the TBM.
    2. Remove from service any equipment that constitutes a safety
hazard until it corrects the hazardous condition and has the correction
approved by a qualified person.
    3. SUNDTJV would have to maintain records of all tests and
inspections of the TBM, as well as associated corrective actions and
repairs, at the job site for the duration of the tunneling project and
for 90 days after the final project report is submitted to OSHA.

I. Compression and Decompression

    SUNDTJV would have to consult with its attending physician
concerning the need for special compression or decompression exposures
appropriate for CAWs not acclimated to hyperbaric exposure.

J. Recordkeeping

    In addition to completing OSHA Form 301 Injury and Illness Incident
Report and OSHA Form 300 Log of Work-Related Injuries and Illnesses,
SUNDTJV would have to maintain records of:
    1. The date, times (e.g., time compression started, time spent
compressing, time performing intervention, time spent decompressing),
and pressure for each hyperbaric intervention.
    2. The names of all supervisors and DMTs involved for each
intervention.
    3. The name of each individual worker exposed to hyperbaric
pressure and the decompression protocols and results for each worker.
    4. The total number of interventions and the amount of hyperbaric
work time at each pressure.
    5. The results of the post-intervention physical assessment of each
CAW for signs and symptoms of decompression illness, barotrauma,
nitrogen narcosis, oxygen toxicity or other health effects associated
with work in compressed air for each hyperbaric intervention.

K. Notifications

    1. To assist OSHA in administering the conditions specified herein,
SUNDTJV would have to:
    (a) Notify the OTPCA and the OSHA Area Office in Dallas, Texas at
www.osha.gov/contactus/byoffice of any recordable injury, illness, or
fatality (by submitting the completed OSHA Form 301 Injuries and
Illness Incident Report) resulting from exposure of an employee to
hyperbaric conditions, including those that do not require
recompression treatment (e.g., nitrogen narcosis, oxygen toxicity,
barotrauma), but still meet the recordable injury or illness criteria
of 29 CFR 1904. The notification would have to be made within 8 hours
of the incident or 8 hours after becoming aware of a recordable injury,
illness, or fatality; a copy of the incident investigation (OSHA Form
301 Injuries and Illness Incident Report) must be submitted to OSHA
within 24 hours of the incident or 24 hours after becoming aware of a
recordable injury, illness, or fatality. In addition to the information
required by OSHA Form 301 Injuries and Illness Incident Report, the
incident-investigation report would have to include a root-cause
determination, and the preventive and corrective actions identified and
implemented.
    (b) Provide certification to the OSHA Area Office in Dallas, Texas
within 15 working days of the incident that SUNDTJV informed affected
workers of the incident and the results of the incident investigation
(including the root-cause determination and preventive and corrective
actions identified and implemented).
    (c) Notify the OTPCA and the OSHA Area Office in Dallas, Texas
within 15 working days and in writing, of any change in the compressed-
air operations that affects SUNDTJV's ability to comply with the
proposed conditions specified herein.
    (d) Upon completion of the Integrated Pipeline Tunnel Project,
evaluate the effectiveness of the decompression tables used throughout
the project, and provide a written report of this evaluation to the
OTPCA and the OSHA Area Office in Dallas, Texas within 30 days after
the workers final day onsite.

    Note:  The evaluation report would have to contain summaries of:
(1) The number, dates, durations, and pressures of the hyperbaric
interventions completed; (2) decompression protocols implemented
(including composition of gas mixtures (air and/or oxygen), and the
results achieved; (3) the total number of interventions and the
number of hyperbaric incidents (decompression illnesses and/or
health effects associated with hyperbaric interventions as recorded
on OSHA Form 301 Injuries and Illness Incident Report and OSHA Form
300 Log of Work-Related Injuries and Illnesses, and relevant medical
diagnoses, and treating physicians' opinions); and (4) root causes
of any hyperbaric incidents, and preventive and corrective actions
identified and implemented.

    (e) To assist OSHA in administering the proposed conditions
specified herein, inform the OTPCA and the OSHA Area Office in Dallas,
Texas as soon as possible, but no later than seven (7) days, after it
has knowledge that it will:
    (i) Cease doing business;
    (ii) Change the location and address of the main office for
managing the tunneling operations specified herein; or
    (iii) Transfer the operations specified herein to a successor
company.
    (f) Notify all affected employees of this proposed modified
permanent variance by the same means required to inform them of its
application for a modified permanent variance.
    2. OSHA would have to approve the transfer of the proposed modified
permanent variance to a successor company through a new application for
a modified variance.

VII. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW, Washington,
DC 20210, authorized the preparation of this notice. Accordingly, the
agency is issuing this notice pursuant to 29 U.S.C. 655(6)(d),
Secretary of Labor's Order No. 8-2020 (85 FR 58393, Sept. 18, 2020),
and 29 CFR 1905.11.

    Signed at Washington, DC, on April 24, 2023.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-09118 Filed 4-28-23; 8:45 am]
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[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Notices]
[Pages 10814-10815]
[FR Doc No: 2014-04095]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0811]

Guidance for Industry: Enforcement Policy Regarding
Investigational New Drug Requirements for Use of Fecal Microbiota for
Transplantation To Treat Clostridium difficile Infection Not Responsive
to Standard Therapies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Enforcement Policy Regarding Investigational New Drug Requirements
for Use of Fecal Microbiota for Transplantation to Treat Clostridium
difficile Infection Not Responsive to Standard Therapies,'' dated March
2014. This draft guidance informs members of the medical and scientific
community and other interested persons that we intend to exercise
enforcement discretion regarding the investigational new drug (IND)
requirements for the use of fecal microbiota for transplantation (FMT)
to treat C. difficile infection not responding to standard therapies,
provided the licensed health care provider treating the patient obtains
adequate informed consent from the patient or his or her legally
authorized representative for use of the FMT products, the stool is
obtained from a donor known to either the patient or the licensed
health care provider treating the patient, and the donor and stool are
qualified by screening and testing performed under the direction of the
licensed health care provider for the purpose of providing the FMT
product to treat his or her patient. This draft guidance, when
finalized, is intended to supersede the guidance document entitled
``Enforcement Policy Regarding Investigational New Drug Requirements
for Use of Fecal Microbiota for Transplantation to Treat Clostridium
difficile Infection Not Responsive to Standard Therapies,'' dated July
2013 (July 2013 Guidance).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 28, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written

comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Enforcement Policy Regarding Investigational
New Drug Requirements for Use of Fecal Microbiota for Transplantation
to Treat Clostridium difficile Infection Not Responsive to Standard
Therapies,'' dated March 2014.
    Fecal microbiota collected from healthy individuals are being
investigated for use in the treatment of C. difficile infection that is
not responsive to standard therapies. Published data suggest that the
use of fecal microbiota to restore intestinal flora may be an effective
therapy in the management of refractory C. difficile infection.
However, the efficacy and safety profile of this intervention has not
yet been fully evaluated in controlled clinical trials.
    In the Federal Register of July 18, 2013 (78 FR 42965), FDA
announced the availability of the July 2013 Guidance. At that time, FDA
informed members of the medical and scientific community, and other
interested persons that it intended to exercise enforcement discretion
regarding these requirements provided that the physician treating the
patient obtains adequate informed consent from the patient or his or
her legally authorized representative for the use of FMT products. FDA
received several comments on the guidance, all of which supported
enforcement discretion with regard to the continued use of FMT products
to treat C. difficile infection not responsive to standard therapies.
    Since publishing the July 2013 Guidance, FDA has reviewed and
intends to modify its enforcement discretion policy. In this draft
guidance, FDA explains that it intends to exercise enforcement
discretion regarding the IND requirements for the use of FMT to treat
C. difficile infection not responding to standard therapies provided
that: (1) The licensed health care provider treating the patient
obtains adequate informed consent from the patient or his or her
legally authorized representative for the use of FMT products; (2) the
FMT product is obtained from a donor known to either the patient or the
licensed health care provider treating the patient; and (3) the stool
donor and stool are qualified by screening and testing performed under
the direction of the licensed health care provider for the purpose of
providing the FMT product to treat his or her patient. This policy does
not extend to the use of an FMT product when the FMT product is
manufactured from the stool of a donor who is not known by the patient
and/or the licensed health care provider treating the patient, or the
donor and donor stool are not qualified under the direction of the
licensed health care provider. Furthermore, this policy does not extend
to other uses of FMT. Data related to the use and study of FMT to treat
diseases or conditions other than C. difficile infection are limited,
and study of FMT for these other uses is not included in this
enforcement policy.
    FDA intends to exercise this discretion on an interim basis while
the Agency further considers the matter, and continues to evaluate its
enforcement policy. The draft guidance is being issued consistent with
FDA's good guidance practices regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent FDA's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirement of the applicable
statutes and regulations.

II. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04095 Filed 2-25-14; 8:45 am]
BILLING CODE 4160-01-P