[Federal Register Volume 83, Number 80 (Wednesday, April 25, 2018)]
[Notices]
[Pages 18042-18051]
[FR Doc No: 2018-08574]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2017-0427; FRL-9975-48-OAR]
RIN 2060-AT73

National Emission Standards for Hazardous Air Pollutants for
Asbestos: Request for Approval of an Alternative Work Practice for
Asbestos Cement Pipe Replacement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of request for comments.

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SUMMARY: This action provides public notice and solicits comment on an
alternative work practice (AWP) request under the Clean Air Act, to use
new technology and work practices developed for removal and replacement
of asbestos cement (A/C) pipe. In this action, the Environmental
Protection Agency (EPA) is soliciting comment on all aspects of this
request for an AWP that, in order to be approved, should be at least
environmentally equivalent to the existing work practices in the
National Emission Standards for Hazardous Air Pollutants for Asbestos
(Asbestos NESHAP), which applies to the removal and replacement of A/C
pipe.

DATES:
    Comments. The EPA must receive written comments on or before June
25, 2018.
    Public Hearing. If a public hearing is requested by April 30, 2018,
then we will hold a public hearing on May 10, 2018 at the EPA William
Jefferson Clinton (WJC) East Building, 1201 Constitution Avenue NW,
Washington, DC 20004. If a public hearing is requested, then we will
provide additional details about the public hearing on our website at
https://www.epa.gov/stationary-sources-air-pollution/asbestos-national-emission-standards-hazardous-air-pollutants. To request a hearing, to
register to speak at a hearing, or to inquire if a hearing will be
held, please contact Aimee St. Clair at<PHONE_NUMBER> or by email at
[email protected]. The EPA does not intend to publish any future
notices in the Federal Register regarding a public hearing on this
proposed action and directs all inquiries regarding a hearing to the
website and contact person identified above. The last day to pre-
register in advance to speak at the public hearing will be May 8, 2018.

ADDRESSES: Comments. Submit your comments, identified by Docket ID No.
EPA-HQ-OAR-2017-0427, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. Regulations.gov is our
preferred method of receiving comments. However, other submission
formats are accepted. To ship or send mail via the United States Postal
Service, use the following address: U.S. Environmental Protection
Agency, EPA Docket Center, Docket ID No. EPA-HQ-OAR-2017-0427, Mail
Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460. Use the
following Docket Center address if you are using express mail,
commercial delivery, hand delivery, or courier. EPA Docket Center, WJC
West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC
20004. Delivery verification signatures will be

available only during regular business hours.
    Do not submit electronically any information you consider to be
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Send or deliver information
identified as CBI only to the following address. OAQPS Document Control
Officer (C404-02), Office of Air Quality Planning and Standards,
Environmental Protection Agency, Research Triangle Park, North Carolina
27711, Attention Docket ID No. EPA-HQ-OAR-2017-0427.
    The EPA may publish any comment received to its public docket.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the Web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Public Hearing. If a public hearing is requested, it will be held
at EPA Headquarters, EPA WJC East Building, 1201 Constitution Avenue
NW, Washington, DC 20004. If a public hearing is requested, then we
will provide details about the public hearing on our website at:
https://www.epa.gov/stationary-sources-air-pollution/asbestos-national-emission-standards-hazardous-air-pollutants. The EPA does not intend to
publish another document in the Federal Register announcing any updates
on the request for a public hearing. Please contact Aimee St. Clair at
(919) 541-1063 or by email at [email protected] to request a public
hearing, to register to speak at the public hearing, or to inquire as
to whether a public hearing will be held.
    The EPA will make every effort to accommodate all speakers who
arrive and register. If a hearing is held at a U.S. government
facility, individuals planning to attend should be prepared to show a
current, valid state- or federal-approved picture identification to the
security staff in order to gain access to the meeting room. An expired
form of identification will not be permitted. Please note that the Real
ID Act, passed by Congress in 2005, established new requirements for
entering federal facilities. If your driver's license is issued by a
noncompliant state, you must present an additional form of
identification to enter a federal facility. Acceptable alternative
forms of identification include: Federal employee badge, passports,
enhanced driver's licenses, and military identification cards.
Additional information on the Real ID Act is available at https://www.dhs.gov/real-id-frequently-asked-questions. In addition, you will
need to obtain a property pass for any personal belongings you bring
with you. Upon leaving the building, you will be required to return
this property pass to the security desk. No large signs will be allowed
in the building, cameras may only be used outside of the building, and
demonstrations will not be allowed on federal property for security
reasons.

FOR FURTHER INFORMATION CONTACT: For questions about this action,
contact Ms. Susan Fairchild, Sector Policies and Programs Division (D-
243-04), Office of Air Quality Planning and Standards (OAQPS), U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
and email address: [email protected].

SUPPLEMENTARY INFORMATION:
    Docket. The EPA has established a docket for this rulemaking under
Docket ID No. EPA-HQ-OAR-2017-0427. All documents in the docket are
listed in the Regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the internet and will be
publicly available only in hard copy. Publicly available docket
materials are available either electronically in Regulations.gov or in
hard copy at the EPA Docket Center, Room 3334, EPA WJC West Building,
1301 Constitution Avenue NW, Washington, DC. The Public Reading Room is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the EPA Docket Center is
(202) 566-1742.
    Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2017-0427. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be CBI or other information whose disclosure is restricted by
statute. Do not submit information that you consider to be CBI or
otherwise protected through http://www.regulations.gov or email. This
type of information should be submitted by mail (see ADDRESSES section
of this preamble for correct mailing address). The http://www.regulations.gov website is an ``anonymous access'' system, which
means the EPA will not know your identity or contact information unless
you provide it in the body of your comment. If you send an email
comment directly to the EPA without going through http://www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should not include
special characters or any form of encryption and be free of any defects
or viruses. For additional information about the EPA's public docket,
visit the EPA Docket Center homepage at http://www.epa.gov/dockets.
    Submitting CBI. Do not submit information containing CBI to the EPA
through http://www.regulations.gov or email. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information in
a disk or CD-ROM that you mail to the EPA, mark the outside of the disk
or CD-ROM as CBI and then identify electronically within the disk or
CD-ROM the specific information that is claimed as CBI. In addition to
one complete version of the comments that includes information claimed
as CBI, you must submit a copy of the comments that does not contain
the information claimed as CBI for inclusion in the public docket. If
you submit a CD-ROM or disk that does not contain CBI, mark the outside
of the disk or CD-ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and the EPA's
electronic public docket without prior notice. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 Code of Federal Regulations (CFR) part 2.
    Acronyms and Abbreviations. We use multiple acronyms and terms in
this notice. While this list may not be exhaustive, to ease the reading
of this

notice and for reference purposes, the EPA defines the following terms
and acronyms here:

A/C asbestos cement
ACM asbestos-containing material
ACPRP asbestos cement pipe replacement project
ACWM asbestos-containing waste material
ASTM American Society for Testing and Materials
AWP alternative work practice
CBI confidential business information
CFR Code of Federal Regulations
CTPS close tolerance pipe slurrification
EPA Environmental Protection Agency
NESHAP national emission standards for hazardous air pollutants
OAQPS Office of Air Quality Planning and Standards
PVC polyvinyl chloride
RACM regulated asbestos-containing material, as defined in 40 CFR
61.141
VE visible emissions, as defined in 40 CFR 61.141

    Organization of This Document. The information in this notice is
organized as follows:

I. General Information
    A. Does this action apply to me?
    B. How do I obtain a copy of this document and other related
information?
II. Background Information
    A. Why are asbestos cement pipes being replaced?
    B. What is the Asbestos NESHAP?
    C. How is an alternative work practice approved?
    D. How do the Asbestos NESHAP requirements apply to replacement
of A/C pipe?
    E. What techniques are approved for removal and replacement of
A/C pipes?
III. Alternative Work Practice Request
    A. What is the close tolerance pipe slurrification technique for
A/C pipe replacement?
    B. What is the EPA's proposed action on the AWP request?
IV. What are the proposed work practices for A/C pipe replacement?
    A. What is the proposed CTPS AWP?
    B. What notification requirements would apply?
    C. What inspection, operation, and maintenance requirements
would apply?
    D. What sampling, testing, and utility map notation requirements
would apply?
    E. What labeling and transportation requirements would apply?
    F. What recordkeeping and reporting requirements would apply?
V. Request for Comments

I. General Information

A. Does this action apply to me?

    Categories and entities potentially affected by this
reconsideration action include those listed in Table 1 of this
preamble.

    Table 1--NESHAP and Industrial Source Categories Affected by This
                             Proposed Action
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              NESHAP and source category                 NAICS \1\ code
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Water treatment plants................................            221310
Distribution line, sewer and water, construction,                 237110
 rehabilitation, and repair...........................
Sewer main, pipe and connection, construction,                    237110
 rehabilitation, and repair...........................
Storm sewer construction, rehabilitation, and repair..            237110
Irrigation systems construction, rehabilitation, and              237110
 repair...............................................
Water main and line construction, rehabilitation, and             237110
 repair...............................................
Pipeline rehabilitation contractors...................            237120
Horizontal drilling (e.g., underground cable,                     237990
 pipeline, sewer installation)........................
Pipe fitting contractors..............................            238220
Power, communication and pipeline right-of-way                    238910
 clearance (except maintenance).......................
Pipeline transportation (except crude oil, natural                486990
 gas, refined petroleum products).....................
Pipeline terminal facilities, independently operated..            488999
Pipeline inspection (i.e., visual) services...........            541990
Asbestos removal contractors..........................            562910
Asbestos abatement services...........................            562910
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\1\ North American Industry Classification System.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
proposed action. To determine whether your A/C pipe replacement project
(ACPRP) would be affected by this proposed action, you should examine
the applicability criteria in the Asbestos NESHAP (40 CFR part 61,
subpart M). If you have any questions regarding the applicability of
any aspect of this proposed action, please contact the person listed in
the preceding FOR FURTHER INFORMATION CONTACT section of this preamble.

B. How do I obtain a copy of this document and other related
information?

    The docket number for this proposed action regarding the Asbestos
NESHAP is Docket ID No. EPA-HQ-OAR-2017-0427. In addition to being
available in the docket, an electronic copy of this document will also
be available on the internet. The EPA will post a copy of this proposed
action at https://www.epa.gov/stationary-sources-air-pollution/asbestos-national-emission-standards-hazardous-air-pollutants following
official Agency signature.
    Following publication in the Federal Register, the EPA will post
the Federal Register version and key technical documents on this same
website.

II. Background Information

A. Why are asbestos cement pipes being replaced?

    Drinking water, waste water, and storm water are handled by a
system of pipes which deliver water to residences, commercial,
institutional, and industrial users; transfer waste water from users to
wastewater treatment plants; and carry untreated storm water to streams
and lakes. As the infrastructure of municipalities age, utilities
serving the population need to replace deteriorated water pipes.
Existing water pipes can be made of various components, such as clay,
iron, polyvinyl chloride (PVC), concrete, and A/C. These A/C pipes are
potentially subject to regulation under the Asbestos NESHAP when
replaced.
    When A/C pipes age, the cementitious bonds in the pipe matrix
weaken, primarily due to the pH of the water, particulate in
suspension, acidic gases in sewage, and the scrubbing effect of sandy
soil caused by movement, such as tidal changes against the outside of
the pipe (e.g., in coastal environments). These mechanisms degrade both
the outside and the inside of the pipes, causing them to become
compromised and to leak.
    Once pipes begin to leak, the environment can be harmed in several
ways. Leaking waste water pipes can pollute nearby waterways, such as
oceans, rivers, and lakes. Compromised storm water pipes can allow
excess ground water, produced during high volume storm events, to seep
into the

pipe through cracks. This influx of ground water (or ``infiltration'')
can create a significant increase in the volume of waste water arriving
at waste water treatment plants. If treatment plants become
overburdened, waste water may be forced to be routed to the nearest
waterway without being properly treated, leading to increased waterway
contamination. Compromised drinking water pipes waste valuable finished
water, which can leak out of the degraded pipes into surrounding soils.
Water pipes carrying finished water have been known to rupture due to a
combination of degradation and a high-pressure load, also known as a
water main break.
    Because existing water pipes of all types run beneath and beside
major roadways, beneath buildings, and overlap other utilities (e.g.,
gas, electricity, cable), their replacement can potentially be
problematic, especially in high density residential, industrial, and
urban areas. Even replacement in suburban and rural areas can require
careful navigation beneath roadways and other major structures.

B. What is the Asbestos NESHAP?

    The Asbestos NESHAP is a set of work practice standards designed to
minimize the release of asbestos, prescribed for the handling,
processing, and disposal of asbestos-containing materials (ACM). The
purpose of these work practices is to minimize the release of asbestos
into the environment.
    Asbestos is a known human carcinogen and the primary route of
exposure is through inhalation of asbestos fibers. The potential for
exposure to asbestos fibers is directly linked to ACM's potential to
become friable, and, thus, for fibers to become airborne. Certain ACM
can readily release asbestos fibers when they are disturbed or damaged.
Asbestos fibers can then become entrained into the ambient air where
they become available for inhalation. More information on the health
effects of asbestos may be found at https://www.epa.gov/asbestos/learn-about-asbestos#effects.
    The Asbestos NESHAP defines friable asbestos material as any
material containing more than 1-percent asbestos as determined using
the method specified in 40 CFR part 763, subpart E, appendix E, section
1, Polarized Light Microscopy (PLM), that, when dry, can be crumbled,
pulverized, or reduced to powder by hand pressure. If the asbestos
content is less than 10 percent, as determined by a method other than
point counting by PLM, the asbestos content must be verified by point
counting using PLM.
    In the preamble to the 1990 Asbestos NESHAP amendments (55 FR
48406, November 20, 1990), the EPA stated in response to comments on
the definition of ``friable'' as it applied to the demolition and
renovation of ACM, that the EPA's intention was to distinguish between
materials that would readily release asbestos fibers when damaged or
disturbed and those materials that were unlikely to result in the
release of significant amounts of asbestos fibers. The Asbestos NESHAP
test to determine if ACM is friable is to attempt to crush the dry
material by hand. If the dry ACM can be crumbled, pulverized, or
crushed to powder by hand pressure, it is friable, and is regulated
under the Asbestos NESHAP.
    Asbestos-contaminated material regulated under the Asbestos NESHAP
is termed regulated asbestos-containing material (RACM). RACM is
defined in 40 CFR 61.141 of the Asbestos NESHAP and includes: (1)
Friable \1\ ACM; (2) Category I nonfriable ACM \2\ that has become
friable; (3) Category I nonfriable ACM that has been or will be sanded,
ground, cut, or abraded; or (4) Category II nonfriable ACM \3\ that has
already been or is likely to become crumbled, pulverized, or reduced to
powder by the forces acting upon it. If the regulatory threshold for
RACM \4\ is met or exceeded in a renovation operation, then all friable
ACM in the operation, and in certain situations, nonfriable ACM in the
operation, are subject to the work practice standards of the Asbestos
NESHAP.
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    \1\ Friable ACM means any material containing more than 1-
percent asbestos as determined using the method specified in 40 CFR
part 763, subpart E, appendix E, section 1, Polarized Light
Microscopy (PLM), that, when dry, can be crumbled, pulverized, or
reduced to powder by hand pressure.
    \2\ Category I nonfriable ACM means asbestos-containing
packings, gaskets, resilient floor covering, and asphalt roofing
products containing more than 1-percent asbestos as determined using
PLM.
    \3\ Category II nonfriable ACM means any material, excluding
Category I nonfriable ACM, containing more than 1-percent asbestos
as determined using PLM, that, when dry, cannot be crumbled,
pulverized, or reduced to powder by hand pressure.
    \4\ The regulatory threshold for RACM is 260 linear feet, 160
square feet, or 35 cubic feet (if the amount of RACM cannot
otherwise be measured in linear or square feet).
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    Thus, the purpose of the work practices required for the removal of
A/C pipe in the Asbestos NESHAP is to minimize the release of asbestos
fibers into the atmosphere, either at the time the material is removed,
or at a later date, as a result of friable materials left in the soil.
Therefore, in evaluating under 40 CFR 61.12(d) whether an AWP will
achieve a reduction in emissions of asbestos fibers at least equivalent
to the reduction achieved under the Asbestos NESHAP work practices, the
EPA will evaluate whether the AWP minimizes the release of asbestos
fibers to the atmosphere.

C. How is an alternative work practice approved?

    The 40 CFR part 61 General Provisions explain under what
circumstances the EPA may approve an alternative means of emission
limitation. At 40 CFR 61.12(d)(1) and (2), the General Provisions
require that the alternative means of emission limitation must achieve
a reduction in emissions at least equivalent to the reduction achieved
by the work practices required under the existing standard, and that
the Federal Register document permitting the use of the alternative be
published only after notice and an opportunity for a hearing.
    Additionally, the Asbestos NESHAP itself contains specific
provisions under which the EPA may receive applications for prior
written approval of an alternative emission control and waste treatment
method. For example, 40 CFR 61.150(a)(4) authorizes ``[u]se [of] an
alternative emission control and waste treatment method that has
received prior approval by the Administrator according to the procedure
described in 40 CFR 61.149(c)(2).'' As required by 40 CFR 61.150(a)(4)
and 40 CFR 61.149(c)(2), before approval may be granted for an AWP, a
written application must be submitted to the Administrator
demonstrating that the following criteria are met: (i) The alternative
method will control asbestos emissions equivalent to currently required
methods; (ii) the suitability of the alternative method for the
intended application; (iii) the alternative method will not violate
other regulations; and (iv) the alternative method will not result in
increased water pollution, land pollution, or occupational hazards.
    In order to be approved, the proposed AWP must meet all
requirements for no visible emissions (VE), adequate wetting, waste
handling, and disposal under the Asbestos NESHAP. The EPA is proposing
that this AWP is equivalent to the work practice in the Asbestos
NESHAP: It removes A/C pipe while replacing it with non-asbestos
materials; converts friable ACM, and ACM that may become friable when
disturbed into nonfriable ACM during the replacement

process; and uses amended water \5\ to achieve adequate wetting of all
ACM.
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    \5\ Amended water is water to which surfactant chemicals
(wetting agents) have been added to reduce the surface tension of
the water.
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D. How do the Asbestos NESHAP requirements apply to replacement of A/C
pipe?

    To the extent A/C pipe is either friable ACM or Category II
nonfriable ACM that has a high probability of becoming or has become
crumbled, pulverized, or reduced to powder by the forces expected to
act on it during the pipe replacement process, the A/C pipes meet the
RACM definition. If Category II nonfriable A/C pipes do not have a high
probability of becoming and have not become crumbled, pulverized, or
reduced to powder by the forces expected to act on them during the pipe
replacement process, those pipes would not be regulated as RACM under
the Asbestos NESHAP.
    For renovations such as a regulated underground ACPRP, if the total
amount of RACM for the project over the course of a single calendar
year to be stripped, removed, dislodged, cut, drilled, or similarly
disturbed during the activity is less than 260 linear feet, the
renovation work practices found in 40 CFR 61.145 of the NESHAP do not
apply, regardless of the pipe replacement method to be used, the type
of material (Category I or II), or its condition (friable versus
nonfriable). See 40 CFR 61.145(a)(4). The waste disposal requirements
found in 40 CFR 61.150 and 61.154 apply to any source regulated under
40 CFR 61.145.
    It is important to note that projects may not be broken up to avoid
regulation under the Asbestos NESHAP, and the EPA has clarified the
requirements of the Asbestos NESHAP as they relate to a project on
several occasions. In our 1995 Clarification of Intent, we stated the
``EPA considers demolitions planned at the same time or as part of the
same planning or scheduling period to be part of the same project. In
the case of municipalities, a scheduling period is often a calendar
year or fiscal year or the term of the contract.'' See 60 FR 38725
(July 28, 1995, Footnote 1). As stated in the 40 CFR part 61 General
Provisions, ``No owner or operator shall build, erect, install, or use
any article, machine, equipment, process, or method, the use of which
would otherwise constitute a violation of an applicable standard. Such
concealment includes, but is not limited to, the use of gaseous
dilutants to achieve compliance with a VE standard, and the piecemeal
carrying out of an operation to avoid coverage by a standard that
applies only to operations larger than a specified size.'' As we said
in addressing this issue in a previous applicability determination,\6\
the relevant part of that requirement is the part that discusses the
prohibition on the piecemeal carrying out of an operation to avoid
coverage by a standard. Therefore, as required by 40 CFR 61.145(a)(iii)
and (iv), owners or operators (owner/operator) must predict the
combined additive amount of RACM to be removed in the course of the
renovation activities (or, in the case of emergency renovations,
estimate that amount) over the calendar year to determine the
applicability of the standard to a project.
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    \6\ Applicability Determination Number A020001. August 30, 2002.
From George Czerniak, Chief, Air Enforcement and Compliance
Assurance Branch, U.S. EPA Region 5, to Robert Swift. https://cfpub.epa.gov/adi/index.cfm?fuseaction=home.dsp_show_file_contents&CFID=27301905&CFTOKEN=85118624&id=A020001.
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    The work practices for asbestos control under the Asbestos NESHAP
exist to minimize the release of asbestos into the ambient air. When a
facility component that contains, is covered with, or is coated with
RACM is being removed from a facility \7\ as a unit or in sections
(e.g., a pipeline), the rule requires adequate wetting of all RACM
exposed during cutting or disjoining operations; and each unit or
section to be carefully lowered to the floor and/or ground level, not
dropping, throwing, sliding, or otherwise damaging or disturbing the
RACM. After a facility component (e.g., pipeline section) containing,
covered with, or coated with RACM has been taken out of the facility as
a unit or in sections pursuant to paragraph (c)(2), it shall be
stripped or contained in leak-tight wrapping.\8\ If stripped, the
owner/operator may either adequately wet the RACM during stripping; or
use a local exhaust ventilation and collection system designed and
operated to capture the particulate asbestos material produced by the
stripping, and this system must exhibit no VE to the outside air, or be
designed and operated in accordance with 40 CFR 61.152 (air cleaning).
For removal of A/C pipe, the owner/operator must ensure that no VE are
exhibited during the removal of the A/C pipe and that all A/C pipe is
kept adequately wet to minimize the release of asbestos emissions,
unless one of the other specific provisions of the Asbestos NESHAP is
followed. Additional requirements apply to the waste handling and
disposal.
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    \7\ See 40 CFR 61.145(c)(2).
    \8\ For large facility components such as reactor vessels, large
tanks, and steam generators, the RACM is not required to be
stripped. However, other requirements for such components apply.
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    The work practices in the Asbestos NESHAP that apply to the removal
and replacement of A/C pipe include procedures for emission control,
handling of asbestos waste, and asbestos waste disposal. These work
practices are discussed in the sections below.
1. Procedures for Emission Control
    The principal controls in the Asbestos NESHAP for renovations such
as pipe replacement operations include requirements that the RACM be
adequately wetted to minimize VE during pipe replacement operations
involving RACM, and that asbestos waste be handled, collected, and
disposed of properly. The emission control requirements must meet the
standard for no VE. ``Adequately wet'' means to sufficiently mix or
penetrate with liquid to prevent the release of particulates. If VE are
observed coming from RACM, then that material has not been adequately
wetted. However, the absence of VE is not sufficient evidence of being
adequately wet. Typically, the emission controls used to achieve
adequate wetting include a fine water spray (or a mist).\9\ The
Asbestos NESHAP (40 CFR 61.145(c)(6)) requires that, after removal, the
RACM must remain adequately wet until collected and contained, or
treated in preparation for disposal in accordance with 40 CFR 61.150.
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    \9\ While not required under the Asbestos NESHAP, the EPA
recommends the use of surfactants to amend the water used to keep
ACM adequately wet because these water amendments greatly enhance
the ability of water to penetrate and mix with ACM.
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    The Asbestos NESHAP specifies at 40 CFR 61.150(a)(5) that the
asbestos-containing waste material (ACWM) handling requirements do not
apply to Category I nonfriable ACM waste (asbestos-containing packings,
gaskets, resilient floor covering, and asphalt roofing products
containing more than 1-percent asbestos) and Category II nonfriable ACM
waste (any other nonfriable ACM containing more than 1-percent
asbestos) that did not become crumbled, pulverized, or reduced to
powder.
2. Handling of Asbestos Waste
    Asbestos containing waste materials from activities regulated by 40
CFR 61.145 must be handled, collected, and disposed of in accordance
with 40 CFR 61.150. No VE may be discharged to the outside air during
the collection, processing, packaging, or transportation of any ACWM.
All ACWM must be kept adequately wet and sealed in leak-tight

containers (40 CFR 61.150(a)(1)) or processed into a nonfriable form,
such as a nonfriable pellet or other shape (40 CFR 61.150(a)(2)).
3. Waste Disposal
    The Asbestos NESHAP requires all ACWM to be deposited as soon as is
practical in a waste disposal site operated in accordance with the
provisions of 40 CFR 61.154 or an EPA-approved site that converts RACM
and ACWM into nonasbestos (asbestos-free) material according to the
provisions of 40 CFR 61.155.

E. What techniques are approved for removal and replacement of A/C
pipes?

    Even A/C pipes in good condition (which would be Category II
nonfriable ACM) become regulated ACM, if the pipe has a high
probability of becoming or has become crumbled, pulverized, or reduced
to powder by the forces expected to act on the pipe during the
renovation activities. Moreover, most of the A/C pipe being replaced by
municipalities is likely to be in poor condition (i.e., friable) due to
the degradation over time as discussed in the section II of this
document.
    The EPA has previously determined \10\ that pipe removal is
generally a renovation unless it is associated with the demolition of a
structure (in which case, it is a demolition). One applicability
determination from 1994 states that removal of A/C pipe ``. . . is a
renovation because the pipe is not a load bearing structural member.''
---------------------------------------------------------------------------

    \10\ See the applicability determination number a960010, October
12, 1994, from John Rasnic regarding removal of pipe, which may be
found in the EPA's Applicability Determination Index.
---------------------------------------------------------------------------

    The accepted technique to remove and replace A/C pipes is known as
``open trench replacement.'' In open trench replacement, the pipe is
located, cleaned, and inspected. Because pipes run beneath and cross
transportation corridors, traffic is rerouted to available detours.
Temporary water and sewer service is installed to handle the water
supply and/or wastewater handling affected by the disruption of
service. Other utilities (electricity, cable, optical fiber) that may
obstruct or interfere with pipe replacement are also identified. Once
the location of the pipe and all utilities are identified, the road
surfacing, and other structures, such as sidewalks, medians, etc., are
removed and an open trench is dug to expose the length of pipe to be
replaced. A pipe cutter is clamped around the A/C pipe being replaced,
and it is scored along the outside of its circumference while water is
applied to prevent emissions of asbestos to the atmosphere, which may
occur along the line of cutting. The pipe is snapped along the cut and
the process is repeated to produce transportable 6- to 8-foot sections
of pipe. Asbestos cement pipe in poor condition may resemble wet
cardboard in the way it responds to these removal activities. It can
simply collapse and tear into smaller pieces, rather than snap, as A/C
pipe in good condition is known to do. Each pipe section is removed,
wrapped in plastic, and placed on a truck labelled according to
regulations for asbestos waste disposal. This process of snap cutting
and removal is repeated for the entire length of A/C pipe to be
replaced.
    No AWPs for the replacement of A/C pipes have yet been approved.

III. Alternative Work Practice Request

A. What is the close tolerance pipe slurrification technique for A/C
pipe replacement?

    The EPA received a request from Trenchless Consulting, LLC, in July
2017, for approval of an AWP, known as the ``Close Tolerance Pipe
Slurrification'' (CTPS) method, for the removal and replacement of A/C
pipes. This is one of two AWPs requested. The second one, which
involves a technique commonly known as ``pipe bursting'' is still under
consideration. We are not discussing ``pipe bursting'' in this Federal
Register document and no decision has been made on whether or not to
propose approval of ``pipe bursting'' as an AWP.
    Documentation for CTPS is found in the Docket, and includes
photographs and video of the CTPS process demonstration on clay
pipe,\11\ schematics of the process, and descriptions of the process.
The CTPS method uses an equipment train to deliver drilling fluids and
clays in suspension through a pipe in the center of the train. The
equipment train uses a cutting head which grinds the underground A/C
pipe to a fine grain while the fluids maintain the adequately wet
requirements of 40 CFR 61.145 and entrain the finely ground pipe
fragments in a slurry. During this process, the slurry mixes with the
drilling fluids to create a homogenous \12\ wet cementitious material,
which is removed from the underground pipe path at vertical access
points (i.e., manholes, trenches, other vertical access cuts). These
vertical access points are sheathed with a nonpermeable lining, such as
plastic, at the beginning and end of the run of pipe being replaced.
The cementitious slurry hardens into a nonfriable A/C after 48-56
hours. The proposed CTPS AWP employs dust suppression using amended
water at all vertical access points to maintain the no VE and
adequately wet requirements of the Asbestos NESHAP, as required by 40
CFR 61.145 and 40 CFR 61.150.
---------------------------------------------------------------------------

    \11\ According to the demonstration of the CTPS process by
Portland Utilities, clay pipe is pulverized and slurrifies similarly
to A/C pipe when subjected to the CTPS process.
    \12\ A homogenous mixture is one in which the components are
uniformly distributed throughout the mixture.
---------------------------------------------------------------------------

    The EPA is proposing to consider the slurry that is formed by the
CTPS AWP for A/C pipe to be nonfriable once hardened. This is important
because the typical A/C pipe that is replaced is usually friable in
many places and in poor condition. The proposed CTPS AWP converts all
the ACM of the A/C pipe into a nonfriable material which is disposed of
in a landfill permitted to receive ACWM. A skim coat of the nonfriable
cementitious ACM remains on the outer rim of the new pipe.
    Because disposal takes place before the slurry hardens, and the
test to determine friability takes place after the slurry hardens, the
slurry must be sealed in containment at disposal (rather than disposed
openly pending the outcome of the test). Although the Asbestos NESHAP
does not require containment of nonfriable ACM, this AWP must ensure
the ACWM is contained because the test indicating the ACWM is
nonfriable would not yet have been conducted at the time of disposal
(the friability test is done on a sample of the material that has cured
and hardened over a period of 48 to 56 hours).
    In contrast to the Asbestos NESHAP work practices for ACPRPs
conducted in temperatures below freezing, the CTPS method may only be
used when temperatures are above 32 [deg]F (0 [deg]C) to prevent
freezing the slurry, drilling fluids, and/or the amended water needed
to maintain adequate wetting.

B. What is the EPA's proposed action on the AWP request?

    The EPA believes that the CTPS work practices are ``consistent with
the EPA's intent to distinguish between material that could release
significant amounts of asbestos fibers during demolition and renovation
operations and those that would not, and to prevent significant
emissions of asbestos fibers to the atmosphere.'' (see 55 FR 48408,
November 20, 1990 Asbestos NESHAP final notice, in our statements in
response to comments on friable vs. nonfriable materials). The EPA is
proposing that, for the following five reasons, CTPS is at least
equivalent to

the Asbestos NESHAP process for A/C pipe removal.
    First, this technique of replacement only exposes a small portion
of the A/C pipe, thereby preventing significant emissions of asbestos
to the atmosphere, a part of the overall reduction in emissions
potential. As described in more detail below, the CTPS approach only
excavates the A/C pipe at predetermined points along the pipe's path.
Vertical access cuts are made to remove A/C pipe only at the beginning
and end of the length of pipe to be removed and in designated vertical
access points to reduce pressure buildup of the slurry. This limited
excavation reduces the level of exposure to asbestos emissions from the
A/C pipe remediation project.
    Second, during periods where ACM is exposed, it is in the liquid
slurry form and is considered adequately wet and, thus, does not become
airborne, where it could be available for inhalation. The slurry is
pumped out of these points into an enclosed tank to be taken to a waste
disposal site approved to receive asbestos.
    Third, the CTPS AWP uses amended water to improve dust suppression
at all cuts, trenches, and vertical access points where A/C pipe may be
exposed to the ambient air. The pipe is otherwise not exposed to the
air.
    Fourth, a skim coat of slurry, which contains ACM and remains on
the new pipe, is not loose in the soil, but adheres to the surface of
the new pipe. The skim coat fills the annular space created by the
close tolerance drill through the ground as it pulls the new pipe
through. Therefore, it has a structural support preventing the thin
coating from being crushed, and also is not free to migrate to the
surface as a result of soil movement, such as frost heaves.\13\
Furthermore, the existence of asbestos in the skim coat is noted on the
utility records so that owners/operators are advised of its presence.
---------------------------------------------------------------------------

    \13\ Frost heaves occur in the top 3 feet of soil, and occur at
low temperatures when available moisture in the soil freezes,
expanding, and displaces materials with higher surface area
(regardless of density) upward due to decreasing pressure. In this
way, chunks of material of various densities may be moved to the
surface.
---------------------------------------------------------------------------

    Fifth, once hardened, the skim coat is nonfriable and has
properties of cement: Similar to light-weight flowable fill (concrete)
purchased from concrete plants, the skim coat has a strength of 50-150
pounds per square inch. Once hardened, the skim coat has static
properties such that it does not settle or compress further. Once the
skim coat is in place, it can only be removed by force, i.e., using a
pipe saw or a pipe cutter. Additionally, the skim coat is not subject
to corrosional forces from inside the pipe. For more information on the
properties of the skim coat that remains on the pipe, see docket item
``Skim Coat Properties, email correspondence from Mike Woodcock,
Portland Utilities Construction, January 2018.''
    The Asbestos NESHAP focuses on asbestos containing materials and
their decline into friable material. Since the advent of new methods
which were not available at the time of the last amendment to the rule,
this may be a procedure whereby friable A/C pipe in poor condition is
partially remediated back to a nonfriable state, and its properties are
similar to the properties of other cement products such as flowable
fill concrete.
    Close tolerance pipe slurrification differs from the conventional
work practices in which the entire pipe, much of which is in poor
condition and may be friable, is excavated and exposed, cut into
numerous 6- to 8-foot transportable sections, sealed in leak-tight
wrapping, labeled, and transported to an approved asbestos waste
disposal site. Five A/C pipe replacement guidance documents from state
and local agencies (from Massachusetts, Maine, Oregon, Utah, and the
city of Richmond, Virginia) are available in the docket for reference
on the conventional work practices.
    Consequently, the EPA believes that by following the CTPS AWP,
adequately wet and no VE protocols, and exposing only small sections of
A/C pipe to the air, asbestos emissions to the atmosphere are
minimized, and the AWP would achieve an emission reduction at least
equivalent to the current Asbestos NESHAP.
    While the Asbestos NESHAP (and associated applicability
determinations) contemplate and provide direction on a number of
situations for handling and managing asbestos, the situation whereby
friable ACM is turned into nonfriable ACM is not one that is
contemplated under the rule. The EPA is proposing that when the CTPS
work practices are adhered to as described in this document, and when
the test for friability confirms that the resulting hardened slurry
(skim coating) is nonfriable ACM, the resulting material can be
regulated as nonfriable ACM. Under 40 CFR 61.145(c)(1)(iv) of the
Asbestos NESHAP, under certain conditions nonfriable ACM need not be
removed, if they are Category II nonfriable ACM and the probability is
low that materials will become crumbled, pulverized, or reduced to
powder during demolition. We are proposing that the nonfriable skim
coating of ACM left on the outer rim of the new pipe be allowed to also
remain in place.
    The EPA is proposing that when CTPS is used to remove the
underground A/C pipe, while maintaining no VE and the adequately wet
requirements of 40 CFR 61.145 and 40 CFR 61.150(a), removing the old A/
C pipe, converting all A/C pipe to Category II nonfriable ACM, and
replacing the underground A/C pipe with new pipe, then CTPS is at least
equivalent, in terms of emission reductions, to the work practices in
the Asbestos NESHAP as they apply to renovations.
    The Asbestos NESHAP waste disposal requirements include deed
notations for inactive asbestos waste disposal sites, where ACWM (e.g.,
friable ACM) has been left behind in the ground. The EPA included this
provision in the Asbestos NESHAP for situations in which manufacturing
waste had been left behind, sometimes buried on property, and that
property later was sold for development. Without a deed notation to
warn potential buyers of its presence, new owners could accidentally
expose themselves to asbestos (for example, by installing a swimming
pool, driveway, or digging a basement). The EPA, therefore, added
requirements for property deed notation when ACWM has been left behind
in the ground, creating an inactive asbestos waste disposal site.
    The EPA is proposing that the nonfriable ACM resulting from CTPS
would not be subject to deed notations. However, as is current
practice, the EPA proposes that owner/operators (e.g., municipality or
utility) using the CTPS AWP would be required to maintain utility maps
with the actual location of each ACPRP identified by the 6-digit
latitude and longitude coordinates of the newly laid line, and that the
utility maps would note the line as covered by a skim coat of ACM for
future work.
    The EPA is also proposing that the other requirements in the
Asbestos NESHAP that apply to renovations, including notification
requirements found in 40 CFR 61.145(b), would apply to the CTPS AWPs.
Additionally, the EPA is proposing that the waste handling and disposal
requirements found in 40 CFR 61.150 and 61.154 would apply to the
slurry that is removed at the ACPRP.

IV. What are the proposed work practices for A/C pipe replacement?

    The EPA is seeking the public's input on Trenchless Consulting's
request that the EPA approve the CTPS approach as an AWP under the
Asbestos NESHAP. We are seeking comments on whether

the CTPS work practices are equivalent to those in the Asbestos NESHAP,
including adequate wetting requirements, no VE, notification,
containment, labeling, waste handling, waste transportation, and
disposal of ACWM. The materials supporting the request for this
approval are available in the Docket and include industry descriptions
of the CTPS work practice and processes, the process patent, records of
the EPA's communication with the industry requestors, and the EPA's
observations of the methods conducted on PVC and clay sewer pipe.
    Based upon our initial review of the proposed AWP request, the
demonstrations of the work practice, and written materials including
equipment, materials, slurry characteristics, testing, and waste
specifications, we propose that, by complying with the following list
of requirements, this proposed AWP will achieve emission reductions at
least equivalent to emission reductions achieved under 40 CFR 61.145,
40 CFR 61.150, and 40 CFR 61.154, as required by the applicable
Asbestos NESHAP, provided that adequate wetting accompanies all
vertical access points, access trenches, and manholes to prevent VE,
and that the A/C cementitious material resulting from this process is
properly handled and contained during and after removal and properly
disposed of as required by the Asbestos NESHAP.
    The patent related to this process, ``Method of Replacing an
Underground Pipe Section,'' is available from the U.S. Patent Office,
patent number US8,641,326B2; February 4, 2014, and a copy is available
in the docket. That patent deals with the replacement of low-pressure
sewer pipes and indicates some parameters that may be different from
the work practices in this notice, depending on the soil composition,
depth of pipe, and serviceable use of the pipe (e.g., a low-pressure
sewer, waste water, or fresh water pipe). While this patented process
is one used by the company requesting approval of this AWP, an owner/
operator would not have to license the patent and could choose
different equipment in order to follow the work practices of this
notice.

A. What is the proposed CTPS AWP?

    The proposed CTPS AWP is as follows:
1. Vertical Access Points
    Vertical access points (e.g., manholes, trenches) are made at
designated intervals along the length of pipe replacement. The distance
between vertical access points is a function of the soil type, pipe
size, pneumatic pressure on the CTPS head, and frictional drag on the
line; and is determined for each project on a case-by-case basis by the
owner/operator. Incorrect estimation of the vertical access point
locations may result in a malfunction. The owner/operator must not
disturb A/C pipe during the digging out of these access points. Water
and suction should be used to uncover as much of the A/C pipe as is
needed to begin the CTPS process.
2. Removal of Pipe at Terminals and Vertical Access Points
    At the starting and terminal points, and at designated intervals
along the length of pipe replacement, sections of pipe are cut and
removed at the vertical access points (i.e., manholes, trenches). The
owner/operator must handle all sections of A/C pipe in accordance with
40 CFR 61.145 and 40 CFR 61.150 of the Asbestos NESHAP.
3. CTPS Equipment Train
    The CTPS technique should use a drilling head train with a slightly
larger diameter than the pipe being replaced. This technology must use
a heavy duty four-stage cutting and wetting train, made of hardened
carbon steel, which is able to be fed directly around the pipe to be
replaced. The cutting head must be drawn around the existing pipe and
must be capable of grinding the old A/C pipe to a fine powder using a
liquid delivery system as described in section IV.A.4 of this preamble.
The process must return the A/C pipe to a cementitious slurry that is a
homogenous mixture and stays adequately wet through disposal according
to the requirements of 40 CFR 61.145. The owner/operator must ensure
that the CTPS train pulls the replacement pipe behind it, and that no
ACM contacts the inside of the new pipe.
4. Liquid Delivery
    The horizontal drilling train must be equipped with ports to
deliver liquid materials to the drilling head. Drilling fluids and
bentonite clay should also be delivered through these ports to reduce
frictional drag on the line, and to lubricate the interface along the
soil to pipe line.
5. Trackable Pipeline
    The owner/operator would be required to ensure that the new
pipeline is trackable by steel cable (or other durable trackable
material) laid with the new pipe.
6. Slurry Characteristics
    The owner/operator would be required to ensure that no visible
emissions are discharged to the air from the slurry, and that the
slurry is a homogenous mixture comprised of finely ground A/C pipe,
drilling fluids, bentonite clay, and other materials suspended in
solution that, when cured (a period of 48-56 hours), re-hardens so that
it meets the sample friability test in section IV.D.2 of this preamble.
The slurry must meet the no visible emissions requirements of 40 CFR
61.145 and 61.150.
7. Slurry Removal, Containment, Transportation, and Disposal
    The A/C pipe slurry is removed at vertical access points using a
vacuum attached to a tank (e.g., vacuum truck). The owner/operator
would be required to ensure that the slurry remains in an adequately
wet state during the slurrification process and remains in containment
throughout the removal, transportation, and disposal processes, meeting
the requirements of 40 CFR 61.145 and 40 CFR 61.150. The slurry must be
contained and in slurry form at the time of disposal in a landfill
permitted to accept ACWM and meeting the requirements of 40 CFR 61.154.
The slurry must be managed at the disposal site using procedures
meeting the requirements of 40 CFR 61.154.
8. Adequate Wetting With No VE
    Any opening to the atmosphere along the pipe is a potential source
of asbestos emissions to the outside (ambient) air. The owner/operator
would be required to ensure that dust suppression equipment (i.e., dust
suppression apparatus or manual misting) using amended water is placed
at each vertical access point. If a new trench is dug to resolve a
malfunction, the owner/operator would be required to ensure that the
new trench is equipped with dust suppression and follow the procedure
in paragraphs (1) and (2) above. Amended water is water to which
surfactant chemicals (wetting agents) have been added to reduce the
surface tension of the water.

B. What notification requirements would apply?

    If an underground ACPRP meets the applicability and threshold
requirements under the NESHAP, then the EPA (or the delegated agency)
must be notified in advance of the replacement in accordance with the
requirements of the Asbestos NESHAP at 40 CFR 61.145(b). See 40 CFR
61.145 for more information on the notification requirements.

C. What inspection, operation, and maintenance requirements would
apply?

1. Inspection
    Prior to using the CTPS for an ACPRP, the owner/operator would
conduct underground pipe inspections (e.g., by using remote
technologies like robotic cameras) and shall identify, locate, and mark
onto an underground utility map of the area all identified potential
areas of malfunctions, such as changes in pipe type, drops in the line,
broken and off-center points, and changes in soil type.
2. Operation and Maintenance
    The owner/operator of a CTPS method system is required to install,
operate, and maintain the drilling head train, CTPS liquid delivery
system, and all equipment used to deliver adequate wetting at all
vertical access points and cut lengths of pipe in accordance with their
written standard operating procedures. The records must be kept in
accordance with section IV.F.1 of this preamble.

D. What sampling, testing, and utility map notation requirements would
apply?

1. Sample Collection
    After the slurry has been pumped from the vertical access points,
but before disposal, the owner/operator of a CTPS method system is
required to collect a 2-inch roughly spherical wet sample of the
slurry. A single sample must be collected for each project discharging
to a single enclosed tank. The owner/operator would be required to seal
the sample in leak-tight wrapping and allow the sample to harden and
dry (usually 48-56 hours).
2. Sample Friability Test and Certification
    When the sample is hardened and dry, the owner/operator would be
required to attempt to crush the sample by hand. The sample that cannot
be crumbled, pulverized, or reduced to powder by hand pressure is
nonfriable, and the remaining slurry from that pipe replacement job is
likewise nonfriable. After testing, the owner/operator would be
required to ensure that the sample is packaged in leak-tight wrapping
for storage, labeled ``Asbestos Containing Material. Do not break or
damage this sealed package,'' dated according to the ACPRP date of
generation, stored in a secure location that is inaccessible to the
general public (such as a locked storage unit), and is maintained by
the owner/operator for a period of 2 years. After this 2-year retention
period, the sample may be disposed of in a landfill permitted to accept
ACWM.
    a. If the sample cannot be crushed, crumbled, or reduced to powder
by hand pressure, the owner/operator would be required to certify this
as follows: ``The hardened slurry sample from the ACPRP conducted on
(date) at (location) could not be crushed, crumbled, or reduced to
powder by hand pressure. I am aware it is unlawful to knowingly submit
incomplete, false, and/or misleading information and there are
significant criminal penalties for such unlawful conduct, including the
possibility of fine and imprisonment.'' The owner/operator would be
required to maintain a signed certificate of this statement so that it
is available to the EPA Administrator, local, and state agency
officials upon demand.
    b. If the sample can be crushed, crumbled, or reduced to powder by
hand pressure, the owner/operator would be required to follow the
malfunction reporting requirements in IV.F. 2 below.
3. Utility Map Notations
    Owner/operators would be required to note utility maps according to
the actual location identified by the 6-digit latitude and longitude
coordinates of the newly laid line. Notations would have to be
maintained for the life of the new pipe by the owner/operator (e.g.,
municipality or utility), and would have to be labeled as covered by a
skim coat of ACM for future work.

E. What labeling and transportation requirements would apply?

    Because all A/C pipe being replaced using the CTPS technique is
converted to a nonfriable state during the replacement, it would be
categorized as Category II ACM and would need to be labeled and
transported in accordance with the corresponding requirements of 40 CFR
61.145 and 40 CFR 61.150 in the Asbestos NESHAP.

F. What recordkeeping and reporting requirements would apply?

    1. The owner/operator would be required to record and maintain for
a period of 2 years the following data:
    a. Date(s) from beginning to end of each ACPRP;
    b. Location(s) of the A/C pipe(s) replaced using CTPS, identified
by 6-digit latitudinal and longitudinal coordinates for each ACPRP;
    c. Diameter and length of A/C pipe replaced at the ACPRP;
    d. Total amount of slurry generated at the ACPRP;
    e. Total amount of slurry disposed by the owner/operator from the
ACPRP;
    f. Slurry disposal site;
    g. Manifest of ACM slurry disposal; and
    h. Malfunction records (if applicable).
    i. Records of VE events and their duration (including the time and
date stamp) of any VE event;
    ii. Records of when and how each VE event was resolved. Indicate
the date and time for each VE period, whether the VE event occurred at
an exposed manhole, trench, or other vertical access point, and the
number of openings to the ambient air affected;
    iii. Procedure used to resolve each VE event; and
    iv. Results of each sample friability test that indicates the
slurry is friable, as required by IV.D.1 and 2 above.
    i. Records of the standard operation procedures for the
installation, operation, and maintenance of the drilling head train,
CTPS liquid delivery system, and all equipment used to deliver adequate
wetting at all vertical access points and cut lengths of pipe.
    2. Each owner/operator is required to submit the following reports
to the Administrator after each occurrence, as follows:
    a. Malfunction Report. The malfunction report must include the
records in section IV.F.1.h.i.-iv of this preamble. The malfunction
report must be submitted as soon as practical after the occurrence, but
in no case later than 30 days.
    b. ACPRP Report. The ACPRP report must be submitted to the Asbestos
NESHAP program office within the EPA Regional office in which the ACPRP
is located. The report may be submitted electronically when the means
to do so are available. The EPA Regional office may, at their
discretion, waive this requirement and delegate this reporting to the
state and municipality. If the EPA Regional office has waived the
reporting, and if the state or municipality is unable to receive
electronic reports, then only a hard copy is required to be submitted.
These reports must be postmarked or electronically submitted within 30
calendar days of completion of the ACPRP.

V. Request for Comments

    We solicit comments on all aspects of this request for approval of
CTPS as an AWP for the work practice standards specified in 40 CFR part
61, subpart M, the Asbestos NESHAP. We specifically seek comments
regarding whether the AWPs, as described in section IV above, will
achieve emission reductions at least equivalent to the work practices
in the

Asbestos NESHAP at 40 CFR 61.145 and 40 CFR 61.150.

    Dated: April 18, 2018.
Panagiotis Tsirigotis,
Director, Office of Air Quality Planning and Standards.
[FR Doc. 2018-08574 Filed 4-24-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13623-13626]
[FR Doc No: 2011-5739]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0116]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on medical device labeling
regulations.

DATES: Submit either electronic or written comments on the collection
of information by May 13, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, PI50-400B, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Device Labeling Regulations--(OMB Control Number 0910-0485)--
(Extension)

    Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 352), among other things, establishes requirements for
the label or labeling of a medical device so that it is not misbranded
and subject to a

regulatory action. Certain provisions under section 502 require
manufacturers, importers, and distributors of medical devices to
disclose information about themselves or the devices, on the labels or
labeling for the devices. Section 502(b) of the FD&C Act requires that
for packaged devices, the label must bear the name and place of
business of the manufacturer, packer, or distributor as well as an
accurate statement of the quantity of the contents. Section 502(f) of
the FD&C Act requires that the labeling for a device must contain
adequate directions for use. FDA may however, grant an exemption, if
the Agency determines that the adequate directions for use labeling
requirements are not necessary for the particular case, as it relates
to protection of the public health.
    FDA regulations under parts 800, 801, and 809 (21 CFR parts 800,
801, and 809) require disclosure of specific information by
manufacturers, importers, and distributors of medical devices about
themselves or the devices, on the label or labeling for the devices to
health professionals and consumers. FDA issued these regulations under
the authority of sections 201, 301, 502, and 701 of the FD&C Act (21
U.S.C. 321, 331, 352, and 371). Most of the regulations under parts
800, 801, and 809 are derived from requirements of section 502 of the
FD&C Act, which provides in part, that a device shall be misbranded if
among other things, its label or labeling fails to bear certain
required information concerning the device, is false or misleading in
any particular way, or fails to contain adequate directions for use.

Reporting Burden

    Sections 800.10(a)(3) and 800.12(c) require that the label for
contact lens cleaning solutions bear a prominent statement alerting
consumers of the tamper-resistant feature. Further, Sec.  800.12
requires that packaged contact lens cleaning solutions contain a
tamper-resistant feature, to prevent malicious adulteration.
    Section 800.10(b)(2) requires that the labeling for liquid
ophthalmic preparations packed in multiple-dose containers provide
information on the duration of use and the necessary warning
information to afford adequate protection from contamination during
use.
    Section 801.1 requires that the label for a device in package form,
contain the name and place of business of the manufacturer, packer, or
distributor.
    Section 801.5 requires that labeling for a device include
information on intended use as defined under Sec.  801.4 and provide
adequate directions to assure safe use by the lay consumers.
    Section 801.61 requires that the principal display panel of an
over-the-counter (OTC) device in package form must bear a statement of
the identity of the device. The statement of identity of the device
must include the common name of the device followed by an accurate
statement of the principal intended actions of the device.
    Section 801.62 requires that the label for an OTC device in package
form must bear a statement of declaration of the net quantity of
contents. The label must express the net quantity in terms of weight,
measure, numerical count, or a combination of numerical count and
weight, measure, or size.
    Section 801.109 establishes labeling requirements for prescription
devices, in which the label for the device must describe the
application or use of the device, and contain a cautionary statement
restricting the device for sale by, or on the order of an appropriate
professional.
    For prescription by a licensed practitioner, Sec.  801.110
establishes labeling requirements for a prescription device delivered
to the ultimate purchaser or user. The device must be accompanied by
labeling bearing the name and address of the licensed practitioner,
directions for use, and cautionary statements if any, provided by the
order.
    Section 801.150(e) requires a written agreement between firms
involved when a nonsterile device is assembled or packaged with
labeling that identifies the final finished device as sterile, for
which the device is ultimately introduced into interstate commerce to
an establishment or contract manufacturer to be sterilized. When a
written agreement complies with the requirements under Sec.
801.150(e), FDA takes no regulatory action against the device as being
misbranded or adulterated. In addition, Sec.  801.150(e) requires that
each pallet, carton, or other designated unit, be conspicuously marked
to show its nonsterile nature when introduced into interstate commerce,
and while being held prior to sterilization.
    Section 801.405(b)(1) provides for labeling requirements for
articles, including repair kits, re-liners, pads, and cushions,
intended for use in temporary repairs and refitting of dentures for lay
persons. Section 801.405(b)(1) also requires that the labeling contain
the word ``emergency'' preceding and modifying each indication-for-use
statement for denture repair kits and the word ``temporary'' preceding
and modifying each indication-for-use statement for re-liners, pads,
and cushions.
    Section 801.405(c) provides for labeling requirements that contain
essentially the same information described under Sec.  801.405(b)(1).
The information is intended to enable a lay person to understand the
limitations of using OTC denture repair kits, and denture re-liners,
pads, and cushions.
    Section 801.420(c)(1) requires that manufacturers or distributors
of hearing aids develop a user instructional brochure to be provided by
the dispenser of the hearing aid to prospective users. The brochure
must contain detailed information on the use and maintenance of the
hearing aid.
    Section 801.420(c)(4) establishes requirements that the user
instructional brochure or separate labeling, provide for technical data
elements useful for selecting, fitting, and checking the performance of
a hearing aid. In addition, Sec.  801.420(c)(4) provides for testing
requirements to determine that the required data elements must be
conducted in accordance with the American National Standards
Institute's (ANSI) ``Specification of Hearing Aid Characteristics,''
ANSI S3.22-1996 (ASA 70-1996); (Revision of ANSI S3.22-1987), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51.
    Section 801.421(b) establishes requirement for the hearing aid
dispenser to provide prospective users with a copy of the user
instructional brochure along with an opportunity to review comments,
either orally or by the predominant method of communication used during
the sale.
    Section 801.421(c) establishes requirements for the hearing aid
dispenser to provide a copy of the user instructional brochure to the
prospective purchaser of any hearing aid upon request or, if the
brochure is unavailable, provide the name and address of the
manufacturer or distributor from which it may be obtained.
    Section 801.430(d) establishes labeling requirements for menstrual
tampons to provide information on signs, risk factors, and ways to
reduce the risk of Toxic Shock Syndrome (TSS).
    Section 801.430(e)(2) requires menstrual tampon package labels to
provide information on the absorbency term based on testing required
under Sec.  801.430(f) and an explanation of selecting absorbencies
that reduce the risk of contracting TSS.
    Section 801.430(f) establishes requirements that manufacturers of

menstrual tampons devise and follow an ongoing sampling plan for
measuring the absorbency of menstrual tampons. Further, manufacturers
must use the method and testing parameters described under Sec.
801.430(f).
    Section 801.435(b), (c), and (h) establishes requirements for
condom labeling to bear an expiration date that is supported by testing
that demonstrates the integrity of three random lots of the product.
    Section 809.10(a) and (b) establishes requirements that a label for
an in vitro diagnostic device and the accompanying labeling (package
insert), must contain information identifying its intended use,
instructions for use and lot or control number, and source.
    Section 809.10(d)(1) provides that the labeling requirements for
general purpose laboratory reagents may be exempt from the requirements
of Sec.  809.10(a) and (b), if the labeling contains information
identifying its intended use, instructions for use, lot or control
number, and source.
    Section 809.10(e) provides that the labeling for ``Analytic
Specific Reagents'' (ASRs) must provide information identifying the
quantity or proportion or each reagent ingredient, instructions for
use, lot or control number, and source.
    Section 809.10(f) provides that the labeling for OTC test sample
collection systems for drugs of abuse must include information on the
intended use, specimen collection instructions, identification system,
and information about use of the test results. In addition, Sec.
809.10(f) requires that this information be in a language appropriate
for the intended users.
    Section 809.30(d) requires that advertising and promotional
materials for ASRs include the identity and purity of the ASR and the
identity of the analyte.
    Section 1040.20(d) provides that manufacturers of sunlamp products
and ultraviolet lamps are subject to the labeling regulations under
part 801.

Recordkeeping Burden

    Section 801.150(a)(2) establishes recordkeeping requirements for
reprocessors, relabelers, or repackagers to retain a copy of the
agreement containing the specifications for the processing, labeling,
or repacking of the device for 2 years after the shipment or delivery
of the device. Section 801.150(a)(2) also requires that the subject
respondents make copies of this agreement available for inspection at
any reasonable hour to any officer or employee of the Department of
Health and Human Services (HHS), upon their request.
    Section 801.421(d) establishes requirements for hearing aid
dispensers to retain copies of all physician statements or any waivers
of medical evaluation for 3 years after dispensing the hearing aid.
    Section 801.410(e) requires copies of invoices, shipping documents,
and records of sale or distribution of all impact resistant lenses,
including finished eyeglasses and sunglasses, be maintained for 3 years
by the retailer and made available upon request by any officer or
employee of FDA or by any other officer or employee acting on behalf of
the Secretary of HHS.
    Section 801.410(f) requires that the results of impact tests and
description of the test method and apparatus be retained for a period
of 3 years.
    Section 801.421(d) requires hearing aid dispensers to retain a copy
of any written statement from a physician required under Sec.
801.421(a)(1), or any written statement waiving medical evaluation
required under Sec.  801.421(a)(2)(iii) for 3 years after the
dispensing the hearing aid.
    Section 801.435(g) requires latex condom manufacturers to document
and provide, upon request, an appropriate justification for the
application of the testing data from one product on any variation of
that product to support expiration dating in the user labeling.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of    Annual frequency   Total annual       Hours per
                           21 CFR Section                              respondents      of response       responses         response        Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.10(a)(3) and 800.12(c).........................................              37             100             3,700               1              3,700
800.10(b)(2).......................................................              37             100             3,700               1              3,700
801.1..............................................................          23,393               6           140,358                .1          140,036
801.5..............................................................           5,000               3.5          17,500              22.35         391,125
801.61.............................................................           5,000               3.5          17,500               1             17,500
801.62.............................................................           1,000               5             5,000               1              5,000
801.109............................................................          18,000               3.5          63,000              17.77       1,119,510
801.110............................................................          10,000              50           500,000               0.25         125,000
801.150(e).........................................................              90              20             1,800               4              7,200
801.405(b)(1)......................................................              99               1.7             168               4                673
801.405(c).........................................................              99               1.7             168               4                673
801.420(c)(1)......................................................             275               5             1,375              40             55,000
801.420(c)(4)......................................................             275               5             1,375              80            110,000
801.421(b).........................................................          10,000             160         1,600,000               0.30         480,000
801.421(c).........................................................          10,000               5            50,000               0.17           8,500
801.430(d).........................................................              45               2                90               2                180
801.430(e)(2)......................................................              45               2                90               2                180
801.430(f).........................................................              45               2                90              80              7,200
801.435(b), (c), and (h)...........................................              86               3.4             292             100             29,200
809.10(a) and (b)..................................................           1,700               6            10,200              80            816,000
809.10(d)(1).......................................................             300               2               600              40             24,000
809.10(e)..........................................................             300              25             7,500               1              7,500
809.10(f)..........................................................              20               1                20             100              2,000
809.30(d)..........................................................             300              25             7,500               1              7,500
1040.20(d).........................................................             110               1               110              10              1,100
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ..............  ................  ..............  .................       3,362,477
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                           Table 2--Estimated Average Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR section              Number of     frequency of    Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
801.150(a)(2)...................              57               1              57          0.50                29
801.410(e) and (f)..............              30         924,100      27,723,000          0.0008          22,178
801.421(d)......................          10,000             160       1,600,000          0.25           400,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         422,207
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The medical device labeling regulations also refer to previously
approved collections of information found in FDA regulations. The
collections of information under Sec.  800.12(d) and 801.437(i) have
been approved under OMB control number 0910-0183; the collections of
information under Sec.  800.12(e) have been approved under OMB control
number 0910-0231; and the collections of information under Sec.
801.435(g) have been approved under OMB control number 0910-0073.
    Further, FDA concludes that labeling statements under Sec. Sec.
801.63, 801.405(b)(2) and (b)(3), 801.420(c)(2) and (c)(3), 801.430(c)
and (e)(1), 801.433, 801.437(d) through (g), and 809.30(d)(2), (d)(3),
and (e) do not constitute a ``collection of information'' under the
PRA. Rather, these labeling statements are ``public disclosure'' of
information originally supplied by the Federal Government to the
recipient for the purpose of ``disclosure to the public'' (5 CFR
1320.3(c)(2)).

Reporting

    These estimates are based on FDA's registration and listing
database for medical device establishments and FDA's knowledge of and
experience with device labeling.

Recordkeeping

    These estimates are based on FDA's registration and listing
database for medical device establishments, Agency communications with
industry, and FDA's knowledge of and experience with device labeling.
    The medical device labeling regulations also refer to previously
approved collections of information. The collections of information
under Sec. Sec.  800.12(d) and 801.437(i) have been approved under OMB
control number 0910-0183; and the collections of information under
Sec.  800.12(e) have been approved under OMB control number 0910-0231.
    The information collection requirements under Sec. Sec.  801.63,
801.405(b)(2) and (b)(3), 801.420(c)(2) and (c)(3), 801.430(c) and
(e)(1), 801.433, 801.437(d) through (g), and 809.30(d)(2), (d)(3), (e)
are not considered information collection because the public
information is originally supplied by the Federal Government to the
recipient for the purpose of disclosure to the public (5 CFR
1320.3(c)(2)).

    Dated: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5739 Filed 3-11-11; 8:45 am]
BILLING CODE 4160-01-P