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Proposed Rule2024-03849

Approval Tests and Standards for Combination Unit Respirators

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Published

March 15, 2024

Issuing agencies

Health and Human Services Department

Abstract

The Department of Health and Human Service (HHS) proposes to amend regulatory requirements that would be used by the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) to test and approve combination unit respirators. This rulemaking would establish this new class of respiratory protective device, combination unit respirators (CURs), by incorporating by reference the performance requirements established in the National Fire Protection Association (NFPA) voluntary consensus standard NFPA 1987, Standard on Combination Unit Respirator Systems for Tactical and Technical Operations.

Full Text

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<title>Federal Register, Volume 89 Issue 52 (Friday, March 15, 2024)</title>
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[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Proposed Rules]
[Pages 18867-18875]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-03849]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

[Docket No. CDC-2024-0005; NIOSH-351]
RIN 0920-AA83

Approval Tests and Standards for Combination Unit Respirators

AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department of Health and Human Service (HHS) proposes to
amend regulatory requirements that would be used by the Centers for
Disease Control and Prevention's (CDC) National Institute for
Occupational Safety and Health (NIOSH) to test and approve combination
unit respirators. This rulemaking would establish this new class of
respiratory protective device, combination unit respirators (CURs), by
incorporating by reference the performance requirements established in
the National Fire Protection Association (NFPA) voluntary consensus
standard NFPA 1987, Standard on Combination Unit Respirator Systems for
Tactical and Technical Operations.

DATES: Comments must be received by May 14, 2024. Comments on the
information collection approval request sought under the Paperwork
Reduction Act must be received by May 14, 2024.

ADDRESSES:
Written comments: Comments, including those related to the
Paperwork Reduction Act, may be submitted by any of the following
methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments to the docket.
<bullet> Mail: NIOSH Docket Office, Robert A. Taft Laboratories,
MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226.
Instructions: All submissions received must include the agency name
(Centers for Disease Control and Prevention, HHS) and docket number
(CDC-2024-0005; NIOSH-351) or Regulation Identifier Number (0920-AA83)
for this rulemaking. All relevant comments, including any personal
information provided, will be posted without change to <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Do not submit comments by email. CDC does not
accept comments by email. For detailed instructions on submitting
public comments, see the ``Public Participation'' heading of the
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Jeffrey Peterson, NIOSH National
Personal Protective Technology Laboratory (NPPTL), Pittsburgh, PA;
(412) 386-6111 (this is not a toll-free number); email to
<a href="/cdn-cgi/l/email-protection#216f686e726953444652614245420f464e57"><span class="__cf_email__" data-cfemail="0a4443455942786f6d794a696e69246d657c">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

Interested persons or organizations are invited to participate in
this rulemaking by submitting written views, opinions, recommendations,
and data. Comments received, including attachments and other supporting
materials, are part of the public record and subject to public
disclosure. Any information in comments or supporting materials that is
confidential or inappropriate for public disclosure

[[Page 18868]]

should not be included. HHS will carefully consider all comments
submitted in preparation of the final rule and may revise the final
rule as appropriate.

II. Statutory Authority

Pursuant to the Occupational Safety and Health (OSH) Act of 1970
(Pub. L. 91-596), the Organic Act of 1910 (Pub. L. 179), and the
Federal Mine Safety and Health Act of 1977 (Pub. L. 91-173 (codified at
30 U.S.C. 842(h), 844, 957)), NIOSH is authorized to approve
respiratory equipment used in mines and other workplaces for the
protection of employees potentially exposed to hazardous breathing
atmospheres. The Occupational Safety and Health Administration (OSHA)
requires U.S. employers to supply NIOSH Approved[supreg] \1\
respirators to their employees whenever the employer requires the use
of a respirator (29 CFR 1910.134(d)(1)). The National Technology
Transfer and Advancement Act of 1995 (Pub. L. 104-113) directs agencies
to use voluntary consensus standards, instead of government-unique
publications, when it is practical and consistent with law.
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\1\ NIOSH Approved[supreg] (NIOSH Approved) is a certification
mark of the U.S. Department of Health and Human Services (HHS)
registered in the United States and several international
jurisdictions.
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III. Background

The NIOSH Respirator Approval Program approves respiratory
protective devices pursuant to the performance standards in 42 CFR part
84, Approval of Respiratory Protective Devices. A combination unit
respirator is a respiratory protective device that employs the
technology of at least two different types of respiratory protective
devices, with one being an open-circuit self-contained breathing
apparatus (SCBA) \2\ and at least one other method being air-purifying
or powered air-purifying,\3\ and that allows the wearer to select the
operating mode. Despite the current lack of a NIOSH approval standard
for CURs, they are used today in military, law enforcement, and some
industrial settings where the versatility of these devices allows users
to perform in various hazardous environments. A CUR allows the worker
to carry or wear one respirator into an environment in which the
hazards are either unknown or might change rapidly, and to readily
switch between types of respiratory protection after assessing their
individual risk.
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\2\ An open-circuit SCBA is designed for use during entry into
and escape from or escape only from hazardous atmospheres. Oxygen is
supplied to the wearer and the wearer's exhalations are vented to
the atmosphere and are not rebreathed. See 42 CFR part 84, subpart
H.
\3\ Air-purifying respirators (APRs) ``utilize the wearer's
negative inhalation pressure to draw the ambient air through the
air-purifying filter elements (filters) to remove particulates from
the ambient air. They are designed for use as respiratory protection
against atmospheres with particulate contaminants at concentrations
that are not immediately dangerous to life or health and that
contain adequate oxygen to support life.'' Powered air-purifying
respirators (PAPRs) use a blower to move air through the filters.
See 42 CFR part 84, subpart K.
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Regulations in 42 CFR part 84 do not currently allow for NIOSH
approval of a single respirator unit for more than one respirator class
where the user can select the appropriate level of protection required
from within a single respirator system. With this rulemaking, HHS
proposes to establish performance standards for NIOSH approval of CURs
in a new part 84, subpart P, by incorporating by reference the
performance requirements in Chapter 7 of NFPA 1987, Standard on
Combination Unit Respirator Systems for Tactical and Technical
Operations, 2023 edition.\4\
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\4\ See <a href="https://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=1987">https://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=1987</a>.
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A. Background and History

NIOSH has explored and discussed the need to develop a regulatory
standard for NIOSH approval of combination unit respirators with
manufacturers and other interested parties since at least 2006, while
developing performance requirements for chemical, biological,
radiological, and nuclear (CBRN) protections. The conceptual
requirements for the CBRN CUR were presented to obtain initial comments
from manufacturers and other interested parties during an October 12,
2006, public meeting.\5\ Using this input, NIOSH identified the need to
promulgate a CUR performance standard in part 84. A public meeting
dedicated to discussion of a combination respirator standard was held
in December 2010; participants expressed their support for a standard
that recognizes each type of respiratory protection comprising the
combination.\6\
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\5\ NIOSH Docket Number 082 [Oct. 2006], Combination Units--
SCBA/PAPR/APR, <a href="http://www.cdc.gov/niosh/docket/archive/docket082.html">http://www.cdc.gov/niosh/docket/archive/docket082.html</a>.
\6\ NIOSH Docket Number 082-A [Dec. 2010], Chemical, Biological,
Radiological and Nuclear (CBRN) Combination Respirator Unit (CRU),
<a href="http://www.cdc.gov/niosh/docket/archive/docket082A.html">http://www.cdc.gov/niosh/docket/archive/docket082A.html</a>.
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NIOSH conducted a respirator manufacturers' meeting \7\ and a
stakeholder webinar \8\ in March 2015 to solicit additional stakeholder
input regarding CUR research needs. It then engaged the National
Academies Institute of Medicine (IOM) to examine aspects of CUR
technology, use, and the development of a performance standard. In
April 2015, IOM convened a public workshop, sponsored by NIOSH, on the
development of a CUR performance standard.\9\ The workshop engaged
OSHA, NFPA, and CUR manufacturers and users, including presenters and
participants engaged in law enforcement, fire service, mining,
military, and hazardous waste remediation. The CUR users and
manufacturers gave presentations to attendees, after which the workshop
participants, speakers, and committee members met in breakout groups to
define priorities in three areas: research, standards and regulations,
and training needs and hazard assessment. Participants discussed the
unique attributes of CURs and expressed concern about a disconnect
between OSHA and NIOSH regulations.\10\ Specifically, in 29 CFR
1910.134(d)(3)(i)(A), OSHA established its assigned protection factors
(APFs) standard and requires that for a combination respirator
``employers must ensure that the assigned protection factor is
appropriate to the mode of operation in which the respirator is being
used.'' \11\
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\7\ NIOSH-NPPTL [Feb. 3, 2015], Letter to All Respirator
Manufacturers, Subject: Implementation Plan for the Respirator
Certification Fees, <a href="https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/Manufacturers/pdfs/lttr-02032015-508.pdf">https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/Manufacturers/pdfs/lttr-02032015-508.pdf</a>.
\8\ NIOSH-NPPTL [Feb. 18, 2015], Webinar Concerning Standard for
Performance Requirements of the Combination Unit Respirator, <a href="https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/interestedparties/pdfs/lttr-02182015-508.pdf">https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/interestedparties/pdfs/lttr-02182015-508.pdf</a>.
\9\ <a href="https://www.nationalacademies.org/our-work/developing-a-performance-standard-for-combination-unit-respirators-a-workshop">https://www.nationalacademies.org/our-work/developing-a-performance-standard-for-combination-unit-respirators-a-workshop</a>
\10\ Institute of Medicine of the National Academies [2015],
Developing a Performance Standard for Combination Unit Respirators--
Workshop in Brief; <a href="https://nap.nationalacademies.org/read/21765/chapter/1">https://nap.nationalacademies.org/read/21765/chapter/1</a>.
\11\ OSHA's regulation requires employers to use the APFs to
select a respirator that meets or exceeds the required level of
employee protection.
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In contrast, in 42 CFR 84.63(b), NIOSH classifies combination
respirators ``by the type of respirator in the combination which
provides the least protection to the user.'' So, for example, pursuant
to Sec. 84.63(b), a respirator that combines an air-purifying mode
(APF=50) and an open-circuit self-contained mode (APF=10,000) will be
classified by NIOSH as an air-purifying respirator, the least
protective of the two modes. Thus, if OSHA requires that the hazards at
a specific worksite necessitate respiratory protection with an APF of
10,000, then the employer cannot use the combined air-purifying/open-
circuit SCBA

[[Page 18869]]

respirator approved by NIOSH at the least protective level (in this
example, 50) because the APF for air-purifying respirators is
insufficient to meet the needs of the worksite.
After the IOM published its workshop summary in June 2015, NIOSH
determined there were no existing CUR performance standards that met
the needs identified by the workshop participants. At that time, NIOSH
considered the following alternative approaches to address those needs:
(1) develop the CUR performance standard and promulgate the
standard into 42 CFR part 84;
(2) collaborate with a voluntary consensus standards development
organization, such as NFPA, to develop the CUR performance standard and
incorporate it into 42 CFR part 84 by reference; or
(3) develop the base respiratory protection requirements and
collaborate with a standards development organization to develop
additional unique requirements, such as communication and tactical
equipment interoperability, to meet the needs of user groups for
incorporation by reference into 42 CFR part 84.
NIOSH evaluated these options and considered both the formal
request from a representative of the Federal Bureau of Investigation
(FBI) and a subsequent Interagency Board endorsement letter of the
FBI's request to the NFPA to develop CUR performance standards.\12\
NIOSH determined that collaborating with NFPA to develop and adopt a
CUR performance standard provided the most effective outcome for users
and was the most efficient use of NIOSH resources. In a letter dated
June 22, 2015, NIOSH endorsed the FBI's request that NFPA develop a CUR
performance standard. In August 2015, NFPA responded to the FBI request
by assigning this new project to the Technical Committee on Tactical
and Technical Operations Respiratory Protection Equipment. User groups
and CUR manufacturers participated throughout the NFPA CUR standard
development process, and unique requirements such as communication and
tactical equipment interoperability requirements were incorporated into
the consensus standard to meet the needs of specific user groups. NIOSH
provided additional expertise to conduct research, fully participated
on the NFPA technical committee, and devoted agency resources to
conduct the necessary research and development testing and evaluation
to support NFPA in developing the CUR standard.
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\12\ See supra note 4 at 1.
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B. Scope of the Proposed Rulemaking

This rulemaking proposes a new 42 CFR part 84, subpart P to create
a new respirator class, combination unit respirators, which are
respirators capable of protecting wearers (a) in open-circuit SCBA-mode
during either entry into or escape from immediately dangerous to life
or health (IDLH) environments, and (b) in air-purifying or powered air-
purifying mode during entry into non-IDLH environments and escape from
non-IDLH or IDLH environments. The combination unit respirator allows
the wearer to select the operating mode and thus change from one APF to
another as necessary.

C. Need for Rulemaking

Providing a mechanism to allow manufacturers to obtain NIOSH
approvals of respirators conforming to the proposed standard for the
new CUR class in subpart P would benefit those workers and employers
who encounter various types of hazardous exposures and currently rely
on multiple types of NIOSH Approved respiratory protective devices in
the course of their duties on OSHA-regulated worksites. The flexibility
provided using one NIOSH Approved respirator that can perform multiple
functions might also benefit employers by allowing them to purchase
fewer respirators, which NIOSH expects will result in cost savings.
This rulemaking would also benefit employers who are required by OSHA
to provide workers with NIOSH Approved respirators but currently use
CURs that do not have NIOSH approval; HHS assumes that, as a result of
this rulemaking, employers will choose to purchase NIOSH Approved
products, allowing them to come into compliance with OSHA rules.
Moreover, the proposed new subpart P would bring the regulations in 42
CFR part 84 into alignment with the OSHA APF standard 29 CFR
1910.134(d)(3)(i)(A), discussed above, allowing employers to purchase
CURs rated at more than one APF.
This rulemaking would benefit approval holders that currently
produce combination unit respirators, and new CUR manufacturers that
would enter the NIOSH Approved CUR market if such approval were to
become available. By promulgating this rule, HHS would be removing a
barrier that currently prevents CUR manufacturers from accessing the
market demand for NIOSH Approved respirators. Adding a new subpart P to
part 84 would allow manufacturers to apply for and obtain NIOSH
approval of CURs capable of allowing the wearer to switch between
operational modes, which can be identified by more than one APF.
This rulemaking also proposes the revision of an existing
definition in 42 CFR 84.2 and the addition of two new terms to reflect
NIOSH's ongoing and evolving relationship with business entities that
produce and sell respirators. HHS proposes revising the existing
definition of the term ``applicant'' to clarify the role and
responsibilities of those parties who submit an application for NIOSH
approval of a product's design, performance, configuration management,
manufacture, quality, and support. A new definition of the term
``approval holder'' would be added to the existing definitions section.
The terms ``applicant'' and ``approval holder'' would replace the term
``manufacturers'' throughout part 84, as appropriate, to reflect the
fact that seeking and maintaining NIOSH approval includes more than the
manufacturing of the respirator or respirator components. An approval
holder has at least one respirator approval on the NIOSH Certified
Equipment List (CEL), a directory of NIOSH Approved respirators, which
would also be defined in Sec. 84.2. The CEL is regularly updated as
respirator approvals are added, made obsolete, or otherwise changed in
status. The CEL is available in a searchable database at <a href="https://wwwn.cdc.gov/niosh-cel/">https://wwwn.cdc.gov/niosh-cel/</a>.

D. Effects of Rulemaking on Federal Agencies

The proposed rule would not require OSHA to make any changes to 29
CFR 1910.134, the OSHA respiratory protection requirements. The
proposed rule is expected to benefit Federal law enforcement agencies
and military branches whose members currently rely on CURs that are not
NIOSH Approved respirators. The performance requirements proposed in
this rulemaking are designed to protect workers relying on CURs for
their survival in IDLH atmospheres better than combination respirators
approved pursuant to 42 CFR 84.63(b) or CURs not approved to any
performance standard.

IV. Incorporation by Reference

With this rulemaking, HHS proposes to incorporate by reference the
CUR performance requirements in Chapter 7 of NFPA 1987, Standard on
Combination Unit Respirator Systems for Tactical and Technical
Operations, 2023 edition, into a new part 84, subpart P. NFPA 1987
specifies the minimum requirements for the design,

[[Page 18870]]

performance, testing, and certification of new combination unit
respirator systems. Only the NFPA 1987, Chapter 7, respiratory
performance requirements are incorporated into part 84, subpart P. NFPA
1987, 2023 edition, is reasonably available to interested parties.
Interested parties may purchase a copy from NFPA, 1 Batterymarch Park,
P.O. Box 9101, Quincy, MA 02269-9101, <a href="http://www.nfpa.org">www.nfpa.org</a>. All NFPA codes and
standards can be viewed at no cost at <a href="http://nfpa.org/docinfo">nfpa.org/docinfo</a>.

V. Summary of Proposed Rule

For the reasons discussed above, HHS proposes the following changes
to 42 CFR part 84.

Section 84.2 Definitions

HHS proposes the addition of two new definitions to the existing
Definitions section in 84.2: ``approval holder'' and ``NIOSH Certified
Equipment List (CEL).'' An approval holder is an applicant who has at
least one NIOSH Approved respirator on the NIOSH Certified Equipment
List, which is the directory of NIOSH Approved respirators. Finally,
HHS proposes a revision to the existing term ``applicant,'' to clarify
that the applicant is the entity that maintains and demonstrates
responsibility for, and control of, product design, performance,
configuration management, manufacture, quality, and support. Throughout
part 84, the words ``manufacturer,'' ``manufacturers,'' and
``manufacturer's'' would be replaced with variations of ``applicant''
and ``approval holder,'' as appropriate.

Section 84.63 Test Requirements; General

Existing Sec. 84.63(b) allows the combination of two or more
classes of respirators and requires the resulting combination
respirator to meet the minimum requirements for each class of
respirator in the combination. Each resulting combination respirator
will be classified by the class of respirator in the combination that
provides the least amount of protection to the wearer. Paragraph (b)
would be revised to clarify that CURs approved under the proposed new
subpart P would be excepted from this general rule.

Section 84.400 Combination Unit Respirators (CUR); Description

In a new subpart P, a new Sec. 84.400 would describe that CURs are
intended to protect wearers using the CUR (a) in open-circuit SCBA-mode
during either entry into or escape from immediately dangerous to life
or health (IDLH) environments, and (b) in air-purifying or powered air-
purifying mode during entry into non-IDLH environments and escape from
non-IDLH or IDLH environments.

Section 84.401 Technical Specifications and Performance Requirements

A new Sec. 84.401(a) would incorporate by reference the
performance requirements established in Chapter 7 of NFPA 1987,
Standard on Combination Unit Respirator Systems for Tactical and
Technical Operations, 2023 edition. Tables in paragraphs (a)(1), (2),
(3), and (4) would specify the NFPA 1987 performance requirements for
CUR systems, including the CUR open-circuit self-contained mode, the
powered air-purifying mode, and the air-purifying mode. The
incorporation of NFPA 1987 would establish systems evaluation and
minimum performance requirements for each operational mode providing
respiratory protection, including air-purifying, powered air-purifying,
and open-circuit self-contained breathing apparatus; the ability to
safely switch operational modes; universal emergency breathing safety
system; end-of-service-time indicator; and for assessing the chemical,
biological, radiological, and nuclear performance of the CUR. A new
paragraph (b) would stipulate that the 42 CFR part 84 provisions
prevail in the event that there is a conflict with the requirements of
NFPA 1987.

Section 84.402 General Construction and Approval Requirements

A new Sec. 84.402(a) would specify that CURs are required to meet
the minimum construction requirements in subpart G of part 84.
Paragraph (b) would specify that the prospective approval holder must
concurrently submit the device to an organization accredited to ISO/IEC
17065, Conformity Assessment--Requirements for Bodies Certifying
Products, Processes and Services, for NFPA 1987 certification. The
conformity assessment body will assess those requirements in NFPA 1987
that are not incorporated by reference into 42 CFR part 84, subpart P.
NIOSH approval is contingent upon the applicant receiving NFPA 1987
certification from a conformity assessment body. The certification
letter issued by the conformity assessment body will be issued
concurrent with the NIOSH National Personal Protective Technology
Laboratory approval letter.

Updates to Internal References

In Sec. Sec. 84.30, 84.50, 84.51, 84.52, 84.53, 84.60, 84.63,
84.64, 84.65, the text would be edited to point to the technical
standards in subparts H through the proposed new subpart P.

VI. Regulatory Impact Analyses

HHS has examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), Executive Order 14094 entitled ``Modernizing
Regulatory Review'' (April 6, 2023), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the
Social Security Act, section 202 of the Unfunded Mandates Reform Act of
1995 (March 22, 1995; Pub. L. 104-4), and Executive Order 13132 on
Federalism (August 4, 1999).

A. Executive Order 12866 (Regulatory Planning and Review), Executive
Order 13563 (Improving Regulation and Regulatory Review), and Executive
Order 14094 (Modernizing Regulatory Review)

Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). The
Executive Order 14094 entitled ``Modernizing Regulatory Review''
(hereinafter, the Modernizing E.O.) amends section 3(f)(1) of Executive
Order 12866 (Regulatory Planning and Review). The amended section 3(f)
of Executive Order 12866 defines a ``significant regulatory action'' as
an action that is likely to result in a rule: (1) having an annual
effect on the economy of $200 million or more in any 1 year (adjusted
every 3 years by the Administrator of OIRA for changes in gross
domestic product), or adversely affect in a material way the economy, a
sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, territorial, or
tribal governments or communities; (2) creating a serious inconsistency
or otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlement
grants, user fees, or loan programs or the rights and obligations of
recipients thereof; or (4) raise legal or policy issues for which
centralized review would meaningfully further the President's
priorities or the principles set forth in this Executive order, as
specifically authorized in a timely manner by the Administrator of OIRA
in each case. A

[[Page 18871]]

regulatory impact analysis (RIA) must be prepared for major rules with
significant regulatory action/s and/or with significant effects as per
section 3(f)(1) ($200 million or more in any 1 year).
This proposed rule has been determined not to be a ``significant
regulatory action'' under section 3(f) of E.O. 12866. The rulemaking is
intended to remove regulatory barriers to the manufacturing, labeling,
and selling of new CUR designs with NIOSH approval that include both
open-circuit self-contained breathing apparatus and either air-
purifying or powered air-purifying respirator capabilities. This
rulemaking would give applicants the option to seek NIOSH approval of
CURs meeting the performance requirements in chapter 7 of NFPA 1987,
Standard on Combination Unit Respirator Systems for Tactical and
Technical Operations, 2023 edition, incorporated by reference into a
new 42 CFR part 84, subpart P. NIOSH approval would be contingent on
concurrent NFPA 1987 certification from the certification body.
Costs
This rule would not impose any mandatory costs on the public and
would benefit applicants who choose to develop a product under these
new technical requirements and the employers who purchase CURs. HHS
estimates the fees associated with CUR approvals, including
applications, site qualifications, and testing fees, pursuant to 42 CFR
part 84, subpart C--Fees and Fee Schedule B--Application-Based Fees in
part 84, appendix B. Because CUR-specific testing fees must be added to
Fee Schedule B by rulemaking,\13\ until HHS can conduct such a
rulemaking, fees associated with those tests would be assessed pursuant
to Sec. 84.24, which authorizes NIOSH to
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\13\ 42 CFR part 84, Appendix B.

conduct or cause to be conducted any additional examinations,
inspections, or tests it deems necessary to determine the quality
and effectiveness of any respirator submitted to NIOSH for the
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purposes of seeking a certificate of approval.

CUR-specific testing fees would be charged under the New and
Unspecified Tests category of Fee Schedule B, allowing the NIOSH
Respirator Approval Program to recoup $500 per day plus the actual cost
of non-NIOSH staff (typically medical staff and test subjects), which
is roughly equivalent to the actual costs of those tests. The
application plus NIOSH testing and evaluation fees are estimated to be
$15,600 in total.
The costs associated with the CBRN chemical warfare agent (CWA)
tests, which NIOSH requires to be conducted by the U.S. Army Combat
Capabilities Development Command (DEVCOM), Chemical Biological Center
(CBC), are estimated to cost $101,000. These fees are established by
CBC.
Fees associated with the independent certification body NFPA 1987
certification will be assessed by the certification body utilized. HHS
estimates that NFPA 1987 certification will cost $90,000 for initial
testing and evaluation and $42,000 annually thereafter. Finally, HHS
estimates that the application itself will take an average of 240 hours
to complete, costing applicants approximately $11,374 per application
(see Section V.C., below).
In addition to the one-time cost of a new NIOSH approval, pursuant
to Respirator Certification Fee Schedule A--Annual (Fixed) Fees, the
annual NIOSH approval maintenance costs to maintain one approval are
estimated to be $10,691.
In total, HHS estimates that the initial cost of a new CUR approval
application submitted to NIOSH will be $217,974. HHS further estimates
that the total cost of maintaining a NIOSH CUR approval will be
$52,691. See Table 1.

Table 1--Estimated Cost of NIOSH CUR Approval
[2023$]
----------------------------------------------------------------------------------------------------------------
Estimated first-year Estimated annual costs
Fees costs for 1 approval for 1 approval
----------------------------------------------------------------------------------------------------------------
NIOSH approval, Fee Schedule A................................ ....................... $10,691
NIOSH approval, Fee Schedule B................................ $15,600 .......................
Application paperwork burden.................................. 11,374 .......................
CBRN testing by DEVCOM........................................ 101,000 .......................
NFPA 1987 certification....................................... 90,000 .......................
NFPA 1987 certification annual fee............................ ....................... 42,000
-------------------------------------------------
Total..................................................... 217,974 52,691
----------------------------------------------------------------------------------------------------------------

Benefits
HHS anticipates that the benefits of this rulemaking far outweigh
the costs to applicants of obtaining NIOSH CUR approval. CURs without
NIOSH approval currently cost from $7,500 to $12,000; HHS does not have
information about the potential cost of NIOSH Approved CURs but expects
CUR approval holders to recoup the full cost of the NIOSH approval and
profit from the sale of CURs to end users.
Moreover, this rulemaking would open up a new market segment to
approval holders, allowing them to sell NIOSH Approved CURs to
employers who are only able to purchase NIOSH Approved respirators as
well as those who currently use non-NIOSH Approved CUR but wish to use
NIOSH Approved respirators. Such employers are likely to include State
and local law enforcement agencies in states that have an OSHA-approved
State Plan, Department of Defense contractors, and private businesses
where workers encounter hazards in industrial settings.
HHS expects that employers who must supply workers on OSHA-
regulated jobsites with more than one type of NIOSH Approved respirator
to protect them from more than one type of inhalational hazard would
see a cost savings when those respirators are replaced with one NIOSH
Approved CUR. Employers may also save resources by reducing employee
trainings on multiple types of respirators.
Finally, the performance requirements proposed in this rulemaking
are designed to protect workers relying on CURs for their survival in
IDLH atmospheres better than combination respirators approved pursuant
to 42 CFR 84.63(b) or CURs that are not approved to any performance
standard. CURs approved under this new subpart will

[[Page 18872]]

demonstrate that the NIOSH Approved CUR maintains a minimum level of
protection when the modes of protection are switched by the user, as
needed to perform their work. The concurrent NFPA 1987 approval issued
by NIOSH and the ISO 17065 certification body ensures minimum
performance is demonstrated for the respiratory and non-respiratory
requirements needed to protect these users. Although HHS lacks
information on the number of workers annually who rely on a CUR for
their survival and the quantifiable benefit they would derive from this
rule, HHS anticipates that the use of NIOSH Approved CURs will result
in cost savings associated with reducing illness, death, or disability
resulting from work in IDLH atmospheres.
HHS encourages submission to the docket of any information or data
that would inform our understanding of the impact of this rulemaking on
regulated entities.

B. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires each agency to consider the potential impact of its
regulations on small entities, including small businesses, small
governmental units, and small not-for-profit organizations. The
Secretary certifies that this proposed rule would have ``no significant
economic impact upon a substantial number of small entities'' within
the meaning of the RFA. HHS estimates that two manufacturers considered
to be small businesses are currently producing combination unit
respirators used in military, law enforcement, and some industrial
settings. HHS expects that any economic burden accrued through
compliance with this rulemaking would not disproportionately or
unfairly impact small CUR manufacturers and that any such burden would
be offset by economic gains from compliance with the new CUR
performance standard.

C. Paperwork Reduction Act

The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires
an agency to invite public comment on, and to obtain OMB approval of,
any regulation that requires 10 or more people to report information to
the agency or to keep certain records. The Office of Management and
Budget (OMB) has already approved the information collection and
recordkeeping requirements for certification and approval of
respiratory protective devices under OMB Control Number 0920-0109,
Information Collection Provisions in 42 CFR Part 84--Tests and
Requirements for Certification and Approval of Respiratory Protective
Devices (expiration date March 31, 2024). Due to this proposed rule,
which would allow for the NIOSH approval of respirators in a new class,
combination unit respirators, there is likely to be a change in burden
in the approved collection of information.
Comments are invited on the following: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Agency, including whether the information will
have practical utility; (b) the accuracy of the Agency's estimate of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents. Written comments must be received within 60
days of the publication of this notice. The addition of additional
paperwork requirements resulting from this proposed rule will increase
the burden associated with the addition of a new 42 CFR part 84,
subpart P.
Based on known manufacturers of combination unit respirators on the
market, NIOSH estimates that up to 5 respirator manufacturers may
submit approximately 15 applications for CUR approvals to the National
Personal Protective Technology Laboratory from April 2024 to April
2025. Each application is expected to require an average of 240 hours
to complete and maintain.
Accordingly, NIOSH expects 3,600 burden hours to be attributed to
applications for CUR approvals under the new subpart P. NIOSH estimates
an average hourly wage rate of $47.39 for industrial engineers.\14\
---------------------------------------------------------------------------

\14\ U.S. Bureau of Labor Statistics, Occupational Employment
and Wages, May 2022: 1702112 Industrial Engineers, <a href="https://www.bls.gov/oes/current/oes172112.htm">https://www.bls.gov/oes/current/oes172112.htm</a>.

----------------------------------------------------------------------------------------------------------------
Average Average burden
Section Title Number of responses per per response Total burden
respondents respondent (hr) (hr)
----------------------------------------------------------------------------------------------------------------
84.400...................... Combination unit 5 3 240 3,600
respirators
(CUR);
description.
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
Total burden Estimated
Section Title hours (from hourly wage Total cost of
above) rate hour burden
----------------------------------------------------------------------------------------------------------------
84.400.............................. Combination unit 3,600 $47.39 $170,604
respirators (CUR);
description.
----------------------------------------------------------------------------------------------------------------

D. Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2
U.S.C. 1531 et seq.) directs agencies to assess the effects of Federal
regulatory actions on State, local, and Tribal governments, and on the
private sector ``other than to the extent that such regulations
incorporate requirements specifically set forth in law.'' Section 202
of the UMRA also requires that agencies assess anticipated costs and
benefits before issuing any rule whose mandates require spending in any
1 year of $100 million in 1995 dollars, updated annually for inflation.
In 2023, that threshold is approximately $177 million. This proposed
rule does not mandate any requirements for State, local, or tribal
governments, or for the private sector, and this rule would not impose
a mandate that will result in the expenditure by State, local, and
Tribal governments, in the aggregate, or by the private sector, of more
than $177 million in any 1 year.

E. Executive Order 12988 (Civil Justice Reform)

This proposed rule has been drafted and reviewed in accordance with
Executive Order 12988 and will not unduly burden the Federal court
system. This proposed rule has been

[[Page 18873]]

reviewed carefully to eliminate drafting errors and ambiguities.

F. Executive Order 13132 (Federalism)

HHS has reviewed this proposed rule in accordance with Executive
Order 13132 regarding federalism and has determined that it does not
have ``federalism implications.'' The rule does not ``have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''

G. Executive Order 13045 (Protection of Children From Environmental
Health Risks and Safety Risks)

In accordance with Executive Order 13045, HHS has evaluated the
environmental health and safety effects of this proposed rule on
children. HHS has determined that the proposed rule would have no
environmental health and safety effect on children.

H. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)

In accordance with Executive Order 13211, HHS has evaluated the
effects of this proposed rule on energy supply, distribution, or use,
and has determined that the proposed rule will not have a significant
adverse effect.

I. Plain Writing Act of 2010

Under Public Law 111-274 (October 13, 2010), executive Departments
and Agencies are required to use plain language in documents that
explain to the public how to comply with a requirement the Federal
government administers or enforces. HHS has attempted to use plain
language in issuing the notice of proposed rulemaking consistent with
the Federal Plain Writing Act guidelines but notes that these standards
are technical in nature.

List of Subjects in 42 CFR Part 84

Fees, Incorporation by reference, Labeling, Laboratories, Mine
safety and health, Occupational safety and health, Personal protective
equipment, Respirators.
For the reasons discussed in the preamble, the Department of Health
and Human Services proposes to amend 42 CFR part 84 as follows:

PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

0
1. The authority citation for Part 84 continues to read as follows:

Authority: 29 U.S.C. 651 et seq., and 657(g); 30 U.S.C. 3, 5,
7, 811, 842(h), 844.

Subpart A--General Provisions

0
2. Amend Sec. 84.2 by revising the definition for ``Applicant'' and
adding the definitions for ``Approval holder'' and ``NIOSH Certified
Equipment List'' in alphabetical order to read as follows:

Sec. 84.2 Definitions.

Applicant means an individual, partnership, company, corporation,
association, or other organization that controls the design,
manufactures, and controls the assembly of a respirator and who seeks
to obtain a certificate of approval for such respirator. The applicant
demonstrates responsibility for, and control of, product design,
performance, configuration management, manufacture, quality, and
support. The applicant may be an existing approval holder.
* * * * *
Approval holder means an applicant who has successfully received
and maintains at least one approval currently listed on the NIOSH
Certified Equipment List. The approval holder maintains responsibility
for, and control of, product design, performance, configuration
management, quality, and support.
* * * * *
NIOSH Certified Equipment List (CEL) means a directory maintained
by NIOSH of respirators which have been granted approval.
* * * * *

Subpart B--Application for Approval

Sec. 84.10 [Amended]

0
3. Amend Sec. 84.10(d) by replacing ``manufacturers'' with ``approval
holders''.

Subpart C--Fees

Sec. 84.22 (c) [Amended]

0
4. Amend Sec. 84.22(c) by removing ``manufacturer'' and adding in its
place ``applicant or approval holder''.

Subpart D--Approval and Disapproval

Sec. 84.30 [Amended]

0
5. Amend Sec. 84.30(a) by removing ``H through L'' and adding in its
place ``H through P''.

Subpart F--Classification of Approved Respirators; Scope of
Approval; Atmospheric Hazards; Service Time

Sec. 84.50 [Amended]

0
6. Amend Sec. 84.50 by removing ``G through L'' and adding in its
place ``G through P''.

Sec. 84.51 [Amended]

0
7. Amend Sec. 84.51 by removing ``H through L'' and adding in its
place ``H through P''.

Sec. 84.52 [Amended]

0
8. Amend Sec. 84.52 by removing ``H through L'' and adding in its
place ``H through P''.

Sec. 84.53 [Amended]

0
9. Amend Sec. 84.53(a) by removing ``H through L'' and adding in its
place ``H through P''.

Subpart G--General Construction and Performance Requirements

Sec. 84.60 [Amended]

0
10. Amend Sec. 84.60(a) by removing ``H through O'' and adding in its
place ``H through P'' and (b) by removing ``H through L'' and adding in
its place ``H through P''.

Sec. 84.63 [Amended]

0
11. Amend Sec. 84.63 by:
0
A. In paragraphs (a) and (c) remove ``H through O'' and add in its
place ``H though P''.
0
B. In paragraph (b) removing the phrase ``except as specified in Sec.
84.70(b)(2)'' and adding in its place the phrase ``except as specified
in Sec. 84.70(b)(2) and subpart P''.

Sec. 84.64 [Amended]

0
12. Amend Sec. 84.64 by removing ``H through O'' and adding in its
place ``H through P''.

Sec. 84.65 [Amended]

0
13. Amend Sec. 84.65 by removing ``H through O'' and adding in its
place ``H through P''.

Subpart J--Supplied-Air Respirators

Sec. 84.149 [Amended]

0
14. In Sec. 84.149, amend paragraph (b) by removing ``manufacturer''
and adding in its place ``applicant'' and amend paragraph (d)(2) by
removing ``manufacturer's'' and adding in its place ``applicant's''.

Subpart K--Air-Purifying Particulate Respirators

Sec. 84.171 [Amended]

0
15. Amend Sec. 84.171(b) by removing ``The respirator manufacturer, as
part of the application for certification,'' and adding in its place
``The applicant''.

Sec. 84.172 [Amended]

0
16. Amend Sec. 84.172(b) by removing ``manufacturer'' and adding in
its place ``applicant''.

[[Page 18874]]

Subpart N--Special Use Respirators

Sec. 84.252 [Amended]

0
17. Amend Sec. 84.252 by removing ``manufacturer's'' and removing ``a
manufacturer'' and adding in its place ``an applicant''.

Sec. 84.257 [Amended]

0
18. Amend Sec. 84.257(a) by removing ``manufacturer's'' and adding in
its place ``approval holder's''.

Subpart O--Closed-Circuit Escape Respirators

Sec. 84.301 [Amended]

0
19. Amend Sec. 84.301(c) by removing ``manufacturer-requested'' and
adding in its place ``approval holder-requested''.

Sec. 84.302 [Amended]

0
20. Amend Sec. 84.302(a)(2) and (c) by removing ``manufacturer'' and
adding in its place ``applicant''.

Sec. 84.304 [Amended]

0
21. Amend Sec. 84.304(a)(3) and (c) by removing ``manufacturer'' and
adding in its place ``applicant''.

Sec. 84.305 [Amended]

0
22. Amend Sec. 84.305(d) by removing ``manufacturer's'' and adding in
its place ``applicant's''.

Sec. 84.306 [Amended]

0
23. Amend Sec. 84.306(b)(1) by removing ``manufacturer'' and adding in
its place ``applicant''.

Sec. 84.309 [Amended]

0
24. Amend Sec. 84.309(d) by removing ``manufacturer'' and adding in
its place ``applicant''.
0
25. Add subpart P to read as follows:

Subpart P--Combination Unit Respirators

Sec.
84.400 Combination unit respirators (CUR); description.
84.401 Technical specifications and performance requirements.
84.402 General construction and approval requirements.

Sec. 84.400 Combination unit respirators (CUR); description.

(a) Combination unit respirators including all completely assembled
respirators are designed for use as respiratory protection during:
(1) Entry into or escape from atmospheres immediately dangerous to
life or health, when active in the open-circuit self-contained
operational mode, and
(2) Entry into atmospheres not immediately dangerous to life or
health, or escape only from hazardous atmospheres containing adequate
oxygen to support life when active in the air-purifying or powered air-
purifying operational mode.
(b) A respirator that meets the minimum requirements for such
respirators set forth in this subpart will be classified as a
combination unit respirator.

Sec. 84.401 Technical specifications and performance requirements.

(a) Combination unit respirators must meet those respiratory
protection performance requirements established in NFPA 1987, Standard
on Combination Unit Respirator Systems for Tactical and Technical
Operations, 2023 edition, specified in paragraphs (a)(1), (2), (3), and
(4) of this section. Accordingly, the NFPA 1987 performance
requirements in Chapter 7, specified in paragraphs (a)(1), (2), (3,),
and (4), are incorporated by reference into this section and have been
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. This material is available for
inspection at the National Institute for Occupational Safety and Health
(NIOSH) and at the National Archives and Records Administration (NARA).
Contact NIOSH at National Personal Protection Technology Laboratory,
P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236. To
arrange for an inspection at NIOSH, call 412-386-6111 or email
<a href="/cdn-cgi/l/email-protection#ca9a9a8f89a5a4a9afb8a4b98aa9aea9e4ada5bc"><span class="__cf_email__" data-cfemail="2d7d7d686e42434e485f435e6d4e494e034a425b">[email&#160;protected]</span></a>. For information on the availability of this
material at NARA, visit <a href="http://www.archives.gov/federal-register/cfr/ibr-locations">www.archives.gov/federal-register/cfr/ibr-locations</a> or email <a href="/cdn-cgi/l/email-protection#e48296ca8d8a97948187908d8b8aa48a859685ca838b92"><span class="__cf_email__" data-cfemail="afc9dd81c6c1dcdfcaccdbc6c0c1efc1ceddce81c8c0d9">[email&#160;protected]</span></a>. The material may be obtained
from the National Fire Protection Association at: phone: 800-344-3555;
email: <a href="/cdn-cgi/l/email-protection#b8dbcdcbcccbddcacef8d6dec8d996d7cadf"><span class="__cf_email__" data-cfemail="9cffe9efe8eff9eeeadcf2faecfdb2f3eefb">[email&#160;protected]</span></a>; website: <a href="https://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=1987">https://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=1987</a>.
(1) CUR system performance requirements:

------------------------------------------------------------------------
NFPA 1987
NFPA 1987 performance requirements section
------------------------------------------------------------------------
(i) Chemical Agent Permeation and Penetration Resistance 7.1.1
against Distilled Sulfur Mustard (HD) and Sarin (GB)
Performance Requirements..................................
(ii) Laboratory Respiratory Protection Level (LRPL)........ 7.1.2
(iii) Flexible Facepiece Lens Abrasion Resistance 7.1.5
Performance...............................................
------------------------------------------------------------------------

(2) CUR/open-circuit self-contained mode performance requirements:

------------------------------------------------------------------------
NFPA 1987
NFPA 1987 performance requirements section
------------------------------------------------------------------------
(i) Service Time Performance............................... 7.2.2
(ii) Human Subject Performance Test for Low-Temperature 7.2.3
Operations................................................
(iii) Human Subject Performance Tests During Physical 7.2.4
Exertions.................................................
(iv) Integrity of Couplings Performance.................... 7.2.5
(v) CUR Standby Air Supply Airflow Performance............. 7.2.6
(vi) CUR Connection to a Standby Air Source Performance.... 7.2.7
(vii) CUR Air Flow Capabilities in Event of Second-Stage 7.2.8
Regulator Failure Performance.............................
(viii) CUR Gauge Accuracy Performance...................... 7.2.9
------------------------------------------------------------------------

[[Page 18875]]

(3) CUR/powered air-purifying mode performance requirements:

(4) CUR/air-purifying mode performance requirements:

------------------------------------------------------------------------
NFPA 1987
NFPA 1987 performance requirements section
------------------------------------------------------------------------
(i) Breathing Resistance................................... 7.4.1
(ii) Hydration Leakage..................................... 7.4.2
(iii) Canister Test Challenge and Test Breakthrough 7.4.3
Concentrations............................................
(iv) Particulate/Aerosol Canister.......................... 7.4.4
(v) Low-Temperature/Fogging................................ 7.4.5
(vi) ESLI Drop Test for Canisters.......................... 7.4.6
(vii) ESLI Test for Canisters.............................. 7.4.7
------------------------------------------------------------------------

(b) To the extent there is a conflict between the terms or
provisions of NFPA 1987 and this part, the provisions of this part
control.

Sec. 84.402 General construction and approval requirements.

(a) Each CUR must meet the minimum construction requirements set
forth in subpart G of this part.
(b) Applications for NFPA 1987 certification must be submitted to a
conformity assessment body accredited to ISO/IEC 17065, Conformity
Assessment--Requirements for Bodies Certifying Products, Processes and
Services, at the same time the CUR approval application is submitted to
NIOSH. NIOSH approval is contingent upon and will be issued in
conjunction with NFPA 1987 certification.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-03849 Filed 3-14-24; 8:45 am]
BILLING CODE 4163-18-P

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