[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 [www.gpo.gov]
[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:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments to the docket.
     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 http://www.regulations.gov. 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 
[email protected].

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 https://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=1987.
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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, http://www.cdc.gov/niosh/docket/archive/docket082.html.
    \6\ NIOSH Docket Number 082-A [Dec. 2010], Chemical, Biological, 
Radiological and Nuclear (CBRN) Combination Respirator Unit (CRU), 
http://www.cdc.gov/niosh/docket/archive/docket082A.html.
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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, https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/Manufacturers/pdfs/lttr-02032015-508.pdf.
    \8\ NIOSH-NPPTL [Feb. 18, 2015], Webinar Concerning Standard for 
Performance Requirements of the Combination Unit Respirator, https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/interestedparties/pdfs/lttr-02182015-508.pdf.
    \9\ https://www.nationalacademies.org/our-work/developing-a-performance-standard-for-combination-unit-respirators-a-workshop
    \10\ Institute of Medicine of the National Academies [2015], 
Developing a Performance Standard for Combination Unit Respirators--
Workshop in Brief; https://nap.nationalacademies.org/read/21765/chapter/1.
    \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 https://wwwn.cdc.gov/niosh-cel/.

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, www.nfpa.org. All NFPA codes and 
standards can be viewed at no cost at nfpa.org/docinfo.

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$]
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                                                                  Estimated first-year    Estimated annual costs
                             Fees                                 costs for 1 approval        for 1 approval
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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
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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, https://www.bls.gov/oes/current/oes172112.htm.

----------------------------------------------------------------------------------------------------------------
                                                                      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 
[email protected]. For information on the availability of this 
material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The material may be obtained 
from the National Fire Protection Association at: phone: 800-344-3555; 
email: [email protected]; website: https://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=1987.
    (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:

------------------------------------------------------------------------
                                                              NFPA 1987
             NFPA 1987 performance requirements                section
------------------------------------------------------------------------
(i) PAPR Airflow Performance...............................        7.3.1
(ii) PAPR Silica Dust Loading Performance..................        7.3.2
(iii) Airflow Resistance Performance in Breath-Responsive,         7.3.3
 Powered Air-Purifying Respirators.........................
(iv) PAPR Performance with the Blower Off..................        7.3.4
------------------------------------------------------------------------

    (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