[Federal Register Volume 85, Number 72 (Tuesday, April 14, 2020)]
[Rules and Regulations]
[Pages 20598-20611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07804]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 84
[Docket No. CDC-2020-0036; NIOSH-335]
RIN 0920-AA69
Approval Tests and Standards for Air-Purifying Particulate
Respirators
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Interim final rule with comment.
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SUMMARY: The Department of Health and Human Service (HHS) is publishing
this interim final rule to update the regulatory requirements used by
the Centers for Disease Control and Prevention's (CDC) National
Institute for Occupational Safety and Health (NIOSH) to test and
approve air-purifying particulate respirators for use in the ongoing
public health emergency. With this rulemaking, parallel performance
standards are added to existing regulatory requirements for PAPRs to
allow for the approval of respirators in a new class, PAPR100, that may
be better suited to the needs of workers in the healthcare and public
safety sectors currently experiencing a shortage of air-purifying
particulate respirators due to Coronavirus Disease 2019 (COVID-19), the
disease caused by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2). This rulemaking also consolidates the technical standards
for all types of air-purifying particulate respirators into one
subpart, and standards pertaining to obsolete respirators designed for
dust, fume, and mist; pesticide; and paint spray are removed from the
regulation entirely. This rulemaking will have no substantive impact on
the continued certification testing and approval by the NIOSH National
Personal Protective Technology Laboratory of existing PAPR class HE
(high-efficiency series) respirators or non-powered air-purifying
particulate respirators, including N95 filtering facepiece respirators,
currently in demand by healthcare workers and emergency responders.
NIOSH expects
[[Page 20599]]
that the addition of PAPR100 devices to the marketplace will help to
relieve the current high demand for possibly hundreds of thousands of
additional particulate filtering facepiece respirators needed
specifically for healthcare and emergency medical response settings.
DATES: This rule is effective on April 14, 2020. Comments must be
received by August 12, 2020.
ADDRESSES:
Written comments: Comments 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-2020-0036; NIOSH-335) or Regulation Identifier Number (0920-AA69)
for this rulemaking. All relevant comments, including any personal
information provided, will be posted without change to http://www.regulations.gov. 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 Palcic, NIOSH National
Personal Protective Technology Laboratory (NPPTL), Pittsburgh, PA,
(412) 386-5247 (this is not a toll-free number). Information requests
can also be submitted by email to [email protected].
SUPPLEMENTARY INFORMATION:
I. Public Participation
Interested parties may 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 not intended to be disclosed
should not be included. Comments may be submitted on any topic related
to this interim final rulemaking, including the following:
[ssquf] What operational and/or functional characteristics should
be considered in establishing a standard for a healthcare PAPR?
[ssquf] Should there be more than one class of healthcare PAPR, for
example, surgical versus non-surgical?
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 respirators to their
employees whenever the employer requires the use of a respirator. (29
CFR 1910.134(d))
III. Background
A. Introduction
Air-purifying respirators use either filters, cartridges, or
canisters (or combinations of filters and cartridges or filters and
canisters), to protect users from gases; vapors; aerosols, including
viruses capable of being transmitted by aerosolized droplets; and other
contaminants in the air. Since these respirators simply purify the
ambient atmosphere and do not provide an independent supply of
breathing air to the wearer, most types cannot be used in atmospheres
that are immediately dangerous to life and health (IDLH).\1\ Air-
purifying particulate respirators, a subclass of air-purifying
respirators, are approved by NIOSH pursuant to 42 CFR part 84.
Currently, testing and performance standards for non-powered air-
purifying particulate respirators are codified in part 84, subpart K;
standards for powered air-purifying particulate respirators are
codified in subpart KK.
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\1\ With the exception of gas masks designed for escape from
IDLH atmospheres. See 42 CFR 84, subpart I--Gas Masks.
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Non-powered air-purifying particulate respirators include filtering
facepiece respirators and elastomeric half- and full-facepiece
respirators, and are used in a very wide variety of work settings.
Powered air-purifying particulate respirators (PAPRs) are used in
many similar work settings and are distinguished from the non-powered
type by the powered blower that moves air through the attached filters,
canisters, and/or cartridges. This respirator type comes in a variety
of sizes, weights, and mounting configurations. PAPRs play an integral
role in respiratory protection programs across multiple sectors,
including general industry, healthcare, and police operations.
Current regulatory standards provide for the NIOSH approval of
high-efficiency (HE) particulate filters which are incorporated into
PAPRs. The NIOSH National Personal Protective Technology Laboratory has
determined the need for increasing the utility of PAPRs in the
workplace and offering a wider array of options for today's work
practices. Although the current PAPR approval program has proven
protections, these interim requirements offer the potential to extend
the same proven level of protection to smaller, lighter systems which
may be more comfortable to wear, as discussed below.
B. PAPR Certification and Approval
NIOSH currently approves PAPRs under 42 CFR part 84, Approval of
Respiratory Protective Devices. Within part 84, subpart KK, Dust, Fume
and Mist; Pesticide; Paint Spray; Powered Air-Purifying High Efficiency
Respirators and Combination Gas Masks, specifies testing and
certification requirements for PAPRs with high-efficiency particulate
filters. NIOSH reviews and approves such respirators for use, for
example, by industrial, healthcare, and public safety workers.
C. Scope of the Rulemaking
This rulemaking applies to air-purifying particulate respirators
and gas and vapor respirators which also incorporate a particulate
filter. NIOSH is (1) consolidating all air-purifying, particulate
respirator requirements, whether powered or non-powered, into subpart
K; (2) eliminating unneeded and archaic parts of the standard related
to PAPRs which were left in place since the 1995 promulgation of part
84; and (3) better aligning PAPR particulate filter testing for a new
class of PAPR with the requirements for non-powered particulate
respirators which were established in the 1995 rulemaking.
With this rulemaking, a new class of PAPR is established, PAPR100,
in parallel with the current PAPR class HE, to open opportunities for
designs offering the characteristics desired by many end-users, as
revealed through user-sector input following the public meetings in
2003-2008 and a 2014 Institute of Medicine workshop, discussed below.
PAPRs tested to the current requirements relocated from subpart KK are
designated series ``HE''; those requirements are otherwise unchanged.
PAPR100s tested to the new alternative testing and approval
requirements are designated either series ``PAPR100-N,'' which is not
for use against oil-based aerosols, or
[[Page 20600]]
``PAPR100-P,'' which is strongly resistant to oil aerosols.
Requirements for the current class HE are unchanged because those
devices have a proven track record and widespread use. The existing HE
requirements result in the approval of PAPRs that are well-suited to
heavy industry settings where the particulates of concern may be dense
in terms of their airborne concentration. In those settings, the PAPR
is often unavoidably challenged to remove a large quantity of larger,
non-respirable particles while it is doing the important work of
removing the much smaller, but much more hazardous, respirable-sized
particles. While the existing silica dust test specified in subpart KK
demonstrates a portion of the unit's ability to remove the respirable-
sized particles, it is a very good test to demonstrate the PAPR's
ability to provide ongoing filtration across the wider aerosol size
spectrum in these ``dirtier'' industrial settings. With this
rulemaking, NIOSH is promulgating a new standard for the new class
PAPR100, which replaces the silica dust test with a sodium chloride
aerosol when testing PAPR100-N series filters, and with a dioctyl
phthalate aerosol when testing PAPR100-P series filters. NIOSH will not
designate either class specifically for industrial or non-industrial
use, but it is thought that the PAPR class HEs will continue to be the
design of choice in industrial settings. Since protections provided by
the current class HE respirators are considered equivalent to the
protections expected by the new PAPR100 devices, respiratory safety
continues to be assured, regardless of the setting.
This rulemaking also eliminates the requirements for other obsolete
types of respirators, including dust, fume, and mist; pesticide; and
paint spray respirators identified in current subpart KK. Subpart KK is
removed from part 84 in its entirety.
D. Need for Rulemaking
PAPRs are often used in high-hazard procedures in the healthcare
setting because they are designed to filter chemicals, blood-borne
pathogens, and aerosol-transmissible diseases. However, the size and
weight of the PAPRs approved under the current regulations has been
said to limit their widespread adoption in healthcare and by first
responders. The current requirements for PAPR class HE (high-efficiency
series) contained in 42 CFR part 84 were established in 1972 primarily
for more industrial-type uses and exposures, such as mining and milling
operations. The silica dust loading test is currently incorporated
among the requirements which determine the PAPR filter efficiency. In
order to pass the silica dust test, current NIOSH-approved PAPRs must
provide a high flow of breathing air against a highly loaded filter for
a duration of 4 hours. This generally results in approved PAPRs having
blowers and batteries which may be inconveniently large, heavy, or
both. Respirator designers and end-users have expressed a desire for
greater latitude in the regulatory requirements in order to reduce the
bulk and weight of currently approved PAPR class HE devices, given the
advances in modern battery and sensor technology that would allow for
smaller, lighter designs with service durations continuously monitored
by required flow-detection devices.
During the past 20 years, PAPRs have played an increasing role in
respiratory protection programs in the United States in sectors beyond
general industry, including healthcare. PAPRs are also frequently
considered for public safety and other specialized industrial uses. The
2002 Severe Acute Respiratory Syndrome (SARS), the 2009 H1N1 influenza,
and the 2014 Ebola virus outbreaks ushered in more extensive use of
respiratory protection, and specifically PAPRs, for today's 18 million
healthcare workers.
In a 2014 assessment designed to quantify the amount of personal
protective equipment held in U.S. acute care hospitals, the Association
of States and Territorial Health Officials (ASTHO) estimated that acute
care hospitals across the United States had no more than 83,196 PAPRs
on-hand in 2012 compared with 114,694,159 N95s, demonstrating that the
currently approved PAPRs are not as widely-used in healthcare as the
N95s.\2\ However, the Association for Professionals in Infection
Control and Epidemiology (APIC) reported that healthcare employers are
expected to increase the relative number of PAPRs used in healthcare as
the devices become less expensive and lighter.\3\ PAPRs have a number
of advantages over N95 filtering facepiece respirators, including that
they are reusable and can be cleaned and disinfected, loose-fitting
PAPR do not need to be fit tested and often can be worn with facial
hair, and have a higher assigned protection factor (as determined by
the Occupational Safety and Health Administration in the Department of
Labor). Designs not requiring fit testing are expected to be especially
advantageous in a public health emergency, such as the Coronavirus
Disease 2019 (COVID-19) response, by saving resources including both
person-hours and the need to fit test multiple makes and models to find
the right fit for an individual worker. Loose-fitting PAPR designs are
also typically equipped with a head covering that delivers filtered air
over the user's entire head, including the eyes and hair, thus offering
greater overall protection from contact with any airborne infectious
agents.
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\2\ ASTHO, Assessment of Respiratory Personal Protective
Equipment in U.S. Acute Care Hospitals--2012 (2014).
\3\ See APIC public comment submitted to NIOSH Docket-272 for
National Institute for Occupational Safety and Health, CDC,
Respiratory Protective Devices Used in Healthcare; Notice of Request
for Information and Comment, 79 FR 14515 [March 14, 2014].
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Healthcare workers and first responders are on the front line of
efforts to contain COVID-19, the disease caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus is thought
to spread primarily by person-to-person contact through respiratory
droplets produced when an infected person coughs or sneezes; it may
also spread through contact with contaminated surfaces or objects. The
ease of SARS-CoV-2 transmission has resulted in a surge in
hospitalizations in many jurisdictions, resulting in a well-documented
shortage of personal protective equipment, especially respiratory
protection, for healthcare workers and emergency responders. An APIC
survey conducted March 23-24, 2020 found that 20 percent of respondents
indicated they do not have any respirators and 61 percent of
respondents indicated they are almost out of respirators. Only 18
percent of respondents said they have a sufficient number of
respirators.\4\
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\4\ APIC, Protecting Healthcare Workers During the COVID-19
Pandemic: A Survey of Infection Preventionists (March 27, 2020),
https://apic.org/wp-content/uploads/2020/03/Protecting-Healthcare-Workers-Survey_Report_3_26_20_Final.pdf.
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Between March 16 and April 3, 2020, five potential approval holders
seeking to develop PAPRs to support the COVID-19 response solicited
NIOSH to explore the possibility of producing PAPRs for healthcare and
emergency responders to increase the inventory of PAPRs across the
nation. NIOSH expects that PAPR100s will be purchased to replace the
current inventory of larger class HE devices designed for industrial
use, as well as to substitute for the use of disposable N95 filtering
facepiece respirators which require fit testing for effective use.
NIOSH expects that the addition of PAPR100 devices to the marketplace
will help to relieve the current high demand for possibly hundreds of
[[Page 20601]]
thousands of additional particulate filtering facepiece respirators
designed specifically for healthcare settings.
E. History of the PAPR100 Concept
NIOSH held a series of public meetings from 2003 through 2008 to
discuss technical issues regarding a new PAPR concept.\5\ Participants
raised issues regarding the existing PAPR certification requirements
and offered input on the need to eliminate the silica dust test and
incorporate warnings for low air flow, pressure, and/or battery life.
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\5\ Transcripts of the public meetings as well as presentations
and submissions from interested parties are available in NIOSH
Dockets 008 and 008a.
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In response to the growing number of PAPRs in healthcare, NIOSH
sponsored an Institute of Medicine (IOM) workshop on the ``Use and
Effectiveness of PAPRs in Healthcare'' in 2014.\6\ The intent of the
workshop was to assist NIOSH with prioritizing and updating approval
requirements for NIOSH-approved PAPRs suitable for use in the
healthcare sector. IOM workshop participants included government
agencies, healthcare institutions, professional associations,
respirator manufacturers, and unions representing healthcare workers. A
general finding from the IOM workshop stated that current PAPR
requirements are not always suitable for the healthcare work
environment. Workshop participants indicated that powered air-purifying
respirators should have the following attributes:
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\6\ IOM [2015], The Use and Effectiveness of Powered Air
Purifying Respirators in Health Care: Workshop Summary (National
Academies Press: Washington, DC).
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Suitable for use in sterile field;
Good visibility and communication;
Ease of donning, doffing, and cleaning;
Variable flows based on work rates;
Smaller and less bulky;
Sensors and alarms that monitor flow and power; and
Training materials as part of certification.
In addition to the IOM workshop, NIOSH reached out to the
International Safety Equipment Association (ISEA) and 10 manufacturers
of NIOSH-approved PAPRs in August and September 2016 to better
understand how current requirements impact PAPR designs and how today's
technologies are being integrated into PAPR designs. According to the
input NIOSH received, the aerosol threat in the healthcare setting, as
compared with the industrial settings the current PAPR class HE
requirements in part 84 are designed to address, is composed mainly of
respirable-sized (or smaller) particles, with practically no other
larger particles in the mix. Therefore, the ability to continue to
provide needed air flow against high total filter loading is not a
necessary consideration for PAPRs suitable for use in the healthcare
setting. These experts indicated the following main areas of concern:
1. Silica dust testing adds to the size and weight of PAPR
systems.
2. Silica dust test equipment is outdated and the test is a
challenge to reproduce, not representative of today's workplace dust
conditions, and requires operational safeguards to avoid the test
operator's hazardous exposure to silica dust.
3. If the PAPR continuously monitors critical conditions such as
flow, pressure, and battery life, the silica dust test would not be
needed since the complete system is also evaluated with a
quantitative human subject testing (corn oil test).
4. Technologies such as sensors and alarms for monitoring
airflow rate, battery life, facepiece pressure, and other critical
components are being integrated into many of today's PAPR designs.
The current PAPR requirements prevent these technologies from being
fully deployed.
NIOSH presented its new PAPR concept at the 2016 biennial
International Society for Respiratory Protection (ISRP) conference in
Yokohama, Japan and the 2017 meetings of the ISRP Americas Section in
Pittsburgh, Pennsylvania and the National Academies Standing Committee
on Personal Protective Equipment for Workplace Safety and Health.
Attendees of these meetings generally supported the concepts presented.
By modifying and replacing some of the current PAPR requirements,
NIOSH would enable manufacturers to take advantage of contemporary
technology that could result in smaller and lighter-weight PAPRs having
the same effective particulate protections while increasing workplace
utility for today's diverse workforces. The addition of requirements
for NIOSH-approved PAPRs intended for healthcare and other settings
with lower overall particulate presence would allow stakeholders to
incorporate additional technologies such as integrated circuits,
sensors, batteries, motors, plastics, and fabrics to improve PAPR
designs intended to be used in cleaner settings, such as healthcare.
F. Impact on Rulemaking and Other Activities of OSHA
The interim final rule would not require OSHA to make any changes
to 29 CFR 1910.134, the OSHA respiratory protection requirements.
IV. Issuance of an Interim Final Rule With Immediate Effective Date
Rulemaking under the Administrative Procedure Act (APA) generally
requires a public notice and comment period and consideration of the
submitted comments prior to promulgation of a final rule (5 U.S.C.
553). However, the APA provides for exceptions to its notice and
comment procedures when an agency finds that there is good cause for
dispensing with such procedures on the basis that they are
impracticable, unnecessary, or contrary to the public interest. In
accordance with the provisions in 5 U.S.C. 553(b)(B), HHS finds good
cause to waive the use of prior notice and comment procedures for this
interim final rule and to make this action effective immediately.
This interim final rule amends 42 CFR part 84 to allow respirator
manufacturers to produce an equally protective or equivalent new class
of PAPR, the PAPR100, including both N-series and P-series particulate
respirators, designed for use in healthcare or other workplace settings
that will benefit the most from smaller, lighter devices. HHS has
determined that it is impracticable to use prior notice and comment
procedures for this interim final rule because of the ongoing public
health emergency. As discussed above, respirator manufacturers have
participated in discussions with NIOSH about the need for these new
standards and are generally supportive of this effort. Recently, some
manufacturers have notified NIOSH that they are ready to submit
approval applications for PAPR100s that would be employable in the
current public health emergency as soon as the effective date of this
interim final rule. Thus, HHS is waiving the prior notice and comment
procedures in the interest of protecting the health of healthcare
workers and emergency responders who are on the front lines of the
current public health emergency as soon as possible.
Under 5 U.S.C. 553(d)(3), HHS also finds good cause to make this
interim final rule effective immediately. As stated above, in order to
protect the health of healthcare workers and emergency responders, it
is necessary that HHS act quickly to amend the existing standards in 42
CFR part 84 to allow NIOSH to approve a new class of PAPR suitable for
use in healthcare settings. The addition of this new class of
respirator to the market will improve safety of healthcare workers
because it will result in the development of PAPRs that are less bulky,
less noisy, and more suitable for use in healthcare and emergency
response settings to meet the
[[Page 20602]]
immediate needs of those treating patients during the COVID-19
pandemic. The cost of these devices is expected to be lower than the
costs of PAPRs currently on the market. Loose-fitting PAPRs do not
require fit testing, and because the devices are reusable and have a
higher filter efficiency and higher assigned protection factor, thus
they are a cost-effective alternative to other respiratory protective
devices currently on the market. Because these PAPRs are reusable, it
is likely that 1 percent of the stock of PAPRs would be required
compared to that of single-use items such as the N95 filtering
facepiece respirator, assuming the ability to reuse a PAPR one hundred
times. Healthcare organizations using PAPRs in healthcare settings have
reported cleaning their PAPR filters for several years prior to
replacement, which is well beyond the 1 percent estimate.
While amendments to part 84 are effective on the date of
publication of this interim final rule, we request public comment on
this rule. After full consideration of public comments, HHS will
publish a final rule with any necessary changes. (See Section I. Public
Participation, above.)
V. Summary of Interim Final Rule
As discussed above, this interim final rule consolidates all air-
purifying particulate respirator requirements in 42 CFR part 84,
subpart K, and establishes alternative requirements for the testing and
approval of class PAPR100 respirators designed for use in settings such
as healthcare, public safety, and other workplaces that require or
otherwise place a premium on the use of smaller, lighter devices. Other
existing sections in part 84 that reference subpart KK are updated as
necessary.
The table directly below matches the reorganized part 84, subpart
K, with the originating sections in the current regulation. These
changes are discussed in full below the table.
Reorganization and Section Title Amendments
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Interim final rule section Originating section
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84.170(a).................... Non-powered air-purifying 84.170...................... Non-powered air-
particulate respirators purifying particulate
(series N, R, and P). respirators;
description.
84.170(b).................... Powered air-purifying 84.1100(d).................. Scope and effective
particulate respirators dates--powered air-
(PAPR classes HE and purifying particulate
PAPR100). respirator.
84.1130(a)(4)............... Respirators,
description--air-
purifying respirators.
New for PAPR100 class.
84.171....................... Required components and 84.171...................... Non-powered air-
attributes. purifying particulate
respirators; required
components.
84.1131..................... Respirators; required
components.
84.171(a).................... Respiratory inlet 84.175...................... Half-mask facepiece,
covering. full facepiece, hoods,
helmets, and
mouthpieces; fit;
minimum requirements.
84.171(a)................... Non-powered air-
purifying particulate
respirators; required
components.
84.1135..................... Half-mask facepiece,
full facepiece, hoods,
helmets, and
mouthpieces; fit;
minimum requirements.
84.1136..................... Facepieces, hoods, and
helmets; eyepieces;
minimum requirements.
84.171(b)(1)................. Filters for non-powered 84.179...................... Non-powered air-
respirators. purifying particulate
respirators; filter
identification.
84.171(b)(2)................. Filters for powered 84.1130(a)(4)............... Respirators;
respirators. description--Powered
air-purifying
particulate
respirators; filter
identification.
84.171(c).................... Valves................... 84.177 84.1137.............. Inhalation and
exhalation valves;
minimum requirements.
84.171(d).................... Head harness............. 84.178, 84.1138............. Head harness; minimum
requirements.
84.171(e).................... Breathing tube........... 84.172 84.1132.............. Breathing tubes; minimum
requirements.
84.171(f).................... Drink tube............... ............................ New.
84.171(g).................... Container................ 84.174 84.1134.............. Respirator containers;
minimum requirements.
84.171(h).................... Harness.................. 84.173 84.1133.............. Harnesses; Installation
and construction;
minimum requirements.
84.171(i).................... Attached blower.......... 84.1156(f).................. Minimum air flows.
84.171(j).................... Low-flow warning device.. ............................ New.
84.172....................... Airflow resistance test.. 84.180...................... Airflow resistance
tests.
84.1156(a)(1) and (2)....... Pesticide respirators;
performance
requirements; general--
breathing resistance
test.
84.1157(a).................. Chemical cartridge
respirators with
particulate filters;
performance
requirements; general--
breathing resistance
test.
84.173....................... Exhalation valve leakage 84.182 84.1150.............. Exhalation valve leakage
test. test; minimum
requirements.
84.174....................... Filter efficiency level 84.181...................... Non-powered air-
determination test--non- purifying particulate
powered series N, R, and filter efficiency level
P filtration. determination.
84.175....................... Instantaneous filter 84.1151..................... DOP filter test.
efficiency level 84.1156(c)(2)............... Pesticide respirators;
determination test--PAPR performance
series HE, PAPR100-N, requirements; general--
and PAPR100-P filtration. silica dust test.
84.176(a).................... Isoamyl acetate (IAA) fit 84.1156(b)(5)............... Pesticide respirators;
test. performance
requirements; general--
isoamyl acetate
tightness test.
84.176(b).................... Generated Aerosol........ ............................ New.
84.177....................... Total noise level test-- 84.1139..................... Air velocity and noise
PAPR classes HE and levels; hoods and
PAPR100. helmets.
[[Page 20603]]
84.178....................... Breath response type, ............................ New.
airflow resistance test--
PAPR classes HE and
PAPR100.
84.179....................... Silica dust loading test-- 84.1144..................... Silica dust test for
PAPR series HE dust, fume, and mist
filtration. respirators; single-use
or reusable filters;
minimum requirements.
84.1152..................... Silica dust loading
test.
84.180....................... Particulate loading test-- ............................ New.
PAPR series PAPR100-N
and PAPR100-P filtration.
84.181....................... Communication performance ............................ New.
test--class PAPR100.
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Section 84.2 Definitions
In this existing section, located in 42 CFR part 84, subpart A, HHS
adds definitions for the terms ``respiratory inlet covering,'' ``tight
fitting,'' ``loose fitting,'' and ``warning device.''
Section 84.126 Canister Bench Tests; Minimum Requirements
In this existing section in subpart I--Gas Masks, a new paragraph
(f) specifies that PAPRs designed with one or more canisters and
particulate filters must meet the end-of-service-life requirements both
as received from the applicant and after being equilibrated at room
temperature.
Section 84.207 Bench Tests; Gas and Vapor Tests; Minimum Requirements;
General
In this existing section in subpart L--Chemical Cartridge
Respirators, a new paragraph (h) specifies that PAPRs designed with one
or more canisters and particulate filters must meet the end-of-service-
life requirements both as received from the applicant and after being
equilibrated at room temperature.
Subpart K--Air-Purifying Particulate Respirators
Subpart K is retitled from ``Non-Powered Air-Purifying Particulate
Respirators'' to ``Air-Purifying Particulate Respirators.'' The intent
of the new title is to properly indicate the broadened scope of the
subpart, which includes the requirements for both non-powered and
powered air-purifying particulate respirators.
Section 84.170 Air-Purifying Particulate Respirators; Description
This section provides a general description of air-purifying
particulate respirators as a class of respirator. It is intended to
inform the public and to serve as a legal and practical definition for
the purposes of the NIOSH respirator approval program.
Paragraphs (a)(1), (2), and (3), which describe non-powered
devices, remain substantively unchanged from the existing language. New
paragraphs (b)(1), (2), and (3) describe PAPRs. Specifically, paragraph
(b)(1) provides a general description of PAPRs and paragraph (b)(2)
indicates that PAPRs are classified into one of two PAPR classes, HE or
PAPR100, and one of three filter series, ``HE,'' ``PAPR100-N,'' and
``PAPR100-P.'' Paragraph (b)(3) establishes that the minimum efficiency
level for filters employed as part of powered respirator configurations
is 99.97 percent for all three filter series, HE (high-efficiency),
PAPR100-N, or PAPR100-P.
Requirements for two series of filters have been established for
the PAPR100 class to give manufacturers greater flexibility in
designing these devices. The PAPR100-P series filter requirements are
established to provide a filter that, like the existing PAPR class HE
(high-efficiency series) filter, is suitable for use against all
aerosols, including those which are comprised of oils.
The PAPR100-N series filter, which is not intended to be used
against oil-based aerosols, has also been added to allow for greater
use of electrostatic filter media. New filter efficiency requirements
in Sec. 84.180 are intended to allow manufacturers to optimize
PAPR100-N series filters for environments with very low concentrations
of non-oil based (solid- or water-based) aerosols where disposal of the
filter after each use is preferred over extended use. The minimum
filtration efficiency for the two new series of PAPR filters is
maintained at 99.97 percent, the minimum filtration efficiency of the
existing and ongoing HE series filters.
Section 84.171 Required Components and Attributes
The title of this existing section is revised to describe the
requirements for components and attributes that apply to both powered
and non-powered air-purifying particulate respirators. The regulatory
language itself is revised to replace terminology such as ``facepiece,
mouthpiece with nose clip, hood, or helmet'' with ``respiratory inlet
covering''; ``half-mask facepieces and full facepieces'' with ``tight-
fitting respiratory inlet coverings''; and ``hoods and helmets'' with
``loose-fitting respiratory inlet coverings.'' The entire section is
revised to not only include a list of the required components, but to
include the required design attributes of those components.
Paragraph (a) specifies the required attributes for the respiratory
inlet covering, currently described in Sec. Sec. 84.175 and 84.1135.
Paragraph (b)(1) addresses the filter unit, currently described in
Sec. 84.179 for non-powered devices; paragraph (b)(2) includes new
provisions specifying that powered devices must be labeled as series HE
(high-efficiency) or series PAPR100-N or -P.
Paragraph (c) addresses valves, currently described in Sec. Sec.
84.177 and 84.1137.
Paragraph (d) addresses the head harness, currently described in
Sec. Sec. 84.178 and 84.1138.
Paragraph (e) addresses the breathing tube, currently described in
Sec. Sec. 84.172 and 84.1132.
Paragraph (f) is new, and describes requirements for a drink tube,
should the design require a drink tube.
Paragraph (g) addresses the container, currently described in
Sec. Sec. 84.174 and 84.1134.
Paragraph (h) addresses the harness, currently described in
Sec. Sec. 84.173 and 84.1133.
Paragraph (i) is moved from Sec. 84.1156(f) to describe the
airflow rate required of PAPR HE class and PAPR100 class tight-fitting
and loose-fitting respiratory inlet coverings.
Finally, a new paragraph (j) requires a low-flow warning device for
the new PAPR100 class respirators only. There are no requirements for
PAPR warning devices in 42 CFR part 84 for class HE respirators.
However, if any PAPR system is submitted for approval equipped with a
warning device, NIOSH verifies that the warning functions
[[Page 20604]]
properly as per the manufacturer's user instructions. In accordance
with this paragraph, the required PAPR100 warning must alert users to
breathing air flow that falls below 115 liters per minute for tight-
fitting facepieces or 170 liters per minute for loose-fitting hoods and
helmets (the minimum required in Sec. 84.175). Warning devices must
also be able to be heard or otherwise detected by the wearer and must
also be readily distinguishable from one another. For example, if an
optional low-battery warning is included in addition to the low-flow
warning, it needs to be distinguishable from the required low-flow
warning. The PAPR100 warning system must also not de-energize while the
unit's blower is energized (i.e., power to the warning system must be
prioritized), and must not switch off automatically or be able to be
switched off manually. The warning should remain active until the
reason for the warning is corrected.
Section 84.172 Airflow Resistance Test
This section specifies the test criteria and acceptable performance
criteria for inhalation and exhalation resistance of a complete air-
purifying particulate respirator. The requirements for non-powered air-
purifying particulate respirators are currently specified in Sec.
84.180 and would be consolidated in Sec. 84.172 with requirements for
PAPRs, unchanged. The existing requirements for PAPR class HE are moved
from Sec. 84.1156(a)(1) and (2) and combined into Sec. 84.172, where
the maximum airflow resistance standard for the new class PAPR100 would
also be established.
Paragraph (a) addresses the inhalation and exhalation resistance of
the complete air-purifying particulate respirator. This paragraph is
essentially unchanged in meaning but updated from the existing language
in Sec. 84.180(a) to reflect industry standard terminology, replacing
``facepiece, mouthpiece, hood, or helmet'' with ``respiratory inlet
covering.''
Paragraph (b) indicates that the airflow resistance of tight-
fitting PAPRs is measured with the blower off if the model is designed
not to be immediately doffed in the event of a blower failure.
Paragraph (c) maintains the current requirements in Sec.
84.1157(a) for the maximum inhalation and exhalation resistances of
complete PAPRs (both classes HE and PAPR100) and the current
requirements in Sec. 84.180(b) for non-powered air-purifying
respirators.
Section 84.173 Exhalation Valve Leakage Test
This section contains the existing requirements in Sec. Sec.
84.182 and 84.1150 that describe the NIOSH tests for exhalation valve
leakage. The exhalation valve leakage testing is conducted on both non-
powered and powered devices.
Section 84.174 Filter Efficiency Level Determination Test--Non-Powered
Series N, R, and P Filtration
Text from existing section Sec. 84.181 specifies the test criteria
and acceptable performance criteria for non-powered air-purifying
particulate filter efficiency levels; it is re-numbered Sec. 84.173.
This section is also re-named to clarify the content and indicate its
application for all types of air-purifying particulate respirators. The
word ``shall'' is replaced with ``will'' throughout the section, to
clarify intent and reflect plain language principles. No substantive
changes are made to the testing requirements and technical standards
for filter efficiency for non-powered devices.
Section 84.175 Instantaneous Filter Efficiency Level Determination
Test--PAPR Series HE, PAPR100-N, and PAPR100-P Filtration
This new section describes the NIOSH filter efficiency testing
requirements for both classes of PAPR and all three particulate series
filters, HE, PAPR100-N, and PAPR100-P. This instantaneous dioctyl
phthalate (DOP) test is unchanged from the current Sec. 84.1151. PAPRs
are tested at the minimum required flow rates specified in Sec.
84.1156(c)(2).
Paragraph (a) indicates that three filters from each powered air-
purifying particulate respirator will have their filtration efficiency
evaluated using DOP.
Paragraph (b) describes the current atmospheric concentration of
DOP. The test concentration, 100 milligrams per cubic meter, is
unchanged. Paragraph (b) also includes the airflow rates for tight- and
loose-fitting respiratory inlet coverings currently found in Sec.
84.1156(c)(2).
Paragraph (c) indicates that PAPRs designed with multiple filters
will be tested by dividing the specified flow rate by the total number
of filters.
Finally, paragraph (d) requires the filters, including holders and
gaskets, when separable, to be tested while mounted on a test fixture
in the manner as used on the respirator. This allows NIOSH to test the
assembly in a configuration as it will actually be used.
Section 84.176 Fit Test--PAPR Classes HE and PAPR100
This section specifies the test criteria and acceptable performance
criteria to fit test a complete PAPR. Two options are available to
assess fit: Isoamyl acetate (IAA) or generated aerosol.
Paragraph (a) specifies the existing IAA tightness test, originally
established in subpart KK, Sec. 84.1156(a)(5). The IAA testing
standard is unchanged.
Paragraph (b) describes a new generated aerosol (corn oil) test,
intended as an alternative to the IAA method for those powered devices
that are equipped solely with particulate filters. The corn oil
quantitative fit test was developed by NIOSH, at the behest of
respirator manufacturers, and has been used as a voluntary substitute
test in place of the qualitative IAA test for series HE PAPRs since
approximately 2008. This test utilizes a concentration of 20-40
milligrams per cubic meter of corn oil aerosol with a mass median
aerodynamic diameter of 0.4 to 0.6 micrometers. Paragraph (b)(1)
describes the work schedule performed by the wearer during the test.
The activities that are specified in this paragraph--nodding and
turning head, calisthenic arm movements, running in place, and pumping
a tire pump--are used by the agency to test the facepiece fit of
respirator types by simulating the types of activities workers might
perform while wearing the respirator.
Paragraph (b)(2) allows NIOSH to verify that the facepiece is
capable of adjustment and that the applicant's donning instructions
should be followed. Paragraph (b)(3) requires that the appropriate fit
factors for the applicant respirator be exceeded.
Section 84.177 Total Noise Level Test--PAPR Classes HE and PAPR100
This section replicates the testing standard for PAPR noise levels
currently found in Sec. 84.1139. The standard requires that the noise
levels generated by any PAPR (i.e., HE hood or helmet and any PAPR100)
must not exceed 80 decibels using the A-weighting frequency response
(dBA) measured at each ear location while the system operates at its
maximum airflow obtainable. Today, PAPR designs include head-, neck-,
and face-mounted blowers in closer proximity to the user's ears.
Additionally, for class HE hood and helmet designs, the provision is
revised to clarify that the noise level measurement will be taken at
the entrance to the ear rather than ``inside the hood or helmet'' as
the standard currently states.
[[Page 20605]]
Section 84.178 Breath Response Type, Airflow Resistance Test--PAPR
Classes HE and PAPR100
This new section specifies the minimum test criteria for a breath-
responsive PAPR. Breath-responsive PAPRs are designed to maintain a
positive pressure in the facepiece to match the user's respiratory
requirements. Current PAPR requirements in 42 CFR part 84 do not
address these design features. Therefore, pursuant to 42 CFR 84.60 and
84.63, these types of PAPRs have been evaluated using the requirements
of 42 CFR 84.157, which are applicable to certain types of atmosphere-
supplying respirators.
This section specifies that the breath-responsive PAPR airflow will
be measured with a breathing machine described in Sec. 84.88(b) and
(c). Paragraph (a) specifies that the minimum inhalation resistance
shall be greater than zero. Paragraph (b) specifies that the maximum
exhalation resistance must be less than 89 millimeters (3.5 inches) of
water-column height, in accordance with current requirements in Sec.
84.91(c) and (d).
Section 84.179 Silica Dust Loading Test--PAPR Series HE Filtration
This section contains the requirements from existing Sec. Sec.
84.1144 and 84.1152, which are themselves removed from part 84 in this
action. This section specifies the test criteria for the silica dust
loading test of a complete powered PAPR series HE. This test procedure
is not used to test PAPR100-N or -P series devices, which NIOSH expects
will allow PAPR100 designs to be smaller and lighter than series HE
devices. Paragraphs (a) and (f), respectively, specify the test period
and flowrate as well as the amount of unretained test suspension; these
testing standards are taken from Sec. 84.1152. Paragraphs (b), (c),
(d), and (e) establish the test chamber conditions and size and
concentration of the test particulate.
Section 84.180 Particulate Loading Test--PAPR Series PAPR100-N and
PAPR100-P Filtration
This new section adopts the existing particulate loading test for
non-powered air-purifying respirators in Sec. 84.181, applying it to
both PAPR100 series filters. Paragraph (a) specifies that NIOSH will
test the efficiency of 20 filters of each powered air-purifying
particulate respirator model submitted for a class PAPR100 approval.
Paragraph (a)(1) specifies that NIOSH will use a sodium chloride
aerosol when testing PAPR100-N series filters. Paragraph (a)(2)
specifies that NIOSH will use a dioctyl phthalate or equivalent aerosol
when testing PAPR100-P series filters.
Paragraph (b) requires that 20 PAPR100-N series filters be
preconditioned with humid air prior to being subjected to the
filtration efficiency loading test specified in paragraph (d)(1).
Paragraph (c) specifies the continuous test aerosol flow rates for
the filter efficiency testing. Single filters are to be tested at a
rate of 85 4 liters per minute; filters used in pairs at a
rate of 42.5 2 liters per minute through each filter; and
filters used in threes at a rate of 28.3 1 liters per
minute through each filter.
Paragraph (d)(1) specifies the filter efficiency test aerosol for
series PAPR100-N, sodium chloride or an equivalent solid aerosol. The
test conditions for the solid aerosol are specified to be at 25 5 degrees Celsius. The sodium chloride aerosol specified to be
used in these tests is to be neutralized to the Boltzmann equilibrium
state, and the maximum concentration will not exceed 200 milligrams per
cubic meter. This paragraph also specifies the particle size, and size
distribution of the sodium chloride test aerosol at a count median
diameter of 0.075 0.020 micrometer and a standard
geometric deviation not exceeding 1.86 at the specified test conditions
as determined with a scanning mobility particle sizer or equivalent.
Paragraph (d)(2) specifies the filter efficiency test aerosol for
series PAPR100-P, DOP or an equivalent oil liquid particulate aerosol.
The test conditions for the liquid aerosol are specified to be at 25
5 degrees Celsius. The DOP aerosol specified to be used in
these tests is to be neutralized to the Boltzmann equilibrium state,
and the maximum concentration will not exceed 200 milligrams per cubic
meter. This paragraph also specifies the particle size, and sized
distribution of the DOP test aerosol at a count median diameter of
0.185 0.020 micrometer and a standard geometric deviation
not exceeding 1.60 at the specified test conditions as determined with
a scanning mobility particle sizer or equivalent.
Paragraph (e) specifies that both the solid and the liquid aerosol
filtration efficiency test must continue until minimum efficiency is
achieved or until an aerosol mass of 200 5 milligrams has
contacted the filter. This paragraph further specifies that for
PAPR100-P series filters, if the filter efficiency is decreasing when
the 200 5 mg challenge point is reached, the test shall be
continued until there is no further decrease in efficiency.
Paragraph (f) requires the efficiency of the filter (i.e., the
amount of aerosol particles that are removed by the filter) to be
monitored and recorded throughout the test period by a suitable
forward-light-scattering photometer or equivalent instrumentation.
Paragraph (g) requires the minimum filter efficiency for each of
the 20 filters to be determined and recorded. The minimum efficiency of
each tested filter must be greater than or equal to 99.97 percent for
both PAPR100-N and PAPR100-P series filters.
Section 84.181 Communication Performance Test--PAPR Class PAPR100
This new section specifies testing criteria for PAPR communication
performance. The 2014 IOM workshop highlighted the limitations posed by
PAPRs with regard to communication with patients, potentially
compromising patient safety. This test is intended to address
healthcare, first responders, and other workers' needs for PAPR100s
designed and tested to ensure a PAPR's ability to meet a minimum
communication performance level of speech conveyance and
intelligibility.
Paragraph (a) requires that PAPR100s are designed to allow minimum
communication while being worn.
Paragraph (b) specifies that the Modified Rhyme Test (MRT) will be
used to conduct the test. The MRT consists of lists of 50 monosyllabic,
phonetically-balanced words and evaluates a listener's ability to
comprehend single words spoken by the respirator wearer.
Paragraph (c) specifies that for each MRT trial the overall
performance rating is calculated. The performance rating is the ratio
of the number of correct responses to the number of incorrect responses
with and without a respirator being worn. To obtain a passing score,
the PAPR100 must obtain an average overall performance rating greater
than or equal to 70 percent.
VI. Regulatory Assessment Requirements
A. Executive Order 12866 (Regulatory Planning and Review) and Executive
Order 13563 (Improving Regulation and 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
[[Page 20606]]
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). E.O. 13563 emphasizes the
importance of quantifying both costs and benefits, of reducing costs,
of harmonizing rules, and of promoting flexibility.
This interim final rule has been determined to be a ``significant
regulatory action'' under section 3(f) of E.O. 12866. The rulemaking is
considered a deregulatory action because it removes a barrier to the
manufacturing, labeling as NIOSH-approved, and selling of new PAPR
designs intended for healthcare and other workplace settings. With the
promulgation of the interim final requirements, manufacturers have a
choice to submit approval applications under either the existing PAPR
class HE standard or the new class PAPR100 standard.
The new PAPR100 respirators are required to meet most of the
requirements and testing standards applied to class HE respirators
except for the silica dust loading test in Sec. 84.179, which requires
that the device perform for a minimum service time of 4 hours. Three
new requirements--a low-flow warning device (Sec. 84.171(j)),
particulate loading test (Sec. 84.180), and communication performance
testing (Sec. 84.181)--apply to class PAPR100 respirators only. HHS
requests data that would facilitate quantification of: (a) The
incremental cost savings resulting from the removal of the silica dust
loading test requirements, and (b) the incremental costs resulting from
each of the three new requirements.
This rule does not impose any mandatory costs on the public and
benefits manufacturers who choose to develop a product under these new
technical requirements. Healthcare facilities that currently utilize
PAPR class HE devices that are designed for industrial use may also see
a cost saving because class PAPR100 respirators designed for healthcare
or other workplace settings may be more affordable than the current
devices. In discussions with NIOSH, manufacturers have indicated that
the cost of future class PAPR100 respirators is likely to be
substantially less than the current cost of class HE devices. HHS
requests data that would facilitate estimation of: (a) The increase in
PAPR device availability resulting from this likely cost reduction, and
(b) the timing of such availability relative to the issuance of this
interim final rule.
HHS also requests data or other comment relevant to the benefits of
this rulemaking--including, but not limited to, quantitative evidence
on the duration of worker exposure to the hazards that class PAPR100
devices and other respirators protect against.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) does not apply to a rulemaking
when a general notice of proposed rulemaking is not required. 5 U.S.C.
603 and 604. As noted previously, the Agencies have determined for good
cause that it is impracticable and contrary to the public interest to
publish a general notice of proposed rulemaking for this joint final
rule. Accordingly, the RFA's requirements relating to an initial and
final regulatory flexibility analysis do not apply.
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 April 30, 2021). Due to this interim final
rule, which would allow for the NIOSH approval of respirators in a new
class, PAPR100, there is likely to be a change in burden in the
approved collection of information.
Based on PAPR activity over the last several years and also the
increased number of related inquiries in response to the COVID-19
pandemic, NIOSH estimates that up to 5 respirator manufacturers may
submit approximately 23 applications for PAPR100 approvals to the
National Personal Protective Technology Laboratory from April 2020
through April 2021. Each application is expected to require an average
of 229 hours to complete and maintain.
Accordingly, NIOSH expects 5,267 burden hours to be attributed to
applications for PAPR100 approvals. NIOSH estimates an hourly wage rate
of $79.89 (wage data is the average unspecified manufacturing industry
engineer wage of $45.68 as reported in the 2016 National Sector NAICS
Industry-Specific estimates multiplied by 1.06 inflation adjustment and
1.65 factor for overhead expenses).
----------------------------------------------------------------------------------------------------------------
Average Average burden
Section TitleC Number of responses per per response Total burden
respondents respondent (hr) (hr)
----------------------------------------------------------------------------------------------------------------
Sec. 84.170................. Air-purifying 5 4.6 229 5,267
particulate
respirators;
description.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Total burden Estimated
Section Title hours (from hourly wage Total cost of
above) rate hour burden
----------------------------------------------------------------------------------------------------------------
Sec. 84.170..................... Air-purifying particulate 5,267 79.89 $420,780
respirators; description.
----------------------------------------------------------------------------------------------------------------
The agency will submit the adjustment in burden for OMB Control No.
0920-0109 to OMB for its emergency review and approval.
D. Congressional Review Act
As required by Congress under the Congressional Review Act (5
U.S.C. 801 et seq.), HHS will report the promulgation of this rule to
Congress prior to its effective date. This rule is not likely to result
in an annual effect on the economy of $100,000,000 or more; a major
increase in costs or prices for consumers, individual industries,
Federal, State, or local government agencies, or geographic regions; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of U.S.-based enterprises
to compete with foreign-based enterprises
[[Page 20607]]
in domestic and export markets. Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory
Affairs designated this rule as not a ``major rule,'' as defined by 5
U.S.C. 804(2).
E. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531
et seq.) directs agencies to assess the effects of Federal regulatory
actions on State, local, and Tribal governments, and the private sector
``other than to the extent that such regulations incorporate
requirements specifically set forth in law.'' For purposes of the
Unfunded Mandates Reform Act, this interim final rule does not include
any Federal mandate that may result in increased annual expenditures in
excess of $100 million by State, local, or Tribal governments in the
aggregate, or by the private sector.
F. Executive Order 12988 (Civil Justice Reform)
This interim final rule has been drafted and reviewed in accordance
with Executive Order 12988 and will not unduly burden the Federal court
system. This rule has been reviewed carefully to eliminate drafting
errors and ambiguities.
G. Executive Order 13132 (Federalism)
HHS has reviewed this interim final 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.''
H. 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 interim final rule on
children. HHS has determined that the rule would have no environmental
health and safety effect on children.
I. 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 interim final rule on energy supply, distribution or
use, and has determined that the rule will not have a significant
adverse effect.
J. 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 promulgating the interim final rule 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
Mine safety and health, Occupational safety and health, Personal
protective equipment, Respirators.
Final Rule
For the reasons discussed in the preamble, the Department of Health
and Human Services amends 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.; 30 U.S.C. 3, 5, 7, 811,
842(h), 844.
Subpart A--General Provisions
0
2. Amend Sec. 84.2 by adding definitions for ``Loose fitting'',
``Respiratory inlet covering'', ``Tight fitting'', and ``Warning
device'' in alphabetical order to read as follows:
Sec. 84.2 Definitions.
* * * * *
Loose fitting means respiratory inlet covering that covers the
wearer's head and neck, or head, neck, and shoulders, or whole body
(when integral to the design).
* * * * *
Respiratory inlet covering means that portion of a respirator that
forms the protective barrier between the user's respiratory tract and
an air-purifying device or breathing air source, or both.
* * * * *
Tight fitting means a respiratory inlet covering that forms a
complete gas tight or dust tight seal with the face or neck.
* * * * *
Warning device is a component of a respiratory protective device
that informs the wearer to take some action.
Subpart G--General Construction and Performance Requirements
Sec. 84.60 [Amended]
0
3. Amend Sec. 84.60, in paragraph (a), by removing the words
``subparts H through KK'' and adding in their place the words
``subparts H through O''.
Sec. 84.63 [Amended]
0
4. Amend Sec. 84.63, paragraphs (a) through (c) by removing the words
``subparts H through KK'' and adding in their place the words
``subparts H through O''.
Sec. 84.64 [Amended]
0
5. Amend Sec. 84.64, in paragraph (b), by removing the words
``subparts H through KK'' and adding in their place the words
``subparts H through O''.
Sec. 84.65 [Amended]
0
6. Amend Sec. 84.65, in paragraph (a), by removing the words
``subparts H through KK'' and adding in their place the words
``subparts H through O''.
Subpart I--Gas Masks
Sec. 84.125 [Amended]
0
7. Amend Sec. 84.125 by removing the words ``Sec. Sec. 84.170 through
84.183, except for the airflow resistance test of Sec. 84.181'' and
adding in their place the words ``Sec. Sec. 84.170 through 84.181,
except for the airflow resistance test of Sec. 84.172''.
0
8. Amend Sec. 84.126 by adding paragraph (f) to read as follows:
Sec. 84.126 Canister bench tests; minimum requirements.
* * * * *
(f) Powered air-purifying respirators with a canister(s) and
particulate filter(s) must meet the as-received minimum service-life
requirements and half of the equilibrated minimum service-life
requirements set forth in Tables 5, 6, and 7 of subpart I using the
flows specified in subpart K, Sec. 84.175(b) and equilibrated in
accordance with paragraphs (a) through (e) of this section using the
flows specified in subpart K, Sec. 84.175(b).
Subpart L--Chemical Cartridge Respirators
Sec. 84.206 [Amended]
0
9. Amend Sec. 84.206, in paragraph (b), by removing the words
``Sec. Sec. 84.179 through 84.183'' and adding in their place the
words ``Sec. Sec. 84.170 through 84.181''.
0
10. Amend Sec. 84.207 by adding paragraph (h) to read as follows:
[[Page 20608]]
Sec. 84.207 Bench tests; gas and vapor tests; minimum requirements;
general.
* * * * *
(h) Powered air-purifying respirators with a cartridge(s) and
particulate filter(s) must meet the as-received minimum service-life
requirements and half of the equilibrated minimum service-life
requirements set forth in table 11 of subpart L using the flows
specified in subpart K, Sec. 84.175(b) and equilibrated in accordance
with paragraphs (a) through (g) of this section using the flows
specified in subpart K, Sec. 84.175(b).
0
11. Subpart K is revised to read as follows:
Subpart K--Air-Purifying Particulate Respirators
Sec.
84.170 Air-purifying particulate respirators; description.
84.171 Required components and attributes.
84.172 Airflow resistance test.
84.173 Exhalation valve leakage test.
84.174 Filter efficiency level determination test--non-powered
series N, R, and P filtration.
84.175 Instantaneous filter efficiency level determination test--
PAPR series HE, PAPR100-N, and PAPR100-P filtration.
84.176 Fit test--PAPR classes HE and PAPR100.
84.177 Total noise level test--PAPR classes HE and PAPR100.
84.178 Breath response type, airflow resistance test--PAPR classes
HE and PAPR100.
84.179 Silica dust loading test--PAPR series HE filtration.
84.180 Particulate loading test--PAPR series PAPR100-N and PAPR100-P
filtration.
84.181 Communication performance test--PAPR class PAPR100.
Subpart K--Air-Purifying Particulate Respirators
Sec. 84.170 Air-purifying particulate respirators; description.
(a) Non-powered air-purifying particulate respirators (series N, R,
and P). (1) Non-powered air-purifying particulate respirators 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.
(2) Non-powered air-purifying particulate respirators are
classified into three series, N-, R-, and P-series. The N-series
filters are restricted to use in those workplaces free of oil aerosols.
The R- and P-series filters are intended for removal of any particulate
that includes oil-based liquid particulates.
(3) Non-powered air-purifying particulate respirators are
classified according to the efficiency level of the filter(s) as tested
according to the requirements of this part.
(i) N100, R100, and P100 filters must demonstrate a minimum
efficiency level of 99.97 percent.
(ii) N99, R99, and P99 filters must demonstrate a minimum
efficiency level of 99 percent.
(iii) N95, R95, and P95 filters must demonstrate a minimum
efficiency level of 95 percent.
(b) Powered air-purifying particulate respirators (PAPR classes HE
and PAPR100). (1) Powered air-purifying particulate respirators utilize
a blower to move the ambient air through the air-purifying filter
elements (filters) to remove particulate contaminants and deliver clean
air to the respiratory inlet covering. They are designed for use as
respiratory protection against atmospheres considered not immediately
dangerous to life or health and that contain adequate oxygen to support
life.
(2) Powered air-purifying particulate respirators are classified
into two classes, HE and PAPR100, and three series, HE, PAPR100-N, and
PAPR100-P. The N-series filters are restricted to use in those
workplaces free of oil aerosols. The P-series filters are intended for
removal of any particulate that includes oil-based liquid particulates.
(3) All three filter series, HE, PAPR100-N, and PAPR100-P, for
powered air-purifying particulate respirators must demonstrate a
minimum efficiency level of 99.97 percent.
Sec. 84.171 Required components and attributes.
The components of each air-purifying particulate respirator must
meet the minimum construction requirements set forth in subpart G of
this part. Each air-purifying particulate respirator described in Sec.
84.170 must, where its design requires, contain the following component
parts:
(a) Respiratory inlet covering. (1) Tight fitting respiratory inlet
coverings must be designed and constructed to fit persons with various
facial shapes and sizes either:
(i) By providing more than one size; or
(ii) By providing one size which will fit varying facial shapes and
sizes.
(2) Full facepieces must provide for optional use of corrective
spectacles or lenses, which must not reduce the respiratory protective
qualities of the respirator.
(3) Loose fitting respiratory inlet coverings must be designed and
constructed to fit persons with various head sizes, provide for the
optional use of corrective spectacles or lenses, and insure against any
restriction of movement by the wearer.
(4) Mouthpieces must be equipped with noseclips which are securely
attached to the mouthpiece or respirator and provide an airtight seal.
(5) Respiratory inlet coverings that incorporate a lens or
faceshield must be designed to prevent eyepiece fogging.
(6) Half-mask facepieces must not interfere with the fit of common
industrial safety spectacles, including corrective safety spectacles.
(7) Respiratory inlet coverings must be designed and constructed to
provide adequate vision which is not distorted by the eyepieces.
(b) Filter unit. The respirator manufacturer, as part of the
application for certification, must specify the filter series and the
filter efficiency level (i.e., ``N95,'' ``R95,'' ``P95,'' ``N99,''
``R99,'' ``P99,'' ``N100,'' ``R100,'' ``P100,'' ``HE,'' ``PAPR100-N''
or ``PAPR100-P'') for which certification is being sought.
(1) Filters for non-powered respirators (series N, R, and P) must
be prominently labeled as follows:
(i) N100 filters must be labeled ``N100 Particulate Filter (99.97%
filter efficiency level)'' and must be a color other than magenta.
(ii) R100 filters must be labeled ``R100 Particulate Filter (99.97%
filter efficiency level)'' and must be a color other than magenta.
(iii) P100 filters must be labeled ``P100 Particulate Filter
(99.97% filter efficiency level)'' and must be color coded magenta.
(iv) N99 filters must be labeled ``N99 Particulate Filter (99%
filter efficiency level)'' and must be a color other than magenta.
(v) R99 filters must be labeled ``R99 Particulate Filter (99%
filter efficiency level)'' and must be a color other than magenta.
(vi) P99 filters must be labeled ``P99 Particulate Filter (99%
filter efficiency level)'' and must be a color other than magenta.
(vii) N95 filters must be labeled as ``N95 Particulate Filter (95%
filter efficiency level)'' and must be a color other than magenta.
(viii) R95 filters must be labeled as ``R95 Particulate Filter (95%
filter efficiency level)'' and must be a color other than magenta.
(ix) P95 filters must be labeled as ``P95 Particulate Filter (95%
filter
[[Page 20609]]
efficiency level)'' and must be a color other than magenta.
(2) Filters for powered respirators (classes HE and PAPR100) must
be prominently labeled as follows:
(i) HE filters must be labeled as ``HE Particulate Filter (99.97%
filter efficiency level)'' and must be color coded magenta.
(ii) PAPR100-N filters must be labeled as ``PAPR100-N Particulate
Filter (99.97% filter efficiency level)'' and must be color coded
magenta.
(iii) PAPR100-P filters must be labeled as ``PAPR100-P Particulate
Filter (99.97% filter efficiency level)'' and must be color coded
magenta.
(c) Valves. (1) Inhalation and exhalation valves must be protected
against distortion.
(2) Inhalation valves must be designed and constructed and provided
where necessary to prevent excessive exhaled air from adversely
affecting filters, except where filters are specifically designed to
resist moisture.
(3) Exhalation valves must be:
(i) Provided where necessary;
(ii) Protected against damage and external influence; and
(iii) Designed and constructed to prevent inward leakage of
contaminated air.
(d) Head harness. (1) All facepieces must be equipped with head
harnesses designed and constructed to provide adequate tension during
use and an even distribution of pressure over the entire area in
contact with the face.
(2) Facepiece head harnesses, except those employed on filtering
facepiece respirators, must be adjustable and replaceable.
(3) Mouthpieces must be equipped, where applicable, with adjustable
and replaceable harnesses, designed and constructed to hold the
mouthpiece in place.
(e) Breathing tube. Flexible breathing tubes used in conjunction
with respirators must be designed and constructed to prevent:
(1) Restriction of free head movement;
(2) Disturbance of the fit of facepieces, mouthpieces, or loose
fitting respiratory-inlet covering;
(3) Interference with the wearer's activities; and
(4) Shutoff of airflow due to kinking, or from chin or arm
pressure.
(f) Drink tube. (1) For particulate respirators equipped with a
drink tube, the respirator must meet all requirements of the standard
with the drink tube in place.
(2) Dry drinking tube assembly will be subjected to a suction of 75
mm water column height while in a normal operating position (closed).
(3) Leakage through the drinking tube assembly must not exceed 30
mL per minute.
(g) Container. (1) Except as provided in paragraph (b) of this
section, each respirator must be equipped with a substantial, durable
container bearing markings which show the applicant's name, the type of
respirator it contains, and all appropriate approval labels.
(2) Containers for respirators may provide for storage of more than
one respirator; however, such containers must be designed and
constructed to prevent contamination of respirators which are not
removed, and to prevent damage to respirators during transit.
(h) Harness. (1) Each respirator must, where necessary, be equipped
with a suitable harness designed and constructed to hold the components
of the respirator in position against the wearer's body.
(2) Harnesses must be designed and constructed to permit easy
removal and replacement of respirator parts, and, where applicable,
provide for holding a full facepiece in the ready position when not in
use.
(i) Attached blower--PAPR classes HE and PAPR100. Blowers must be
designed to achieve the air flow rates required by the testing
standards in Sec. 84.175.
(j) Low-flow warning device--PAPR class PAPR100. (1) The design
must include a low-flow warning. It must actively and readily indicate
when flow inside the respiratory inlet covering falls below the minimum
air flow defined in Sec. 84.175.
(2) Any warning must be detectable by the wearer without any
intervention by the wearer.
(3) Warning devices must be configured so that they may not be de-
energized while the blower is energized.
(4) During use, warning devices must not switch off automatically
and must not be capable of being switched off by the wearer.
(5) Any warnings which require different reactions by the wearer
must be distinguishable from one another.
(6) If the warning provided is audible only, or other warnings are
not readily apparent to the wearer, the minimum sound level must be 80
dBA.
Sec. 84.172 Airflow resistance test.
(a) Resistance to airflow will be measured in the tight-fitting
respiratory inlet covering of a complete particulate respirator mounted
on a test fixture with air flowing at continuous rate of 85 2 liters per minute, before each test conducted in accordance
with Sec. 84.173.
(b) Resistance of a complete tight-fitting powered air-purifying
particulate respirator system will be measured with the blower off if
the manufacturer indicates that the respirator should not be doffed in
the event of a blower failure.
(c) The maximum allowable resistance requirements for air-purifying
particulate respirators are as follows:
Maximum Resistance
[mm water-column height]
----------------------------------------------------------------------------------------------------------------
Inhalation
Respirator type -------------------------------- Exhalation
Initial Final
----------------------------------------------------------------------------------------------------------------
Non-Powered (N, R, and P)....................................... 35 N/A 25
Powered (tight fitting) (HE class and PAPR100 class)............ 50 70 20
----------------------------------------------------------------------------------------------------------------
Sec. 84.173 Exhalation valve leakage test.
(a) Dry exhalation valves and valve seats will be subjected to a
suction of 25 mm water-column height while in a normal operating
position.
(b) Leakage between the valve and valve seat must not exceed 30 mL
per minute.
Sec. 84.174 Filter efficiency level determination test--non-powered
series N, R, and P filtration.
(a) Twenty filters of each non-powered air-purifying particulate
respirator model will be tested for filter efficiency against:
(1) A solid sodium chloride particulate aerosol as per this
section, if N-series certification is requested by the applicant.
(2) A dioctyl phthalate (DOP) or equivalent liquid particulate
aerosol as per this section, if R-series or P-series
[[Page 20610]]
certification is requested by the applicant.
(b) Filters including holders and gaskets, when separable, will be
tested for filter efficiency level, as mounted on a test fixture in the
manner as used on the respirator.
(c) Prior to filter efficiency testing of 20 N-series filters, the
20 to be tested will be taken out of their packaging and placed in an
environment of 85 5 percent relative humidity at 38 2.5 [deg]C for 25 1 hours. Following the pre-
conditioning, filters will be sealed in a gas-tight container and
tested within 10 hours.
(d) When the filters do not have separable holders and gaskets, the
exhalation valves will be blocked so as to ensure that leakage, if
present, is not included in the filter efficiency level evaluation.
(e) For non-powered air-purifying particulate respirators with a
single filter, filters will be tested at a continuous airflow rate of
85 4 liters per minute. Where filters are to be used in
pairs, the test-aerosol airflow rate will be 42.5 2 liters
per minute through each filter.
(f) Filter efficiency test aerosols:
(1) When testing N-series filters, a sodium chloride or equivalent
solid aerosol at 25 5 [deg]C and relative humidity of 30
10 percent that has been neutralized to the Boltzmann
equilibrium state will be used. Each filter will be challenged with a
concentration not exceeding 200 mg/m\3\.
(2) When testing R-series and P-series filters, a neat cold-
nebulized dioctyl phthalate (DOP) or equivalent aerosol at 25 5 [deg]C that has been neutralized to the Boltzmann equilibrium
state will be used. Each filter will be challenged with a concentration
not exceeding 200 mg/m\3\.
(3) The test will continue until minimum efficiency is achieved or
until an aerosol mass of at least 200 5 mg has contacted
the filter. For P-series filters, if the filter efficiency is
decreasing when the 200 5 mg challenge point is reached,
the test will be continued until there is no further decrease in
efficiency.
(g) The sodium chloride test aerosol will have a particle size
distribution with count median diameter of 0.075 0.020
[mu]m and a standard geometric deviation not exceeding 1.86 at the
specified test conditions as determined with a scanning mobility
particle sizer or equivalent. The DOP aerosol will have a particle size
distribution with count median diameter of 0.185 0.020
[mu]m and a standard geometric deviation not exceeding 1.60 at the
specified test conditions as determined with a scanning mobility
particle sizer or equivalent.
(h) The efficiency of the filter will be monitored and recorded
throughout the test period by a suitable forward-light-scattering
photometer or equivalent instrumentation.
(i) The minimum efficiency for each of the 20 filters will be
determined and recorded and must be equal to or greater than the filter
efficiency criterion listed for each level as follows:
------------------------------------------------------------------------
Filter series Efficiency (%)
------------------------------------------------------------------------
P100, R100, N100........................................ >=99.97
P99, R99, N99........................................... >=99
P95, R95, N95........................................... >=95
------------------------------------------------------------------------
Sec. 84.175 Instantaneous filter efficiency level determination
test--PAPR series HE, PAPR100-N, and PAPR100-P filtration.
(a) Three filters from each powered air-purifying particulate
respirator for efficiency will be tested against a neat cold-nebulized
dioctyl phthalate (DOP) or equivalent aerosol at 25 5
[deg]C that has been neutralized to the Boltzmann equilibrium state.
(b) Single air-purifying particulate respirator filter units will
be tested in an atmosphere concentration of 100 mg/m\3\ of DOP at the
following continuous flow rates for a period of 5 to 10 seconds:
------------------------------------------------------------------------
Airflow rate
Type of respiratory inlet covering (liters per
minute)
------------------------------------------------------------------------
Tight-fitting........................................... 115
Loose-fitting........................................... 170
------------------------------------------------------------------------
(c) Powered air-purifying particulate respirators with multiple
filter units will be tested by dividing the flow rate specified in
paragraph (b) of this section by the total number of filters used.
(d) The filter will be mounted on a connector in the same manner as
used on the respirator and the total efficiency must be >=99.97
percent.
Sec. 84.176 Fit test--PAPR classes HE and PAPR100.
NIOSH will assess powered air-purifying respirator fit using either
isoamyl acetate or generated aerosol.
(a) Isoamyl acetate (IAA) fit test. The applicant must provide a
charcoal-filled canister or cartridge of a size and resistance similar
to the filter unit with connectors which can be attached to the
facepiece in the same manner as the filter unit.
(1) The canister or cartridge will be used in place of the filter
unit, and persons will each wear a modified half-mask facepiece for 8
minutes in a test chamber containing 100 parts (by volume) of isoamyl
acetate vapor per million parts of air.
(i) The following work schedule will be performed by each wearer in
the test chamber:
(A) Two minutes nodding up and down, and turning head side to side;
and
(B) Two minutes calisthenic arm movements.
(C) Two minutes running in place.
(D) Two minutes pumping with tire pump.
(ii) The facepiece must be capable of adjustment, according to the
applicant's instructions, to each wearer's face, and the odor of
isoamyl acetate must not be detectable by any wearer during the test.
(2) Where the respirator is equipped with a full facepiece, hood,
helmet, or mouthpiece, the canister or cartridge will be used in place
of the filter unit, and persons will each wear the modified respiratory
inlet covering for 8 minutes in a test chamber containing 500 parts (by
volume) of isoamyl acetate vapor per million parts of air, performing
the work schedule specified in paragraph (b)(2) of this section.
(b) Generated aerosol fit test. The powered air-purifying
particulate respirator system is tested in an atmosphere containing 20-
40 mg/m\3\ corn oil aerosol having a mass median aerodynamic diameter
of 0.4 to 0.6 [mu]m.
(1) The following activities will be performed by each wearer in
the test chamber:
(i) Two minutes, nodding and turning head;
(ii) Two minutes, calisthenic arm movements;
(iii) Two minutes, running in place; and
(iv) Two minutes, pumping with a tire pump into a 28-liter (1
ft\3\) container.
(2) The respiratory inlet covering will be adjusted, according to
the applicant's instructions, to each wearer's face.
(3) The appropriate fit factor must be exceeded during the entire
test.
Sec. 84.177 Total noise level test--PAPR classes HE and PAPR100.
Noise levels generated by any powered air-purifying respirators
that cover the ears (i.e., hood or helmet) will be measured at the
entrance to each ear at maximum airflow obtainable and must not exceed
80 dBA.
Sec. 84.178 Breath response type, airflow resistance test--PAPR
classes HE and PAPR100.
Resistance to airflow will be measured with a breathing machine as
described in Sec. 84.88.
(a) Minimum inhalation resistance must be greater than zero mm of
water-column height.
[[Page 20611]]
(b) Maximum exhalation resistance must be less than 89 mm of water-
column height.
Sec. 84.179 Silica dust loading test--PAPR series HE filtration.
(a) Three powered air-purifying particulate respirators will be
tested for a period of 4 hours each at a flowrate not less than 115
liters per minute for tight-fitting facepieces, and not less than 170
liters per minute for loose-fitting hoods and helmets.
(b) The relative humidity in the test chamber will be 20-80
percent, and the room temperature approximately 25 [deg]C.
(c) The test suspension in the chamber will not be less than 50 nor
more than 60 mg of flint (99 + percent free silica) per m\3\ of air.
(d) The flint in suspension will be 99 + percent through a 270-mesh
sieve.
(e) The particle-size distribution of the test suspension will have
a geometric mean of 0.4 to 0.6 [mu]m and the standard geometric
deviation will not exceed 2.
(f) The total amount of unretained test suspension in samples taken
during testing must not exceed 14.4 mg for a powered air-purifying
particulate respirator with tight-fitting facepiece, and 21.3 mg for a
powered air-purifying particulate respirator with loose-fitting hood or
helmet.
Sec. 84.180 Particulate loading test--PAPR series PAPR100-N and
PAPR100-P filtration.
(a) Twenty filters of each powered air-purifying particulate
respirator design will be tested for filter efficiency against:
(1) A solid sodium chloride particulate aerosol, in accordance with
paragraph (d)(1) of this section, if series PAPR100-N approval is
requested by the applicant.
(2) A dioctyl phthalate or equivalent liquid particulate aerosol,
in accordance with paragraph (d)(2) of this section, if series PAPR100-
P approval is requested by the applicant.
(b) Prior to filter efficiency testing of 20 series PAPR100-N
filters, the 20 to be tested will be taken out of their packaging and
placed in an environment of 85 5 percent relative humidity
at 38 2.5 [deg]C for 25 1 hours. Following the
pre-conditioning, filters will be sealed in a gas-tight container and
tested within 10 hours.
(c) For powered air-purifying particulate respirators with a single
filter, filters will be tested at a continuous airflow rate of 85
4 liters per minute. Where filters are to be used in pairs,
the test-aerosol airflow rate will be 42.5 2 liters per
minute through each filter.
(d) Filter efficiency test aerosols:
(1) Series PAPR100-N filters:
(i) A sodium chloride or equivalent solid aerosol at 25 5 [deg]C and relative humidity of 30 10 percent that
has been neutralized to the Boltzmann equilibrium state will be used.
Each filter will be challenged with a concentration not exceeding 200
mg/m\3\.
(ii) The sodium chloride test aerosol will have a particle size
distribution with count median diameter of 0.075 0.020
[mu]m and a standard geometric deviation not exceeding 1.86 at the
specified test conditions as determined with a scanning mobility
particle sizer or equivalent.
(2) Series PAPR100-P filters:
(i) A neat cold-nebulized dioctyl phthalate (DOP) or equivalent
aerosol at 25 5 [deg]C that has been neutralized to the
Boltzmann equilibrium state will be used. Each filter will be
challenged with a concentration not exceeding 200 mg/m\3\.
(ii) The DOP aerosol shall have a particle size distribution with
count median diameter of 0.185 0.020 [mu]m and a standard
geometric deviation not exceeding 1.60 at the specified test conditions
as determined with a scanning mobility particle sizer or equivalent.
(e) The test will continue until minimum efficiency is achieved or
until an aerosol mass of at least 200 5 mg has contacted
the filter. For PAPR100-P series filters, if the filter efficiency is
decreasing when the 200 5 mg challenge point is reached,
the test will be continued until there is no further decrease in
efficiency.
(f) The efficiency of the filter will be monitored and recorded
throughout the test period by a suitable forward-light scattering
photometer or equivalent instrumentation.
(g) The minimum efficiency for each of the 20 filters will be
determined and recorded and must be equal to or greater than the filter
efficiency criterion for PAPR100-N and PAPR100-P, efficiency >=99.97
percent, pursuant to Sec. 84.170(b).
Sec. 84.181 Communication performance test--PAPR class PAPR100.
(a) Powered air-purifying respirators must be designed to allow for
proper communication while worn.
(b) A Modified Rhyme Test \7\ will be used to test the wearer's
ability to communicate efficiently.
---------------------------------------------------------------------------
\7\ The Modified Rhyme Test is used in speech intelligibility
experiments. See https://www.nist.gov/ctl/pscr/modified-rhyme-test-audio-library.
---------------------------------------------------------------------------
(c) The communications requirement is met if the overall
performance rating is greater than or equal to 70 percent.
Subpart KK [Removed]
0
12. Subpart KK, consisting of Sec. Sec. 84.1100 through 84.1158 and
the tables, is removed.
Dated: April 7, 2020.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2020-07804 Filed 4-9-20; 4:15 pm]
BILLING CODE 4150-18-P