14168 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 84 

[Docket NIOSH–005] 

RIN 0920–AA10 

Approval Tests and Standards for 

Closed-Circuit Escape Respirators 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Final rule. 

SUMMARY: This final rule announces 

updated requirements that the National 

Institute for Occupational Safety and 

Health (NIOSH or Agency), located 

within the Centers for Disease Control 

and Prevention (CDC) in the Department 

of Health and Human Services (HHS or 

Department), will employ to test and 

approve closed-circuit respirators used 

for escaping atmospheres considered to 

be immediately dangerous to life and 

health, including such respirators 

required by the Mine Safety and Health 

Administration (MSHA) for use in 

underground coal mines. NIOSH and 

MSHA jointly review and approve this 

type of respirator used for mine 

emergencies under regulations 

concerning approval of respiratory 

protective devices. NIOSH also 

approves these respirators for use in 

other work environments where escape 

equipment may be provided to workers, 

such as on vessels operated by U.S. 

Navy and Coast Guard personnel. The 

purpose of these updated requirements 

is to enable NIOSH and MSHA to more 

effectively ensure the performance, 

reliability, and safety of CCERs. 

DATES: This final rule is effective April 

9, 2012. The incorporation by reference 

of certain publications listed in the rule 

is approved by the Director of the 

Federal Register as of April 9, 2012. 

FOR FURTHER INFORMATION CONTACT: Tim 

Rehak, NIOSH National Personal 

Protective Technology Laboratory 

(NPPTL), P.O. Box 18070, 626 Cochrans 

Mill Road, Pittsburgh, PA, 15236; (412) 

386–5200 (this is not a toll-free 

number). Information requests can also 

be submitted by email to 

nioshdocket@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Preamble Table of Contents 

I. Background 

A. Introduction 

B. Approval of CCERs 

C. Need for Rulemaking 

D. Scope of the Rulemaking 

E. Effects of Rulemaking on Federal 

Agencies 

II. Summary of Public Comments 

A. Need 

B. Size 

C. Scope 

D. Feasibility 

E. State Stakeholders 

F. Railroads 

G. Training 

H. Section 84.300 Closed-Circuit Escape 

Respirator; Description 

I. Section 84.301 Applicability to New 

and Previously Approved CCERs 

J. Section 84.302 Required Components, 

Attributes, and Instructions 

1. Chemical Bed Physical Integrity 

Iindicator 

2. Instructions and Service Life Plan 

3. Labeling 

K. Section 84.303 General Testing 

Conditions and Requirements 

1. Breathing & Metabolic Simulator 

2. Carbon Dioxide 

3. Oxygen 

4. Peak Breathing Pressures 

5. Wet-Bulb Temperature 

L. Section 84.304 Capacity Test 

Requirements 

1. Man Test 4 

2. Duration Versus Capacity 

3. Capacity Ratings 

4. Achieved Capacity 

M. Section 84.305 Performance Test 

Requirements 

1. Performance Testing 

2. Work Rates 

3. Hypoxia 

N. Section 84.306 Wearability Test 

Requirements 

O. Section 84.307 Environmental 

Treatments 

1. Humidity 

2. Temperature 

3. Shock 

4. Vibration 

P. Section 84.308 Additional Testing 

Q. Section 84.309 Additional Testing and 

Requirements for Dockable CCERs 

R. Section 84.310 Post-Approval Testing 

III. Summary of the Rule 

A. Subpart O—Closed-Circuit Escape 

Respirators 

1. Section 84.300 Closed-Circuit Escape 

Respirator, Description 

2. Section 84.301 Applicability to New 

and Previously Approved CCERs 

3. Section 84.302 Required Components, 

Attributes, and Instructions 

4. Section 84.303 General Testing 

Conditions and Requirements 

5. Section 84.304 Capacity Test 

Requirements 

6. Section 84.305 Performance Test 

Requirements 

7. Section 84.306 Wearability Test 

Requirements 

8. Section 84.307 Environmental 

Treatments 

9. Section 84.308 Additional Testing 

10. Section 84.309 Additional Testing 

and Requirements for Dockable CCERs 

11. Section 84.310 Post-Approval Testing 

12. Section 84.311 Registration of CCER 

Units Upon Purchase 

B. Subpart G—General Construction and 

Performance Requirements 

1. Sections 84.60, 84.63–84.65 

C. Subpart H—Self-Contained Breathing 

Apparatus 

1. Section 84.70 Self-Contained Breathing 

Apparatus; Description 

IV. Regulatory Assessment Requirements 

A. Executive Order 12866 and 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act of 1995 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Language in Government Writing 

V. Final Rule 

I. Background 

A. Introduction 

A closed-circuit escape respirator 

(CCER) technically defined as a closedcircuit, self-contained breathing 

apparatus used for escape, is used in 

certain industrial and other work 

settings during emergencies to enable 

users to escape from atmospheres that 

can be immediately dangerous to life 

and health. The CCER, known in the 

mining industry as a self-contained selfrescuer, is used by miners to escape 

dangerous atmospheres in mines. It is 

also used by certain Navy and Coast 

Guard personnel, such as crews working 

below decks on vessels, where it is 

referred to as an emergency escape 

breathing device, and in the railroad 

industry, where it is known as an 

emergency escape breathing apparatus. 

To a lesser extent, it is also used by 

other workers who work underground 

or in confined spaces, such as in 

tunneling operations in the construction 

industry. 

CCERs are commonly worn on 

workers’ belts or stored in close 

proximity to be accessible in an 

emergency. They are relatively small 

respirators, typically the size of a water 

canteen, which employ either 

compressed oxygen with a chemical 

system for removing exhaled carbon 

dioxide from the breathing circuit, or a 

chemical that both provides a source of 

oxygen and removes exhaled carbon 

dioxide. Users re-breathe their 

exhalations after the oxygen and carbon 

dioxide levels have been restored to 

suitable levels, which distinguishes 

these ‘‘closed-circuit’’ respirators from 

‘‘open-circuit’’ respirators, which vent 

each exhalation. The total capacity for 

oxygen supply and carbon dioxide 

removal vary by respirator model to 

address different work and escape 

needs. The greater the oxygen supply 

capacity of a respirator, the larger the 

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Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 14169 

respirator size and the less practical or 

comfortable it might be to wear during 

work tasks. Current models are encased 

in hard, water-resistant cases to protect 

the respirators from damage by impact, 

puncture, or moisture. 

B. Approval of CCERs 

NIOSH and MSHA jointly review and 

approve such respirators for use by 

miners to escape hazardous 

atmospheres generated during 

emergencies in underground coal mines 

(42 CFR 84.3). NIOSH currently 

approves or certifies CCERs under 42 

CFR Part 84—Approval of Respiratory 

Protective Devices, Subpart H—SelfContained Breathing Apparatus, as 

closed-circuit apparatus for ‘‘escape 

only.’’ Subpart H also specifies 

requirements for other related, but 

distinct, types of respirators, including 

open-circuit escape respirators and 

respirators (closed- and open-circuit) 

used by rescuers responding to an 

emergency (‘‘entry’’ and ‘‘entry and 

escape’’ apparatus); none of those other 

types of respirators are covered by this 

rulemaking. 

C. Need for Rulemaking 

This final rule addresses problems 

that have been identified by NIOSH and 

users regarding CCERs and is intended 

to: 

• Reduce reliance on human testing 

of devices, which is difficult to conduct 

precisely and consistently and to 

replicate, through the use of a machinebased testing regime that can be 

accurately and completely calibrated 

and produces replicable results; 

• Establish new performance-based 

standards for the quality of the 

breathing supply produced by the 

CCER, based on the best available 

physiological research; 

• Replace the measurement of the 

duration of breathing gas supplied with 

the measurement of the volume of 

breathing gas supplied (in liters of 

oxygen) as a principal certification 

parameter. CCERs are presently 

approved as providing a specified 

duration of breathing gas based on the 

performance of test subjects, but this 

can be misleading since the actual 

durations of breathing gas received by 

users during escapes can differ 

substantially from those received by test 

subjects; 

• Require design features, as 

necessary, to allow users to check the 

material integrity of a deployed unit. 

This will make it easier for employers 

and users to detect suspect units 

through inspection and remove them 

from service; 

• Establish performance-based testing 

requirements for durability since CCERs 

are often used in relatively harsh 

environmental and handling conditions, 

such as in coal mining; and 

• Provide for the approval of new 

‘‘dockable’’ CCER designs that would 

allow the user to replenish the breathing 

gas supply of the CCER safely, reliably, 

and quickly under escape conditions. 

The final rule will result in the 

approval of CCERs that provide 

improved protection over those 

currently approved under the existing 

regulatory provisions and will facilitate 

the introduction of new technologies. 

D. Scope of the Rulemaking 

This rulemaking applies only to 

closed-circuit escape respirators. It will 

establish a new Subpart O codifying 

new testing and approval requirements 

for these respirators, replacing all 

testing and approval requirements of 42 

CFR Part 84, Subpart H, that are 

uniquely applicable to closed-circuit 

escape respirators used only for escape. 

This rulemaking will not alter the 

testing and approval requirements 

applicable to the other types of 

respirators included under Subpart H. 

E. Effects of Rulemaking on Federal 

Agencies 

Federal agencies may wish to 

harmonize their policies and/or 

regulations to be consistent with 

NIOSH’s change from the durationbased to capacity-based rating system. 

Federal agencies that require training as 

a component of their respirator use 

regulations may also need to assess and 

perhaps modify that training in concert 

with this rule. 

II. Summary of Public Comments 

On December 10, 2008, HHS 

published a notice of proposed 

rulemaking (73 FR 75027) proposing to 

update the requirements employed by 

NIOSH to test and approve closedcircuit respirators used for escaping 

atmospheres considered to be 

immediately dangerous to life and 

health. This class of respirators also 

includes such respirators required by 

MSHA for use in underground coal 

mines. HHS initially solicited public 

comments from December 10, 2008 to 

February 9, 2009. On March 4, 2009, 

HHS reopened the public comment 

period from March 4, 2009 to April 10, 

2009 and announced it would hold two 

public meetings on the proposed rule on 

March 16, 2009 and March 23, 2009 (74 

FR 9380). HHS again reopened the 

comment period from May 21, 2009 to 

June 19, 2009 (74 FR 23814). 

HHS received comments from 14 

organizations, including one labor 

union representing coal miners, four 

respirator manufacturers, one railroad, 

four trade associations, two federal 

agencies, one state agency, and one 

government technology consulting 

organization. One comment was 

received after the public comment 

period was closed and was not 

considered. In developing this final 

rule, HHS considered the comments and 

presentations at the public meetings. 

Summaries of these comments 

submitted to the docket and/or made at 

the public hearings and the 

corresponding responses from HHS are 

provided below. The description of the 

public comments and HHS’s responses 

are followed by Section III, a description 

of the rule and the changes made in 

response to the comment received. 

A. Need 

Comment: HHS received several 

comments regarding the need for this 

rulemaking. One commenter suggested 

that the proposed rule does not 

sufficiently address the range of 

problems associated with closed-circuit 

escape respirators. The commenter’s 

concerns related to matters outside the 

scope of this rulemaking, such as 

compliance enforcement. 

Response: HHS believes that while 

the final rule may not resolve every 

issue involving CCERs, it, along with 

enhanced training on the proper 

inspection and use of deployed units, 

will improve the protection provided by 

CCERs to the workers who rely on these 

devices to escape from environments 

immediately dangerous to life or health. 

As indicated in the notice of proposed 

rulemaking preamble, HHS has relied 

extensively on its investigations of units 

taken from the field to identify problems 

that could be addressed through 

improvements to the current 

performance standards. 

For example, a common problem 

among units deployed in various 

industries, including maritime, is that 

the handling of individual units tends to 

physically degrade or displace the 

chemicals necessary for oxygen 

production and carbon dioxide removal. 

This final rule addresses the issue of 

degradation by establishing improved 

performance measures to ensure the 

units are reasonably rugged and the user 

is able to inspect the unit and readily 

identify units which fail the 

manufacturers’ inspection criteria. 

Comment: Another commenter stated 

that HHS presents no documentary 

evidence from device users to support 

the need for the rulemaking. 

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14170 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 

1 42 CFR 84.53. 

2See, e.g., Kyriazi N, Shubilla JP. Self-contained 

self-rescuer field evaluation: seventh-phase results. 

Pittsburgh, PA: U.S. Department of Health and 

Human Services, Centers for Disease Control and 

Prevention, National Institute for Occupational 

Safety and Health; March 2002. DHHS (NIOSH) 

Publication No. 2002–127, RI 9656. 

Response: HHS has taken this 

regulatory action in response to decades 

of reports from the field, from 

underground coal miners in particular, 

which have demonstrated that 

expectations training cannot always 

prepare a user for the reality of how a 

CCER will function in an actual escape. 

It is widely acknowledged that over the 

course of many coal mine disasters, 

users have repeatedly reported that (a) 

units failed to work, (b) units appeared 

to work but stopped far short of the 

expected 1-hour duration, or (c) the 

decision to don a unit was delayed 

because fresh air was more than 1 hour 

away. 

In NIOSH’s judgment, the current 

certification requirements might be 

contributing to a risk communication 

and risk management problem resulting 

in the situations indicated above. 

NIOSH is currently required to approve 

these respirators as providing protection 

for a specific duration 1 applicable to the 

particular class of respirator. Durations 

may be misleading to employers and 

users, however, because the duration for 

which a respirator will provide effective 

protection in the workplace, versus in 

laboratory testing, will depend on the 

body weight and physical condition of 

the user and on the amount of exertion 

required by the escape. The heavier the 

user and the greater the exertion, the 

more rapidly the user will consume the 

limited oxygen supply and exhale 

carbon dioxide into the unit; the faster 

this is done, the greater the likelihood 

that the exhaled carbon dioxide will 

accumulate excessively within the 

user’s breathing zone, making breathing 

intolerable. 

Since 1982, NIOSH has received 

reports of incidents in which users 

purportedly have not received the 

duration of protection implied by the 

approval. While such incidents could 

have resulted from the respirator failing 

to perform as approved, they might also 

reflect limitations of understanding 

about the testing criteria regarding 

duration. Accordingly, this rulemaking 

eliminates the duration-specific 

approval, replacing it with a capacity 

rating system based on the quantity of 

usable oxygen supplied by the model. 

(See below for a more thorough 

discussion of the change to a volumebased standard). 

In addition to what NIOSH considers 

a risk communication/management 

problem, NIOSH field evaluations of 

approved CCERs conducted 

systematically and in response to the 

concerns of users have identified 

damaged respirators that failed to meet 

the performance criteria under which 

they were approved.2 In some instances, 

the designs of these respirators did not 

allow the user or employer to evaluate 

the condition of a particular respirator 

prior to its use in either an evacuation 

drill or an actual emergency. In 

response to the problems identified, 

respirator manufacturers have made 

design improvements to allow persons 

to check for certain types of damage. 

However, such checks or indicators are 

not governed by current regulations and 

do not exist in some of the respirators 

currently available. The final rule 

addresses these indicators which will 

simplify the inspection of units by 

employers and users and result in the 

removal from service of those which 

show evidence of exposure to 

conditions that may cause performance 

problems. 

This rulemaking also upgrades testing 

standards by more stringently verifying 

the quantity and quality of breathing gas 

supplied by approved CCERs. In certain 

circumstances, particularly during a 

prolonged or highly energetic escape, 

this type of respirator may provide the 

user with a constrained supply of 

oxygen and permit levels of carbon 

dioxide that can feel uncomfortable. The 

upgraded testing standards provide 

improved assurance that the levels of 

oxygen and carbon dioxide will be 

maintained consistently within tolerable 

limits throughout their use during an 

escape. Together with effective training 

to ensure that users are familiar with the 

particular breathing experience to be 

expected of this type of respirator, these 

improvements should help to ensure 

that workers can make full use of the 

respirators during an escape. 

HHS is also improving on the existing 

standard by avoiding human test subject 

variability in defining capacity and 

limiting its use in testing performance 

characteristics. Use of the breathing and 

metabolic simulator will ensure that 

neither the capacity nor the 

performance test criteria are wholly 

dependent on human subjects, which 

will establish a consistent and hence 

more reliable testing regimen. 

Comment: Finally, a commenter from 

the maritime sector expressed concern 

that the rulemaking and expenses 

associated with the replacement of 

currently-deployed units were 

unwarranted because HHS has not 

demonstrated that CCERs used on ships 

are problematic. 

Response: HHS does not expect the 

promulgation of this final rule to be a 

hardship on the maritime sector. The 6- 

year grandfather clause in the proposed 

rule has been omitted from this final 

rule, allowing units currently deployed 

on ships to remain in service until the 

end of their service life. To ensure no 

disruption in the supply of CCERS, 

currently-approved devices may not be 

manufactured and labeled as NIOSHapproved and sold after April 9, 2015. 

B. Size 

Comment: Seven commenters 

expressed concern that the improved 

standards might result in the production 

of larger, heavier CCERs. 

Response: HHS does not expect that a 

manufacturer would increase the size or 

weight of a CCER design in response to 

the new standards. It is possible that 

manufacturers could enlarge certain 

individual respirator designs or increase 

their weight in order to meet the new 

capacity rating standards and the more 

effective eye protection requirements. 

However, because most current CCER 

designs include eye protection, HHS 

does not expect an increase in either 

size or weight solely for this reason. 

Further, NIOSH bench testing on 

currently-approved units demonstrates 

that they can provide the same amount 

of oxygen as required by the capacity 

standards in this final rule. For 

example, current 1-hour units provide 

80 liters (L) of oxygen, comparable to a 

Cap 3 device; 10-minute units provide 

approximately 25 liters of oxygen, 

comparable to a Cap 1. The new 

standards afford greater latitude 

regarding potential variety in the 

capacity of individual respirator 

designs, given that each capacity rating 

encompasses a range of oxygen volumes 

(e.g. Cap 1 units can contain from 20 L 

to 59 L of oxygen). This latitude should 

promote designs that more closely meet 

the varied capacity, size, weight, and 

other requirements of different users, 

occupational settings, and emergency 

provisions and contingencies. 

C. Scope 

Comment: HHS received three 

comments indicating that the scope of 

the rulemaking should be expanded to 

also include technical standards for 

open-circuit escape respirators. Another 

commenter concurred with the Agency’s 

approach, stating that limiting this 

rulemaking to CCERs is warranted 

because of the clear distinctions 

between the two types of technology. 

HHS also received a comment 

demanding that the scope of the 

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proposed rule address all aspects of 

development, purchase, deployment, 

tracking, and use of CCERs in coal 

mines. 

Response: NIOSH is updating all of its 

standards under 42 CFR Part 84 using 

an incremental or modular approach. 

The updating of CCER standards was a 

high priority to the Agency and to users 

and employers because of the extensive 

concerns raised regarding this 

technology. Open-circuit escape 

respirators employ distinct technology 

that is likely to require different changes 

to the current standards. HHS intends to 

address open-circuit escape respirators 

in a future rulemaking. 

Under 42 CFR Part 84, HHS 

establishes applicable construction, 

performance and respiratory protection 

requirements for respirators. Section 

84.3 describes MSHA’s authority to coapprove respirators determined to be 

suitable for use in mines. HHS does not 

have authority to regulate the 

deployment and use of CCERs in coal 

mining or other industries. 

D. Feasibility 

Comment: HHS received one 

comment stating that HHS has not 

provided data indicating that it would 

be feasible for CCER manufacturers to 

produce designs capable of meeting the 

new certification standards before the 3- 

year cut-off date for sales of currently 

approved models. 

Response: CCER manufacturers have 

provided extensive comments during 

the development of this rule and have 

not indicated this concern. As discussed 

below, this final rule omits the proposed 

6-year grandfather clause limiting the 

duration over which currently approved 

CCERs may continue to be used within 

their prescribed service lives; as 

discussed below under § 84.301, the 

final rule does not discontinue the 

approvals of CCERs currently deployed 

or sold within 3 years of the effective 

date of this rule. Moreover, while the 

rule provides incentive for innovation, 

it does not specify new performance 

parameters that cannot be met by 

existing technology. 

E. State Stakeholders 

Comment: One commenter indicated 

that the Department’s efforts to reach 

out to state mine safety agencies on the 

development of this rule were 

inadequate. 

Response: HHS reached out to all 

stakeholders by providing numerous 

opportunities to comment throughout 

this rulemaking process. HHS 

announced all public meetings and 

opportunities to provide written 

comment in the Federal Register during 

both the concept and rulemaking stages. 

During the concept development work 

carried out by the Agency preceding this 

rulemaking, public meetings were held 

to solicit input from all stakeholders. 

These meetings included participation 

from representatives of labor and 

industry, other federal and state 

agencies, as well as manufacturers and 

academia. Subsequently, during this 

rulemaking, the docket and public 

comment meetings were open to all 

interested parties and included 

participation by a consultant to the 

mine safety agency of West Virginia. 

F. Railroads 

Comment: Two commenters advised 

HHS to consider the use of CCER by 

railroads. 

Response: HHS acknowledges the use 

of escape respirators by the railroad 

industry, and specifically recognizes the 

respirator requirements codified by the 

Rail Safety Improvement Act (RSIA) of 

2008 (49 U.S.C. 20166; Pub. L. 110–432, 

sec. 413). While no final rule concerning 

escape respirators have yet been 

promulgated under the RSIA, HHS has 

considered the RSIA requirements in 

drafting this final rule. This final rule 

does not conflict with the RSIA 

respirator requirements, which address 

the supply of CCERs on railways but do 

not include design or performance 

specifications. The omission from the 

final rule of the proposed 6-year 

grandfather provision regarding the 

continued use of already deployed 

CCER units should eliminate any 

feasibility concern of the railroads. 

G. Training 

Comment: HHS received two 

comments questioning whether the new 

rule will affect the training given to coal 

miners. 

Response: Such training is governed 

by MSHA, Department of Labor, 

pursuant to its authority under the 

Federal Mine Safety and Health Act (30 

U.S.C. 952, 811), and codified under 30 

CFR 75.1504. The Agency has worked 

with MSHA throughout the course of 

this rulemaking to ensure that MSHA 

policies will be consistent with the 

amendments to Part 84. 

H. Section 84.300 Closed-Circuit 

Escape Respirator; Description 

Comment: HHS received three 

comments objecting to the use of the 

term ‘‘closed-circuit escape respirator’’ 

to identify the subject of this 

rulemaking. These commenters would 

prefer to classify these devices as ‘‘selfcontained self-rescuer,’’ the term 

commonly used by the mining industry. 

One of these commenters suggested that 

the use of a terminology not recognized 

by the mining industry resulted in that 

community not understanding the rule’s 

potential impact. 

Response: While the mining industry 

categorizes these devices under one 

term, they are referred to as ‘‘emergency 

escape breathing apparatus’’ on 

railroads, and as ‘‘emergency escape 

breathing devices’’ onboard ships. CCER 

is the classification of this type of 

respirator under any of these 

designations. HHS will retain the 

classification ‘‘closed-circuit escape 

respirator’’ because it is the technically 

correct name of the devices to be 

considered for approval and because 

HHS does not intend to impose one 

industry’s designation on other 

industries that have their own. The use 

of the term ‘‘closed-circuit escape 

respirator’’ in this rulemaking does not 

in any way proscribe the use of the term 

‘‘self-contained self-rescuer’’ by 

manufacturers or the mining industry, 

or other terms used by other industries. 

This is consistent with the current 

standard (42 CFR Part 84, Subpart H), 

which does not refer to the devices as 

‘‘self-contained self-rescuers,’’ but rather 

‘‘closed-circuit self-contained breathing 

apparatus.’’ 

I. Section 84.301 Applicability to New 

and Previously Approved CCERs 

Comment: HHS received various 

comments on the proposed 3-year 

certification phase-in period for new 

devices and the proposed 6-year 

grandfather clause for units purchased 

prior to the effective date of the final 

rule. One commenter supported both 

the 3-year phase-in and the grandfather 

clause, and opposed the option 

discussed in the notice of proposed 

rulemaking of omitting the grandfather 

clause, which could result in currently 

approved CCER units remaining in the 

field for 13–18 years (their potential 

service life) following promulgation of 

this final rule. One commenter 

requested that HHS include no phase-in 

period, and that instead manufacturers 

should be prepared to supply new units, 

approved under the final rule, 

immediately upon promulgation. The 

same commenter suggested that HHS 

would otherwise exceed its authority 

under the Mine Improvement and New 

Emergency Response (MINER) Act of 

2006 (29 U.S.C. 671(h), Pub. L. 109–236, 

sec. 6) by delaying the deployment of 

new technologies. Two other 

commenters concurred with HHS 

regarding the exemption of the 

Department of Defense (DOD) from the 

6-year grandfather provision of the 

proposed rule, as proposed therein. 

Finally, four commenters opposed the 6- 

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3U.S. Government Accountability Office. 

Additional guidance and oversight of mines’ 

emergency response plans would improve the safety 

of underground coal miners. April 2008; GAO–08– 

424 at 24. http://www.gao.gov/new.items/ 

d08424.pdf. Accessed October 7, 2010. 

4See Section IV.A of this preamble for a 

discussion of potential economic costs. 

5One product has a service life of 15 years, but 

to achieve this service life, it must be reconditioned 

by the manufacturer at 10 years if stored and at 5 

years if carried. 

6NIOSH evaluations of the physical condition 

and performance of deployed CCERs are conducted 

routinely as a quality assurance measure and in 

response to complaints, concerns, and emergency 

incidents. The findings of these evaluations are 

documented in published Long-Term Field 

Evaluations and NIOSH internal reports; actionable 

findings provide the basis for remedies addressed 

by NIOSH and the applicant. 

year grandfather clause for units 

approved under the current standards. 

They argued that the discarding of 

CCERs with remaining service life 

would be financially costly and 

potentially infeasible, considering the 

difficulties experienced by 

manufacturers in producing sufficient 

CCER supplies for the mining industry 

under the expanded deployment 

requirements promulgated by MSHA 

under the MINER Act (30 U.S.C. 876 

(E)(iii)).3

Response: HHS recognizes that recent 

amendments to the statutory schemes 

governing two of the three main users of 

CCERs—mining and railroads—require 

the deployment of substantially 

increased numbers of units of escape 

respirators. For example, the Rail Safety 

Improvement Act of 2008 requires that 

the Federal Railroad Administration in 

the Department of Transportation enact 

regulations mandating respirators on 

certain locomotives for all crewmembers 

(49 U.S.C. 20166; Pub. L. 110–432, sec. 

413). Similarly, the MINER Act requires 

mine operators to make additional 

caches of respirators available to 

workers, a provision which has been 

implemented by MSHA and mine 

operators. HHS also recognizes that the 

relevant, industry-specific regulatory 

agencies and DOD are authorized to 

govern respirator use within their 

specific industry domains and that their 

authorizations differ. 

Within 3 years of the effective date of 

this final rule, NIOSH will continue to 

recognize respirators manufactured and 

labeled as NIOSH-approved devices and 

sold by manufacturers under the current 

approvals as long as they continue to be 

maintained and used in accordance 

with the conditions of approval. It is not 

appropriate for HHS, which is not 

authorized to govern respirator use in 

particular industries, to consider 

requirements or limitations on the 

continued use of approved CCERs that 

are deployed currently or may be 

deployed within the 3-year 

manufacturing/labeling and selling 

limitation of this final rule. Such 

consideration would involve matters 

outside of HHS’s purview, including the 

varying service life ranges of different 

CCER designs currently approved by 

NIOSH; the different storage, 

maintenance, and use conditions; 

differing feasibility concerns regarding 

maintenance of an adequate supply of 

CCERs; and the agencies’ different 

statutory and regulatory requirements. 

Eliminating the 6-year grandfather 

period in the final rule removes 

potential economic costs 4 to employers 

that could result from replacing or 

retrofitting any respirator designs that 

remain in use at their worksite but are 

not submitted to NIOSH for retesting 

under the new approval tests. This 

change also fully addresses the 

feasibility concerns raised in the public 

comments. On the other hand, it allows 

that some currently-approved CCERs 

may remain in service for their entire 

service life, unless the relevant 

regulatory or purchasing agencies 

determine otherwise. Designations of 

service life for currently-approved 

CCERs range from 10 to 15 years.5 As 

noted in the notice of proposed 

rulemaking, these designations do not 

account for the highly varied conditions 

of storage and handling of CCERs across 

different work environments. Through 

extensive field studies evaluating the 

condition of CCERs deployed in coal 

mines, NIOSH and MSHA have found 

that the actual deployment duration of 

current CCERs in coal mines tends to be 

substantially less than designated, due 

to wear and tear and damaging 

environmental conditions.6 In other 

industries involving less physically 

degrading conditions, CCERs may be 

more likely to remain available for 

deployment for their full service life. 

With respect to the 3-year phase in 

period, HHS recognizes the difficulty 

experienced by some manufacturers in 

meeting the current demand for 

respirators and the potential need for 

design development and related 

production line changes. The 

Department finds that it would not be 

feasible to require manufacturers to 

redesign products and change their 

production processes immediately upon 

promulgation of the final rule. 

Therefore, HHS has retained in the final 

rule the proposed allowance for CCER 

manufacturers to continue the sale of 

manufactured and NIOSH-labeled 

currently-approved CCERs for 3 years, 

upon this rule’s effective date. The final 

rule has been changed slightly from the 

language that was originally proposed, 

to indicate that respirators must be 

manufactured and labeled NIOSHapproved within the 3-year deadline, as 

well as sold by manufacturers within 

that deadline, to ensure that respirators 

approved under the new standard are 

integrated into the field as quickly as 

possible. 

As of the effective date of this rule, 

NIOSH will only accept applications for 

approval of CCERs under these new 

standards. NIOSH believes there are 

manufacturers who will be ready to 

submit applications to meet the new 

standards at that time and will do so to 

enhance the marketability of their 

products. In addition, the new rule 

permits the introduction of new 

technology, such as the dockable unit. 

J. Section 84.302 Required 

Components, Attributes, and 

Instructions 

Comment: HHS received various 

comments regarding components 

required to indicate specific types of 

damage that might reduce the 

effectiveness of the CCER unit. Two 

commenters supported the provision in 

its entirety; one supported the objective 

but proposed that the indicators be 

designed to minimize false positives 

(when the indicator falsely indicates 

there is a problem) and false negatives 

(when the indicator falsely indicates 

there is not a problem). One commenter 

requested that all indicators be failsafe 

(100 percent accurate in indicating 

problems) and that indicators should 

become permanently altered to indicate 

material or functional degradation. 

Another commenter suggested that the 

rule should require an additional 

indicator, specific to CCERs that use 

compressed oxygen or chlorate candles, 

which would allow the user to verify 

that the oxygen starter will activate. 

Another commenter requested that 

oxygen starters employed in CCERs be 

required to include a pressure gauge. 

Response: HHS has retained 

requirements for indicators in certain 

circumstances. These requirements are 

intended to codify what has become 

standard equipment on currentlyapproved respirators. Some types of 

damage are obvious, but the purpose of 

the indicators is to reveal critical 

damage or unacceptable environmental 

exposures that would not be otherwise 

evident to users. Such indicators are 

required only to address susceptibilities 

of the particular CCER design and are 

required only for those components or 

attributes critical to the life-preserving 

functions of the respirator. While it may 

not be possible to build a device that 

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cannot be broken, it is possible to build 

a device that clearly indicates when it 

should no longer be relied upon to 

protect the wearer. HHS will require 

manufacturers to include indicators that 

unambiguously alert users to the 

detection of damage or degradation. 

These indicators will permit employers 

and users to inspect units, and remove 

from service those units that 

demonstrate exposure to conditions that 

may cause performance problems. 

NIOSH will examine the accuracy and 

reliability of indicators on a case-bycase basis, as this is an important 

element of ensuring that they are 

effective. A substantial potential for 

false negatives would be of particular 

concern since it might mislead 

employers and users regarding CCER 

units that should be removed from 

service. A high potential for false 

positives would also be problematic 

because the employer might remove 

undamaged units from service based on 

the false indications, which has cost 

implications but also could impact the 

credibility of the indicators, potentially 

discouraging compliance. However, in 

NIOSH’s experience—which includes 

Long-Term Field Evaluations, 

manufacturer audits, and investigated 

field complaints—true false positives 

are rare, as indicators are designed to 

minimize their occurrence. CCER units 

are known to experience performance 

degradation after exposure to extreme 

(as defined by the manufacturer) heat 

and moisture; temperature and heat 

indicators on currently-approved units 

reliably alert users to exposures that 

have the potential to cause a unit to be 

unable to supply oxygen or scrub carbon 

dioxide at sufficient levels to effect an 

escape. The standard, as written, does 

not require that an indicator alert the 

user that the unit has sustained damage, 

but that the unit has been subjected to 

environmental conditions that could 

cause damage to the unit. NIOSH will 

validate indicators during the 

certification process and through postapproval testing under its Long Term 

Field Evaluation program discussed in 

the notice of proposed rulemaking (73 

FR 75027 at 75037, December 10, 2008) 

and its Certified Product Investigation 

Program. HHS agrees that manufacturers 

should attempt to design indicators to 

minimize false positives and negatives, 

but will not require that standard in the 

final rule. To enable NIOSH to 

effectively evaluate the indicators, the 

final rule text requires manufacturers to 

provide NIOSH with information about 

each indicator, including an explanation 

of how the indicator works, any relevant 

data that will enable the evaluation, and 

any tools used by the manufacturer to 

evaluate indicator function. 

In this final rule, HHS has added a 

provision requiring an oxygen starter 

indicator or other component to detect 

certain damage or deficiencies to the 

starter if it is a critical component to the 

effective use of the CCER. For 

compressed air starters, this may mean 

a pressure gauge; for a chemical starter, 

it could mean a color change chemical 

indicator observable through a port/ 

window; for any unit, it could mean 

instructions to observe conditions that 

may prevent intended activation and 

release of the starter oxygen (i.e., 

denting or damage or a pulled or broken 

starter pin) or an indicator of the starter 

assembly’s exposure to moisture, 

excessive temperature, g-force, or other 

physical damage. 

1. Chemical Bed Physical Integrity 

Indicator 

Comment: Two commenters 

addressed the issue of chemical bed 

physical integrity indicators for carbon 

dioxide scrubbers: One believed such an 

indicator is unwarranted since quality 

control during manufacturing will 

ensure that the scrubber will work when 

required, and post-approval testing will 

verify continuing effectiveness after 

deployment; the other commenter 

requested specific requirements for 

these indicators. 

Response: The chemical bed physical 

integrity indicator will not be required 

if the chemical oxygen supply or 

chemical carbon dioxide scrubber 

cannot be altered by impact, vibration, 

or any other environmental factor. This 

indicator would only be required when 

the design of the CCER would allow for 

the degradation of chemical oxygen 

supply or the carbon dioxide scrubber. 

The text of this provision has been 

revised to indicate that units in which 

the chemical oxygen storage or chemical 

carbon dioxide scrubber can be altered 

by impact or any other effect must 

include the chemical bed integrity 

indicator. 

HHS has not added any specific 

requirements for the design of such an 

indicator. An indicator, when required, 

must accurately and reliably indicate 

when the capacity or performance 

attributes of the CCER have been 

degraded such that the unit does not 

meet the capacity and performance 

testing requirements of this final rule. 

NIOSH will examine and/or test the 

accuracy and reliability of the indicator 

appropriate to the indicator’s design 

attributes and their potential 

susceptibilities to failure. The 

manufacturer is not limited with respect 

to the possible indicator designs 

permissible to achieve this performance 

standard. 

2. Instructions and Service Life Plan 

Comment: The proposed rule would 

have required manufacturers to include 

instructions and a service life plan with 

each new CCER unit. One commenter 

found the requirement unwarranted 

while another asserted in support of the 

proposal that the service life plan is an 

essential requirement. 

Response: Manufacturers include 

instructions with currently approved 

units in a variety of manners and this 

information is often lost or damaged 

because of the way in which units are 

handled in the field. Users are required 

to be trained in the donning and use of 

CCERs such that users should be 

thoroughly familiar with the devices in 

the event of an emergency. Accordingly, 

HHS agrees with the commenter noted 

above that manufacturers should not be 

required to provide instructions or a 

service life plan with each individual 

unit. The final rule has been modified 

accordingly. 

3. Labeling 

Comment: HHS received one 

comment recommending that the 

capacity rating be identified on the 

device. 

Response: The Department does 

intend to require manufacturers to 

indicate the capacity rating (e.g. Cap 3) 

as well as the number of liters of oxygen 

as determined by the capacity test on 

the label of each CCER unit. This intent 

was implicit in the proposed rule’s 

provisions for capacity ratings and 

NIOSH reporting of achieved capacity 

values under § 84.304. This comment is 

adopted in the final rule and the 

language in the rule text has been 

clarified. 

K. Section 84.303 General Testing 

Conditions and Requirements 

1. Breathing & Metabolic Simulator 

Comment: HHS received several 

comments on the conduct of capacity 

and performance testing using the 

breathing and metabolic simulator for 

quantitative evaluation, and the use of 

human subjects for qualitative 

evaluation of units. 

One commenter supported the 

retention of some human subject testing 

to assess the human factors associated 

with CCERs; several commenters 

supported the use of simulators to 

conduct quantitative analysis on CCER 

units, however one of those commenters 

would have preferred that the use of 

human subjects represent the broader 

mining community and not be limited 

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7The Federal Mine Safety and Health Act which 

governs the mandatory health and safety standards 

issued by the Secretary of Labor requires that ‘‘no 

mandatory health or safety standard * * * shall 

reduce the protection afforded miners by an 

existing mandatory health or safety standard.’’ 30 

U.S.C. 811(a)(9). The continued use of man test 4, 

as a supplement to the new testing requirements 

and capacity rating system, will be the most 

practical method of ensuring that the use of these 

respirators, as approved under this final rule, is 

consistent with the standard set by the Act. 

8 Glatte HA, Motsay GJ, Welch BE. Carbon 

dioxide tolerance studies. Brooks AFB, TX. U.S. Air 

Force, Aerospace Medicine Division, USAF School 

of Aerospace Medicine. Report #SAM–TR–67–77; 

1967:1–22. 

Henning RA, Sauter SL, Reddan W, Lanphier EH. 

Behavioral impairment with altered ventilatory 

response to CO2. Federation of American Societies 

for Experimental Biology, Abstracts of 67th Annual 

Meeting, Chicago, IL, 10–15 April 1983. Federation 

Proceedings: 1983;42(4):1013. 

Kamon E, Deno S, Vercruyyen M. Physiological 

responses of miners to emergency. Vol. 1—Selfcontained breathing apparatus stressors. University 

Park, PA: The Pennsylvania State University. U.S. 

Bureau of Mines contract No. J0100092; 1984:13. 

Sheehy JB, Kamon E, Kiser D. Effects of carbon 

dioxide inhalation on psychomotor and mental 

performance during exercise and recovery. Human 

Factors. 1982;24(5), 581–588. 

Storm WF, and Giannetta CL. Effects of 

hypercapnia and bed rest on psychomotor 

performance. Aviation, Space, and Environmental 

Medicine. 1974;45:431–33. 

to a single subject. Finally, one 

commenter requested that capacity and/ 

or performance testing include a 

simulation of multiple realistic demand 

models, which should not terminate 

until the breach of specific performance 

thresholds. 

Response: HHS continues to find it 

appropriate to shift from human-based 

testing to the breathing and metabolic 

simulator model to assess the 

quantitative aspects of CCER capacity 

and performance and has retained the 

breathing and metabolic simulator 

testing in the final rule. Breathing and 

metabolic simulator testing will provide 

a uniform, consistent basis for 

evaluating the functional characteristics 

of CCERs and allows NIOSH to evaluate 

CCER performance to the point at which 

the CCER gas supply is completely 

depleted, ensuring that the CCER’s 

capacity and performance is fully 

evaluated. HHS has also retained 

limited human subject testing in the 

final rule, as specified in the proposed 

rule, to make ergonomic assessments 

and to ensure consistency with statutory 

requirements applicable to mining.7

In the Agency’s judgment, it is not 

feasible for NIOSH to conduct scenario 

testing. The capacity testing protocol 

cannot fully predict a range of escape 

scenarios to address all situations in 

which CCERs might be deployed. Man 

test 4, required for capacity testing units 

intended for use in coal mines, is not 

designed to represent a mine escape; it 

is included as an ergonomic assessment 

of the physical orientations that may be 

required during a mine escape. This 

ergonomic assessment is sufficiently 

realistic; in NIOSH’s judgment, a more 

realistic demand model is unwarranted. 

Comment: Two commenters said the 

proposed rule lacks test protocols to 

determine which respirators will pass or 

fail. 

Response: HHS has clearly specified 

in the proposed rule and in this final 

rule the performance standards by 

which respirators will be evaluated 

using the breathing and metabolic 

simulator and through human testing, 

addressing respirator capacity and 

performance. Upon request, NIOSH will 

make available to manufacturers its 

specific protocols and breathing and 

metabolic simulator performance 

specifications so that manufacturers can 

duplicate NIOSH testing methods. 

Standard test procedures will be posted 

on the NIOSH Web site at http:// 

www.cdc.gov/niosh/npptl. 

Comment: One commenter has 

requested that HHS provide verification 

of the performance and accuracy of each 

breathing and metabolic simulator used 

by NIOSH for capacity and performance 

testing. 

Response: NIOSH is willing to share 

fully its experience over many years 

with its breathing and metabolic 

simulator, as well as its design 

specifications, as noted above. The 

technology used in the breathing and 

metabolic simulator used by NIOSH is 

readily calibrated and when calibrated, 

is not subject to significant variability in 

relation to the simulation and 

measurement performance required for 

testing specified under this final rule. 

To ensure the accuracy of the 

breathing and metabolic simulator, the 

analyzers are calibrated before each test 

along with transport and response time 

of the gas measurement system. All of 

these will be documented in the 

standard test procedures developed for 

the certification tests. 

Comment: HHS received one 

comment suggesting that the 

manufacturer’s respirator donning and 

use instructions be applied during 

capacity and performance testing. The 

commenter offered text changes to 

provide that capacity and performance 

tests would be conducted in accordance 

with the manufacturer’s instructions. 

While earmarked for § 84.303(a), it 

appears this comment is meant to refer 

specifically to the hypoxia testing 

component of § 84.305. 

Response: HHS believes the hypoxia 

test procedure is well-conceived and 

essential for determining whether a unit 

will expose a user to low inhaled 

oxygen concentrations. Many CCER 

users are trained to exhale into a CCER 

upon donning it because this is the 

recommended practice for CCERs 

supplied with chemical oxygen if the 

oxygen starter fails. In an emergency, it 

is likely that some users will exhale into 

the CCER regardless of its design, in 

which case NIOSH needs to ensure that 

the respirator will perform adequately. 

The final rule’s requirements assume 

that a reasonably likely donning 

procedure will be applied by the user 

irrespective of the specific type of CCER 

available to the user. Therefore, 

performance tests will begin with two 

exhalations into the unit and then the 

manufacturer’s instructions will be 

followed in order to determine the 

design’s susceptibility to hypoxia. 

HHS also received many comments 

concerning the values included in Table 

1—Monitored Stressors and Their 

Acceptable Ranges, including all four 

criteria (average inhaled carbon dioxide, 

average inhaled oxygen, peak breathing 

pressures, and wet-bulb temperature). 

Capacity, performance, and wearability 

tests will continuously monitor the 

stressors listed in this table. Those 

comments and HHS’s responses follow 

below. 

2. Carbon Dioxide 

Comment: Three commenters 

addressed acceptable operating average 

and acceptable range excursion values 

for carbon dioxide in Table 1. One 

commenter objected to the 1.5 percent 

average carbon dioxide concentration, 

and requested that HHS justify the 

change in this value for closed-circuit 

devices when the value for open-circuit 

devices (currently 2.5 percent) remains 

unchanged. The other two commenters 

objected to the proposed 4 percent 

carbon dioxide ‘‘parameter,’’ given the 

potential for slightly impaired decisionmaking in some subjects when exposed 

to this amount of carbon dioxide. 

Response: HHS has retained the 

average and acceptable range excursion 

values in the final rule. The 1.5 percent 

average limit for carbon dioxide is 

feasible using current technology (based 

on NIOSH testing of existing designs) 

and it is an important improvement for 

assuring the protection of users. As 

carbon dioxide levels rise users are 

increasingly likely to interpret the 

breathing experience as faulty and 

possibly indicative of a malfunctioning 

CCER. This could lead the user to 

abandon the CCER when its use is 

critical for survival. 

An excursion limit of 4 percent is 

physiologically tolerable for brief 

periods 8 and its application to all CCER 

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Vercruyssen M, Kamon E. Behavioral effects of 

breathing 3% and 4% carbon dioxide during and 

following physical work. Toronto, Ontario, Canada, 

7–9 May, 1984. Proceedings of the 1984 

International Conference on Occupational 

Ergonomics. 

9Ainslie PN, Barach A, Cummings KJ, Murrell C, 

Hamlin M and Hellemans J. Cardiorespiratory and 

cerebrovascular responses to acute poikilocapnic 

hypoxia following intermittent and continuous 

exposure to hypoxia in humans. Journal of Applied 

Physiology. 2007;102:1953–1961. 

Fowler B, Paul M, Porlier G, Elcombe DD, Taylor 

M. A re-evaluation of the minimum altitude at 

which hypoxic performance decrements can be 

detected. Ergonomics. 1985;28(5): 781–791. 

Malkin VB. Barometric pressure and gas 

composition. In Foundations of Space Biology and 

Medicine. Vol II, Book 1 (Ecological and 

physiological bases of space biology and medicine). 

1975;25–31. 

Paul MA, Fraser WD. Performance during mild 

acute hypoxia. Aviation, Space, and Environmental 

Medicine. 1994;65(10):891–899. 

West JB, et al. Maximal exercise at extreme 

altitudes on Mt. Everest. Journal of Applied 

Physiology. 1983;55:688–698. 

Zoll J, et al. Exercise training in normobaric 

hypoxia in endurance runners. Journal of Applied 

Physiology. 2006;100:1238–1248. 

10 73 FR 75,027 at 75,032 (December 10, 2008). 

11Hodgson JL. Physiological costs and 

consequences of mine escape and rescue. 

University Park, PA: The Pennsylvania State 

University. U.S. Bureau of Mines contract No. 

J0345327; 1993:19. 

designs would improve the quality of 

breathing gas in these respirators, as 

discussed above with respect to the 

average limit. With respect to the 

concern that the 4-percent level might 

be too high, HHS notes that 4 percent 

is allowed only as an excursion level. 

Excursions are recorded during testing 

in 1-minute increments, with the 

average level determined over the entire 

expended breathing gas supply of the 

unit. CCER designs that allow carbon 

dioxide levels to approach the excursion 

limit repeatedly or for significant time 

would not achieve the specified limit on 

the average carbon dioxide level. 

Accordingly, NIOSH will not approve 

units that would allow a carbon dioxide 

excursion for a duration that would 

impair the user during an escape. 

Finally, capacity and performance 

standards for open-circuit designs will 

be addressed in a future rulemaking. 

3. Oxygen 

Comment: Two commenters 

discussed the proposed acceptable range 

excursion value for oxygen: One 

commenter found the excursion range 

unwarranted, and expressed concern 

that manufacturers would attempt only 

to meet this ‘‘minimum threshold.’’ The 

other commenter opposed the excursion 

limit and recommended further study. 

Response: HHS disagrees with the 

commenters and has retained the 

proposed acceptable excursion value for 

oxygen in Table 1. The 15 percent range 

excursion limit for oxygen is not an 

operating parameter. As discussed 

above with respect to the carbon dioxide 

excursion limit, it allows only for brief 

variation to a low oxygen level, within 

physiologically established tolerance.9

To raise this excursion limit would 

require CCERs that would be 

‘‘overbuilt,’’ resulting in unnecessarily 

large and/or heavy designs. The average 

limit of 19.5 percent, which is the level 

of oxygen available at approximately 

2,000 feet above sea level, will ensure 

that users receive a fully adequate 

oxygen supply to execute their escapes. 

The brief excursions that would be 

allowed by this average level limit do 

not pose any impairment risk to the 

user. 

During testing, readings are taken in 

1-minute intervals, with the average 

level determined over the entire 

expended breathing gas supply of the 

unit; oxygen concentrations from 20 to 

100 percent are recorded as 20 percent. 

Concentrations between 19.5 percent 

and the lowest allowable level, 15 

percent, are recorded as the actual 

value. The average of these values must 

remain at or above 20 percent over the 

entire test. In a worst case scenario, this 

method of averaging allows for 

approximately 10 percent of the sample 

intervals to be at the excursion limit of 

15 percent. For example, during a test 

composed of 60, 1-minute sample 

intervals, five samples could indicate an 

oxygen level of 15 percent. If an 

additional 1-minute interval were to 

exhibit an oxygen level of less than 19.5 

percent, the unit would not pass the 

test. 

Comment: One commenter requested 

that HHS consider CCER designs 

equipped with hoods, which effectively 

store unused oxygen for use after the 

oxygen source has been expended. This 

commenter believes that § 84.303(c) 

restricts manufacturers’ design options. 

Response: Section 84.303(c) would 

not restrict CCER designs. Section 

84.303(c) specifies that tests will 

conclude when the oxygen supply has 

been fully expended. This would 

include oxygen that remains stored in a 

hood if a hood is part of the CCER 

design. 

4. Peak Breathing Pressures 

Comment: HHS received two 

comments pertaining to peak breathing 

pressures. One commenter suggested 

that that the proposed values should be 

more conservative. Specifically, the 

commenter has proposed the value ±100 

millimeters of water (mm H2O) for the 

acceptable range operating average, and 

±200 mm H2O for the acceptable range 

excursion, on the grounds that the 

operating and excursion ranges offered 

in the proposed rule are unacceptable 

and may result in the user discarding 

the unit prematurely. Similarly, another 

commenter objected to the assertion that 

‘‘Users who cannot generate these [peak 

breathing] pressures may be forced at 

some point to slow the pace of their 

escape.’’ 10

Response: The values proposed by 

HHS are based on human physiological 

capability 11 and are retained in the final 

rule. The lower pressure range 

suggested by the commenter would 

result in a bulkier, heavier device than 

is practical. The assertion that some 

users may be forced to slow their escape 

is based on the mechanical and 

chemical limitations of this type of 

respirator; certain users, especially very 

large individuals, would be able to 

exceed the supply capability required 

for an unlimited level of exertion. This 

inherent limitation of the technology is 

appropriately addressed through the 

training provided to users. 

5. Wet-Bulb Temperature 

Comment: HHS received four 

comments regarding wet-bulb 

temperature, included in the table of 

monitored stressors to represent the 

temperature of the inhaled breathing gas 

in the CCER user’s trachea. One 

commenter warned against adopting the 

highest threshold number for evaluating 

wet-bulb temperatures. Another 

suggested that the proposed standard 

should rely on dry-bulb instead of wetbulb temperature because dry-bulb 

temperature is technically easier to 

measure in the laboratory. This 

commenter further suggested that the 

comparison of wet-bulb temperature to 

a user’s trachea is not accurate, as the 

trachea is not always a wet surface. 

Another commenter expressed concern 

that standardizing humidity responses 

between different simulators will be 

difficult, as the temperature reading is 

not a fundamental property and is 

specific to each breathing and metabolic 

simulator. For example, the commenter 

asserted that wet-bulb response will 

‘‘vary with different flow rates, different 

amounts of water on the thermocouple, 

or different size thermocouples,’’ and 

suggested that HHS consider using a 

fast-response sensor. Finally, one 

commenter asserted that the inhaled gas 

temperature (<43 °C acceptable range 

operating average) is arbitrary, and 

suggested adopting International 

Organization for Standardization (ISO) 

23269–1:2008, Ships and marine 

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12 Kamon E, Deno S, Vercruyyen M. Physiological 

responses of miners to emergency. Vol. 1—Selfcontained breathing apparatus stressors. University 

Park, PA: The Pennsylvania State University. U.S. 

Bureau of Mines contract No. J0100092; 1984:117, 

119. 13 30 U.S.C. 811(a)(9). 

technology—Breathing apparatus for 

ships—Part 1: Emergency escape 

breathing devices (EEBD) for shipboard 

use, which sets the maximum inhaled 

gas temperature at 50 °C. 

Response: HHS has retained in the 

final rule the use of wet-bulb 

temperature and the average and 

excursion ranges specified (<43 and ≤50 

°C, respectively) because the trachea is 

always wet and because monitoring wetbulb temperature provides a more 

accurate measure of the heat content of 

the inhaled gas and human thermal 

sensitivity is related to the wet-bulb 

temperature.12 As with other testing 

protocols, manufacturers may copy the 

technology and technique to be applied 

by NIOSH for certification testing. 

The ISO 23269–1:2008 performance 

requirements establish that ‘‘the 

temperature of inhalation gas shall not 

exceed 50 °C’’ for respirators deployed 

for shipboard use. In accordance with 

the ISO standard, this final rule also 

establishes that the acceptable range 

excursion for CCERs is 50 °C, while the 

average operating temperature must be 

less than 43 °C. 

From running many treadmill tests on 

both compressed- and chemical-oxygen 

breathing apparatus, NIOSH knows that 

the exhalation temperature of human 

subjects rises as inhalation temperature 

rises. The exhalation temperature of 

human subjects breathing room air 

varies from 30 to 33 °C. As inhalation 

temperature rises, NIOSH has observed 

the exhalation temperature rise to as 

high as 45 °C. The ventilatory 

components of our breathing and 

metabolic simulator were designed to 

simulate human subjects based on 

shape, size, and orientation. There is a 

water reservoir which heats the water 

and pumps it into a plenum above the 

lung where it spreads out and rains 

down onto the piston. The water in the 

lung is a moderate quantity, unlike most 

other simulators which have a larger 

quantity. This enables our simulator to 

be overwhelmed by higher inhalation 

temperatures, emulating human beings. 

The air pathway between the lung/ 

piston and the mouth port is divided 

into three pipes covered both with heat 

tape and metal fins. This simulates the 

volume and surface area of the trachea, 

enabling heat transfer to and from the 

air stream, respectively, again emulating 

human response to the temperature of 

inhalation gases. NIOSH can set and 

specify the exhalation temperature of 

the airway gas while breathing room air, 

but cannot specify the breathing and 

metabolic simulator exhalation 

temperature for every combination of 

inhalation wet- and dry-bulb 

temperature. Because it is designed to 

physically simulate the human lung and 

airway, the simulator responds in a 

human-like manner to rising inhalation 

temperatures. 

The wet-bulb thermocouple, designed 

and built in-house at NIOSH, is the only 

such instrument known which has a 

response time of <1 second. Since the 

human respiratory tract is essentially a 

wet-bulb thermometer, human beings 

are sensitive to wet-bulb temperature, 

not dry-bulb temperature. For this 

reason, the inhalation temperature 

limits are specified in terms of wet-bulb 

temperature. Large wet-bulb 

thermometers have long response times 

due to their large size and, thus, large 

thermal inertias. They need high flows 

and long times to achieve the full wetbulb depression. The NIOSH wet-bulb 

thermocouple, due to its small size, 

requires neither high flow rates nor long 

response times to achieve the full wetbulb depression. Also, the miniscule 

quantity of water on the wet-bulb 

thermocouple will have a 

commensurately miniscule effect on the 

apparatus bed reaction. 

L. Section 84.304 Capacity Test 

Requirements 

Section 84.304(a)(5) is changed from 

the proposed rule to require that CCER 

designs of any capacity submitted to 

NIOSH for deployment in U.S. coal 

mines pass man test 4 which is set forth 

in the present regulation at § 84.99 and 

§ 84.100. The test provides assurance 

that the CCER certification testing for 

devices used in mine escape remains at 

least as rigorous as testing under the 

current standards. Section 84.304(d) 

establishes a new rating system for 

CCERs, shifting the classification 

scheme from duration to oxygen 

capacity. 

1. Man Test 4 

Comment: HHS received several 

comments regarding the proposed use of 

man test 4: One commenter objected to 

the use of the 50th percentile weight test 

subject, and suggested that the rule 

should be expanded to include a wider 

range of workers. Another commenter 

requested clarification regarding use of 

the 50th percentile worker and whether 

that standard is consistent with 

established certification test practices 

(which, according to the commenter, 

represents the 95th and at times the 

99th percentile miner). Another 

questioned whether it is possible that 

the device could pass the duration test 

on the breathing and metabolic 

simulator but fail man test 4, and 

recommended that the breathing and 

metabolic simulator be used to 

determine duration and the man test for 

wearability. Finally, one commenter 

suggested that the inclusion of man test 

4 does not address the legal duty under 

the Federal Mine Safety and Health Act 

requiring that ‘‘no mandatory health or 

safety standard promulgated under this 

title shall reduce the protection afforded 

miners by an existing mandatory health 

or safety standard.’’13

Response: HHS has retained the 

provision in the final rule that requires 

those units used in coal mines pass man 

test 4. HHS, however, has amended the 

provision slightly to indicate that any 

size unit submitted to NIOSH for 

approval for use in coal mining will be 

subject to man test 4. Man test 4 is an 

exceptionally challenging test with the 

average miner in mind, and translates to 

demanding performance requirements. 

Neither the present regulation nor this 

final regulation specifies the weight 

range of the test subject for man test 4. 

With regard to the established 

approval testing, this improved standard 

is changing the metrics used to approve 

CCERs. The work rate for the 50th 

percentile miner is already used to 

assess deployed units during the longterm field evaluations conducted by 

NIOSH. Using that standard here is 

consistent with current NIOSH 

practices. 

Finally, as of the effective date of this 

rule, NIOSH will no longer approve 

CCERs according to the duration of 

breathing gas supply. The breathing and 

metabolic simulator will be used to 

evaluate the oxygen capacity of a given 

CCER design; man test 4 is included 

here to establish that approval of 

devices intended for use in a specific 

application—underground coal mines— 

is at least as effective as the current 

standard, and that the devices will 

perform as required by the Federal Mine 

Safety and Health Act. However, with 

regard to the comment that a unit might 

fail the simulator testing but pass man 

test 4, a unit that fails on the simulator 

at the capacity rating indicated by the 

manufacturer will not proceed to man 

test 4. 

With respect to Federal Mine Safety 

and Health Act sec. 811(a)(9), HHS is 

promulgating these CCER approval 

standards because they are an 

improvement over the current 

standards. The main developments are 

that the new standards shift to a more 

instructional and informative rating 

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14See, e.g., U.S. Mine Safety and Health 

Administration. Report of Investigation: Fatal 

underground coal mine explosion; January 2, 2006; 

Sago Mine, Wolf Run Mining Co.; Tallmansville, 

Upshur County, WV. ID No. 46–08791. 

15 Kamon E, Bernard T, Stein R. Steady state 

respiratory responses to tasks used in Federal 

testing of self-contained breathing apparatus. 

AIHAJ. 1975;36:886–896. 

system that addresses the documented 

shortcomings with the traditional, 

duration-based system; the new 

standards avoid human test subject 

variability in defining capacity by 

relying on the breathing and metabolic 

simulator; the quality of breathing gas is 

more closely monitored; and 

requirements for durability and 

functionality checks are codified. 

2. Duration Versus Capacity 

Comment: HHS received ten 

comments on the proposal to rate these 

respirators by capacity rather than by 

duration, as has been done historically. 

Several of these commenters 

acknowledged that rating CCERs 

according to their duration of breathing 

air poses problems for users in the field, 

because, for example, 1-hour rated units 

often do not provide 1 hour of air. One 

commenter in particular noted a 

concern that ‘‘miners have historically 

complained about units that stop 

working prematurely,’’ and that ‘‘the 

criterion, ‘good for one hour,’ is 

misleading, at best.’’ Two commenters 

said the change from duration to 

capacity ratings will aid in the selection 

of CCERs for specific industrial 

applications and will benefit 

physiologists and other knowledgeable 

professionals. However, many 

commenters claimed the change would 

be confusing to users and one 

commenter noted this would be 

especially true where other selfcontained breathing apparatus used in 

the same workplace were still rated by 

duration. Some asserted that no 

evidence exists to justify the need for 

such a change. Two of these 

commenters opposing the change were 

among those who also acknowledged 

that certifying CCERs according to 

duration is problematic and potentially 

dangerous, as discussed above. One 

commenter asserted that the proposed 

change is inconsistent with the rating 

system for every open- and closedcircuit escape respirator in the world. 

Several commenters requested that the 

final rule prescribe ‘‘common sense’’ 

instructions intended for use by the 

end-user, to provide a ‘‘rule of thumb’’ 

example of the relationship between 

capacity and duration. One commenter 

was particularly concerned that the 

change to a capacity rating system will 

undermine the current 1-hour duration 

standard for respirators used in 

underground coal mines, and sees no 

benefit to miners of having information 

about capacity rather than duration. 

This commenter suggested that the 

formula for assessing duration is not 

rigid enough to ensure a full 1-hour 

duration and referred to complaints by 

miners that, at times, units have 

appeared to stop working prematurely 

or failed to function during escapes. The 

commenter requested that HHS 

establish in the rule that units of less 

than 1-hour duration cannot be used as 

a substitute for 1-hour units. Finally, 

one respondent further commented that 

capacity-based certification could result 

in conflicts under the Rail Safety 

Improvement Act (RSIA) of 2008; 

another expressed concern that 

capacity-based certification could result 

in conflicts with ISO 23269–1:2008 

Ships and marine technology— 

Breathing apparatus for ships—Part 1: 

Emergency escape breathing devices 

(EEBD) for shipboard use. 

Response: HHS has considered these 

comments carefully, and has decided to 

retain the provision that approved 

devices will be classified according to 

capacity in the final rule. Because the 

duration of adequate breathing gas 

supply actually provided to a user by a 

CCER will depend on the degree of 

exertion involved in the particular 

escape and the size of the respirator 

user, HHS believes the change from an 

approval based on duration to one based 

on capacity is important. The present 

duration rating is misleading and 

potentially dangerous to users. The 

capacity rating system in the final rule 

provides important information to those 

selecting CCERs that will permit them to 

decide which respirator meets their 

needs. 

The final rule establishes a 3-capacity 

ratings system: ‘‘Cap 1,’’ ‘‘Cap 2,’’ and 

‘‘Cap 3.’’ Cap 1 provides 20 to 59 liters 

of oxygen for short escapes that could be 

accomplished quickly; Cap 2 provides 

60 to 79 liters for escapes of moderate 

distance; and Cap 3 provides 80 or more 

liters for the lengthiest escapes. The 

three capacity ratings correspond to the 

liter quantities of breathing gas supplies 

that are expended during the NIOSH 

capacity testing within approximately 

10, 30, and 60 minutes, respectively. 

As several commenters recognized, 

there is evidence that the present 

duration system causes the user to 

believe that the apparatus will last for 

a specific time, regardless of the user’s 

weight, physical condition, or activity.14

This is not an accurate interpretation. 

Relying on a 1-hour unit to supply 1 

hour of oxygen to all users under all 

circumstances can lead to inappropriate 

deployment and misuse in emergencies. 

It is important to remember that a 

CCER contains a fixed quantity of 

oxygen; the duration of the oxygen it 

ultimately supplies will be inversely 

proportional to its rate of use. A CCER 

will operate for a shorter duration when 

the oxygen consumption rate is high. 

Hypothetically, a 190-pound man, at 

rest, is estimated to consume a volume 

of oxygen of .5 liters per minute. If he 

were walking in an upright position at 

3 miles per hour, it is estimated that he 

could consume 1.18 liters per minute. 

The same man running in an upright 

position at 5 miles per hour is estimated 

to consume 2.72 liters per minute.15

Under the final rule, NIOSH will 

measure the capacity of a CCER in terms 

of the volume of oxygen, in liters, that 

the CCER effectively delivers for 

consumption by the user. The final rule 

will require the manufacturer to list on 

its label the liters of oxygen actually 

delivered to the user as measured 

during the NIOSH capacity testing (see 

§ 84.304(e)). 

This information will enable 

employers to readily compare 

differences in respirator capacity within 

a given rating, more closely match a 

respirator model to their particular 

needs, and choose the respirator model 

that best serves their employees. An 

employer might determine through 

simulation or analysis of possible 

escape scenarios that its employees will 

need a Cap 3 CCER model that provides 

95 liters to allow for the worst 

contingencies. Alternatively, an 

employer might determine that a Cap 3 

model that provides 80 liters is 

sufficient and better designed, in terms 

of physical dimensions or operational 

characteristics of its workplace, to 

accommodate the routine work tasks 

and escape contingencies of the 

employees. HHS believes that providing 

the employers and the other 

professionals doing this analysis with 

information as to the general capacity of 

the unit (low (Cap 1), moderate (Cap 2) 

and high (Cap 3)) and the actual least 

achieved quantity of oxygen the 

specified CCER will supply will greatly 

aid in their ability to select the proper 

respirator. 

This change to capacity rating will not 

result in a rating system that is 

inconsistent with how other countries 

classify or are considering classifying 

similar types of self contained breathing 

apparatus. The European Norms (EN 

standards) currently categorize openand closed-circuit self-contained 

breathing apparatus (a type of respirator 

similar to the CCER but used for entry 

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14178 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 

16See European Standard BS EN 137:2006. 

Respiratory protective devices—Self-contained 

open-circuit compressed air breathing apparatus 

with full face mask—Requirements, testing, 

marketing. British Standards Institute. 

17 73 FR 75,027 at 75,032 (December 10, 2008). 

18 Kamon E, Bernard T, Stein R. Steady state 

respiratory responses to tasks used in Federal 

testing of self-contained breathing apparatus. 

AIHAJ. 1975;36:886–896. 

19 Johnson, AT. A review of self-contained selfrescuer research. University of Maryland, Biological 

Resources Engineering, Human Performance 

Laboratory; 2005. 

20Louhevaara V, et al. Cardiorespiratory strain in 

jobs that require respiratory protection. Int. Arch. 

Occup. Environ. Health. 1985;55:195–206. Lemon 

PW and Hermiston TT. The human energy cost of 

fire fighting. J. Occup. Med. 1977;19:558–562. 

21 Kamon E, Bernard T, Stein R. Steady state 

respiratory responses to tasks used in Federal 

testing of self-contained breathing apparatus. 

AIHAJ. 1975;36:886–896 [emphasis in original]. 22 73 FR 75,027 at 75,033 (December 10, 2008). 23 73 FR 75,027 at 75,042 (December 10, 2008). 

as well as escape) by volume and 

pressure of breathing gas; 16 users decide 

what size unit best meets their 

application. Moreover, while CCERs are 

currently certified in Europe according 

to the duration of oxygen provided by 

a unit, the International Standards 

Organization, whose standards are 

intended to replace this current system, 

is also considering a change to capacity 

ratings. HHS plans, in future 

rulemakings, to move toward this 

capacity rating system for other selfcontained breathing apparatus that it 

regulates. 

HHS will not require manufacturers to 

provide users with capacity versus work 

activity information, although 

manufacturers are not prohibited from 

providing such information. However, 

HHS does not encourage or support the 

provision of such information, as it may 

misinform CCER users about the actual 

amount of oxygen available to them in 

any given escape, as discussed in the 

notice of proposed rulemaking.17

Employers and their employees should 

test CCERs in realistic scenarios and 

engage in appropriate training to 

identify CCER models that meet their 

needs and to establish a clear 

understanding of related performance 

factors. In particular, training is 

essential for the employees to 

understand that the duration of time 

that they receive protection from the 

device varies according to the actual 

amount of oxygen in the unit and the 

rate of oxygen use which depends on 

the escape conditions and the 

employee’s body size and the 

employee’s physical condition. 

With regard to the use of CCERs in 

coal mines, the record of perceived and 

actual failures in coal mining played a 

substantial role in instigating these 

improvements in respirator certification 

standards. CCERs intended for use in 

mines will be so identified in the 

NIOSH application for approval and 

subject to man test 4 as a condition of 

MSHA co-approval. In addition to Cap 

3 devices, Cap 1 and Cap 2 devices may 

be very appropriate for certain 

deployment conditions. This 

deployment issue is not subject to HHS 

regulation or oversight. 

With regard to the RSIA, the 

regulations required under that statute 

concerning the use of emergency escape 

breathing apparatus (nomenclature used 

by the railroad industry) have not yet 

been promulgated. There is no reason to 

believe, however, that the capacity 

rating to be implemented under this 

final rule would be problematic with 

respect to such regulations. Similarly, 

with regard to the maritime consensus 

standard, ISO 23269–1:2008, HHS does 

not find any element of this final rule 

to conflict with the standard, which is 

more restrictive than this rule. The 

maritime industry would not be 

prevented from identifying CCERs as 

having a service duration of at least 10 

minutes, as specified under its 

consensus standard. 

3. Capacity Ratings 

Comment: HHS received several 

comments concerned with the capacity 

ratings themselves, and the values 

proposed to achieve them. Two 

comments questioned the proposed 

work rates for Cap 1 and 2 capacity 

testing; in particular, the comments 

claimed that no evidence supports the 

Cap 1 and 2 work rates. One comment 

disputed the use of the 1975 Kamon 

study 18 to justify the proposed work 

rates, and also argued that a 2005 

University of Maryland study,19 which 

found that exceptionally high work rates 

can exhaust current 60-minute CCERs in 

far less than 60 minutes, provides 

evidence that the proposed capacity 

work rates for Cap 1 and Cap 2 CCERs 

would require that these CCERs increase 

in size and weight. Another comment 

proposed adding two capacity ratings, 

and modifying Cap 3 oxygen capacity to 

range from 80 ≤ L ≤ 89. Finally, one 

comment suggested that the ventilation 

rate for Cap 1 devices is contrary to 

experience with open-circuit escape 

respirators that function with lower 

ventilation rates. 

Response: With regard to the Cap 1 

and 2 work rates, higher sustained work 

rates over shorter durations are fully 

supported by human physiology 

research as cited in the proposed rule 20

and by the Kamon study. While the 

commenter notes the discrepancy 

between the values determined by 

Kamon and the values applied in this 

rule, Kamon cautioned that his data 

presented ‘‘do not include the effects of 

a breathing apparatus,’’ and thus 

‘‘represents a minimum of the oxygen 

requirements.’’ 21 HHS has taken into 

account the increased work rate 

demands associated with the use of a 

breathing apparatus and with the 

physiological limits defined by research. 

The work rates in this final rule, 

including the higher rates specified for 

lower capacity devices, were supported 

by the Navy in their comments during 

the concept development stage of this 

rulemaking.22 The Navy makes 

extensive use of these lower capacity 

CCERs and expects them to be designed 

to support the high exertion levels 

expected for sailors escaping during 

below-deck emergencies. 

With regard to the University of 

Maryland study, NIOSH notes that 

CCER capacity testing will be 

determined ‘‘depending on the capacity 

specified by the manufacturer.’’ 23 Thus, 

for example, a device identified as an 80 

liter unit by the manufacturer will be 

tested at the Cap 3 work rate (1.35 VO2

liters/minute), not at the high work rate 

tested in the University of Maryland 

study. The study does not provide any 

indication of size or weight changes to 

CCERs that might be produced in 

response to this final rule. It does 

validate the basis indicated by HHS for 

changing from a duration-based rating 

system to one that is capacity-based by 

demonstrating that test subjects of 

differing sizes and walking at variable 

speeds will not receive the same 

duration of breathable oxygen. The 

study reinforces the point that the only 

reliable metric for rating a respirator’s 

capacity is the quantity of oxygen 

supplied by the respirator. 

HHS has retained in this final rule the 

3-tier rating system proposed. Since the 

actual liters of oxygen capacity achieved 

during testing by NIOSH will be 

specified on the label of the respirator, 

more capacity rating categories would 

be unnecessary. Nor would finer 

categorical distinctions be meaningful 

with respect to the differing escape 

contingencies or the need for further 

testing differences contingent on such 

distinctions. The three broad categories 

sufficiently delineate low, medium, and 

high capacity devices as general 

reference points for purchasers to 

identify devices potentially suited to the 

emergency needs of their employees. 

Similarly, they sufficiently delineate 

capacity for the assignment of 

appropriate testing regimens. 

The current ventilation rate for testing 

open-circuit escape respirators is not a 

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Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 14179 

24Bink B. The physical working capacity in 

relation to working time and age. Ergonomics. 

January 1962;5:25–28. 

25See U.S. Air Force School of Aerospace 

Medicine. Physical fitness status of USAF 

firefighters. Final Report ESL–TR–86–05; 1986. U.S. 

Bureau of Mines. Biomechanical and work 

physiology study in underground mining excluding 

low coal. Final Contract Report #J0308058; July 

1984. 26 Kyriazi N. Proposal for certification tests and 

standards for closed-circuit breathing apparatus. 

Pittsburgh, PA: U.S. Department of Health and 

Human Services, Public Health Service, Centers for 

Disease Control and Prevention, National Institute 

for Occupational Safety and Health; 1999. DHHS 

(NIOSH) Publication No. 99–144, IC 9449. 

27 Kyriazi N. Proposal for certification tests and 

standards for closed-circuit breathing apparatus. 

Pittsburgh, PA: U.S. Department of Health and 

Human Services, Public Health Service, Centers for 

Disease Control and Prevention, National Institute 

for Occupational Safety and Health; 1999. DHHS 

(NIOSH) Publication No. 99–144, IC 9449. 

consideration for determining the rate to 

be applied to testing Cap 1 devices 

under this final rule for CCERs. As 

discussed above, the rates for CCERs are 

based on physiological capacity. The 

current rate for open-circuit escape 

respirators is a matter that will be 

considered in future rulemaking 

addressing that different technology. 

4. Achieved Capacity 

Comment: HHS received one 

comment regarding how the capacity 

rating is assigned. The commenter 

suggested that the rating be based on the 

average of the seven units tested, rather 

than on the least value achieved by the 

seven units tested using the breathing 

and metabolic simulator as proposed, 

and that all of the values should be 

within the capacity rating requested by 

the applicant. The commenter 

recommended corresponding text edits 

to § 84.304(e). 

Response: HHS has retained in the 

final rule the approach presented in the 

proposed rule to use the least value 

achieved by the seven units tested. The 

use of the breathing and metabolic 

simulator to conduct these tests will 

indicate variability attributable to the 

CCER. HHS is using the lowest capacity 

demonstrated by testing to err on the 

side of safety. This conservatism is 

particularly important considering the 

small number of units being tested. 

M. Section 84.305 Performance Test 

Requirements 

1. Performance Testing 

Comment: HHS received one 

comment requesting the rate of speed 

and incline of the treadmill test 

(§ 84.305(a)(3)). Another commenter 

offered that the rule should require 

evaluation of the quality of the 

breathing gas at the first inhalation by 

the user. 

Response: Manufacturers must 

calibrate the treadmill to the specific 

physiology of each test subject. This 

standard is work rate, not exercise 

driven. So, for example, a smaller 

subject will require a steeper grade and 

faster speed than a larger subject to 

achieve the same work rate. 

HHS agrees that a performance 

standard might be appropriate for 

governing the quality of the breathing 

gas supplied by a CCER at the first 

inhalation. Such performance 

parameters and related testing have yet 

to be developed but the possibility will 

be evaluated for future rulemaking. 

2. Work Rates 

Comment: HHS received a number of 

comments addressing the proposed 

performance test work rates; two 

suggested that the work rates are not 

supported by data. One of these 

commenters questioned why NIOSH has 

not conducted empirical testing of 

realistic mine escapes. Another 

commenter suggested modifying the 

proposed work rate test sequence to 

repeat only the high and low work rates, 

rather than cycling through the peak 

(highest) work rate as well. This 

commenter also recommended that 

units that are exhausted before the 

completion of the full test sequence 

only be permitted to continue with 

testing if the entire initial peak flow test 

was successfully completed. One 

commenter expressed concern that the 

30-minute performance test will not 

provide accurate performance data for 

‘‘shorter duration’’ units, and offered the 

example that some carbon dioxide 

scrubbers absorb less in the first minute 

of operation; if multiple units were 

required for completion of the test 

sequence, higher concentrations of 

carbon dioxide would result each time 

a new unit replaced a spent unit, thus 

skewing the test results. This 

commenter suggested that HHS design a 

test for the capacity of the unit being 

tested, rather than requiring the testing 

of multiple units. Finally, one 

commenter asserted that the work rates 

for Cap 1 and 2 devices can only be met 

by large increases in the sizes of units. 

Response: The performance tests are 

applicable to all uses of CCERs, 

representing realistically achievable and 

varying work rates for each category of 

devices (Cap 1 through Cap 3). Lower 

work rates would result in smaller, 

lighter devices more suitable for 

carrying, but if using such a device 

stresses the wearer beyond the human 

tolerance level, it may very well fail to 

meet their need for a successful escape. 

The performance test is a composite 

test including both high and low work 

rates intended to draw into use all the 

components of the apparatus, including 

the demand and relief valves. According 

to physiological research 24 as well as 

common experience, the higher the 

work rate, the less time one can sustain 

that work rate. Accordingly, NIOSH is 

applying a high work rate for 5 minutes 

and then a lower work rate for 15 

minutes. This protocol tests the ability 

of the carbon dioxide absorbent canister 

to absorb high rates of exhaled carbon 

dioxide and the accompanying 

breathing pressures at a high ventilation 

rate, due to both the canister and the 

demand valve. Reducing the work rate 

after 5 minutes reflects human 

physiological limits while examining 

the performance of the carbon dioxide 

absorbent in a low demand mode. 

The work rates in the standard were 

not intended to simulate an escape. 

There are an infinite number of escape 

scenarios, ranging from walking at a 

very slow pace, feeling one’s way out of 

the mine while impeded by heavy 

smoke and debris to running at speed or 

carrying an impaired victim. Given the 

impossibility of conducting 

representative simulations, NIOSH 

selected reasonable, scientificallyevaluated limits of likely human 

performance 25 which are consistent 

with NIOSH’s own laboratory 

experience.26 A well-established model 

developed by physiologists (the BinkBonjer curve) predicts that 95th 

percentile miners can maintain 3.0 

liters/minute VO2 for 30 minutes and 

2.0 liters/minute VO2 for 160 minutes. 

Accordingly, the peak work rate value is 

set at 3.00 VO2, which reflects a very 

high work rate attainable by an average 

adult. The high work rate is set at 2.00 

VO2, which represents a reasonably 

hard work rate. Longstanding laboratory 

testing of respirator users by NIOSH 

supports this work rate, which is 

expected to exceed the work rate 

experienced by users during escape 

under oxygen.27 The low work rate is set 

at 0.50 VO2, which represents a 

sedentary rate. NIOSH laboratory testing 

experience also supports this work rate, 

which is expected during escape under 

oxygen when the wearer is sedentary, as 

if awaiting rescue. With regard to the 

conduct of empirical studies, NIOSH 

has not conducted further research as 

suggested. 

The performance test requirements 

are suitable for Cap 1 units and do not 

require a specialized test sequence. As 

discussed above, the purpose of the 

performance test is to ensure that an 

apparatus is able to provide life support 

to a user at high work rates for 

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reasonable lengths of time, and to draw 

into use all the components of the 

apparatus that could be activated by a 

user, in order to ensure that stressor 

levels do not exceed human tolerances. 

If an apparatus contains <45 L of 

oxygen, more than one unit must be 

tested in order to be able to evaluate the 

relief valve which may not yet have 

been used. For example, testing a CCER 

which has approximately 24 L of oxygen 

would theoretically result in that unit 

running out of oxygen 4.5 minutes into 

period 2. This will sufficiently test the 

demand valve and carbon dioxide 

absorbent canister; however, the 

pressure required to operate the relief 

valve will still be unknown. Therefore, 

a second unit would have to be tested 

at the sedentary work rate (0.5 liters/ 

minute VO2) in order to evaluate the 

characteristics of the relief valve. 

The 1-minute average carbon dioxide 

measurement will not be tested 

cumulatively over the duration of 

multiple units; carbon dioxide cannot 

accumulate during testing and skew the 

test results, as suggested by one 

commenter. If the first unit tested fails 

to scrub carbon dioxide within the first 

minute at a 3-liter per minute demand, 

it will not pass the test; testing will 

conclude at that point, eliminating the 

need for multiple units. 

With respect to the comment that Cap 

1 and Cap 2 devices would have to be 

larger than currently available devices 

to perform adequately under the 

proposed work rates for capacity testing, 

HHS does not believe this is accurate. 

At least one currently approved device 

meets the capacity requirements 

specified for a Cap 1 rating. This also 

suggests that higher capacity devices 

intended for the Cap 2 and Cap 3 ratings 

would also not need to be larger than 

currently approved devices and 

certainly manufacturers have market 

incentive to minimize size and weight at 

any given capacity. 

3. Hypoxia 

Comment: One commenter supported 

the proposed hypoxia testing, but 

requested that HHS address the problem 

posed by the utilization of units of 

different designs on user proficiency. 

Another stated that the hypoxia test 

could not be conducted on designs that 

include an initial oxygen starter, and 

suggested that the rule follow the 

hypoxia test with activation of the 

starter. Finally, a commenter opposed 

the hypoxia test on the grounds that the 

expectation by NIOSH that some users 

would exhale into a unit in opposition 

to manufacturer instructions, is an 

‘‘arbitrary assumption.’’ This 

commenter also stated the performance 

test should be conducted in accordance 

with approved donning procedures for 

chemical oxygen units, including cold 

start procedures without the use of 

oxygen starters. 

Response: HHS does not have 

authority to govern whether CCERs from 

multiple manufacturers or otherwise of 

different designs can be used in a single 

locale or workplace, although the 

Department does recognize that 

problems can arise from this situation. 

The assumption that some users will 

inappropriately exhale into a CCER 

upon donning it or in an attempt to 

improve its performance is not arbitrary, 

and is supported by evidence from 

actual practice during emergencies. For 

example, in the MSHA investigation 

report on the Greenwich Collieries 

Number 1 mine explosion of 16 

February 1984, the miners were asked 

the general question, ‘‘Did you have any 

problems breathing after you put on the 

self-rescuer?’’ Their testimony provides 

evidence that (1) some users do fill up 

the breathing bag apparatus with 

exhaled air, and (2) some users attempt 

to escape at an oxygen consumption rate 

higher than the apparatus’ constant flow 

rate, which together cause the hypoxia 

scenario evaluated in the performance 

test. In the Department’s judgment, it is 

important to evaluate the potential for 

the user to experience hypoxia. HHS is 

retaining the requirement that the 

performance test will begin with two 

exhalations and then follow the 

manufacturer’s instructions, and has 

clarified in the rule text that the hypoxia 

test will be conducted upon initial 

donning. 

NIOSH does agree with the 

commenter that the performance test 

should evaluate the ability of chemical 

oxygen units to function using a cold 

(manual) start procedure. Accordingly, 

NIOSH will begin the hypoxia test with 

sufficient breaths to start chemical units 

without the benefit of their oxygen 

starters. Since not all CCER designs 

employ oxygen starters and this is a 

very specific testing protocol detail, it is 

not specified in the rule text. 

N. Section 84.306 Wearability Test 

Requirements 

Comment: HHS received three 

comments addressing wearability 

testing: One suggested that test subjects 

should receive instruction in the use of 

the CCER prior to testing their ability to 

don it within the 30-second limit. The 

other two comments requested that HHS 

address the potential need to ‘‘coldstart’’ a second unit when transitioning 

between units while in a toxic 

environment. Cold starting means 

exhaling sufficiently into a unit to 

stimulate the oxygen supply when the 

oxygen starter has malfunctioned. 

Response: The intent of the provision 

of concern is to ensure that the CCER 

can be donned and fully functional 

(under oxygen) within 30 seconds. Test 

subjects will be provided with the 

manufacturer’s instructions for donning 

and will be trained in their use, but an 

integral part of this test will be to 

observe the effectiveness of the supplied 

instructions; therefore, NIOSH will not 

supplement the manufacturer’s 

instructions with any further 

information. 

A cold start is an aberrant situation 

but may not be a critical failure; 

depending on the system design, the 

CCER may still provide protection even 

if the user has to take additional steps 

to stimulate an increase in the level of 

oxygen supply. Nevertheless, this 

wearability test will require that CCERs 

that make use of oxygen starters can be 

donned and operational within the 30- 

second limit, irrespective of whether the 

oxygen starter functions. 

O. Section 84.307 Environmental 

Treatments 

Comment: HHS received one general 

comment suggesting that evidence to 

support the proposed environmental 

treatments is lacking. The same 

commenter noted that the proposed rule 

does not address the environmental 

conditions in other industrial 

applications aside from mining. 

Response: The environmental 

treatments are not intended to be 

accelerated aging tests or to replicate the 

most severe field conditions in which 

units might be deployed. The purpose of 

these treatments is to expose CCERs to 

realistically harsh conditions 

representative of many industrial 

applications in order to assess that they 

are reasonably robust for their intended 

uses. HHS believes that these treatments 

are adequate for this purpose. 

1. Humidity 

Comment: Two comments 

recommended adding a test of humidity 

resistance. 

Response: NIOSH will conduct a 

review to examine potential impact of 

humidity on CCER capacity or 

performance. If the review indicates that 

humidity degrades certain CCER designs 

within their expected service life, then 

HHS would consider further rulemaking 

to add such a requirement. Until such 

time, purchasers could use their 

acquisition processes to require 

humidity testing by manufacturers of 

designs they purchase, or conduct such 

testing through an independent testing 

laboratory, should they be concerned 

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Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 14181 

about the potential impact of humidity 

in the environments where their CCERs 

are stored and worn. 

2. Temperature 

Comment: HHS received one 

comment asking for clarification on 

whether the extreme temperature 

storage test is designed to evaluate the 

effect of temperature shock by changing 

the test temperature applied to the 

CCER from one extreme temperature 

immediately to the other (hot to cold or 

cold to hot). This commenter suggested 

allowing the units to return to room 

temperature between testing steps. 

Response: HHS agrees with the 

suggestion and has adopted it in the 

final rule. NIOSH did not intend to 

simulate temperature shock, which is 

not an expected environmental 

condition. 

3. Shock 

Comment: HHS received two 

comments regarding shock testing of 

CCER units. One commenter sought 

clarification regarding which six 

orientations are to be tested, and 

recommended that a diagram be 

included in the final rule. The second 

commenter requested clarification 

regarding whether the shock testing 

should be conducted with units packed 

in their stowage containers, or whether 

the testing is meant to simulate the unit 

being dropped while being removed 

from its packaging. 

Response: The intent of the 

requirement is to test the CCER along its 

three principal axes: Top to bottom, left 

to right, and front to back. HHS has 

revised the text in the final rule to 

clarify the definition of these axes. 

NIOSH intends for testing to be 

conducted in the packaging condition 

designed by the applicant for individual 

use while deployed. If the CCER is 

provided within a container intended 

for storage, versus the state in which it 

is worn on a belt, carried, or transported 

by the user, the unit would be removed 

from the storage container. The text of 

the final rule reflects this intent. 

4. Vibration 

Comment: HHS received one 

comment suggesting that vibration 

testing to high frequencies is not 

relevant if CCERs are properly stored or 

worn. 

Response: HHS has retained the 

vibration testing in the final rule 

because CCERs deployed in the mining 

environment experience such vibration 

when set on or near certain mining 

equipment (e.g. continuous miners, 

mantrips). Exposure to vibration would 

also be expected in association with 

engines and other machinery on ships 

and in tunneling and other underground 

construction and maintenance 

operations as well as during the 

transportation of CCERs. 

P. Section 84.308 Additional Testing 

Comment: Three comments were 

received regarding issues not addressed 

in the proposed rule: Fire hazard 

attributable to the use of potassium 

superoxide and chlorate candles in 

chemical oxygen units. 

Response: With regard to the 

potassium superoxide and chlorate 

candles used in some chemical oxygen 

units, while NIOSH is aware of the 

potential for this chemical to create a 

hazard, experience with CCERs has 

shown that such hazards are generally 

created by misuse or mishandling of a 

device. Potassium superoxide is not 

known to pose a hazard to the 

individual when the unit is properly 

worn on a belt, but has been known, for 

example, to ignite upon being crushed 

by mining machinery. Use of CCER 

designs that employ potassium 

superoxide and chlorate candles is not 

within the purview of HHS; HHS is not 

authorized to address safety issues 

related to the proper transport and 

storage of these respirators. 

Comment: HHS received five 

comments regarding the provisions for 

eye protection. Two supported the 

proposed standards; two suggested that 

impact-resistant eye protection is not 

supported by end users and would 

increase the size of CCER units. A final 

commenter requested that goggles meet 

the high impact and flammability 

requirements of ANSI Z87.1–2003 

Occupational and Educational Personal 

Eye and Face Protection Devices for 

maritime applications. 

Response: All manufacturers provide 

eye protection with currently certified 

1-hour CCERs. The requirement for 

reasonable durability according to the 

cited consensus standard (Sub-clause 

3.1 of ISO 4855:1981, Personal Eye 

Protectors—Non-Optical Test Methods) 

is appropriate for the potentially 

physically challenging conditions while 

CCERs are belt-worn and during their 

use for an escape. NIOSH does not 

expect that compliance with this 

consensus standard would result in an 

increase in the size of the eye protection 

or, consequently, the CCER units in 

which they are stored. 

HHS does not find that the high 

impact and flammability requirements 

of ANSI Z87.1–2003 are relevant to most 

escape scenarios. Under particular use 

conditions, more stringent performance 

requirements could be specified in the 

acquisition process if deemed necessary 

by the purchaser. 

HHS has made clarifications to the 

text of § 84.308(c)(3) and (4) which 

indicate the intent of the durability and 

fogging tests. It is imperative for the 

users’ vision to be unimpeded by the 

eye protection when attempting to use 

the respirator for an escape. 

Q. Section 84.309 Additional Testing 

and Requirements for Dockable CCERs 

Comment: One comment submitted to 

HHS supported the intent behind the 

dockable CCER provisions but was 

concerned that the provisions were not 

extensive enough. In particular, the 

commenter recommended HHS ‘‘force’’ 

the introduction of this new technology 

for use in the mining industry. 

Response: The proposed provisions 

for dockable CCERs have been retained 

in the final rule. These provisions cover 

the apparent potential technical 

concerns associated with such 

technology that HHS has been able to 

identify. The use of this technology in 

mining is not regulated by HHS. 

Accordingly, this final rule includes 

provisions that will allow the approval 

of such devices, but does not include 

provisions to force the development of 

this technology and its introduction into 

the mining industry. 

R. Section 84.310 Post-Approval 

Testing 

Comment: HHS received various 

comments on post-certification testing 

of deployed CCERs. One commenter 

encouraged HHS to expand the program. 

Another supported the program but 

suggested that the government should 

not be obligated to replace units that it 

tests. In relation to the replacement of 

CCERs obtained by NIOSH for postapproval testing, another commenter 

questioned the ramifications of a 

manufacturer’s decision to discontinue 

production of a certain unit, and 

whether manufacturers would be 

required to produce more of the 

discontinued units to replace those 

tested. Another commenter suggested 

that field evaluations do not accurately 

demonstrate the extent of problems 

associated with respirators in field, and 

suggested that at least 3 percent of all 

deployed units be tested at random. A 

final commenter suggested that the text 

of the rule specify that only units 

passing user inspection criteria should 

be examined in the post-certification 

testing. 

Response: HHS has specified in the 

final rule under § 84.310(f) that 

manufacturers who discontinue a 

particular line of respirators selected for 

field evaluation can replace those units 

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14182 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 

28 Kyriazi N, Shubilla JP. Self-contained selfrescuer field evaluation: seventh-phase results. 

Pittsburgh, PA: U.S. Department of Health and 

Human Services, Centers for Disease Control and 

Prevention, National Institute for Occupational 

Safety and Health; March 2002. DHHS (NIOSH) 

Publication No. 2002–127, RI 9656. 

29 Kyriazi N, Shubilla JP (2000). Self-contained 

self-rescuer field evaluation: sixth-phase results. 

Pittsburgh, PA: U.S. Department of Health and 

Human Services, Public Health Service, Centers for 

Disease Control and Prevention, National Institute 

for Occupational Safety and Health; July 2000. 

DHHS (NIOSH) Publication No. 2000–128, RI 9451. 

with similar, NIOSH-approved CCERs. 

HHS does not intend for the 

replacement requirement to create any 

barriers to the market exit of a 

discontinued product. Furthermore, 

NIOSH would continue to purchase 

replacement units, as currently 

practiced and proposed. The cost of 

these field evaluations, which are 

carried out as part of the research and 

assurance function of the NIOSH 

respirator certification program, would 

not be appropriate to impose on CCER 

owners. NIOSH believes this life-cycle 

evaluation (inspection and testing) 

program, as enhanced by the provisions 

of this final rule, will continue to be an 

effective method for the early 

identification of possible problems in 

these respirators after deployment. 

NIOSH randomly selects deployed 

CCER units for testing. The availability 

of resources has determined and will 

continue to determine the sample size. 

The evaluations select units from the 

field that are identified by the employer 

as having passed user inspection 

criteria; furthermore, the NIOSH 

evaluation itself begins with application 

of these same inspection criteria. 

III. Summary of the Rule 

This rule establishes new 

requirements for testing and approval of 

CCERs under a new Subpart O of 42 

CFR Part 84—Approval of Respiratory 

Protective Devices. The new subpart 

replaces all current requirements for 

testing and approval of CCERs found 

under Subpart H. The following is a 

section-by-section summary which 

describes and explains the provisions of 

the rule. The complete, final regulatory 

text is provided in the last section of 

this notice. 

In the summary below, HHS indicates 

the changes made in provisions of this 

rule since the notice of proposed 

rulemaking. These occur under 

§§ 84.300, 84.301, 84.302, 84.304, 

84.307, 84.308, and 84.310. 

A. Subpart O—Closed-Circuit Escape 

Respirators 

1. Section 84.300 Closed-Circuit 

Escape Respirator, Description 

This section provides a general 

description of the CCER 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 and MSHA respirator 

approval program. In response to public 

comments, the definition of CCER now 

includes a brief description of respirator 

uses in the maritime and railroad 

industries, in addition to underground 

coal mining. 

2. Section 84.301 Applicability to New 

and Previously Approved CCERs 

This section establishes a 3-year 

period for continued manufacture and 

labeling of CCERs approved under the 

current regulations and sold by 

manufacturers in order to phase-in the 

implementation of the testing and 

approval requirements of this final rule. 

This provision, which is changed 

slightly from the proposed rule, allows 

respirator manufacturers a reasonable 

period of time to modify existing CCER 

designs, if necessary, or to develop 

entirely new designs that respond to the 

new testing and certification 

requirements. It also ensures that during 

the interim, a constant supply of 

approved CCERs will remain available 

for purchase. The new requirements 

will be applied to all new CCER designs 

that are submitted for approval after the 

effective date of this rule. Manufacturers 

may continue to manufacture and label 

as NIOSH-approved and sell CCERs 

with current approvals for up to 3 years 

after the effective date. 

As discussed in the public comment 

section of the preamble above, HHS has 

eliminated from the final rule the 

proposal that currently approved CCERs 

be re-approved under the new 

requirements of this final rule to retain 

their approval beyond a 6-year 

grandfather period. CCERs with current 

approvals that are already deployed or 

are manufactured and labeled NIOSHapproved within the 3-year phase-in 

period will remain as NIOSH-approved 

devices until the conclusion of their 

service life. 

3. Section 84.302 Required 

Components, Attributes, and 

Instructions 

This section specifies the 

components, attributes, and instructions 

required for each CCER. Some of these 

requirements simply continue the 

current Subpart H requirements, 

including the requirements for eye 

protection (paragraph (a)(1)); oxygen 

storage vessel (paragraph (a)(4)); and 

general construction (paragraph (c)). 

Paragraph (a)(2) requires that 

manufacturers include thermal exposure 

indicators to allow a person to 

determine whether the unit has been 

exposed to temperatures that exceed any 

temperature storage limits specified by 

the manufacturer. Currently, one 

manufacturer includes such indicators 

in response to NIOSH evaluations 

finding that exceptionally low and high 

storage temperatures degrade the 

functionality and performance of certain 

CCER designs. Adverse effects of low 

temperature storage on current products 

are reversible, but high storage 

temperatures can damage critical 

internal CCER components, as 

documented in the manufacturers’ 

service life plans. There must be a 

means to detect and replace units 

exposed to such storage conditions. 

Paragraph (a)(3) requires that 

manufacturers include a means by 

which a person can detect any damage 

or alteration of the chemical oxygen 

storage or chemical carbon dioxide 

scrubber that could diminish the 

NIOSH-certified performance of the unit 

or pose a hazard to the user. These 

chemical components of CCERs, as 

presently designed, are susceptible to 

such degradation.28 Two manufacturers 

currently design their CCERs with a 

means of detecting such damage. 

Paragraph (a)(4) maintains an existing 

requirement under Subpart H that if a 

CCER includes an oxygen storage vessel, 

the vessel must be approved by the U.S. 

Department of Transportation (DOT) 

under 49 CFR Part 107: ‘‘Hazardous 

Materials Program Procedures,’’ unless 

exempted under Subpart B of the DOT 

regulation. 

Paragraph (a)(5) requires that 

manufacturers design and construct the 

protective casing of the CCER to prevent 

the user from accidentally opening it 

and to prevent or clearly indicate its 

prior opening, unless the CCER casing 

were designed for such openings, for 

inspection or purposes other than use in 

an actual escape. These protections are 

needed because the opening and reclosing of a unit not designed for such 

operations, and the replacement of parts 

not intended for replacement, can 

damage the unit and degrade its 

performance. NIOSH has investigated 

circumstances in which units were 

opened and modified by unauthorized 

persons, effectually altering the design 

from the version that received NIOSH 

testing and certification.29

Paragraph (a)(6) requires that 

manufacturers include a means to detect 

the ingress of any water or water vapor 

that could degrade the performance of 

the unit, unless the CCER was designed 

for its casing to be opened for frequent 

inspection. Because the chemical 

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30 Kyriazi N. Development of an automated 

breathing and metabolic simulator. Pittsburgh, PA: 

U.S. Department of the Interior, Bureau of Mines; 

1986. IC 9110. 

31 Kyriazi N, Kovac JG, Shubilla JP, Duerr WH, 

Kravitz J. Self-contained self-rescuer field 

evaluation: first-year results of 5-year study. 

Pittsburgh, PA: U.S. Department of the Interior, 

Bureau of Mines; January 1986. RI 9051. 

Kyriazi N, Shubilla JP. Self-contained self-rescuer 

field evaluation: results from 1982–1990. 

Pittsburgh, PA: U.S. Department of the Interior, 

Bureau of Mines; January 1992. RI 9401. 

Kyriazi N, Shubilla JP. Self-contained self-rescuer 

field evaluation: fourth-phase results. Pittsburgh, 

PA: U.S. Department of the Interior, Bureau of 

Mines; January 1994. RI 9499. 

Kyriazi N, Shubilla JP. Self-contained self-rescuer 

field evaluation: fifth-phase results. Pittsburgh, PA: 

U.S. Department of Energy; December 1996. RI 

9635. 

Kyriazi N, Shubilla JP. Self-contained self-rescuer 

field evaluation: sixth-phase results. Pittsburgh, PA: 

U.S. Department of Health and Human Services, 

Public Health Service, Centers for Disease Control 

and Prevention, National Institute for Occupational 

Safety and Health; July 2000. DHHS (NIOSH) 

Publication No. 2000–128, IC 9451. 

Kyriazi N, Shubilla JP. Self-contained self-rescuer 

field evaluation: seventh-phase results. Pittsburgh, 

PA: U.S. Department of Health and Human 

Services, Centers for Disease Control and 

Prevention, National Institute for Occupational 

Safety and Health; March 2002. DHHS (NIOSH) 

Publication No. 2002–127, RI 9656. 

32Wet-bulb temperature is a measurement of the 

temperature of a wet surface. It represents the 

temperature of the inhaled breathing gas in the 

CCER user’s trachea. 

components of CCERs are especially 

susceptible to damage or degradation 

from moisture, the user must be able to 

readily and reliably check a unit for 

potential water damage before each 

work shift. 

Paragraph (a)(7) is new (as discussed 

above), and requires that manufacturers 

provide a means to detect damage or 

deficiencies to units with oxygen 

starters if they are a component critical 

to the satisfactory performance of the 

CCER. 

Paragraph (b) requires that an 

indicator must clearly and 

unambiguously indicate the occurrence 

of the monitored condition. 

Paragraph (c) requires that 

manufacturers provide NIOSH with 

information about indicators, where 

they are required, to enable thorough 

evaluation by NIOSH. Such information 

should include an explanation of the 

operation and function of the indicator, 

data generated by the manufacturer, and 

any equipment or special devices used 

by the manufacturer to develop or test 

the indicators. 

Paragraph (d) mandates that CCER 

components must meet the general 

construction requirements in § 84.61. 

Paragraph (e) requires that 

manufacturers construct the CCER to 

protect the user from inhaling most 

toxic gases that might occur in a work 

environment during an escape. To 

ensure such gases cannot readily 

penetrate the breathing circuit of the 

CCER during its use, NIOSH will test 

the integrity of the CCER breathing 

circuit by following the gasoline vapor 

test procedure for breathing bags 

available from the NIOSH Web site 

http://www.cdc.gov/niosh/npptl. The 

test will be conducted on a single CCER 

unit. 

The specified gasoline vapor test 

provides reasonable assurance that the 

breathing gas supply of the user will be 

protected from atmospheres that include 

hazardous vapors possibly associated 

with escapes from mines and most other 

enclosed or confined spaces. The 

proposed requirement for this testing is 

not new. It is included under Subpart H 

of this part (§ 84.85) for all selfcontained breathing apparatus (the class 

of respirators to which CCERs belong) 

currently approved by NIOSH. 

Paragraphs (f) and (g) require that the 

design, construction, and materials of 

CCERs not introduce combustion or 

other unspecified safety or health 

hazards. 

In response to public comments, 

paragraph (h) requires that 

manufacturers provide purchasers with 

instructions, rather than requiring 

instructions to accompany each 

individual unit, as was proposed in the 

notice of proposed rulemaking. A 

service life plan must accompany each 

application to NIOSH for CCER 

approval. These requirements generally 

reflect current practice. 

In response to the public comment 

regarding labeling, paragraph (i) 

requires manufacturers to identify on 

each CCER approval label the capacity 

rating and number of liters of oxygen as 

determined by NIOSH through capacity 

testing. 

4. Section 84.303 General Testing 

Conditions and Requirements 

This section establishes the general 

testing conditions and requirements for 

the approval of CCERs. 

Paragraph (a) specifies that NIOSH 

will use the breathing and metabolic 

simulator tests specified in this subpart 

for all quantitative evaluations of the 

performance of a CCER. NIOSH will use 

human subject tests for qualitative 

evaluations, which include evaluations 

of the ‘‘wearability’’ of the CCER design 

(e.g., ergonomic considerations 

concerning its practical impact on the 

user’s escape). 

Breathing and metabolic simulators 

are mechanical devices that simulate 

human respiratory functions.30 They 

allow for precisely controlled and 

monitored tests, whereas comparable 

testing conducted using human subjects 

on a treadmill involves substantial 

variability with respect to one or more 

metabolic parameters. The use of these 

simulators to evaluate respirator 

performance has been validated by 

NIOSH through a series of MSHA peerreviewed studies over the past 20 

years.31 These studies, which include 

side-by-side comparisons using threeperson panels of human subjects on 

treadmills against testing using an 

ABMS, demonstrate that the simulator 

replicates the performance of human 

subjects with respect to all important 

metabolic variables, including oxygen 

consumption rate, average rates of 

carbon dioxide production, ventilation 

rates, respiratory frequencies, 

respiratory temperatures (dry- and wetbulb), and breathing pressures. An 

advantage of the simulators is that their 

performance for all metabolic 

parameters can be calibrated and 

replicated, whereas each human test 

subject performs uniquely, making the 

testing more difficult to replicate. 

Manufacturers and others who would 

wish to duplicate NIOSH breathing and 

metabolic simulators in their own 

testing facilities can obtain technical 

specifications from NIOSH. General, 

non-proprietary information on the 

design and operation of the simulators 

is also available from the NIOSH Web 

site: http://www.cdc.gov/niosh/npptl. 

Paragraph (b) specifies that 4 stressors 

will be monitored constantly throughout 

testing: The average concentrations of 

inhaled carbon dioxide and oxygen, 

peak breathing pressures at inhalation 

and exhalation, and the wet-bulb 

temperature (the temperature of inhaled 

breathing gas as would be? sensed by 

the CCER user’s trachea). Paragraph (d) 

establishes that CCERs must perform 

within the acceptable ranges of 

measurement specified in Table 1 

below. 

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14184 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 

33 Kamon E, Deno S, Vercruyyen M. Physiological 

responses of miners to emergency. Vol. 1—Selfcontained breathing apparatus stressors. University 

Park, PA: The Pennsylvania State University. U.S. 

Bureau of Mines contract No. J0100092; 1984:13. 

34Paul MA, Fraser WD. Performance during mild 

acute hypoxia. Aviation, Space, and Environmental 

Medicine. 1994;65(10):891–899; Malkin VB. 

Barometric pressure and gas composition. 

Foundations of Space Biology and Medicine, Vol. 

II, Book 1: Ecological and Physiological Bases of 

Space Biology and Medicine. 1975 at 25–31; and 

Fowler B, Paul M, Porlier G, Elcombe DD, and 

Taylor M. A re-evaluation of the minimum altitude 

at which hypoxic performance decrements can be 

detected. Ergonomics. 1985;28(5):781–791. 

35Fowler B, Paul M, Porlier G, Elcombe DD, 

Taylor M. A reevaluation of the minimum altitude 

at which hypoxic performance decrements can be 

detected. Ergonomics. 1985;28(5):781–791. 36For the same inhaled air temperature, the 

thermal load of humid air is higher than that of dry 

air. The maximum thermal load tolerated by a 

human being can be specified by many 

combinations of dry-bulb temperature and relative 

humidity, or by one wet-bulb temperature, for 

which the temperature is measured using a wet 

thermometer surface. Researchers have 

demonstrated that the wet-bulb temperature of the 

inspired air most accurately measures heat stress to 

the tissues of the mouth, as compared to 

temperature readings from an ordinary, dry 

thermometer, even when combined with the control 

of relative humidity. Kamon E, Bernard T, Stein R. 

Steady state respiratory responses to tasks used in 

Federal testing of self-contained breathing 

apparatus. AIHAJ. 1975;36:886–896. 

37 Kamon E, Bernard T, Stein R. Steady state 

respiratory responses to tasks used in Federal 

testing of self-contained breathing apparatus. 

AIHAJ. 1975;36:886–896. 38Hodgson JL. Physiological costs and 

consequences of mine escape and rescue. 

University Park, PA: The Pennsylvania State 

University. U.S. Bureau of Mines contract No. 

J0345327; 1993:19. 

TABLE 1—MONITORED STRESSORS AND THEIR ACCEPTABLE RANGES

Stressor 

Acceptable range 

operating 

average 

Acceptable range 

excursion 

Average inhaled CO2 ..................................................................................................... <1.5% ................................. ≤4%. 

Average inhaled O2 ....................................................................................................... >19.5% ............................... ≥15%. 

Peak Breathing ..............................................................................................................

Pressures .......................................................................................................................

DP ≤ 200 mm H2O ............. ¥300 ≤ DP 

≤ 200 mm H2O. 

Wet-bulb temperature.32 ................................................................................................ <43 °C ................................ ≤50 °C. 

The acceptable ranges for inhaled 

carbon dioxide were determined by 

physiological testing performed at the 

Noll Lab for Human Performance 

Research at Pennsylvania State 

University. This research showed no 

disabling physical effects in active men 

breathing 5 percent carbon dioxide for 

long periods of time.33 Decision-making 

was slightly impaired in some subjects 

after breathing 4 percent carbon dioxide 

for 1 hour. NIOSH has found in the 

testing of escape respirators that carbon 

dioxide levels of 1.5 percent can be 

tolerated for the limited periods for 

which these devices are designed 

without any deleterious effect on the 

test subjects. Therefore, NIOSH requires 

the CCER to maintain the inhaled levels 

of carbon dioxide below 4 percent (as a 

1-minute average) during all testing and 

below an average of 1.5 percent over the 

full duration of the test. 

The normal, sea-level oxygen content 

of air is approximately 21 percent. The 

minimum acceptable operating average 

of 19.5 percent for inhaled oxygen that 

NIOSH requires the CCER to provide 

over the full duration of the certification 

tests was determined based on OSHA’s 

respiratory protection standard 29 CFR 

1910.134, which establishes a minimum 

level of oxygen for protecting the health 

and safety of workers. However, 

permitting oxygen levels to go as low as 

15 percent enables size and weight 

reductions of CCERs with little user 

impact.34 The acceptable range for these 

excursions was determined based on 

testing of pilots at various altitudes. 

This research indicates that judgment, 

reaction time, spatial orientation, and 

other cognitive processes begin to 

become impaired from chronic exposure 

at oxygen levels below 15 percent.35

Therefore, NIOSH requires the CCER to 

provide levels of oxygen above 15 

percent (as a 1-minute average) during 

all testing and above an average of 19.5 

percent over the full duration of the test. 

These limits would provide assurance 

that the CCER user would never be 

prevented from escaping due to an 

insufficient concentration of oxygen in 

the breathing gas supplied by the CCER. 

The acceptable ranges for wet-bulb 36

temperature are based on physiological 

research conducted at Pennsylvania 

State University. Researchers found the 

highest tolerable wet-bulb temperature 

of inhaled air was approximately 

50 °C.37 Based on such research and 

NIOSH findings from testing escape 

respirators, NIOSH establishes 50 °C as 

an excursion limit and 43 °C as an 

average operating requirement. Test 

subjects have found this temperature to 

be tolerable during the 1-hour 

certification tests. 

The ranges for peak breathing 

pressures were determined based on 

physiological research indicating that 

most individuals can generate peak 

breathing pressures equaling or 

exceeding ¥300 to 200 mm of H2O for 

only a short period of time.38 Based on 

NIOSH findings from testing escape 

respirators, the 200 mm average 

operating requirement provides a 

tolerable limit for the duration of an 

escape. Use of these values as limits will 

allow most CCER users to escape 

without any constraint on their level of 

exertion. Users who cannot generate 

these pressures may be forced at some 

point to slow the pace of their escape. 

In addition to establishing these 

stressor limits for testing, this section 

provides under paragraph (c) that 

capacity and performance tests 

conclude when the stored breathing gas 

supply has been fully expended. This is 

important because the adequacy of the 

performance of a CCER depends upon 

the user clearly recognizing when the 

breathing gas supply is expended. High 

carbon dioxide levels can deceive the 

user into believing the respirator is not 

working and hence to prematurely 

abandon use of the CCER during an 

escape. Designing CCERs so that carbon 

dioxide levels are controlled until the 

oxygen supply is fully expended will 

help ensure that a user can make use of 

all of the available oxygen. 

This section also provides under 

paragraph (d)(2) that a CCER will fail a 

wearability test if a human subject 

cannot complete the test for any reason 

related to the CCER. Any design, 

construction, or performance attribute of 

a CCER that prevents a user from 

completing the wearability test will 

threaten the successful use of the CCER 

for an escape. 

5. Section 84.304 Capacity Test 

Requirements 

This section specifies the testing 

regime that will be used to rate and 

quantify the capacity of the CCER, in 

terms of the volume of oxygen that the 

respirator provides to the user. It 

ensures the CCER will provide the 

quantity as measured in the NIOSH 

testing as a constantly adequate supply 

of breathing gas, in terms of the stressors 

addressed in § 84.303 of this part. The 

capacity will be evaluated in terms of 

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39 Kamon E, Bernard T, Stein R. Steady state 

respiratory responses to tasks used in Federal 

testing of self-contained breathing apparatus. 

AIHAJ. 1975;36:886–896. 

40See 42 CFR 84.100, Table 4 for the specific 

requirements of man test 4. 

41 Kamon E, Bernard T, Stein R. Steady state 

respiratory responses to tasks used in Federal 

testing of self-contained breathing apparatus. 

AIHAJ. 1975;36:886–896. 

the volume of oxygen, in liters, that the 

CCER effectively delivers for 

consumption by the user. All volumes 

are given at standard temperature (0 ßC) 

and pressure (760 mm Hg), dry, unless 

otherwise noted. This capacity can 

differ from the volume of oxygen stored 

by the CCER, some of which may be 

wasted rather than inhaled by the user, 

depending on the particular design of 

the CCER and the work rate of the user. 

A CCER will operate for a shorter 

duration when the oxygen consumption 

rate is high. Hypothetically, a 190- 

pound man, at rest, is estimated to 

consume a volume of oxygen of .5 liters 

per minute. If he were walking in an 

upright position at 3 miles per hour, it 

is estimated that he could consume 1.18 

liters per minute. The same man 

running in an upright position at 5 

miles per hour is estimated to consume 

2.72 liters per minute.39

A 3-capacity ratings system is 

established in this section: ‘‘Cap 1—Cap 

3.’’ Cap 1 provides 20 to 59 liters of 

oxygen for short escapes that could be 

accomplished quickly; Cap 2 provides 

60 to 79 liters for escapes of moderate 

distance; and Cap 3 provides 80 or more 

liters for the lengthiest escapes. The 3 

capacity ratings correspond to the liter 

quantities of breathing gas supplies that 

are expended during the NIOSH 

capacity testing within approximately 

10, 30, and 60 minutes, respectively. 

The Cap 3 rating is comparable to the 

current NIOSH-certified 60-minute 

rating for CCERs; 10-minute units 

provide approximately 25 liters of 

oxygen, comparable to a Cap 1. The 

oxygen consumption rate associated 

with this rating is the average rate 

demonstrated through NIOSH testing of 

the 50th percentile miner by weight 

(191 pounds) performing the 1-hour 

‘‘man test 4.’’ 40 The test is a series of 

laboratory-based physical activities 

similar to those involved in coal mine 

rescues and escapes, including vertical 

treadmill climbs, walks, runs, and 

carries and pulls of substantial weights. 

As discussed under II(C), however, the 

duration of adequate breathing gas 

supply actually provided to a user by a 

respirator of a given capacity rating will 

depend on the degree of exertion 

involved in the particular escape and 

the size of the respirator user. For this 

reason, as discussed under II(C), NIOSH 

believes the change from a certification 

based on duration to one based on 

capacity is important. Using the 

hypothetical example of the 190-pound 

man above, the following table provides 

a set of possible use durations for 

illustrative purposes. These are 

calculated based on a consideration of 

limited factors and ideal use conditions 

and would be unlikely to match actual 

durations achieved by users in actual or 

simulated escapes. 

CAPACITY VERSUS WORK ACTIVITY

Capacity 1 

(20 liters) 

Capacity 2 

(60 liters) 

Capacity 3 

(80 liters) 

At Rest ................................................................................................

(.5 L/minute) 

40 minutes .................. 120 minutes ................ 160 minutes. 

Run at 3 mph ......................................................................................

(1.18 L/minute) 

17 minutes .................. 51 minutes .................. 68 minutes. 

Run at 5 mph ......................................................................................

(2.72 L/minute) 

7 minutes .................... 21 minutes .................. 28 minutes. 

In addition to having a capacity rating 

system to categorize products, 

manufacturers will use the actual tested 

capacity of approved respirator models, 

which NIOSH will report to the 

manufacturer in increments of 5 liters, 

to specify more precisely the capacity of 

each product. This will enable 

employers to readily compare 

differences in respirator capacity within 

a given rating, more closely match a 

respirator model to their particular 

needs, and choose the respirator model 

that best serves their employees. For 

example, an employer might determine 

through simulation of escapes that 

employees will need a Cap 3 CCER 

model that provides 95 liters to allow 

for the worst contingencies. 

Alternatively, an employer might 

determine that a Cap 3 model that 

provides 80 liters is sufficient and better 

designed, in terms of physical 

dimensions or operational 

characteristics, to accommodate the 

routine work tasks and escape 

contingencies of the employees. 

The capacity testing will evaluate 

seven CCER units using the breathing 

and metabolic simulator. Three will be 

tested in the condition received from 

the applicant (i.e., ‘‘new’’ condition), 

two will receive environmental 

treatments prior to capacity testing, and 

the remaining two units will be tested 

at the cold-temperature limit specified 

by the manufacturer, after being stored 

at the specified temperature. 

Each unit will be tested at the work 

rate identified in Table 2 below, 

according to the capacity level 

designated by the applicant. In terms of 

the rate of oxygen usage, carbon dioxide 

production, ventilation rate, and 

respiratory frequency, the work rates are 

representative of the average work rate 

that the typical CCER user might sustain 

during an escape, based on laboratory 

physiological testing involving 

miners.41 As Table 2 shows, the greater 

the capacity of the CCER, the lower the 

work rate that would be used to test the 

CCER, reflecting the lower average rate 

of exertion that the typical user would 

be capable of sustaining for escapes of 

longer duration. Low capacity devices 

are likely to be used for short, very 

challenging escapes that would induce 

exceptionally high work rates. NIOSH 

finds it is appropriate to apply a work 

rate that represents the level of exertion 

sustainable by a typical user while using 

a device of a particular capacity. Hence, 

NIOSH specifies such an approach in 

this rule. 

One of the units submitted will be 

tested by a human subject on a 

treadmill. The purpose of this human 

test is to provide assurance that the 

simulator is reasonably measuring the 

capacity of the respirator as it would be 

expended in actual use. 

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42 30 U.S.C. 811(a)(9). 

43Turner N, Beeckman D, Hodous T. Evaluation 

of proposed methods to update human testing of 

self-contained breathing apparatus. AIHAJ. Dec. 

1995;56:1195–1200. 

Louhevaara V, Tuomi T, Smolander J, et al. 

Cardiorespiratory strain in jobs that require 

respiratory protection. Int. Arch. Occup. Environ. 

Health. 1985;55:195–206. 

Lemon PW, Hermiston RT. The human energy 

cost of fire fighting. J. Occup. Med. Aug. 

1977;19:558–562. 

TABLE 2—CAPACITY TEST REQUIREMENTS

Capacity rating Capacity 

(L of O2) 

VO2

(L/min) 

VCO2

(L/min) 

Ve 

(L/min) 

RF 

(Breaths/ 

min) 

Cap 1 ........................................................ 20 ≤ L ≤ 59 ............................................... 2.50 2.50 55 22 

Cap 2 ........................................................ 60 ≤ L ≤ 79 ............................................... 2.00 1.80 44 20 

Cap 3 ........................................................ L ≥ 80 ....................................................... 1.35 1.15 30 18 

VO2 = volume of oxygen consumed per minute; VCO2 = volume of carbon dioxide produced per minute. 

Ve = ventilation rate in liters of air per minute; RF = respiratory frequency. 

In addition to this standard testing 

regime to be used for all CCERs, when 

testing CCER models to be co-approved 

with MSHA for use in coal mines, 

NIOSH will also continue to conduct 

the appropriate man test 4 protocol 

discussed above for determination of the 

suitability of these CCERs to be used in 

U.S. underground coal mines. This 

testing is the same as is required under 

the current 42 CFR Part 84 regulations. 

The Federal Mine Safety and Health Act 

requires that ‘‘no mandatory health or 

safety standard * * * shall reduce the 

protection afforded miners by an 

existing mandatory health or safety 

standard.’’ 42 The use of the capacity 

rating system and associated tests to 

approve equipment for use in 

underground coal mines will not 

constitute a reduction in protection or a 

reduction in the duration of breathing 

supply regulated under the current 

MSHA duration requirements for selfcontained self-rescuers. Nevertheless, 

NIOSH and MSHA agree that the 

continued use of man test 4, as a 

supplement to the final new testing 

requirements and capacity rating 

system, will be the most practical 

method demonstrating such compliance 

with the cited provision of the Federal 

Mine Safety and Health Act. The Cap 3 

unit approved for use in mining also 

meets the 1-hour requirement and the 

Cap 1 and Cap 2 units approved for use 

in mining also meet no less than the 10- 

minute requirement under MSHA’s 

existing standards. 

6. Section 84.305 Performance Test 

Requirements 

This section specifies the performance 

testing regimen that will be used to 

certify the ability of the CCER to provide 

a constantly adequate breathing supply 

for the user immediately upon donning 

and under varied work rates, including 

a level representative of peak demand 

and minimal demand. The high work 

rates used during the test will activate 

the demand valve, if present in the 

CCER model, and stress the carbon 

dioxide absorbent. The low work rate 

would activate the relief valve, if 

present. The test includes a procedure 

(immediate exhalation into the unit 

upon donning) to evaluate the potential 

for the user to experience hypoxia (a 

deficient oxygen concentration) upon 

donning the CCER. Hypoxia could occur 

with a CCER using compressed oxygen 

and a demand valve if the user forces 

enough nitrogen into the breathing 

circuit to prevent the activation of the 

demand valve and the user had 

consumed more oxygen than the 

constant quantity supplied by the CCER. 

Such a situation is more likely to arise 

if a CCER user is not adequately trained 

in its use. 

Many CCER users are trained to 

exhale into a CCER upon donning it 

because this is the recommended 

practice for CCERs supplied with 

chemical oxygen if the oxygen starter 

fails. In an emergency, it is likely that 

some users will exhale into the CCER 

regardless of its design, in which case 

NIOSH needs to ensure that the 

respirator will perform adequately. For 

this reason, NIOSH is establishing a 

generic performance testing protocol, 

irrespective of CCER design, that 

includes the hypoxia testing procedure 

in which the test will begin with two 

exhalations into the unit at the specified 

ventilation rate and then follow the 

manufacturer’s instructions to 

determine the design’s susceptibility to 

hypoxia upon initial donning. 

The performance testing will evaluate 

CCER units using the breathing and 

metabolic simulator. Of these, three 

units will be tested in new condition, 

and two will receive environmental 

treatments prior to performance testing. 

The testing regimen will employ the 

following oxygen use-rate cycle: 3.0 

liters per minute for 5 minutes, 2.0 liters 

per minute for 15 minutes, and 0.5 liters 

per minute for 10 minutes. Other 

parameters of the testing are specified in 

Table 3 below. 

TABLE 3—PERFORMANCE TEST REQUIREMENTS

Work-rate test sequence 

Duration per 

cycle 

(in minutes) 

VO2

(L/min) 

VCO2

(L/min) 

Ve 

(L/min) 

RF 

(breaths/ 

min) 

1. Peak ..................................................................................................... 5 3.00 3.20 65.0 25

2. High ..................................................................................................... 15 2.00 1.80 44.0 20 

3. Low ...................................................................................................... 10 0.50 0.40 20.0 12 

VO2 = volume of oxygen consumed per minute; VCO2 = volume of carbon dioxide produced per minute. 

Ve = ventilation rate in liters of air per minute; RF = respiratory frequency. 

The 3.0 liters per minute oxygen userate represents peak exertion. The 2.0 

liters per minute oxygen use-rate is 

high, representing substantial exertion. 

The 0.5 liters per minute oxygen userate is very low, representing a 

sedentary person, such as a worker who 

might be trapped and awaiting rescue.43

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Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 14187 

44The size range is intended to be representative 

of respirator users. See: Zhuang Z and Bradtmiller 

B. Head-and-face anthropometric survey of U.S. 

respirator users. J. Occup. Environ Hyg. 2005;2:567– 

576. 45 Vaught C, Brnich MJ, and Kellner HJ. 

Instructional mode and its effect on initial selfcontained self-rescuer donning attempts during 

training. Pittsburgh, PA: U.S. Department of the 

Interior, Bureau of Mines; 1988. RI 9208. 

The test will be started by the 

exhalation of two large breaths into the 

unit before donning it. This will 

determine the susceptibility of the CCER 

to hypoxia. 

Since the testing cycle requires 50 

liters of oxygen, CCERs that have less 

than a 50 liter capacity will exhaust 

their capacity prior to completing a full 

cycle as specified. To accommodate this 

limitation, if a unit contains less than 50 

liters of useable oxygen (as determined 

by the capacity test under § 84.304), 

NIOSH will require the submission of 

additional units so that the test can be 

completed through the testing of a 

sequence of two or three units, as 

necessary. Such a requirement ensures 

that the CCER is tested at each work rate 

in its entirety. CCERs with greater than 

a 50 liter capacity will repeat the cycle 

until the oxygen supply is exhausted, as 

indicated in the graph below. 

One unit will be tested by a human 

subject on a treadmill. The purpose of 

the human subject test is to provide 

assurance that the respirator will 

perform effectively when responding to 

the more variable loading produced by 

a human subject. 

7. Section 84.306 Wearability Test 

Requirements 

This section specifies the testing 

regimen that will be used to ensure that 

the CCER can be easily and quickly 

donned. The testing procedures also 

ensure that during any reasonably 

anticipated activity, the CCER will not 

physically harm or significantly hinder 

the user and would provide an adequate 

and uninterrupted supply of breathing 

gas. Testing will be conducted using 

three human subjects of differing 

heights and weights,44 as specified, to 

provide reasonable assurance that the 

results would be representative of most 

potential CCER users. 

Subsection (b) requires that trained 

users be able to successfully don the 

CCER, initiating breathing through the 

device within 30 seconds. This 

criterion, derived from current training 

requirements for the use of CCERs used 

in mining,45 is reasonably protective in 

the case of emergency scenarios 

involving an explosion or sudden 

detection of a hazardous breathing 

environment. This subsection allows 

NIOSH to determine whether any 

particular design, construction, or 

material characteristic of the CCER 

could hinder the user in the correct and 

timely donning of the CCER. These 

determinations may be made based on 

either the demonstrated ability of a 

human subject to don the CCER as 

required or the identification of 

plausible circumstances that would 

prevent the required timely donning. 

Subsection (c) and the table below 

specify the activities that will be 

performed by the human subjects to test 

the CCER. These activities are derived 

from the present regulations and 

represent the types of activities and 

physical orientations that may occur 

during escapes. The test will 

continuously monitor the CCER to 

ensure these activities and orientations 

do not adversely affect the adequacy of 

the CCER’s supply of breathing gas and 

to identify any potential for the CCER to 

harm or hinder the user during an 

escape. 

TABLE 4—WEARABILITY TEST

REQUIREMENTS

Activity Minimum duration 

Sitting ......................... 1 minute. 

Stooped walking ........ 1 minute. 

Crawling ..................... 1 minute. 

TABLE 4—WEARABILITY TEST

REQUIREMENTS—Continued 

Activity Minimum duration 

Lying on left side ....... 1 minute. 

Lying on right side ..... 1 minute. 

Lying on back ............ 1 minute. 

Bending over to touch 

toes.

1 minute. 

Turning head from 

side to side.

1 minute (at least 10 

times). 

Nodding head up and 

down.

1 minute (at least 10 

times). 

Climbing steps or a 

laddermill.

1 minute (1 step/second). 

Carrying 50-lb bag on 

treadmill at 5 kph.

1 minute. 

Lifting 20-lb weight 

from floor to an upright position.

1 minute (at least 10 

times). 

Running on treadmill 

at 10 kph.

1 minute. 

8. Section 84.307 Environmental 

Treatments 

This section specifies the 

environmental treatments that will be 

administered to the CCER to ensure that 

it is reasonably durable and resistant to 

the potentially performance-degrading 

environmental factors of extreme storage 

temperatures, shock, and vibration. 

The extreme storage temperature test 

specified in subsection (b) is based on 

worst-case scenarios. For example, the 

high temperature (71 °C) test is based on 


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14188 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 

46 Dayton T. Brown, Inc. Environmental test 

criteria for the acceptability of mine 

instrumentation. Phase 1, Final Report DTB2GR80– 

0643. U.S. Bureau of Mines contract No. J0100040; 

June 1980;72. 

47 ISO 4855:1981, Personal eye-protectors—Nonoptical test methods. International Organization for 

Standardization. Clauses 13, 14; Sub-Clause 3.1. 

Copies are available for inspection at NIOSH (see 

rule text for details) and for purchase from the ISO 

Web site at: http://www.iso.org/iso/ 

catalogue_detail.htm?csnumber=10838. Accessed 

October 7, 2010. 

48European Standard BS EN 168:2002, Personal 

eye-protection, Non-optical test methods. European 

Committee for Standardization. January 2002. 

Copies are available for inspection at NIOSH (see 

rule text for details) and for purchase from the BSI 

British Standards Web site at: http:// 

shop.bsigroup.com/en/ProductDetail/ 

?pid=000000000030036280. Accessed October 7, 

2010. 

49McAteer JD, et al. The Sago Mine disaster: a 

preliminary report to Governor Joe Manchin III. 

Buckhannon, West Virginia; July 2006;14. http:// 

www.wvgov.org/ 

SagoMineDisasterJuly2006FINAL.pdf. Accessed 

October 7, 2010. 

the temperature associated with storage 

in the trunks of vehicles. In response to 

public comments, units will be allowed 

to return to room temperature between 

steps. 

The shock test specified in subsection 

(c), which is a series of 1-meter drops 

onto a concrete surface, is based on the 

height at which the respirator would be 

handled and attached to the user’s belt. 

In response to public comments, the 

provision specifies that the shock test 

will be conducted on units in the casing 

in which they are deployed for 

individual use. 

The vibration test specified in 

subsection (d) is a composite test based 

on the vibration levels measured on the 

frames of underground longwall and 

continuous mining machines and on 

underground and surface haulage 

vehicles.46

9. Section 84.308 Additional Testing 

This section specifies several other 

tests that NIOSH will conduct, as 

appropriate. Each unit tested must meet 

the conditions specified in the test to 

receive approval. 

Under subsection (b), NIOSH will 

perform safety hazard tests on any CCER 

that stores more than 200 liters of 

oxygen or that stores compressed 

oxygen at pressures exceeding 3,000 psi. 

None of the current 1-hour CCER 

designs has such storage capacities. 

However, if such a design were 

submitted for approval, the applicant 

would have to provide an additional 15 

units of the CCER for these additional 

tests. The specifications for the tests are 

provided in a series of Bureau of Mines 

reports referenced in the regulatory text. 

Under subsection (c), NIOSH will 

perform a series of tests on one or more 

units of every CCER submitted for 

approval to evaluate the effectiveness of 

the required eye protection (goggles or 

an escape hood lens) against dust, gas, 

and fogging that could impair the user’s 

vision, as well as for durability. The 

tests proposed for dust and gas and 

durability were established by the 

International Organization for 

Standardization (ISO), a globally 

recognized consensus standard setting 

organization.47 The test for fogging was 

established by the European Committee 

for Standardization, a consensus 

standard-setting organization within the 

European Union.48 These specified 

tests, which are widely accepted by the 

safety and manufacturing communities, 

are incorporated by reference into this 

rule. 

10. Section 84.309 Additional Testing 

and Requirements for Dockable CCERs 

This section will provide for NIOSH 

to test and approve dockable CCERs, 

which are CCERs that would allow the 

user to resupply the breathing gas 

source included in the CCER through 

the attachment (docking) of breathing 

gas resupply sources that would be 

cached at locations along escape routes. 

Such dockable CCERs do not presently 

exist in the U.S. respirator market, but 

substantial interest in such technology 

has been expressed in the mining 

community, most recently in response 

to the Sago Mine disaster in 2006.49

Paragraph (a) specifies that NIOSH 

will conduct testing to ensure that the 

CCER user will be able to perform the 

docking process safely, reliably, and 

quickly under escape conditions. 

Precise testing protocols are not 

specified because they will depend on 

the technology, which has yet to be 

developed; test protocols will be posted 

on the NIOSH Web site once they are 

created. However, the provisions clearly 

specify the qualitative performance 

characteristics required for approval. 

Paragraph (b) provides that NIOSH 

will designate CCERs that meet the 

testing requirements of this section as 

‘‘Dockable.’’ 

Paragraph (c) provides that NIOSH 

will assign the capacity rating to the 

dockable CCER using only the breathing 

gas supply included for the initial use 

of the wearable apparatus. In other 

words, the capacity of the breathing gas 

resupply units will not be taken into 

account in rating the capacity of the 

CCER. 

Paragraph (d) provides that NIOSH 

test the breathing gas resupply units 

produced for the dockable unit and 

specify their capacities using capacity 

testing procedures consistent with those 

applied to testing the dockable CCER. 

This testing is necessary so that users 

have NIOSH verification of the capacity 

of the resupply units. The provision also 

provides for appropriate labeling to 

specify the capacity of the resupply unit 

and its compatibility with the CCER. 

Paragraph (e) provides that NIOSH 

will be able to require the applicant to 

provide additional units of the CCER for 

the additional testing associated with 

dockable units. NIOSH cannot 

determine at this time whether 

additional units will be needed. 

Paragraph (f) provides that NIOSH 

will not approve a CCER with docking 

components, even without the NIOSH 

‘‘Dockable’’ designation, unless it 

satisfies the testing and other 

requirements proposed for approving 

dockable units. This provision is 

intended to avoid the plausible 

circumstance of users mistaking 

certified CCERs with docking 

components as having been approved by 

NIOSH as dockable. 

11. Section 84.310 Post-Approval 

Testing 

This section provides for NIOSH to 

conduct periodic testing of deployed 

units of approved CCERs. The purpose 

of such post-approval testing is to 

evaluate the capacity and performance 

of the approved CCER after it has been 

subject to actual field conditions 

including operations, storage, and 

handling at worksites. NIOSH will 

obtain such units from employers in 

exchange for new units, substituted at 

no cost to the employer. NIOSH will 

require, as a condition of continued 

approval, that the applicant make 

available for purchase by NIOSH a 

sufficient number of new units (not to 

exceed 100 units annually) to support 

the post-approval testing program. On 

several occasions, NIOSH has been 

hampered by the lack of an available 

supply of a CCER model, either because 

the manufacturer produces the products 

intermittently or has ceased production 

permanently. In response to public 

comments, the rule allows 

manufacturers that discontinue a 

particular line of respirators selected for 

field evaluation to replace those units 

with similar, NIOSH-approved CCERs. 

If testing indicates that deployed units 

of a CCER are not consistently meeting 

the capacity and performance standards 

under which the CCER was approved, 

NIOSH will request remedial actions by 

the applicant. NIOSH will be authorized 

to revoke the approval of a CCER if the 

applicant does not remediate the 

cause(s) of the problem(s). In such a 

case, NIOSH will work with the relevant 

regulatory agencies and industry and 

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50U.S. Department of Labor, Mine Safety and 

Health Administration. Mining Industry Accident, 

Continued 

labor organizations to notify users of the 

revocation. 

A program of post-approval testing is 

important for assuring users of the 

effectiveness of their equipment. 

Simulations of environmental 

conditions conducted in a laboratory 

during the approval process cannot 

perfectly and comprehensively replicate 

all conditions that might be associated 

with the actual storage and wearing of 

CCERs in mines and other work 

environments. The post-approval testing 

also serves to identify potential 

problems of quality control in the 

manufacturing process. The regulatory 

requirements of this section ensure the 

feasibility of a post-approval testing 

program and establish specific 

authorities and obligations in 

connection with the results of such 

testing. 

12. Section 84.311 Registration of 

CCER Units Upon Purchase 

This section requires that 

manufacturers provide each purchaser 

of a CCER unit with copies of 

procedures for registering purchased 

units with NIOSH. NIOSH will also 

work with relevant agencies and 

industry and labor associations to 

publicize the registration program. It is 

particularly important to reach 

purchasers and users of CCERs who 

obtain their devices from secondary 

markets and through equipment 

transfers from other work sites. This 

registration will enable NIOSH to notify 

purchasers when: (1) A problem 

associated with a model of CCER is 

identified; (2) such a problem requires 

a remedial action; or (3) NIOSH revokes 

the certification of a CCER. Presently, 

NIOSH has limited ability to locate 

users of particular CCER models. 

Manufacturers do not consistently retain 

records of purchasers and may sell 

product through distributors. Also, there 

is a secondary market for re-selling 

purchased CCERs as purchasers go out 

of business, reduce their employment, 

or select an alternate CCER model. 

B. Subpart G—General Construction 

and Performance Requirements 

1. Sections 84.60, 84.63–84.65 

These sections of Subpart G, which 

provide general construction and 

performance requirements for 

respirators approved under 42 CFR Part 

84, are presently limited to covering 

respirator types specified under 

Subparts H through L. Since this rule 

removes CCER provisions from under 

Subpart H and places them under a 

newly created Subpart O, Subpart G is 

revised to cover Subpart O as well as 

Subparts H through L. Furthermore, by 

technical error, existing Subparts N and 

KK have been inadvertently omitted 

from coverage under Subpart G, even 

though this provision was intended to 

apply to all respirators types. In this 

final rule, HHS extends the coverage of 

Subpart G to all respirators certified 

under this Part (i.e., Subparts H through 

KK) to clearly specify the 

comprehensive coverage of Subpart G to 

all respirator types presently approved. 

This change also provides coverage 

under Subpart G for respirator types that 

might be distinguished under newly 

created sections in the future. 

C. Subpart H—Self-Contained Breathing 

Apparatus 

1. Section 84.70 Self-Contained 

Breathing Apparatus; Description 

This section excludes CCERs from 

coverage under any provisions of 

Subpart H, except as provided for under 

§ 84.304(a)(5). The provisions of Subpart 

H concerning respirators used for escape 

only from hazardous environments 

apply solely to those with an opencircuit design. 

IV. Regulatory Assessment 

Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

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). E.O. 13563 emphasizes the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. 

This rule is being treated as a 

‘‘significant regulatory action’’ within 

the meaning of E.O. 12866 because it 

raises novel legal or policy issues. 

Current MSHA regulations (30 CFR 

75.1714–1) require that underground 

coal mine operators provide miners 

with CCERs (referred to in the mining 

community as a self-contained selfrescuer or SCSR) which have been 

approved by MSHA and NIOSH under 

42 CFR Part 84, as follows: 

(a) 1-hour SCSR; 

(b) A SCSR of not less than 10 

minutes and a 1-hour canister; or 

(c) Any other self-contained breathing 

apparatus which provides protection for 

a period of 1 hour or longer and which 

is approved for use by MSHA as a selfrescue device when used and 

maintained as prescribed by MSHA. 

By changing the nomenclature used to 

identify different size CCER models, the 

new rule will change the criteria by 

which NIOSH and MSHA approve 

CCERs intended for use in mines. 

MSHA, as a co-approver, will determine 

whether they meet the requirements of 

paragraphs (a) and (b) of the MSHA 

regulation, consistent with the NIOSH 

approval process. As discussed above in 

Section I.C. of the preamble, there is 

evidence that the duration rating system 

causes the user to believe that the 

apparatus will last for a specific length 

of time, regardless of the user’s weight, 

physical condition, or activity. This is 

not an accurate interpretation. Relying 

on a 1-hour unit to supply 1 hour of 

oxygen to all users under all 

circumstances can lead to inappropriate 

deployment and misuse in emergencies. 

NIOSH believes that transition to the 

capacity rating will alleviate these 

misinterpretations. 

The rule is not considered 

economically significant, as defined in 

sec. 3(f)(1) of E.O. 12866. HHS 

anticipates that respirator manufacturers 

will need to modify some existing CCER 

designs and make related changes to 

their manufacturing processes to meet 

the new capacity and performance 

testing requirements. However, these 

changes are not expected to require 

manufacturers to use fundamentally 

different or substantially more costly 

technology. Similarly, NIOSH does not 

expect the new requirements for 

indicators of excessive thermal 

exposure, moisture damage, or chemical 

bed integrity to have a substantial 

impact on the manufacturing cost of 

CCERs. Such indicators have already 

been incorporated into CCER designs by 

some manufacturers without 

substantially increasing product prices. 

Hence, NIOSH does not expect that 

manufacturers will have to engage in 

new manufacturing processes that 

would substantially increase 

manufacturing costs or product prices. 

Moreover, even a substantial cost 

increase in CCERs would not be 

economically significant. The scope of 

the market for CCERs is presently very 

limited. According to MSHA, there are 

approximately 47,000 coal miners, the 

principal users of CCERS in the private 

sector, working underground in such 

positions as mining machine operators, 

excavating machine operators, roof 

bolters, earth drillers, electricians, 

helpers, and first line supervisors.50 The 

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Injuries, Employment, and Production Data— 

Address & Employment Self-Extracting Files. http:// 

www.msha.gov/stats/part50/p50y2k/aetable.htm. 

Accessed July 7, 2011. 

51This figure was supplied by MSHA, which 

maintains a registry of all CCER units deployed to 

U.S. coal mines. 

52NIOSH calculated this average price based on 

the products supplied by the three CCER 

manufacturers that supply U.S. coal mines, unit 

prices to NIOSH for its recent purchases of these 

products, and the approximate deployment 

distribution of these products among U.S. coal 

mines as indicated by the MSHA CCER registry for 

coal mines. 

53Estimated from information provided by the 

Naval Surface Warfare Center, Panama City, 

Florida, December 20, 2004. 

service lives of current CCER models 

range from 10 to 15 years, although 

some units may be damaged or used for 

an escape or escape simulation and 

consequently would be taken out of 

service sooner. Assuming conservatively 

that each CCER unit is replaced every 10 

years on average and given that 

approximately 180,000 units 51 are 

currently deployed, the mining industry 

would purchase an average of 18,000 

units annually. Given an average cost of 

$675 per unit,52 these data suggest that 

this principal component of the current 

CCER market represents approximately 

$12.2 million in annual sales. Other 

major components of the CCER market 

include sales to the Navy and Coast 

Guard and possibly the maritime 

industry. Among these, the Navy is the 

largest consumer, with over 400,000 

units in current use; assuming 

conservatively that each of the Navy’s 

CCER units is replaced every 10 years, 

the Navy purchases an estimated 40,000 

units annually; therefore, the annual 

CCER market for the Navy represents 

approximately $27 million.53 In sum, 

the CCER market is estimated to be 

approximately $39.2 million per year. 

Although HHS does not expect the cost 

of individual CCER units to rise 

significantly in response to the new 

testing and approval standards, a 

hypothetical increase of 50 percent in 

the price per unit would result in an 

average annual market of $58.8 million. 

The estimated impact of the final rule 

on respirator sales (the difference 

between estimated current annual sales 

and estimated annual sales under the 

new standards calculated using a 50 

percent per unit increase) is $19.6 

million per year, or less than 20 percent 

of the $100 million threshold for a 

significant regulatory action having an 

annual effect on the economy. Further, 

the rule will not 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, or tribal 

governments or communities. No 

respirator manufacturer or underground 

coal mine operator offered comment on 

this analysis. 

The new requirements will likely 

produce economic benefits. First, they 

will provide more product performance 

information to purchasers, which will 

result in a more efficient market. 

Respirators will be tested for their 

specific capacity, in addition to being 

rated by general categories of capacity. 

As discussed under Section III—84.304 

of the preamble, this specificity will 

allow purchasers to match respirators 

more closely to their particular needs. 

As a result, manufacturers will have 

incentive to innovate and address the 

diverse needs of users. Further, having 

specific NIOSH-approved capacity 

levels will provide manufacturers with 

more incentive to differentiate the 

performance of their products from 

those of their competitors. This 

competition should result in a market of 

products that more closely meet the 

design and performance needs of 

different work sites, thereby improving 

the protection of miners and other 

workers who rely on CCERs in 

emergencies. While NIOSH is unable to 

quantify the benefits of a more efficient 

market, it is reasonable to assume that 

the development of products more 

specifically tailored to the needs of 

purchasers will eliminate wasteful 

spending by employers and improve 

worker protection. 

Second, the new requirements for 

safety features (which provide for the 

detection of units that have undergone 

excessive environmental stresses or 

mishandling) have the potential to 

increase the ability of purchasers, users, 

inspectors, and others to contribute to 

assuring the reliability of deployed 

CCER units. This should make operator 

safety programs and regulatory 

compliance investments by the 

government more efficient by making it 

less likely that bad product will make 

its way to a worker’s hands. While HHS 

cannot quantify this benefit, it is logical 

and reasonable to expect that a positive 

economic impact will derive from 

improved safety features. 

Third, the new requirements for safety 

features and for capacity and 

performance testing are designed to 

better protect workers relying on CCERs 

for their survival. Although NIOSH 

lacks information on the number of 

workers annually who rely on a CCER 

for their survival and the quantifiable 

benefit they will derive from the 

improvements in this rule, the improved 

standards are likely to result in fewer 

negative outcomes and lower associated 

costs. In addition, substantial costs 

associated with rescue operations could 

be averted if workers escape 

independently. 

The rule will not interfere with State, 

local, or tribal governments in the 

exercise of their governmental 

functions. 

OMB has reviewed this proposed rule 

for consistency with the President’s 

priorities and the principles set forth in 

E.O. 12866. 

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-forprofit organizations. The Department of 

Health and Human Services (HHS) 

certifies that this rule will not have a 

significant economic impact on a 

substantial number of small entities, 

including both small manufacturers of 

CCERs and the small mining operators 

that are required to purchase them, 

within the meaning of the RFA. 

CCERs currently sold in the United 

States are manufactured by only two 

U.S. companies: CSE Corporation of 

Monroeville, Pennsylvania, and Ocenco 

Incorporated of Pleasant Prairie, 

Wisconsin. (A third company, Draeger, 

is based in Germany.) These 

manufacturing companies are small 

businesses as defined under the Small 

Business Act for this industry sector 

(NAICS 339113—Surgical Appliance 

and Supplies Manufacturing), 

employing fewer than 500 employees. 

Accordingly, HHS has given 

consideration to the potential impact of 

this rule on these two companies. 

HHS did not receive any comments 

on the economic analysis published in 

the Federal Register (73 FR 75027, 

December 10, 2008). 

Manufacturers will likely have to 

design new products and make related 

changes to their manufacturing 

processes for these products. However, 

in NIOSH’s judgment, such new designs 

and production changes would not 

require substantial technological 

innovation in order to meet the 

improved performance standards. 

Similarly, NIOSH does not expect the 

new requirements for indicators of 

excessive thermal exposure, moisture 

damage, or chemical bed integrity to 

have a substantial impact on the 

manufacturing cost of CCERs. Such 

indicators have already been 

incorporated into CCER designs by some 

manufacturers without substantially 

increasing product prices. Most 

importantly, any associated costs 

incurred by the manufacturers for 

compliance with this rule could be 

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Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 14191 

54The MINER Act requires underground coal 

mine operators to supply each underground worker 

with at least 4 hours of breathable air; the 

International Convention for the Safety of Life at 

Sea similarly requires ships to carry breathable air 

in designated locations. 

55 Kyriazi N, Shubilla JP. Self-contained selfrescuer field evaluation: seventh-phase results. 

Pittsburgh, PA: U.S. Department of Health and 

Human Services, Centers for Disease Control and 

Prevention, National Institute for Occupational 

Safety and Health; March 2002. DHHS (NIOSH) 

Publication No. 2002–127, RI 9656. 

56U.S. Department of Labor, Mine Safety and 

Health Administration. Mining Industry Accident, 

Injuries, Employment, and Production Data— 

Address & Employment Self-Extracting Files. http:// 

www.msha.gov/stats/part50/p50y2k/aetable.htm. 

Accessed July 7, 2011. 

57U.S. Census Bureau. 2007 Economic Census. 

http://factfinder.census.gov/servlet/ 

IBQTable?_bm=y&-geo_id=&-ds_name=EC0721I1&- 

_lang=en. Accessed August 24, 2011. 

58NIOSH calculated this weighted average price 

using the products of the three CCER manufacturers 

that supply U.S. coal mines, unit prices to NIOSH 

for its recent purchases of these products, and the 

approximate deployment distribution of these 

products among U.S. coal mines as indicated by the 

MSHA CCER registry for coal mines. The use of this 

weighted average price simplifies the analysis and 

is adequate considering the equivalency of these 

prices for the major share holders (Ocenco and CSE) 

as indicated in Table 1. 

59U.S. Department of Labor, Mine Safety and 

Health Administration. Mining Industry Accident, 

Injuries, Employment, and Production Data— 

Address & Employment Self-Extracting Files. http:// 

www.msha.gov/stats/part50/p50y2k/ 

aetable.htm.Accessed July 7, 2011. 

60This replacement rate is an exceptionally 

conservative estimate. A more realistic estimate is 

10 percent annually (i.e., the replacement of a CCER 

unit every 10 years), based on the known servicelife of CCERS of 10–15 years, the MSHA CCER 

registry, and NIOSH long-term field evaluation data. 

These latter two sources indicate the current 

replacement rate is well under 10 percent. 

61The lower value was obtained using a cost of 

capital rate of 3 percent: $675/unit × 0.5 cost 

increase × 180,000 units × 0.2184 annualization 

factor/47,000 underground miners = annual costs 

per underground miner. The higher value was 

obtained using a cost of capital rate of 7 percent: 

$675/unit × 0.5 cost increase × 180,000 units × 

0.2439 annualization factor/47,000 underground 

miners = annual costs per underground miner. 

passed on to consumers entirely since 

the demand for these products is 

essentially inelastic.54 HHS is unable to 

quantify the impact on the two small 

manufacturers; however, the 

Department believes that manufacturers 

did not offer comment on this analysis 

because the cost of compliance is not 

expected by any stakeholder to exceed 

the benefits derived from this final rule. 

Accordingly, HHS finds there would not 

be a significant economic impact on the 

two U.S. respirator manufacturers 

which produce the CCERs covered by 

this rule. The table below identifies the 

two domestic CCER manufacturers and 

the non-U.S. company, the products 

each make that are used in underground 

coal mining, the cost to NIOSH of 

purchasing an individual unit, and the 

market share of each type of 

respirator.55

CLOSED-CIRCUIT ESCAPE RESPIRATOR MANUFACTURERS AND COSTS

Manufacturer Respirator Cost Market share 

(percent) 

CSE ......................................................................... SR–100 .................................................................. $689 46 

Ocenco .................................................................... EBA 6.5 .................................................................. 670 39 

Ocenco .................................................................... M–20 ...................................................................... 412 2 

Draeger ................................................................... OKY–X Plus ........................................................... 537 5 

MSA * ...................................................................... Life-Saver 60 .......................................................... .............................. ..............................

* MSA supplied CCERs to 7% of the market in 2002; they have since stopped U.S. sales. 

Further, because the Mine Act (30 

U.S.C. 842(h)) and MSHA regulations 

(30 CFR 75.1714–1) require coal mine 

operators to supply CCERs approved by 

NIOSH and MSHA for the protection of 

coal miners working in underground 

coal mines, HHS has also considered the 

secondary or ‘‘downstream’’ economic 

impact of this rule on coal mine 

operators that would be considered 

small businesses, which the Small 

Business Administration defines as 

those mines employing fewer than 500 

employees. CCERs are purchased by 

bituminous coal mining companies 

(NAICS 212112) and anthracite coal 

mining companies (NAICS 212113). 

According to MSHA, 488 underground 

coal mines can currently be considered 

small.56 According to the 2007 

Economic Census, the value of coal 

shipments made in these two industries 

is approximately $15.5 billion 

annually; 57 because nearly all 

bituminous and anthracite coal mining 

companies are considered small, it is 

reasonable to assume that this value 

approximates revenues for those small 

manufacturers. 

NIOSH does not expect that the prices 

of CCERs will be substantially affected 

by the new approval testing 

requirements. Respirator manufacturers 

may need to modify existing CCER 

designs to meet the new capacity or 

performance testing requirements. 

However, these requirements should not 

cause the manufacturers to use 

fundamentally different or substantially 

more costly technology, as discussed 

above. Hence, NIOSH does not expect 

that manufacturers would have to 

engage in markedly different 

manufacturing processes that might 

substantially increase product prices. 

The manufacturers would incur onetime costs for redesign of products or 

product components and associated 

production operations, as well as onetime costs for obtaining certification 

testing and approval from NIOSH and 

MSHA. Attempting to calculate price 

increases that would cover such costs 

would require more data than are 

available to NIOSH. Instead, HHS has 

evaluated the relative magnitude of 

possible costs under the extremely 

conservative assumption that CCER 

prices would be increased permanently 

by 50 percent to amortize the one-time 

product and production redesign and 

NIOSH approval application costs. 

Currently, the weighted average price of 

a CCER is $675 58 and MSHA’s CCER 

registry indicates there are 

approximately 180,000 CCERs deployed 

in underground coal mines. There were 

approximately 47,000 coal miners 

working underground in large and small 

U.S. coal mines in the first quarter of 

2011.59 Assuming very conservatively 

that each unit requires replacement 

every 5 years,60 assuming that all CCERs 

deployed in mines would be replaced in 

the first year of this final rule, and 

assuming that the prices of all CCERs 

were to increase by 50 percent as a 

result of this rule, the annualized 

additional costs would amount to 

between approximately $282 and $315 

per underground coal miner.61 This 

increase in labor-associated costs would 

not be significant in the context of the 

total per capita labor costs of 

underground coal mine operators. The 

total earnings of non-union coal miners 

(wages and benefits), which generally 

represents employment for small coal 

mine operators, is approximately 

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14192 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 

62According to the National Mining Association, 

coal miners have average annual earnings of 

$72,200. See National Mining Association. Profile of 

the U.S. coal miner 2008. August 2009. http:// 

www.nma.org/pdf/c_profile.pdf. Accessed October 

23, 2009. This figure is consistent with the pay rate 

reported for non-union underground coal miners at 

$35.56 per hour. See InfoMine USA, Inc. U.S. coal 

mines salaries, wages, and benefits, 2009. February 

2010. This non-union pay rate applied to a 2,000 

hour work year represents total wages and benefits 

paid by small coal mine operators. 

63HHS guidance defines ‘‘significant economic 

impact’’ as a 3–5 percent or more average annual 

impact on the total costs or revenues of small 

entities. See: U.S. Department of Health and Human 

Services. Guidance on proper consideration of 

small entities in rulemakings of the U.S. 

Department of Health and Human Services. May 

2003. 

$72,000.62 HHS finds that an average of 

$282 to $315 in additional annual costs 

per coal miner (less than 0.39 to 0.44 

percent of per capita labor costs), or 

$13.3 to $14.8 million in estimated 

annual costs to the 488 small 

underground coal mines were this rule 

to increase CCER prices by 50 percent, 

does not represent a significant 

economic impact on small mine 

operators (.09 to .1 percent of annual 

revenue); nor would a 100 percent 

increase in CCER prices, which HHS 

does not find to be plausible 

considering the facts discussed here, 

impose a significant economic impact 

on small mine operators.63

HHS consulted with and received 

approval from the Small Business 

Administration on this analysis of the 

final rule’s impact on small entities. 

For the reasons provided, a regulatory 

flexibility analysis, as provided for 

under RFA, is not required. 

C. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (44 U.S.C. 3501 et seq.), a 

Federal agency shall not conduct or 

sponsor a collection of information from 

10 or more persons other than Federal 

employees unless the agency has 

submitted a Standard Form 83, 

Clearance Request, and Notice of 

Action, to the Director of the Office of 

Management and Budget (OMB), and 

the Director has approved the proposed 

collection of information. A person is 

not required to respond to a collection 

of information unless it displays a 

currently valid OMB control number. 

HHS has determined that this final 

rule contains information collections 

that are subject to review by OMB. OMB 

has approved NIOSH’s collection of 

information from applicants under OMB 

Control No. 0920–109, ‘‘Respiratory 

Protective Devices,’’ which covers all 

information collected under 42 CFR Part 

84. Current OMB approval for this data 

collection expires August 31, 2014. The 

requirements of this final rule will not 

pose an additional burden on applicants 

because the application will not change 

from current practices. 

D. Small Business Regulatory 

Enforcement Fairness Act 

As required by Congress under the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (5 U.S.C. 801 et 

seq.), HHS must report to Congress the 

promulgation of a final rule, once it is 

developed, prior to its taking effect. The 

report will state that HHS has 

concluded that the rule is not a ‘‘major 

rule’’ because it is not likely to result in 

an annual effect on the economy of $100 

million or more. 

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 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) 

This rule has been drafted and 

reviewed in accordance with Executive 

Order 12988, Civil Justice Reform, and 

will not unduly burden the Federal 

court system. NIOSH has provided clear 

testing and certification requirements it 

will apply uniformly to all applications 

from manufacturers of CCERs. This rule 

has been reviewed carefully to eliminate 

drafting errors and ambiguities. 

G. Executive Order 13132 (Federalism) 

HHS has reviewed this 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 rule on children. HHS has 

determined that the rule will have no 

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 rule on energy supply, distribution, 

or use because it applies to the 

underground mining sector. The rule 

would not result in any costs to mines. 

Hence this rule does not constitute a 

‘‘significant energy action.’’ 

Accordingly, E.O. 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use, requires no further 

Agency action or analysis. 

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 proposed rule 

consistent with the Federal Plain 

Writing Act guidelines. 

V. Final Rule 

List of Subjects in 42 CFR Part 84 

Incorporation by reference, 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 amends 42 CFR Part 84 

as follows: 

PART 84—APPROVAL OF 

RESPIRATORY PROTECTIVE DEVICES 

■ 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 G—General Construction and 

Performance Requirements 

§ 84.60 [Amended] 

■ 2. Amend § 84.60(a) to remove the 

phrase ‘‘in subparts H through L’’ and 

add in its place the phrase ‘‘in subparts 

H through KK.’’ 

§ 84.63 [Amended] 

■ 3. Amend § 84.63(a), (b), and (c) to 

remove the phrase ‘‘in subparts H 

through L’’ and add in its place the 

phrase ‘‘in subparts H through KK.’’ 

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Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 14193 

§ 84.64 [Amended] 

■ 4. Amend § 84.64(b) to remove the 

phrase ‘‘of subparts H through L’’ and 

add in its place the phrase ‘‘of subparts 

H through KK.’’ 

§ 84.65 [Amended] 

■ 5. Amend § 84.65(a) to remove the 

phrase ‘‘to subparts H through L’’ and 

add in its place the phrase ‘‘to Subparts 

H through KK.’’ 

Subpart H—Self-Contained Breathing 

Apparatus 

■ 6. Amend § 84.70 to: 

■ a. Redesignate paragraphs (a) through 

(d) as (b) through (e), respectively; and 

■ b. Add a new paragraph (a) to read as 

follows: 

§ 84.70 Self-contained breathing 

apparatus; description. 

(a) Limitation on scope. None of the 

provisions of Subpart H apply to closedcircuit escape respirators to be approved 

specifically for escape only from 

hazardous atmospheres, except as 

provided for under § 84.304(a)(5). Such 

respirators are covered under the 

provisions of subpart O of this part. 

* * * * * 

■ 7. Add subpart O to part 84 to read as 

follows: 

Subpart O—Closed-Circuit Escape 

Respirators 

Sec. 

84.300 Closed-circuit escape respirator; 

description. 

84.301 Applicability to new and previously 

approved CCERs. 

84.302 Required components, attributes, 

and instructions. 

84.303 General testing conditions and 

requirements. 

84.304 Capacity test requirements. 

84.305 Performance test requirements. 

84.306 Wearability test requirements. 

84.307 Environmental treatments. 

84.308 Additional testing. 

84.309 Additional testing and requirements 

for dockable CCERs. 

84.310 Post-approval testing. 

84.311 Registration of CCER units upon 

purchase. 

Subpart O—Closed-Circuit Escape 

Respirators 

§ 84.300 Closed-circuit escape respirator; 

description. 

The closed-circuit escape respirator 

(CCER), technically a subset of selfcontained breathing apparatus (SCBAs) 

which are otherwise covered under 

subpart H of this part, is used in certain 

industrial and other work settings in 

emergencies to enable users to escape 

from atmospheres that can be 

immediately dangerous to life and 

health. Known in the mining 

community as self-contained selfrescuers (SCSRs), and in other 

industries as emergency escape 

breathing devices (EEBDs) or apparatus 

(EEBAs), CCERs are relied upon 

primarily by underground coal miners, 

sailors in federal service, and railroad 

workers to escape dangerous 

atmospheres after a fire, explosion, or 

chemical release. CCERs are commonly 

worn on workers’ belts or stored in close 

proximity to be accessible in an 

emergency. They are relatively small 

respirators, typically the size of a water 

canteen, that employ either compressed 

oxygen with a chemical system for 

removing exhaled carbon dioxide from 

the breathing circuit, or a chemical that 

both provides a source of oxygen and 

removes exhaled carbon dioxide. Users 

re-breathe their exhalations after the 

oxygen and carbon dioxide levels have 

been restored to suitable levels, which 

distinguishes these ‘‘closed-circuit’’ selfcontained respirators from ‘‘opencircuit’’ self-contained respirators, 

which vent each exhalation. 

§ 84.301 Applicability to new and 

previously approved CCERs. 

This subpart applies to the following 

CCERs: 

(a) All CCERs submitted to NIOSH for 

a certificate of approval after April 9, 

2012; and 

(b) All CCERs manufactured and 

labeled NIOSH-approved and sold by 

manufacturers after April 9, 2015. 

§ 84.302 Required components, attributes, 

and instructions. 

(a) Each CCER must include 

components and/or attributes 

appropriate to its design, as follows: 

(1) Eye protection: Each CCER must 

include safety goggles or an escape hood 

lens that protects against impact, 

fogging, and permeation by gas, vapor, 

and smoke, as specified under 

§ 84.308(c); 

(2) Thermal exposure indicators: If the 

manufacturer specifies a maximum and/ 

or minimum environmental temperature 

limit for storage of the CCER, then the 

CCER must include a component, an 

attribute, or other means by which a 

person can determine whether the CCER 

has been exposed to temperatures that 

exceed the limit(s); 

(3) Chemical bed physical integrity 

indicators: If the CCER includes a 

chemical oxygen storage or chemical 

carbon dioxide scrubber that can be 

functionally damaged by impact, 

vibration, or any other environmental 

factor to which the CCER might be 

exposed, then the CCER must include a 

component, an attribute, or other means 

by which a person can detect any 

damage or alteration of the chemical 

oxygen storage or chemical carbon 

dioxide scrubber that could diminish 

the NIOSH-certified performance of the 

CCER, as tested under this subpart; 

(4) Oxygen storage vessel: If the CCER 

includes an oxygen storage vessel, the 

vessel must be approved by the U.S. 

Department of Transportation (DOT) 

under 49 CFR part 107, ‘‘Hazardous 

Materials Program Procedures,’’ unless 

exempted under subpart B of 49 CFR 

part 107; 

(5) Tamper-resistant/tamper-evident 

casing: If the CCER is not designed for 

its casing to be opened prior to use for 

an actual escape (e.g., for maintenance, 

escape drills, or inspection of the 

components), the casing must include a 

component, an attribute, or other means 

to prevent a person from accidentally 

opening the casing and, upon such 

opening, to either prevent the casing 

from being closed or to clearly indicate 

to a potential user that the casing has 

been previously opened; and 

(6) Moisture damage indicators: If the 

CCER is not designed for its casing to be 

opened for inspection of its internal 

components, the casing must include a 

component, an attribute, or other means 

by which a person can detect any 

ingress of water or water vapor that 

could diminish the NIOSH-certified 

performance, as tested under this 

subpart. 

(7) Oxygen starter indicators: If the 

oxygen starter is a critical component of 

the CCER design, then the CCER must 

include a component, an attribute, or 

other means by which a person can 

detect observable damage, premature 

activation, or recognized potential 

defect of the starter. 

(b) Where an indicator is required, the 

indication of the occurrence of the 

monitored condition must be clear and 

unambiguous: It must not depend on a 

subjective interpretation of subtle, 

graduated, or other non-discrete changes 

to the indicator. 

(c) Where an indicator is required, the 

manufacturer shall provide NIOSH with 

an explanation of its function and 

operation, and shall provide relevant 

data and equipment to allow NIOSH to 

conduct a thorough evaluation of its 

accuracy and reliability. 

(d) The components of each CCER 

must meet the general construction 

requirements specified in § 84.61. 

(e) The CCER must be resistant to the 

permeation of the breathing circuit by 

gasoline vapors. To verify such 

resistance, NIOSH will test one unit by 

applying the gasoline vapor permeation 

test specified on the NIOSH Web site at 

http://www.cdc.gov/niosh/npptl, using a 

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breathing machine applying a 

ventilation rate of 40 liters per minute, 

performing the test for the longest 

duration achieved by any of the units 

that underwent the capacity testing 

specified under § 84.304. 

(f) Exposed parts of the CCER must 

not be composed of metals or other 

materials that could, upon impact, 

create frictional sparks or that could 

store or generate static electrical charges 

of sufficient energy to ignite flammable 

gaseous mixtures. 

(g) The design, construction, or 

materials of the CCER must not 

constitute a hazard to the user as a 

result of the wearing, inspection, or use 

of the CCER. 

(h) CCER instructions and a service 

life plan must be provided to 

purchasers. This document must be 

clearly written. 

(1) Instructions must address the 

following topics and elements: 

(i) An explanation of how the CCER 

works; 

(ii) A schematic diagram of the CCER; 

(iii) Procedures for donning and use; 

(iv) Procedures for inspecting the 

operating condition of the CCER; 

(v) Procedures and conditions for 

storage, including but not limited to any 

recommended minimum and maximum 

temperatures for storage; 

(vi) Limitations on use, including but 

not limited to any recommended 

minimum and maximum temperatures 

for use; 

(vii) Procedures for disposal; and 

(viii) Procedures for registration of the 

unit with NIOSH, pursuant to § 84.311. 

(2) The service life must be addressed 

covering at least the following topics: 

(i) The maximum number of years, 

from the date of manufacture, that the 

unit may remain available for use; this 

limit is intended to prevent the 

continued use of a unit that the 

applicant cannot assure would continue 

to perform as approved by NIOSH, due 

to reasonably foreseeable degradation of 

materials used in its construction; 

(ii) Any other conditions, other than 

that specified under paragraph (h)(2)(i) 

of this section, that should govern the 

removal from service of the CCER 

(including an indication given by the 

activation or operation of any required 

indicator showing the monitored 

condition has occurred); and 

(iii) Any procedures by which a user 

or others should inspect the CCER, 

perform any maintenance possible and 

necessary, and determine when the 

CCER should be removed from service. 

(i) Each individual CCER unit 

approval label shall identify the 

capacity rating and number of liters of 

oxygen as determined by the capacity 

testing, pursuant to § 84.304. 

§ 84.303 General testing conditions and 

requirements. 

(a) NIOSH will conduct capacity and 

performance tests on the CCER using a 

breathing and metabolic simulator to 

provide quantitative evaluations and 

human subjects on a treadmill to 

provide qualitative evaluations. 

Information on the design and operation 

of the simulator is available from the 

NIOSH Web site at http://www.cdc.gov/ 

niosh/npptl. Technical specifications 

can be obtained from NIOSH by 

contacting the National Personal 

Protective Technology Laboratory 

(NPPTL) by mail: P.O. Box 18070, 626 

Cochrans Mill Road, Pittsburgh, PA 

15236. Telephone: 412–386–4000 (this 

is not a toll-free number). Email: 

npptl@cdc.gov. 

(b) Capacity, performance, and 

wearability tests will continuously 

monitor the stressors listed in Table 1. 

The stressors and their respective 

acceptable ranges will be measured at 

the interface between the CCER and the 

mouth by instruments capable of breathby-breath measurement. Stressor 

measurements will be evaluated as 1- 

minute averages. The operating averages 

of each stressor will be calculated upon 

the completion of each test as the 

average of the 1-minute measurements 

of the stressor recorded during the test. 

The level of any excursion for a stressor 

occurring during a test will be defined 

by the 1-minute average value(s) of the 

excursion(s). 

TABLE 1—MONITORED STRESSORS AND THEIR ACCEPTABLE RANGES

Stressor Acceptable range operating average Acceptable range excursion 

Average inhaled CO2 ....................................................... <1.5% ............................................................................... ≤4%. 

Average inhaled O2 .......................................................... >19.5% ............................................................................. ≥15%. 

Peak Breathing Pressures ............................................... DP ≤ 200 mm H2O ........................................................... ¥300 ≤ DP ≤ 200 mm H2O. 

Wet-bulb temperature1 ..................................................... <43°C ............................................................................... ≤50°C. 

1Wet-bulb temperature is a measurement of the temperature of a wet surface. It represents the temperature of the inhaled breathing gas in the 

CCER user’s trachea. 

(c) Capacity and performance tests 

will conclude when the stored breathing 

gas supply has been fully expended. 

(d) NIOSH will determine a CCER to 

have failed a capacity, performance, or 

wearability test if any of the following 

occurs: 

(1) A 1-minute average measurement 

of any stressor listed in Table 1 occurs 

outside the acceptable excursion range 

specified in Table 1; or an average 

stressor measurement calculated at the 

completion of a performance or capacity 

test exceeds the acceptable operating 

average range specified in Table 1; or 

(2) A human subject cannot complete 

the test for any reason related to the 

CCER, as determined by NIOSH. 

(e) Unless otherwise stated, tests 

required under this subpart will be 

conducted at the following ambient 

conditions: 

(1) Ambient temperatures of 23 °C ± 

3 °C; and 

(2) Atmospheric pressures of 735 mm 

Hg ± 15 mm Hg. 

§ 84.304 Capacity test requirements. 

(a) NIOSH will conduct the capacity 

test on a total of 8 to 10 of the units 

submitted for approval, as follows: 

(1) Three units will be tested on a 

breathing and metabolic simulator in 

the condition in which they are received 

from the applicant; 

(2) Two units will be tested on a 

breathing and metabolic simulator after 

being subjected to the environmental 

treatments specified in § 84.307 of this 

subpart; 

(3) Two units will be tested on a 

breathing and metabolic simulator at the 

cold-temperature limit recommended by 

the manufacturer under § 84.302(h)(1), 

after the unit has been stored for a 

minimum of 24 hours at this limit; and 

(4) One unit, in the condition in 

which it is received from the applicant, 

will be tested by a human subject on a 

treadmill. 

(5) To approve a CCER for use in coal 

mines, two units will also be tested by 

a human subject under the 

specifications of §§ 84.99 and 84.100 

that are applicable to man test 4. 

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1This time limit does not apply to any additional 

steps that might be required after the lungs are 

protected to adjust the unit for wear. 

(b) The capacity test will begin upon 

the first inhalation from or exhalation 

into the unit. 

(c) Each unit will be tested at a 

constant work rate, depending on the 

capacity value specified by the 

manufacturer, according to the 

requirements specified in Table 2. All 

volumes are given at standard 

temperature (0 ßC) and pressure (760 

mm Hg), dry, unless otherwise noted. 

(d) NIOSH will rate an approved 

CCER using the appropriate capacity 

rating, as specified in Table 2. 

TABLE 2—CAPACITY TEST REQUIREMENTS

Capacity rating Capacity 

(L of O2) 

VO2

(L/min) 

VCO2

(L/min) 

Ve 

(L/min) 

RF 

(Breaths/ 

min) 

Cap 1 ........................................................ 20 ≤ L ≤ 59 ............................................... 2.50 2.50 55 22 

Cap 2 ........................................................ 60 ≤ L ≤ 79 ............................................... 2.00 1.80 44 20 

Cap 3 ........................................................ L ≥ 80 ....................................................... 1.35 1.15 30 18 

VO2 = volume of oxygen consumed per minute; VCO 2 = volume of carbon dioxide produced per minute. 

Ve = ventilation rate in liters of air per minute; RF = respiratory frequency. 

(e) NIOSH will document the least 

value achieved by the seven units tested 

using the breathing and metabolic 

simulator. NIOSH will quantify this 

value of achieved capacity within an 

increment of 5 liters, rounding 

intermediate values to the nearest lower 

5-liter increment. 

§ 84.305 Performance test requirements. 

(a) NIOSH will conduct the 

performance test on a total of six of the 

units submitted for approval, as follows: 

(1) Three units will be tested on a 

breathing and metabolic simulator in 

the condition in which they were 

received from the applicant; and 

(2) Two units will be tested on a 

breathing and metabolic simulator after 

being subjected to the environmental 

treatments specified in § 84.307; and 

(3) One unit will be tested, in the 

condition in which it was received from 

the applicant, by a human subject on a 

treadmill. 

(b) Except as provided under 

paragraph (c) of this section, the 

performance test will apply a repeating 

cycle of work rates, according to the 

sequence and requirements specified in 

Table 3, until the oxygen supply of the 

unit is exhausted. 

(c) Testing of CCERs with less than 50 

liters of capacity, as determined by the 

capacity testing under § 84.304, will 

require the submission of additional test 

units to fully apply the work-rate test 

sequence and requirements specified in 

Table 3. The testing of each individual 

unit will complete the cycle specified in 

Table 3 until the breathing supply of the 

initial test unit is exhausted. This initial 

test unit will then be replaced by a 

second unit, which will continue the 

test cycle, beginning at the work rate in 

the cycle at which the initial unit was 

exhausted, and completing the full 

period specified in Table 3 for that work 

rate before proceeding to the subsequent 

work rate, if any, specified in Table 3. 

Each initial testing unit will be replaced 

as many times as necessary to complete 

the cycle, not to exceed two 

replacement units per initial test unit. 

(d) The performance test will begin 

with two exhalations into the unit at the 

specified ventilation rate and then 

follow the manufacturer’s instructions 

to determine the design’s susceptibility 

to hypoxia upon initial donning. 

TABLE 3—PERFORMANCE TEST REQUIREMENTS

Work-rate 

test sequence 

Duration per 

cycle (in 

minutes) 

VO2 (L/min) VCO2 (L/ 

min) Ve (L/min) RF (breaths/ min) 

1. Peak ..................................................................................................... 5 3.00 3.20 65.0 25

2. High ..................................................................................................... 15 2.00 1.80 44.0 20 

3. Low ...................................................................................................... 10 0.50 0.40 20.0 12 

VO2 = volume of oxygen consumed per minute; VCO2 = volume of carbon dioxide produced per minute. 

Ve = ventilation rate in liters of air per minute; RF = respiratory frequency. 

§ 84.306 Wearability test requirements. 

(a) NIOSH will conduct the 

wearability test on a total of three of the 

units submitted for approval. Three 

human subjects (two males and one 

female), one subject per unit, will 

conduct the test. The three subjects will 

range in height and weight as follows: 

One subject of height ≥174 cm and 

weight ≥90 kg; one subject of either 163 

cm ≤ height <174 cm, regardless of 

weight, or 72 kg ≥ weight <90 kg, 

regardless of height; and one subject of 

height <163 cm and weight <72 kg. All 

units tested must meet all conditions 

specified in this section to receive 

approval. 

(b) NIOSH will evaluate the ease and 

speed with which users can don the 

CCER, as follows: 

(1) Each test subject will be provided 

with manufacturer instructions, and 

must be able to don the CCER correctly, 

isolating the lungs within 30 seconds; 1

and 

(2) A CCER must not include any 

design, construction, or material 

characteristic that can be anticipated or 

demonstrated, under plausible 

conditions, to hinder the user in the 

correct and timely donning of the CCER. 

(c) NIOSH will continuously monitor 

CCER use by each test subject during the 

activities specified in Table 4 to 

evaluate the ability of the CCER to 

provide an adequate and uninterrupted 

breathing supply, including but not 

limited to the requirements of 

§ 84.303(b), without harming or 

hindering a user. NIOSH will not 

approve a CCER if the use of any unit 

during these activities indicates any 

potential for the CCER to harm or hinder 

the user or to fail to provide an adequate 

and uninterrupted breathing supply to 

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the user during reasonably anticipated 

conditions and activities of an escape. 

TABLE 4—WEARABILITY TEST REQUIREMENTS

Activity Minimum duration 

Sitting ................................................................................................................................................................ 1 minute. 

Stooped walking ................................................................................................................................................ 1 minute. 

Crawling ............................................................................................................................................................ 1 minute. 

Lying on left side ............................................................................................................................................... 1 minute. 

Lying on right side ............................................................................................................................................. 1 minute. 

Lying on back .................................................................................................................................................... 1 minute. 

Bending over to touch toes ............................................................................................................................... 1 minute. 

Turning head from side to side ......................................................................................................................... 1 minute (at least 10 times). 

Nodding head up and down .............................................................................................................................. 1 minute (at least 10 times). 

Climbing steps or a laddermill .......................................................................................................................... 1 minute (1 step/second). 

Carrying 50-lb bag on treadmill at 5 kph .......................................................................................................... 1 minute. 

Lifting 20-lb weight from floor to an upright position ........................................................................................ 1 minute (at least 10 times). 

Running on treadmill at 10 kph ......................................................................................................................... 1 minute. 

§ 84.307 Environmental treatments. 

(a) Four units submitted for approval 

will be tested for capacity and 

performance, pursuant to the 

requirements of §§ 84.303 through 

84.305, after exposure to environmental 

treatments simulating extreme storage 

temperatures, shock, and vibration. 

(b) The units will be stored for 16 

hours at a temperature of ¥45 °C and 

for 48 hours at a temperature of 71 °C. 

Units will be returned to room 

temperature between high and low 

temperature treatments. The maximum 

rate of change for thermal loading shall 

not exceed 3 °C per minute and constant 

temperatures shall be maintained within 

±2 °C. 

(c) The units, in the casing in which 

they are deployed for individual use, 

will be subjected to physical shock 

according to the following procedure: 

(1) The unit will be dropped six times 

from a height of 1 meter onto a concrete 

surface; and 

(2) Each drop will test a different 

orientation of the unit, with two drops 

along each of its three major axes (top 

to bottom, left to right, and front to 

back). 

(d) The units will be subjected to 

vibration according to the following 

procedure: 

(1) The unit will be firmly secured to 

a shaker table, which will be vibrated 

with motion applied along a single axis 

for 180 minutes; 

(2) The unit will be vibrated one axis 

at a time along each of three axes for a 

total of 9 hours; and 

(3) The vibration frequency regimen 

applied to each axis will be cyclical, 

repeating the sequence and 

specifications provided in Table 5 every 

20 minutes. 

TABLE 5—VIBRATION TEST SEQUENCE

Sequence Frequency 

(Hertz) 

Acceleration 

g (± peak) 

1 ........................ 5–92 2.5 

2 ........................ 92–500 3.5 

3 ........................ 500–2000 1.5 

§ 84.308 Additional testing. 

(a) NIOSH will conduct additional 

tests, as indicated below, on one or 

more of the units submitted for 

approval. Each unit tested must meet 

the conditions specified in these tests 

for the CCER to receive approval. 

(b) NIOSH will perform safety hazard 

tests on any CCER that stores more than 

200 liters of oxygen or that stores 

compressed oxygen at pressures 

exceeding 3,000 psi. The applicant must 

submit 15 units in addition to the 21– 

23 units required for testing under 

§§ 84.304 through 84.307. These units 

will be evaluated for fire and explosion 

hazards using the tests specified in RI 

9333, pages 4–18; RI 8890, pages 6–62; 

and PRC Report No. 4294, pages 18–62. 

(c) NIOSH will perform the following 

tests on the eye protection (gas-tight 

goggles or escape hood lens) of one or 

more units of every CCER submitted for 

approval: 

(1) NIOSH will test the effectiveness 

of the eye protection against dust using 

the method specified in ISO 4855– 

1981(E) Clause 13, Test for protection 

against dust. The result will be 

satisfactory if the reflectance after the 

test is equal to or greater than 80 percent 

of its value before testing. 

(2) NIOSH will test the effectiveness 

of the eye protection against gas using 

the method specified in ISO 4855– 

1981(E), Clause 14, Test for protection 

against gas. The test must not result in 

staining of the area enclosed by the eye 

protection. 

(3) NIOSH will test the durability of 

the eye protection using the method 

specified in International Standard ISO 

4855–1981(E), Sub-clause 3.1, 

Unmounted oculars. The lens shall not 

crack or fracture as a result of the test. 

(4) NIOSH will test the eye 

protection’s resistance to fogging in 

accordance with the method specified 

in BS EN 168:2002, Clause 16, Test for 

resistance to fogging of oculars. The lens 

shall remain free from fogging for a 

minimum of 8 seconds, pursuant to 

Clause 16. 

(d) The standards required in this 

section are incorporated by reference 

into this section with the approval of 

the Director of the Federal Register 

under 5 U.S.C. 552(a) and 1 CFR Part 51. 

All approved material is available for 

inspection at NIOSH, National Personal 

Protection Technology Laboratory 

(NPPTL), Bruceton Research Center, 626 

Cochrans Mill Road, Pittsburgh, PA 

15236. To arrange for an inspection at 

NIOSH, call 412–386–6111. Copies are 

also available for inspection at the 

National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030 or 

go to http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(1) British Standards Institute, 389 

Chiswick High Road, London W4 4AL, 

UK, http://www.bsigroup.com/en/ 

Standards-and-Publications: 

(i) BS EN 168:2002, Personal Eye 

Protectors—Non-Optical Test Methods, 

November 2001. 

(ii) [Reserved] 

(2) International Organization for 

Standardization, 1, ch. de la VoieCreuse, Case postale 56, CH–1211 

Geneva 20, Switzerland, http:// 

www.iso.org/iso/store.htm: 

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Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Rules and Regulations 14197 

(i) ISO 4855–1981(E), Personal Eye 

Protectors—Non-Optical Test Methods, 

First edition April 1, 1981. 

(ii) [Reserved] 

(3) U.S. Department of the Interior, 

Bureau of Mines, 2401 E Street, NW., 

MS #9800, Washington, DC 20241– 

0001. These reports are also available 

from NIOSH upon request 1–800–CDC– 

INFO (232–4636). 

(i) Pittsburgh Research Center (PRC) 

Report No. 4294, Evaluation of the 

Safety of One-Hour Chemical Self 

Rescuers, July 1980; 

(ii) Report of Investigations (RI) 8890, 

Evaluation of the Safety of One-Hour 

Compressed Oxygen Self-Rescuers— 

Results of Destructive Testing, 1984; 

(iii) RI 9333 Evaluation of the Safety 

of the CSE SR–100 Self-Contained SelfRescuer, 1991. 

§ 84.309 Additional testing and 

requirements for dockable CCERs. 

(a) NIOSH will conduct additional 

testing of the CCERs that are designed 

to allow the user to resupply the oxygen 

source and the carbon dioxide scrubber 

while using the respirator during an 

escape. 

(1) NIOSH will test the docking 

mechanism and procedure to ensure 

that they maintain the integrity of the 

breathing circuit (against the intake of 

hazardous fumes or gases) and the 

continuity of the breathing gas supply 

throughout the docking process. 

(2) NIOSH will test the docking 

mechanism and procedure to ensure 

that users can employ the docking 

process reliably, safely, and quickly 

under escape conditions. 

(b) NIOSH will designate CCERs that 

pass the tests specified in this section as 

‘‘Dockable.’’ 

(c) NIOSH will assign the capacity 

rating to the dockable CCER, as 

specified under § 84.304(d), by 

conducting the capacity testing using 

only the breathing gas supply included 

for the initial use of the wearable 

apparatus. 

(d) NIOSH will test the supplemental 

capacities of all breathing gas resupply 

units produced by the manufacturer for 

use with the dockable CCER. Such tests 

will follow procedures consistent with 

those specified under § 84.304, 

including the rating requirements in 

§ 84.304(d). The manufacturer must 

label the breathing gas resupply unit to 

indicate its capacity as tested by NIOSH 

and its compatibility with the CCER for 

which it is designed. 

(e) NIOSH may require the applicant 

to provide additional units of the CCER 

and breathing gas resupply units to 

conduct the testing specified in this 

section. 

(f) NIOSH will not approve a CCER 

with docking components, with or 

without the ‘‘Dockable’’ NIOSH 

designation, unless it satisfies the 

testing and other requirements of this 

section. 

§ 84.310 Post-approval testing. 

(a) NIOSH will periodically test the 

capacity and performance of units of 

approved CCERs. 

(b) NIOSH may test units that are new 

and/or units that have been deployed in 

the field and have remaining service 

life. 

(c) NIOSH will conduct such testing 

pursuant to the methods specified in 

§§ 84.303 through 84.305, except as 

provided under paragraph (d) of this 

section. 

(d) The numbers of units of an 

approved CCER to be tested under this 

section may exceed the numbers of 

units specified for testing in §§ 84.304 

and 84.305. 

(e) Failure of a unit to meet the 

capacity and performance requirements 

of this section may result in revocation 

of the approval for the CCER or in 

requirements for specific remedial 

actions to address the cause or causes of 

the failure. 

(f) NIOSH will replace deployed units 

obtained for testing with new NIOSHapproved units of the same or similar 

design, at no cost to the employer. 

(g) To maintain the approved status of 

a CCER, an applicant must make 

available for purchase by NIOSH, within 

3 months of a NIOSH purchase request, 

the number of units requested by the 

Institute. Within any 12-month period, 

NIOSH will not request to purchase 

more than 100 units for post-approval 

testing. 

§ 84.311 Registration of CCER units upon 

purchase. 

(a) The user instructions will include 

a copy of procedures for registering the 

units with NIOSH. The applicant can 

obtain a copy of these procedures from 

the NIOSH web page: http:// 

www.cdc.gov/niosh/npptl. 

(b) The applicant shall notify in 

writing each purchaser of the purpose of 

registering a unit with NIOSH, as 

specified under paragraph (c) of this 

section. If the purchaser is a distributor 

of the CCER, the applicant must request 

in writing that the distributor 

voluntarily notify in writing each of its 

purchasers of the purpose of registering 

a unit with NIOSH, as specified under 

paragraph (c) of this section. 

(c) ‘‘The National Institute for 

Occupational Safety and Health 

(NIOSH) requests, but does not require, 

that purchasers of this respirator register 

each unit with NIOSH. Registration will 

enable NIOSH, which approved this 

model of respirator, to attempt to notify 

you if a problem is discovered that 

might affect the safety or performance of 

this respirator. Registration will also 

assist NIOSH in locating deployed units 

to periodically evaluate whether this 

respirator model is remaining effective 

under field conditions of storage and 

use.’’ 

Dated: October 11, 2011. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2012–4691 Filed 3–7–12; 8:45 am] 

BILLING CODE 4163–18–P 

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