2618 Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Rules and Regulations 

therefore it is categorically excluded 

from further review under paragraph 

34(g) of Figure 2–1 of the Commandant 

Instruction. An environmental analysis 

checklist supporting this determination 

and a Categorical Exclusion 

Determination are available in the 

docket where indicated under 

ADDRESSES. We seek any comments or 

information that may lead to the 

discovery of a significant environmental 

impact from this rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 46 U.S.C. 

Chapters 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1. 

■ 2. Add § 165.T09–1099 to read as 

follows: 

§ 165.T09–1099 Safety Zone; Bridge 

Demolition Project, Indiana Harbor Canal, 

East Chicago, Indiana. 

(a) Location. The safety zone will 

encompass all waters of the Indiana 

Harbor Canal in the vicinity of the Cline 

Avenue Bridge at approximate position 

41°39′4.3′′ N and 87°27′54.3′′ W (NAD 

83). 

(b) Effective and Enforcement Period. 

This rule is effective from 12:00 p.m. on 

January 1, 2013 until 12:00 a.m. on 

February 1, 2013. The Captain of the 

Port, Sector Lake Michigan, will 

establish enforcement dates that will be 

announced with a Notice of 

Enforcement and marine information 

broadcasts. 

(c) Regulations. 

(1) In accordance with the general 

regulations in section 165.23 of this 

part, entry into, transiting, or anchoring 

within this safety zone is prohibited 

unless authorized by the Captain of the 

Port, Sector Lake Michigan or his 

designated on-scene representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the Captain of the Port, 

Sector Lake Michigan or his designated 

on-scene representative. 

(3) The ‘‘on-scene representative’’ of 

the Captain of the Port, Sector Lake 

Michigan is any Coast Guard 

commissioned, warrant or petty officer 

who has been designated by the Captain 

of the Port, Sector Lake Michigan to act 

on his behalf. 

(4) Vessel operators desiring to enter 

or operate within the safety zone shall 

contact the Captain of the Port, Sector 

Lake Michigan or his on-scene 

representative to obtain permission to 

do so. The Captain of the Port, Sector 

Lake Michigan or his on-scene 

representative may be contacted via 

VHF Channel 16. Vessel operators given 

permission to enter or operate in the 

safety zone must comply with all 

directions given to them by the Captain 

of the Port, Sector Lake Michigan, or his 

on-scene representative. 

Dated: December 28, 2012. 

J.W. Davenport, 

Commander, U.S. Coast Guard, Acting 

Captain of the Port, Sector Lake Michigan. 

[FR Doc. 2013–00514 Filed 1–11–13; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 84 

[Docket No. CDC–2012–0009; NIOSH–258] 

RIN 0920–AA38 

Self-Contained Breathing Apparatus 

Remaining Service-Life Indicator 

Performance Requirements 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Final rule. 

SUMMARY: On June 25, 2012, the 

Department of Health and Human 

Services (HHS) published a notice of 

proposed rulemaking proposing to 

update respirator approval standards in 

response to a petition to amend our 

regulations, current requirements for 

self-contained breathing apparatus 

(SCBA) remaining service-life indicators 

or warning devices. These indicators are 

built into a respirator to alert the user 

that the breathing air provided by the 

respirator is close to depletion. In this 

final rule, HHS responds to public 

comment on the proposed rule and 

revises the current standard, employed 

by the National Institute for 

Occupational Safety and Health 

(NIOSH) located within the Centers for 

Disease Control and Prevention (CDC), 

to allow greater flexibility in the setting 

of the indicator alarm to ensure that the 

alarm more effectively meets the 

different worker protection needs of 

different work operations. This final 

rule sets a minimum alarm point at 25 

percent of the rated service time and 

allows the manufacturer to offer 

remaining service life set point at a 

higher value or values appropriate to the 

purchaser’s use scenario. 

DATES: This final rule is effective 

February 13, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Szalajda, 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 tollfree number). 

SUPPLEMENTARY INFORMATION: The 

preamble to this final rule is organized 

as follows: 

I. Public Participation 

II. Background 

III. Summary of Final Rule and Response to 

Public Comments 

IV. Regulatory Assessment Requirements 

A. Executive Orders 12866 and 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

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 Writing Act of 2010 

V. Final Rule 

I. Public Participation 

Interested persons or organizations 

were invited to participate in this 

rulemaking by submitting written views, 

arguments, recommendations, and data. 

Comments were invited on any topic 

related to this proposal, but comments 

were specifically solicited regarding 

whether: (1) 25 percent of the rated 

service time of the respirator is an 

appropriate default setting for the 

indicator to alarm; (2) the rule should 

specify an upper limit that would 

require that the indicator be set to alarm 

no earlier than a set amount, such as 50 

percent of rated service time; and (3) 

there are possible emergency or rescue 

scenarios for which one would want an 

indicator to alarm at 50 percent or more 

of the rated service time? 

HHS received 8 submissions from the 

public in response to this rulemaking. 

Commenters represented local fire 

departments, manufacturers of selfcontained breathing apparatus (SCBA) 

used in the fire service, and a 

firefighters’ union. A summary of 

comments and the HHS response are 

found in Section III, below. 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Rules and Regulations 2619 

1National Institute for Occupational Safety and 

Health, National Personal Protective Technology 

Laboratory, transcript of public meeting held 

December 2, 2008. Available at http://www.cdc.gov/ 

niosh/docket/archive/pdfs/NIOSH-034-A/0034-A120208-Transcript.pdf. Last accessed October 25, 

2011. 

2The official transcript of this meeting as well as 

public comments are available on NIOSH Docket 

34–A (See http://www.cdc.gov/niosh/docket/ 

archive/docket034A.html). NIOSH had previously 

collected public comments on remaining servicelife indicators in 2004 (See NIOSH Docket 34, 

http://www.cdc.gov/niosh/docket/archive/ 

docket034.html). 

3NFPA 1981: Standard on open-circuit selfcontained breathing apparatus (SCBA) for 

emergency services, Chapter 4. 2007 Edition. 

II. Background 

In 2003, NIOSH received a petition 

from David Bernzweig of the Columbus 

(OH) Professional Firefighters 

International Association of Fire 

Fighters (IAFF) Local 67 requesting that 

the agency initiate rulemaking to amend 

42 CFR 84.83(f).1 The current rule 

requires that the self-contained 

breathing apparatus (SCBA) service-life 

indicator (also known in the firefighter 

community as an end-of-service-time 

indicator (EOSTI), or a low-air alarm) 

give an alarm within the 20 to 25 

percent range. Stakeholders in 

agreement with Mr. Bernzweig 

requested that HHS eliminate the lower 

value (20 percent) and require the 

indicator to alarm no later than at 25 

percent of rated service time. NIOSH 

considered the request and facilitated 

discussion among stakeholders by 

holding a public meeting to discuss 

underlying issues and technical matters 

on December 2, 2008, in Pittsburgh, 

Pennsylvania (73 FR 65860, November 

5, 2008).2

The National Fire Protection 

Association (NFPA), which sets 

standards for personal protective 

equipment used in the fire service, 

initiated an effort in 2008 to develop 

consensus on the matter and recently 

decided to amend NFPA 1981: Standard 

on Open-Circuit Self-Contained 

Breathing Apparatus (SCBA) for 

Emergency Services 3 to require that the 

indicator alarm at 33 percent. 

For reasons discussed in the notice of 

proposed rulemaking published in the 

Federal Register on June 25, 2012 (77 

FR 37862), HHS finds that amending 

§ 84.83(f) to allow greater latitude with 

regard to setting the indicator alarm 

would not reduce the amount of 

protection afforded to firefighters and 

other SCBA users. In fact, HHS has 

determined that specifying a minimum 

setting of 25 percent and allowing 

manufacturers to offer different alarm 

settings more suited to purchasers’ use 

scenarios will result in a more 

meaningful alarm that may offer greater 

protection for users. 

III. Summary of Final Rule and 

Response to Public Comments 

The amendment to 42 CFR 84.83(f) 

establishes that the low-air indicator 

must activate at a minimum setting of 

25 percent of the SCBA’s rated service 

time. If a purchaser has determined that 

an earlier alarm will benefit the specific 

occupational purpose for which the 

respirator is to be used, the purchaser 

may request that the manufacturer offer 

a remaining service-life indicator alarm 

set-point at a higher value (or values) 

appropriate to the purchaser’s use 

scenario. If the manufacturer chooses to 

offer a respirator with a different setpoint (at no less than 25 percent of the 

SCBA’s rated service time), the modified 

respirator must be approved by NIOSH. 

Purchasers may also have the indicator 

setting modified for already fielded 

SCBA units by an authorized 

representative of the manufacturer, 

provided that the respirator model has 

received a new NIOSH approval 

specifying the new alarm set-point. 

The final rule also codifies a longstanding NIOSH policy requiring the 

indicator for demand and pressuredemand open-circuit (OC)SCBA to 

alarm continuously until the respirator’s 

breathing air supply is depleted. 

Changes to the proposed rule text are 

made in response to public comment, to 

clarify our overall intent; to specify that 

the requirement for continuous alarming 

is intended for open-circuit, demand 

and pressure demand units only; and to 

require that manufacturers identify the 

indicator setting on each unit. Specific 

comments and responses are discussed 

below. The rule text is also amended 

slightly to better comply with Federal 

plain language requirements. 

Comment: Two commenters were 

fully supportive of the rulemaking. One 

commenter stated that requiring fire 

service respirators to alarm when 

breathing air reaches 25 percent ‘‘does 

not serve the needs or interests of 

today’s fire service.’’ According to the 

commenter, ‘‘[t]here is no safety 

purpose served by not allowing an 

earlier set point for the EOSTI. An 

earlier set point would allow for a 

greater margin of safety for the end user. 

Not having an earlier set point would 

continue to place firefighters at risk by 

not having an adequate air reserve when 

the EOSTI activates.’’ The commenter 

further agreed that the alarm should not 

be field-adjustable and that purchasers 

should be able to specify the setting at 

the time of purchase or service. 

HHS response: We thank these 

commenters for their response. 

Comment: We received two comments 

that appeared to confuse the standard 

proposed by HHS (a default of 25 

percent unless the purchaser requests a 

different, higher, value) with the 

standard being developed by NFPA 

(alarm activation at 33 percent). One 

commenter expressed approval for 

giving purchasers the ability to set the 

remaining service-life indicator alarm 

between 33 percent and 50 percent. The 

other commenter expressed disapproval 

for changing the indicator to activate at 

33 percent rather than 25 percent. 

HHS response: The amended standard 

is responsive to the various concerns. 

Manufacturers are not required to 

modify existing approvals to comply 

with this rule; they may continue to 

market and sell respirators approved 

under the current standard, indefinitely. 

If, in response to purchaser needs, the 

manufacturer chooses to market and sell 

respirators that activate at the 25 

percent minimum requirement or 

earlier, the manufacturer must obtain a 

new or revised NIOSH approval. 

Comment: One commenter supported 

the inclusion of a 50 percent upper limit 

for the alarm set-point; other 

commenters neither supported nor 

opposed the upper limit. 

HHS response: We did not receive 

justification for applying a 50 percent 

upper limit. It is conceivable that some 

use scenarios might warrant an earlier 

alarm point. Accordingly, we have not 

revised the proposal in response to the 

comment. 

Comment: One commenter suggested 

that allowing individual fire 

departments to determine their own 

remaining service-life indicator setting 

may cause ‘‘incident related’’ problems. 

The commenter further stated that there 

was no discussion in the notice of 

proposed rulemaking about the use of 

the heads-up-display for monitoring 

breathing air depletion or the reliance 

on teamwork to maintain situational 

awareness. 

HHS response: This comment raises 

training issues regarding the users’ 

response to an alarm being activated. 

We understand that a change in the 

mechanical alarm setting may 

necessitate a change in training 

protocols. However, training for the 

proper use of these respirators is outside 

the scope of this rulemaking. 

Comment: One commenter agreed 

with the intent of the proposed rule text 

but suggested a number of edits. The 

commenter stated that the proposed rule 

text did not account for the distinction 

between respirator models whose 

alarms are designed either to activate 

electronically or activate using the 

device’s compressed air. According to 


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2620 Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Rules and Regulations 

the commenter, ‘‘[i]f the EOSTI is 

activated electrically then the alarm can 

sound continuously until the depletion 

of the breathing air supply. If the EOSTI 

is activated using the compressed air in 

the system then at some point the alarm 

sound will decrease in decibels and 

even cease to sound before the breathing 

air is depleted.’’ The commenter 

suggested adding the text ‘‘if electrically 

controlled or to a pressure of 10 bar (145 

psi) if operated by the compressed air in 

the system’’ to the text in § 84.83(f). 

HHS response: The purpose of the 

alarm is to advise the user that the 

system is depleting its air supply. While 

the rule text does not specifically 

identify models that alarm either 

electronically or using compressed air, 

we intend for the indicator to alarm 

until the air supply runs out in order to 

warn the user of the situation so they 

can take appropriate action for their 

setting. That the indicator may not 

continue to alarm until the air supply is 

absolutely depleted is understood and is 

evaluated in NIOSH testing (see NIOSH 

standard testing procedure RCT–ASR– 

STP–0124, Determination of Remaining 

Service-Life Indicator—Open-Circuit, 

Demand and Pressure-Demand, SelfContained Breathing Apparatus, at 

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

pdfs/RCT-ASR-0124.pdf, which will be 

updated to comport with this 

rulemaking). 

Comment: Another comment referred 

to long duration closed-circuit breathing 

apparatus (CCBA), which are also 

regulated under Subpart H in Part 84. 

The commenter stated that ‘‘it can be 

interpreted that even long duration 

CCBA would also need to meet the 

proposed new requirements. For 

example, this would require that a 

CCBA with a rated service time of 4 

hours would need to have the EOSTI 

alarm continuously for 1 hour and this 

would be annoying to the users and may 

affect their activities in a negative 

manner.’’ The commenter accordingly 

suggested that the text in § 84.83(f) 

should address only open-circuit 

devices, and offers a new § 84.83(g) 

which suggests that, for closed-circuit 

devices, the indicator should alarm for 

a limited time period when the reserve 

capacity of the apparatus is reached, 

and a continuous alarm when a 

prescribed pressure is reached. 

HHS response: HHS did not intend for 

the continuous alarm requirement to 

pertain to long-duration closed-circuit 

devices. However, the open-circuit 

demand and pressure-demand devices 

are expected to alarm continuously once 

activated. Accordingly, we have 

amended the final rule text to require 

that only open-circuit demand and 

pressure-demand (as described in 42 

CFR 84.70(a)(2)(i) and 42 CFR 

84.70(a)(2)(ii)) respirators need to alarm 

continuously. 

Comment: One commenter suggested 

that only purchasers who are required 

by a third-party standard to request an 

alarm set-point other than the default 25 

percent be allowed to request a different 

alarm setting. 

HHS response: We do not agree that 

the 25 percent default value should only 

be raised when prescribed by a third 

party standard. While § 84.83(f) is 

amended in response to a petition on 

behalf of the U.S. fire service, we note 

that OC–SCBAs are used by industries 

and in occupational settings other than 

firefighting. We intend to maintain 

flexibility with regard to the alarm 

setting requirement to avoid further 

limitations on the ability of purchasers 

to request an alarm set-point 

appropriate to their use scenarios and 

the ability of manufacturers to offer 

such respirators. 

Comment: One commenter stated that 

the terms ‘default’ and ‘adjusted’ used 

in the rule summary are vague and 

‘‘cause policy or test requirement 

issues.’’ The commenter recommended 

that the word ‘default’ be removed 

because it ‘‘implies the product must 

meet the minimum setting and shall be 

capable of fulfilling a higher setting. We 

believe this is not the intent of the 

proposed changes and can lead to 

unnecessarily design-restrictive 

interpretations.’’ The commenter 

requested that, in addition to adjustable 

designs, the rule should ‘‘allow 

flexibility to permit others such as 

dedicated set point designs.’’ The 

commenter suggested that the rule text 

should be modified to state: ‘‘Each 

remaining service-life indicator or 

warning device shall give an alarm 

when the remaining service life of the 

apparatus is reduced to the 

manufacturers’ specified range and shall 

alarm continuously until the breathing 

air supply approaches depletion. The 

manufacturer can specify either a set 

point of 25 or 33 percent of its rated 

service time in response to the user’s 

specific request.’’ 

HHS response: The terms ‘default’ 

and ‘adjusted’ do not occur in the rule 

text; however, HHS does intend for the 

product to be able to meet the 25 

percent value as the minimum setting 

and/or any higher setting requested by 

the purchaser. During performance 

testing for approval, NIOSH will test the 

alarm setting identified by the 

manufacturer in its request for approval 

of the respirator system. If the 

manufacturer does not identify an alarm 

setting, the indicator will be tested to 

show that it activates at the value of 25 

percent of its rated service life. 

The rule does not specify or restrict 

how manufacturers must comply with 

its provisions; manufacturers who find 

it in their best interest may offer specific 

set-points. Manufacturers are not 

required to produce a device that is 

adjustable to different users’ needs, and 

can continue to market and sell SCBA 

models approved by NIOSH prior to the 

effective date of this rule. However, 

should the manufacturer wish to modify 

such a model for any reason, including 

a change to their service-life indicator 

set point, the manufacturer is required 

to apply to NIOSH for a new approval. 

Additionally, in evaluating this 

comment, HHS determined that the user 

should be able to readily identify a 

respirator’s alarm setting to distinguish 

models from one another. Models that 

meet the revised performance 

requirements of this rule should have 

labels and/or markings that identify the 

alarm setting for that particular model. 

At the discretion of the manufacturer, 

these markings could be addressed as 

part of the cautions and limitations 

associated with these devices, or as an 

additional label. In accordance with this 

determination, the final rule text is 

amended to address labels and/or 

markings. 

Comment: One commenter 

recommended that 42 CFR 84.82 

‘‘include an additional section for a 33 

percent’’ remaining service-life 

indicator. According to the commenter, 

‘‘[a]llowing manufacturers the ability to 

utilize the same gauge for both alarm set 

points will reduce cost and complexity 

within the market.’’ 

HHS response: HHS has determined 

that the provisions in 42 CFR 84.82 are 

sufficiently flexible to allow 

manufacturers to produce gauges that 

accurately indicate the amount of 

breathing air contained in a unit. 

Comment: HHS received one 

comment on the E.O. 12866 and E.O. 

13563 analysis in Section IV.A., below. 

According to the commenter, ‘‘[i]t is 

important to realize that additional costs 

for multiple or adjustable set points are 

inevitable. In addition to added design 

and documentation costs, options 

introduced into production will 

increase assembly and inspection times. 

Inventory costs increase with optional 

material warehousing.* * *. While they 

may be independent, other pressure 

gauges and electronic systems must be 

designed to correlate with the RSLI and 

the system(s) must be thoroughly 

verified. Differing RSLI settings may 

require differing gauge faces and 

electronics/programming designs to 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Rules and Regulations 2621 

maintain correlation. For all these 

reasons, costs will increase.’’ 

HHS response: The commenter 

misunderstands the requirement. HHS 

does not require manufacturers to 

produce products with new features 

allowing for adjustment of the service 

life indicator alarm set point, or for 

various product models with different 

set points. Any manufacturer can 

choose to meet product demand by 

either manufacturing products with 

fixed set points or by manufacturing 

products with manufacturer-adjustable 

set points. Alternatively, the 

manufacturer can choose to take no 

action, and continue to sell respirators 

under existing NIOSH approvals. HHS 

is reducing the longstanding constraint 

on these product designs for a single 

alarm set point. Accordingly, we 

continue to conclude that there are no 

costs associated with this rulemaking, 

and solely benefits in terms of greater 

flexibility for manufacturers to meet the 

diverse needs of their customers. 

IV. Regulatory Assessment 

Requirements 

A. Executive Orders 12866 and 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). 

This final rule is not being treated as 

a ‘‘significant’’ action under E.O. 12866. 

It modifies the settings for an indicator 

required by current regulation, as well 

as codifies a long-standing policy of 

requiring that the OC demand and 

pressure demand SCBA indicator alarm 

continuously once it has begun. The 

current rule requires that a remaining 

service-life indicator activate when the 

breathing air provided by an OC 

demand and pressure demand SCBA 

reaches between 20 and 25 percent of its 

rated limit. The final rule replaces the 

range with a default value of 25 percent, 

and allows manufacturers to offer 

indicator set-point values at a higher 

limit than 25 percent of remaining 

breathing air. 

All approved OC demand and 

pressure demand SCBA models have a 

remaining service-life indicator for 

which alarm limits are set during 

manufacturing. Allowing respirator 

manufacturers to offer a respirator with 

an earlier activation set-point value will 

ensure that the alarm more effectively 

meets the varying worker protection 

needs of different work operations. 

Although HHS determined that there 

are no costs and only benefits associated 

with this rulemaking, we received one 

comment on this economic analysis, 

summarized above. As discussed above, 

HHS continues to conclude that there 

are no costs associated with this 

rulemaking, and solely benefits in terms 

of greater flexibility for manufacturers to 

meet the diverse needs of their 

customers. 

The rule does not interfere with State, 

local, or tribal governments in the 

exercise of their governmental 

functions. 

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. As discussed 

above, all OC demand and pressuredemand SCBA models are equipped 

with a remaining service-life indicator 

that will not require additional 

expenditure of resources to set at the 

activation limit. This final rule allows 

small organizations such as local fire 

departments to request an earlier 

indicator activation set-point when 

purchasing new devices from the 

manufacturer. The Secretary of HHS has 

certified to the Chief Counsel, Office of 

Advocacy of the Small Business 

Administration, that this rule does not 

have a significant impact on a 

substantial number of small entities. 

Accordingly, no regulatory impact 

analysis is required. 

C. Paperwork Reduction Act of 1995 

The Paperwork Reduction Act (PRA), 

44 U.S.C. 3501 et seq., requires an 

agency to invite public comment on and 

to obtain OMB approval of any 

regulation that requires 10 or more 

people to report information to the 

agency or to keep certain records. This 

rule does not contain any information 

collection requirements; thus HHS has 

determined that the PRA does not apply 

to this rule. 

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 will 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 final rule 

does not include any Federal mandate 

that may result in increased annual 

expenditures in excess of $100 million 

by state, local or tribal governments in 

the aggregate, or by the private sector, 

adjusted annually for inflation. For 

2012, the inflation-adjusted threshold is 

$139 million. 

F. Executive Order 12988 (Civil Justice) 

This final rule has been drafted and 

reviewed in accordance with Executive 

Order 12988, Civil Justice Reform, and 

will not unduly burden the Federal 

court system. The amendment to an 

existing respirator approval standard 

will apply uniformly to all applicants. 

This final rule has been reviewed 

carefully to eliminate drafting errors and 

ambiguities. 

G. Executive Order 13132 (Federalism) 

HHS has reviewed this final rule in 

accordance with Executive Order 13132 

regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The final 

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 final rule on children. HHS has 

determined that the final 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 final rule on energy supply, 

distribution, or use and has determined 

that the rule will not have a significant 

adverse effect. 


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2622 Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Rules and Regulations 

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 final rule consistent 

with the Federal Plain Writing Act 

guidelines. HHS did not receive any 

public comments on this matter. 

V. Final Rule 

List of Subjects in 42 CFR Part 84 

Occupational safety and health, 

Personal protective equipment, 

Respirators. 

Text of the Rule 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services amends 42 CFR part 84 

as follows: 

PART 84—APPROVAL OF 

RESPIRATORY PROTECTIVE DEVICES 

■ 1. The authority citation for part 84 

continues to read as follows: 

Authority: 29 U.S.C. 577a, 651 et seq., and 

657(g); 30 U.S.C. 3, 5, 7, 811, 842(h), 844. 

■ 2. In § 84.83, revise paragraph (f) to 

read as follows: 

§ 84.83 Timers; elapsed time indicators; 

remaining service life indicators; minimum 

requirements. 

* * * * * 

(f) Each remaining service-life 

indicator or warning device must give 

an alarm when the remaining service 

life is reduced to a minimum of 25 

percent of its rated service time or any 

higher minimum percent value or 

values as specified in the approval. 

Open-circuit demand and pressuredemand respirators must alarm 

continuously until depletion of the 

breathing air supply. The percent value 

set for indicator activation must be 

identified by labels and/or markings on 

each respirator unit. 

Dated: December 28, 2012. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2013–00371 Filed 1–11–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2012–0003; Internal 

Agency Docket No. FEMA–8265] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. Also, information 

identifying the current participation 

status of a community can be obtained 

from FEMA’s Community Status Book 

(CSB). The CSB is available at http:// 

www.fema.gov/fema/csb.shtm. 

DATES: The effective date of each 

community’s scheduled suspension is 

the third date (‘‘Susp.’’) listed in the 

third column of the following tables. 

FOR FURTHER INFORMATION: If you want 

to determine whether a particular 

community was suspended on the 

suspension date or for further 

information, contact David Stearrett, 

Federal Insurance and Mitigation 

Administration, Federal Emergency 

Management Agency, 500 C Street SW., 

Washington, DC 20472, (202) 646–2953. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

Federal flood insurance that is not 

otherwise generally available from 

private insurers. In return, communities 

agree to adopt and administer local 

floodplain management measures aimed 

at protecting lives and new construction 

from future flooding. Section 1315 of 

the National Flood Insurance Act of 

1968, as amended, 42 U.S.C. 4022, 

prohibits the sale of NFIP flood 

insurance unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed in this document no 

longer meet that statutory requirement 

for compliance with program 

regulations, 44 CFR part 59. 

Accordingly, the communities will be 

suspended on the effective date in the 

third column. As of that date, flood 

insurance will no longer be available in 

the community. We recognize that some 

of these communities may adopt and 

submit the required documentation of 

legally enforceable floodplain 

management measures after this rule is 

published but prior to the actual 

suspension date. These communities 

will not be suspended and will continue 

to be eligible for the sale of NFIP flood 

insurance. A notice withdrawing the 

suspension of such communities will be 

published in the Federal Register. 

In addition, FEMA publishes a Flood 

Insurance Rate Map (FIRM) that 

identifies the Special Flood Hazard 

Areas (SFHAs) in these communities. 

The date of the FIRM, if one has been 

published, is indicated in the fourth 

column of the table. No direct Federal 

financial assistance (except assistance 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act not in connection with a 

flood) may be provided for construction 

or acquisition of buildings in identified 

SFHAs for communities not 

participating in the NFIP and identified 

for more than a year on FEMA’s initial 

FIRM for the community as having 

flood-prone areas (section 202(a) of the 

Flood Disaster Protection Act of 1973, 

42 U.S.C. 4106(a), as amended). This 

prohibition against certain types of 

Federal assistance becomes effective for 

the communities listed on the date 

shown in the last column. The 

Administrator finds that notice and 

public comment procedures under 5 

U.S.C. 553(b), are impracticable and 

unnecessary because communities listed 

in this final rule have been adequately 

notified. 

Each community receives 6-month, 

90-day, and 30-day notification letters 

addressed to the Chief Executive Officer 

stating that the community will be 

suspended unless the required 

floodplain management measures are 

met prior to the effective suspension 

date. Since these notifications were 

made, this final rule may take effect 

within less than 30 days. 

National Environmental Policy Act. 

This rule is categorically excluded from 

the requirements of 44 CFR part 10, 

Environmental Considerations. No 

environmental impact assessment has 

been prepared. 

Regulatory Flexibility Act. The 

Administrator has determined that this 


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