39150 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 211 

[EPA–HQ–OAR–2003–0024; FRL–8934–9] 

RIN 2060–A025 

Product Noise Labeling Hearing 

Protection Devices 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: By this action the 

Environmental Protection Agency 

proposes to revise the Noise Labeling 

Standards for Hearing Protection 

Devices (HPD). These standards have 

not been amended since 1979 and 

technologies have evolved and 

improved in the interim. The proposed 

revisions provide manufacturers with 

newly developed testing methodologies 

that are the most appropriate to assess 

and label hearing protection devices, 

and to allow legitimate hearing 

protection products to be sold as such 

in U.S. markets. In particular, this 

action should result in the availability 

of a new generation of significantly 

improved devices that are precluded 

from entering the marketplace as 

‘‘hearing protectors’’ by the 1979 

regulation. Finally, the Agency is 

mindful of the relatively large 

percentage of small entities that 

comprise the HPD industry. In 

recognition of the evolutionary changes 

in marketing and selling products 

brought about by the internet, and in 

order to minimize the potential 

economic burden on manufacturers that 

sell their products ‘‘exclusively’’ over 

the internet, the Agency is proposing to 

allow ‘‘electronic labeling’’ as a means 

for certain manufacturers (as defined in 

subpart B) to comply with the labeling 

requirements of this proposed rule. 

DATES: Comments. Written comments 

must be received on or before 

September 4, 2009. 

Public Hearing. If requested by 

August 17, 2009 the EPA will hold a 

public hearing on August 25, 2009. If a 

public hearing is held, anyone that 

would like to speak at the hearing 

should notify the EPA by August 18, 

2009. 

ADDRESSES: Submit your comments, 

identified by docket ID number EPA– 

HQ–OAR–2003–0024, by one of the 

following methods: 

• www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

• E-mail: a-and-r-docket@epa.gov. 

• Fax: (202) 566–1741. 

• Mail: EPA Labeling Regulation, 

Docket Number EPA–HQ–OAR–2003– 

0024, Environmental Protection Agency, 

EPA Docket Center, Mailcode 6102T, 

1200 Pennsylvania Ave., NW., 

Washington, DC 20460. 

• Hand Delivery: EPA Docket Center, 

Public Reading Room, EPA West, Room 

3334, 1301 Constitution Ave., NW., 

Washington, DC 20460. Such deliveries 

are only accepted during the Docket’s 

normal hours of operation (Monday 

through Friday, from 8:30 a.m. to 4:30 

p.m.), excluding legal holidays and 

special arrangement should be made for 

deliveries of boxed information. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the Air Docket 

is (202) 566–1742. 

Instructions: Direct your comments to 

Docket ID Number EPA–HQ–OAR– 

2003–0024. EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or e-mail. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an e-mail 

comment directly to EPA without going 

through www.regulations.gov, your email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name or other content 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defect 

or viruses. For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket 

are listed in the www.regulations.gov 

index. Although listed in the index, 

some information is not publicly 

available, e.g., confidential business 

information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the EPA Air Docket, EPA/DC, EPA West, 

Room 3334, 1301 Constitution Ave., 

NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the Air Docket is (202) 566– 

1742. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Catrice Jefferson, U.S. Environmental 

Protection Agency, Office of Air and 

Radiation, Mail Code 6103A, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460. Telephone 

Number—(202) 564–1668; Fax 

Number—(202) 564–1554; and E-mail 

Address—jefferson.catrice@epa.gov. 

SUPPLEMENTARY INFORMATION: Outline. 

The information presented in this 

preamble is organized as follows: 

I. Noise Control Act Authorities 

II. Introduction 

III. Background 

IV. Product Applicability 

V. Incorporation by Reference 

VI. Test Methodologies 

VII. Noise Reduction Rating Strategies 

VIII. Label Format and Content 

IX. Compliance Requirements 

X. Cost Impact Analysis 

XI. Statutory and Executive Order Reviews 

I. Noise Control Act Authorities 

In the Noise Control Act of 1972 (42 

U.S.C. 4907), hereinafter ‘‘the Act’’, the 

Congress declared that it is the ‘‘policy 

of the United States to promote an 

environment for all Americans free from 

noise that jeopardizes their health and 

welfare.’’ Congress further declared that 

one purpose of this Act is ‘‘* * * to 

authorize the establishment of Federal 

noise emission standards for products 

distributed in commerce, and to provide 

information to the public respecting the 

noise emission and noise reduction 

characteristics of such products.’’ 

Section 8 (Labeling) of the Act states 

that ‘‘the Administrator (of the 

Environmental Protection Agency) shall, 

by regulation, designate any product (or 

class thereof)—(1) which emits noise 

capable of adversely affecting the public 

health or welfare; or (2) which is sold 

wholly or in part on the basis of its 

effectiveness in reducing noise.’’ 

Further, of direct relevance to this 

proposal, it provides that ‘‘the 

Administrator shall by regulation 

require that notice be given to the 


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prospective user of the level of the noise 

the product emits, or of its effectiveness 

in reducing noise, as the case may be. 

Such regulations shall specify (1) 

whether such notice shall be affixed to 

the product or to the outside of its 

container, or to both, at the time of its 

sale to the ultimate purchaser or 

whether such notice shall be given to 

the prospective user in some other 

manner, (2) the form of the notice, and 

(3) the methods and units of 

measurement to be used’’ [in developing 

the required information notice].’’ 

II. Introduction 

EPA has issued rules, found at 40 CFR 

Part 211, subpart B, which implement 

section 8 of the Act. EPA issued these 

rules in 1979 (44 FR 56120). These rules 

require manufacturers of hearing 

protection devices (HPD), that are 

entered into commerce in the United 

States, to provide the prospective user 

with information regarding the 

products’ effectiveness in reducing the 

level of noise (unwanted sound) 

entering a user’s ears. The regulation 

requires that such information be 

presented at the time of its sale to the 

ultimate purchaser on a label(s) that is 

readily visible at the point of purchase 

or distribution to users. 

Since 1979, the demand for hearing 

protector devices has increased 

dramatically due, in part, to an 

increased awareness of hearing loss in 

the workplace and the increased 

stringency of occupation and health 

regulations at the federal and state 

levels. The Agency estimates the current 

legal hearing protector market to be 

approximately four (4) billion units 

annually, comprised of about 2.1 billion 

units sold to industrial users and an 

estimated 1.9 billion sold to military 

and commercial users. 

As a result of an increased demand for 

more effective products, significant 

technological changes have occurred in 

the design, performance and comfort of 

hearing protectors with the resultant 

introduction of new products that, 

unfortunately, are not amenable to the 

current regulatory testing and rating 

schemes. These products include 

special purpose ‘‘passive’’ (nonelectronic aided) devices, custom 

molded and tuned devices, electronic 

noise reduction devices, sound 

restoration devices and combination 

hearing protector (communication 

headset). Other changes that have 

occurred in the hearing protector 

industry include the consolidation of 

U.S. and foreign manufacturers, and an 

increasing number of foreign-made 

products finding their way into U.S. 

commerce that are not in compliance 

with the existing rule. 

Today’s proposal reflects these 

technological advances and specifies the 

new and revised test methods to 

determine product effectiveness; the 

mathematical process to determine a 

numeric effectiveness rating(s) (i.e., 

Noise Reduction Rating (NRR)); the 

required graphic and textual 

information for the required labels; the 

introduction of electronic labeling for 

organizations that sell their hearing 

protectors exclusively via the internet; 

and future compliance testing to assure 

the continuous accuracy of product 

effectiveness and label information. 

EPA’s overall objectives remain, as they 

were 30 years ago: 

(1) Provide accurate and 

understandable information to hearing 

protector purchasers, users, and hearing 

conservation professionals regarding the 

acoustic performance of hearing 

protection products in specific noise 

environments so that meaningful 

product comparisons, with respect to 

the reduction of sound entering a user’s 

ears, can be made as part of a product 

purchase or use decision. 

(2) Provide such information with 

minimal Federal involvement by 

ensuring the labeling requirements are 

structured to minimize administrative, 

economic, and technical impacts on 

manufacturers, distributors, and other 

interested parties. 

(3) Promote improvements in hearing 

protector design, performance, and user 

acceptability. 

(4) Promote public awareness of 

potential damage to hearing that can 

result from unprotected exposure to 

high intensity sound. 

III. Background 

Since EPA’s promulgation of the 1979 

regulation, the federal government, 

universities and industry have 

conducted research on the effectiveness 

of hearing protection devices when used 

in ‘‘real world’’ settings. Professional 

and trade organizations, manufacturers 

and other federal agencies have 

presented their concerns to the EPA on 

a number of significant issues including 

the currently required test method, the 

required Noise Reduction Rating (NRR), 

and the required textual information on 

labels. All interested parties generally 

agree that the existing regulation needs 

to be revised to address new technology 

products, related test methodologies, 

and current user needs. 

In response, EPA gave notice via the 

Agency’s Web site and by written 

invitation to interested parties to 

participate in a workshop at EPA 

headquarters in Washington, DC on 

March 27–28, 2003. The EPA sought 

detailed technical concerns, new 

information and recommendations 

relevant to the current federal labeling 

requirements for hearing protection 

devices, with particular emphasis in the 

following areas: 

(1) Product Label 

• Primary label information and 

format 

• Supporting information 

• Label size and placement 

(2) New Hearing Protector Technologies 

• Sound restoration systems 

• Active and passive devices 

• Active noise reduction 

• Communication headset 

(3) Noise Reduction Effectiveness Rating 

• Test methodologies 

• Passive and active devices 

• Effectiveness metric 

• Periodic retesting of products 

The two-day workshop included 

presentations of invited papers that 

provided the historic basis for the 

current hearing protector regulation; a 

review of technical revisions to test 

methods since the 1979 promulgation of 

the regulation; an analysis of the 

relationship of the current Noise 

Reduction Rating (NRR) to current 

American National Standards Institute 

(ANSI) and International Standards 

Organization (ISO) test protocols; and 

an overview of new hearing protector 

technologies. 

The workshop also included ‘‘breakout’’ sessions to address the three major 

topic areas noted above. The sessions 

were facilitated by personnel from the 

National Institute for Safety and Health 

(NIOSH), and conducted informally 

without transcript to stimulate the free 

flow of ideas and exchange of 

information. However, the session 

facilitators recorded the essence of the 

discussions, while preserving the 

autonomy of the commenters. 

All formal presentations are available 

in EPA Docket Number EPA–HQ–OAR– 

2003–0024. The docket also contains 

summaries of each of the breakout 

sessions and an overall summary that 

integrates the conclusions and 

recommendations of the sessions. The 

proceedings of the workshop, including 

all presentations and summaries, will be 

referred to henceforth as ‘‘the report’’ or 

‘‘the workshop report.’’ The report may 

be found at document number twentynine (29) in the above referenced 

docket. 

The workshop presented a number of 

reasons why the existing regulation 

should be revised. The most notable are 

summarized below: 


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1The referenced studies can be found in the 

Federal Docket at http://www.regulations.gov, 

docket number EPA–HQ–OAR–2003–0024. 

2Occupational Safety and Health Administration 

(1999). OSHA Technical Manual, Section IV, 

Appendix IV:C, Methods for Estimating Hearing 

Protector Attenuation. Washington DC: Office of 

Science and Technology assessment http:// 

www.osha.gov/dts/osta/otm/noise/hcp/ 

attenuation_estimation.html. 

3National Institute for Occupational Safety and 

Health (1998). Occupational Noise Exposure, 

Revised Criteria, 1998. Publication No. 98–126. 

Cincinnati, OH: U.S. Department of Health and 

Human Services, Public Health Service, Centers for 

Disease Control and Prevention, National Institute 

for Occupational Safety and Health. 

A. Product Applicability 

The Agency has been aware of 

electronic devices such as active noise 

cancellation, sound restoration, 

combination communication protectors, 

that were essentially barred from 

claiming the acoustic noise reduction 

benefits attendant to these devices due 

to the limitations of the federal test 

procedures designed for non-electronic 

hearing protectors. Similarly, some 

protectors that rely upon acoustical and 

mechanical behavior to increase 

attenuation were also barred. This is 

because absent an appropriate measure 

of the product’s noise reduction 

effectiveness, it cannot be sold as a 

hearing protection device. 

B. Noise Reduction Rating 

The most-expressed concern was with 

the currently-required noise reduction 

rating (NRR) metric the single-number 

rating scheme that EPA specified to 

quantitatively rate the effectiveness (i.e., 

the sound attenuation or sound 

reduction) offered by a hearing 

protection device when used as 

instructed by its manufacturer. In 

particular, it was alleged that most 

purchasers and users of hearing 

protectors have a limited understanding 

of the NRR, believing that the higher the 

numerical rating, the better the product. 

While technically correct, it was 

suggested that purchasers or users may 

select products primarily on the basis of 

NRR differences as small as 1 decibel 

(dB), whereas issues of comfort, 

compatibility with safety equipment, 

communication needs, and ease of use 

can be of equal or greater importance to 

the ultimate user. 

Field studies by various researchers,1

over the past three decades, revealed a 

relatively poor correlation between the 

labeled NRR of selected protectors, as 

determined from testing in accordance 

with the American National Standards 

Institute (ANSI) S3.19–1974 test 

procedure, and the attenuation realized 

by typical users of these protectors 

when tested without the benefit of the 

experimenter fitting the device as 

required in ANSI S3.19. This difference 

was more pronounced with earplugs 

than with earmuffs, where the former 

device requires specific fitting skills by 

the user. 

Based in large part on these 

referenced field studies, one Federal 

agency has made significant 

modifications to their criteria governing 

the application of the NRR for 

determining acceptable employee noise 

exposure in the work place. The 

Department of Labor/Occupational 

Safety and Health Administration 

(OSHA) has instructed its inspectors to 

‘‘derate’’ (reduce) a hearing protector’s 

estimated attenuation by 50 percent 

when assessing the relative effectiveness 

of hearing protectors in lieu of 

engineering noise reduction controls.2

The National Institute for 

Occupational Safety and Health 

(NIOSH) also suggests the derating of 

protectors in the workplace. However, 

in contrast to OSHA, they suggest 

subtracting differing percentages from 

the labeled NRR for each of the three 

types of hearing protectors: 25% from 

the labeled NRR of earmuffs, 50% from 

the labeled NRR of foam earplugs, and 

70% from the NRR of all other 

earplugs.3

In both cases the recommended 

‘‘derating’’ is based on the agencies’ 

engineering judgment and not 

controlled scientific determination and 

consequently could lead to unintended 

consequence of ‘‘over protection’’ that 

could obscure warning signals or 

necessary voice communication. 

C. Test Methodology 

The American National Standards 

Institute has withdrawn the S3.19–1974 

performance test standard (‘‘Method for 

the Measurement of Real-Ear Protection 

of Hearing Protectors and Physical 

Attenuation of Earmuffs’’), which is 

mandated in the current regulation (40 

CFR 211 subpart B) and replaced it with 

ANSI/ASA S12.6–2008, ‘‘Methods for 

Measuring the Real-Ear Attenuation of 

Hearing Protectors,’’ which is believed 

to yield data that more closely mirrors 

the ‘‘real world’’ effectiveness of hearing 

protector devices. 

The principal concern with S3.19– 

1974 is its requirement that testing 

laboratory personnel (hereinafter the 

experimenter) physically fit the HPD on 

the human test subject. The basis for 

using human test subjects is to address 

the range of differences in both the 

external and internal structure of the 

human ear. Clearly, the original intent 

of the experimenter fitting the device 

was to minimize the variability of 

product effectiveness that could occur 

due to the user’s lack of skill in fitting 

the device and not that due to the sound 

reduction effectiveness of the device 

itself when used as instructed by the 

manufacturer. However, this procedure 

can lend itself to experimenter fit 

adjustments of the product on the test 

subject to achieve the maximum sound 

reduction possible without regard for a 

test subject’s comfort or intended fit. 

Finally, a major deficiency of ANSI 

S3.19 with regard to current and 

potential future products is its inability 

to be used to determine the performance 

of special devices, such as those 

utilizing active noise reduction and 

those used in high level impulsive noise 

fields. 

EPA agrees with interested parties 

that the current required test 

methodology, based upon ANSI S3.19– 

1974, can result in unrealistically high 

sound reductions that are generally not 

attainable in real world use. The 

resultant labeled NRR can lead to 

product selections that may leave users 

under-protected and subject to potential 

hearing damage. Further, the procedure 

lacks suitability for the testing of other 

than passive devices. For these reasons, 

the EPA has concluded, subject to 

consideration of public comment, that 

ANSI S 3.19–1974 is no longer 

appropriate for HPD label requirements. 

D. Test Subjects 

ANSI S3.19–1974, requires 10 

subjects to be tested regardless of the 

type of protector. Each subject is tested 

three times and their mean attenuations 

and standard deviations are determined 

without averaging the individual subject 

results. Interested parties have 

suggested that more test subjects should 

be utilized for passive insert devices in 

order to achieve a more statistically 

accurate representation of the user 

population. They also proposed that 

each test subject be required to undergo 

multiple tests on each product in order 

to obtain an average fit sound reduction 

value. They have also suggested that 

fewer test subjects be required for 

devices that fit over the user’s ears (ear 

muffs) because such protectors require 

minimal user skill in obtaining a proper 

fit. 

The EPA favors any changes in the 

testing protocol that will improve the 

quality of information that can be 

provided to the ultimate user of an HPD 

while offering the potential for reduced 

testing costs. 

E. Compliance Testing 

The current regulation was written at 

a time when, in large part, ear plugs 

made of wax-impregnated cotton, 


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silicon, early formulas of polyurethane 

foam, and earmuffs, were the only types 

of products on the market. For many 

reasons, too numerous to detail here, the 

EPA decided to require compliance 

testing of a HPD only once prior to its 

entry into commerce. Further tests are 

required if (1) a manufacturer modifies 

the design or changes materials or 

structure such that the acoustic 

performance of the product may be 

degraded; (2) the Administrator has 

reason to believe the original 

effectiveness rating is in error, or 

otherwise requires information pursuant 

to section 13 of Noise Control Act; or (3) 

a selective enforcement audit revealed 

products in non-compliance with their 

labeled information. With the entry of 

many new HPD materials, designs, and 

electronic and mechanical systems, the 

Agency has become concerned with the 

adequacy of its present once in a 

product lifetime test requirement. 

IV. Product Applicability 

This proposed regulation would apply 

to all devices or materials sold as 

explicit or implicit ‘‘hearing protection 

devices’’ on the basis of their ability to 

reduce the level of sound entering the 

user’s ears and thus serve to protect the 

user’s hearing. The proposed regulation 

also applies to devices whose primary 

function may not be hearing protection, 

but which are nonetheless sold in-part 

as providing protection to the user’s 

hearing. 

To the extent that a product 

manufacturer, importer, packager or any 

other party introduces into U.S. 

commerce any product that incorporates 

an explicit or implicit claim that the 

product can protect the hearing of the 

user or stipulates the level of sound 

reduction offered by such product, then 

it would be subject to the requirements 

of this proposed regulation. 

The Agency has attempted to 

establish product definitions on the 

broadest basis in order to capture all 

current and future HPD designs and 

characteristics. The EPA recognizes that 

by taking this broad approach, certain 

products presently on the market, that 

are intended to provide a level of 

comfort for sleeping, listening to music, 

restricting the entry of water into ears 

during swimming or bathing, etc., may 

be captured as possible hearing 

protectors. As stated above, this rule 

does not apply to those devices or 

materials. 

While not necessarily a complete 

listing, the general categories of hearing 

protector devices that are subject to this 

proposed regulation are described 

below: 

(1) Passive Hearing Protection Device. 

A device that relies solely on its 

structural elements to block or 

otherwise control the transmission of 

sound into the ear canal and that does 

not use electronic circuits or acoustic 

elements to reduce the entry of external 

sound. 

(2) Active Hearing Protection Device. 

A device that contains electronic 

components including transducers (i.e. 

speakers and microphones) to increase 

or decrease the transmission of sound 

into the ear canal. Also referred to as an 

electronic hearing protection device. 

(3) Ear plug. A hearing protection 

device that is designed to be inserted 

into the ear canal and held in place 

principally by virtue of its fit inside the 

ear canal. 

(4) Ear muff. A hearing protection 

device usually comprised of a headband 

which applies spring-like force/pressure 

to two ear cups with soft cushions to 

seal against the external ear or pinna 

(supra-aural) or the sides of the head 

around the pinna (circumaural). The ear 

cups may also be held in position by 

attachment arms mounted on a hardhat 

or hardcap. 

(5) Active Noise Reduction Hearing 

Protection Device. A device that uses 

single or in combination, electrical and 

structural elements to reduce the sound 

transmitted to the ear canal through 

acoustic cancellation of the airconducted and/or bone-conducted 

external sound. 

(6) Amplitude Sensitive Hearing 

Protection Device. A device that is 

designed to produce a change in sound 

attenuation as a function of the external 

sound level. 

(7) Communication Headset. A voice 

communication device (ear plug, ear 

muff, semi-insert device or helmet) that 

is designed also to reduce the level of 

sound at the users’ ears by either 

structural elements and/or electronic 

means. 

(8) Custom-molded Hearing 

Protection Device. A device that is made 

to conform to a specific person’s ears 

(pinnas) and ear canals. 

(9) Helmet. A hearing protection 

device that provides impact protection 

to the head or skull and that is designed 

also to reduce the external sound 

through either structural elements and/ 

or electronic means. 

(10) Semi-insert Device. An ear pluglike hearing protection device consisting 

of soft pods or tips that are held in place 

by a lightweight band. The pods are 

positioned in the conchae covering the 

entrances to the ear canals, or fitted to 

varying depths within the ear canals. 

Semi-inserts that cap the canal require 

the force of the band to retain their 

position and acoustic seal. Semi-inserts 

that enter the canal behave more like ear 

plugs; they seal the ear to block noise 

with or without the application of band 

force. Also referred to as canal cap or 

banded hearing protector. 

V. Incorporation by Reference 

The test methodologies that are being 

proposed in subpart B rely in whole or 

in part on established consensus 

standards of the American National 

Standards Institute (ANSI) and design 

standard of the International 

Electrotechnical Commission (IEC). The 

version of the standards that are 

incorporated in the rule remains the 

applicable standard unless and until the 

EPA amends the rule to reflect any 

change in the test procedures. In 

recognition of the copyrights that 

protect these standards, the Agency is 

‘‘incorporating by reference,’’ into 

subpart B, the following ANSI and IEC 

standards: 

(1) ANSI/ASA S12.6—2008, 

‘‘Methods for Measuring the Real-Ear 

Attenuation of Hearing Protectors’’ 

(2) ANSI S12.42—1995 (R2002), 

‘‘Microphone-in-Real-Ear and Acoustic 

Test Fixture Methods for the 

Measurement of Insertion Loss of 

Circumaural Hearing Protection 

Devices’’ 

(3) ANSI/ASA S12.68—2007, 

‘‘Methods of Estimating Effective Aweighted Sound Pressure Levels When 

Hearing Protectors are Worn’’ 

(4) IEC 60711, ‘‘Occluded-ear 

simulator for the measurement of 

earphones coupled to the ear by ear 

inserts’’ 

VI. Test Methodologies 

The EPA has determined, after 

extensive investigations, multilaboratory testing and discussions with 

experts in the field, that the following 

test methodologies are appropriate for 

use on the broad spectrum of present 

and potentially future materials and 

devices that are sold wholly or in-part 

on the basis of their ability to reduce the 

level of sound entering the human ear. 

Further, to avoid the potential 

creation of a technical barrier to U.S. 

manufacturers’ global trade, the Agency 

has considered foreign testing and 

labeling standards regarding HPD rating 

schemes and their relationship to the 

U.S. Noise Reduction Rating (NRR). In 

that regard, the Agency has given 

particular attention to the International 

Standards Organization (ISO) standard 

4869, parts 1 and 2 which describe, for 

the most part, the European testing and 

rating methods for HPDs. ISO 4869 part 

1 permits subjects to be experienced and 

trained in proper product use technique. 


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However, the Agency has concluded 

that the referenced ISO standards do not 

add substantively to the intended 

testing and rating objectives of the 

proposed regulation over that offered by 

the selected ANSI standards. 

The Agency’s consideration of ANSI 

S12.6–2008 was preceded by 

considerable debate within the hearing 

protector device community regarding 

the qualifications of the human test 

subjects. ANSI S12.6–2008 offers two 

significantly different testing protocols, 

Method A and Method B, as they relate 

to prior experience of the test subjects 

and role of the experimenter in the 

preparation of test subjects prior to 

product testing. In brief, Method A test 

subjects are informed and experienced 

regarding the use of HPDs, based upon 

detailed instruction and demonstration 

from the experimenter or from previous 

HPD use. Method B test subjects are 

selected principally because of their 

lack of prior knowledge and experience 

with HPDs. They are not provided any 

guidance from the experimenter with 

regard to product use, beyond that given 

by the manufacturer’s normally 

provided written instructions. There 

was no consensus on whether EPA 

should require Method A or Method B. 

A. Method Selection 

Several factors must be considered in 

the selection of testing protocols. First, 

the measured sound attenuation is the 

principal determinant of the potential 

noise reduction rating (effectiveness) of 

the device. Second, the variability of the 

rating metric, which is primarily a 

function of subject selection and 

training and test laboratory practices, 

must be accounted for. Third, to the 

extent possible, the test method should 

give a measure of product effectiveness 

under real-world use conditions. 

Finally, the method should provide a 

reliable and repeatable means for 

assessing product performance, with 

minimal influence and impact of nonproduct related factors. The competing 

methods and their differing means to 

account for user capabilities are 

presented below. 

1. Method A 

Supporters of Method A believe it is 

the appropriate protocol to assess the 

acoustic performance and sound 

attenuation capability of an HPD 

attributes that are a function of product 

design, materials and construction, 

rather than user skills. When subjects 

are trained in the proper use of hearing 

protectors, they demonstrate higher 

average attenuation for devices such as 

earplugs and semi-aural inserts than do 

‘‘inexperienced’’ subjects. In the EPAsponsored interlaboratory studies, 

earmuffs exhibited little change in 

attenuation between experienced and 

inexperienced test subjects. However, 

for earplugs and semi-aural devices, 

there were marked improvements in 

attenuation when Method B subjects 

were given training; attenuation results 

for foam roll-down earplugs showed 

significant improvement as a result of 

correct fit. The range of attenuation 

results tended to be larger with Method 

A, but the variability across test subjects 

was reduced markedly from that of 

Method B. 

Method A is similar to the 

International Standards Organization 

(ISO) test standard 4869–1 that permits 

subjects to be experienced with the use 

and fitting of protectors. The 

Occupational Safety and Health 

Administration (OSHA) and the military 

require training in the use of hearing 

protectors, thus supporting the use of 

Method A that reflects the attenuation 

obtained by trained users. Supporters 

also maintain that Method B is an 

assessment of the product’s ergonomics 

and manufacturers’ instructions, but not 

necessarily the products’ noise 

reduction capabilities. Thus, the use of 

inexperienced subjects increases the 

variance of the attenuation data and 

may serve to mask procedural variances 

between testing laboratories. Finally, 

they expressed concern that selection of 

a Method-B rated protector could result 

in user over-protection due to the 

understated attenuation results from 

inexperienced subjects. This, in turn, 

can lead to potential safety hazards, 

particularly in those noise environments 

that rely on speech communications and 

audible warning signals. 

2. Method B 

Supporters of Method B maintained 

that the use of inexperienced test 

subjects is a better predictor of the level 

of sound reduction (attenuation) that 

might be expected by users in the real 

world as opposed to the laboratory. Data 

from field studies show slightly lower 

real-world attenuation than the 

laboratory data using Method B, and 

even studies of well-trained users (as 

opposed to test subjects) showed results 

similar to Method B data. Further, it 

appears that the rank ordering of 

hearing protector attenuation using 

Method B correlates well with the data 

from field studies. While Method-B 

results exhibited better reproducibility, 

the measured attenuations were lower. 

Finally, the variability of the Method-B 

results was greater than that of MethodA results. 

Method B supporters also suggest that 

the use of subject fit testing methods 

will eventually lead to protector designs 

that facilitate the user fitting the 

protector correctly. 

3. Training 

Although disagreement exists 

between Method A and B supporters 

and parties that will be affected by this 

revised regulation, there is common 

agreement that the ultimate 

effectiveness of a product can only be 

realized with proper training or, at a 

minimum, user-friendly instructions. 

The Department of Defense (DOD) 

requires that enlisted personnel, 

officers, and civilians who are exposed 

to noise receive instruction in the 

proper use and maintenance of hearing 

protectors. The OSHA requires that 

workers involved in a hearing 

conservation program be instructed 

about the harmful effects of noise and 

trained in the proper use of hearing 

protectors. NIOSH recommends that 

training is an essential element of every 

hearing loss prevention program, along 

with noise control engineering and 

administrative measures to prevent 

hearing loss. Finally, the National 

Hearing Conservation Association 

(NHCA) recommends that training in 

the proper use of hearing protectors be 

provided to noise-exposed persons. 

4. Test Protocol Selection 

The EPA is proposing to adopt the 

ANSI S12.6–2008—Method-A testing 

protocol for all hearing protectors in 

their ‘‘passive’’ mode. EPA believes, 

subject to consideration of public 

comment, that Method A is more 

appropriate to the intent and fulfillment 

of the hearing protector labeling 

program objective—to provide an 

accurate assessment of the acoustic 

performance of only the product (see 

section 8(b) of the Act, authorizing 

labeling which describes a product’s 

‘‘effectiveness in reducing noise’’). 

EPA agrees that Method B can more 

nearly represent the anticipated 

protection for uninformed HPD users. 

But it is not reasonable to assume that 

HPD users will be typically uninformed, 

or that they would remain so as they 

grow accustomed to the use of an HPD. 

In fact, the federal labeling regulation is 

but one leg of a three legged stool and 

is not intended to be all-encompassing 

in the prevention of hearing damage or 

loss. The other two legs of a hearing 

conservation program must include user 

training and, to the extent possible, 

engineering controls of noise. 

The Agency has several concerns with 

the use of Method B. First, it believes 

the concept of ‘‘naı ̈ve’’ test subjects, as 

prescribed in ANSI S12.6, is not 

appropriate for the determination of a 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39155 

4National Institute for Occupational Safety and 

Health (NIOSH)/EPA Interlab Study Comparison of 

ANSI S12.6, Method A and B. Refer to the Federal 

Docket at http://www.regulations.gov, docket 

number EPA–HQ–OAR–2003–0024. 

5National Institute for Occupational Safety and 

Health (NIOSH)/EPA Interlab Study Comparison of 

ANSI S12.6, Method A and B. Refer to the Federal 

Docket at http://www.regulations.gov, docket 

number EPA–HQ–OAR–2003–0024. 

product’s acoustical performance, 

absent human intervention. EPA 

believes that the naivety of the test 

subject (hereinafter ‘‘inexperienced’’ test 

subject) disappears (or is at least 

reduced) once the test subject has 

completed his or her first series of tests. 

Consequently, the use of such subjects 

for multiple testing of similar products 

is questionable regarding their 

inexperience. Second, based upon 

results from an EPA sponsored and 

NIOSH managed multi-laboratory test 4

of six different products, significant 

differences in technique between testing 

laboratories became evident from 

Method A data. However, such 

differences appeared to be masked by 

the large variability between test 

subjects based upon Method B data. 

Third, the Agency believes the true 

potential effectiveness (NRR) of the 

HPD, when used correctly as instructed 

by the manufacturer, could be 

understated because of low attenuation 

measurements that resulted from 

improper fit by inexperienced test 

subjects; this is particularly important 

with ear insert HPDs. 

Further, EPA agrees with supporters 

of Method A regarding potential overprotection as a result of user selection 

based on a low Noise Reduction Rating 

determined from Method B testing. EPA 

believes the HPD rating should show, 

within a reasonable range, the sound 

reduction that users can expect to 

receive when the device is worn as 

instructed by the manufacturer. Since 

EPA cannot regulate human behavior 

nor provide training in the proper use 

of HPDs, its only regulatory option is to 

provide the most accurate product 

performance information available and 

rely on training from other entities to 

assure proper use. It is on the above 

basis that EPA is proposing to require 

the use of Method A. 

Finally, in the absence of suitable 

ANSI or other recognized testing 

standards that address devices that 

incorporate electronics to enhance their 

sound reduction (attenuation) 

performance (i.e., ‘‘active’’ mode) or that 

are intended for use in extremely high 

impulsive noise environments (levels 

greater than 140 decibels), the Agency, 

in collaboration with NIOSH and the 

U.S. Air Force, has developed test 

methods for these devices. An 

explanation of these ‘‘non-consensus 

standard’’ test protocols is given below. 

The EPA is seeking comment on these 

new test protocols. 

B. Proposed Testing Protocols 

1. Passive Noise Reduction Testing 

As stated above, EPA is proposing 

that ANSI 12.6–2008, Method A, Real 

Ear Attenuation at Threshold (REAT) 

test protocol be used for the 

determination of the passive noise 

reduction performance of all categories 

of hearing protector materials and 

devices. The key elements of the REAT 

test method includes: 

• Subject Selection and Qualification 

• Fitting Protocol 

• Test Procedure 

• Reporting of Test Data 

a. Subject Selection and Qualification 

The ANSI S12.6–2008 standard 

specifies test subject requirements for 

the Method-A protocol. Subjects must 

have pure-tone air conducted hearing 

thresholds better than 25 dB HL 

(Hearing Level) in both ears. Subjects 

must also demonstrate their proficiency 

in obtaining a hearing threshold in the 

test environment with the specific 

equipment used in the testing 

laboratory. Proficiency is demonstrated 

through repeated threshold testing 

without hearing protectors being worn 

such that the subject has a range of 

thresholds that does not exceed a 

difference of 5 decibels for each test 

frequency. The Agency believes that 

subject selection criteria can be used to 

identify a population of test subjects 

that produce high attenuations and 

which have a narrow range of 

attenuations across subjects. Therefore, 

the Agency will permit subjects to be 

rejected for various physical reasons 

during the pretest process, but they may 

not be removed from the pool of tested 

subjects due to their poor attenuation 

results. 

b. Fitting Protocol 

Under the 1979 regulation, the fitting 

protocol requires an experimenter-fit 

method. The subject serves as an 

acoustical test fixture capable of 

providing a response to the test 

stimulus. The experimenter places the 

protectors on the subject’s head or in the 

subject’s ear canals and prohibits the 

subject from making any adjustments to 

the fit of the product. This practice 

provided a repeatable measurement of 

the maximum attenuation that a product 

could achieve for deeply inserted 

earplugs. For devices such as earmuffs 

and semi-aural inserts, the ability to 

achieve a greater attenuation was less 

susceptible to experimenter 

manipulation. 

The proposed ANSI S12.6–2008 

Method-A incorporates specific 

instructions for the experimenter and 

limits the interaction between the 

subject and experimenter once training 

in the use of the product is completed. 

The process of defining how a subject 

should be trained was found to be more 

complex than defining the process for 

an inexperienced subject. The Working 

Group responsible for the development 

of ANSI S12.6–2008 Method-A settled 

on an approach that in many ways 

reflects the reality of how protectors 

should be issued to noise-exposed 

persons. The experimenter is allowed to 

provide training to the subject in how to 

best fit and use the specific hearing 

protector. However, once the subject 

enters the test room, the experimenter is 

prohibited from providing further 

instruction. When one considers how 

protectors are distributed and worn in 

most settings, if any training is given, it 

generally is of a short duration and the 

user must ultimately fit the protector on 

his/her head or in their ear canals. 

c. Test Panel Size 

The protocol stipulated in the 1979 

regulation specifies that ten subjects are 

to be tested three times for occluded and 

unoccluded thresholds and, upon their 

meeting specified hearing criteria, be 

selected as the test panel. These 

requirements were based upon research 

conducted by the U.S. Air Force and 

represented the best estimates of 

variability available in 1979. Since that 

time, the ANSI S12, Working Group 11 

determined that 20 subjects are 

statistically appropriate for testing ear 

plugs and semi-aural inserts and 10 

subjects are appropriate for ear muffs. 

The most recent interlaboratory study 

conducted by EPA and NIOSH found 

that 20 subjects were adequate for 

repeatable intra-laboratory tests with 

both Method-A and Method-B 

protocols.5 Section 5.8, ‘‘Number of 

subjects’’, of ANSI S12.6 requires that 

10 subjects be tested for earmuffs or 

helmets and 20 subjects for each test on 

earplugs or semi-insert devices. 

Questions have been raised about the 

appropriate number of subjects to be 

used in certain circumstances. It has 

been suggested that the regulation allow 

manufacturers to increase the sample 

size indefinitely, with the proviso they 

report to EPA the total number of 

subjects tested for each HPD. The 

Agency is not opposed to this latter 

approach provided the test data from all 

subjects is included in the calculations 

leading to the NRR. However, at this 

time the EPA is proposing to adopt the 


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39156 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

6Murphy WJ, ‘‘Analysis of the necessity to test at 

3150 and 6300 Hz and the effect on the Noise 

Reduction Rating.’’ 

7Franks JR, Graydon PS, Jeng C, Murphy WJ, 

‘‘NIOSH Hearing Protector Device Compendium,’’ 

http://www2d.cdc.gov/hp-devices/hp_srchpg01.asp 

(2003). as of July 6, 2008. 

requirements for 10 and 20 test subjects 

as specified in ANSI S12.6, Section 5.8. 

The Agency will consider comments on 

this topic. 

d. Test Room Environment 

EPA is proposing to change the 

requirements of the test room 

environment from those specified in 

ANSI S3.19–1974. Changes of particular 

note are the reverberation time of the 

room and the characterization of the 

sound field with respect to uniformity 

and diffusivity; both parameters are 

more specific under ANSI S12.6–2008. 

The procedure to determine the 

occluded and unoccluded thresholds is 

defined as a modified Bekesy procedure. 

This procedure was not selected on the 

basis of superior psychophysical 

techniques, but was selected by the 

ANSI S12 Working Group because most 

of the testing labs used a variant of the 

method; variation across testing labs 

could be minimized by standardizing 

the method. 

e. Test Frequencies 

The ANSI S3.19–1974 standard 

required the REAT test include 

attenuation measurements at 3150 and 

6300 Hz. However, later analysis 6 of the 

added benefit realized by the current 

NRR due to the inclusion of test 

frequencies at 3150 and 6300 Hz, 

revealed differences on the order of 0.1 

to 0.3 decibels. NIOSH conducted a 

similar analysis on 435 devices listed in 

the NIOSH Compendium 7 of Hearing 

Protection Devices and confirmed the 

earlier results. Thus, the voluntary 

standards community concluded that 

the small differences in the NRR 

through the inclusion of these two 

added test frequencies do not justify the 

additional time and effort in testing 

subjects at those frequencies. 

Consequently, in the recent versions of 

ANSI S12.6 the requirement to test at 

3150 and 6300 Hz has been eliminated 

for REAT measurements. The Agency 

concurs with these findings and is 

proposing to no longer require tests of 

attenuation at 3150 and 6300 Hz. 

f. Computation of the Noise Reduction 

Rating (NRR) 

The 1979 regulation requires the NRR 

be computed with the mean 

attenuations and standard deviations 

from all test subjects at each frequency 

band. The ANSI S12.68–2007 standard 

requires that data from the individual 

subjects be used in determining a 

device’s rating across a range of 

different noise spectra. The inclusion of 

both subject and spectral variability 

provides results that are more 

representative of the product’s 

performance when used by different 

persons in different types of noise 

environments. 

The Agency is proposing that the 

ANSI S12.68 methods be used to 

compute the required NRRs for Passive 

hearing protectors on the basis that such 

NRRs provide the best available means 

of describing product performance that 

is likely to occur in real-world 

environments. 

2. Active Noise Reduction Testing 

Active Noise Reduction (ANR) 

devices require additional 

measurements beyond those described 

above for the passive attenuation 

methods. An ANR device utilizes 

electronic circuitry to sample an 

external sound signal, analyzes the 

principle acoustic component(s), and 

then generates a 180 degree out-of-phase 

signal to be played into the occluded 

volume (the space under the protector) 

that, in effect, cancels the external 

signal that is present under the 

protector. An error correction 

microphone in the occluded volume is 

used to determine the effectiveness of 

the control, thus allowing adjustment of 

control parameters to maximize 

effectiveness. 

ANR circuitry has been incorporated 

in both earplug and earmuff HPDs in 

several forms; digital or analog controls 

or a combination of the two have been 

used. Digital control circuits tend to 

isolate specific tonal components of the 

external sound and effect a significant 

noise reduction. Analog circuits tend to 

be simpler to implement and have a 

broader share of the market. The type of 

control can be feedback, feed forward or 

a hybrid of the two. In a feedback 

circuit, the signal must be sampled in 

the occluded volume and the control is 

based upon the error correction 

microphone. In a feed forward circuit, 

the external microphone is sampled and 

the control is predicted. The error 

correction microphone is used to help 

the circuit determine the effectiveness 

of the control. 

a. Test Method Design Parameters 

ANR devices pose a particular 

problem when attempting to determine 

a noise reduction rating. The use of a 

REAT procedure yields an attenuation 

setting for the device that is biased due 

to the residual noise produced by the 

ANR circuitry. When activated, ANR 

devices tend to produce a small level of 

electronic noise that is audible in quiet 

environments. Because REAT testing 

requires the test subject to identify the 

presence of a sound produced by 

electro-mechanical speakers in the test 

environment, any sound produced by 

the hearing protector can interfere with 

the ability to measure near the subject’s 

threshold of hearing, resulting in an 

inaccurate assessment of the device’s 

active noise reduction performance. An 

alternative method for determining the 

noise reduction of the active device is 

to utilize the Microphone In Real Ear 

(MIRE) technique where a small 

microphone is placed in the subject’s 

occluded volume and the insertion loss 

(the difference in noise level when the 

device is activated and not activated) is 

measured. Alternatively, the 

transmission loss (the difference in 

noise levels between the external sound 

field and occluded volume) can be 

measured. A potential limitation of the 

MIRE technique is that it 

underestimates noise reduction at low 

frequencies when compared to the 

REAT method. 

The use of the MIRE technique for 

earmuff ANR devices can be readily 

applied since the occluded volume is 

sufficiently large that a miniature 

microphone can be placed completely 

within the earmuff and positioned in 

the ear canal without interfering with 

the seal of the muff cushions to the side 

of the head. The diameter of the lead 

wires to the MIRE microphone can be 

small enough such that no gaps in the 

seal will be created. Alternatively, the 

MIRE microphone can be wireless, thus 

eliminating the need for any wires to 

exit underneath the cushions of the ear 

muffs. 

In the case of ANR earplugs, the use 

of a MIRE measurement becomes 

complicated. Some prototypes rely on a 

deep-insertion custom-molded earplug 

that houses the electronic package. For 

these devices, the occluded volume may 

only be 0.5 cubic centimeters. 

Placement of the miniature microphone 

in the occluded volume could adversely 

affect the operation of control circuits 

designed for a specific occluded 

volume. If the test method uses a probe 

microphone, then the probe either has 

to be placed alongside the earplug or 

must be passed through a sound bore in 

the device. Placement of a probe 

microphone alongside the earplug 

creates a potential leakage path that 

changes the acoustic impedance of the 

occluded volume. Requiring a sound 

bore through the device deprives the 

manufacturer of critical volume within 

the device that may be necessary to 

house additional circuitry. The seal of 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39157 

8Birch RS, Gerges SN, Vergara EF, ‘‘Design of a 

pulse generator and shock tube for measuring 

hearing protector attenuation of high-amplitude 

impulsive noise’’ Appl. Acoustics 64:269–286 

(2003). 

9Parmentier G., Dancer A., Buck K., Kronenberger 

G., Beck C., ‘‘Artificial Head (ATF) for Evaluation 

of Hearing Protectors’’ Acustica,Volume 86 (2000). 

10Zera J. and Mlynski R. ‘‘Attenuation of highlevel impulses by earmuffs’’ J. Acoust. Soc. Am. 

122:2082–2096 (2007). 

11Tubbs RL, Murphy WJ, ‘‘Health Hazard 

Evaluation Report 2002–0131–2898 Fort Collins 

Police Services, Fort Collins Colorado’’ DHHS– 

CDC–NIOSH, HETA #2002–0131–2898 (2003). 

12Harney J., King B., Tubbs R., Crouch K., 

Hayden C., Kardous C., Khan A., Mickelsen L., 

Willson R., ‘‘Health Hazard Evaluation Report 

2000–0191–2960 Immigration and Naturalization 

Service, National Firearms Unit, Altoona, PA’’, 

DHHS–CDC–NIOSH, HETA #2000–0191–2960 

(2005). 

13Berger, E. ‘‘Methods of measuring the 

attenuation of hearing protection devices’’, J. 

Acosut. Soc. Am. 79:1655–1687 (1986). 

14Parmentier, G., Dancer, A., Buck, K., 

Kronenberger, G., and Beck, C. (2000). ‘‘Artificial 

Head (ATF) for Evaluation of Hearing Protectors,’’ 

Acta Acustica 86(5), 847–852. 

the sound bore with the probe tube can 

also present a sound leakage path. 

The Agency has received input from 

researchers in the field of active noise 

reduction hearing protection devices 

and has determined that the method to 

evaluate ANR noise reduction must 

include a combination of both the REAT 

and the MIRE techniques. As stated 

earlier, every hearing protector 

manufacturer would be required to 

conduct a REAT passive measurement 

and publish a passive NRR. 

Consequently, a REAT tests would have 

to be carried out on all ANR devices 

with their electronic circuitry turned 

off. 

For ANR earplugs, the active 

contribution would be measured on an 

acoustic test fixture. The test fixture 

would include artificial ear canals 

(tapered cylinder) and ear simulators 

that approximate the occluded volume 

and acoustic impedance of the human 

ear; such devices are commercially 

available. 

For earmuffs, the method uses the 

same test subjects who participated in 

the REAT testing. MIRE microphones 

are mounted on ear plugs underneath 

both the left and right ear muffs and the 

microphones are centered in the ear 

canal flush with the floor of the concha. 

To overcome the discrepancy between 

MIRE and REAT, the MIRE technique 

would be used to measure the active 

contribution to the total HPD noise 

reduction. In both the earmuff and 

earplug cases, the device would be 

assessed with the electronics turned on 

and off in a broadband noise field. The 

difference between the noise levels 

measured in the on and off conditions 

are calculated to estimate the active 

attenuation contribution. The active 

contribution is added to the 

attenuations measured with the REAT 

method. Together, these attenuations for 

each subject would be used to estimate 

the NRR according to the ANSI S12.68– 

2007 method. 

b. Method Requirement 

No standardized testing method(s) has 

yet been developed for determining the 

peak noise reduction of hearing 

protection devices. Several 

organizations have investigated a range 

of impulse generation techniques. 

University of Florinapolis, Brazil has a 

large diameter acoustic shock tube in 

which a mannequin head can be placed 

to test the performance of a protector.8

The Finish Institute of Occupational 

Health and the Polish Central Institute 

for Labour Protection have reported the 

attenuation of hearing protectors 

exposed to an acoustic shock tube.9 10

The French German Research Institute 

de Saint Louis (ISL) evaluates hearing 

protector performance with explosives 

and an anthropometric mannequin with 

an embedded ear simulator. The US 

Army has conducted mannequin 

measurements with explosives and also 

with an acoustic shock tube. The US Air 

Force has also evaluated protectors on a 

mannequin with an explosive impulse 

source. NIOSH has conducted exposure 

measurements for gunshots and various 

occupational impulsive noises and has 

utilized a mannequin.11 12 The use of a 

mannequin with simulated ears, in 

place of human test subjects, is essential 

to avoid the risk of hearing damage at 

the required high impulse sound levels. 

Berger 13 published a review of 

methods for measuring attenuation of 

hearing protection devices and has 

noted that one problem common to 

many of the artificial ear or head test 

fixtures available at that time was a lack 

of isolation of the sensing microphone. 

The purpose of the mannequin or test 

fixture is to determine the performance 

of the air conducted pathway of the 

device. Berger previously identified that 

bone conduction of the impulse through 

the skull was a limiting factor for 

hearing protector performance. Thus, 

the test fixture must incorporate 

isolation of the acoustic sensors from 

mechanical vibrations that are 

analogous to that of bone conduction. 

Currently there are several 

mannequins (test fixtures) available for 

acoustic research as well as other 

fixtures of varied design that could be 

potentially used to determine peak 

sound reduction. Three of the most 

well-known mannequins are the 

G.R.A.S. KEMAR (Knowles Electronic 

Manikin for Acoustic Research), the 

Bruel and Kjaer HATS (Head and Torso 

Simulator) and the Head Acoustics RMS 

fixture. Parmentier et al. reported that 

the isolation of the KEMAR and the 

early model of the Head Acoustics 

fixtures did not achieve sufficient 

isolation to get below bone 

conduction.14 The HATS device suffers 

from a similar problem as KEMAR; the 

volume of the head is devoid of any 

sound or vibration absorbing mass. 

Parmentier et al. isolated the ear 

simulator inside a suspended capsule 

within a relatively solid acrylic body. 

The additional features were the use of 

a replaceable ear canal and pinna set 

which allow both muffs and plugs to be 

tested. The ISL mannequin has the 

added benefit of being 

anthropometrically correct and thus 

more nearly simulates sound diffraction 

effects around the head. 

a. Test Procedure 

The proposed test procedure consists 

of three parts: calibration, data 

collection from a hearing protector 

exposed to the impulse sound source 

and computation of the of the peak 

noise reduction. 

Calibration is accomplished by 

simultaneously measuring sound 

impulses having a peak sound pressure 

level (SPL) of approximately 150 dBA. 

The pulse waveforms at both the freefield source location and the impulse 

acoustic test fixture (IATF), without a 

protector in place (unoccluded), are 

recorded. For consistency, five impulses 

are electronically captured and their 

waveforms analyzed to obtain the real 

and imaginary components necessary to 

calculate an acoustic transfer function. 

This transfer function will be used to 

transform the free-field impulse 

waveforms to their equivalent impulses 

at the IATF during the conduct of 

occluded tests. This impulse calibration 

and transformation is essential to the 

determination of a hearing protector’s 

effectiveness in high sound level 

impulse environments. 

The second part of the proposed test 

procedure is the determination of the 

peak sound reduction provided by a 

hearing protector for different peak 

impulse levels. For this part of the 

procedure, three ranges of impulsive 

sound levels are required: 130 to 134, 

148 to 152 and 166 to 170 dBA peak 

sound pressure level. The specified 

ranges of impulse sound levels 

approximate the peak impulse levels 

created by a wide variety of everyday 

sources e.g. pneumatic tools, powderVerDate Nov<24>2008 18:45 Aug 04, 2009 Jkt 217001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 E:\FR\FM\05AUP2.SGM 05AUP2

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actuated tools, construction equipment, 

firearms and fireworks. 

The hearing protector is installed on 

the IATF, the particular SPL range is 

selected and the impulse sound source 

is activated. The free field and IATF 

impulse waveforms are electronically 

captured simultaneously with their 

respective microphones. The Agency 

has determined that for each sample 

type a minimum of five protectors will 

be tested. Each protector will be 

removed and refitted on the IATF for 

testing at each of the three impulse SPL 

ranges. 

The third part of the proposed 

procedure is the calculation of the 

impulse sound reduction. The transfer 

function computed from the calibration 

waveforms is used to transform the freefield impulses to their counterparts at 

the location of the IATF microphone, 

absent the acoustic disturbances that 

result from the IATF. The transfer 

function effectively yields a filter that 

adjusts both the frequency amplitude 

response and the phase response of the 

free-field wave to account for 

differences due to the response of the 

ear simulator and resonance of the IATF 

ear canal. The waveforms from the IATF 

measured underneath the hearing 

protector and the transformed free-field 

waveforms are evaluated to identify the 

maximum peak sound pressures in both 

pairs of waveforms. The difference in 

decibels yields the peak reduction for a 

single trial of a protector and impulse 

SPL range. Once each of the waveform 

pairs has been evaluated, the maximum 

and minimum peak sound reductions 

across the range of levels would be 

determined for use in developing the 

NRRs. 

d. Computation of the Noise Reduction 

Rating (NRR) 

Manufacturers of amplitude sensitive 

devices are required to measure the 

passive REAT performance levels under 

the device with the electronics turned 

on and turned off for all test subjects. 

For ear muffs and helmets, where it is 

possible to use the MIRE technique, the 

levels will be measured for all test 

subjects. For ear plugs, the testing lab is 

required to perform repeated placement 

and replacement fittings of the device 

on the acoustic test fixture. The 

laboratory must conduct as many 

repeated measurements as required for 

the number of subjects tested. 

VII. Noise Reduction Rating Strategies 

This proposed regulation sets forth a 

new rating scheme that, while 

preserving the current NRR rating 

metric (e.g. a numeric rating of 

effectiveness), is expanded to provide 

the ultimate user and hearing 

conservation specialist with additional 

information regarding the potential 

range of protector effectiveness based on 

the users’ ability to achieve proper fit. 

The single number Noise Reduction 

Rating has been the focus of attention 

since promulgation of 40 CFR Part 211 

subpart B, in 1979. Initial concerns 

ranged from a lack of understanding of 

the relationship between NRR and 

hearing protection, to concerns that 

such numeric ratings would result in a 

‘‘rating war’’ within the hearing 

protector industry. While both 

situations have occurred intermittently 

since 1979, the user population has 

become increasingly informed in the use 

of the NRR, particularly the hearing 

conservation community. Manufacturers 

have concluded, for the most part, that 

products of like designs are very close 

in performance. Thus, marketing skills 

and pricing are the major influences 

affecting market share. 

The EPA has paid considerable 

attention to the ‘‘user-friendly’’ 

elements of the required label. The 

Workshop Report served to provide 

valuable suggestions for improvement. 

The Agency recognizes that the user 

community encompasses a wide range 

of applications from very infrequent use 

(home shop tools & lawn care) to daily 

use (workplace). Consequently, a userfriendly label must satisfy the needs and 

levels of understanding across this 

broad spectrum of applications. To this 

end, the Agency is proposing a 

significant change to the label content 

and numerical rating scheme, while 

retaining the now-familiar NRR 

acronym. 

A. HPD Rating Scheme 

The significant change in NRR, as 

proposed here, introduces a range of 

protection rather than a single value as 

required in the current regulation, in 

recognition of the fact that users may fit 

the device differently and thus obtain 

greater or lesser levels of protection than 

would be indicated by the single value 

NRR. The NRR is determined from the 

results of standardized tests using a 

representative sampling of human test 

subjects. The range is anchored by two 

NRR values that represent the ‘‘lesser’’ 

and ‘‘greater’’ levels of protection that a 

user may expect when the product is 

used as instructed by the manufacturer. 

The range of assumed protection is 

determined from sound attenuation 

measurements for narrow band noises 

centered at octave-band center 

frequencies from 125 to 8000 Hz. The 

resultant measured attenuations for each 

test subject are used to develop a 

statistical rating (20 subjects for all 

devices except earmuffs and helmets 

which use 10 subjects). The lesser 

sound attenuation rating estimates the 

protection achieved by at least 80 

percent of the test subjects (80th 

percentile). The greater sound 

attenuation rating estimates the 

protection achieved by at least 20 

percent of the test subjects (20th 

percentile). 

B. Labeled NRR Values 

The diversity of hearing protector 

designs and intended uses is 

significantly greater today than 30 years 

ago when HPDs were predominantly 

passive. Today’s devices incorporate 

specially formulated materials, 

ergonomic designs, sophisticated 

electronic circuitry and selective 

acoustic performance that provide 

hearing protection in a broad range of 

noise environments. In order to provide 

the ultimate user with information that 

will allow product selection based upon 

the user’s intended noise environment, 

the EPA has developed three separate 

NRR labeling schemes as presented 

below: 

1. Passive Hearing Protector: All 

hearing protectors provide a ‘‘passive’’ 

mode of protection against continuous 

noise. Therefore, EPA is proposing that 

the passive effectiveness of all HPDs be 

tested and rated. The passive mode of 

operation provides a basis for 

comparing the effectiveness of all 

protectors and establishes a benchmark 

against which other modes of 

performance (i.e. electronic and 

mechanically actuated) alter a product’s 

overall effectiveness. The NRR range of 

protection is depicted by a bar graph 

with end points representing the lesser 

and greater levels of protection. 

2. Active Noise Reduction (ANR) 

Hearing Protector: In addition to its 

passive range of protection, EPA is 

proposing that active hearing protector 

devices be tested and rated in their 

‘‘active’’ mode. The NRR range of 

protection in the active mode is also 

depicted by a bar-graph with end points 

representing the lesser and greater levels 

of protection. In this case, the label 

would contain two NRR ranges, one of 

passive mode operation, the second for 

active mode operation. 

The Agency has been advised by 

various manufacturers, NIOSH and the 

U.S. Air Force that the most significant 

noise reduction offered by ANR devices 

will be found at lower noise 

frequencies. On this basis, the Agency is 

proposing that the active noise 

reduction rating for both ear muffs and 

ear plugs be determined for 

predominantly low frequency noise. 

The purpose of choosing the low 


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15Reference ‘‘workshop report’’ in the Docket at 

http://www.regulations.gov, docket number EPA– 

HQ–OAR–2003–0024. 

frequency performance is to allow the 

end user to understand the potential 

advantage of the device in a noise field 

where the ANR device provides its best 

sound reduction performance. The 

Agency considered having three ratings 

for ANR devices (Passive performance, 

Active with broadband noise, and 

Active with low frequency noise). 

The EPA believes, subject to 

comment, that the small sound reducing 

benefit in broadband noise 

environments detracted from the real 

benefit afforded by these products— 

significant low frequency sound 

protection. Therefore, the Agency is 

proposing that labels on ANR devices 

only address their passive and low 

frequency active performance. If a 

manufacturer sells a product on the 

basis of its active noise reduction 

capability, then such product must be 

tested accordingly. 

3. Impulsive Noise Hearing Protector: 

In addition to their passive range of 

protection, hearing protector devices 

that are intended for use in high-level 

impulsive noise environments (greater 

than 140 dBA), must be tested and rated 

in such noise environments. The label 

will present two NRR ranges, one for the 

standard passive low-level noise 

reduction and a second for the highlevel impulsive noise reduction. The 

impulsive NRR range will represent the 

lesser and greater levels of assumed 

protection in such environments. If the 

device is an active hearing protector, it 

must be tested and rated in its active 

mode in the high impulsive noise 

environment. If a manufacturer sells a 

product on the basis of its impulsive 

noise reduction capability, then such 

product must be tested accordingly. 

4. Communication Headsets 

Incorporating Hearing Protection: Under 

the proposal, communication headsets 

would be required to have a Noise 

Reduction Rating label if the device is 

sold in whole or in part for the purpose 

of providing hearing protection. 

Communication headsets sometimes 

have a NRR rating but many sold in the 

United States do not. If a manufacturer 

sells a product on the basis of its 

acoustic noise reduction effectiveness 

then the Agency believes that 

purchasers and users of these devices 

are entitled to know the hearing 

protection that such devices offer, prior 

to purchase or use. EPA is also 

proposing that if the device incorporates 

active noise reduction circuitry, sound 

restoration circuitry and/or level 

limiting circuitry (i.e. is not merely a 

passive HPD), then the appropriate 

impulse noise reduction and/or active 

noise reduction test(s) must be 

conducted. The EPA believes this 

testing and labeling is particularly 

important for communication headsets 

used in the general aviation industry 

where pilot and ground crew may 

experience noise exposure for extended 

periods. 

C. Noise Reduction Rating Calculator 

The Noise Reduction Rating 

Calculator (NRRC) is an EPA/NIOSHdesigned executable program that will 

allow manufacturers to calculate their 

products’ NRR’s by inputting their HPD 

attenuation measurements, which are 

obtained from the testing laboratory. 

The NRRC will generate a NRR test 

report. The intent of the NRRC is to 

afford manufacturers the ability to verify 

the NRR values from the laboratory test 

data prior to having their products 

labeled. This tool is a free downloadable 

product that will be made available to 

manufacturers via the EPA Web site. 

The use of this tool is voluntary and 

will serve no other purpose than a 

verification mechanism of the laboratory 

test results and the labeled NRR values. 

VIII. Label Format and Content 

The Agency has received a range of 

comments from interested parties 

regarding the current required primary 

and secondary product labels and their 

content.15 The comments were 

relatively narrow in focus with 

principal attention directed at EPA’s 

mandated statements, their technical 

accuracy and usefulness to both 

ultimate users and hearing conservation 

professionals. The Agency 

acknowledges that any mandated 

information must accurately reflect the 

performance and intended use of the 

product and do so in a manner that is 

understandable by the ultimate user. To 

this end the Agency is retaining the 

requirements set forth in 40 CFR, Part 

211, subpart B, but is proposing 

significant changes to the information 

content, format, and mandated 

statements of both the primary and 

secondary labels. 

A. Primary Label 

The intent of the primary label is to 

provide any purchaser or user with 

readily visible information (on the 

package exterior) upon which they may 

make an informed decision regarding 

the effectiveness of the product relative 

to their specific hearing protection 

needs. To this end, the proposed 

regulation will require a more 

informative primary label that provides 

a range of the noise reduction 

effectiveness as opposed to the single 

NRR value required currently. The label 

will identify the protector’s intended 

function (Passive, Active, or Impulsive) 

and provide the respective range(s) of 

effectiveness afforded by the product. 

The range will be presented as a bar 

graph with endpoints representing the 

estimated lesser and greater levels of 

effectiveness. In addition, the primary 

label will contain an explanation of the 

product’s intended function, use 

environment, and determination of 

levels of protection based on the 

effectiveness rating(s) (NRR). Where 

appropriate, a caution statement that 

speaks to the potential unintended use 

of the product is provided. The label 

will identify the manufacturer and its 

relevant contact information, the 

protector model, and the mandated EPA 

prohibition and regulatory 

authorization. 

There are a number of products that 

fit into or over a person’s ears to 

provide, for example, relief from sleep 

disturbance, prevent water entry during 

swimming or to enhance the listening 

quality of music and video dialogue 

presentations. While not designed or 

intended for use as hearing protection 

devices, their similarity in appearance 

to bonafide HPDs may result in their 

inadvertent purchase or use for hearing 

protection due to the marketing 

language on the product label. While 

these products may offer some level of 

noise reduction to the user, they are not 

designed nor intended for the protection 

of hearing and thus are not subject to 

this proposed regulation. However, to 

the extent that a product manufacturer, 

importer, packager or any other party 

introduces into U.S. commerce any 

product that incorporates an explicit or 

implicit claim that it can protect the 

hearing of the user, or stipulates the 

level of acoustic sound reduction 

offered by it, then such product is 

subject to the testing and labeling 

requirements of this proposed 

regulation. 

For companies that sell their products 

exclusively via the internet, the primary 

label must be visible to the purchaser at 

the time of the sale to ensure that the 

purchaser is fully aware of the product’s 

NRR values. The primary label would 

replicate the appropriate format, as 

identified in § 211.204–1, and be 

automatically downloaded to the 

purchaser with the sale confirmation 

document. This proposal implements 

the requirements of section 8 of the Act 

that ‘‘the Administrator shall by 

regulation require that notice be given to 

the prospective user of the level of the 

noise the product emits, or of its 

effectiveness in reducing noise’’. This 


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authority is not limited by the medium 

by which HPDs are marketed and sold. 

B. Secondary Label 

The intent of the secondary label is to 

provide an in-depth explanation to 

experienced users and/or hearing 

conservation professionals of the HPDs 

functional performance, noise reduction 

capabilities and, where appropriate, 

unique features. Consistent with the 

1979 regulation, the secondary label is 

to be located within the individual 

product packaging or, in the case of bulk 

packaging, affixed to the exterior of the 

bulk container. In the case of the newly 

proposed electronic labeling, the 

secondary label must be readily 

viewable on the manufacturer’s webpage along with the primary label and 

be automatically downloaded to the 

purchaser with the sale confirmation 

document. The secondary label would 

include various mandatory data tables, 

product performance graphics, 

examples of calculations to determine 

specific levels of protection and 

information regarding the products use 

and limitations. 

The Agency is proposing the 

following product specific information 

and mandatory statements: 

1. All devices (PASSIVE mode): 

provide the products octave band 

attenuation and standard deviations and 

graphical and tabular presentations of 

the variability of the products NRR for 

different frequency spectra (Spectral 

Balance). This information is important 

to hearing conservation programs where 

protection is selected to reduce user 

exposure to particular sounds in the 

noise environment. 

2. All devices (PASSIVE mode): 

provide the statement ‘‘When this 

device is used as instructed, the 

approximate range of noise levels 

entering a user’s ears may be 

determined by the differences between 

the lesser and greater NRRs and the Aweighted environmental noise level.’’ 

3. ACTIVE devices: provide the 

variability of the NRR with spectral 

balance for the device operating in its 

PASSIVE and ACTIVE modes 

(electronics turned on and off). 

4. ACTIVE devices: provide the 

following statement ‘‘When this device 

is used as instructed and operated in its 

passive mode, the level of noise entering 

a person’s ears is approximated by the 

differences between the A-weighted 

environmental noise level and the lesser 

and greater PASSIVE NRRs. When this 

device is operated in its active mode, 

the level of noise entering a person’s 

ears is approximated by the difference 

between the A-weighted environmental 

noise level and the lesser and greater 

ACTIVE NRRs.’’ 

5. ACTIVE devices: provide the 

statement ‘‘This device, in its ACTIVE 

mode, is recommended for use in 

environmental noise levels from X to Y 

dBA.’’ X and Y are to be designated by 

the manufacturer since only the 

manufacturer knows the design 

limitations of the noise cancellation or 

sound augmentation of the electronic 

circuitry incorporated in the device. 

6. IMPULSIVE devices: provide a 

graphical and tabular presentation of the 

impulsive noise reduction for impulses 

with peak sound pressure levels that 

range between 130 and 170 dBA sound 

pressure level (re 20 μPa). This peak 

sound pressure range is designated by 

the testing protocol that is set forth in 

the proposed regulation. Testing to peak 

sound pressure levels in excess of 170 

dBA would require specialized 

equipment and testing environment 

which may not be readily available to 

commercial testing laboratories. 

7. IMPULSIVE devices: provide the 

statement ‘‘This device is recommended 

for use in impulsive noise environments 

having peak levels from 130 to X dBA 

SPL.’’ The Agency acknowledges that 

products are available for use in 

impulsive noise environments that 

exceed the maximum sound pressure 

level specified in the proposed 

regulation. Consequently, testing and 

labeling for levels in excess of the 170 

dBA will be allowed provided the 

manufacturer designates the upper noise 

limit (X dB) and the test protocol that 

was used to determine the effectiveness 

rating (NRR). 

8. IMPULSIVE devices: for reasons 

stated in numbers 6 and 7 above this 

statement must be provided ‘‘Caution: 

This device is not intended for use in 

impulsive noise environments 

exceeding X dBA peak sound pressure 

levels (as determined by the 

manufacturer). Repeated exposures to 

high peak impulsive sound pressure 

levels may result in hearing loss.’’ 

9. Devices that have not been tested 

for impulse noise reduction rating: 

provide the statement ‘‘The PASSIVE 

Noise Reduction Rating is based on the 

attenuation of continuous noise and is 

not an accurate indicator of the 

protection attainable against impulsive 

noise. The IMPULSIVE Noise Reduction 

Rating is based on the attenuation of 

high-level impulsive noise and is not an 

accurate indicator of the protection 

attainable for continuous noise.’’ 

10. All devices except IMPULSIVE: 

provide the statement ‘‘Caution: For 

predominantly low frequency noise 

environments in which the difference in 

the measured C-weighted and Aweighted noise levels (dBC–dBA) 

exceeds 3 dB, the user should refer to 

the enclosed graph of the variability of 

noise reduction with noise spectra to 

determine the level of protection.’’ 

IX. Compliance Requirements 

EPA is proposing that all hearing 

protection devices manufactured after 

the effective date of this regulation, and 

meeting the applicability requirements 

of section IV, must be labeled prior to 

entry into U.S. commerce. The Noise 

Reduction Ratings, as determined by the 

designated test procedure, must be 

readily visible to the purchaser or the 

ultimate user, on the exterior of the HPD 

package, bulk container or at its point of 

sale. The advent of the internet has 

introduced a new ‘‘point of sale’’ of 

products to the public. In recognition of 

this new sales mechanism the EPA is 

proposing to allow ‘‘electronic labeling’’ 

of hearing protector devices that are 

sold exclusively via the internet. As 

noted above, regulating the content of 

electronic labels is consistent with 

EPA’s broad authority to give users 

notice of noise levels and HPD 

effectiveness. Moreover, although the 

Act’s labeling requirements refer to 

labels being affixed to a product or its 

container, the requirement that these 

electronic labels be provided to users at 

the time of sale is equivalent to labels 

being affixed to the product—fulfilling 

the Act’s evident purpose of providing 

users with needed information at the 

time of sale so as to allow for a 

considered decision. The proposed 

electronic labeling must comply with all 

provisions attendant to both the 

‘‘primary’’ and ‘‘secondary’’ labels. 

A. Transition Testing Requirements 

The proposed regulation will require 

testing and labeling procedures 

significantly different than required by 

the 1979 regulation. Consequently, after 

the effective date of this regulation all 

HPDs must be tested to determine their 

respective NRRs in accordance with 

these new test protocols. Testing will be 

conducted on protectors selected from 

the product lot (batch) of protectors that 

are scheduled for entry into commerce 

on or after the date of the transition test. 

The manufacturer will be required to 

submit the test results to the Agency 

within ten (10) business days of the 

transition test date. The Agency 

recognizes that the industry is 

composed of manufacturers that have 

single or multiple HPD product lines 

with various functions that will need to 

be tested. The Agency identified 

approximately 1,029 different HPD 

products currently for sale in the U.S., 

including 403 models of earplugs or 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39161 

16U.S. Environmental Protection Agency. 2008. 

Cost Analysis for Proposed Labeling Regulation of 

Hearing Protection Device Industry. EC/R Inc. 

Chapel Hill, NC. 

17National Institute for Occupational Safety and 

Health (NIOSH)/EPA Interlab Study Comparison of 

ANSI S12.6, Method A and B. Refer to the Federal 

Docket at http://www.regulations.gov, docket 

number EPA–HQ–OAR–2003–0024. 

semi-aural devices, 572 models of 

earmuffs sold either alone or 

incorporated into communication 

headsets and 54 models of active noise 

reduction devices. Of these 1,029 HPDs, 

an additional impulse noise reduction 

test would be required for 

approximately 156 products. 

Based on information obtained from 

industry sources, the EPA estimates 

approximately 20 percent of the 

products will be tested in-house by their 

respective manufacturers. The 

approximately 80 percent of remaining 

products are expected to be tested by 

two independent testing laboratories 

and by two manufacturer laboratories 

that test for fee. Based on information 

from both in-house and independent 

testing laboratories, the Agency 

estimates the testing capacity for a 

single laboratory to be between 150 and 

200 products per year.16 Assuming there 

are 1,029 existing HPDs plus an 

arbitrarily estimated 50 new products to 

be tested and labeled, the average yearly 

demand on each of the four testing 

laboratories would be about 108 

products. Consequently, the Agency 

believes that the available testing 

laboratories can carry out all required 

transition testing within thirty (30) 

months from the effective date of this 

proposed rule. In addition, we believe 

that a period of thirty (30) months from 

the effective date of this proposed rule 

will provide adequate time for 

manufacturers to deplete their 

inventories of product that was tested 

and labeled pursuant to the 1979 

regulation. Since manufacturers have 

discretion to select the order in which 

their products are to be tested and 

labeled, we believe that full compliance 

with the proposed rule can be achieved 

within thirty (30) months without any 

disruption in the availability of any 

product category. 

B. Recurrent Testing Requirements 

The current regulation requires that 

HPDs be tested and rated only once in 

the lifetime of the product category. 

While a manufacturer may claim that a 

specific product has not been changed 

from its initial design, fabrication/ 

assembly technique or materials, the 

EPA believes that economic factors 

associated with any one or combination 

of these elements can produce changes 

in product performance. 

EPA is proposing to require recurrent 

testing for all product categories subject 

to this proposed regulation. The 

purpose of recurrent testing is to 

provide a comparison of effectiveness 

ratings of a product over a period of 

time and to ensure that product labels 

accurately reflect current effectiveness. 

To insure the continuing validity of the 

effectiveness rating (NRR) and to 

recognize changes in product design or 

use, manufacturers will be required to 

retest their products on a periodic basis 

and to relabel as necessary. For the 

purpose of the cost analysis two 

recurrent testing periods, three and five 

years were considered. 

Relabeling of a protector would be 

required if the recurrent test yields a 

lesser and/or greater NRR that is more 

than 3 dB different from the 

corresponding transition or new product 

NRR values given on the product label. 

The basis for a 3-dB criterion to initiate 

the relabeling requirement is two fold. 

First, a 3-dB change in attenuation can 

either double or halve the effective 

protection of a device. Second, the 

variability of the effectiveness rating for 

earplugs and earmuffs was found to be 

approximately 3 dB according to the 

EPA/NIOSH interlaboratory study.17 To 

this end the Agency is proposing that all 

HPDs be retested every five (5) years 

after the date of their respective 

transition test and each recurrent test 

thereafter. Since it is believed that 

manufacturers will time-stream the 

testing of their product categories, the 

first recurrent test could occur as early 

as approximately sixty-one (61) months 

and as long as ninety (90) months after 

the effective date of this proposed 

regulation. 

The Agency believes that linking the 

recurrent testing to the transition test 

and subsequent recurrent tests, rather 

than the effective date of the regulation, 

will allow manufacturers to stagger their 

testing and thus minimize testing 

burdens during any one period of time. 

For the purpose of recurrent testing, 

protectors would be selected by the 

manufacturer from the product lot 

(batch) of protectors that are scheduled 

for entry into commerce on the date of 

the required recurrent test. 

C. Product Change Retesting 

Requirement 

The Agency recognized in its current 

regulation that manufacturers may make 

product changes to take advantage of 

new materials, lower cost materials, 

more efficient manufacturing processes, 

etc. While the EPA supports any 

product change that may improve 

product performance, it has concern 

that such changes could serve to 

degrade product performance from its 

initial state. Therefore, the Agency is 

proposing to continue the product retest 

requirement if the manufacturer alters 

the product design, product materials, 

manufacturing process or takes any 

action that may alter the noise reduction 

performance of the product from its 

previous test state. Relabeling would be 

required if the recurrent test yields a 

lesser and/or greater NRR value(s) that 

differs by more than 3 dB from the 

current NRR value(s) given on the 

product label. The manufacturer will be 

required to submit the test results to the 

Agency within ten (10) business days of 

the change testing date. 

D. Compliance Audit Testing 

In the 1979 regulation, the EPA 

defined the basis on which the 

Administrator may order verification of 

the claimed performance of a product. 

Since the Agency is proposing 

mandatory retesting of all HPDs entering 

United States commerce, it is 

anticipated that an administrative order 

for verification testing will only be 

required in those cases where there is a 

reasonable basis to believe a 

manufacturer (or any party entering 

HPDs into U.S. commerce) or particular 

product is not in compliance with all 

requirements of the proposed rule. In 

such case, the compliance audit testing 

requirements of Subpart B, § 211.212 

would be ordered by the Administrator. 

Nothing herein, however, restricts the 

Administrator’s authority under section 

13 of the Noise Control Act. [42 U.S.C. 

4912] 

E. Maintenance of records and submittal 

of information 

The 1979 regulation required 

manufacturers, which include any party 

that enters a hearing protection device 

into commerce in the United States, to 

establish, maintain and retain 

adequately organized and indexed 

records that provide the basis for the 

claimed NRR values. These records 

included, in part: 

1. Identification and description by 

category parameters of protectors 

comprising the manufacturer’s product 

line. 

2. A complete record of all noise 

attenuation tests performed including 

all individual worksheets, and other 

documentation relating to each test 

required by the Federal test procedure. 

3. A description of any test 

procedures, other than those contained 

in this regulation, used to perform noise 

attenuation tests on any protector, and 

the results of those tests. 


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18U.S. Environmental Protection Agency. 1999. 

Economic Analysis Resource Document. RTP, NC: 

EPA. 

19The referenced report can be found in the 

Docket at http://www.regulations.gov, docket 

number EPA–HQ–OAR–2003–0024. 

4. A record, signed by an authorized 

representative of the testing laboratory, 

of any calibration that was performed 

during testing by the test laboratory. 

The manufacturer was able to fulfill 

this record retention requirement by 

keeping a copy of the labeling 

verification report. In addition, the 

current regulation limited testing to 

once in a products lifetime unless 

altered by design, materials or 

construction. This rather simplistic 

record keeping scheme was appropriate 

at a time when protectors were 

primarily designed as ‘‘passive’’ 

devices, prior to the advent of a plethora 

of new technology devices that will be 

available in the marketplace as a result 

of this proposed regulation. 

The Agency has determined that the 

complexity of device designs, their 

multi-mode performance and diverse 

testing protocols dictate the need for 

periodic retesting as discussed 

previously. In order to establish reliable 

baseline performance information for 

each device against which future 

performance can be compared, the EPA 

is proposing the manufacturer provide 

the Agency with their product test 

information, according to § 211.209–1, 

following each required product test. As 

required by the 1979 regulation, the 

manufacturer would still retain all 

required records for a period 

corresponding to the time interval 

specified by the recurrent testing 

schedule. Records may be retained as 

electronic or hard copy or reduced to 

microfilm, or other forms of data storage 

depending on the record retention 

procedures of the manufacturer. The 

manufacturer must submit to the EPA, 

in electronic or hardcopy format, a copy 

of all measurement information, test 

results and calculated lesser and greater 

NRRs obtained from the testing 

laboratory for each product or product 

category within ten (10) business days 

of completion of the required test. These 

test data would be maintained by EPA 

in the docket for this regulation and be 

available for public review. 

X. Cost Impact Analysis 

As part of EPA’s analysis in 

determining the feasibility and 

reasonableness of this proposal, EPA 

has carefully assessed its projected 

costs. Various Agency, Executive Office 

and Congressional policies, orders and 

mandates, respectively, specify the 

required analyses. The EPA’s Economic 

Analysis Resource Document provides 

guidance for economic analyses that 

support rulemaking.18

A traditional benefit-cost analysis for 

HPD labeling is not possible due to the 

diverse makeup of the user population 

and its use practices that preclude 

quantification. Because a major 

percentage of the 2.1 billion HPDs 

purchased annually by industry are 

disposable earplugs (approximately 1.94 

billion), the numbers strongly suggest 

that a ‘‘workplace’’ user may dispose of 

many pairs per day. This user practice 

does not lend itself to using product 

sales to quantify the user population 

that is requisite to a benefit–cost 

analysis. While the practice of disposal 

does not extend to the earmuff type HPD 

or to those HPDs that incorporate 

electrical or mechanical systems and 

thus are more costly, a benefit-cost 

analysis based on this latter user 

population would not be representative 

of the principal user population. 

Further, while product use inside the 

workplace may be mandatory in some 

sectors where they serve as alternatives 

to engineering solutions to employee 

noise exposure, HPD use may be 

voluntary in others; they are totally 

discretionary in the non-industrial 

sector, i.e., recreational activities, home 

workshop, home lawn care, etc. 

Finally, because the effectiveness of 

an HPD depends on the user’s ability to 

‘‘install’’ or fit the product as instructed 

by the manufacturer, it is difficult to 

estimate the level of hearing damage or 

loss avoided through the use of any 

specific product. 

In light of the above impediments to 

a traditional benefit-cost analysis, the 

EPA has carried out a cost impact 

analysis. This analysis indicates that the 

estimated cost impact of the proposed 

rule change will be well below the $100 

million annual economic impact 

threshold that would trigger a benefitcost analysis under Executive Order 

12866. 

The purpose of this cost impact 

analysis is to assess the costs which 

would be imposed by changes to the 

testing and labeling requirements and to 

evaluate the impacts of these costs on 

all parties subject to this regulation with 

particular emphasis on potential cost 

impacts on small businesses. The 

following sections provide a summary 

profile of the HPD industry and an 

assessment of those anticipated costs 

and potential economic impacts that are 

attendant to the proposed revisions. The 

detailed cost analysis report, entitled 

‘‘Cost Analysis for Proposed Labeling 

Regulation of the Hearing Protection 

Device Industry,’’ 19 is hereinafter 

referred to as the cost analysis report. 

A. Industry Profile 

The direct economic impacts of 

revisions to the labeling requirements 

will apply to all HPD manufacturers (as 

defined in § 211.203 of subpart B) that 

enter their products into U.S. 

commerce. Consequently, the potential 

cost impact could extend to foreign 

manufacturers that export to the United 

States, non-manufacturing packagers, 

and testing laboratories because the 

revisions include revised or new test 

methods. The following sections 

describe HPD products and markets, 

outline the market structure of this 

industry, and provide currently 

available information on HPD sales 

volumes in the U.S. 

1. Markets 

The main applications for hearing 

protection devices are in occupational 

settings, such as in industrial 

workplaces, military, law enforcement, 

forestry and landscaping, by musicians, 

in home hobby workshops and lawn 

garden activities and the aviation 

community. In the industrial workplace 

HPDs are frequently used in lieu of 

engineering controls, to comply with 

maximum employee noise exposure 

standards set by the OSHA. Absent 

engineering noise control measures or 

severe time limitations on employee 

exposure, there are no substitutes for 

HPDs to reduce human noise exposure. 

As stated previously, the Agency 

determined that the industrial sector 

purchases approximately 2.1 billion 

HPDs annually. The breakdown by 

product type is approximately 1.94 

billion disposable earplugs, 155 million 

reusable earplugs, 2.4 million semiaural inserts, and 3 million earmuffs. 

Although a detailed count of hearing 

protector types and quantities was not 

possible for the non-industrial sector, 

including the military and law 

enforcement, discussions with major 

U.S. manufacturers suggests this sector 

accounts for an additional 1.9 billion 

units annually. Thus, the combined 

industry and commercial market is 

estimated at approximately 4 billion 

units annually. 

Within the HPD categories, the choice 

of an ear plug, ear muff, or semi-aural 

device is largely dependent on the 

assumed level of protection, as 

indicated by the product NRR, cost, 

personal comfort and, product care 


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20Frost & Sullivan. 2005. U.S. Markets for 

Industrial Hearing Protection Products. 

requirements. For the general public the 

three types of HPDs can be easily 

substituted depending on user 

preference. However, for industrial 

workers the specific characteristics of 

the noise environment may dictate the 

appropriate HPD to comply with OSHA 

exposure requirements. 

2. Product Sales Volume 

The Frost & Sullivan market research 

group has estimated total sales of HPDs 

for the industrial market in the U.S. at 

$242.9 million.20 Table A–1 presents 

the estimated breakdown of the 

industrial HPD market among earplugs, 

semi-aural devices, and earmuffs, giving 

the estimated average wholesale price 

for each of these product types. As 

noted, earplugs account for about 75 

percent of the industrial market, 

earmuffs account for about 20 percent 

and semi-aural devices account for 

about 5 percent. Frost & Sullivan has 

estimated the average unit prices of 

HPDs at $0.06–0.07 for disposable 

earplugs, $0.36 for reusable earplugs, $5 

for semi-aural devices, and $16 for 

earmuffs. 

The Frost & Sullivan estimates do not 

include military or consumer uses of 

HPDs; consequently, monetary size of 

these markets was not available. 

However, based on limited information 

the Agency obtained from visits to 

various HPD manufacturers, it estimates 

the commercial/military market to be 

approximately 89 percent of the 

industrial market. It was not possible to 

obtain a breakdown of product 

categories, as in the case of the 

industrial market. However, the Agency 

believes that a conservative estimate of 

the total sales of HPDs for the 

commercial/military market in the U.S. 

to be $216.2 million. 

Information is not available on the 

size of the market for active noise 

reduction (ANR) HPDs or for 

communication headsets that also serve 

as HPD’s; under the 1979 regulation 

these products cannot be sold as 

‘‘hearing protection devices.’’ However, 

the Agency believes some sales of these 

devices may be included in the estimate 

of earmuffs produced for the industrial 

hearing protection, the music 

entertainment, and the aviation markets. 

TABLE A–1—ESTIMATED SALES OF

HPD FOR INDUSTRIAL APPLICATIONS

IN 2004a

Product type 

Total U.S. 

industrial 

sales 

(million $) 

Average 

wholesale 

price per 

unit 

($) 

Disposable 

earplugs ........ 126.3 0.06–0.07 

Reusable 

earplugs ........ 55.9 0.36 

Semi-aural inserts .............. 12.1 5 

Earmuffs ........... 48.6 16 

Total .............. 242.9 ....................

aSource: Frost & Sullivan.3

3. Industry Categorization 

The U.S. Census Bureau compiles 

economic statistics for manufacturing 

and trade sectors in the U.S. using the 

North American Industrial 

Classification System (NAICS), which 

has replaced the earlier Standard 

Industrial Classification (SIC) system. 

The NAICS and SIC codes can be used 

to retrieve company financial 

information from various market 

databases, such as Dun and Bradstreet 

and Thomas Register. 

The NAICS system includes HPD 

manufacturing and other personal safety 

manufacturing under the general 

miscellaneous manufacturing category 

339113, ‘‘Miscellaneous 

Manufacturing—Surgical Appliance and 

Supplies Manufacture.’’ Specifically, 

subcategory 3391136 within this 

category covers ‘‘Personal Industrial and 

Non-industrial Safety Equipment and 

Clothing,’’ including ‘‘personal noise 

protector manufacturing.’’ Similarly, the 

SIC system classified HPD 

manufacturing under category 3842, 

‘‘Orthopedic, Prosthetic, and Surgical 

Appliances and Supplies,’’ and 

subcategory 38423, ‘‘Personal Industrial 

Safety Devices.’’ 

Most manufacturers of HPDs list the 

general miscellaneous manufacturing 

category 339113 as their primary NAICS 

code. However, some manufacturers 

also manufacture other products, and 

determine their primary NAICS on the 

basis of these other products. For 

instance, many manufacturers of noise 

cancellation devices are also 

manufacturers of other electronic 

equipment. Similarly, some 

manufacturers of foam-based earplugs 

define their NAICS code based on the 

manufacture of polymer products. Table 

A–2 lists the various NAICS and SIC 

codes used by HPD manufacturers and 

distributors. 

TABLE A–2—NAICS AND SIC CODES GIVEN BY MANUFACTURERS AND WHOLESALERS OF HEARING PROTECTION

DEVICES a

NAICS 

code 

SIC 

code Description Number of companies 

Manufacturers 

339113 .................................................................................. 3842 Surgical Appliance and Supplies Manufacturing 22 

334290 .................................................................................. 3669 Other Communications Equipment Manufacturing 4 

334310 .................................................................................. 3651 Audio and Video Equipment Manufacturing ........ 2 

326112 .................................................................................. 3089 Plastics Packaging Film and Sheet (including 

Laminated) Manufacturing.

2 

325212 .................................................................................. 2822 Synthetic Rubber Manufacturing .......................... 1 

334514 .................................................................................. 3824 Totalizing Fluid Meter and Counting Device Manufacturing.1 

339932 .................................................................................. 3944 Game, Toy, and Children’s Vehicle Manufacturing.1 

334220 .................................................................................. 3663 Radio and Television Broadcasting and Wireless 

Communications Equipment Manufacturing.

1 

334419 .................................................................................. 3679 Other Electronic Component Manufacturing ........ 1 

339111 .................................................................................. 3821 Laboratory Apparatus and Furniture Manufacturing.1 

325211 .................................................................................. 2821 Plastics Material and Resin Manufacturing .......... 1 


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21Franks JR, Graydon PS, Jeng C, Murphy WJ, 

‘‘NIOSH Hearing Protector Device Compendium,’’ 

http://www2d.cdc.gov/hp-devices/hp_srchpg01.asp 

(2003). as of July 6, 2008. 

22Frost & Sullivan. 2005. U.S. Markets for 

Industrial Hearing Protection Products. 

23Thomas Publishing (Thomas Register), 

ThomasNet: Hearing Protection Devices, Accessed 

July 31, 2007, http://www.thomasnet.com 

24Telephone Contact Report. Deering, A., EC/R 

Incorporated, with Graydon, P., NIOSH. September 

20, 2004. 

25 International Trade Administration. 339113 

Surgical Appliance & Supplies: Customs Value by 

Customs Value for ALL Countries. http:// 

TABLE A–2—NAICS AND SIC CODES GIVEN BY MANUFACTURERS AND WHOLESALERS OF HEARING PROTECTION

DEVICES a—Continued 

NAICS 

code 

SIC 

code Description Number of companies 

333514 .................................................................................. 3544 Special Die and Tool, Die Set, Jig, and Fixture 

Manufacturing.

1 

339115 .................................................................................. 3851 Ophthalmic Goods Manufacturing ........................ 1 

Wholesalers 

423450 .................................................................................. 5047 Medical, Dental, and Hospital Equipment and 

Supplies Merchant Wholesalers.

3 

423990 .................................................................................. 5099 Other Miscellaneous Durable Goods Merchant 

Wholesalers.

1 

423860 .................................................................................. 5088 Transportation Equipment and Supplies (except 

Motor Vehicle) Merchant Wholesalers.

1 

423840 .................................................................................. 5085 Industrial Supplies Merchant Wholesalers ........... 1 

541710 .................................................................................. 8731 Research and Development in the Physical, Engineering, and Life Sciences.1 

423 ........................................................................................ 5065 Wholesalers of Electronic Parts and Equipment 1 

aSource: Dunn and Bradstreet database. 

4. U.S. Manufacturers 

The EPA has identified 96 companies 

that it believes to be suppliers of HPDs 

in the U.S. market under their own 

brand names. Of the 96 companies, 34 

produce or sell only one or two 

products. Another 31 companies 

produce or sell 3 to 10 products, and the 

remaining 31 companies produce or sell 

more than 10 different products. These 

products may be of the same category, 

i.e. ear plugs, ear muffs, ANR, or 

impulsive or encompass all categories. 

This list was compiled from the NIOSH 

Hearing Protection Device 

Compendium,21 trade association 

directories and buyer’s guides and from 

market databases. A search of the 

internet was also conducted to identify 

companies advertising themselves as 

manufacturers of HPDs. The 

International Safety Equipment 

Association (ISEA) provided the Agency 

with information regarding private 

labeling of products from various major 

HPD manufacturers. A list of these 

manufacturers is given in the EPA cost 

analysis report. Most of the 

manufacturers of HPDs also 

manufacture other personal safety 

equipment, such as helmets, respirators, 

and face shields. Manufacturers of 

electronic noise cancellation systems 

generally also manufacture other 

electronic equipment. Similarly, the 

manufacturers of communications 

equipment, which include built-in HPD 

components, generally also manufacture 

other electronic equipment such as 

communications equipment. 

Although there are many 

manufacturers supplying the HPD 

market in the U.S., available 

information suggests the industrial HPD 

market is dominated by a small number 

of companies. Frost & Sullivan estimates 

that three companies account for about 

78 percent of the industrial HPD market. 

The Agency was unable to quantify 

market share for the commercial/ 

military HPD market. 

This type of market structure, with a 

small number of suppliers accounting 

for most of the industrial HPD market, 

is termed an oligopoly, where prices 

generally remain relatively stable. If one 

of the three major firms drops its price, 

all other firms will quickly follow suit 

and equilibrium is re-established 

without any change in market share. If 

a firm chooses to increase its price, the 

other firms will stay where they are and 

quickly take a portion of the original 

firm’s market share. Thus, firms tend to 

keep their prices at a stable level, as 

evidenced by the fact that average prices 

of HPDs have been stable from 2001– 

2004.22 However, some manufacturers 

serve niche markets, such as custom-fit 

or special needs hearing protector 

devices, i.e. helmets, where they may 

have flexibility to raise prices and pass 

along regulatory costs due to limited 

competition. 

5. Distributors and Packagers 

Manufacturers of HPDs generally sell 

their products to distributors of safety 

equipment or industrial supplies, rather 

than directly to industrial users. 

According to the Thomas Register there 

are at least 220 distributors in the 

United States,23 resulting in a less 

concentrated market than that of 

manufacturers. 

NIOSH estimated there are at least 20 

packagers, or ‘‘private labelers,’’ of 

HPDs in the U.S.24 In many cases the 

primary manufacturer will package his 

product with the private label of a 

distributor or retailer such as 

supermarkets and home supply chains. 

In other cases the packagers or private 

labelers will purchase, in bulk, HPDs 

that they then package under their 

private label in smaller quantities or as 

individual pairs of HPDs for retail sale. 

Some private labelers go so far as to 

change the color of their product from 

that of the original manufacturer in 

order to establish or preserve their 

private brand identity. 

6. Imports to the U.S. 

A number of foreign manufacturers 

supply HPDs to the U.S. industrial and 

consumer markets. EPA has identified 

seven manufacturers in Canada and 

Europe and 18 manufacturers in Asia.23

The Agency believes there may be 

others but is unable to obtain a reliable 

identification or count. 

The International Trade 

Administration (ITA) publishes 

statistics on imports and exports for 

different NAICS codes. Total U.S. 

imports for NAICS code 339113 in 2004, 

were estimated at $4.7 billion.25


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www.ita.doc.gov/td/health/imp339113.htm 

Accessed October 17, 2007. 26 International Trade Administration, Surgical 

Appliances and Supplies Manufacturing (NAICS 

339113), http://www.ita.doc.gov/td/industry/otea/ 

industry_sector/tables_naics/339113.htm 27 International Trade Administration. 339113 

Surgical Appliance and Supplies: U.S. Domestic 

Exports. http://www.ita.doc.gov/td/health/ 

exp339113.html Accessed October 17, 2007. 

28 International Trade Administration. 339113 

Surgical Appliance and Supplies: U.S. Domestic 

Exports. http://www.ita.doc.gov/td/health/ 

exp339113.html Accessed October 17, 2007. 

29U.S. Census Bureau, 2002 Economic Census, 

Manufacturing Industry Series: Surgical Appliance 

and Supplies Manufacturing, EC02–311–339113 

(RV), 2002, http://www.census.gov/prod/ec01/ 

ec023li339113.pdf. 

30U.S. Census Bureau, Quarterly Financial Report 

for Manufacturing, Mining, and Trade 

Corporations, QFR/06–Q1, 2006, http:// 

www.census.gov/prod/2006pubs/qfr06q1.pdf. 

31Faison, C. Douglas. What is the National 

Institute of Standards and Technology. National 

Voluntary Laboratory Accreditation Program 

(NVLAP)? May 2006. http://ts.nist.gov/Standards/

upload/What-is-the-NVLAP.pdf. 

However, this figure is not restricted to 

HPDs and includes other personal safety 

equipment, clothing, and surgical 

supplies. For comparison, the total 

volume of shipments in 2001 for 

domestic manufacturers in NAICS code 

339113 was approximately $18.9 

billion.26 Thus, imports are about 25 

percent of domestic production for the 

overall NAICS category (including 

HPDs, other safety equipment, and 

surgical supplies). The majority of the 

imports in NAICS code 339113 are from 

Mexico, China, Taiwan, and Canada. 

The impact of these foreign imports 

on the U.S. market is unclear as the 

quantity imported to the U.S. cannot be 

readily determined. Considering that 

three or four companies hold the larger 

market share of industrial HPDs, the 

impact of foreign manufacturers on the 

industrial market is believed to be 

small. The Agency believes these latter 

imports are primarily directed toward 

the public consumer market through 

retailers. 

7. U.S. Exports 

Exports from the U.S. in 2004 for 

NAICS code 339113 have been 

estimated at $4.8 billion.27 This is about 

25 percent of estimated total domestic 

production in that category.28 However, 

as noted previously, this category 

includes a number of products in 

addition to HPDs. 

B. Costs of Production 

The U.S. Census Bureau compiles 

information on production costs and 

income for manufacturing industries in 

the U.S. The Census’s Manufacturing 

series gives estimates of production 

costs for various industrial categories 

and subcategories. Table B–1 presents 

cost estimates for NAICS code 339113, 

which covers surgical appliance and 

supplies manufacturing and personal 

safety equipment. In addition, the table 

shows the estimated cost breakdown for 

the ‘‘Personal Industrial and 

Nonindustrial Safety Equipment and 

Clothing’’ subcategory (coded as 

subcategory 3391136). Production costs 

in this category are estimated as 18 

percent of sales for labor, 47 percent for 

materials, and 3 percent for capital 

investment.29 However, these costs may 

not include certain elements, such as 

cost of sales. 

The Census’s Quarterly Financial 

Report series gives income estimates 

and other financial information for 

broader industrial categories. In this 

series, information is available at the 

level of NAICS code 339, 

‘‘Miscellaneous Manufacturing.’’ Within 

this category, estimated income from 

operations in 2006 was 11.4 percent of 

net sales. For small companies in this 

category, estimated income was 5.1 

percent of net sales.30

TABLE B–1—ESTIMATED COSTS OF PRODUCTION AND NET INCOME AS A FRACTION OF SALES FOR SAFETY EQUIPMENT

MANUFACTURE AND MISCELLANEOUS MANUFACTURE a

Quantity 

Estimated costs and income as a fraction of the total value of shipments (%) 

NAICS code Labor cost Cost of materials 

Capital investment Total costs b Income from 

operation 

Surgical Appliance and Supplies Manufacture 

(including personal safety equipment) ............. 339113 18 30 3 51 

Personal industrial and nonindustrial safety 

equipment and clothing subcategory ............... 3391136 18 47 3 68 

All miscellaneous manufacturing, all companies 339 ...................... ...................... ...................... ...................... 11.4 

Small miscellaneous manufacturing c .................. 339 ...................... ...................... ...................... ...................... 5.1 

a Source: Census Bureau b These costs include labor, materials, and capital investment. Certain other costs such as costs of sales may not be included. c For the purposes of this Census survey, small companies have been defined as companies with less than $25 million of assets. 

1. Hearing Protector Testing 

Laboratories 

The 1979 regulation requires the 

devices be tested to determine their 

effectiveness. As stated previously, 

under the current rule, product 

effectiveness testing is required only 

once in a product’s life unless the 

product is altered in a way that may 

affect its sound reduction performance. 

EPA is proposing to require new test 

methods and recurrent testing 

throughout a product’s life to ensure the 

continuing accuracy of the labeled NRRs 

and other performance properties. 

Table B–2 provides a list of eight 

laboratories in the U.S. that perform the 

ANSI S3.19 tests required by the current 

regulation. The EPA believes that these 

laboratories will continue to test HPDs 

in accordance with the new ANSI S12.6 

standard specified in this proposed 

regulation. Four laboratories currently 

perform tests on a commercial basis for 

a fee; two are owned and operated by 

HPD manufacturers; and two are 

independent testing laboratories. The 

remaining four are U.S. government 

laboratories and, at this time, do not 

conduct testing for commercial 

organizations on a fee basis. However, 

the Agency believes that the new 

requirement for recurrent testing will 

stimulate the entry of additional testing 

laboratories to the market. 

Three of the laboratories listed below 

are accredited under the National 

Voluntary Laboratory Accreditation 

Program (NVLAP) managed by the 

National Institute of Standards and 

Technology (NIST).31 This 

accreditation, although not required by 

the EPA, is used by some companies in 

their advertisements to give increased 

credibility to their reported NRR values 

as compared to their non-accredited 

competition. The EPA is not requiring 

NVLAP accreditation of testing 

laboratories in this proposed regulation 


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because it does not believe that such 

accreditation significantly enhances the 

technical qualifications of the laboratory 

to carry out the required tests nor the 

quality of the test results. More 

important, the Agency believes that the 

initial and recurring annual 

recertification costs of such 

accreditation may have a chilling effect 

on the entry of new testing laboratories 

into the market. 

TABLE B–2—HEARING PROTECTION DEVICE TESTING LABORATORIES

Laboratory name Location NVLAP accreditation 

Currently carries out 

testing for a fee 

Aearo Corporation’s E–A–RCAL Acoustical Laboratory .............. Indianapolis, Indiana ................. Yes .......................... Yes. 

Howard Leight Acoustical Testing Laboratory ............................. San Diego, California ............... Yes .......................... Yes. 

Michael and Associates ............................................................... College Station, Pennsylvania .. Yes .......................... Yes. 

Auditory Systems Laboratory at Virginia Polytechnic Institute 

and State University (Virginia Tech.).

Blacksburg, Virginia .................. No ............................ * Yes. 

U.S. Air Force Research Laboratory ........................................... Wright-Patterson Air Force 

Base, Ohio.

No ............................ No. 

National Institute of Occupational Safety and Health (NIOSH) 

Robert Taft Laboratories.

Cincinnati, Ohio ........................ No ............................ No. 

NIOSH Pittsburgh Research Laboratories ................................... Pittsburgh, Pennsylvania .......... Yes .......................... No. 

U.S. Army Aero Medical Research Laboratory ........................... Fort Rucker, Alabama .............. No ............................ No. 

* The testing conducted at Virginia Polytechnic Institute is primarily focused on research. 

C. Cost Analysis 

To comply with the proposed rule the 

HPD industry will incur various costs 

beyond those that are attendant to the 

current rule. Information obtained from 

seven HPD manufacturers, selected as a 

representative cross-section of the 

industry, and two HPD testing 

laboratories, formed the initial basis for 

estimating the potential costs and 

economic effects of the proposed rule. 

Once word of EPA’s activities to revise 

the current regulation was heard by 

interested parties, a number of 

additional companies volunteered 

information. 

The questionnaire that was used in 

the formal interviews with the seven 

manufacturers and the list of companies 

providing information for this study are 

contained in the report, ‘‘Cost Analysis 

for Proposed Labeling Regulation of the 

Hearing Protection Device Industry’’. 

Information was also obtained from 

commercial market databases and 

advertising materials published by HPD 

manufacturers. The following sections 

discuss the estimated costs and 

potential economic effects of the revised 

labeling rule and the potential impacts 

on the HPD industry. A separate 

analysis of the potential cost impact on 

small entities is provided in section XI, 

paragraph C (Statutory and Executive 

Order Reviews) below. 

This proposed regulation would 

require all hearing protector devices to 

be tested and rated using new ANSI and 

EPA test methods. The proposed 

regulation will also require periodic 

label verification testing (recurrent 

testing), that is not required by the 1979 

regulation. As stated previously, EPA 

examined the recurring test intervals of 

three and five years to determine the 

effects on all size manufacturers. Based 

on this analysis the Agency is proposing 

recurrent testing every five years from 

the date of the transition test date. As 

discussed above, if recurrent testing 

reveals changes in NRR values in excess 

of the 3 dB criteria the product must be 

relabeled. In contrast, the current 

regulation only requires retesting and 

attendant label changes if the design, 

composition, or manufacturing process 

for a product changes its measured 

performance. 

1. Costs of Revised Testing and Labeling 

Requirements 

The cost analysis carried out for this 

proposed regulation includes the 

following elements: 

• Transition testing required for all 

existing HPD products using the new 

ANSI and EPA test methods and rating 

scheme. 

• Labeling all existing products to 

incorporate the new NRR range 

information and new label content; 

applicable to both primary and 

secondary labels. 

• Recurrent testing for all HPDs at 

either 3 or 5 year intervals. 

• Changing the label to reflect a new 

NRR range of any product for which the 

recurrent testing yields NRRs that are 

significantly lower or higher than 

previously stated on the products label. 

• Additional recordkeeping and 

reporting costs attendant to the periodic 

retests. 

a. Transition Testing and Labeling Costs 

Seven HPD manufacturers and two 

testing laboratories provided a range of 

estimates of the unit costs to test and 

label each of their HPD product lines. 

Some companies provided cost 

estimates based on their in-house test 

facilities. Others provided estimates 

based on historic charges from 

independent testing laboratories. Most 

companies provided cost data based on 

the existing test method; however, 

some, including one independent test 

laboratory, provided estimates based on 

their experience using the new ANSI 

method. 

Table C–1 summarizes the ranges of 

cost estimates for the existing test 

method and the new ANSI/EPA test 

methods. The table also presents the 

range of unit cost estimates developed 

from the information collected by this 

study to analyze the impacts of the 

proposed rule changes. Testing costs for 

earmuffs are given for each potential 

headband position. This means that if a 

particular earmuff can be worn with the 

headband in three different positions 

(behind-the-head, over-the-head, or 

under-the-chin), then three tests may be 

required—this analysis provides a 

conservative evaluation of costs since 

many manufacturers are expected to 

identify a preferred headband position. 

The testing cost estimates reflect the 

costs of testing using an outside 

laboratory, although several major 

manufacturers are expected to use their 

in-house testing facilities. 

The costs of testing using the new 

ANSI/EPA methods are estimated to be 

somewhat higher than the costs of 

testing using the 1979 standard for a 

number of reasons, the principal one 

being the requirement for twice as many 

test subjects. Testing costs are somewhat 

higher for earplugs and inserts than for 

earmuffs because of the need to train 

subjects on how to correctly insert the 

plugs into their ears. 

In addition, the table presents the cost 

estimates provided by the sampled 

companies for creating an entirely new 

product label to reflect the change from 


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32This cost figure includes the expense for both 

passive and active testing. 

33This cost is in addition to the required passive 

testing. 

34Personal Communication. Battye, W., EC/R 

Incorporated, with Erika Schmidt, The Frause 

Group. August 15, 2007. 

a single number NRR to a range of two 

NRRs. 

The ranges of cost estimates are quite 

broad, even for the existing test 

methods. This may be the result of 

changes in the unit cost of testing 

depending on the number of products 

tested at a given time; costs do not 

reflect potential savings afforded by the 

use of test subjects for multiple product 

tests. Further, the relatively large cost 

range for testing electronic noise 

cancellation (ANR) systems stems, in 

part, from uncertainties about the 

entirely new test method that is 

proposed here for those devices. The 

Agency is soliciting comment and cost 

estimates based on the proposed test 

protocols. 

TABLE C–1—ESTIMATED COSTS OF TESTING AND LABELING FOR EACH PRODUCT LINE

Device type Range of cost estimates given by industry sources ($) 

Range of estimates used in 

analysis ($) 

Testing: 

Existing test methods: 

Earplugs and semi-aural inserts ................................ 2,000–3,000 ............................................................................. 2,000–3,000 

Earmuffs and headsets (per headband position, excluding electronic noise cancellation systems).1,700–4,000 ............................................................................. 1,700–4,000 

Revised test methods: 

Earplugs and semi-aural inserts ................................ 2,800–4,000 ............................................................................. 2,800–4,000 

Earmuffs and headsets (per headband position, excluding electronic noise cancellation systems).2,000–4,000 ............................................................................. 2,000–3,000 

Electronic noise cancellation systems 32 .................... 2,500–10,000 ........................................................................... 2,500–10,000 

Impulse noise reduction 33 .......................................... 2,000–4,000 ............................................................................. 2,000–4,000 

Labeling: 

Initial label design and printing setup ................................ 5,000–10,000 to 25,000–48,000 .............................................. 5,000–10,000 

Modification of a label to change the NRR ....................... one manufacturer estimated this cost at 2,700–3,700, while 

others indicated that it would be the same as a complete 

label change.

2,700–5,000 

The proposed changes in the labeling 

rule are expected to result in a 

substantial increase in the volume of 

product testing. First, all HPDs are to be 

tested in accordance with the newly 

proposed ANSI and EPA/NIOSH 

standards. A transition-testing period of 

thirty (30) months following the 

effective date of this proposed 

regulation is expected to reduce the 

workload on existing testing facilities. 

Second, the Agency is proposing that all 

products must be retested periodically 

at five (5) year intervals from the 

completion of the respective transition 

test; the current regulation does not 

require such recurrent testing and label 

verification. As explained above, EPA is 

proposing a recurrent test period of 5 

years was selected to (a) provide a 

uniform testing period for all parties, (b) 

allow a longer time between transition 

test and first recurrent test for the less 

than three product line manufacturers, 

(c) provide manufacturers with more 

than two product lines adequate time to 

complete transition testing before first 

recurrent tests become necessary and (d) 

to amortize near-term testing costs over 

a reasonable period of time. 

The Agency believes the increase in 

testing volumes may result in lower per 

product testing costs than the current 

industry estimates in Table C–1 for two 

reasons. First, the Agency anticipates 

additional testing laboratories will enter 

the marketplace to satisfy the increased 

and continuing testing demand resulting 

from the recurrent testing requirement, 

thereby increasing price competition 

that may result in lower fees. Second, 

the increased volume may provide 

opportunities for improved testing 

efficiency due to economies of scale. 

However, for the purpose of this 

analysis, we have used the average cost 

estimates from Table C–1 to develop a 

conservative assessment. 

The Agency has also considered the 

required redesign of the label to display 

the results of transition testing using the 

new ANSI/EPA test methods and twovalue NRR effectiveness range. Most 

companies responding to the Agency’s 

questionnaire estimated the cost of 

developing new product labels to be 

between $5,000 and $10,000 per HPD 

model; one company estimated these 

costs at $25,000–48,000 (Table C–1). 

These estimates reflect design costs and 

fabrication of the necessary printing 

plates and the preparation of required 

revised secondary labels. The main 

source of variation in the cost estimates 

is the estimated time to develop the 

label design. However, since the EPA is 

specifying the design, format and 

content of the new label, the cost 

estimates for ‘‘creative’’ label designs 

are believed to be on the high side. 

Discussions with an independent source 

in the public relations field indicated 

the cost of label design can be expected 

to be the lower range of estimates given 

by industry representatives, i.e., $5,000– 

10,000.34

The Agency was particularly 

concerned with labeling costs that may 

be incurred by very small manufacturers 

and repackagers (one or two product 

lines). In assessing the marketing 

methods of this segment of the industry, 

the Agency believes that their point of 

sale is principally via the internet. 

Further, their customer base is primarily 

individuals or small groups that 

purchase their products for personal use 

only. It is primarily for this segment of 

the industry that the Agency has 

developed and is proposing the concept 

of ‘‘electronic labeling.’’ We believe that 

an electronic reproduction of the EPA 

label will eliminate the costs of art work 

and printing plates requisite to 

producing paper labels or printing on 

packaging for organizations that sell 

exclusively on the internet. The Agency 

also believes that electronic labeling 

will greatly simplify and reduce any 

future costs that would be incurred 

should recurrent testing dictate new 

NRR ratings for these small 

manufacturers. 

In light of the proposed recurrent 

testing requirement, we believe that 

NRR effectiveness ranges may require 

change from time to time. In that regard 


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35Franks JR, Graydon PS, Jeng C, Murphy WJ, 

‘‘NIOSH Hearing Protector Device Compendium,’’ 

http://www2d.cdc.gov/hp-devices/hp_srchpg01.asp 

(2003). as of July 6, 2008. 

36Murphy W.J., Byrne D.C., Gauger D., Ahroon 

W.A., Berger E., Gerges S.N.Y., McKinley R., Witt 

we have attempted to quantify the 

associated cost of relabeling. One 

company estimated the costs of 

relabeling to present a revised NRR 

range would be somewhat lower than 

the costs of developing the initial new 

label but was unable to quantify without 

a definitive cost estimate for the initial 

new label. However, other 

manufacturers believed the costs would 

be roughly the same as those associated 

with the new transition label. 

Table C–2 presents estimates of the 

nationwide costs of carrying out the 

transition testing in accordance with 

ANSI/EPA test methods. The table also 

presents cost estimates related to 

changing all existing product labels to 

reflect the new test results and label 

information. These estimates are 

derived using the unit costs given in 

Table C–1 and the estimated nationwide 

numbers of HPD currently being sold. 

The estimates are conservative in that 

they do not include any estimates of 

cost savings that may be realized 

through electronic labeling. The Agency 

identified approximately 1,029 different 

HPDs currently for sale in the U.S. The 

HPD population is believed to consist of 

403 earplugs or semi-aural passive 

devices, 572 passive earmuffs sold 

either alone or incorporated into 

communication headsets, 2 active noise 

reduction (ANR) earplugs and 52 active 

noise reduction (ANR) earmuffs. 

As required in subpart B, § 211.206– 

1, all HPDs must be tested in their 

‘‘passive’’ mode which yields 1029 

separate tests. In addition, those 54 

products identified as ANR will require 

a second test in their ‘‘active’’ mode. 

Finally, those 156 products identified as 

‘‘impulsive’’ will require a second test 

in a high intensity impulse noise 

environment where human test subjects 

are replaced by a test fixture. 

Consequently, 1239 separate tests must 

be carried out on the 1029 products. The 

difference between the number of HPDs 

given above and the actual number of 

tests given in Table C–2 represents 

products which are tested by the 

manufacturer and are labeled for sale by 

another entity which relies upon the 

manufacturer’s effectiveness data. 

Foreign manufacturers that export to the 

U.S. are included in our estimations. 

Even though the testing and 

manufacturing costs are incurred 

outside the U.S., any effects on prices 

due to the revised regulation may be 

passed along to the distributors in the 

U.S. These distributors, as previously 

mentioned, may pass along the price 

changes to the buyer. 

TABLE C–2—ESTIMATED NATIONWIDE COSTS OF TRANSITION PRODUCT EFFECTIVENESS TESTING AND LABELING

Product type Number of HPD 

tests 

Unit cost per 

HPD test ($) 

Estimated nationwide cost 

($1000) 

Testing 

Earplugs and semi-aural inserts ..................................................................................... 375 2,000–4,000 750–1,500 

Earmuffs and headsets .................................................................................................. 550 a 2,540–3,810 1,400–2,100 

Active Noise Reduction systems .................................................................................... 108 1,250–5,000 140–540 

Impulse noise reduction ................................................................................................. 156 2,000–4,000 310–620 

Subtotal ................................................................................................................... 1,189 .......................... 2,600–4,760 

Number of HPD 

products 

Unit cost per 

HPD product 

($) 

Estimated 

nationwide cost 

($1000) 

Labeling 

Earplugs and semi-aural inserts ..................................................................................... 375 5,000–10,000 1,880–3,750 

Earmuffs and headsets .................................................................................................. 550 5,000–10,000 2,750–5,500 

Electronic noise cancellation systems ............................................................................ 54 5,000–10,000 270–540 

Subtotal ................................................................................................................... 979 .......................... 4,900–9,790 

Grand total ....................................................................................................... .......................... .......................... 7,630–15,090 

aBased on a testing cost of $2,000–3,000 per headband position, and an average of 1.27 headband positions per product. 

The number of HPD products was 

estimated from reviews of 

manufacturer’s catalogs and 

advertisements (as published on the 

Internet). In addition, the NIOSH 

‘‘Hearing Protection Device 

Compendium’’ provided significant 

information on the HPD products sold 

in the U.S.35

Because earmuffs may sometimes be 

manufactured to be worn in different 

head band positions, the product must 

be tested in each position to determine 

whether their performance/attenuation 

is changed due to the position. When 

we account for the positions, and 

consider that each position requires 

another test, an average of 1.27 potential 

headband positions per product-line 

was used to estimate the number of 

headband position tests required for 

earmuffs. This factor is based on the 

average number of headband positions 

per product-line for all earmuff models 

included in the NIOSH Hearing 

Protector Device Compendium. 

b. Costs of Recurrent Testing and 

Relabeling 

Table C–3 presents estimates of costs 

for recurrent testing and potential 

relabeling of products due to measured 

changes in product NRR range. Unit 

costs of testing each HPD are the average 

industry estimates shown in Table C–1. 

Costs have been estimated for a three (3) 

and five (5) year recurrent testing 

interval. In each case we have assumed 

that testing will be spread evenly over 

the respective time period. Thus, for the 

3-year interval we assumed that one 

third of the HPD models will be tested 

each year, and for the 5-year interval, 

we assumed that 20 percent of HPD 

models would be tested each year. 

Based on analysis of inter and intra 

laboratory variations of product 

recurrent tests in a recent interlaboratory test program carried out by 

EPA and NIOSH,36 we estimate twelve 


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B., Krieg E.F. (2009). ‘‘Results of the National 

Institute for Occupational Safety and Health—U.S. 

Environmental Protection Agency Interlaboratory 

Comparison of American National Standards 

Institute S12.6–1997 Methods A and B.’’ J. Acoust. 

Soc. Am. 125(5):3262–3277. 

(12) percent of all HPD products will 

require relabeling based on recurrent 

tests every five years. The agencies 

commissioned parallel tests of six 

different HPD products at six different 

laboratories. The study provided 180 

laboratory-to-laboratory comparisons of 

the test results; 30 for each of the six 

products tested. For each of these 

comparisons, the average test results 

and the 95 percent confidence intervals 

for two tests of a single HPD model were 

determined. If the second test was lower 

than the first test to the extent that the 

two 95 percent confidence intervals did 

not overlap, then it was assumed that 

the product would need to be relabeled. 

This occurred in 12 percent of the 

comparisons. The fraction was the same 

for earplugs and earmuffs. However, for 

reasons stated above, the Agency has 

selected a ± 3dB criteria rather than the 

95 percent confidence interval to 

initiate relabeling. Therefore, for this 

analysis the 12 percent represents a 

conservative assessment of the potential 

cost impact. 

TABLE C–3—ESTIMATED NATIONWIDE ANNUAL COSTS OF PRODUCT RECURRENT TESTING AND RELABELING FOR

MANUFACTURERS

Product type 

Estimated number of HPD tests 

per year Unit Cost per 

HPD test ($) 

Estimated nationwide costs 

($1000/year) 

3-Year interval a 5-Year interval b 3-Year interval 5-Year interval 

Periodic Recurrent Testing 

Earplugs and semi-aural inserts ......................... 125.0 75.0 2,000–4,000 250–500 150–300 

Earmuffs and headsets ....................................... 183.3 110.0 c 2,540–3,810 470–700 280–420 

Electronic noise cancellation systems ................ 36.0 21.6 d 2,500–10,000 90–360 54–216 

Impulse noise reduction ...................................... 52.0 31.2 2,000–4,000 100–210 60–120 

Subtotal ........................................................ 396.3 237.8 .......................... 910–1,770 544–1,056 

Relabel as Necessary Estimated number of HPD 

products per year 

eSubtotal ..................................................... 39.2 23.5 .......................... 106–196 63–117 

Grand total ............................................ .......................... .......................... .......................... 1,016–1,966 607–1,173 

a Under the 3-year recurrent test interval, one third of all HPD models are assumed to be retested each year. 

b Under the 5-year recurrent test interval, 20% of all HPD models are assumed to be retested in a given year. 

cBased on a testing cost of $2,000–3,000 per headband position, and an average of 1.27 headband positions per product. 

dThis cost figure includes both the expense for passive and active testing. 

eBased on NIOSH/EPA inter-laboratory testing, a change in the label NRR may be required for 12% of products tested in periodic effectiveness tests. fBased on the cost of making a simple modification to the label to change the NRR (Table 3–1). 

c. Manufacturers’ Costs of Reporting and 

Recordkeeping 

Pursuant to Sec. 13 (a)(1) of the Noise 

Control Act, manufacturers are required 

to provide the EPA Administrator 

reports of the laboratory test results for 

each HPD model. The cost of generating 

these reports is incorporated in the cost 

of product testing (as summarized in 

Table C–1). However, we believe 

manufacturers may incur limited 

additional costs to track and retain 

periodic recurrent testing reports. Table 

C–4 presents estimates of the 

nationwide costs of these recordkeeping 

and reporting requirements. We have 

estimated that 30 minutes per product 

may be required for record keeping and 

reporting. 

TABLE C–4—ESTIMATED ANNUAL ONGOING COSTS OF RECORDKEEPING AND REPORTING

Product type 

Estimated number of HPD tests 

per year Clerical labor 

per product 

line (hours) 

Labor cost 

($/hour) c

Estimated nationwide costs 

($1000/year) 

3-Year 

interval a

5-Year 

interva lb

3-Year 

interval 

5-Year 

interval 

Earplugs and semi-aural inserts .............. 125 75.0 0.5 31 1.9 1.2 

Earmuffs and headsets ............................ 183.3 110.0 0.5 31 2.8 1.7 

Electronic noise cancellation systems ..... 18.0 10.8 0.5 31 0.3 0.2 

Total .................................................. 326.3 195.8 ........................ ........................ 5.0 3.1 

a Under the 3-year recurrent testing interval, about one third of all HPD models are assumed to be retested each year. 

b Under the 5-year recurrent testing interval, about 20% of all HPD models are assumed to be retested in a given year. 

cEstimate based on Bureau of Labor Statistics information for the medical supplies manufacturing industry, hourly rates include an overhead 

factor (including benefits) of 100%. 

d. Costs for Relabelers 

Companies that relabel products 

manufactured by other companies for 

sale under their own label or under the 

labels of brand name retailers may also 

incur labeling costs. These companies, 

identified as ‘‘relabelers’’ typically use 

the results of NRR tests carried out by 

the products manufacturers, and 

therefore, are not expected to incur costs 

for product testing. However, they are 


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39170 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

expected to incur costs for redesigning 

product labels to incorporate new NRR 

values and required labeling 

information. Table C–5 summarizes the 

estimated costs of compliance for these 

relabelers. However, no adjustments 

have been made for those relabelers that 

sell exclusively via the internet and 

adopt electronic labeling. In this latter 

case the costs of relabeling are expected 

to be significantly less than those of 

Table C–5 since no changes will be 

required for artwork or packaging. The 

Agency has not quantified these costs 

savings. Consequently, we believe the 

costs presented in Table C–5 to be very 

conservative (i.e. likely overestimated). 

TABLE C–5—ESTIMATED NATIONWIDE LABELING COSTS FOR COMPANIES WHICH DO NOT MANUFACTURE HPD, BUT ONLY

RELABEL PRODUCTS

Product type 

Estimated number of 

products Unit cost per 

HPD product 

test ($) 

Estimated nationwide costs 

($1,000) 

3-Year 

interval a

5-Year 

interval b

3-Year 

interval 

5-Year 

interval 

Transition Label Costs 

Earplugs and semi-aural inserts ............................................ 46 5,000–10,000 230–460 

Earmuffs and headsets ......................................................... 32 5,000–10,000 160–320 

Electronic noise cancellation systems ................................... 83 5,000–10,000 420–830 

Total ................................................................................ ..................... ..................... ........................ 810–1,610 

Recurrent label costs Products per 

year Cost per year 

Earplugs and semi-aural inserts ................................................................... 1.8 1.1 2,700–5,000 5–9 3–6

Earmuffs and headsets ................................................................................ 1.3 0.8 2,700–5,000 4–7 2–4

Electronic noise cancellation systems .......................................................... 3.3 2.0 2,700–5,000 9–17 5–10 

Total ....................................................................................................... ........................ ........................ 18–33 10–20 

a Under the 3-year recurrent test interval, one third of all HPD models are assumed to be retested each year. 

b Under the 5-year recurrent test interval, 20% of all HPD models are assumed to be retested in a given year. 

cBased on NIOSH/EPA inter-laboratory testing, a change in the label NRR may be required for 12% of products tested in periodic effectiveness tests. 

D. Summary of Nationwide Costs of 

Revised HPD Labeling Rule 

Table D–1 summarizes the estimated 

nationwide costs of the proposed 

revisions to the HPD labeling rule. The 

initial or capital costs will be primarily 

transition testing of all HPD products in 

the U.S. market on the effective date of 

this proposed rule. In addition, we have 

incorporated the amortized costs of 

transition product labeling to reflect the 

new NRR range presentation and 

revised user information. In the latter 

case, the transition labeling costs have 

been amortized over a 20-year period 

using an interest rate of 7 percent. The 

transition testing costs are estimated to 

be between $2.5 million and $4.6 

million and are expected to be spread 

over a period of 30 months from the 

effective date of the regulation. New 

labeling costs are estimated to be 

between $5.1 and $10.1 million to 

produce product labels with the new 

NRR range presentation and mandated 

statements. The industry provided cost 

estimates associated with the required 

secondary labels are incorporated in the 

total cost of labeling. 

Annualized costs of the revised rule 

depend, in large part, on the recurrent 

product testing intervals. Two options 

have been evaluated: A 3-year interval 

and a 5-year interval. As stated 

previously, after evaluating the two 

approaches, the Agency is proposing the 

5-year interval for all manufacturers. 

Recurrent testing of products would 

commence 5 years from the date of 

completion of their respective transition 

test. The annualized costs include the 

costs of changing product labels to 

reflect the new NRR range of the 12% 

of products that fail their recurrent test 

and costs of reporting and 

recordkeeping. 

TABLE D–1—TOTAL COSTS COMPARED WITH TOTAL SALES

Cost element Estimated nationwide costs 

($1000/year) 

Manufacturers: 

Transition costs 

Product model testing a ............................................................................................................................ 2,600–4,760 

Initial revisions to labels a ......................................................................................................................... 4,900–9,790 

3-Year 

recurrent test 

interval 

5-Year 

recurrent test 

interval 

Annualized costs 

Periodic product effectiveness tests b ...................................................................................................... 910–1,770 544–1,056 

Changing product labeling, as necessary c .............................................................................................. 106–196 63–117 

Recordkeeping and reporting ........................................................................................................................ 5.0 3.1 

Amortized cost of initial labeling e, f ............................................................................................................... 462–924 462–924 


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3-Year 

recurrent test 

interval 

5-Year 

recurrent test 

interval 

Total annualized costs for manufacturers ..................................................................................................... 1,484–2,896 1,073–2,101 

Relabelers: g

Initial revisions to labels ....................................................................................................................................... 810–1,610 

Annualized costs.

Amortized cost of initial labeling e f ................................................................................................................ 76–152 76–152 

Label changes as necessary from recurrent ftesting .................................................................................... 18–33 10–20 

Total annualized costs for relabelers g ......................................................................................................... 94–185 86–172 

Total annual cost ......................................................................................................................................................... 1,578–3,081 1,159–2,273 

Annual cost as a fraction of total industrial product sales f .................................................................................... 0.3–0.7% 0.3–0.5% 

aTable C–2 provides additional details on initial testing and labeling costs for manufacturers. 

bProduct tests are assumed to be carried out at a uniform rate over the recurrent test period. (See Table C–3). 

cBased on NIOSH/EPA inter-laboratory testing, a change in the label NRR may be required for 12% of products tested in periodic effectiveness tests. (See Table C–3) d Costs of developing product labels to reflect the revised test methods are amortized over a 20 year period using an interest rate of 7%. eAnnualized costs do not include the amortized costs of the initial tests, since this would double-count the first round of recurrent testing costs. fTotal industrial product sales were obtained from Frost & Sullivan (see Table A–2). Consumer sales are believed to be minor in comparison 

with industrial sales. gTable C–5 provides additional details on costs for relabelers. 

Table D–1 presents the total 

annualized costs of complying with the 

proposed labeling rule changes. These 

are estimated to be 0.3–0.5 percent of 

total industrial product sales for the 5- 

year interval. Industrial product sales 

were obtained from the Frost & Sullivan 

market research report, totaling $242.9 

million. Estimates developed by EPA 

from limited information obtained from 

site visits for consumer and military 

sales are $216.2 million. Therefore, the 

estimated costs of compliance with the 

proposed labeling rule changes may 

range from 0.16 to 0.4 percent of total 

combined industrial, consumer and 

military sales. 

E. Economic Impacts 

Based on the results of analyses in the 

previous section, compliance costs 

associated with the proposed labeling 

rule changes are expected to be on 

average 0.3 to 0.6 percent of the total 

wholesale price. As noted earlier, seven 

HPD manufacturers were interviewed 

on the potential costs and economic 

impacts of the new labeling rule. The 

larger companies indicated they did not 

plan to pass along the costs of 

compliance in the prices of their 

products. However, some of the smaller 

companies indicated that they would 

probably pass on a portion or all of the 

costs of compliance to distributors and 

consumers. 

In the event that prices are increased 

to cover the cost of compliance, 

industrial and other occupational sales 

of HPDs are not expected to change. 

These uses are generally mandated by 

occupational safety regulations and are 

not an optional purchase. Consumer 

purchases of HPDs are also not expected 

to be significantly impacted, since the 

overall impact of compliance costs is a 

relatively small fraction of the 

wholesale price. 

HPD manufacturers indicated they do 

not expect to close any operations as a 

result of increased compliance costs. 

However, most indicated they would 

probably discontinue some marginally 

profitable product lines rather than 

incur the associated cost of transition 

testing and labeling. In particular, the 

companies indicated that product lines 

which are not selling well on the 

current market due to their effectiveness 

rating, comfort, or competition may be 

discontinued when the new labeling 

rules are implemented. 

F. Impacts on Small Business 

Please see paragraph XI—C (Statutory 

and Executive Order Reviews) below. 

XI. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

This action is not a ‘‘significant 

regulatory action’’ under terms of 

Executive Order (EO) 12866 (58 FR 

51735, October 4, 1993) and is therefore 

not subject to review under that Order 

Although a Regulatory Impact 

Analysis was not required or conducted, 

EPA did carry out a cost impact 

analysis, as just set forth in the previous 

section. The annual effect on the 

economy resulting from the proposed 

compliance costs is estimated to be less 

than $2,800,000. A copy of the ‘‘Cost 

Analysis for Proposed Labeling 

Regulation of the Hearing Protection 

Device Industry’’ is available in the 

docket for this action. 

B. Paperwork Reduction Act 

The information collection 

requirements in this proposed rule have 

been submitted for approval to the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act, 44 U.S.C. 3501 et seq. The 

Information Collection Request (ICR) 

document prepared by EPA has been 

assigned EPA ICR number 2341.01. 

Section 13 of the Act, ‘‘Records, 

Reports and Information,’’ states that 

manufacturers of products which emit 

noise capable of adversely affecting the 

public health or welfare, or which is 

sold wholly or in part on the basis of its 

effectiveness in reducing noise, shall 

establish and maintain such records, 

make such reports, provide such 

information, and make such tests, as the 

Administrator may reasonably require to 

enable him to determine whether such 

manufacturer has acted or is acting in 

compliance with the Act. 

Pursuant to this provision, the Agency 

proposes to collect information to 

ensure compliance with the provisions 

in this rule. EPA is also proposing 

recurrent testing requirements, as 

discussed previously. In order to 

establish reliable baseline performance 

information for each device, against 

which future performance can be 

compared, the EPA is proposing that 

manufacturers provide the Agency with 

their product test information following 

each required product test. 

The 1979 regulation required 

manufacturers to establish and retain 

adequately organized and indexed 

records of the testing protocols that 

provide the basis for the claimed Noise 

Reduction Ratings (NRR) that is placed 

on the mandated label. The regulation 

also required manufacturers to submit 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
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hearing protector test data reports for 

the attendant NRR to the EPA. In 1982, 

40 CFR Part 211 was amended to 

suspend the submittal of test data 

reports to the EPA due to the closure of 

the Agency’s Office of Noise Abatement 

and Control. However, manufacturers 

were still required to retain all pertinent 

test data reports for recordkeeping 

purposes. EPA is proposing to 

reinstitute the requirement for 

manufacturers to submit to the Agency 

test data reports following each required 

product test. The reports would have to 

include measurement information, test 

results and calculated lesser and greater 

NRRs obtained from the testing 

laboratory for each product or product 

category. Manufacturers would continue 

to retain such records for a period of 

two (2) testing periods. However, if a 

manufacturer elects to alter the product 

design or materials prior to expiration of 

the 5 year recurrent testing cycle, the 

manufacturer would be required to test 

and submit the product’s new test data 

report to the EPA. 

The annual reporting burden for this 

collection of information for the initial 

test data report for approximately 81 

respondents is estimated to be 185 labor 

hours per year [555 total hours] at a total 

annual cost of $5,735 [$17,205 total 

cost]. This burden estimate includes 

time to complete the cover sheet per 

Annex A of the proposed regulation, 

time to convert the results into a PDF 

document, and time to submit the test 

data report(s) to the EPA. Burden is 

defined at 5 CFR 1320.3(b). 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in 40 

CFR are listed in 40 CFR Part 9. 

To comment on the Agency’s need for 

this information, the accuracy of the 

provided burden estimates, and any 

suggested methods for minimizing 

respondent burden, EPA has established 

a public docket for this rule, which 

includes this ICR, under Docket ID 

number EPA–HQ–OAR–2003–0024. 

Submit any comments related to the ICR 

to the EPA docket noted above and to 

OMB. See ‘Addresses’ section at the 

beginning of this notice for where to 

submit comments to EPA. Send 

comments to OMB at the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 725 

17th Street, NW., Washington, DC 

20503, Attention: Desk Office for EPA. 

Since OMB is required to make a 

decision concerning the ICR between 30 

and 60 days after August 5, 2009, a 

comment to OMB is best assured of 

having its full effect if OMB receives it 

by September 4, 2009. The final rule 

will respond to any OMB or public 

comments on the information collection 

requirements contained in this proposal. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

generally requires an agency to prepare 

a regulatory flexibility analysis of any 

rule subject to notice and comment 

rulemaking requirements under the 

Administrative Procedure Act or any 

other statute unless the agency certifies 

that the rule will not have a significant 

economic impact on a substantial 

number of small entities. Small entities 

include small businesses, small 

organizations, and small governmental 

jurisdictions. 

For purposes of assessing the impacts 

of today’s proposed rule on small 

entities, small entity is defined as: (1) A 

small business engaged in 

manufacturing, distributing, relabeling 

and/or importing of hearing protection 

devices having NAICS codes presented 

in Table A–2; (2) a small governmental 

jurisdiction that is a government of a 

city, county, town, school district or 

special district with a population of less 

than 50,000; and (3) a small 

organization that is any not-for-profit 

enterprise which is independently 

owned and operated and is not 

dominant in its field. 

After considering the economic 

impacts of today’s proposed rule on 

small entities, I certify that this action 

will not have a significant economic 

impact on a substantial number of small 

entities. The small entities directly 

regulated by this proposed rule are 

manufacturers, distributors, repackagers 

and importers of hearing protector 

devices. We have determined that fewer 

than 100 U.S. small businesses are 

expected to be subject to the planned 

rule changes and using conservative 

assumptions only 1 or 2 of those 

potentially affected face significant 

adverse impacts. 

In its analysis of the impacts of the 

rule, EPA made a significant effort was 

made to ensure that we identified as 

many as possible of the companies that 

manufacture or distribute HPDs, 

including any that are small businesses. 

A number of steps were taken to 

identify these companies, including 

reviews of the NIOSH Hearing 

Protection Device Compendium and the 

membership directory of the National 

Hearing Conservation Association 

(NHCA). Further, the NHCA was 

contacted to obtain a listing of small 

companies engaged in the manufacture 

or relabeling of HPDs. The NHCA 

assisted by providing information on 

some companies which obtain HPD 

from manufacturers for sale under their 

own labels. We also reviewed a number 

of directories of HPD and safety 

equipment vendors, including the Noise 

Pollution Clearinghouse, the 

International Safety Equipment 

Association Buyer’s Guide, the Thomas 

directory, the Business Internet, 

Hoover’s Online, and Mergent Online. 

It is possible that some manufacturers 

or distributors were not identified in 

these efforts. Because of the 

classification of HPD manufacturers in 

the Census, it is particularly difficult to 

identify all HPD manufacturers. As 

discussed in paragraph X (A), HPD 

manufacturers are generally in a 

miscellaneous manufacturing category 

(NAICS Code 339113) along with 

manufacturers of surgical appliances 

and supplies because many HPD 

manufacturers also produce other 

products. In addition, many of these 

companies classify themselves under 

other NAICS categories. Therefore, the 

Census does not provide an explicit 

count of HPD manufacturers. We believe 

that most of the small manufacturers 

and distributors of HPDs have been 

identified, but we invite reviewers to 

submit any additional relevant data in 

this regard. 

For most categories applicable to HPD 

manufacturers, a small business is 

defined as any company which employs 

fewer than 500 employees (and which is 

not owned by another large business). 

The small business size threshold is 750 

employees for firms which also produce 

electronic or communications 

equipment, as is the case with most 

manufacturers of active HPDs. For 

distributors that merely relabel HPDs, 

the small business size threshold is 100 

employees. 

Using the applicable NAICS size 

thresholds, 54 of the 96 identified HPD 

manufacturers and relabelers would be 

classified as small businesses. However, 

it must be noted that the NAICS 

thresholds overstate the number of truly 

small businesses. This is because most 

passive HPD manufacturers fall into a 

catch-all miscellaneous manufacturing 

category which was primarily designed 

to characterize the manufacturers of 

surgical equipment. Thus, the 500 

employee threshold used for this 

category probably does not reflect the 

conditions of the HPD manufacturing 

industry. Nevertheless, we have 

analyzed the costs of compliance for all 

of the companies that would be 

classified as small under the applicable 

NAICS threshold. However, we have 

also paid special attention to a subset of 

‘‘very small’’ companies, which produce 

only one or two HPD product lines. Of 


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37The referenced interviews can be found in the 

Federal Docket at http://www.regulations.gov, 

docket number EPA–HQ–OAR–2003–0024. 

the 96 identified HPD manufacturers 

and relabelers, 34 would fall into this 

‘‘very small’’ business category. 

After identifying the small businesses 

likely to be subject to the rule, we 

estimated the potential economic 

impacts of the proposed rule on small 

entities. For this proposed rule, we 

evaluated the compliance costs as a 

percentage of total sales for any small 

businesses affected by any proposed 

regulatory action. Costs of compliance 

were identified for each of these small 

and very small companies based on the 

numbers of HPD models they sell and 

using the calculation methods and 

assumptions outlined in paragraph X (C) 

above. Some of these companies were 

interviewed as part of the effort to 

develop background information to 

estimate the costs and economic 

impacts of labeling rule changes; these 

companies gave information on the 

number of HPD models sold.37 We 

estimated the numbers of product 

models sold by other small businesses 

from catalogs and other advertising 

materials published on the Internet. 

Table F–1 summarizes the estimated 

impacts of the proposed labeling rule 

changes on U.S. small businesses, 

including the initial costs of compliance 

and the ongoing annualized costs for the 

3-year and 5-year recurrent test options. 

Therefore, we have analyzed small 

business impacts for both ends of this 

range. In addition, we have analyzed 

impacts for the ranges of testing and 

labeling costs identified in Table F–1, 

and the ranges of labor requirements 

shown in Table C–4 for reporting and 

recordkeeping. The table gives ranges of 

costs, depending on which underlying 

unit cost estimates are used for testing, 

labeling, and recordkeeping. 

We have estimated that the initial 

testing and labeling costs would average 

1.1–2.1 percent of sales during the 

initial compliance period for all 54 U.S. 

small businesses affected by the rule. 

For the 3-year recurrent test interval, we 

have estimated that the average annual 

compliance costs for all 54 U.S. small 

businesses affected by the rule would be 

0.5–0.7 percent of annual sales. The 

estimates of ongoing annual costs 

include the amortized initial 

compliance costs. The majority of small 

businesses (44 to 47) are expected to 

incur ongoing annual costs of less than 

1 percent of the total annual sales. 

However, between 7 and 10 small 

businesses are expected to incur annual 

ongoing compliance costs exceeding 1 

percent of their total annual sales. (Of 

these small businesses, we estimate that 

one or two are very small businesses 

(produce less than 3 types of product)). 

It is possible that one or more small 

businesses may experience costs 

exceeding 3 percent of sales. However, 

our data set is limited for sources in this 

size range (generally facilities with very 

low annual sales volume). 

TABLE F–1—SUMMARY OF IMPACTS ON SMALL BUSINESSES

Cost element 3-Year recurrent 

testing 

5-Year recurrent 

testing 

Total number of small businesses affected by the rule in the U.S ......................................................... 54 

Initial testing and labeling: 

Estimated initial costs of compliance: 

Lowest cost for a small business .............................................................................................. <1,000 

Average cost for a small business ............................................................................................ 47,000–94,000 

Maximum cost for a small business .......................................................................................... 298,000–620,000 

Ongoing annual costs of compliance 

Estimated annual costs 

Lowest cost for a small business .............................................................................................. 500 500 

Average cost for a small business ............................................................................................ 10,000–14,000 8,000–11,000 

Maximum cost for a small business .......................................................................................... 63,000–90,000 49,000–68,000 

Estimated annual cost as a fraction of annual sales: a b

Lowest cost for a small business .............................................................................................. <0.01% <0.01% 

Average cost for a small business ............................................................................................ 0.5–0.7% 0.4–0.6% 

Maximum cost for a small business .......................................................................................... 11–17% 9–12% 

Number of small businesses with estimated annual compliance costs greater than: 

1% of annual sales .................................................................................................................... 7–10 4–8 

3% of annual sales c .................................................................................................................. 1 1 

aSales figures used in these calculations are from market databases, such as Dun and Bradstreet, and include not only HPD, but all products 

sold by the companies, such as other safety equipment. bAnnualized costs of compliance include amortized costs of initial testing and labeling. 

cOne or more companies may experience costs above 3% of sales, but our data set is limited in this size range. 

At the 5-year recurrent test interval, 

the average annual compliance costs for 

all 54 U.S. small businesses affected by 

the rule is estimated to be 0.4–0.6 

percent of annual sales. The majority of 

small businesses (46 to 50) are expected 

to incur ongoing annual costs of less 

than 1 percent of the total annual sales. 

However, between 4 and 8 small 

businesses are expected to incur 

ongoing annual compliance costs above 

1 percent of their annual sales. This 

means that 7 to 15 percent of the small 

businesses subject to the rule are 

expected to face economic impacts 

greater than 1 percent. (Of these small 

businesses, we estimate that one or two 

are very small businesses (produce less 

than 3 types of product)). It is possible 

that one or more small businesses may 

experience costs that exceed 3 percent 

of sales. Once again, we note that our 

data set is limited for sources in this 

size range (generally facilities with very 

low annual sales volume). 

Given that there are some impacts on 

small businesses, we looked for ways to 

mitigate these impacts. One step we 

have taken, as discussed earlier, is to 

exempt companies that sell exclusively 

over the Internet from the requirement 

to provide hard copy labels on their 

product packaging; an electronic label is 

being proposed as the exclusive labeling 

requirement for such entities. 

Additionally, after considering 


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regulatory options to require retesting 

every 3 years versus every 5 years, we 

have selected the 5-year option. This 

option will allow manufacturers to timestream the testing of their product 

categories. Finally, we think that 

companies will take steps on their own 

to reduce compliance costs by reviewing 

their product slates and reducing the 

number of HPD models that are low 

sales products and/or older products 

that have updated versions. These 

actions would reduce their costs of 

compliance with the revised testing and 

labeling requirements. We continue to 

be interested in the potential impacts of 

this proposed rule on small entities and 

solicit comments on issues related to 

such impacts. 

Small governments are not affected 

since enforcement of the proposed 

regulation would continue to be carried 

out by the federal EPA. Further, not-forprofit enterprises engaged in the 

distribution of hearing protectors do not 

assume responsibility or incur the costs 

of testing and labeling of a product and 

therefore, are not impacted by the rule. 

Although this proposed rule will not 

have a significant economic impact on 

a substantial number of small entities, 

EPA nonetheless has tried to reduce the 

impact of this rule on small entities 

through the means described above. 

When developing the proposed rule, we 

took special steps to ensure that the 

burdens imposed on small entities were 

minimal. We continue to be interested 

in the potential impacts of this proposed 

rule on small entities and solicit 

comments on issues related to such 

impacts. 

D. Unfunded Mandates Reform Act 

This action contains no Federal 

mandates under the provisions of Title 

II of the Unfunded Mandates Reform 

Act of 1995 (UMRA), 2 U.S.C. 1531– 

1538 for State, local, or tribal 

governments or the private sector. This 

action imposes no enforceable duty on 

any State, local or tribal governments or 

the private sector. 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA), Public 

Law 104–4, establishes requirements for 

Federal agencies to assess the effects of 

their regulatory actions on State, local, 

and tribal governments and the private 

sector. Under section 202 of the UMRA, 

EPA generally must prepare a written 

statement, including a cost-benefit 

analysis, for proposed and final rules 

with ‘‘Federal mandates’’ that may 

result in expenditures to State, local, 

and tribal governments, in the aggregate, 

or to the private sector, of $100 million 

or more in any one year. Before 

promulgating an EPA rule for which a 

written statement is needed, section 205 

of the UMRA generally requires the 

Agency to identify and consider a 

reasonable number of regulatory 

alternatives and to adopt the least 

costly, most cost-effective, or least 

burdensome alternative that achieves 

the objectives of the rule. The 

provisions of section 205 do not apply 

when they are inconsistent with 

applicable law. Moreover, section 205 

allows EPA to adopt an alternative other 

than the least costly, most cost-effective, 

or least burdensome alternative if the 

Administrator publishes with the final 

rule an explanation why that alternative 

was not adopted. Before we establish 

any regulatory requirements that may 

significantly or uniquely affect small 

governments, including tribal 

governments, a small government plan 

must be developed under section 203 of 

the UMRA. The plan must provide for 

notifying potentially affected small 

governments, enabling officials of 

affected small governments to have 

meaningful and timely input in the 

development of EPA regulatory 

proposals with significant Federal 

intergovernmental mandates, and 

informing, educating, and advising 

small governments on compliance with 

the regulatory requirements. 

We have determined that this 

proposed action does not contain a 

Federal mandate that may result in 

expenditures of $100 million or more 

for State, local, and tribal governments, 

in the aggregate, or to the private sector 

in any one year. Thus, this proposed 

action is not subject to the requirements 

of sections 202 and 205 of the UMRA. 

E. Executive Order 13132: Federalism 

Executive Order 13132, entitled 

‘‘Federalism,’’ (64 FR 43255, August 10, 

1999), requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by State 

and local officials in the development of 

regulatory policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive Order to include 

regulations that 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.’’ 

This proposed rule does not have 

federalism implications. It will 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, as specified in 

Executive Order 13132. This proposed 

rule applies to manufacturers and 

distributors of hearing protection 

devices and has no association with 

State and local governments. Thus, 

Executive Order 13132 does not apply 

to this rule. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications, as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). Executive Order (EO) 13175, 

requires EPA to develop an accountable 

process to ensure ‘‘meaningful and 

timely input by tribal officials in the 

development of regulatory policies that 

have tribal implications.’’ This proposed 

action will have no substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

government and Indian tribes as 

specified in EO 13175. Thus, Executive 

Order 13175 does not apply to this 

proposed action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

EPA interprets EO 13045 (62 FR 

19885, April 23, 1997) as applying to 

those regulatory actions that concern 

health or safety risks to children, such 

that the analysis required under section 

5–501 of the Order has the potential to 

influence the regulation. This action is 

not subject to EO 13045 because it is 

based solely on technology 

performance. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 (66 FR 28355 (May 22, 

2001)), because it is not a significant 

regulatory action under Executive Order 

12866. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (‘‘NTTAA’’), Public Law No. 

104–113 (15 U.S.C. 272 note) directs 

EPA to use voluntary consensus 

standards (VCS) in its regulatory 

activities unless to do so would be 

inconsistent with applicable law or 

otherwise impractical. VCS are 

technical standards (e.g., materials 

specifications, test methods, sampling 

procedures, and business practices) that 

are developed or adopted by VCS 


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bodies. NTTAA directs EPA to provide 

Congress, through OMB, explanations 

when the Agency decides not to use 

available and applicable VCS. 

This proposed rulemaking involves 

technical standards. Therefore, EPA 

conducted a search to identify 

potentially applicable VCS. We 

identified several that have direct or 

partial applicability to the technical 

requirements specified in the rule. To 

the extent possible the Agency has 

incorporated by reference the principal 

elements of the American National 

Standards Institute (ANSI) standard 

S12.6 (2008). In addition, we have also 

incorporated by reference various 

elements of ANSI S12.68 (2007) and 

S12.42. The Agency also gave careful 

consideration to all relevant standards 

of the International Standards 

Organization (ISO) and the International 

Electrotechnical Commission (IEC) and 

determined that the above mentioned 

ANSI standards and the IEC standard 

60711 were the most appropriate for this 

action. 

EPA welcomes comments on this 

aspect of the proposed rulemaking and, 

specifically, invites the public to 

identify potentially-applicable VCS and 

to explain why such standards should 

be used in this regulation. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order (EO) 12898 (59 FR 

7629 (Feb. 16, 1994)) establishes federal 

executive policy on environmental 

justice. Its main provision directs 

federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this 

proposed rule will not have 

disproportionately high and adverse 

human health or environmental effects 

on minority or low-income populations 

because hearing protectors provide 

protection to the human health of all 

affected populations without having any 

disproportionately high and adverse 

human health or environmental effects 

on any population, including any 

minority or low-income population. 

List of Subjects in 40 CFR Part 211 

Environmental Protection, 

Incorporation by reference, Noise 

Abatement Programs, Product Noise 

Labeling, Hearing Protection Devices. 

Dated: July 21, 2009. 

Lisa P. Jackson, 

Administrator. 

For the reasons stated in the 

preamble, title 40, chapter I of the Code 

of Federal Regulations is proposed to be 

amended as follows: 

PART 211—PRODUCT NOISE 

LABELING 

1. The authority citation for part 211 

continues to read as follows: 

Authority: Sec. 8, Noise Control Act of 

1972, (42 U.S.C. 4907), and other authority as 

specified. 

Subpart B—[Amended] 

2. Section 211.201 is revised to read 

as follows: 

§ 211.201 Applicability. 

(a) Unless this part states otherwise, 

the provisions of subpart B, part 211, 

apply to all devices or materials sold as 

‘‘hearing protection devices’’ on the 

basis of their ability to reduce the level 

of sound entering the user’s ears and 

thus claim to protect the users hearing. 

The proposed regulation also applies to 

devices of which hearing protection 

may not be their primary function, but 

which are nonetheless sold in-part as 

providing protection to the user’s 

hearing. 

(b) To the extent that a product 

manufacturer, importer, packager or any 

other party introduces into U.S. 

commerce any product that incorporates 

an explicit or implicit claim that said 

product can protect the hearing of the 

user, or stipulates the level of sound 

reduction offered by such product, then 

it shall be subject to the requirements of 

this proposed regulation (See 211.203(u) 

for definition of ‘‘hearing protection 

device.’’) 

(c) This rule does not apply to those 

devices or materials that are designed to 

fit over or into the user’s ears to, for 

example, preclude the entrance of water 

during swimming, reduce the level of 

annoyance from snoring or to enhance 

listening to music or video dialogue 

presentations. 

(d) This regulation is also applicable 

to those devices or materials that while 

not designed for or intended to be used 

as hearing protection devices can, due 

to their similarity in appearance or 

function, be easily mistaken for 

products that are hearing protection 

devices. To the extent that a product 

manufacturer, importer, packager or any 

other party introduces into U.S. 

commerce any product that incorporates 

an explicit or implicit claim that said 

product can protect the hearing of the 

user, or stipulates the level of sound 

reduction offered by such product, then 

such product shall be subject to the 

requirements of this proposed 

regulation. 

(e) The provisions of subpart A apply 

to all products for which regulations are 

published under part 211 and 

manufactured after [EFFECTIVE DATE 

OF FINAL RULE], unless they are made 

inapplicable by product-specific 

regulations. 

3. Section 211.202 is revised to read 

as follows: 

§ 211.202 Effective Date. 

Manufacturers of hearing protection 

devices must comply with the 

requirements set forth in this subpart for 

hearing protective devices 

manufactured on or after [date TBD]. All 

hearing protection devices that are 

manufactured on or after the effective 

date of this subpart must be tested and 

labeled in accordance with the 

applicable procedures set forth herein. 

4. Section 211.203 is revised to read 

as follows: 

§ 211.203 Definitions. 

As used in subpart B, all terms not 

defined here have the meaning given 

them in the Noise Control Act of 1972 

(the Act) (42 U.S.C. 4907), or in subpart 

A of this part. 

(a) A-Duration. The duration of an 

impulsive sound from its initial sharp 

increase in positive sound pressure to 

the point where the sound pressure 

becomes negative. 

(b) A-Weighted Sound Level. A single 

number representing the overall sound 

level of a noise that emphasizes sounds 

containing frequencies between about 

500 and 5000 Hz and deemphasizes 

frequencies outside that range. The 

resultant sound level is referred to as Aweighted units in dB, generally 

indicated as dBA and considered to be 

representative of the human ears 

frequency response to sounds. 

(c) Acoustic Test Fixture (ATF). A 

device that approximates the size and 

shape of a human head and which 

includes acoustic elements to simulate 

the acoustic response of the ear canal. 

An ATF with ear canals approximates 

the cross sectional area and length of the 

human ear canal. 

(d) Active Noise Reduction. The 

reduction of sound transmission based 

on the use of electronic elements (e.g. 

circuits and transducers) to produce 

acoustic signals of approximately equal 

and opposite phase and amplitude to 

reduce the transmitted sound. 


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(e) ANSI/ASA S12.6–2008. ‘‘American 

National Standard—Methods for 

Measuring the Real-Ear Attenuation of 

Hearing Protectors.’’ A procedure for 

measuring the hearing protector sound 

attenuation values at various 

frequencies using one-third octave band 

noise stimuli presented to subjects in a 

diffuse sound field. 

(f) ANSI S12.42–1995 (R2002). 

‘‘American National Standard— 

Microphone-in-Real-Ear and Acoustic 

Test Fixture Methods for the 

Measurement of Insertion Loss of 

Circumaural Hearing Protection 

Devices.’’ A procedure for measuring 

the acoustical insertion loss of earmuff 

using a miniature microphone 

positioned in the ear canal. 

(g) ANSI/ASA S12.68–2007. 

‘‘American National Standard— 

Methods of Estimating Effective Aweighted Sound Pressure Levels When 

Hearing Protectors are Worn.’’ 

Procedures for calculating Noise 

Reduction Ratings. 

(h) Assumed Protection Value (APVfx). 

The protection in a given octave band 

computed as the mean attenuation, 

minus the standard deviation of that 

octave band multiplied by a constant. 

(i) Attenuation. The reduction of 

sound pressure level provided by a 

hearing protection device by either 

structural elements, acoustic pathways, 

electronic or mechanical means. 

(j) Carrying Case. The container used 

to store reusable hearing protectors. 

(k) Category. A group of hearing 

protectors which are identical in all 

aspects to the parameters listed in 

§ 211.210–2(a)(3). 

(l) Claim. An assertion made by a 

manufacturer regarding the intended 

purpose, general performance and the 

sound attenuating effectiveness of his 

product. 

(m) Decibel (dB). Unit of measure of 

sound level used in this regulation for 

both sound pressure level and hearing 

threshold level. 

(n) Dispenser. The permanent or 

disposable container designed to hold 

more than one complete set of hearing 

protector(s) for the express purpose of 

display to promote sale or display to 

promote use or both. 

(o) Disposable Device. A hearing 

protection device that is intended to be 

discarded after one or otherwise 

specified period of use. 

(p) Effective A-weighted Sound 

Pressure Level (L’A). The sound pressure 

level, A-weighted and referred to an 

equivalent diffuse sound field 

condition, that is estimated to be 

experienced by users when the hearing 

protector is worn. 

(q) Effective Peak Sound Pressure 

Level (L’P). The estimated peak sound 

pressure level underneath the hearing 

protection device. 

(r) Estimated Noise Level Reduction 

(ENR). The value in decibels derived 

from the variability of noise reduction 

as a function of noise spectra. 

(s) Fitting Instruction. Guidance on 

the demonstration and fitting of a 

hearing protection device that is 

provided to the testing laboratory and 

included with the product as entered 

into commerce. 

(t) Headband. A component of a 

hearing protection device that applies 

force to, and holds in place on a 

person’s head, the sound attenuating 

component that is intended to 

acoustically seal the ear canal. The 

headband can be positioned over-thehead, behind-the-head or under-thechin of the user. 

(u) Hearing Protection Device (HPD). 

Devices or materials intended to reduce 

the level of sound entering a user’s ears. 

Such devices include those of which 

hearing protection may not be the 

primary function, but which are 

nonetheless sold partially as providing 

hearing protection to the user. This term 

is used interchangeably with the terms, 

‘‘hearing protective device’’, ‘‘hearing 

protector’’, ‘‘device’’ and ‘‘HPD’’ in 

subpart B. The following list, although 

not all inclusive, presently represents 

products that are subject to this part. 

(1) Passive Hearing Protection Device. 

A device that relies solely on its 

structural elements to block or 

otherwise control the transmission of 

sound into the ear canal and that does 

not use electronic circuits or fluid 

dynamic means to reduce the entry of 

external sound. 

(2) Active Hearing Protection Device. 

A device that contains electronic 

components including transducers (i.e. 

speakers and microphones) to increase 

or decrease the transmission of sound 

into the ear canal. Also referred to as an 

electronic hearing protection device. 

(3) Ear plug. A hearing protection 

device that is designed to be inserted 

into the ear canal and held in place 

principally by virtue of its fit inside the 

ear canal. 

(4) Ear cap. See ‘‘Semi-insert Device’’. 

(5) Ear cup. The combination of the 

hard shell, soft cushion and sound 

attenuating material that encloses the 

external ear or pinna in ear muff 

applications. 

(6) Ear muff. A hearing protection 

device usually comprised of a headband 

which applies spring-like force/pressure 

to two ear cups with soft cushions to 

seal against the external ear or pinna 

(supra-aural) or the sides of the head 

around the pinna (circumaural). The ear 

cups may also be held in position by 

attachment arms mounted on a hardhat 

or hardcap. 

(7) Active Noise Reduction Hearing 

Protection Device. A device that uses 

single or in combination, electrical 

components and structural elements to 

reduce the sound transmitted to the ear 

canal through acoustic cancellation of 

the air-conducted and/or boneconducted external sound. 

(8) Amplitude-Sensitive Hearing 

Protection Device. A device that is 

designed to produce a change in sound 

attenuation as a function of the external 

sound level. Amplitude-sensitive 

hearing protection devices include 

passive devices, active devices, and 

impulsive noise devices. 

(9) Communication Headset. A voice 

communication device (ear plug, ear 

muff, semi-insert device or helmet) that 

is also designed to reduce the level of 

sound at the users’ ears by either 

structural elements and/or electronic 

means. 

(10) Custom-molded Hearing 

Protection Device. A device that is made 

to conform to a specific person’s ears 

(pinnas) and ear canals. 

(11) Electronic Hearing Protection 

Device. See ‘‘Active Hearing Protection 

Device.’’ 

(12) Helmet. A hearing protection 

device that provides impact protection 

to the head or skull and designed with 

ear cups to reduce the external sound 

from entering the ears through either 

structural elements and/or electronic 

means. 

(13) Level-Dependent Hearing 

Protection Device. See AmplitudeSensitive Hearing Protection Device. 

(14) Semi-insert Device. An ear pluglike hearing protection device consisting 

of soft pods or tips that are held in place 

by a lightweight band. The pods are 

positioned in the conchae covering the 

entrances to the ear canals, or fitted to 

varying depths within the ear canals. 

Semi-inserts that cap the ear canal 

require the force of the band to retain 

their position and acoustic seal. Semiinserts that enter the ear canal behave 

more like ear plugs; they seal the ear to 

block noise with or without the 

application of band force. Also referred 

to as canal cap or banded hearing 

protector. 

(v) Impulsive Acoustic Test Fixture 

(IATF). A device that approximates the 

size and shape of a human head, 

simulates the acoustic response of the 

human ear canal, and includes a 

microphone(s) and electronic circuitry 

to detect acoustic signals. 

(w) Impulsive Noise. A sound or 

series of sounds that are characterized 


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by a sharp rise and rapid decay in sound 

pressure level and have duration of less 

than one second. 

(x) Impulsive Noise Reduction. The 

reduction of peak impulse sound 

transmission based upon the single or 

combined use of passive and/or active 

noise reduction elements. 

(y) Insertion Loss. The arithmetic 

difference in decibels between the 

sound pressure levels measured at a 

reference point (i.e. the ear canal or 

microphone of the acoustic test fixture) 

with and without a hearing protection 

device in place. 

(z) Label. A notice, as described in 

this subpart, which is inscribed on, 

affixed to or appended to a product, its 

packaging, or both for the purpose of 

giving the purchaser or product user 

information regarding the products 

designed use, noise reduction 

effectiveness, operating or fitting 

instructions and other information 

appropriate to the product. 

(aa) Manufacturer. Any person 

engaged in the manufacturing or 

assembling of products, or the importing 

of products for resale, or who purchases 

products from an original equipment 

manufacturer (OEM) for the purpose of 

repackaging or relabeling or who acts 

for, and is controlled by any such 

person in connection with the 

distribution of such products in U.S. 

commerce. 

(bb) Microphone in Real Ear (MIRE). 

A testing method where miniature 

microphones are positioned at the 

entrance to the subject’s blocked ear 

canals to measure the sound pressure 

level underneath a hearing protection 

device. 

(cc) Noise. Undesired or unwanted 

sound. For the purpose of this subpart, 

noise and sound are used 

interchangeably. 

(dd) Noise Reduction Rating (NRR). A 

single number metric used to describe 

noise reduction in decibels. 

(ee) Noise Reduction Variability Data 

Points. The values of the noise 

reductions calculated for the spectral 

balances given by LC–LA = (¥1, 2, 6 and 

13 dB). 

(ff) Occluded Threshold of Hearing. 

The minimum level of sound heard at 

a specific frequency when a hearing 

protection device is worn. 

(gg) Octave Band Attenuation. The 

amount of sound reduction determined 

according to the measurement 

procedure of § 211.206 for one-third 

octave bands of noise. 

(hh) Open Threshold of Hearing. The 

minimum level of sound heard at a 

specific frequency when a hearing 

protection device is not worn. Also 

referred to as ‘‘unoccluded’’ threshold of 

hearing. 

(ii) Package. The container in which 

a hearing protection device is presented 

for purchase or use. The package in 

some cases may be the same as the 

carrying case. 

(jj) Passive Noise Reduction. The 

reduction of sound transmission based 

solely on the use of materials and/or 

structural elements. 

(kk) Pink Noise. Noise for which the 

spectrum density varies as the inverse of 

frequency. 

(ll) Primary Panel. The surface of the 

product package that is considered to be 

the front surface or that surface on the 

package which is intended for initial 

viewing at the point of ultimate sale or 

the point of distribution for use. 

(mm) Random Incident Field. A 

sound field in which sound waves are 

incident from all directions with equal 

probability. 

(nn) Real-Ear Attenuation at 

Threshold (REAT). The mean value in 

decibels of the occluded threshold of 

hearing minus the open threshold of 

hearing for all trials of each test subject 

under otherwise identical test 

conditions. 

(oo) Real-Ear Attenuation at 

Threshold (REAT). The mean value in 

decibels of the occluded threshold of 

hearing minus the open threshold of 

hearing for all trials of each test subject 

under otherwise identical test 

conditions. 

(pp) Residual Volume. The volume of 

air between the termination of an ear 

plug and the sensing surface of the 

microphone when an ear plug is 

inserted into an acoustic test fixture. 

(qq) Reverberation Time. The time, in 

seconds, required for a sound produced 

in an enclosure to decay to a designated 

level once the sound source is turned 

off. 

(rr) Spectral Balance (B). The 

difference in decibels between the Cweighted and A-weighted levels of a 

sound spectrum (LC ¥ LA), indicating 

the proportion of energy at low 

frequencies in the spectrum. 

(ss) Sound pressure level (dB SPL). 

Ten times the logarithm to the base 10 

of the ratio of the time mean square 

sound pressure to the square of the 

reference sound pressure, given by: Lp = 

10 log10 (p2/p0

2), where p is the root 

mean square value of sound pressure in 

pascals, and the reference sound 

pressure p0 is 20 micropascal (20 × 10¥6

Newtons per meter squared) for 

measurements in air. Unit: decibel (dB). 

(tt) Spectral uncertainty. Variation in 

the attenuation provided by a hearing 

protector due to the frequency content 

of the noise in which a device is worn. 

(uu) Subject uncertainty. Variation in 

the attenuation provided by a hearing 

protector due to the effect of different 

subjects fitting the device when the 

attenuation is assessed. 

(vv) Tag. Stiff paper, metal or other 

hard material that is tied or otherwise 

affixed to the packaging of a protector. 

(ww) Test Facility. A laboratory that 

tests hearing protection devices in 

accordance with the requirements of 

this subpart. 

(xx) Test Hearing Protector. A hearing 

protector that has been selected for 

testing to determine the NRR value(s) to 

be put on the label, or which has been 

designated for testing to verify the 

labeled value(s) and determine 

compliance of the protector with this 

subpart. 

(yy) Test Request. A request 

submitted to the manufacturer by the 

Administrator of the Environmental 

Protection Agency (EPA) that will 

specify the hearing protector category, 

and test sample size to be tested 

according to § 211.212, and other 

information regarding the audit. 

(zz) Test Subject. Any person of any 

gender, ethnicity or age who is selected 

from a group of candidates that exhibit 

physical and mental characteristics 

requisite to the conduct of testing in 

accordance with § 211.206–1(b)(5) and 

other requirements of this subpart. 

(aaa) Third-octave band microphone 

free-field rejection. The variation in 

sound field (decibels) of the microphone 

polar response (front to back for 

cardioid and front to side for cosine) for 

each measured third-octave band. 

(bbb) Threshold of Hearing. For a 

specified signal, the average minimum 

sound pressure level as indicated by the 

test subject’s responses. 

(ccc) Trial. A complete series of 

occluded and unoccluded hearing 

threshold measurements on a single test 

subject for a single hearing protector. 

(ddd) White Noise. Noise for which 

the spectrum density is independent of 

frequency over a specified frequency 

range. 

5. Section 211.204–1 is revised to read 

as follows: 

§ 211.204–1 Information content of primary 

label. 

The information to appear on the 

primary label must be according to 

§ 211.104 of Subpart A except as stated 

here and prescribed in Figures 1, 2 and 

3 of § 211.204–1. 

(a) Primary Label for all PASSIVE 

Hearing Protection Devices (Figure 1): 

(1) Area A must state ‘‘Noise 

Reduction Rating’’. 

(2) Area B must contain the range(s) 

of the Noise Reduction Ratings (NRR) in 


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39178 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

decibels for the designed mode(s) of use 

of that model hearing protector. 

(i) The range shall be depicted by a 

bar-graph that shall include a numeric 

scale from 0 to 50 decibels in equal 

increments of 10 decibels. 

(ii) A solid color bar, as presented in 

Figure 1 of this section, shall be 

superimposed on the bar-graph scale 

indicating the lesser and greater Noise 

Reduction Ratings from the 80th and 

20th percentiles. 

(iii) The lesser and greater NRR values 

shown on the numeric scale shall be 

determined in accordance with 

§ 211.207–2. 

(iv) For devices with headbands that 

may be used in different positions, the 

labeled NRR shall represent the 80th 

and 20th percentiles for the 

manufacturers recommended position 

as determined in § 211.207–2. 

(v) The word ‘‘PASSIVE’’ shall be 

placed and centered below the bargraph. For multi-positional head band 

protectors, the tested position shall be 

indicated by the words, ‘‘OVER HEAD’’, 

‘‘BEHIND HEAD’’ or ‘‘UNDER CHIN’’ 

placed immediately following 

‘‘PASSIVE’’. 

(3) Area C must state ‘‘PASSIVE NRR 

values indicate range of noise reduction 

when used as instructed by the 

manufacturer. When used in steady and 

intermittent noise environments, the 

difference between the noise level and 

respective NRRs is the user’s estimated 

exposure level. This protector was not 

tested for impulse noise.’’ 

(4) Area D of the primary label must 

state the manufacturers’ name, city and 

state of principal office and may include 

a primary web address. 

(b) Primary Label for ACTIVE Noise 

Reduction Hearing Protection Devices 

(Figure 2): 

(1) Area A must state ‘‘Noise 

Reduction Rating’’. 

(2) Area B must contain the range(s) 

of the Noise Reduction Ratings (NRR) in 

decibels for the designed mode(s) of use 

of that model hearing protector. 

(i) There shall be two bar-graphs with 

numeric scales from 0 to 50 decibels in 

equal increments of 10 decibels. The 

two bar-graphs shall be aligned one 

above the other as shown in Figure 2 of 

this section. 

(ii) The word ‘‘ACTIVE’’ shall be 

placed and centered above the upper 

bar-graph. 

(iii) The word ‘‘PASSIVE’’ shall be 

placed and centered below the lower 

bar-graph. 

(iv) A solid color bar shall be 

superimposed on the respective bargraphs indicating their lesser and 

greater Noise Reduction Ratings from 

the 80th and 20th percentiles. 

(v) The lesser and greater NRR values 

shown on the upper bar-graph shall be 

determined in accordance with 

§ 211.207–3. 

(vi) The lesser and greater NRR values 

shown on the lower numeric scale shall 

be determined in accordance with 

§ 211.207–3. 

(vii) For devices with headbands that 

may be used in different positions, the 

labeled NRR shall represent the 80th 

and 20th percentiles for the 

manufacturers recommended position(s) 

as determined in § 211.207–3. The 

tested position shall be indicated by the 

words, ‘‘OVER HEAD’’, ‘‘BEHIND 

HEAD’’ or ‘‘UNDER CHIN’’ placed 

immediately following ‘‘PASSIVE’’ and 

‘‘ACTIVE’’. 

(2) Area C must state ‘‘ACTIVE and 

PASSIVE NRR values indicate range of 

noise reduction with and without 

electronic activation when used as 

instructed by the manufacturer. In 

steady and intermittent noise 

environments, the difference between 

the noise level and respective NRRs is 

the user’s estimated exposure level. This 

protector was not tested for impulse 

noise.’’ 

(3) Area D of the primary label must 

state the manufacturers’ name, city and 

state of principal office and may include 

a primary web address. 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39179 

(c) Primary Label for IMPULSIVE 

Noise Hearing Protection Devices 

(Figure 3): 

(1) Area A must state ‘‘Noise 

Reduction Rating’’. 

(2) Area B must contain the range(s) 

of the Noise Reduction Ratings (NRR) in 

decibels for the designed mode(s) of use 

of that model hearing protector. 

(i) There shall be two bar-graphs with 

numeric scales from 0 to 50 decibels in 

equal increments of 10 decibels. The 

two bar-graphs shall be aligned one 

above the other as shown in Figure 3 of 

this section. 

(ii) The word ‘‘IMPULSIVE’’ shall be 

placed and centered above the upper 

bar-graph. 

(iii) The word ‘‘PASSIVE’’ shall be 

placed and centered below the lower 

bar-graph. 

(iv) A solid color bar shall be 

superimposed on the respective scales 

indicating their lesser and greater Noise 

Reduction Ratings from the 80th and 

20th percentiles. 

(v) The lesser impulsive NRR values 

shown on the upper numeric scale shall 

be determined in accordance with 

§ 211.207–4(f). 

(vi) The greater impulsive NRR values 

shown on the upper numeric scale shall 

be determined in accordance with 

§ 211.207–4(g). 

(vii) The lesser and greater passive 

NRR values shown on the lower 

numeric scale shall be determine in 

accordance with § 211.207–2. 

(viii) For devices with headbands that 

may be used in different positions, the 

labeled NRR shall represent the 80th 

and 20th percentiles for the 

manufacturers recommended position 

as determined in § 211.207–2. The 

tested position shall be indicated by the 

words, ‘‘OVER HEAD’’, ‘‘BEHIND 

HEAD’’ or ‘‘UNDER CHIN’’ placed 

immediately following ‘‘IMPULSIVE’’ 

and ‘‘PASSIVE.’’ 

(3) Area C must state ‘‘IMPULSIVE 

and PASSIVE NRR values indicate the 

range of noise reduction in impulsive 

and continuous noise environments 

when used as instructed by the 

manufacturer. The difference between 

the noise level and respective NRRs is 

the user’s estimated exposure level.’’ 

(4) Area D of the primary label must 

state the manufacturers’ name, city and 

state of principal office and may include 

a primary web address. 


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39180 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

6. Section 211.204–2 is amended as 

follows: 

a. Revise paragraphs (b)(2) and (b)(3). 

b. Revise (c) and (d). 

c. Add new paragraphs (e) through (l). 

§ 211.204–2 Primary label size, print 

and color. 

* * * * * 

(b) * * * 

(2) Area B—2.1 mm or 6 point for 

numerals and 

(3) Area A and B—1.7 mm or 5 point 

for words. 

* * * * * 

(c) The use of upper and lower case 

letters and the general appearance of the 

label must be similar to the example in 

Figure 1 of § 211.204–1. 

(d) The color of the EPA logo shall be 

a solid color with sufficient contrast 

with surrounding information or if it is 

printed in full color, it must be the 

colors of the official EPA logo. 

(e) The minimum dimensions of the 

scale shall be 2.2 (cm) (0.87 inch) long 

and 0.3 (cm) (0.12 inch) high. 

(f) The minimum font size of the 

labels for the bar shall be 4 point type. 

(g) The values depicted on the bar 

shall be at least 6 point in bold type 

face. 

(h) The solid range bar shall be a 

minimum of 0.2 (cm) (0,079 inch) high, 

vertically centered in the bar-graph 

scale and of sharply contrasted solidcolor with the endpoints positioned at 

the respective numeric limits. 

(i) For all PASSIVE hearing protection 

devices the layout shall be according to 

Figure 1 of § 211.204–1. 

(j) For ACTIVE hearing protection 

devices the layout shall be according to 

Figure 2 of § 211.204–1. 

(k) For IMPULSIVE hearing protection 

devices the layout shall be according to 

Figure 3 of § 211.204–1. 

7. Section 211.204–3 is amended by 

revising paragraphs (a) introductory text 

and (a)(2) and by adding paragraph 

(a)(3) to read as follows: 

§ 211.204–3 Label location and type. 

(a) The manufacturer or entity that 

introduces the product into commerce is 

responsible for labeling the product for 

ultimate sale or use. Such manufacturer 

or entity shall select the primary 

product label in accordance with 

§ 211.204–1 and locate it as follows: 

* * * * * 

(2) Affixed to the primary panel of the 

product packaging if the label 

complying with § 211.204–1 is not 

visible at the point of ultimate purchase 

or the point of distribution to users. 

(3) Products that are sold exclusively 

over the Internet and thus constitute the 

point of sale to ultimate purchasers or 

users, shall present the requisite 

primary and secondary labels as readily 

visible electronic images for each 

product category offered for sale. Such 

electronic labels shall contain all 

information that is required for labels 

that are required to be affixed to and 

contained within the package of 

products with a point of sale outside the 

Internet. Such labels must be 

automatically downloaded to the 

purchaser along with confirmation of 

acceptance of payment from the 

purchaser. Electronic labels shall not be 

used for bulk container sales or for nonInternet resale. 

* * * * * 

8. Section 211.204–4 is revised to read 

as follows: 

§ 211.204–4 Supporting information. 

The following minimum supporting 

information must accompany all hearing 

protection devices in a manner that 

ensures its availability to the 

perspective user in an easily readable 

format. In the case of bulk packaging 

and dispensing, such supporting 

information must be affixed to the bulk 

container or dispenser in the same 

manner as the label, and in a readily 

visible location. Such information shall 

be presented in tabular form except 

where specified otherwise. 

(a) The mean sound attenuation for 

each octave band test frequency as 

determined from the measurements 

prescribed in § 211.206–1. 

(b) The standard deviation of the 

mean sound attenuation across subjects 

for each octave band test frequency as 

determined from the measurements 

prescribed in § 211.206–1. 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39181 

(c) The Assumed Protection Values 

(APV) for the 80th and 20th percentiles 

of the sound attenuation for each octave 

band test frequency as determined from 

the measurements prescribed in 

§ 211.206–1. 

(d) The noise reduction as a function 

of spectral balance shall be presented as 

shown in the example given in Table 1 

of this section. 

TABLE 1—EXAMPLE—NOISE REDUCTION VARIABILITY DATA POINTS

[spectral balance] 

¥1 dB ¥2 dB 6 dB 13 dB 

Noise Reductions (dB) 

20th Percentile ................................................................................................. 30.6 24.0 18.7 11.9 

80th Percentile ................................................................................................. 26.8 19.2 13.7 8.1 

(e) The variability of attenuation as a 

function of noise spectrum shall be 

presented in a graphical format as 

shown in Figure 1 of this section. 

(1) The figure caption shall be 

‘‘Variability of Noise Reduction as a 

function of Noise Spectra.’’ 

(2) The dimensions of the body of the 

graph shall be no smaller than 5.0 cm 

wide by 3.8 cm high (1.97 x 1.5 inches). 

(3) The dimensions of the body of the 

graph shall be no smaller than 5.0 cm 

wide by 3.8 cm high (1.97 x 1.5 inches). 

(4) The ordinate scale shall be linear 

from ¥2 to 16 decibels with increments 

of 2 decibels. The axis label shall be 

‘‘Spectral Balance B = LC ¥ LA (dB)’’. 

(5) The abscissa scale shall be linear 

from 0 to 50 decibels with increments 

of 5 decibels. The abscissa scale shall be 

labeled ‘‘Estimated Noise Reduction 

(dB)’’. 

(6) The use of a grid is optional to 

facilitate interpolation of values. 

(7) The symbols for the 80th 

percentile shall be filled and connected 

by solid lines. 

(8) The symbols for the 20th 

percentile shall be unfilled and 

connected by solid lines. 

(9) A legend shall be placed in the 

body of the graph as shown in the 

example of Figure 1 of this section. 

(f) For hearing protection devices with 

a headband that can be worn in multiple 

positions (over head, behind head and/ 

or under chin) the mean sound 

attenuation values, standard deviations 

and APV, as prescribed in paragraphs 


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39182 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

(a), (b), (c), (d) and (e) of this section, 

shall be provided for each tested 

position. 

(g) The following statement, ‘‘When 

this device is worn as directed, the level 

of noise entering a person’s ear is 

approximated by the differences 

between the A-weighted environmental 

noise level and the lesser and greater 

NRRs.’’ except as stated in § 211.204–5 

for ACTIVE devices and as stated in 

§ 211.204–6 for IMPULSIVE devices. 

(h) The following example shall be 

included except as stated in § 211.204– 

5 for ACTIVE devices and in § 211.204– 

6 for IMPULSIVE devices: 

‘‘Example: 

(1) X: the sound pressure level as 

measured at the user’s location in 

decibels A-weighted (dBA). 

(2) Lesser and greater NRRs: the 

PASSIVE NRR ratings obtained from the 

primary label or from the graph of noise 

reduction variability with spectral 

balance. 

(3) The approximate range of sound 

pressure levels at the user’s ears with 

hearing protection: 

(X — lesser NRR) = the greater sound 

pressure level. 

(X — greater NRR) = the lesser sound 

pressure level. 

The sound pressure level at the user’s 

ears will depend upon the fit of the 

protector.’’ 

(i) The following cautionary note shall 

be included except as stated in 

§ 211.204–5 for ACTIVE devices and as 

stated in § 211.204–6 for IMPULSIVE 

devices. 

‘‘Caution: For predominantly low 

frequency noise environments in which 

the difference in the measured Cweighted and A-weighted noise levels 

(dBC—dBA) exceeds 3 dB, the user is 

directed to the enclosed graph of the 

variability of noise reduction with noise 

spectra to determine the level of 

protection.’’ 

(j) The month and year of production 

of the device shall be printed on the 

outside of the package using a minimum 

font size of 8 point. 

(k) Instructions as to the proper use, 

fitting technique and care of the device. 

(l) The following statement: 

‘‘Improper fit or improper use of this 

device will decrease noise reduction 

effectiveness and increase the risk of 

hearing damage. 

9. Section 211.204–5 is added to read 

as follows: 

§ 211.204–5 Supporting information for 

Active Noise Reduction Hearing Protection 

Devices. 

In addition to the supporting 

information required in § 211.204–4, the 

following minimum supporting 

information must accompany all 

ACTIVE devices in an easily readable 

format. 

(a) The mean total sound attenuation 

for each octave band test frequency as 

determined from the measurements 

prescribed in § 211.206–2. 

(b) The standard deviation of the 

mean total sound attenuation across 

subjects for each octave band test 

frequency as determined from the 

measurements prescribed in § 211.206– 

2. 

(c) The Assumed Protection Values 

(APV) for the 80th and 20th percentiles 

of the sound attenuation for each octave 

band test frequency as determined from 

the measurements prescribed in 

§ 211.206–2. 

(d) The passive, active and total noise 

reduction data points as a function of 

spectral balance shall be presented as 

shown in the example in Table 1 of this 

section. 

TABLE 1—EXAMPLE—COMBINED ACTIVE AND PASSIVE NOISE REDUCTION VARIABILITY AS A FUNCTION OF SPECTRAL

BALANCE

¥1 dB 2 dB 6 dB 13 dB 

Noise Reductions (dB) 

20th Percentile Passive ................................................................................... 21.0 14.0 9.0 5.0 

80th Percentile Passive ................................................................................... 27.0 21.0 15.0 10.0 

20th Percentile Active ...................................................................................... ¥1.0 0.7 6.2 12.5 

80th Percentile Active ...................................................................................... 0.0 0.0 7.5 14.0 

20th Percentile Total ........................................................................................ 20.0 14.7 15.2 17.5 

80th Percentile Total ........................................................................................ 27.0 21.0 22.5 24.0 

(e) The variability of attenuation as a 

function of noise spectrum shall be 

presented in a graphical format as 

shown in Figure 1 of this section. 

(1) The figure caption shall be 

‘‘Variability of Noise Reduction as a 

Function of Noise Spectra.’’ The 

dimensions of the body of the graph 

shall be no smaller than 5.0 cm wide by 

3.8 cm high (1.97 x 1.5 inches). 

(2) The font size for the title, ordinate 

and abscissa scales, and the legends 

shall be no smaller than 4 point. 

(3) The ordinate scale shall be linear 

from ¥2 to +16 decibels with 

increments of 2 decibels. The axis label 

shall be ‘‘Spectral Balance B = LC—LA 

(dB)’’. 

(4) The abscissa scale shall be linear 

from 0 to 50 decibels with increments 

of 5 decibels. The abscissa scale shall be 

labeled ‘‘Estimated Noise Reduction 

(dB)’’. 

(5) The use of a grid is optional to 

facilitate interpolation of values. 

(6) The symbols for the 80th 

percentile passive noise reductions shall 

be filled and connected by solid lines. 

(7) The symbols for the 20th 

percentile passive noise reductions shall 

be unfilled and connected by solid 

lines. 

(8) The symbols for the 80th 

percentile total noise reductions shall be 

filled, distinctly different from the 

passive symbols and connected by 

dashed lines. 

(9) The symbols for the 20th 

percentile total noise reductions shall be 

unfilled, distinctly different from the 

passive symbols and connected by 

dashed lines. 

(10) A legend shall be placed in the 

body as shown in the example given in 

Figure 1 of this section. 


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(f) The following statement, ‘‘When 

this device is worn as instructed and 

operated in its PASSIVE mode, the level 

of noise entering a person’s ear is 

approximated by the differences 

between the A-weighted sound pressure 

level at the user’s location and the lesser 

and greater PASSIVE NRRs. When this 

device is operated in its ACTIVE mode, 

the level of noise entering the person’s 

ear is approximated by the difference 

between the A-weighted sound pressure 

level at the user’s location and the lesser 

and greater ACTIVE NRRs.’’ 

(g) The following example shall be 

included for ACTIVE devices: 

‘‘Example: 

(1) X: The sound pressure level as 

measured at the user’s location in 

decibels A-weighted (dBA). 

(2) Lesser and greater NRR: The 

ACTIVE or PASSIVE ratings obtained 

either from the primary label or from the 

graph of noise reduction variability with 

spectral balance. 

(3)(I) The approximate range of sound 

pressure levels at the user’s ears with 

the HPD in either its ACTIVE or 

PASSIVE mode: 

(A) (X¥lesser NRR) = the greater sound 

pressure level. 

(B) (X¥greater NRR) = the lesser sound 

pressure level. 

(ii) The sound pressure level at the 

user’s ears will depend upon the fit and 

operating mode of the protector.’’ 

(h) The following cautionary note 

shall be included in the secondary label 

for active noise reduction hearing 

protectors: ‘‘Caution: For the ACTIVE 

mode in predominantly low frequency 

environments in which the difference in 

the measured C-weighted and Aweighted sound pressure levels (dBCdBA) exceeds 3 dB, the user is directed 

to the enclosed graph of the variability 

of noise reduction with noise spectra to 

determine the level of protection.’’ 

(i) The following statement shall be 

included: ‘‘This device, in ACTIVE 

mode, is recommended for use in 

environmental noise levels from X to Y 

dBA.’’ The manufacturer shall designate 

the values of X and Y. 

(j) If the total combined attenuation of 

REAT and LACTIVE, as calculated in 

§ 211.206–2, for any octave band 

exceeds 50 dB, the following cautionary 

statement shall be included: ‘‘The 

combined attenuation of this device has 

been measured to be in excess of 50 dB 

at XXX Hz. Sound energy transmitted 

through the head or oral/nasal cavities 

to the inner ear may be greater than the 

level of sound when attenuated by the 

hearing protection device.’’ The 

manufacturer shall designate the 

frequency band(s) where the attenuation 

exceeds 50 dB. 

(k) The battery type, number of 

batteries and expected use time for the 

product. 

10. Section 211.204–6 is added to 

read as follows: 

§ 211.204–6 Supporting information for 

Amplitude-Sensitive Hearing Protection 

Devices. 

In addition to the supporting 

information required in § 211.204–4, the 

following minimum supporting 

information must accompany all 

Amplitude-Sensitive hearing protection 

devices in an easily readable format. In 

the case of bulk packaging and 

dispensing, such supporting 

information must be affixed to the bulk 

container or dispenser in the same 

manner as the label, and in a readily 

visible location. The information 


srobinson on DSKHWCL6B1PROD with PROPOSALS2EP05AU09.009</GPH>
39184 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

resulting from the measurements 

prescribed in § 211.206–3 shall be 

presented in tabular and graphical form 

as shown in Table 1 and Figure 1 of this 

section for PASSIVE AmplitudeSensitive hearing protection devices and 

as shown in Table 2 and Figure 2 of this 

section for ACTIVE AmplitudeSensitive devices. 

(a) The mean peak sound pressure 

levels. 

(b) The mean impulsive noise 

reduction at each mean peak sound 

pressure level. 

(c) The minimum and maximum 

impulsive noise reduction values at 

each mean peak sound pressure level. 

TABLE 1—EXAMPLE—VARIABILITY OF IMPULSIVE NOISE REDUCTION FOR ABC PROTECTOR

[Passive mode] 

Mean peak sound pressure level 131 dB 150 dB 167 dB 

Mean Impulse Noise Reduction .................................................................................................. 23.2 22.9 23.4 

Maximum Impulse Noise Reduction ............................................................................................ 24.0 23.1 24.4 

Minimum Impulse Noise Reduction ............................................................................................. 21.5 22.4 22.7 

TABLE 2—EXAMPLE—VARIABILITY OF IMPULSIVE NOISE REDUCTION FOR XYZ PROTECTOR

[Active and passive modes] 

Mean peak sound pressure level 133 dB 150 dB 167 dB 

Mean Impulse Noise Reduction (Passive) .................................................................................. 32.2 32.8 33.9 

Maximum Impulse Noise Reduction (Passive) ............................................................................ 32.6 33.4 34.2 

Minimum Impulse Noise Reduction (Passive) ............................................................................. 31.2 31.7 33.7 

Mean Impulse Noise Reduction (Active) ..................................................................................... 32.0 31.6 32.7 

Maximum Impulse Noise Reduction (Active) .............................................................................. 32.1 32.3 33.8 

Minimum Impulse Noise Reduction (Active) ............................................................................... 30.5 31.2 30.6 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39185 

(d) The battery type, number of 

batteries and expected operating time 

for the product as appropriate. 

(e) The following statement: ‘‘This 

device is recommended for use in 

impulsive noise environments having 

peak levels between 130 to X dB SPL.’’ 

(X dB is equal to 130 dB plus the mean 

passive impulsive noise reduction) 

(f) The following cautionary note shall 

be included for ACTIVE noise reduction 

hearing protectors. ‘‘Caution: This 

device is not intended for use in 

impulsive noise environments 

exceeding Y dB peak sound pressure 

levels. The risk of hearing loss increases 

with multiple exposures to high level 

peak impulses.’’ (Y dB is equal to 130 

dB plus the mean active impulsive noise 

reduction) 

(g) The following statement: ‘‘The 

PASSIVE Noise Reduction Rating is 

based on the attenuation of continuous 

noise and is not an accurate indicator of 

the protection attainable against 

impulsive noise. The IMPULSIVE Noise 

Reduction Rating is based on the 

attenuation of high-level impulsive 

noise and is not an accurate indicator of 

the protection attainable for continuous 

noise.’’ 

(h) The following example shall be 

included for amplitude-sensitive 

devices: 

‘‘Example: 

(1) X: the peak sound pressure level 

as measured at the user’s location in 

decibels A-weighted (dBA). 

(2) Lesser and greater NRR: the 

IMPULSIVE ratings obtained from the 

primary label. 

(3)(i) The approximate range of sound 

pressure levels at the user’s ears with 

hearing protection: 

(A) (X¥Lesser NRR) = the greater 

effective peak sound pressure level. 

(B) (X¥Greater NRR) = the lesser 

effective peak sound pressure level. 

(ii) The peak sound pressure level at 

the user’s ears will depend upon the fit 

and operating mode of the protector. For 

a more accurate estimate of the 

impulsive noise reduction the user is 

directed to the graph of Figure 2 of this 

section.’’ 

11. Section 211.204–7 is added to 

read as follows: 

§ 211.204–7 Supporting information for 

Amplitude-Sensitive Hearing Protection 

Devices with Active Noise Reduction. 

Devices that incorporate both ACTIVE 

noise reduction and ACTIVE amplitudesensitive noise reduction shall comply 

with both sections § 211.204–1(b) and 

§ 211.204–1(c) for primary labeling and 

with both sections § 211.204–5 and 

§ 211.204–6 for supporting information. 

12. Section 211.205 is revised to read 

as follows: 

§ 211.205 Special claims and exceptions. 

(a) Any manufacturer wishing to make 

claims regarding the acoustic 

effectiveness of a device, other than its 

Noise Reduction Ratings, must 

demonstrate the validity of such claims, 

including the presentation of test data 

and the specific methods used to 

validate the claims. 

(b) Any request concerning an 

exception must be supported by 

scientific test data that establishes the 

exception without doubt, and must be 

submitted for consideration and 

approval to: The Administrator or his 

designee at U.S. EPA, Office of the 

Administrator. The Agency will notify 

the manufacturer within thirty (30) 

business days of receipt of the request 

if: the special claim or exception is 

approved, disapproved, additional 

information is needed, or the Agency 

needs additional time to consider the 

request. 

13. Section 211.206–1 is revised to 

read as follows: 


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39186 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

§ 211.206–1 Real ear attenuation at 

threshold (REAT). 

(a) The provisions of this section shall 

apply to the following devices: 

(1) Passive Hearing Protection 

Devices; 

(2) Active Hearing Protection Devices 

in their ‘‘off’’ mode of operation; 

(3) Active Noise Reduction Hearing 

Protection Devices in their ‘‘off’’ mode 

of operation; and 

(4) Amplitude-Sensitive Hearing 

Protection Devices in their ‘‘off’’ mode 

of operation (if they incorporate 

electronics). 

(b) The sound attenuation to be used 

in the calculation of the Noise 

Reduction Rating shall be determined in 

accordance with all clauses of ANSI/ 

ASA S12.6–2008 ‘‘Methods for 

Measuring the Real-ear Attenuation of 

Hearing Protectors,’’ incorporated by 

reference at § 211.213 of this subpart, 

except as stipulated in the identified 

ANSI clauses below: 

(1) For subpart B, the word 

‘‘requester’’ as used in ANSI/ASA 

S12.6–2008 shall be replaced with the 

word ‘‘manufacturer’’ as defined in 

§ 211.203. 

(2) For subpart B, only those 

requirements addressing Method A of 

ANSI/ASA S12.6–2008 shall be 

applicable. 

(3) Clause 3 of ANSI/ASA S12.6– 

2008. Terms and Definitions. The 

definitions given in § 211.203 shall be 

used in this subpart. 

(4) Clause 4 of ANSI/ASA S12.6– 

2008. Physical Requirements of Test 

Facility. For subpart B, the following 

new provision shall be in addition to 

that of Clause 4.3.1: ‘‘The electrical test 

signals measured at the input terminals 

of the speaker or speakers shall consist 

of one-third octave bands of pink or 

white noise, with a spectrum shape 

equivalent to that which would be 

created by a filter meeting the 

requirements of Class O of ANSI S1.11– 

2004, incorporated by reference at 

§ 211.213 of this subpart. The mode of 

operation in changing from one band to 

another shall be a discrete step function; 

a gradual continuously adjustable mode 

of change shall not be used.’’ 

(5) Clause 5 of ANSI/ASA S12.6– 

2008—Test Subjects. 

(i) For subpart B, the following new 

provision shall be in addition to Clause 

5.3. ‘‘Prior to audiometric qualification 

and participation in attenuation testing, 

the dimensions of both the right and left 

ear canals, and the bitragion width and 

head height of the test subject shall be 

measured in accordance with the 

procedure of ANSI 12.6–2008, Annex B. 

(6) Clause 6 of ANSI/ASA S12.6– 

2008. Product Samples. 

(i) For subpart B, the following new 

provisions shall be in addition to Clause 

6.1 of ANSI/ASA S12.6–2008: 

(A) Formable ear plugs: a minimum of 

three pairs of ear plugs per test subject 

shall be provided. A new pair shall be 

used for training and for each 

subsequent occluded trial. When a 

specific product is available in different 

sizes, three pairs of each product size 

shall be provided per test subject. 

(B) Premolded ear plugs and semiinsert devices: a minimum of one pair 

of ear plugs per test subject shall be 

provided. When a specific product is 

available in different sizes, one pair of 

each product size shall be provided per 

test subject. 

(C) Custom ear plugs: One pair of 

custom ear plugs for each test subject 

shall be provided. 

(D) Ear muffs: a minimum of one pair 

of ear muffs for every two test subjects 

shall be provided. When a specific 

product is available in different sizes, 

one pair of each product size shall be 

provided for every two test subjects. 

(E) Ear muffs attached to a hardhat: 

The hardhat sample shall be specified 

by the manufacturer of the hearing 

protection device. A minimum of one 

pair of ear muffs for every two test 

subjects shall be provided. When an ear 

muff is available in different sizes, one 

pair of each size shall be provided for 

every two test subjects. For each size of 

hardhat, two samples shall be provided 

in each size. 

(F) Helmets: a minimum of one 

sample shall be provided for each size 

helmet to be tested. Helmets 

incorporating other hearing protection 

devices (e.g. ear plugs, ear muffs) shall 

be tested as a system. The hearing 

protection device(s) incorporated in a 

helmet shall be provided by the 

manufacturer of the helmet. The 

minimum number of samples of the 

hearing protection device(s) to be used 

in combination with the helmet shall be 

as specified in paragraph (b)(6)(i)(A) 

through (E) of this section. 

(ii) For subpart B, the following new 

provisions shall be in addition to Clause 

6.2 of ANSI/ASA S12.6–2008: ‘‘Ear 

muffs and semi-insert devices with 

bands or attached to hardhats, which 

include adjustment mechanisms 

allowing the band force to be varied, 

shall be initially set to the minimum 

application force of their adjustment 

range prior to being provided to each 

subject. During fitting, the devices may 

be readjusted per the provisions of 

Clauses 8.1 of ANSI/ASA S12.6–2008.’’ 

(iii) For subpart B, Clause 6.3 of 

ANSI/ASA S12.6–2008, shall not be 

applicable. 

(7) Clause 7 of ANSI/ASA S12.6– 

2008—Psychophysical Procedure. 

(i) For subpart B, Clause 7.1.1 of 

ANSI/ASA S12.6–2008, shall not be 

applicable. 

(ii) For subpart B, Clause 7.5 of ANSI/ 

ASA S12.6–2008, shall read as follows: 

‘‘If the range of open threshold 

measurements at any frequency exceeds 

6 dB during a test session, the threshold 

at that frequency shall be retested until 

two open thresholds are obtained within 

6 dB of each other.’’ 

(8) Clause 8 of ANSI/ASA S12.6– 

2008—Method A: Trained-subject Fit: 

(i) For subpart B, the following new 

provisions shall be in addition to Clause 

8.1 of ANSI/ASA S12.6–2008: 

(A) ‘‘The experimenter shall give each 

subject precise directions and practice 

in fitting the hearing protector in 

accordance with the instructions that 

are provided by the manufacturer with 

the product to all users. The 

manufacturer’s instructions shall not be 

modified by the experimenter’s own 

knowledge in fitting the same or similar 

devices. No indicators, marks, or 

lubricants shall be utilized unless 

supplied or recommended by the 

manufacturer as a part of normal use. 

No alterations shall be made to the 

device to facilitate fitting. When 

applicable the experimenter shall assist 

the subject in selecting the appropriate 

size hearing protector, and in adjusting 

products with variable band force. 

Subjects can select the size appropriate 

to fit their right and left ears. The 

selected size(s) must be used throughout 

the two product trials. 

(B) The experimenter may provide 

demonstrations of the manufacturer’s 

fitting instructions during the training 

period. The experimenter may 

personally fit the device to the test 

subject as part of the training process. 

The experimenter shall train the subject 

in the use of the fitting noise (Clause 

4.3.6 of ANSI/ASA S12.6–2008) to assist 

in fitting the protector. There is no 

limitation on either the duration of the 

training or the number of practice 

fittings that may be performed. Trial 

sound attenuation measurements during 

the training period are prohibited. Once 

the experimenter has determined the 

subject can properly fit the hearing 

protector, the test shall begin.’’ 

(ii) For subpart B, the following new 

provisions shall be in addition to Clause 

8.2 of ANSI/ASA S12.6–2008: ‘‘After 

training, a subject shall be dismissed if 

the subject cannot obtain an acceptable 

product fit based on any one of the 

following criteria: 

(A) Subjects assessment of the quality 

of the hearing protector fit based on 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39187 

listening to the loudness of the fitting 

noise, 

(B) Visual evaluation by the 

experimenter, 

(C) Tactile evaluation by the 

experimenter working in conjunction 

with the subject, 

(D) Guidance specific to that product 

as provided by the manufacturer, 

(E) Repeated failure to meet the 

requirements of Clause 7.5 

(F) Illness or physical inability to 

participate on the day of the test, and 

(G) Inability to remain attentive 

during instruction or testing sessions. 

Subjects shall not be retested or 

dismissed as the result of the 

attenuation they obtained during the 

testing process.’’ 

(iii) For subpart B, the following new 

provisions shall be in addition to Clause 

8.3 of ANSI/ASA S12.6–2008: 

(A) ‘‘For the occluded tests, the 

subject shall fit the hearing protector 

without the experimenter present in the 

test chamber. The fitting noise shall be 

introduced into the test chamber and 

the subject shall be told to manipulate 

the hearing protector to obtain the 

lowest level of perceived noise. The 

experimenter shall observe the subject 

during the fitting test from outside the 

chamber. Once the subject is satisfied 

with the fit, and after observing the 

quiet period specified in Clause 7.6 and 

the waiting period specified in Clause 

7.7 of ANSI/ASA S12.6–2008, the test 

shall begin. 

(B) Adjustments of the fit of the 

hearing protector during the occluded 

threshold tests are not allowed. 

However, the subject shall be instructed 

to inform the experimenter if, during the 

test, a change in fit of the device is 

noticed, and if so, the test shall be 

stopped. The subject shall refit the 

device and the occluded threshold test 

restarted from the beginning. If this 

occurs a second time the occluded 

threshold testing shall be completed 

without refit and the attenuation data 

shall be used in the computation of the 

rating.’’ 

(9) For subpart B, Clause 9 of ANSI/ 

ASA S12.6–2008 is not applicable. 

14. Section 211.206–2 is revised to 

read as follows: 

§ 211.206–2 Active noise reduction (ANR). 

The provisions of this section shall 

apply to all Active Noise Reduction 

hearing protection devices as defined in 

§ 211.203(u)(7). 

(a) The measurement of active sound 

attenuation requisite to the Noise 

Reduction Rating for Active Noise 

Reduction hearing protection devices 

shall be in accordance with the methods 

defined in this section and only those 

clauses of ANSI S12.42–1995 (R2004), 

incorporated by reference at § 211.213 of 

this subpart, stated below. The octave 

band attenuation shall be calculated 

using one-third octave band insertion 

loss measurements as described in 

paragraph (m)(2) of this section. 

(b) The definitions given in § 211.203 

shall be used. 

(c) Acoustic Environment of Test 

Room: The requirements of this subpart 

shall be applicable to measurements of 

all Active Noise Reduction devices. 

(1) Sound Field Generation 

Equipment: For subpart B, Clause 6.1 of 

ANSI/ASA S12.6–2008, shall be 

applicable. 

(2) Sound Field Characteristics: For 

subpart B, Clauses 6.2.1 and 6.2.2 and 

Table 1 of ANSI S12.42, shall be 

applicable. 

(3) Sound Field Frequency 

Characteristics: The sound field shall be 

a broad band noise incorporating 

frequencies from 100 to 10000 Hz. The 

difference between the maximum and 

minimum one-third octave band levels 

within the specified frequency range 

shall not exceed 10 dB. The difference 

between adjacent one-third octave band 

levels shall not exceed 3 dB. 

(4) Sound Field Integration Time: The 

integration time shall not be less than 32 

seconds using linear spectral averaged 

third octave band analysis. 

(5) Sound Field Reference Levels 

(LREF(f)): The signal generation 

equipment shall be capable of 

producing a continuous sound field of 

105 dB SPL without a subject in the 

room. The field shall be measured with 

an ANSI Type I Pressure Microphone. 

The attenuation settings shall be 

recorded to permit replication. 

(6) Ambient Noise Floor of Test 

Room: The noise floor of the test 

chamber, with all external equipment 

operating and no sound field present, 

shall be at least 60 dB less than sound 

field levels measured at each third 

octave band. 

(7) Fitting Noise: The fitting noise 

shall be as specified in paragraph (c)(3) 

of this section and presented at a level 

of 85 dB SPL. 

(d) Measurement Equipment: 

(1) For subpart B, Clauses 6.3.1, 6.3.2, 

and 6.3.4 of ANSI S12.42, shall be 

applicable. 

(2) For subpart B, the following new 

provision shall be in addition to Clause 

6.3.6 of ANSI S12.42: ‘‘A spectrum 

analyzer using a third-octave band 

analog or digital filter bank or a Type I 

sound level meter with a third-octave 

band filter set shall be used for 

measuring the sound pressure levels. 

The measurement system shall have 

sufficient dynamic range such that all 

measurements are a minimum of 10 dB 

above the instrumentation noise floor 

and test chamber’s ambient background 

noise level. When using a Fast Fourier 

Transform (FFT) analyzer, it shall have 

internally generated digital 

pseudorandom white and pink noise 

sources with known statistical 

characteristics, i.e., wide sense 

stationary, and shall be used for the 

third-octave band calculation of true 

random noises. All decibel 

measurements shall be referenced to 20 

× 10¥6 N/m2 (20 μPa).’’ 

(3) Signal to Noise Ratio of the 

measurement microphone in the test 

chamber: The difference in microphone 

output levels with and without the 

sound field present shall be at least 10 

dB in each third-octave band from 80 to 

12500 Hz. 

(e) Active Attenuation Method for ear 

muffs using Microphone In Real Ear 

(MIRE). 

(1) MIRE Microphone: For subpart B, 

a microphone that fulfills the 

requirements set forth in Clause 8 of 

ANSI S12.42, is required. 

(2) For subpart B, the following new 

provision shall be in addition to Clause 

8.1.2 of ANSI/ASA S12.6–2008: ‘‘The 

microphone may be wireless or wired. 

If wired, the wires from the microphone, 

including insulation, shall not be more 

than 0.3204 millimeters (0.0126 inches) 

in diameter to minimize leakage of 

sound into the protector cavity.’’ 

(3) For subpart B, the following new 

provision shall be in addition to Clause 

8.1.3 of ANSI/ASA S12.6–2008: ‘‘The 

experimenter shall fit appropriate ear 

plugs into the subject’s ear canals such 

that their external surfaces are flush 

with the base of each ears conchae. The 

subject shall be instructed that removal 

of any hearing protector is prohibited 

during the test without permission from 

the experimenter.’’ 

(4) Position of microphone: The MIRE 

microphone shall be positioned by the 

experimenter on the external surface of 

the ear plug at the entrance of the ear 

canal, as shown in Figure 1 of this 

section. The sensing surface shall be 

perpendicular to the axis of the ear 

canal, centered in the ear canal and 

directed away from the center of the 

subject’s head. 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
39188 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

(f) Product selection: 

(1) Ear muffs: A minimum of one pair 

of ear muffs for every two test subjects 

shall be provided. Subjects shall use the 

same ear muff as for the REAT testing. 

When a specific product is available in 

different sizes, one pair of each product 

size shall be provided for every two test 

subjects. 

(2) Ear muffs attached to a hardhat: 

The hardhat sample shall be specified 

by the manufacturer of the hearing 

protection device. A minimum of one 

pair of ear muffs for every two test 

subjects shall be provided. When an ear 

muff is available in different sizes, one 

pair of each size shall be provided for 

every two test subjects. For each size of 

hard hat, two samples shall be provided 

in each size. 

(3) Helmets: A minimum of one 

sample for each size helmet to be tested 

shall be provided. Helmets 

incorporating ear muffs shall be tested 

as a system. The integral ear muffs for 

a helmet shall be provided by the 

manufacturer of the helmet. If the ear 

muffs are removable, the minimum 

number to be used in combination with 

the helmet shall be as specified in 

§ 211.206–1(b)(6)(i)(D). 

(g) Measurement Procedure: 

(1) Subject Selection: Only those 

subjects who completed the REAT tests 

with protectors specified in § 211.206– 

1(a)(3) shall be used for the MIRE tests 

set forth in this section. 

(2) Subject Position: A headpositioning device, such as a plumb-bob 

to the nose or the forehead of the 

subject, shall be used to maintain the 

subject’s head at the reference point. 

The head positioning device shall not 

transmit to the head vibrations that 

affect the threshold measurements, and 

shall not measurably affect the 

uniformity of the sound field of the 

room as specified in Clause 6.2.1 of 

ANSI S12.42. The use of a headrest or 

bite bar is not permitted. 

(h) Fitting the protectors: 

(1) The subject shall fit the protector 

as instructed for the REAT testing. No 

additional fitting training shall be given. 

However, the experimenter shall ensure 

that the integrity of the MIRE 

microphone and its wires is maintained 

during the fit process. 

(2) The fitting noise shall be 

introduced into the test chamber and 

the subject shall be told to adjust the 

hearing protector to minimize the level 

of the perceived noise. 

(3) To allow hearing protectors to 

conform to the subject’s ears and/or 

head, MIRE measurements shall begin a 

minimum of two minutes after the 

hearing protectors have been fitted 

unless the manufacturer’s standard 

instructions state otherwise. 

(4) Adjustments of hearing protector 

fit during the test are not permitted. The 

subject shall be told to inform the 

experimenter if a change in the fit of the 

device is noticed. If the experimenter is 

so informed, the occluded test shall be 

stopped. The subject shall refit the 

device and the experimenter shall 

confirm the integrity of the MIRE 

system, after which the test shall be 

restarted from the beginning. If change 

in the fit occurs a second time but the 

MIRE system is unaffected, the test shall 

be completed without refit and the 

attenuation data shall be used in the 

computation of the active noise 

reduction. 

(i) MIRE Sound Levels with Protectors 

Activated (LTOTAL(f)): 

(1) The experimenter shall verify that 

the device is activated as specified by 

the manufacturer’s standard 

instructions. 

(2) The sound field shall be presented 

in the test chamber at the reference level 

of 105 dB SPL as specified in paragraph 

(c)(5) of this section. 

(3) The MIRE output signal shall be 

measured in one-third octave bands 

(LTOTAL(f)) using linear spectral 

averaging and an integration time of no 

less than 32 seconds. 

(j) MIRE Sound Levels with Protectors 

Deactivated (LPASSIVE(f)): 

(1) The experimenter shall verify that 

the device is deactivated as specified by 

the manufacturer’s standard 

instructions. 

(2) The sound field shall be presented 

in the test chamber at the reference level 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39189 

of 105 dB SPL as specified in paragraph 

(c)(5) of this section. 

(3) The MIRE output signal shall be 

measured in one-third octave bands 

(LPASSIVE(f)) using linear spectral 

averaging and an integration time of no 

less than 32 seconds. 

(4) The measurements in paragraph 

(i)(j) of this section shall be repeated 

and the LPASSIVE(f) and LTOTAL(f) levels 

for each measurement recorded. 

(5) Verification of MIRE microphone 

position: Upon completion of the 

measurements in paragraph (i)(j) of this 

section, the experimenter shall confirm 

the position of the MIRE has not 

changed. If the position has changed, 

the measurements shall be repeated. 

(k) Active Attenuation Method for ear 

plugs using Acoustic Test Fixture 

(ATF). 

(1) Acoustic Test Fixture: 

(i) The ATF shall incorporate two ear 

canal couplers and ear simulators. 

(ii) The ATF ear simulators shall 

comply with the International 

Electrotechnical Commission (IEC) 

specification 60711—‘‘Occluded-ear 

simulator for the measurement of 

earphones coupled to the ear by ear 

inserts,’’ 

(iii) The length of the ear canal 

couplers shall provide a residual 

volume of between 0.5 and 2.0 cubic 

centimeters after insertion of the ear 

plug. 

(iv) The ATF microphones shall meet 

or exceed the following minimum 

specifications. 

(A) Frequency range 20 to 12500 Hz. 

(B) Dynamic range: 40 to 130 dB SPL. 

(v) The insertion loss of the ATF shall 

not be less than 60 dB for a sound field 

as specified in § 211.206–2(c)(5). 

(2) Product selection: 

(i) Custom Ear plugs: 

(A) The testing lab shall provide the 

manufacturer with impressions of the 

ATF ear canal that provide a residual 

volume between 0.5 cubic centimeters 

(cc) and 1.0 cc. 

(B) The manufacturer shall provide 

the testing lab a minimum of five ANR 

electronic control units and five pairs of 

ANR ear plugs that are custom fitted to 

the ATF ear canal coupler. 

(ii) Non-custom Ear plugs: 

(A) The manufacturer shall provide 

the testing lab a minimum of five ANR 

electronic control units and five pairs of 

ANR ear plugs. 

(B) Alternatively, the ear plugs from 

the REAT test may be reused for this 

ATF test. 

(3) Measurement Procedure for Active 

Noise Reduction Performance of ear 

plugs. 

(i) Fitting the protectors: 

(A) The experimenter shall fit the 

protectors into the ear couplers of the 

ATF such that their respective residual 

volumes are not less than 0.5 cc and no 

greater than 1.0 cc. 

(ii) ATF Sound Levels with Protectors 

Activated (LTOTAL(f)): 

(A) The experimenter shall activate 

the device as specified by the 

manufacturer’s standard instructions. 

(B) The sound field in the test room 

shall be at the reference level of 105 dB 

SPL as specified in paragraph (c)(5) of 

this section. 

(C) The output signals of the ATF 

microphone(s) shall be measured in 

one-third octave bands (LTOTAL(f)) using 

linear spectral averaging and a 

minimum integration time of 32 

seconds. 

(iii) ATF Sound Levels with 

Protectors Deactivated (LPASSIVE(f)): 

(A) The experimenter shall deactivate 

the device as specified by the 

manufacturer’s standard instructions. 

(B) The sound field in the test room 

shall be at the reference level of 105 dB 

SPL as specified in paragraph (c)(5) of 

this section. 

(C) The ATF microphone(s) output 

signal shall be measured in one-third 

octave bands (LPASSIVE(f)) using linear 

spectral averaging and a minimum 

integration time of 32 seconds. 

(D) The measurements in paragraphs 

(k)(3)(ii) and (iii) of this section shall be 

repeated for a total of forty trials. Each 

ANR control unit and each pair of ear 

plugs shall be used an equal number of 

times. The LPASSIVE(f) and LTOTAL(f) 

levels for each measurement shall be 

recorded. 

(l) ANR performance for helmets with 

integral ear plugs or ear muffs or both 

ear plugs and ear muffs. 

(1) The tests set forth in paragraph 

(k)(3) of this section for ANR muffs and 

plugs shall be used singularly or in 

combination as appropriate. 

(m) Calculation of Attenuation of 

ANR devices: 

(1) The passive attenuation for each 

subject shall be the average of the 

individual REAT attenuation 

measurements for octave band 

frequencies from 125 to 8000 Hz. 

(2) The octave band active attenuation 

for each trial shall be calculated using 

the third octave band insertion loss 

measurements (from 100 to 10000 Hz), 

as follows: 

(i) LACTIVE (one-third octave band 

insertion losses) for each trial for each 

one-third octave band shall be 

calculated as: 

(A) LACTIVE (1⁄3 OB) = LTOTAL ¥ LPASSIVE

(B) LACTIVE (octave band insertion 

losses) for each trial shall be calculated 

as the median of the one-third octave 

band active attenuations, described in 

§ 211.206–2(k)(3)(ii) and (iii), measured 

for both the right and left ears. 

(C) An example calculation is 

presented in Table 1 of this section. The 

six (6) insertion losses for the active 

mode have a median of 11.4 dB. The six 

values are sorted first (10.4, 10.8, 11.1, 

11.7, 12.1 and 12.6). The values 11.1 

and 11.7 bracket the 50th percentile and 

their average is 11.4 dB. 

TABLE 1—EXAMPLE OF THE MEDIAN OCTAVE BAND INSERTION LOSS COMBINED WITH REAT FOR ACTIVE MODE

¥1⁄3 octave Center band +1⁄3 octave 

REAT Attenuation ........................................................................................................................ ........................ 25.4 ........................

Right Ear Active Insertion Loss ................................................................................................... 10.4 12.1 11.7 

Left Ear Active Insertion Loss ..................................................................................................... 10.8 11.1 12.6 

Median Insertion Loss ................................................................................................................. ........................ 11.4 ........................

REAT + Median Insertion Loss ................................................................................................... ........................ 36.8 ........................

(3) The total octave band attenuation 

for each trial in the Active mode 

(electronics turned on) shall be the sum 

of the REAT octave band attenuations 

and the LACTIVE octave band insertion 

losses as computed in paragraph (m)(2) 

of this section. These total octave band 

attenuation values (REAT + LACTIVE) 

shall be used in the computation of the 

NRR and the NRRG as specified in ANSI 

S12.68–2007. If the total octave band 

attenuation values exceed 50 dB in any 

band then a cautionary note must be 

provided regarding the influence of 

bone conduction according to 

§ 211.204–5(j). 

15. Section 211.206–3 is added to 

read as follows: 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
39190 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

§ 211.206–3 Reduction of Peak Impulsive 

Noise. 

Hearing protection devices sold or 

offered on the basis of providing 

protection from impulsive noises in 

excess of 130 dB peak sound pressure 

level shall be tested in accordance with 

this section. 

(a) Product Selection. 

(1) Custom Ear plugs: 

(i) The manufacturer shall provide the 

testing lab a minimum of five pairs of 

ear plugs that are custom fit to the ear 

canal couplers of the ATF. 

(ii) The testing lab shall provide the 

manufacturer with impressions of the 

ATF ear canals such that the residual 

volume is not less than 0.5 cubic 

centimeters (cc) or greater than 1.0 cc. 

(2) Ear plugs: 

(i) The manufacturer shall provide the 

testing lab a minimum of five pairs of 

ear plugs selected at random from 

production lots. 

(ii) Alternatively, the ear plugs from 

the REAT test may be reused for this 

ATF test. 

(iii) The testing lab shall insert the ear 

plug such that the residual volume is 

not less than 0.5 cc or greater than 1.0 

cc. 

(3) Ear muffs: 

(i) The manufacturer shall provide the 

testing lab a minimum of five pairs of 

ear muffs selected at random from 

production lots, appropriately sized for 

the ATF. 

(ii) Alternatively, the ear muffs from 

the REAT test may be reused for this 

ATF test if they meet the ATF size 

requirements. 

(4) Ear muffs attached to a hardhat: 

(i) The manufacturer shall provide the 

testing lab a minimum of five pairs of 

ear muffs attached to a hardhat selected 

at random from production lots, 

appropriately sized for the ATF. 

(ii) Alternatively, the hard hat(s) and 

ear muffs from the REAT test may be 

reused for this test if they meet the ATF 

size requirements. 

(5) Helmets incorporating ear cups: 

(i) Helmets incorporating ear cups 

shall be tested as a system for impulse 

noise reduction. The manufacturer shall 

provide the testing lab a minimum of 

one helmet and five pairs of ear cups 

selected at random from production 

lots, appropriately sized for the ATF. 

(ii) Reserved. 

(6) Combination of ear plugs, ear 

muffs and/or helmets: 

(i) The manufacturer shall provide the 

testing lab five (5) pairs of each 

protector. The device shall be tested as 

a system in combination as appropriate. 

(ii) Reserved. 

(b) Impulsive Noise Characteristics. 

(1) Three different peak impulse noise 

levels shall be used. The peak impulse 

levels shall be in the following ranges 

130–134 dB, 148–152 dB and 166–170 

dB. Manufacturers may elect to test at 

levels in excess of the required 170 dB, 

in which case notice must be given on 

both the primary and secondary labels 

as required in § 211.204–1(c) and 

§ 211.204–6 and the information 

reported to the EPA on the required test 

report per § 211.212–5. 

(2) The minimum permissible Aduration shall not be less than 0.5 

milliseconds and the maximum shall 

not be greater than 2.0 milliseconds. 

(3) The peak level and A-duration of 

the impulse noise shall not be affected 

by acoustic reflections. 

(c) Measurement Equipment. 

(1) Impulsive Acoustic Test Fixture or 

Dummy Head (IATF). 

(i) The hearing protection device shall 

be tested on an IATF which meets the 

requirements of ANSI S12.42–1995, 

Section 9.1—Acoustic Test Fixture 

Method. 

(ii) The insertion loss of the IATF 

shall not be less than 65 dB for impulses 

in the ranges described in paragraph 

(b)(1) of this section. 

(iii) The IATF shall include two 

identical simulated ears, including 

representative pinnas, conchas, and ear 

canal coupler, and identical 

instrumentation. The ear canal coupler 

shall be in accordance with IEC 60711 

(1984) but incorporate a 6.35 mm (0.25 

inch) pressure microphone to satisfy the 

required dynamic range of 130 db to 170 

dB. 

(2) Free-Field Pressure Probe/ 

Microphone. 

(i) A free-field pressure probe/ 

microphone capable of accurately 

measuring impulse levels of 180 dB 

peak SPL shall be used as the external 

microphone. 

(ii) The free-field pressure probe shall 

be a cylindrical body as depicted in 

Figure 1 of this section, having a 

minimum length, d3, of 40.64 cm (16 

inches), a maximum diameter of 5.08 

cm (2 inches) and a taper from the tip, 

d1, of 5.08 to 10.16 cm (2 to 4 inches). 

The pressure transducer shall be flush 

with the side of the cylindrical body 

and located a distance d2, from the tip, 

of between 15.24 and 20.32 cm (6 and 

8 inches). 

(iii) The free-field pressure probe/ 

microphone shall be positioned as 

shown in Figure 2 of this section, 

equidistant and at the same elevation as 

the microphone(s) of the IATF from the 

impulse noise source. 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39191 

(3) Impulsive Noise Measurement 

Instrumentation 

(i) Sampling rate: The data acquisition 

system shall be capable of 

simultaneously sampling the acoustic 

response of the two ears of the IATF and 

the free-field pressure probe/ 

microphone with a minimum sampling 

rate of 96,000 samples per second (96 

kHz) for each channel. 

(ii) Signal to Noise Ratio: The Signal 

to Noise Ratio of any captured signal 

must be greater than 10 dB from 100 to 

10000 Hz. 

(iii) Sampling Resolution: The 

resolution of the data acquisition system 

shall be a minimum of 16-bits. 


srobinson on DSKHWCL6B1PROD with PROPOSALS2EP05AU09.013</GPH> EP05AU09.014</GPH>
39192 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

(4) Instrumentation layout for 

Measurement of Reduction of Peak 

Impulsive Noise. 

(i) The instrumentation shall be 

arranged such that each ear of the IATF 

and the free-field pressure probe/ 

microphone are located equidistant 

from the impulse noise source as shown 

in Figure 2 of this section. 

(5) Measurement Procedure for the 

Impulsive Noise Reduction Rating. 

(i) Calibration of the Free-field to ear 

canal transfer function. 

(ii) Five impulses shall be produced 

in the range of 148 to 152 dB peak 

impulse sound pressure level. The 

measurement of the free field to ear 

canal transfer function is not required if 

impulse peaks are within ± 0.5 dB. 

(iii) The complex free-field to ear 

canal transfer functions (HFF–Right-i and 

HFF–Left-i) shall be calculated for each 

impulse and each ear. 

(iv) The free-field to ear canal transfer 

functions (HFF–Right and HFF–Left) shall be 

the average of the five respective 

individual calculated transfer functions. 

(A) HFF–Right, i(f) = F(PEAR–Right,i(t))/F(PFF,

i(t)) 

(B) HFF–Left, i(f) = F(PEAR–Left,i(t))/F(PFF,

i(t)) 

(6) Measurement of the Peak 

Impulsive Noise Reduction for a hearing 

protection device. 

(i) For each sample of the hearing 

protection device, a minimum of one 

impulse at each of the three pressure 

ranges shall be produced as specified in 

paragraph (b)(1) of this section. The 

peak pressure can be adjusted by 

varying the acoustic impulse source 

and/or altering the distance from the 

source to the test fixture. 

(ii) Each impulse shall be recorded 

from the free-field, IATF left and right 

ear canal microphones by the data 

acquisition system. The total duration of 

the captured signal shall not be less 

than 50 milliseconds. The time duration 

from the beginning of the captured 

signal to its peak amplitude shall be a 

minimum of 1.0 millisecond. The time 

waveforms from the IATF and the freefield pressure probe/microphone shall 

be sampled simultaneously. 

(iii) The measured time waveforms 

shall be labeled as PFF, j, k for the freefield pressure probe/microphone and as 

PATF–RIGHT, j, k and PATF–LEFT, j, k for the 

acoustic test fixture/dummy head ear 

microphones, where j = 1 to 5 for the 

protector samples, and k=1 to 3 are the 

respective impulse noise peak ranges, 

respectively. 

(iv) The hearing protector shall be 

removed and refitted to the IATF for 

each impulse noise trial. 

(v) If an acoustic impulse or HPD 

fitting is unacceptable, the HPD shall be 

refitted and the impulse trial shall be 

repeated. The data from an unacceptable 

trial shall be discarded. 

16. Section 211.206–4 is added to 

read as follows: 

§ 211.206–4 Consideration of alternative 

test procedures. 

The Administrator may approve 

applications from manufacturers of 

hearing protectors for the approval of 

test procedures which differ from those 

contained in this subpart so long as the 

alternative procedures have been 

demonstrated to correlate with the 

prescribed procedures. To be 

acceptable, alternative test procedures 

must be such that the hearing protector 

test results obtained will fulfill all test 

and data requirements prescribed in 

§ 211.206 when the product is tested in 

accordance with the specified 

methodology. After approval by the 

Administrator, testing conducted by 

manufacturers using alternative 

procedures may be accepted by the 

Administrator for all purposes 

including, but not limited to, 

production verification testing and 

selective enforcement audit testing. 

§ 211.207 [Amended] 

17. Section 211.207 is amended by 

removing the introductory text and 

Figure 2. 

18. Section 211.207–1 is added to 

read as follows: 

§ 211.207–1 Computation of NRR based on 

statistical and graphical methods. 

(a) The Noise Reduction Rating (NRR) 

in this subpart shall be determined in 

accordance with the procedures set 

forth in Clauses 5, 6 and 7 of ANSI/ASA 

S12.68–2007, incorporated by reference 

at § 211.213 of this subpart, except as 

stipulated in paragraphs (b)(1) through 

(4), (c)(1) and (2), (d), and (e) of this 

section. 

(b) ANSI Clause 5: The computation 

of the NRR, as set forth in this clause, 

shall be used to determine the 

‘‘PASSIVE mode’’ noise reduction 

performance of all hearing protector 

devices subject to this regulation. 

(1) The ‘‘Noise Level Reduction 

Statistic for use with A-weighting 

(NRSA)’’ shall be replaced by the ‘‘Noise 

Reduction Rating (NRR)’’ as used in this 

subpart. 

(2) For subpart B, ANSI Clause 5.1 

shall be replaced by the paragraph (b)(3) 

of this section. 

(3) ‘‘The NRR for a hearing protector, 

as used in this subpart, is comprised of 

a pair of values representing the lower 

and upper A-weighted noise level 

reductions that can be expected when 

the device is used as directed by the 

manufacturers’ instructions.’’ 

(4) ANSI Clause 5.2: The value of a 

as used in this subpart shall be for the 

80% and 20% protection performance 

and equal to 0.8416 and -0.8416 

respectively. 

(c) ANSI Clause 6: The computation 

of the NRR, as set forth in this clause, 

shall be used to determine the ‘‘ACTIVE 

mode’’ noise reduction performance of 

all hearing protector devices that rely in 

whole or in part on either mechanical, 

electronic and/or acoustically variable 

(with respect to sound pressure level) 

methods of increasing their noise 

reduction performance. 

(1) For subpart B, ANSI Clause 6.0: 

the ‘‘Noise Level Reduction Statistic, 

Graphical (NRSG) shall be replaced by 

the ‘‘Noise Reduction Rating, Graphical 

(NRRG). 

(2) This method shall not be used to 

compute either the ‘‘PASSIVE mode’’ or 

the ‘‘ACTIVE mode’’ performance of 

hearing protectors intended for 

protection from high level impulsive 

noise. The appropriate computation is 

given in paragraph § 211.207–4. 

(d) ANSI Clause 7—Octave-Band 

Method: The computation of the mean 

attenuation, the standard deviation of 

attenuations and the Assumed 

Protection Values (APVs) as a function 

of frequency, as set forth in this clause, 

shall be used for all hearing protectors 

for the ‘‘PASSIVE mode’’ and for active 

noise reduction hearing protectors in 

the ‘‘ACTIVE mode.’’ 

(e) For subpart B, ANSI Annex A of 

ANSI/ASA 12.68–2007—‘‘Noise Spectra 

Used in Calculating the NRRA and 

NRRG,’’ shall be applicable. 

19. Section 211.207–2 is added to 

read as follows: 

§ 211.207–2 Computation of the Passive 

Noise Reduction Rating. 

The PASSIVE Noise Reduction Rating 

shall be calculated using the REAT data 

obtained in § 211.206–1. 

(a) Noise Reduction Rating: For each 

subject, the attenuations from both trials 

at each octave band frequency (125, 250, 

500, 1000, 2000, 4000, and 8000 Hz) 

shall be averaged, yielding seven 

attenuations. The averaged attenuation 

data shall be used for the Rp f(k) in 

Equation 1 of ANSI S12.68–2007. The 

Noise Reduction Rating shall be 

determined according to Equations 1, 2, 

3, 4, 5 and 6 as specified in Clause 5.2 

of ANSI/ASA S12.68–2007, 

incorporated by reference at § 211.213 of 

this subpart, using the alpha (a) values 

of 0.8416 and –0.8416, corresponding to 

the 20th and 80th percentiles. 

(b) Variability of Noise Reduction 

Rating with Spectral Levels: The 

variability of the Noise Reduction 

Rating with the spectral level of the 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39193 

noise environment in which the hearing 

protector is worn shall be determined 

according to Equation 8 in Clause 6 of 

ANSI S12.68–2007 and shall use the 

noise spectra as specified in Annex B of 

ANSI S12.68 for determining the 

variability. For the variability of passive 

devices, the Estimated Noise Level 

Reduction shall be determined at the 

spectral balance values of LC¥LA = [– 

1, 2, 6 and 13 dB]. The variability shall 

be determined for the 20th and 80th 

percentile assumed protection values. 

The variability results shall be reported 

in the supporting information specified 

in § 211.204–4. 

(c) Mean attenuations and standard 

deviations: The mean attenuations and 

standard deviations across subjects as a 

function of octave band frequency (f) 

from 125 to 8000 Hz are determined as 

follows: 

(1) The mean attenuations are: 

m

P f pf R p

P

= =

∑

1

1

Where Rpf is the averaged attenuations for 

each subject and octave band frequency, 

P is the total number of subjects tested, 

p is the subject index. 

(2) The standard deviations of the 

mean attenuation are: 

s

P f pf f R m p

P

= − ( ) − =

∑ 1

1

2

1

Where Rpf is the averaged attenuations for 

each subject and octave band frequency, 

P is the total number of subjects tested, 

p is the subject index. 

(d) Assumed Protection Values: The 

assumed protection values (APVf) for 

the ‘‘passive mode’’ of a hearing 

protector as a function of octave band 

frequency (f) from 125 to 8000 Hz are 

determined as follows: 

(1) The assumed protection values are 

APVf = mf±asf

Where the 20th percentile APV is determined 

when a = +0.8416 and the 80th 

percentile APV is determined when a = 

–0.8416 is used. 

(2) [Reserved] 

20. Section 211.207–3 is added to 

read as follows: 

§ 211.207–3 Computation of the Active 

Noise Reduction Rating. 

The Active Noise Reduction Rating 

shall be calculated using total octave 

band attenuation determined in § 211– 

206–2(m). 

(a) Noise Reduction Rating: The total 

octave band attenuation (the sum of the 

REAT octave band attenuations and the 

LACTIVE octave band insertion losses) 

shall be used for the Rp f(k) in Equation 

1 of ANSI S12.68–2007. The Noise 

Reduction Rating shall be determined 

according to Equations 1, 2, 3, 4, 5 and 

6 as specified in Clause 5.2 of ANSI 

S12.68–2007, using the alpha (a) value 

of 0.8416 and –0.8416, corresponding to 

the 20th and 80th percentiles. 

(b) Variability of Noise Reduction 

Rating with Spectral Levels: The 

variability of the Noise Reduction 

Rating with the spectral level of the 

noise environment in which the hearing 

protector is worn, shall be determined 

according to Equation 8 in Clause 6 of 

ANSI S12.68–2007 and shall use the 

noise spectra as specified in Annex B of 

ANSI S12.68 for determining the 

variability. 

(1) For the variability of passive 

devices, the Estimated Noise Level 

Reduction shall be determined at the 

spectral balance values of LC¥LA = 

[–1, 2, 6 and 13 dB]. The variability 

shall be determined for the 20th and 

80th percentile assumed protection 

values. The variability results shall be 

reported in the supporting information 

specified in § 211.204–4. 

(2) The Estimated Noise Level 

Reduction (20th and 80th percentiles) 

determined for the spectral balance 

value of LC¥LA = 13 dB shall be used 

to identify the performance of an active 

noise reduction hearing protection 

device in a low frequency noise 

environment. 

(c) Mean attenuations and standard 

deviations: The mean total attenuations 

(REAT + LACTIVE) and standard 

deviations across subjects as a function 

of octave band frequency (f) from 125 to 

8000 Hz are determined as follows: 

(1) The mean attenuations are 

m

P f pf R p

P

= =

∑

1

1

Where Rpf is the averaged total attenuation 

for each subject and octave band 

frequency, P is the total number of 

subjects tested, p is the subject index. 

(2) The standard deviations of the 

mean attenuation are 

s

P f pf f R m

p

P

= − ( ) − =

∑ 1

1

2

1

Where Rpf is the averaged total attenuation 

for each subject and octave band 

frequency, P is the total number of 

subjects tested, p is the subject index. 

(d) The standard deviations of the 

mean attenuation are 

s

P f pf f R m

p

P

= − ( ) − =

∑ 1

1

2

1

Where Rpf is the averaged total attenuation 

for each subject and octave band 

frequency, P is the total number of 

subjects tested, p is the subject index. 

(1) The assumed protection values are 

APVf = mf±asf

Where the 20th percentile APV is determined 

when a = +0.8416 and the 80th 

percentile APV is determined when a = 

–0.8416 is used. 

(2) [Reserved] 

21. Section 211.207–4 is added to 

read as follows: 

§ 211.207–4 Computation of the Impulsive 

Noise Reduction Rating. 

(a) The equivalent ear canal time 

waveform shall be calculated from the 

measured free-field waveform, PFF,j,k,

and the free field to the ear canal 

transfer function HFF for each ear. 

(b) These waveforms shall be referred 

to as PFF–EAR–Left,j,k and PFF–EAR–Right,j,k

and shall be computed by applying the 

average free-field to ear canal transfer 

functions (HFF–Right and HFF–Left) to the 

free-field waveforms (PFF). The 

corrected waveforms shall be computed 

as: 

PFF–EAR–Right, j, k (f) = PFF, j, k(f) 

* HFF–Right(f), 

PFF–EAR–Left, j, k (f) = PFF, j, k (f) 

* HFF–Left(f), 

PFF–Right, j, k (t) = F¥1(PEAR–Right, j, k (f)), 

PFF–Left, j, k (t) = F¥1(PEAR–Left, j, k (f)), 

Where: 

F¥1( ) is the inverse Fourier transform 

function. The respective waveforms and 

transfer functions are represented as 

linear quantities in the frequency 

domain. 

(c) The reduction of the peak impulse, 

as affected by the hearing protection 

device, shall be: 

(1) DPImpulse-Right, k = Sj = 1 to 5

[max(PFF_EAR–Right, j, k)— 

max(PATF–Right, j, k)]/5 

(2) DPImpulse-Left, k = Sj = 1 to 5

[max(PFF_EAR–Left, j, k)— 

max(PATF–Left, j, k)]/5, 

Where: 

Max( ) is the maximum positive peak 

pressure of the impulse. 

(d) The average impulse noise 

reduction for each pressure range (k) 

shall be the average impulse noise 

reduction for each pressure range (k) 

shall be: 

DPImpulse, k = [avg(DPImpulse-Right, k) + 

avg(DPImpulse-Left, k)]/2 

(e) The three average impulse noise 

reductions shall be used to provide the 

data points for § 211.204–6, Table 2. The 

three average impulse noise reduction 

values shall be graphed with a range for 

the abscissa of 130 to 180 dB (re 20 μPa) 

and a range for the ordinate of 0 to 50 


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39194 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

dB with the symbols connected by a 

solid line. 

(f) The minimum of the three impulse 

noise reduction values calculated in 

paragraph (d) of this section shall be the 

lower endpoint in the impulse noise 

reduction rating as required in 

§ 211.204–1(c) Figure 3. 

(g) The maximum of the three impulse 

noise reduction values calculated in 

paragraph (d) of this section, shall be 

the upper endpoint in the impulse noise 

reduction rating as required in 

§ 211.204–1(c) Figure 3. 

22. Section 211.209 is added to read 

as follows: 

§ 211.209 Maintenance of records. 

(a) The manufacturer, as defined in 

§ 211.203(aa), of any hearing protective 

device subject to this regulation must 

establish, maintain and retain the 

following adequately organized and 

indexed records. 

(1) General records. 

(i) Identification and description by 

category parameters of protectors 

comprising the manufacturer’s product 

line; 

(ii) A description of any procedures, 

other than those contained in this 

regulation used to perform noise 

attenuation tests on any test protector, 

and the results of those tests; 

(iii) A record, signed by an authorized 

representative of the laboratory, of any 

calibration that was performed during 

testing by the test laboratory; and 

(iv) A record of the date of 

manufacture of each protector subject to 

this regulation, keyed to the serial 

number or other coded identification 

contained in the supporting information 

required by § 211.204–4. 

(2) Individual records for the test 

protectors. A complete record, or exact 

copies of the complete record of all 

noise attenuation tests performed 

(except tests performed by EPA directly) 

which includes all individual 

worksheets, and other documentation 

relating to each test required by subpart 

B. 

(3) The manufacturer may fulfill this 

record retention requirement by keeping 

a copy of the labeling verification report 

that he has submitted to the EPA in the 

format recommended by the 

Administrator (see Appendix A of this 

part) and by establishing a record of the 

information required by § 211.212–5. 

(4) The manufacturer must retain all 

required records for the life of each 

specific product line. Records may be 

retained as electronic or hard copy or 

reduced to microfilm, or other forms of 

data storage depending on the record 

retention procedures of the 

manufacturer. 

22a. Section 211.209–1 is added to 

read as follows: 

§ 211.209–1 Reporting requirements. 

(a) The manufacturer must submit to 

the EPA, in hardcopy or electronic 

format, a completed coversheet 

according to Annex A, a copy of all 

authorized measurement information, 

including test results and calculated 

NRR values, obtained from the testing 

laboratory for each product or product 

category, within ten (10) business days 

of completion of the required test. The 

test results are to be in the format 

recommended in Appendix A and sent 

to: U.S. Environmental Protection 

Agency, Attn: Docket Center, Docket 

Number EPA–HQ–OAR–2003–0024, 

Mail Code—2822T, 1200 Pennsylvania 

Avenue, NW., Washington, DC 20460. 

(b) On request by the Administrator, 

the manufacturer must submit to the 

Administrator information regarding the 

number of protectors, by category, 

produced or scheduled for production 

during the time period designated in the 

request. 

23. Section 211.210–1 is revised to 

read as follows: 

§ 211.210–1 General requirements. 

(a) Each manufacturer of hearing 

protectors for distribution in commerce 

in the United States, which are subject 

to the requirements of this regulation as 

specified in § 211.201. 

(1) Must affix a label to each product, 

as specified in § 211.204, that is readily 

visible at the point of sale to the 

ultimate purchaser or distribution to the 

prospective user. 

(2) Must assure that each product 

meets or exceeds the sound attenuation 

values determined by the procedures in 

§ 211.206 and explained in § 211.207. 

(b) Product manufacturers who 

introduce protectors into commerce for 

sale to another manufacturer, as defined 

herein, for packaging and sale to 

ultimate purchaser or user, must 

provide to that manufacturer the 

attenuation values and standard 

deviations of each of the one-third 

octave band center frequencies as 

determined by the test procedures in 

§ 211.206. The product manufacturer 

must also provide the Noise Reduction 

Ratings calculated according to the 

appropriate product as specified in 

§ 211.207. 

24. Section 211.210–2 is amended as 

follows: 

a. Revise paragraphs (a)(1) and (a)(2). 

b. Revise paragraph (b)(1). 

c. Add and reserve paragraph (b)(2). 

d. Revising paragraph (c). 

e. Designate the undesignated 

paragraph at the end of the section as 

paragraph (d). 

§ 211.210–2 Labeling requirements. 

(a)(1) A manufacturer responsible for 

labeling must satisfy the requirements of 

this subpart for a category of hearing 

protectors, as defined in § 211.203, 

before distributing that category of 

hearing protectors in commerce. 

(2) A manufacturer may apply to the 

Administrator for an extension of time 

to comply with the labeling 

requirements of this subpart for a 

category of protectors that are currently 

being distributed in commerce. The 

Administrator may grant the 

manufacturer an extension of up to 60 

days from the date of distribution. The 

manufacturer must provide reasonable 

assurance that the protectors will equal 

or exceed their currently labeled NRR 

range, and that testing and labeling 

requirements of this subpart will be 

satisfied before the extension expires. 

Requests for extension shall go to the 

Administrator, U.S. Environmental 

Protection Agency, Washington, DC 

20460. The Administrator will respond 

to a request within ten (10) business 

days from receipt of request. Responses 

may be either written or electronic. 

* * * * * 

(b) * * * 

(1) Testing hearing protectors 

according to §§ 211–204 through 211– 

206. The hearing protectors must have 

been assembled by the manufacturer’s 

normal production process and must 

have been intended for distribution in 

commerce. 

(2) [Reserved] 

(c) Each category of hearing protectors 

is determined by one or a combination 

of the following parameters. 

Manufacturers may use additional 

parameters as needed to create and 

identify additional categories of 

protectors. 

(1) Ear muffs. 

(i) Head band tension (spring 

constant); 

(ii) Ear cup volume or shape; 

(iii) Mounting of ear cup on head 

band; 

(iv) Ear cushion; 

(v) Material composition. 

(2) Ear plugs. 

(i) Shape; 

(ii) Size; 

(iii) Material composition. 

(3) Custom ear plugs. 

(i) Manufacturing Method; 

(ii) Acoustic Filter(s); 

(iii) Material composition. 

(4) Semi-insert Devices. 

(i) Hand band tension (spring 

constant); 

(ii) Mounding on pod or tip on head 

band; 

(iii) Shape; 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 39195 

(iv) Size; 

(v) Material composition. 

(5) Active Noise Reduction Devices. 

(i) Protector Style; 

(A) Ear plug; 

(B) Ear muff. 

(ii) Circuitry; 

(A) Feed-forward control circuit; 

(B) Feed-back control circuit; 

(6) Amplitude-Sensitive Devices. 

(i) Active design; 

(A) Level-limiting; 

(B) Compression circuit; 

(C) Peak-clipping. 

(ii) Passive design. 

(A) Nonlinear resistive orifice. 

(B) Physical control valve. 

(iii) Protector Style. 

(A) Ear plug. 

(B) Ear muff. 

* * * * * 

§ 211.211 [Removed and Reserved] 

25. Section 211.211 is removed and 

reserved. 

26. Section 211.211–1 is added to 

read as follows: 

§ 211.211–1 Compliance with labeling 

requirements. 

(a) All hearing protection devices 

manufactured after the effective date of 

this regulation, and meeting the 

applicability requirements of § 211.201, 

must be labeled according to this 

subpart, and must comply with the 

range of Noise Reduction Ratings as 

determined by the appropriate test 

procedure as specified in § 211.204 

through 211.206 of this subpart. 

(b) A manufacturer must take into 

account both product variability and 

test-to-test variability when labeling his 

devices in order to meet the 

requirements of paragraph (a) of this 

section. A specific category is 

considered when the attenuation value 

at the tested one-third octave band is 

equal to or greater than the Labeled 

Value, or mean attenuation value, stated 

in the supporting information required 

by § 211.204–4, for that tested 

frequency. The attenuation value must 

be determined according to the test 

procedures of § 211.206. The range of 

Noise Reduction Ratings for the label 

must be calculated using the mean 

attenuation that will be included in the 

supporting information required by 

§ 211.204–4. 

27. Section 211.211–2 is added to 

read as follows: 

§ 211.211–2 Transition testing and labeling 

requirements. 

All hearing protection devices 

manufactured on or after the effective 

date of this subpart, and meeting the 

applicability requirements of § 211.201, 

must be tested with the appropriate 

procedure specified in § 211.206 and 

labeled as specified in § 211.204. 

Manufacturers shall complete testing 

and labeling of all categories within 

thirty (30) months from the effective 

date of subpart B. 

28. Section 211.211–3 is added to 

read as follows: 

§ 211.211–3 Recurrent testing 

requirements. 

All hearing protection devices 

manufactured after the effective date of 

this subpart, and meeting the 

applicability requirements of § 211.201, 

must be retested periodically, following 

their initial transition testing and 

labeling pursuant to § 211.210–2. 

Manufacturers shall retest their 

products every five (5) years 

commencing from the date of a 

categories transition test. 

29. Section 211.211–4 is added to 

read as follows: 

§ 211.211–4 Product change retesting 

requirement. 

(a) Any product that meets the 

applicability requirements of § 211.201, 

must be retested prior to entry into 

commerce if the manufacturer alters the 

product design, product materials, 

manufacturing process or takes any 

action that may alter the noise reduction 

performance of the product from its 

previous test state. In the event the NRR 

values (lesser and/or greater) are a 

minimum of 3 dB less than the current 

labeled NRR values, the manufacturer 

must relabel as specified in § 211.211– 

3. 

(b) The recurrent testing of such 

product shall commence in accordance 

with the appropriate schedule in 

§ 211.211–3. 

30. Section 211.212–1 is amended as 

follows: 

a. Revise paragraph (a). 

b. Revise paragraph (b). 

c. Revise paragraphs (e)(2) and (e)(3). 

d. Revise paragraph (f). 

§ 211.212–1 Test request. 

(a) The Administrator will request all 

compliance audit testing under this 

section by means of a written request 

addressed to the manufacturer listed on 

the product label. The test request will 

be signed by the Assistant 

Administrator for Enforcement or his 

designee. 

(b) The test request will be delivered 

by an EPA Enforcement Officer or sent 

by certified mail to the plant manager or 

other responsible official as designated 

by the listed manufacturer. 

* * * * * 

(e) * * * 

(2) The manufacturer must complete 

the required testing within ten (10) 

business days following commencement 

of the testing. 

(3) The manufacturer will be allowed 

five (5) business days to send test 

hearing protectors from the assembly 

plant to the testing facility. The 

Administrator may approve more time 

based upon a request by the 

manufacturer. The request must be 

accompanied by a satisfactory 

justification. 

(f) Failure to comply with any of the 

requirements of this section will not be 

considered a violation of these 

regulations if conditions and 

circumstances outside the control of the 

manufacturer render it impossible for 

him to comply. 

* * * * * 

31. Section 211.212–5 is amended by 

revising paragraph (a)(1) and removing 

paragraph (c). 

The revision reads as follows: 

§ 211.212–5 Reporting test results. 

(a)(1) The manufacturer must submit 

in electronic format within five (5) 

business days of completion of testing, 

to the Administrator or his designated 

enforcement representative, a copy of 

the Compliance Audit Test report for all 

testing conducted under § 211.212. A 

suggested compliance audit test report 

form is included as Appendix B of this 

part. 

* * * * * 

32. Section 211.212–6 is amended by 

revising paragraph (a)(2) to read as 

follows: 

§ 211.212–6 Determination of compliance. 

(a) * * * 

(2) The Noise Reduction Rating values 

(lesser and/or greater), as determined by 

Compliance Audit Test, are equal to or 

greater than the Noise Reduction Rating 

values as stated on the label required by 

§ 211.204. 

* * * * * 

33. Section 211.213 is revised to read 

as follows: 

§ 211.213 Incorporation by Reference. 

The American National Standards 

Institute/Acoustical Society of America 

standards are incorporated by reference 

into subpart B with the approval of the 

Director of the Federal Register under 5 

U.S.C. 552(a) and 1 CFR part 51. The 

materials are incorporated as they exist 

on the date of approval, and notice of 

any change in these materials will be 

published in the Federal Register. They 

are available for inspection at the HQ 

Air Docket Center, EPA/DC, EPA West, 

Room 3334, 1301 Constitution Ave., 

NW., Washington, DC, and at the 


srobinson on DSKHWCL6B1PROD with PROPOSALS2
39196 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Proposed Rules 

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.go/

federal_register/code_of_federal_

regulations/ibr_locations.html. 

(a) The following materials are 

available for purchase from: Acoustical 

Society of America, Standards 

Secretariat, 35 Pinelawn Road, Suite 

114E, Melville, New York 11747. Phone: 

(631) 390–0215; e-mail: asastds@aip.org; 

and Web: http://asastore.aip.org. 

(1) ANSI/ASA S12.6–2008, ‘‘Methods 

for Measuring the Real-Ear Attenuation 

of Hearing Protectors,’’ incorporated by 

reference (IBR) approved for § 211.206– 

1(b)(1), (b)(2), (b)(3), (b)(4), (b)(5), 

(b)(6)(i)(A)(B)(C)(D)(E)(F), (6)(ii), (6)(iii), 

(7)(i), (7)(ii), (8)(i)(A)(B), 

(8)(ii)(A)(B)(C)(D)(E)(F)(G)(H), 

(8)(iii)(A)(B), and (9). 

(2) ANSI S12.42–1995 (R2002), 

‘‘Microphone-in-Real-Ear and Acoustic 

Test Fixture Methods for the 

Measurement of Insertion Loss of 

Circumaural Hearing Protection 

Devices,’’ IBR approved for §§ 211.206– 

2(a), (c)(1), (c)(2), (d)(1), (d)(2), (e)(1), 

(e)(2), (e)(3), (g)(2), and 211.206– 

3(c)(1)(i). 

(3) ANSI/ASA S12.68–2007, 

‘‘Methods of Estimating Effective Aweighted Sound Pressure Levels When 

Hearing Protectors are Worn,’’ IBR 

approved for § 211.206–2(l)(3) and 

§§ 211.207–1(a), and 211.207–2(a), (b), 

and 211.207–3(a)(b). 

(4) ANSI S1.11–2004, ‘‘Specification 

for Octave-Band and Fractional-OctaveBand Analog and Digital Filters’’ 

incorporated by reference (IBR) 

approved for § 211.206–1(b)(4). 

(b) The following material is available 

for purchase from: American National 

Standards Institute, Customer Service 

Department, 25 W. 43rd Street, 4th 

Floor, New York, New York 10036. 

Phone: (212) 642–4980; e-mail: 

info@ansi.org; and web: http:// 

webstore.ansi.org. 

(1) International Electrotechnical 

Commission (IEC) standard 60711, 

Occluded-ear simulator for the 

measurement of earphones coupled to 

the ear by ear inserts,’’ incorporated by 

reference (IBR) approved for 

§§ 211.206–1(k)(1)(ii) and 211.206– 

1(c)(1)(iii). 

(2) [Reserved] 

Appendix A to Part 211 [Redesignated 

as Appendix B to Part 211] 

34. Appendix A is redesignated as 

Appendix B to Part 211 and a new 

Appendix A is added to read as follows: 

Appendix A to Part 211—Reporting 

Requirements—Attenuation Test 

Results and Label Verification 

1. Date of Report. 

2. Manufacturer’s Name. 

3. Manufacturer’s Address. 

4. Name of original equipment 

manufacturer (OEM), if different from above. 

5. OEM address if different from above. 

6. Name and position of responsible 

individual for manufacturer. 

7. Product country of origin if other than 

U.S. 

8. Product Name. 

9. Product Model. 

10. Date of Manufacture. 

11. Date of last test. 

12. Name of Testing Laboratory. 

This coversheet must be accompanied by 

the authorized attenuation test measurements 

and calculated NRR values obtained from the 

testing laboratory for each product of product 

category. 

[FR Doc. E9–18003 Filed 8–4–09; 8:45 am] 

BILLING CODE 6560–50–P 


srobinson on DSKHWCL6B1PROD with PROPOSALS2