[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Proposed Rules]
[Page 39149-39196]
[DOCID:fr05au09-39]

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Part II

Environmental Protection Agency

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40 CFR Part 211

Product Noise Labeling Hearing Protection Devices; Proposed Rule

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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.

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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<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     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<PHONE_NUMBER>, and the telephone number for the Air
Docket is<PHONE_NUMBER>.
    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 e-mail 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
<EMAIL_ADDRESS>
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

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'' (non-electronic 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 ``break-out'' 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 twenty-nine (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:

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.
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    \1\ The referenced studies can be found in the Federal Docket at
http://www.regulations.gov, docket number EPA-HQ-OAR-2003-0024.
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    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\
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    \2\ Occupational 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.
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    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\
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    \3\ National 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.
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    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,

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 air-conducted 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 plug-like 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 A-
weighted 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, multi-
laboratory 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.

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 non-product 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 EPA-sponsored 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
Method-A 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 ``na[iuml]ve'' test subjects, as prescribed in
ANSI S12.6, is not appropriate for the determination of a

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.
---------------------------------------------------------------------------

    \4\ National 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.
---------------------------------------------------------------------------

    Further, EPA agrees with supporters of Method A regarding potential
over-protection 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.
---------------------------------------------------------------------------

    \5\ National 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.
---------------------------------------------------------------------------

    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

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.
---------------------------------------------------------------------------

    \6\ Murphy WJ, ``Analysis of the necessity to test at 3150 and
6300 Hz and the effect on the Noise Reduction Rating.''
    \7\ Franks 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.
---------------------------------------------------------------------------

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

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.
---------------------------------------------------------------------------

    \8\ Birch 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).
    \9\ Parmentier G., Dancer A., Buck K., Kronenberger G., Beck C.,
``Artificial Head (ATF) for Evaluation of Hearing Protectors''
Acustica,Volume 86 (2000).
    \10\ Zera J. and Mlynski R. ``Attenuation of high-level impulses
by earmuffs'' J. Acoust. Soc. Am. 122:2082-2096 (2007).
    \11\ Tubbs 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).
    \12\ Harney 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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \13\ Berger, E. ``Methods of measuring the attenuation of
hearing protection devices'', J. Acosut. Soc. Am. 79:1655-1687
(1986).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \14\ Parmentier, 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.
---------------------------------------------------------------------------

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 free-field 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, powder-

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 free-field 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 user-friendly 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

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 high-level 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/NIOSH-
designed 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.
---------------------------------------------------------------------------

    \15\ Reference ``workshop report'' in the Docket at http://
www.regulations.gov, docket number EPA-HQ-OAR-2003-0024.
---------------------------------------------------------------------------

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 Sec.  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

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 web-page 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 A-weighted 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
[mu]Pa). 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 A-weighted 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

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.
---------------------------------------------------------------------------

    \16\ U.S. Environmental Protection Agency. 2008. Cost Analysis
for Proposed Labeling Regulation of Hearing Protection Device
Industry. EC/R Inc. Chapel Hill, NC.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \17\ National 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.
---------------------------------------------------------------------------

    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,
Sec.  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.

    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 Sec.  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\
---------------------------------------------------------------------------

    \18\ U.S. Environmental Protection Agency. 1999. Economic
Analysis Resource Document. RTP, NC: EPA.
---------------------------------------------------------------------------

    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 benefit-cost 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.
---------------------------------------------------------------------------

    \19\ The referenced report can be found in the Docket at http://
www.regulations.gov, docket number EPA-HQ-OAR-2003-0024.
---------------------------------------------------------------------------

A. Industry Profile

    The direct economic impacts of revisions to the labeling
requirements will apply to all HPD manufacturers (as defined in Sec.
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 semi-aural 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

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.
---------------------------------------------------------------------------

    \20\ Frost & Sullivan. 2005. U.S. Markets for Industrial Hearing
Protection Products.
---------------------------------------------------------------------------

    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
------------------------------------------------------------------------
                                                 Total U.S.    Average
                                                 industrial   wholesale
                 Product type                      sales      price per
                                                (million $)    unit ($)
------------------------------------------------------------------------
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  ...........
------------------------------------------------------------------------
\a\ Source: 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
----------------------------------------------------------------------------------------------------------------
                                                                                Number of
                  NAICS code                       SIC code                Description               companies
----------------------------------------------------------------------------------------------------------------
                                                  Manufacturers
----------------------------------------------------------------------------------------------------------------
339113........................................            3842  Surgical Appliance and Supplies               22
                                                                 Manufacturing.
334290........................................            3669  Other Communications Equipment                 4
                                                                 Manufacturing.
334310........................................            3651  Audio and Video Equipment                      2
                                                                 Manufacturing.
326112........................................            3089  Plastics Packaging Film and                    2
                                                                 Sheet (including Laminated)
                                                                 Manufacturing.
325212........................................            2822  Synthetic Rubber Manufacturing..               1
334514........................................            3824  Totalizing Fluid Meter and                     1
                                                                 Counting Device Manufacturing.
339932........................................            3944  Game, Toy, and Children's                      1
                                                                 Vehicle Manufacturing.
334220........................................            3663  Radio and Television                           1
                                                                 Broadcasting and Wireless
                                                                 Communications Equipment
                                                                 Manufacturing.
334419........................................            3679  Other Electronic Component                     1
                                                                 Manufacturing.
339111........................................            3821  Laboratory Apparatus and                       1
                                                                 Furniture Manufacturing.
325211........................................            2821  Plastics Material and Resin                    1
                                                                 Manufacturing.

333514........................................            3544  Special Die and Tool, Die Set,                 1
                                                                 Jig, and Fixture Manufacturing.
339115........................................            3851  Ophthalmic Goods Manufacturing..               1
----------------------------------------------------------------------------------------------------------------
                                                   Wholesalers
----------------------------------------------------------------------------------------------------------------
423450........................................            5047  Medical, Dental, and Hospital                  3
                                                                 Equipment and Supplies Merchant
                                                                 Wholesalers.
423990........................................            5099  Other Miscellaneous Durable                    1
                                                                 Goods Merchant Wholesalers.
423860........................................            5088  Transportation Equipment and                   1
                                                                 Supplies (except Motor Vehicle)
                                                                 Merchant Wholesalers.
423840........................................            5085  Industrial Supplies Merchant                   1
                                                                 Wholesalers.
541710........................................            8731  Research and Development in the                1
                                                                 Physical, Engineering, and Life
                                                                 Sciences.
423...........................................            5065  Wholesalers of Electronic Parts                1
                                                                 and Equipment.
----------------------------------------------------------------------------------------------------------------
\a\ Source: 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.
---------------------------------------------------------------------------

    \21\ Franks 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \22\ Frost & Sullivan. 2005. U.S. Markets for Industrial Hearing
Protection Products.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \23\ Thomas Publishing (Thomas Register), ThomasNet: Hearing
Protection Devices, Accessed July 31, 2007, http://www.thomasnet.com
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \24\ Telephone Contact Report. Deering, A., EC/R Incorporated,
with Graydon, P., NIOSH. September 20, 2004.
---------------------------------------------------------------------------

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\

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.
---------------------------------------------------------------------------

    \25\ International Trade Administration. 339113 Surgical
Appliance & Supplies: Customs Value by Customs Value for ALL
Countries. http://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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \29\ U.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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \30\ U.S. Census Bureau, Quarterly Financial Report for
Manufacturing, Mining, and Trade Corporations, QFR/06-Q1, 2006,
http://www.census.gov/prod/2006pubs/qfr06q1.pdf.

 Table B-1--Estimated Costs of Production and Net Income as a Fraction of Sales for Safety Equipment Manufacture
                                         and Miscellaneous Manufacture a
----------------------------------------------------------------------------------------------------------------
                                 Estimated costs and income as a fraction of the total value of shipments (%)
                             -----------------------------------------------------------------------------------
          Quantity                                           Cost of       Capital     Total costs   Income from
                               NAICS code    Labor cost     materials    investment        \b\        operation
----------------------------------------------------------------------------------------------------------------
Surgical Appliance and              339113            18            30             3            51
 Supplies Manufacture
 (including personal safety
 equipment).................
Personal industrial and            3391136            18            47             3            68
 nonindustrial safety
 equipment and clothing
 subcategory................
All miscellaneous                      339  ............  ............  ............  ............          11.4
 manufacturing, all
 companies..................
Small miscellaneous                    339  ............  ............  ............  ............           5.1
 manufacturing \c\..........
----------------------------------------------------------------------------------------------------------------
\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

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.
---------------------------------------------------------------------------

    \31\ Faison, 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.

                            Table B-2--Hearing Protection Device Testing Laboratories
----------------------------------------------------------------------------------------------------------------
                                                                                Currently carries out
            Laboratory name                     Location           NVLAP accredi-tation      testing for a fee
----------------------------------------------------------------------------------------------------------------
Aearo Corporation's E-A-RCAL            Indianapolis, Indiana..  Yes....................  Yes.
 Acoustical Laboratory.
Howard Leight Acoustical Testing        San Diego, California..  Yes....................  Yes.
 Laboratory.
Michael and Associates................  College Station,         Yes....................  Yes.
                                         Pennsylvania.
Auditory Systems Laboratory at          Blacksburg, Virginia...  No.....................  * Yes.
 Virginia Polytechnic Institute and
 State University (Virginia Tech.).
U.S. Air Force Research Laboratory....  Wright-Patterson Air     No.....................  No.
                                         Force Base, Ohio.
National Institute of Occupational      Cincinnati, Ohio.......  No.....................  No.
 Safety and Health (NIOSH) Robert Taft
 Laboratories.
NIOSH Pittsburgh Research Laboratories  Pittsburgh,              Yes....................  No.
                                         Pennsylvania.
U.S. Army Aero Medical Research         Fort Rucker, Alabama...  No.....................  No.
 Laboratory.
----------------------------------------------------------------------------------------------------------------
* 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