[Federal Register Volume 74, Number 149 (Wednesday, August 5, 2009)]
[Proposed Rules]
[Pages 39150-39196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18003]
[[Page 39149]]
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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
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 /
Proposed Rules
[[Page 39150]]
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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 protected].
Fax: (202) 566-1741.
Mail: EPA Labeling Regulation, Docket Number EPA-HQ-OAR-
2003-0024, Environmental Protection Agency, EPA Docket Center, Mailcode
6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Hand Delivery: EPA Docket Center, Public Reading Room, EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC 20460.
Such deliveries are only accepted during the Docket's normal hours of
operation (Monday through Friday, from 8:30 a.m. to 4:30 p.m.),
excluding legal holidays and special arrangement should be made for
deliveries of boxed information. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the Air
Docket is (202) 566-1742.
Instructions: Direct your comments to Docket ID Number EPA-HQ-OAR-
2003-0024. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov,
your 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 protected].
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
[[Page 39151]]
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:
[[Page 39152]]
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,
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silicon, early formulas of polyurethane foam, and earmuffs, were the
only types of products on the market. For many reasons, too numerous to
detail here, the EPA decided to require compliance testing of a HPD
only once prior to its entry into commerce. Further tests are required
if (1) a manufacturer modifies the design or changes materials or
structure such that the acoustic performance of the product may be
degraded; (2) the Administrator has reason to believe the original
effectiveness rating is in error, or otherwise requires information
pursuant to section 13 of Noise Control Act; or (3) a selective
enforcement audit revealed products in non-compliance with their
labeled information. With the entry of many new HPD materials, designs,
and electronic and mechanical systems, the Agency has become concerned
with the adequacy of its present once in a product lifetime test
requirement.
IV. Product Applicability
This proposed regulation would apply to all devices or materials
sold as explicit or implicit ``hearing protection devices'' on the
basis of their ability to reduce the level of sound entering the user's
ears and thus serve to protect the user's hearing. The proposed
regulation also applies to devices whose primary function may not be
hearing protection, but which are nonetheless sold in-part as providing
protection to the user's hearing.
To the extent that a product manufacturer, importer, packager or
any other party introduces into U.S. commerce any product that
incorporates an explicit or implicit claim that the product can protect
the hearing of the user or stipulates the level of sound reduction
offered by such product, then it would be subject to the requirements
of this proposed regulation.
The Agency has attempted to establish product definitions on the
broadest basis in order to capture all current and future HPD designs
and characteristics. The EPA recognizes that by taking this broad
approach, certain products presently on the market, that are intended
to provide a level of comfort for sleeping, listening to music,
restricting the entry of water into ears during swimming or bathing,
etc., may be captured as possible hearing protectors. As stated above,
this rule does not apply to those devices or materials.
While not necessarily a complete listing, the general categories of
hearing protector devices that are subject to this proposed regulation
are described below:
(1) Passive Hearing Protection Device. A device that relies solely
on its structural elements to block or otherwise control the
transmission of sound into the ear canal and that does not use
electronic circuits or acoustic elements to reduce the entry of
external sound.
(2) Active Hearing Protection Device. A device that contains
electronic components including transducers (i.e. speakers and
microphones) to increase or decrease the transmission of sound into the
ear canal. Also referred to as an electronic hearing protection device.
(3) Ear plug. A hearing protection device that is designed to be
inserted into the ear canal and held in place principally by virtue of
its fit inside the ear canal.
(4) Ear muff. A hearing protection device usually comprised of a
headband which applies spring-like force/pressure to two ear cups with
soft cushions to seal against the external ear or pinna (supra-aural)
or the sides of the head around the pinna (circumaural). The ear cups
may also be held in position by attachment arms mounted on a hardhat or
hardcap.
(5) Active Noise Reduction Hearing Protection Device. A device that
uses single or in combination, electrical and structural elements to
reduce the sound transmitted to the ear canal through acoustic
cancellation of the 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.
[[Page 39154]]
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
[[Page 39155]]
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.
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\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
[[Page 39156]]
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
[[Page 39157]]
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-
[[Page 39158]]
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
[[Page 39159]]
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.
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\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
[[Page 39160]]
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
[[Page 39161]]
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.
[[Page 39162]]
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\
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\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.
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\19\ The referenced report can be found in the Docket at http://www.regulations.gov, docket number EPA-HQ-OAR-2003-0024.
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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
[[Page 39163]]
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.
[[Page 39164]]
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.
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\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.
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\22\ Frost & Sullivan. 2005. U.S. Markets for Industrial Hearing
Protection Products.
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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\
[[Page 39165]]
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
[[Page 39166]]
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
range information and new label content; applicable to both primary and
secondary labels.
Recurrent testing for all HPDs at either 3 or 5 year
intervals.
Changing the label to reflect a new NRR range of any
product for which the recurrent testing yields NRRs that are
significantly lower or higher than previously stated on the products
label.
Additional recordkeeping and reporting costs attendant to
the periodic retests.
a. Transition Testing and Labeling Costs
Seven HPD manufacturers and two testing laboratories provided a
range of estimates of the unit costs to test and label each of their
HPD product lines. Some companies provided cost estimates based on
their in-house test facilities. Others provided estimates based on
historic charges from independent testing laboratories. Most companies
provided cost data based on the existing test method; however, some,
including one independent test laboratory, provided estimates based on
their experience using the new ANSI method.
Table C-1 summarizes the ranges of cost estimates for the existing
test method and the new ANSI/EPA test methods. The table also presents
the range of unit cost estimates developed from the information
collected by this study to analyze the impacts of the proposed rule
changes. Testing costs for earmuffs are given for each potential
headband position. This means that if a particular earmuff can be worn
with the headband in three different positions (behind-the-head, over-
the-head, or under-the-chin), then three tests may be required--this
analysis provides a conservative evaluation of costs since many
manufacturers are expected to identify a preferred headband position.
The testing cost estimates reflect the costs of testing using an
outside laboratory, although several major manufacturers are expected
to use their in-house testing facilities.
The costs of testing using the new ANSI/EPA methods are estimated
to be somewhat higher than the costs of testing using the 1979 standard
for a number of reasons, the principal one being the requirement for
twice as many test subjects. Testing costs are somewhat higher for
earplugs and inserts than for earmuffs because of the need to train
subjects on how to correctly insert the plugs into their ears.
In addition, the table presents the cost estimates provided by the
sampled companies for creating an entirely new product label to reflect
the change from
[[Page 39167]]
a single number NRR to a range of two NRRs.
The ranges of cost estimates are quite broad, even for the existing
test methods. This may be the result of changes in the unit cost of
testing depending on the number of products tested at a given time;
costs do not reflect potential savings afforded by the use of test
subjects for multiple product tests. Further, the relatively large cost
range for testing electronic noise cancellation (ANR) systems stems, in
part, from uncertainties about the entirely new test method that is
proposed here for those devices. The Agency is soliciting comment and
cost estimates based on the proposed test protocols.
Table C-1--Estimated Costs of Testing and Labeling for Each Product Line
------------------------------------------------------------------------
Range of cost
estimates given by Range of
Device type industry sources estimates used
($) in analysis ($)
------------------------------------------------------------------------
Testing:
Existing test methods:
Earplugs and semi-aural 2,000-3,000........ 2,000-3,000
inserts.
Earmuffs and headsets 1,700-4,000........ 1,700-4,000
(per headband position,
excluding electronic
noise cancellation
systems).
Revised test methods:
Earplugs and semi-aural 2,800-4,000........ 2,800-4,000
inserts.
Earmuffs and headsets 2,000-4,000........ 2,000-3,000
(per headband position,
excluding electronic
noise cancellation
systems).
Electronic noise 2,500-10,000....... 2,500-10,000
cancellation systems
\32\.
Impulse noise reduction 2,000-4,000........ 2,000-4,000
\33\.
Labeling:
Initial label design and 5,000-10,000 to 5,000-10,000
printing setup. 25,000-48,000.
Modification of a label to one manufacturer 2,700-5,000
change the NRR. estimated this
cost at 2,700-
3,700, while
others indicated
that it would be
the same as a
complete label
change.
------------------------------------------------------------------------
The proposed changes in the labeling rule are expected to result in
a substantial increase in the volume of product testing. First, all
HPDs are to be tested in accordance with the newly proposed ANSI and
EPA/NIOSH standards. A transition-testing period of thirty (30) months
following the effective date of this proposed regulation is expected to
reduce the workload on existing testing facilities. Second, the Agency
is proposing that all products must be retested periodically at five
(5) year intervals from the completion of the respective transition
test; the current regulation does not require such recurrent testing
and label verification. As explained above, EPA is proposing a
recurrent test period of 5 years was selected to (a) provide a uniform
testing period for all parties, (b) allow a longer time between
transition test and first recurrent test for the less than three
product line manufacturers, (c) provide manufacturers with more than
two product lines adequate time to complete transition testing before
first recurrent tests become necessary and (d) to amortize near-term
testing costs over a reasonable period of time.
---------------------------------------------------------------------------
\32\ This cost figure includes the expense for both passive and
active testing.
\33\ This cost is in addition to the required passive testing.
---------------------------------------------------------------------------
The Agency believes the increase in testing volumes may result in
lower per product testing costs than the current industry estimates in
Table C-1 for two reasons. First, the Agency anticipates additional
testing laboratories will enter the marketplace to satisfy the
increased and continuing testing demand resulting from the recurrent
testing requirement, thereby increasing price competition that may
result in lower fees. Second, the increased volume may provide
opportunities for improved testing efficiency due to economies of
scale. However, for the purpose of this analysis, we have used the
average cost estimates from Table C-1 to develop a conservative
assessment.
The Agency has also considered the required redesign of the label
to display the results of transition testing using the new ANSI/EPA
test methods and two-value NRR effectiveness range. Most companies
responding to the Agency's questionnaire estimated the cost of
developing new product labels to be between $5,000 and $10,000 per HPD
model; one company estimated these costs at $25,000-48,000 (Table C-1).
These estimates reflect design costs and fabrication of the necessary
printing plates and the preparation of required revised secondary
labels. The main source of variation in the cost estimates is the
estimated time to develop the label design. However, since the EPA is
specifying the design, format and content of the new label, the cost
estimates for ``creative'' label designs are believed to be on the high
side. Discussions with an independent source in the public relations
field indicated the cost of label design can be expected to be the
lower range of estimates given by industry representatives, i.e.,
$5,000-10,000.\34\
---------------------------------------------------------------------------
\34\ Personal Communication. Battye, W., EC/R Incorporated, with
Erika Schmidt, The Frause Group. August 15, 2007.
---------------------------------------------------------------------------
The Agency was particularly concerned with labeling costs that may
be incurred by very small manufacturers and repackagers (one or two
product lines). In assessing the marketing methods of this segment of
the industry, the Agency believes that their point of sale is
principally via the internet. Further, their customer base is primarily
individuals or small groups that purchase their products for personal
use only. It is primarily for this segment of the industry that the
Agency has developed and is proposing the concept of ``electronic
labeling.'' We believe that an electronic reproduction of the EPA label
will eliminate the costs of art work and printing plates requisite to
producing paper labels or printing on packaging for organizations that
sell exclusively on the internet. The Agency also believes that
electronic labeling will greatly simplify and reduce any future costs
that would be incurred should recurrent testing dictate new NRR ratings
for these small manufacturers.
In light of the proposed recurrent testing requirement, we believe
that NRR effectiveness ranges may require change from time to time. In
that regard
[[Page 39168]]
we have attempted to quantify the associated cost of relabeling. One
company estimated the costs of relabeling to present a revised NRR
range would be somewhat lower than the costs of developing the initial
new label but was unable to quantify without a definitive cost estimate
for the initial new label. However, other manufacturers believed the
costs would be roughly the same as those associated with the new
transition label.
Table C-2 presents estimates of the nationwide costs of carrying
out the transition testing in accordance with ANSI/EPA test methods.
The table also presents cost estimates related to changing all existing
product labels to reflect the new test results and label information.
These estimates are derived using the unit costs given in Table C-1 and
the estimated nationwide numbers of HPD currently being sold. The
estimates are conservative in that they do not include any estimates of
cost savings that may be realized through electronic labeling. The
Agency identified approximately 1,029 different HPDs currently for sale
in the U.S. The HPD population is believed to consist of 403 earplugs
or semi-aural passive devices, 572 passive earmuffs sold either alone
or incorporated into communication headsets, 2 active noise reduction
(ANR) earplugs and 52 active noise reduction (ANR) earmuffs.
As required in subpart B, Sec. 211.206-1, all HPDs must be tested
in their ``passive'' mode which yields 1029 separate tests. In
addition, those 54 products identified as ANR will require a second
test in their ``active'' mode. Finally, those 156 products identified
as ``impulsive'' will require a second test in a high intensity impulse
noise environment where human test subjects are replaced by a test
fixture. Consequently, 1239 separate tests must be carried out on the
1029 products. The difference between the number of HPDs given above
and the actual number of tests given in Table C-2 represents products
which are tested by the manufacturer and are labeled for sale by
another entity which relies upon the manufacturer's effectiveness data.
Foreign manufacturers that export to the U.S. are included in our
estimations. Even though the testing and manufacturing costs are
incurred outside the U.S., any effects on prices due to the revised
regulation may be passed along to the distributors in the U.S. These
distributors, as previously mentioned, may pass along the price changes
to the buyer.
Table C-2--Estimated Nationwide Costs of Transition Product Effectiveness Testing and Labeling
----------------------------------------------------------------------------------------------------------------
Estimated
Product type Number of HPD Unit cost per nationwide cost
tests HPD test ($) ($1000)
----------------------------------------------------------------------------------------------------------------
Testing
Earplugs and semi-aural inserts.......................... 375 2,000-4,000 750-1,500
Earmuffs and headsets.................................... 550 \a\ 2,540-3,810 1,400-2,100
Active Noise Reduction systems........................... 108 1,250-5,000 140-540
Impulse noise reduction.................................. 156 2,000-4,000 310-620
--------------------------------------------------
Subtotal............................................. 1,189 ............... 2,600-4,760
----------------------------------------------------------------------------------------------------------------
Number of HPD Unit cost per Estimated
products HPD product ($) nationwide cost
($1000)
----------------------------------------------------------------------------------------------------------------
Labeling
Earplugs and semi-aural inserts.......................... 375 5,000-10,000 1,880-3,750
Earmuffs and headsets.................................... 550 5,000-10,000 2,750-5,500
Electronic noise cancellation systems.................... 54 5,000-10,000 270-540
--------------------------------------------------
Subtotal............................................. 979 ............... 4,900-9,790
--------------------------------------------------
Grand total...................................... ............... ............... 7,630-15,090
----------------------------------------------------------------------------------------------------------------
\a\ Based on a testing cost of $2,000-3,000 per headband position, and an average of 1.27 headband positions per
product.
The number of HPD products was estimated from reviews of
manufacturer's catalogs and advertisements (as published on the
Internet). In addition, the NIOSH ``Hearing Protection Device
Compendium'' provided significant information on the HPD products sold
in the U.S.\35\
---------------------------------------------------------------------------
\35\ 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.
---------------------------------------------------------------------------
Because earmuffs may sometimes be manufactured to be worn in
different head band positions, the product must be tested in each
position to determine whether their performance/attenuation is changed
due to the position. When we account for the positions, and consider
that each position requires another test, an average of 1.27 potential
headband positions per product-line was used to estimate the number of
headband position tests required for earmuffs. This factor is based on
the average number of headband positions per product-line for all
earmuff models included in the NIOSH Hearing Protector Device
Compendium.
b. Costs of Recurrent Testing and Relabeling
Table C-3 presents estimates of costs for recurrent testing and
potential relabeling of products due to measured changes in product NRR
range. Unit costs of testing each HPD are the average industry
estimates shown in Table C-1. Costs have been estimated for a three (3)
and five (5) year recurrent testing interval. In each case we have
assumed that testing will be spread evenly over the respective time
period. Thus, for the 3-year interval we assumed that one third of the
HPD models will be tested each year, and for the 5-year interval, we
assumed that 20 percent of HPD models would be tested each year.
Based on analysis of inter and intra laboratory variations of
product recurrent tests in a recent inter-laboratory test program
carried out by EPA and NIOSH,\36\ we estimate twelve
[[Page 39169]]
(12) percent of all HPD products will require relabeling based on
recurrent tests every five years. The agencies commissioned parallel
tests of six different HPD products at six different laboratories. The
study provided 180 laboratory-to-laboratory comparisons of the test
results; 30 for each of the six products tested. For each of these
comparisons, the average test results and the 95 percent confidence
intervals for two tests of a single HPD model were determined. If the
second test was lower than the first test to the extent that the two 95
percent confidence intervals did not overlap, then it was assumed that
the product would need to be relabeled. This occurred in 12 percent of
the comparisons. The fraction was the same for earplugs and earmuffs.
However, for reasons stated above, the Agency has selected a 3dB criteria rather than the 95 percent confidence interval to
initiate relabeling. Therefore, for this analysis the 12 percent
represents a conservative assessment of the potential cost impact.
---------------------------------------------------------------------------
\36\ Murphy W.J., Byrne D.C., Gauger D., Ahroon W.A., Berger E.,
Gerges S.N.Y., McKinley R., Witt B., Krieg E.F. (2009). ``Results of
the National Institute for Occupational Safety and Health--U.S.
Environmental Protection Agency Interlaboratory Comparison of
American National Standards Institute S12.6-1997 Methods A and B.''
J. Acoust. Soc. Am. 125(5):3262-3277.
Table C-3--Estimated Nationwide Annual Costs of Product Recurrent Testing and Relabeling for Manufacturers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated number of HPD tests Estimated nationwide costs
per year ($1000/year)
Product type ---------------------------------- Unit Cost per ---------------------------------
3-Year interval 5-Year interval HPD test ($)
\a\ \b\ 3-Year interval 5-Year interval
--------------------------------------------------------------------------------------------------------------------------------------------------------
Periodic Recurrent Testing
Earplugs and semi-aural inserts................................ 125.0 75.0 2,000-4,000 250-500 150-300
Earmuffs and headsets.......................................... 183.3 110.0 \c\ 2,540-3,810 470-700 280-420
Electronic noise cancellation systems.......................... 36.0 21.6 \d\ 2,500- 90-360 54-216
10,000
Impulse noise reduction........................................ 52.0 31.2 2,000-4,000 100-210 60-120
Subtotal................................................... 396.3 237.8 ............... 910-1,770 544-1,056
--------------------------------------------------------------------------------------------------------------------------------------------------------
Relabel as Necessary Estimated number of HPD products
per year
--------------------------------------------------------------------------------------------------------------------------------------------------------
\e\ Subtotal............................................... 39.2 23.5 ............... 106-196 63-117
------------------------------------------------------------------------------------
Grand total............................................ ............... ............... ............... 1,016-1,966 607-1,173
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Under the 3-year recurrent test interval, one third of all HPD models are assumed to be retested each year.
\b\ Under the 5-year recurrent test interval, 20% of all HPD models are assumed to be retested in a given year.
\c\ Based on a testing cost of $2,000-3,000 per headband position, and an average of 1.27 headband positions per product.
\d\ This cost figure includes both the expense for passive and active testing.
\e\ Based on NIOSH/EPA inter-laboratory testing, a change in the label NRR may be required for 12% of products tested in periodic effectiveness tests.
\f\ Based on the cost of making a simple modification to the label to change the NRR (Table 3-1).
c. Manufacturers' Costs of Reporting and Recordkeeping
Pursuant to Sec. 13 (a)(1) of the Noise Control Act, manufacturers
are required to provide the EPA Administrator reports of the laboratory
test results for each HPD model. The cost of generating these reports
is incorporated in the cost of product testing (as summarized in Table
C-1). However, we believe manufacturers may incur limited additional
costs to track and retain periodic recurrent testing reports. Table C-4
presents estimates of the nationwide costs of these recordkeeping and
reporting requirements. We have estimated that 30 minutes per product
may be required for record keeping and reporting.
Table C-4--Estimated Annual Ongoing Costs of Recordkeeping and Reporting
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated number of HPD tests Estimated nationwide costs
per year Clerical labor ($1000/year)
Product type -------------------------------- per product Labor cost ($/-------------------------------
3-Year 5-Year line (hours) hour) \c\ 3-Year 5-Year
interval \a\ interva l\b\ interval interval
--------------------------------------------------------------------------------------------------------------------------------------------------------
Earplugs and semi-aural inserts......................... 125 75.0 0.5 31 1.9 1.2
Earmuffs and headsets................................... 183.3 110.0 0.5 31 2.8 1.7
Electronic noise cancellation systems................... 18.0 10.8 0.5 31 0.3 0.2
-----------------------------------------------------------------------------------------------
Total............................................... 326.3 195.8 .............. .............. 5.0 3.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Under the 3-year recurrent testing interval, about one third of all HPD models are assumed to be retested each year.
\b\ Under the 5-year recurrent testing interval, about 20% of all HPD models are assumed to be retested in a given year.
\c\ Estimate based on Bureau of Labor Statistics information for the medical supplies manufacturing industry, hourly rates include an overhead factor
(including benefits) of 100%.
d. Costs for Relabelers
Companies that relabel products manufactured by other companies for
sale under their own label or under the labels of brand name retailers
may also incur labeling costs. These companies, identified as
``relabelers'' typically use the results of NRR tests carried out by
the products manufacturers, and therefore, are not expected to incur
costs for product testing. However, they are
[[Page 39170]]
expected to incur costs for redesigning product labels to incorporate
new NRR values and required labeling information. Table C-5 summarizes
the estimated costs of compliance for these relabelers. However, no
adjustments have been made for those relabelers that sell exclusively
via the internet and adopt electronic labeling. In this latter case the
costs of relabeling are expected to be significantly less than those of
Table C-5 since no changes will be required for artwork or packaging.
The Agency has not quantified these costs savings. Consequently, we
believe the costs presented in Table C-5 to be very conservative (i.e.
likely overestimated).
Table C-5--Estimated Nationwide Labeling Costs for Companies Which Do Not Manufacture HPD, but Only Relabel
Products
----------------------------------------------------------------------------------------------------------------
Estimated number of products Estimated nationwide costs
-------------------------------------- Unit cost per ($1,000)
Product type HPD product ---------------------------
3-Year interval 5-Year interval test ($) 3-Year 5-Year
\a\ \b\ interval interval
----------------------------------------------------------------------------------------------------------------
Transition Label Costs ...............
Earplugs and semi-aural 46 5,000-10,000 230-460
inserts.
Earmuffs and headsets.... 32 5,000-10,000 160-320
Electronic noise 83 5,000-10,000 420-830
cancellation systems.
----------------------------------------------------------------------------------
Total................ ................. ................. ............... 810-1,610
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Products per
Recurrent label costs year Cost per year
----------------------------------------------------------------------------------------------------------------
Earplugs and semi-aural inserts............. 1.8 1.1 2,700-5,000 5-9 3-6
Earmuffs and headsets....................... 1.3 0.8 2,700-5,000 4-7 2-4
Electronic noise cancellation systems....... 3.3 2.0 2,700-5,000 9-17 5-10
---------------------------------------------------------------
Total................................... ............... ............... 18-33 10-20
----------------------------------------------------------------------------------------------------------------
\a\ Under the 3-year recurrent test interval, one third of all HPD models are assumed to be retested each year.
\b\ Under the 5-year recurrent test interval, 20% of all HPD models are assumed to be retested in a given year.
\c\ Based on NIOSH/EPA inter-laboratory testing, a change in the label NRR may be required for 12% of products
tested in periodic effectiveness tests.
D. Summary of Nationwide Costs of Revised HPD Labeling Rule
Table D-1 summarizes the estimated nationwide costs of the proposed
revisions to the HPD labeling rule. The initial or capital costs will
be primarily transition testing of all HPD products in the U.S. market
on the effective date of this proposed rule. In addition, we have
incorporated the amortized costs of transition product labeling to
reflect the new NRR range presentation and revised user information. In
the latter case, the transition labeling costs have been amortized over
a 20-year period using an interest rate of 7 percent. The transition
testing costs are estimated to be between $2.5 million and $4.6 million
and are expected to be spread over a period of 30 months from the
effective date of the regulation. New labeling costs are estimated to
be between $5.1 and $10.1 million to produce product labels with the
new NRR range presentation and mandated statements. The industry
provided cost estimates associated with the required secondary labels
are incorporated in the total cost of labeling.
Annualized costs of the revised rule depend, in large part, on the
recurrent product testing intervals. Two options have been evaluated: A
3-year interval and a 5-year interval. As stated previously, after
evaluating the two approaches, the Agency is proposing the 5-year
interval for all manufacturers. Recurrent testing of products would
commence 5 years from the date of completion of their respective
transition test. The annualized costs include the costs of changing
product labels to reflect the new NRR range of the 12% of products that
fail their recurrent test and costs of reporting and recordkeeping.
Table D-1--Total Costs Compared With Total Sales
------------------------------------------------------------------------
Estimated nationwide costs
Cost element ($1000/year)
------------------------------------------------------------------------
Manufacturers:
Transition costs
Product model testing\ a\.......... 2,600-4,760
Initial revisions to labels\ a\.... 4,900-9,790
------------------------------------------------------------------------
3-Year 5-Year
recurrent recurrent
test test
interval interval
------------------------------------------------------------------------
Annualized costs
Periodic product effectiveness 910-1,770 544-1,056
tests\ b\..........................
Changing product labeling, as 106-196 63-117
necessary\ c\......................
Recordkeeping and reporting......... 5.0 3.1
Amortized cost of initial labeling 462-924 462-924
e, f...............................
[[Page 39171]]
Total annualized costs for 1,484-2,896 1,073-2,101
manufacturers......................
---------------------------
Relabelers:\ g\
Initial revisions to labels............. 810-1,610
---------------------------
Annualized costs........................
Amortized cost of initial labeling e 76-152 76-152
f..................................
Label changes as necessary from 18-33 10-20
recurrent ftesting.................
Total annualized costs for 94-185 86-172
relabelers \g\.....................
Total annual cost........................... 1,578-3,081 1,159-2,273
Annual cost as a fraction of total 0.3-0.7% 0.3-0.5%
industrial product sales\ f\...............
------------------------------------------------------------------------
\a\ Table C-2 provides additional details on initial testing and
labeling costs for manufacturers.
\b\ Product tests are assumed to be carried out at a uniform rate over
the recurrent test period. (See Table C-3).
\c\ Based on NIOSH/EPA inter-laboratory testing, a change in the label
NRR may be required for 12% of products tested in periodic
effectiveness tests. (See Table C-3)
\d\ Costs of developing product labels to reflect the revised test
methods are amortized over a 20 year period using an interest rate of
7%.
\e\ Annualized costs do not include the amortized costs of the initial
tests, since this would double-count the first round of recurrent
testing costs.
\f\ Total industrial product sales were obtained from Frost & Sullivan
(see Table A-2). Consumer sales are believed to be minor in comparison
with industrial sales.
\g\ Table C-5 provides additional details on costs for relabelers.
Table D-1 presents the total annualized costs of complying with
the proposed labeling rule changes. These are estimated to be 0.3-0.5
percent of total industrial product sales for the 5-year interval.
Industrial product sales were obtained from the Frost & Sullivan market
research report, totaling $242.9 million. Estimates developed by EPA
from limited information obtained from site visits for consumer and
military sales are $216.2 million. Therefore, the estimated costs of
compliance with the proposed labeling rule changes may range from 0.16
to 0.4 percent of total combined industrial, consumer and military
sales.
E. Economic Impacts
Based on the results of analyses in the previous section,
compliance costs associated with the proposed labeling rule changes are
expected to be on average 0.3 to 0.6 percent of the total wholesale
price. As noted earlier, seven HPD manufacturers were interviewed on
the potential costs and economic impacts of the new labeling rule. The
larger companies indicated they did not plan to pass along the costs of
compliance in the prices of their products. However, some of the
smaller companies indicated that they would probably pass on a portion
or all of the costs of compliance to distributors and consumers.
In the event that prices are increased to cover the cost of
compliance, industrial and other occupational sales of HPDs are not
expected to change. These uses are generally mandated by occupational
safety regulations and are not an optional purchase. Consumer purchases
of HPDs are also not expected to be significantly impacted, since the
overall impact of compliance costs is a relatively small fraction of
the wholesale price.
HPD manufacturers indicated they do not expect to close any
operations as a result of increased compliance costs. However, most
indicated they would probably discontinue some marginally profitable
product lines rather than incur the associated cost of transition
testing and labeling. In particular, the companies indicated that
product lines which are not selling well on the current market due to
their effectiveness rating, comfort, or competition may be discontinued
when the new labeling rules are implemented.
F. Impacts on Small Business
Please see paragraph XI--C (Statutory and Executive Order Reviews)
below.
XI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
This action is not a ``significant regulatory action'' under terms
of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under that Order
Although a Regulatory Impact Analysis was not required or
conducted, EPA did carry out a cost impact analysis, as just set forth
in the previous section. The annual effect on the economy resulting
from the proposed compliance costs is estimated to be less than
$2,800,000. A copy of the ``Cost Analysis for Proposed Labeling
Regulation of the Hearing Protection Device Industry'' is available in
the docket for this action.
B. Paperwork Reduction Act
The information collection requirements in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document prepared by EPA has been
assigned EPA ICR number 2341.01.
Section 13 of the Act, ``Records, Reports and Information,'' states
that manufacturers of products which emit noise capable of adversely
affecting the public health or welfare, or which is sold wholly or in
part on the basis of its effectiveness in reducing noise, shall
establish and maintain such records, make such reports, provide such
information, and make such tests, as the Administrator may reasonably
require to enable him to determine whether such manufacturer has acted
or is acting in compliance with the Act.
Pursuant to this provision, the Agency proposes to collect
information to ensure compliance with the provisions in this rule. EPA
is also proposing recurrent testing requirements, as discussed
previously. In order to establish reliable baseline performance
information for each device, against which future performance can be
compared, the EPA is proposing that manufacturers provide the Agency
with their product test information following each required product
test.
The 1979 regulation required manufacturers to establish and retain
adequately organized and indexed records of the testing protocols that
provide the basis for the claimed Noise Reduction Ratings (NRR) that is
placed on the mandated label. The regulation also required
manufacturers to submit
[[Page 39172]]
hearing protector test data reports for the attendant NRR to the EPA.
In 1982, 40 CFR Part 211 was amended to suspend the submittal of test
data reports to the EPA due to the closure of the Agency's Office of
Noise Abatement and Control. However, manufacturers were still required
to retain all pertinent test data reports for recordkeeping purposes.
EPA is proposing to reinstitute the requirement for manufacturers to
submit to the Agency test data reports following each required product
test. The reports would have to include measurement information, test
results and calculated lesser and greater NRRs obtained from the
testing laboratory for each product or product category. Manufacturers
would continue to retain such records for a period of two (2) testing
periods. However, if a manufacturer elects to alter the product design
or materials prior to expiration of the 5 year recurrent testing cycle,
the manufacturer would be required to test and submit the product's new
test data report to the EPA.
The annual reporting burden for this collection of information for
the initial test data report for approximately 81 respondents is
estimated to be 185 labor hours per year [555 total hours] at a total
annual cost of $5,735 [$17,205 total cost]. This burden estimate
includes time to complete the cover sheet per Annex A of the proposed
regulation, time to convert the results into a PDF document, and time
to submit the test data report(s) to the EPA. Burden is defined at 5
CFR 1320.3(b).
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR Part 9.
To comment on the Agency's need for this information, the accuracy
of the provided burden estimates, and any suggested methods for
minimizing respondent burden, EPA has established a public docket for
this rule, which includes this ICR, under Docket ID number EPA-HQ-OAR-
2003-0024. Submit any comments related to the ICR to the EPA docket
noted above and to OMB. See `Addresses' section at the beginning of
this notice for where to submit comments to EPA. Send comments to OMB
at the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW., Washington, DC 20503,
Attention: Desk Office for EPA. Since OMB is required to make a
decision concerning the ICR between 30 and 60 days after August 5,
2009, a comment to OMB is best assured of having its full effect if OMB
receives it by September 4, 2009. The final rule will respond to any
OMB or public comments on the information collection requirements
contained in this proposal.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of today's proposed rule on
small entities, small entity is defined as: (1) A small business
engaged in manufacturing, distributing, relabeling and/or importing of
hearing protection devices having NAICS codes presented in Table A-2;
(2) a small governmental jurisdiction that is a government of a city,
county, town, school district or special district with a population of
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field.
After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The small
entities directly regulated by this proposed rule are manufacturers,
distributors, repackagers and importers of hearing protector devices.
We have determined that fewer than 100 U.S. small businesses are
expected to be subject to the planned rule changes and using
conservative assumptions only 1 or 2 of those potentially affected face
significant adverse impacts.
In its analysis of the impacts of the rule, EPA made a significant
effort was made to ensure that we identified as many as possible of the
companies that manufacture or distribute HPDs, including any that are
small businesses. A number of steps were taken to identify these
companies, including reviews of the NIOSH Hearing Protection Device
Compendium and the membership directory of the National Hearing
Conservation Association (NHCA). Further, the NHCA was contacted to
obtain a listing of small companies engaged in the manufacture or
relabeling of HPDs. The NHCA assisted by providing information on some
companies which obtain HPD from manufacturers for sale under their own
labels. We also reviewed a number of directories of HPD and safety
equipment vendors, including the Noise Pollution Clearinghouse, the
International Safety Equipment Association Buyer's Guide, the Thomas
directory, the Business Internet, Hoover's Online, and Mergent Online.
It is possible that some manufacturers or distributors were not
identified in these efforts. Because of the classification of HPD
manufacturers in the Census, it is particularly difficult to identify
all HPD manufacturers. As discussed in paragraph X (A), HPD
manufacturers are generally in a miscellaneous manufacturing category
(NAICS Code 339113) along with manufacturers of surgical appliances and
supplies because many HPD manufacturers also produce other products. In
addition, many of these companies classify themselves under other NAICS
categories. Therefore, the Census does not provide an explicit count of
HPD manufacturers. We believe that most of the small manufacturers and
distributors of HPDs have been identified, but we invite reviewers to
submit any additional relevant data in this regard.
For most categories applicable to HPD manufacturers, a small
business is defined as any company which employs fewer than 500
employees (and which is not owned by another large business). The small
business size threshold is 750 employees for firms which also produce
electronic or communications equipment, as is the case with most
manufacturers of active HPDs. For distributors that merely relabel
HPDs, the small business size threshold is 100 employees.
Using the applicable NAICS size thresholds, 54 of the 96 identified
HPD manufacturers and relabelers would be classified as small
businesses. However, it must be noted that the NAICS thresholds
overstate the number of truly small businesses. This is because most
passive HPD manufacturers fall into a catch-all miscellaneous
manufacturing category which was primarily designed to characterize the
manufacturers of surgical equipment. Thus, the 500 employee threshold
used for this category probably does not reflect the conditions of the
HPD manufacturing industry. Nevertheless, we have analyzed the costs of
compliance for all of the companies that would be classified as small
under the applicable NAICS threshold. However, we have also paid
special attention to a subset of ``very small'' companies, which
produce only one or two HPD product lines. Of
[[Page 39173]]
the 96 identified HPD manufacturers and relabelers, 34 would fall into
this ``very small'' business category.
After identifying the small businesses likely to be subject to the
rule, we estimated the potential economic impacts of the proposed rule
on small entities. For this proposed rule, we evaluated the compliance
costs as a percentage of total sales for any small businesses affected
by any proposed regulatory action. Costs of compliance were identified
for each of these small and very small companies based on the numbers
of HPD models they sell and using the calculation methods and
assumptions outlined in paragraph X (C) above. Some of these companies
were interviewed as part of the effort to develop background
information to estimate the costs and economic impacts of labeling rule
changes; these companies gave information on the number of HPD models
sold.\37\ We estimated the numbers of product models sold by other
small businesses from catalogs and other advertising materials
published on the Internet.
---------------------------------------------------------------------------
\37\ The referenced interviews can be found in the Federal
Docket at http://www.regulations.gov, docket number EPA-HQ-OAR-2003-
0024.
---------------------------------------------------------------------------
Table F-1 summarizes the estimated impacts of the proposed labeling
rule changes on U.S. small businesses, including the initial costs of
compliance and the ongoing annualized costs for the 3-year and 5-year
recurrent test options. Therefore, we have analyzed small business
impacts for both ends of this range. In addition, we have analyzed
impacts for the ranges of testing and labeling costs identified in
Table F-1, and the ranges of labor requirements shown in Table C-4 for
reporting and recordkeeping. The table gives ranges of costs, depending
on which underlying unit cost estimates are used for testing, labeling,
and recordkeeping.
We have estimated that the initial testing and labeling costs would
average 1.1-2.1 percent of sales during the initial compliance period
for all 54 U.S. small businesses affected by the rule. For the 3-year
recurrent test interval, we have estimated that the average annual
compliance costs for all 54 U.S. small businesses affected by the rule
would be 0.5-0.7 percent of annual sales. The estimates of ongoing
annual costs include the amortized initial compliance costs. The
majority of small businesses (44 to 47) are expected to incur ongoing
annual costs of less than 1 percent of the total annual sales. However,
between 7 and 10 small businesses are expected to incur annual ongoing
compliance costs exceeding 1 percent of their total annual sales. (Of
these small businesses, we estimate that one or two are very small
businesses (produce less than 3 types of product)). It is possible that
one or more small businesses may experience costs exceeding 3 percent
of sales. However, our data set is limited for sources in this size
range (generally facilities with very low annual sales volume).
Table F-1--Summary of Impacts on Small Businesses
------------------------------------------------------------------------
3-Year recurrent 5-Year recurrent
Cost element testing testing
------------------------------------------------------------------------
Total number of small businesses 54
affected by the rule in the U.S
Initial testing and labeling:
Estimated initial costs of
compliance:
Lowest cost for a small <1,000
business...............
Average cost for a small 47,000-94,000
business...............
Maximum cost for a small 298,000-620,000
business...............
Ongoing annual costs of
compliance
Estimated annual costs
Lowest cost for a small 500 500
business...............
Average cost for a small 10,000-14,000 8,000-11,000
business...............
Maximum cost for a small 63,000-90,000 49,000-68,000
business...............
Estimated annual cost as a
fraction of annual sales: a
b
Lowest cost for a small <0.01% <0.01%
business...............
Average cost for a small 0.5-0.7% 0.4-0.6%
business...............
Maximum cost for a small 11-17% 9-12%
business...............
Number of small businesses
with estimated annual
compliance costs greater
than:
1% of annual sales...... 7-10 4-8
3% of annual sales \c\.. 1 1
------------------------------------------------------------------------
\a\ Sales figures used in these calculations are from market databases,
such as Dun and Bradstreet, and include not only HPD, but all products
sold by the companies, such as other safety equipment.
\b\ Annualized costs of compliance include amortized costs of initial
testing and labeling.
\c\ One or more companies may experience costs above 3% of sales, but
our data set is limited in this size range.
At the 5-year recurrent test interval, the average annual
compliance costs for all 54 U.S. small businesses affected by the rule
is estimated to be 0.4-0.6 percent of annual sales. The majority of
small businesses (46 to 50) are expected to incur ongoing annual costs
of less than 1 percent of the total annual sales. However, between 4
and 8 small businesses are expected to incur ongoing annual compliance
costs above 1 percent of their annual sales. This means that 7 to 15
percent of the small businesses subject to the rule are expected to
face economic impacts greater than 1 percent. (Of these small
businesses, we estimate that one or two are very small businesses
(produce less than 3 types of product)). It is possible that one or
more small businesses may experience costs that exceed 3 percent of
sales. Once again, we note that our data set is limited for sources in
this size range (generally facilities with very low annual sales
volume).
Given that there are some impacts on small businesses, we looked
for ways to mitigate these impacts. One step we have taken, as
discussed earlier, is to exempt companies that sell exclusively over
the Internet from the requirement to provide hard copy labels on their
product packaging; an electronic label is being proposed as the
exclusive labeling requirement for such entities. Additionally, after
considering
[[Page 39174]]
regulatory options to require retesting every 3 years versus every 5
years, we have selected the 5-year option. This option will allow
manufacturers to time-stream the testing of their product categories.
Finally, we think that companies will take steps on their own to reduce
compliance costs by reviewing their product slates and reducing the
number of HPD models that are low sales products and/or older products
that have updated versions. These actions would reduce their costs of
compliance with the revised testing and labeling requirements. We
continue to be interested in the potential impacts of this proposed
rule on small entities and solicit comments on issues related to such
impacts.
Small governments are not affected since enforcement of the
proposed regulation would continue to be carried out by the federal
EPA. Further, not-for-profit enterprises engaged in the distribution of
hearing protectors do not assume responsibility or incur the costs of
testing and labeling of a product and therefore, are not impacted by
the rule.
Although this proposed rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities through the
means described above. When developing the proposed rule, we took
special steps to ensure that the burdens imposed on small entities were
minimal. We continue to be interested in the potential impacts of this
proposed rule on small entities and solicit comments on issues related
to such impacts.
D. Unfunded Mandates Reform Act
This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. This action imposes no enforceable duty on any State, local or
tribal governments or the private sector.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires the Agency to
identify and consider a reasonable number of regulatory alternatives
and to adopt the least costly, most cost-effective, or least burdensome
alternative that achieves the objectives of the rule. The provisions of
section 205 do not apply when they are inconsistent with applicable
law. Moreover, section 205 allows EPA to adopt an alternative other
than the least costly, most cost-effective, or least burdensome
alternative if the Administrator publishes with the final rule an
explanation why that alternative was not adopted. Before we establish
any regulatory requirements that may significantly or uniquely affect
small governments, including tribal governments, a small government
plan must be developed under section 203 of the UMRA. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
We have determined that this proposed action does not contain a
Federal mandate that may result in expenditures of $100 million or more
for State, local, and tribal governments, in the aggregate, or to the
private sector in any one year. Thus, this proposed action is not
subject to the requirements of sections 202 and 205 of the UMRA.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism,'' (64 FR 43255,
August 10, 1999), requires EPA to develop an accountable process to
ensure ``meaningful and timely input by State and local officials in
the development of regulatory policies that have federalism
implications.'' ``Policies that have federalism implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.''
This proposed rule does not have federalism implications. It will
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This proposed rule applies to
manufacturers and distributors of hearing protection devices and has no
association with State and local governments. Thus, Executive Order
13132 does not apply to this rule.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). Executive Order
(EO) 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' This proposed
action will have no substantial direct effects on tribal governments,
on the relationship between the Federal government and Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes as specified in EO 13175. Thus,
Executive Order 13175 does not apply to this proposed action.
G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying
to those regulatory actions that concern health or safety risks to
children, such that the analysis required under section 5-501 of the
Order has the potential to influence the regulation. This action is not
subject to EO 13045 because it is based solely on technology
performance.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law No. 104-113 (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards (VCS) in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. VCS are technical standards
(e.g., materials specifications, test methods, sampling procedures, and
business practices) that are developed or adopted by VCS
[[Page 39175]]
bodies. NTTAA directs EPA to provide Congress, through OMB,
explanations when the Agency decides not to use available and
applicable VCS.
This proposed rulemaking involves technical standards. Therefore,
EPA conducted a search to identify potentially applicable VCS. We
identified several that have direct or partial applicability to the
technical requirements specified in the rule. To the extent possible
the Agency has incorporated by reference the principal elements of the
American National Standards Institute (ANSI) standard S12.6 (2008). In
addition, we have also incorporated by reference various elements of
ANSI S12.68 (2007) and S12.42. The Agency also gave careful
consideration to all relevant standards of the International Standards
Organization (ISO) and the International Electrotechnical Commission
(IEC) and determined that the above mentioned ANSI standards and the
IEC standard 60711 were the most appropriate for this action.
EPA welcomes comments on this aspect of the proposed rulemaking
and, specifically, invites the public to identify potentially-
applicable VCS and to explain why such standards should be used in this
regulation.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because hearing
protectors provide protection to the human health of all affected
populations without having any disproportionately high and adverse
human health or environmental effects on any population, including any
minority or low-income population.
List of Subjects in 40 CFR Part 211
Environmental Protection, Incorporation by reference, Noise
Abatement Programs, Product Noise Labeling, Hearing Protection Devices.
Dated: July 21, 2009.
Lisa P. Jackson,
Administrator.
For the reasons stated in the preamble, title 40, chapter I of the
Code of Federal Regulations is proposed to be amended as follows:
PART 211--PRODUCT NOISE LABELING
1. The authority citation for part 211 continues to read as
follows:
Authority: Sec. 8, Noise Control Act of 1972, (42 U.S.C. 4907),
and other authority as specified.
Subpart B--[Amended]
2. Section 211.201 is revised to read as follows:
Sec. 211.201 Applicability.
(a) Unless this part states otherwise, the provisions of subpart B,
part 211, apply to all devices or materials sold as ``hearing
protection devices'' on the basis of their ability to reduce the level
of sound entering the user's ears and thus claim to protect the users
hearing. The proposed regulation also applies to devices of which
hearing protection may not be their primary function, but which are
nonetheless sold in-part as providing protection to the user's hearing.
(b) To the extent that a product manufacturer, importer, packager
or any other party introduces into U.S. commerce any product that
incorporates an explicit or implicit claim that said product can
protect the hearing of the user, or stipulates the level of sound
reduction offered by such product, then it shall be subject to the
requirements of this proposed regulation (See 211.203(u) for definition
of ``hearing protection device.'')
(c) This rule does not apply to those devices or materials that are
designed to fit over or into the user's ears to, for example, preclude
the entrance of water during swimming, reduce the level of annoyance
from snoring or to enhance listening to music or video dialogue
presentations.
(d) This regulation is also applicable to those devices or
materials that while not designed for or intended to be used as hearing
protection devices can, due to their similarity in appearance or
function, be easily mistaken for products that are hearing protection
devices. To the extent that a product manufacturer, importer, packager
or any other party introduces into U.S. commerce any product that
incorporates an explicit or implicit claim that said product can
protect the hearing of the user, or stipulates the level of sound
reduction offered by such product, then such product shall be subject
to the requirements of this proposed regulation.
(e) The provisions of subpart A apply to all products for which
regulations are published under part 211 and manufactured after
[EFFECTIVE DATE OF FINAL RULE], unless they are made inapplicable by
product-specific regulations.
3. Section 211.202 is revised to read as follows:
Sec. 211.202 Effective Date.
Manufacturers of hearing protection devices must comply with the
requirements set forth in this subpart for hearing protective devices
manufactured on or after [date TBD]. All hearing protection devices
that are manufactured on or after the effective date of this subpart
must be tested and labeled in accordance with the applicable procedures
set forth herein.
4. Section 211.203 is revised to read as follows:
Sec. 211.203 Definitions.
As used in subpart B, all terms not defined here have the meaning
given them in the Noise Control Act of 1972 (the Act) (42 U.S.C. 4907),
or in subpart A of this part.
(a) A-Duration. The duration of an impulsive sound from its initial
sharp increase in positive sound pressure to the point where the sound
pressure becomes negative.
(b) A-Weighted Sound Level. A single number representing the
overall sound level of a noise that emphasizes sounds containing
frequencies between about 500 and 5000 Hz and deemphasizes frequencies
outside that range. The resultant sound level is referred to as A-
weighted units in dB, generally indicated as dBA and considered to be
representative of the human ears frequency response to sounds.
(c) Acoustic Test Fixture (ATF). A device that approximates the
size and shape of a human head and which includes acoustic elements to
simulate the acoustic response of the ear canal. An ATF with ear canals
approximates the cross sectional area and length of the human ear
canal.
(d) Active Noise Reduction. The reduction of sound transmission
based on the use of electronic elements (e.g. circuits and transducers)
to produce acoustic signals of approximately equal and opposite phase
and amplitude to reduce the transmitted sound.
[[Page 39176]]
(e) ANSI/ASA S12.6-2008. ``American National Standard--Methods for
Measuring the Real-Ear Attenuation of Hearing Protectors.'' A procedure
for measuring the hearing protector sound attenuation values at various
frequencies using one-third octave band noise stimuli presented to
subjects in a diffuse sound field.
(f) ANSI S12.42-1995 (R2002). ``American National Standard--
Microphone-in-Real-Ear and Acoustic Test Fixture Methods for the
Measurement of Insertion Loss of Circumaural Hearing Protection
Devices.'' A procedure for measuring the acoustical insertion loss of
earmuff using a miniature microphone positioned in the ear canal.
(g) ANSI/ASA S12.68-2007. ``American National Standard--Methods of
Estimating Effective A-weighted Sound Pressure Levels When Hearing
Protectors are Worn.'' Procedures for calculating Noise Reduction
Ratings.
(h) Assumed Protection Value (APVfx). The protection in a given
octave band computed as the mean attenuation, minus the standard
deviation of that octave band multiplied by a constant.
(i) Attenuation. The reduction of sound pressure level provided by
a hearing protection device by either structural elements, acoustic
pathways, electronic or mechanical means.
(j) Carrying Case. The container used to store reusable hearing
protectors.
(k) Category. A group of hearing protectors which are identical in
all aspects to the parameters listed in Sec. 211.210-2(a)(3).
(l) Claim. An assertion made by a manufacturer regarding the
intended purpose, general performance and the sound attenuating
effectiveness of his product.
(m) Decibel (dB). Unit of measure of sound level used in this
regulation for both sound pressure level and hearing threshold level.
(n) Dispenser. The permanent or disposable container designed to
hold more than one complete set of hearing protector(s) for the express
purpose of display to promote sale or display to promote use or both.
(o) Disposable Device. A hearing protection device that is intended
to be discarded after one or otherwise specified period of use.
(p) Effective A-weighted Sound Pressure Level (L'A). The sound
pressure level, A-weighted and referred to an equivalent diffuse sound
field condition, that is estimated to be experienced by users when the
hearing protector is worn.
(q) Effective Peak Sound Pressure Level (L'P). The estimated peak
sound pressure level underneath the hearing protection device.
(r) Estimated Noise Level Reduction (ENR). The value in decibels
derived from the variability of noise reduction as a function of noise
spectra.
(s) Fitting Instruction. Guidance on the demonstration and fitting
of a hearing protection device that is provided to the testing
laboratory and included with the product as entered into commerce.
(t) Headband. A component of a hearing protection device that
applies force to, and holds in place on a person's head, the sound
attenuating component that is intended to acoustically seal the ear
canal. The headband can be positioned over-the-head, behind-the-head or
under-the-chin of the user.
(u) Hearing Protection Device (HPD). Devices or materials intended
to reduce the level of sound entering a user's ears. Such devices
include those of which hearing protection may not be the primary
function, but which are nonetheless sold partially as providing hearing
protection to the user. This term is used interchangeably with the
terms, ``hearing protective device'', ``hearing protector'', ``device''
and ``HPD'' in subpart B. The following list, although not all
inclusive, presently represents products that are subject to this part.
(1) Passive Hearing Protection Device. A device that relies solely
on its structural elements to block or otherwise control the
transmission of sound into the ear canal and that does not use
electronic circuits or fluid dynamic means to reduce the entry of
external sound.
(2) Active Hearing Protection Device. A device that contains
electronic components including transducers (i.e. speakers and
microphones) to increase or decrease the transmission of sound into the
ear canal. Also referred to as an electronic hearing protection device.
(3) Ear plug. A hearing protection device that is designed to be
inserted into the ear canal and held in place principally by virtue of
its fit inside the ear canal.
(4) Ear cap. See ``Semi-insert Device''.
(5) Ear cup. The combination of the hard shell, soft cushion and
sound attenuating material that encloses the external ear or pinna in
ear muff applications.
(6) Ear muff. A hearing protection device usually comprised of a
headband which applies spring-like force/pressure to two ear cups with
soft cushions to seal against the external ear or pinna (supra-aural)
or the sides of the head around the pinna (circumaural). The ear cups
may also be held in position by attachment arms mounted on a hardhat or
hardcap.
(7) Active Noise Reduction Hearing Protection Device. A device that
uses single or in combination, electrical components and structural
elements to reduce the sound transmitted to the ear canal through
acoustic cancellation of the air-conducted and/or bone-conducted
external sound.
(8) Amplitude-Sensitive Hearing Protection Device. A device that is
designed to produce a change in sound attenuation as a function of the
external sound level. Amplitude-sensitive hearing protection devices
include passive devices, active devices, and impulsive noise devices.
(9) Communication Headset. A voice communication device (ear plug,
ear muff, semi-insert device or helmet) that is also designed to reduce
the level of sound at the users' ears by either structural elements
and/or electronic means.
(10) Custom-molded Hearing Protection Device. A device that is made
to conform to a specific person's ears (pinnas) and ear canals.
(11) Electronic Hearing Protection Device. See ``Active Hearing
Protection Device.''
(12) Helmet. A hearing protection device that provides impact
protection to the head or skull and designed with ear cups to reduce
the external sound from entering the ears through either structural
elements and/or electronic means.
(13) Level-Dependent Hearing Protection Device. See Amplitude-
Sensitive Hearing Protection Device.
(14) 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 ear canal require the force of the band to
retain their position and acoustic seal. Semi-inserts that enter the
ear canal behave more like ear plugs; they seal the ear to block noise
with or without the application of band force. Also referred to as
canal cap or banded hearing protector.
(v) Impulsive Acoustic Test Fixture (IATF). A device that
approximates the size and shape of a human head, simulates the acoustic
response of the human ear canal, and includes a microphone(s) and
electronic circuitry to detect acoustic signals.
(w) Impulsive Noise. A sound or series of sounds that are
characterized
[[Page 39177]]
by a sharp rise and rapid decay in sound pressure level and have
duration of less than one second.
(x) Impulsive Noise Reduction. The reduction of peak impulse sound
transmission based upon the single or combined use of passive and/or
active noise reduction elements.
(y) Insertion Loss. The arithmetic difference in decibels between
the sound pressure levels measured at a reference point (i.e. the ear
canal or microphone of the acoustic test fixture) with and without a
hearing protection device in place.
(z) Label. A notice, as described in this subpart, which is
inscribed on, affixed to or appended to a product, its packaging, or
both for the purpose of giving the purchaser or product user
information regarding the products designed use, noise reduction
effectiveness, operating or fitting instructions and other information
appropriate to the product.
(aa) Manufacturer. Any person engaged in the manufacturing or
assembling of products, or the importing of products for resale, or who
purchases products from an original equipment manufacturer (OEM) for
the purpose of repackaging or relabeling or who acts for, and is
controlled by any such person in connection with the distribution of
such products in U.S. commerce.
(bb) Microphone in Real Ear (MIRE). A testing method where
miniature microphones are positioned at the entrance to the subject's
blocked ear canals to measure the sound pressure level underneath a
hearing protection device.
(cc) Noise. Undesired or unwanted sound. For the purpose of this
subpart, noise and sound are used interchangeably.
(dd) Noise Reduction Rating (NRR). A single number metric used to
describe noise reduction in decibels.
(ee) Noise Reduction Variability Data Points. The values of the
noise reductions calculated for the spectral balances given by
LC-LA = (-1, 2, 6 and 13 dB).
(ff) Occluded Threshold of Hearing. The minimum level of sound
heard at a specific frequency when a hearing protection device is worn.
(gg) Octave Band Attenuation. The amount of sound reduction
determined according to the measurement procedure of Sec. 211.206 for
one-third octave bands of noise.
(hh) Open Threshold of Hearing. The minimum level of sound heard at
a specific frequency when a hearing protection device is not worn. Also
referred to as ``unoccluded'' threshold of hearing.
(ii) Package. The container in which a hearing protection device is
presented for purchase or use. The package in some cases may be the
same as the carrying case.
(jj) Passive Noise Reduction. The reduction of sound transmission
based solely on the use of materials and/or structural elements.
(kk) Pink Noise. Noise for which the spectrum density varies as the
inverse of frequency.
(ll) Primary Panel. The surface of the product package that is
considered to be the front surface or that surface on the package which
is intended for initial viewing at the point of ultimate sale or the
point of distribution for use.
(mm) Random Incident Field. A sound field in which sound waves are
incident from all directions with equal probability.
(nn) Real-Ear Attenuation at Threshold (REAT). The mean value in
decibels of the occluded threshold of hearing minus the open threshold
of hearing for all trials of each test subject under otherwise
identical test conditions.
(oo) Real-Ear Attenuation at Threshold (REAT). The mean value in
decibels of the occluded threshold of hearing minus the open threshold
of hearing for all trials of each test subject under otherwise
identical test conditions.
(pp) Residual Volume. The volume of air between the termination of
an ear plug and the sensing surface of the microphone when an ear plug
is inserted into an acoustic test fixture.
(qq) Reverberation Time. The time, in seconds, required for a sound
produced in an enclosure to decay to a designated level once the sound
source is turned off.
(rr) Spectral Balance (B). The difference in decibels between the
C-weighted and A-weighted levels of a sound spectrum (LC -
LA), indicating the proportion of energy at low frequencies
in the spectrum.
(ss) Sound pressure level (dB SPL). Ten times the logarithm to the
base 10 of the ratio of the time mean square sound pressure to the
square of the reference sound pressure, given by: Lp = 10
log10 (p\2\/p0\2\), where p is the root mean
square value of sound pressure in pascals, and the reference sound
pressure p0 is 20 micropascal (20 x 10-6 Newtons
per meter squared) for measurements in air. Unit: decibel (dB).
(tt) Spectral uncertainty. Variation in the attenuation provided by
a hearing protector due to the frequency content of the noise in which
a device is worn.
(uu) Subject uncertainty. Variation in the attenuation provided by
a hearing protector due to the effect of different subjects fitting the
device when the attenuation is assessed.
(vv) Tag. Stiff paper, metal or other hard material that is tied or
otherwise affixed to the packaging of a protector.
(ww) Test Facility. A laboratory that tests hearing protection
devices in accordance with the requirements of this subpart.
(xx) Test Hearing Protector. A hearing protector that has been
selected for testing to determine the NRR value(s) to be put on the
label, or which has been designated for testing to verify the labeled
value(s) and determine compliance of the protector with this subpart.
(yy) Test Request. A request submitted to the manufacturer by the
Administrator of the Environmental Protection Agency (EPA) that will
specify the hearing protector category, and test sample size to be
tested according to Sec. 211.212, and other information regarding the
audit.
(zz) Test Subject. Any person of any gender, ethnicity or age who
is selected from a group of candidates that exhibit physical and mental
characteristics requisite to the conduct of testing in accordance with
Sec. 211.206-1(b)(5) and other requirements of this subpart.
(aaa) Third-octave band microphone free-field rejection. The
variation in sound field (decibels) of the microphone polar response
(front to back for cardioid and front to side for cosine) for each
measured third-octave band.
(bbb) Threshold of Hearing. For a specified signal, the average
minimum sound pressure level as indicated by the test subject's
responses.
(ccc) Trial. A complete series of occluded and unoccluded hearing
threshold measurements on a single test subject for a single hearing
protector.
(ddd) White Noise. Noise for which the spectrum density is
independent of frequency over a specified frequency range.
5. Section 211.204-1 is revised to read as follows:
Sec. 211.204-1 Information content of primary label.
The information to appear on the primary label must be according to
Sec. 211.104 of Subpart A except as stated here and prescribed in
Figures 1, 2 and 3 of Sec. 211.204-1.
(a) Primary Label for all PASSIVE Hearing Protection Devices
(Figure 1):
(1) Area A must state ``Noise Reduction Rating''.
(2) Area B must contain the range(s) of the Noise Reduction Ratings
(NRR) in
[[Page 39178]]
decibels for the designed mode(s) of use of that model hearing
protector.
(i) The range shall be depicted by a bar-graph that shall include a
numeric scale from 0 to 50 decibels in equal increments of 10 decibels.
(ii) A solid color bar, as presented in Figure 1 of this section,
shall be superimposed on the bar-graph scale indicating the lesser and
greater Noise Reduction Ratings from the 80th and 20th percentiles.
(iii) The lesser and greater NRR values shown on the numeric scale
shall be determined in accordance with Sec. 211.207-2.
(iv) For devices with headbands that may be used in different
positions, the labeled NRR shall represent the 80th and 20th
percentiles for the manufacturers recommended position as determined in
Sec. 211.207-2.
(v) The word ``PASSIVE'' shall be placed and centered below the
bar-graph. For multi-positional head band protectors, the tested
position shall be indicated by the words, ``OVER HEAD'', ``BEHIND
HEAD'' or ``UNDER CHIN'' placed immediately following ``PASSIVE''.
(3) Area C must state ``PASSIVE NRR values indicate range of noise
reduction when used as instructed by the manufacturer. When used in
steady and intermittent noise environments, the difference between the
noise level and respective NRRs is the user's estimated exposure level.
This protector was not tested for impulse noise.''
(4) Area D of the primary label must state the manufacturers' name,
city and state of principal office and may include a primary web
address.
[GRAPHIC] [TIFF OMITTED] TP05AU09.005
(b) Primary Label for ACTIVE Noise Reduction Hearing Protection
Devices (Figure 2):
(1) Area A must state ``Noise Reduction Rating''.
(2) Area B must contain the range(s) of the Noise Reduction Ratings
(NRR) in decibels for the designed mode(s) of use of that model hearing
protector.
(i) There shall be two bar-graphs with numeric scales from 0 to 50
decibels in equal increments of 10 decibels. The two bar-graphs shall
be aligned one above the other as shown in Figure 2 of this section.
(ii) The word ``ACTIVE'' shall be placed and centered above the
upper bar-graph.
(iii) The word ``PASSIVE'' shall be placed and centered below the
lower bar-graph.
(iv) A solid color bar shall be superimposed on the respective bar-
graphs indicating their lesser and greater Noise Reduction Ratings from
the 80th and 20th percentiles.
(v) The lesser and greater NRR values shown on the upper bar-graph
shall be determined in accordance with Sec. 211.207-3.
(vi) The lesser and greater NRR values shown on the lower numeric
scale shall be determined in accordance with Sec. 211.207-3.
(vii) For devices with headbands that may be used in different
positions, the labeled NRR shall represent the 80th and 20th
percentiles for the manufacturers recommended position(s) as determined
in Sec. 211.207-3. The tested position shall be indicated by the
words, ``OVER HEAD'', ``BEHIND HEAD'' or ``UNDER CHIN'' placed
immediately following ``PASSIVE'' and ``ACTIVE''.
(2) Area C must state ``ACTIVE and PASSIVE NRR values indicate
range of noise reduction with and without electronic activation when
used as instructed by the manufacturer. In steady and intermittent
noise environments, the difference between the noise level and
respective NRRs is the user's estimated exposure level. This protector
was not tested for impulse noise.''
(3) Area D of the primary label must state the manufacturers' name,
city and state of principal office and may include a primary web
address.
[[Page 39179]]
[GRAPHIC] [TIFF OMITTED] TP05AU09.006
(c) Primary Label for IMPULSIVE Noise Hearing Protection Devices
(Figure 3):
(1) Area A must state ``Noise Reduction Rating''.
(2) Area B must contain the range(s) of the Noise Reduction Ratings
(NRR) in decibels for the designed mode(s) of use of that model hearing
protector.
(i) There shall be two bar-graphs with numeric scales from 0 to 50
decibels in equal increments of 10 decibels. The two bar-graphs shall
be aligned one above the other as shown in Figure 3 of this section.
(ii) The word ``IMPULSIVE'' shall be placed and centered above the
upper bar-graph.
(iii) The word ``PASSIVE'' shall be placed and centered below the
lower bar-graph.
(iv) A solid color bar shall be superimposed on the respective
scales indicating their lesser and greater Noise Reduction Ratings from
the 80th and 20th percentiles.
(v) The lesser impulsive NRR values shown on the upper numeric
scale shall be determined in accordance with Sec. 211.207-4(f).
(vi) The greater impulsive NRR values shown on the upper numeric
scale shall be determined in accordance with Sec. 211.207-4(g).
(vii) The lesser and greater passive NRR values shown on the lower
numeric scale shall be determine in accordance with Sec. 211.207-2.
(viii) For devices with headbands that may be used in different
positions, the labeled NRR shall represent the 80th and 20th
percentiles for the manufacturers recommended position as determined in
Sec. 211.207-2. The tested position shall be indicated by the words,
``OVER HEAD'', ``BEHIND HEAD'' or ``UNDER CHIN'' placed immediately
following ``IMPULSIVE'' and ``PASSIVE.''
(3) Area C must state ``IMPULSIVE and PASSIVE NRR values indicate
the range of noise reduction in impulsive and continuous noise
environments when used as instructed by the manufacturer. The
difference between the noise level and respective NRRs is the user's
estimated exposure level.''
(4) Area D of the primary label must state the manufacturers' name,
city and state of principal office and may include a primary web
address.
[[Page 39180]]
[GRAPHIC] [TIFF OMITTED] TP05AU09.007
6. Section 211.204-2 is amended as follows:
a. Revise paragraphs (b)(2) and (b)(3).
b. Revise (c) and (d).
c. Add new paragraphs (e) through (l).
Sec. 211.204-2 Primary label size, print and color.
* * * * *
(b) * * *
(2) Area B--2.1 mm or 6 point for numerals and
(3) Area A and B--1.7 mm or 5 point for words.
* * * * *
(c) The use of upper and lower case letters and the general
appearance of the label must be similar to the example in Figure 1 of
Sec. 211.204-1.
(d) The color of the EPA logo shall be a solid color with
sufficient contrast with surrounding information or if it is printed in
full color, it must be the colors of the official EPA logo.
(e) The minimum dimensions of the scale shall be 2.2 (cm) (0.87
inch) long and 0.3 (cm) (0.12 inch) high.
(f) The minimum font size of the labels for the bar shall be 4
point type.
(g) The values depicted on the bar shall be at least 6 point in
bold type face.
(h) The solid range bar shall be a minimum of 0.2 (cm) (0,079 inch)
high, vertically centered in the bar-graph scale and of sharply
contrasted solid-color with the endpoints positioned at the respective
numeric limits.
(i) For all PASSIVE hearing protection devices the layout shall be
according to Figure 1 of Sec. 211.204-1.
(j) For ACTIVE hearing protection devices the layout shall be
according to Figure 2 of Sec. 211.204-1.
(k) For IMPULSIVE hearing protection devices the layout shall be
according to Figure 3 of Sec. 211.204-1.
7. Section 211.204-3 is amended by revising paragraphs (a)
introductory text and (a)(2) and by adding paragraph (a)(3) to read as
follows:
Sec. 211.204-3 Label location and type.
(a) The manufacturer or entity that introduces the product into
commerce is responsible for labeling the product for ultimate sale or
use. Such manufacturer or entity shall select the primary product label
in accordance with Sec. 211.204-1 and locate it as follows:
* * * * *
(2) Affixed to the primary panel of the product packaging if the
label complying with Sec. 211.204-1 is not visible at the point of
ultimate purchase or the point of distribution to users.
(3) Products that are sold exclusively over the Internet and thus
constitute the point of sale to ultimate purchasers or users, shall
present the requisite primary and secondary labels as readily visible
electronic images for each product category offered for sale. Such
electronic labels shall contain all information that is required for
labels that are required to be affixed to and contained within the
package of products with a point of sale outside the Internet. Such
labels must be automatically downloaded to the purchaser along with
confirmation of acceptance of payment from the purchaser. Electronic
labels shall not be used for bulk container sales or for non-Internet
resale.
* * * * *
8. Section 211.204-4 is revised to read as follows:
Sec. 211.204-4 Supporting information.
The following minimum supporting information must accompany all
hearing protection devices in a manner that ensures its availability to
the perspective user in an easily readable format. In the case of bulk
packaging and dispensing, such supporting information must be affixed
to the bulk container or dispenser in the same manner as the label, and
in a readily visible location. Such information shall be presented in
tabular form except where specified otherwise.
(a) The mean sound attenuation for each octave band test frequency
as determined from the measurements prescribed in Sec. 211.206-1.
(b) The standard deviation of the mean sound attenuation across
subjects for each octave band test frequency as determined from the
measurements prescribed in Sec. 211.206-1.
[[Page 39181]]
(c) The Assumed Protection Values (APV) for the 80th and 20th
percentiles of the sound attenuation for each octave band test
frequency as determined from the measurements prescribed in Sec.
211.206-1.
(d) The noise reduction as a function of spectral balance shall be
presented as shown in the example given in Table 1 of this section.
Table 1--Example--Noise Reduction Variability Data Points
[spectral balance]
----------------------------------------------------------------------------------------------------------------
-1 dB -2 dB 6 dB 13 dB
----------------------------------------------------------------------------------------------------------------
Noise Reductions (dB)
---------------------------------------------------------------
20th Percentile................................. 30.6 24.0 18.7 11.9
----------------------------------------------------------------------------------------------------------------
80th Percentile................................. 26.8 19.2 13.7 8.1
----------------------------------------------------------------------------------------------------------------
(e) The variability of attenuation as a function of noise spectrum
shall be presented in a graphical format as shown in Figure 1 of this
section.
(1) The figure caption shall be ``Variability of Noise Reduction as
a function of Noise Spectra.''
(2) The dimensions of the body of the graph shall be no smaller
than 5.0 cm wide by 3.8 cm high (1.97 x 1.5 inches).
(3) The dimensions of the body of the graph shall be no smaller
than 5.0 cm wide by 3.8 cm high (1.97 x 1.5 inches).
(4) The ordinate scale shall be linear from -2 to 16 decibels with
increments of 2 decibels. The axis label shall be ``Spectral Balance B
= LC - LA (dB)''.
(5) The abscissa scale shall be linear from 0 to 50 decibels with
increments of 5 decibels. The abscissa scale shall be labeled
``Estimated Noise Reduction (dB)''.
(6) The use of a grid is optional to facilitate interpolation of
values.
(7) The symbols for the 80th percentile shall be filled and
connected by solid lines.
(8) The symbols for the 20th percentile shall be unfilled and
connected by solid lines.
(9) A legend shall be placed in the body of the graph as shown in
the example of Figure 1 of this section.
[GRAPHIC] [TIFF OMITTED] TP05AU09.008
(f) For hearing protection devices with a headband that can be worn
in multiple positions (over head, behind head and/or under chin) the
mean sound attenuation values, standard deviations and APV, as
prescribed in paragraphs
[[Page 39182]]
(a), (b), (c), (d) and (e) of this section, shall be provided for each
tested position.
(g) The following statement, ``When this device is worn as
directed, the level of noise entering a person's ear is approximated by
the differences between the A-weighted environmental noise level and
the lesser and greater NRRs.'' except as stated in Sec. 211.204-5 for
ACTIVE devices and as stated in Sec. 211.204-6 for IMPULSIVE devices.
(h) The following example shall be included except as stated in
Sec. 211.204-5 for ACTIVE devices and in Sec. 211.204-6 for IMPULSIVE
devices:
``Example:
(1) X: the sound pressure level as measured at the user's location
in decibels A-weighted (dBA).
(2) Lesser and greater NRRs: the PASSIVE NRR ratings obtained from
the primary label or from the graph of noise reduction variability with
spectral balance.
(3) The approximate range of sound pressure levels at the user's
ears with hearing protection:
(X -- lesser NRR) = the greater sound pressure level.
(X -- greater NRR) = the lesser sound pressure level.
The sound pressure level at the user's ears will depend upon the
fit of the protector.''
(i) The following cautionary note shall be included except as
stated in Sec. 211.204-5 for ACTIVE devices and as stated in Sec.
211.204-6 for IMPULSIVE devices.
``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 is directed to the enclosed
graph of the variability of noise reduction with noise spectra to
determine the level of protection.''
(j) The month and year of production of the device shall be printed
on the outside of the package using a minimum font size of 8 point.
(k) Instructions as to the proper use, fitting technique and care
of the device.
(l) The following statement: ``Improper fit or improper use of this
device will decrease noise reduction effectiveness and increase the
risk of hearing damage.
9. Section 211.204-5 is added to read as follows:
Sec. 211.204-5 Supporting information for Active Noise Reduction
Hearing Protection Devices.
In addition to the supporting information required in Sec.
211.204-4, the following minimum supporting information must accompany
all ACTIVE devices in an easily readable format.
(a) The mean total sound attenuation for each octave band test
frequency as determined from the measurements prescribed in Sec.
211.206-2.
(b) The standard deviation of the mean total sound attenuation
across subjects for each octave band test frequency as determined from
the measurements prescribed in Sec. 211.206-2.
(c) The Assumed Protection Values (APV) for the 80th and 20th
percentiles of the sound attenuation for each octave band test
frequency as determined from the measurements prescribed in Sec.
211.206-2.
(d) The passive, active and total noise reduction data points as a
function of spectral balance shall be presented as shown in the example
in Table 1 of this section.
Table 1--Example--Combined Active and Passive Noise Reduction Variability as a function of Spectral Balance
----------------------------------------------------------------------------------------------------------------
-1 dB 2 dB 6 dB 13 dB
----------------------------------------------------------------------------------------------------------------
Noise Reductions (dB)
----------------------------------------------------------------------------------------------------------------
20th Percentile Passive......................... 21.0 14.0 9.0 5.0
80th Percentile Passive......................... 27.0 21.0 15.0 10.0
20th Percentile Active.......................... -1.0 0.7 6.2 12.5
80th Percentile Active.......................... 0.0 0.0 7.5 14.0
20th Percentile Total........................... 20.0 14.7 15.2 17.5
80th Percentile Total........................... 27.0 21.0 22.5 24.0
----------------------------------------------------------------------------------------------------------------
(e) The variability of attenuation as a function of noise spectrum
shall be presented in a graphical format as shown in Figure 1 of this
section.
(1) The figure caption shall be ``Variability of Noise Reduction as
a Function of Noise Spectra.'' The dimensions of the body of the graph
shall be no smaller than 5.0 cm wide by 3.8 cm high (1.97 x 1.5
inches).
(2) The font size for the title, ordinate and abscissa scales, and
the legends shall be no smaller than 4 point.
(3) The ordinate scale shall be linear from -2 to +16 decibels with
increments of 2 decibels. The axis label shall be ``Spectral Balance B
= LC--LA (dB)''.
(4) The abscissa scale shall be linear from 0 to 50 decibels with
increments of 5 decibels. The abscissa scale shall be labeled
``Estimated Noise Reduction (dB)''.
(5) The use of a grid is optional to facilitate interpolation of
values.
(6) The symbols for the 80th percentile passive noise reductions
shall be filled and connected by solid lines.
(7) The symbols for the 20th percentile passive noise reductions
shall be unfilled and connected by solid lines.
(8) The symbols for the 80th percentile total noise reductions
shall be filled, distinctly different from the passive symbols and
connected by dashed lines.
(9) The symbols for the 20th percentile total noise reductions
shall be unfilled, distinctly different from the passive symbols and
connected by dashed lines.
(10) A legend shall be placed in the body as shown in the example
given in Figure 1 of this section.
[[Page 39183]]
[GRAPHIC] [TIFF OMITTED] TP05AU09.009
(f) The following statement, ``When this device is worn as
instructed and operated in its PASSIVE mode, the level of noise
entering a person's ear is approximated by the differences between the
A-weighted sound pressure level at the user's location and the lesser
and greater PASSIVE NRRs. When this device is operated in its ACTIVE
mode, the level of noise entering the person's ear is approximated by
the difference between the A-weighted sound pressure level at the
user's location and the lesser and greater ACTIVE NRRs.''
(g) The following example shall be included for ACTIVE devices:
``Example:
(1) X: The sound pressure level as measured at the user's location
in decibels A-weighted (dBA).
(2) Lesser and greater NRR: The ACTIVE or PASSIVE ratings obtained
either from the primary label or from the graph of noise reduction
variability with spectral balance.
(3)(I) The approximate range of sound pressure levels at the user's
ears with the HPD in either its ACTIVE or PASSIVE mode:
(A) (X-lesser NRR) = the greater sound pressure level.
(B) (X-greater NRR) = the lesser sound pressure level.
(ii) The sound pressure level at the user's ears will depend upon
the fit and operating mode of the protector.''
(h) The following cautionary note shall be included in the
secondary label for active noise reduction hearing protectors:
``Caution: For the ACTIVE mode in predominantly low frequency
environments in which the difference in the measured C-weighted and A-
weighted sound pressure levels (dBC-dBA) exceeds 3 dB, the user is
directed to the enclosed graph of the variability of noise reduction
with noise spectra to determine the level of protection.''
(i) The following statement shall be included: ``This device, in
ACTIVE mode, is recommended for use in environmental noise levels from
X to Y dBA.'' The manufacturer shall designate the values of X and Y.
(j) If the total combined attenuation of REAT and
LACTIVE, as calculated in Sec. 211.206-2, for any octave
band exceeds 50 dB, the following cautionary statement shall be
included: ``The combined attenuation of this device has been measured
to be in excess of 50 dB at XXX Hz. Sound energy transmitted through
the head or oral/nasal cavities to the inner ear may be greater than
the level of sound when attenuated by the hearing protection device.''
The manufacturer shall designate the frequency band(s) where the
attenuation exceeds 50 dB.
(k) The battery type, number of batteries and expected use time for
the product.
10. Section 211.204-6 is added to read as follows:
Sec. 211.204-6 Supporting information for Amplitude-Sensitive Hearing
Protection Devices.
In addition to the supporting information required in Sec.
211.204-4, the following minimum supporting information must accompany
all Amplitude-Sensitive hearing protection devices in an easily
readable format. In the case of bulk packaging and dispensing, such
supporting information must be affixed to the bulk container or
dispenser in the same manner as the label, and in a readily visible
location. The information
[[Page 39184]]
resulting from the measurements prescribed in Sec. 211.206-3 shall be
presented in tabular and graphical form as shown in Table 1 and Figure
1 of this section for PASSIVE Amplitude-Sensitive hearing protection
devices and as shown in Table 2 and Figure 2 of this section for ACTIVE
Amplitude-Sensitive devices.
(a) The mean peak sound pressure levels.
(b) The mean impulsive noise reduction at each mean peak sound
pressure level.
(c) The minimum and maximum impulsive noise reduction values at
each mean peak sound pressure level.
Table 1--Example--Variability of Impulsive Noise Reduction for ABC Protector
[Passive mode]
----------------------------------------------------------------------------------------------------------------
Mean peak sound pressure level 131 dB 150 dB 167 dB
----------------------------------------------------------------------------------------------------------------
Mean Impulse Noise Reduction.................................... 23.2 22.9 23.4
Maximum Impulse Noise Reduction................................. 24.0 23.1 24.4
Minimum Impulse Noise Reduction................................. 21.5 22.4 22.7
----------------------------------------------------------------------------------------------------------------
Table 2--Example--Variability of Impulsive Noise Reduction for XYZ Protector
[Active and passive modes]
----------------------------------------------------------------------------------------------------------------
Mean peak sound pressure level 133 dB 150 dB 167 dB
----------------------------------------------------------------------------------------------------------------
Mean Impulse Noise Reduction (Passive).......................... 32.2 32.8 33.9
Maximum Impulse Noise Reduction (Passive)....................... 32.6 33.4 34.2
Minimum Impulse Noise Reduction (Passive)....................... 31.2 31.7 33.7
Mean Impulse Noise Reduction (Active)........................... 32.0 31.6 32.7
Maximum Impulse Noise Reduction (Active)........................ 32.1 32.3 33.8
Minimum Impulse Noise Reduction (Active)........................ 30.5 31.2 30.6
----------------------------------------------------------------------------------------------------------------
[GRAPHIC] [TIFF OMITTED] TP05AU09.010
[[Page 39185]]
[GRAPHIC] [TIFF OMITTED] TP05AU09.011
(d) The battery type, number of batteries and expected operating
time for the product as appropriate.
(e) The following statement: ``This device is recommended for use
in impulsive noise environments having peak levels between 130 to X dB
SPL.'' (X dB is equal to 130 dB plus the mean passive impulsive noise
reduction)
(f) The following cautionary note shall be included for ACTIVE
noise reduction hearing protectors. ``Caution: This device is not
intended for use in impulsive noise environments exceeding Y dB peak
sound pressure levels. The risk of hearing loss increases with multiple
exposures to high level peak impulses.'' (Y dB is equal to 130 dB plus
the mean active impulsive noise reduction)
(g) The following statement: ``The PASSIVE Noise Reduction Rating
is based on the attenuation of continuous noise and is not an accurate
indicator of the protection attainable against impulsive noise. The
IMPULSIVE Noise Reduction Rating is based on the attenuation of high-
level impulsive noise and is not an accurate indicator of the
protection attainable for continuous noise.''
(h) The following example shall be included for amplitude-sensitive
devices:
``Example:
(1) X: the peak sound pressure level as measured at the user's
location in decibels A-weighted (dBA).
(2) Lesser and greater NRR: the IMPULSIVE ratings obtained from the
primary label.
(3)(i) The approximate range of sound pressure levels at the user's
ears with hearing protection:
(A) (X-Lesser NRR) = the greater effective peak sound pressure level.
(B) (X-Greater NRR) = the lesser effective peak sound pressure level.
(ii) The peak sound pressure level at the user's ears will depend
upon the fit and operating mode of the protector. For a more accurate
estimate of the impulsive noise reduction the user is directed to the
graph of Figure 2 of this section.''
11. Section 211.204-7 is added to read as follows:
Sec. 211.204-7 Supporting information for Amplitude-Sensitive Hearing
Protection Devices with Active Noise Reduction.
Devices that incorporate both ACTIVE noise reduction and ACTIVE
amplitude-sensitive noise reduction shall comply with both sections
Sec. 211.204-1(b) and Sec. 211.204-1(c) for primary labeling and with
both sections Sec. 211.204-5 and Sec. 211.204-6 for supporting
information.
12. Section 211.205 is revised to read as follows:
Sec. 211.205 Special claims and exceptions.
(a) Any manufacturer wishing to make claims regarding the acoustic
effectiveness of a device, other than its Noise Reduction Ratings, must
demonstrate the validity of such claims, including the presentation of
test data and the specific methods used to validate the claims.
(b) Any request concerning an exception must be supported by
scientific test data that establishes the exception without doubt, and
must be submitted for consideration and approval to: The Administrator
or his designee at U.S. EPA, Office of the Administrator. The Agency
will notify the manufacturer within thirty (30) business days of
receipt of the request if: the special claim or exception is approved,
disapproved, additional information is needed, or the Agency needs
additional time to consider the request.
13. Section 211.206-1 is revised to read as follows:
[[Page 39186]]
Sec. 211.206-1 Real ear attenuation at threshold (REAT).
(a) The provisions of this section shall apply to the following
devices:
(1) Passive Hearing Protection Devices;
(2) Active Hearing Protection Devices in their ``off'' mode of
operation;
(3) Active Noise Reduction Hearing Protection Devices in their
``off'' mode of operation; and
(4) Amplitude-Sensitive Hearing Protection Devices in their ``off''
mode of operation (if they incorporate electronics).
(b) The sound attenuation to be used in the calculation of the
Noise Reduction Rating shall be determined in accordance with all
clauses of ANSI/ASA S12.6-2008 ``Methods for Measuring the Real-ear
Attenuation of Hearing Protectors,'' incorporated by reference at Sec.
211.213 of this subpart, except as stipulated in the identified ANSI
clauses below:
(1) For subpart B, the word ``requester'' as used in ANSI/ASA
S12.6-2008 shall be replaced with the word ``manufacturer'' as defined
in Sec. 211.203.
(2) For subpart B, only those requirements addressing Method A of
ANSI/ASA S12.6-2008 shall be applicable.
(3) Clause 3 of ANSI/ASA S12.6-2008. Terms and Definitions. The
definitions given in Sec. 211.203 shall be used in this subpart.
(4) Clause 4 of ANSI/ASA S12.6-2008. Physical Requirements of Test
Facility. For subpart B, the following new provision shall be in
addition to that of Clause 4.3.1: ``The electrical test signals
measured at the input terminals of the speaker or speakers shall
consist of one-third octave bands of pink or white noise, with a
spectrum shape equivalent to that which would be created by a filter
meeting the requirements of Class O of ANSI S1.11-2004, incorporated by
reference at Sec. 211.213 of this subpart. The mode of operation in
changing from one band to another shall be a discrete step function; a
gradual continuously adjustable mode of change shall not be used.''
(5) Clause 5 of ANSI/ASA S12.6-2008--Test Subjects.
(i) For subpart B, the following new provision shall be in addition
to Clause 5.3. ``Prior to audiometric qualification and participation
in attenuation testing, the dimensions of both the right and left ear
canals, and the bitragion width and head height of the test subject
shall be measured in accordance with the procedure of ANSI 12.6-2008,
Annex B.
(6) Clause 6 of ANSI/ASA S12.6-2008. Product Samples.
(i) For subpart B, the following new provisions shall be in
addition to Clause 6.1 of ANSI/ASA S12.6-2008:
(A) Formable ear plugs: a minimum of three pairs of ear plugs per
test subject shall be provided. A new pair shall be used for training
and for each subsequent occluded trial. When a specific product is
available in different sizes, three pairs of each product size shall be
provided per test subject.
(B) Premolded ear plugs and semi-insert devices: a minimum of one
pair of ear plugs per test subject shall be provided. When a specific
product is available in different sizes, one pair of each product size
shall be provided per test subject.
(C) Custom ear plugs: One pair of custom ear plugs for each test
subject shall be provided.
(D) Ear muffs: a minimum of one pair of ear muffs for every two
test subjects shall be provided. When a specific product is available
in different sizes, one pair of each product size shall be provided for
every two test subjects.
(E) Ear muffs attached to a hardhat: The hardhat sample shall be
specified by the manufacturer of the hearing protection device. A
minimum of one pair of ear muffs for every two test subjects shall be
provided. When an ear muff is available in different sizes, one pair of
each size shall be provided for every two test subjects. For each size
of hardhat, two samples shall be provided in each size.
(F) Helmets: a minimum of one sample shall be provided for each
size helmet to be tested. Helmets incorporating other hearing
protection devices (e.g. ear plugs, ear muffs) shall be tested as a
system. The hearing protection device(s) incorporated in a helmet shall
be provided by the manufacturer of the helmet. The minimum number of
samples of the hearing protection device(s) to be used in combination
with the helmet shall be as specified in paragraph (b)(6)(i)(A) through
(E) of this section.
(ii) For subpart B, the following new provisions shall be in
addition to Clause 6.2 of ANSI/ASA S12.6-2008: ``Ear muffs and semi-
insert devices with bands or attached to hardhats, which include
adjustment mechanisms allowing the band force to be varied, shall be
initially set to the minimum application force of their adjustment
range prior to being provided to each subject. During fitting, the
devices may be readjusted per the provisions of Clauses 8.1 of ANSI/ASA
S12.6-2008.''
(iii) For subpart B, Clause 6.3 of ANSI/ASA S12.6-2008, shall not
be applicable.
(7) Clause 7 of ANSI/ASA S12.6-2008--Psychophysical Procedure.
(i) For subpart B, Clause 7.1.1 of ANSI/ASA S12.6-2008, shall not
be applicable.
(ii) For subpart B, Clause 7.5 of ANSI/ASA S12.6-2008, shall read
as follows: ``If the range of open threshold measurements at any
frequency exceeds 6 dB during a test session, the threshold at that
frequency shall be retested until two open thresholds are obtained
within 6 dB of each other.''
(8) Clause 8 of ANSI/ASA S12.6-2008--Method A: Trained-subject Fit:
(i) For subpart B, the following new provisions shall be in
addition to Clause 8.1 of ANSI/ASA S12.6-2008:
(A) ``The experimenter shall give each subject precise directions
and practice in fitting the hearing protector in accordance with the
instructions that are provided by the manufacturer with the product to
all users. The manufacturer's instructions shall not be modified by the
experimenter's own knowledge in fitting the same or similar devices. No
indicators, marks, or lubricants shall be utilized unless supplied or
recommended by the manufacturer as a part of normal use. No alterations
shall be made to the device to facilitate fitting. When applicable the
experimenter shall assist the subject in selecting the appropriate size
hearing protector, and in adjusting products with variable band force.
Subjects can select the size appropriate to fit their right and left
ears. The selected size(s) must be used throughout the two product
trials.
(B) The experimenter may provide demonstrations of the
manufacturer's fitting instructions during the training period. The
experimenter may personally fit the device to the test subject as part
of the training process. The experimenter shall train the subject in
the use of the fitting noise (Clause 4.3.6 of ANSI/ASA S12.6-2008) to
assist in fitting the protector. There is no limitation on either the
duration of the training or the number of practice fittings that may be
performed. Trial sound attenuation measurements during the training
period are prohibited. Once the experimenter has determined the subject
can properly fit the hearing protector, the test shall begin.''
(ii) For subpart B, the following new provisions shall be in
addition to Clause 8.2 of ANSI/ASA S12.6-2008: ``After training, a
subject shall be dismissed if the subject cannot obtain an acceptable
product fit based on any one of the following criteria:
(A) Subjects assessment of the quality of the hearing protector fit
based on
[[Page 39187]]
listening to the loudness of the fitting noise,
(B) Visual evaluation by the experimenter,
(C) Tactile evaluation by the experimenter working in conjunction
with the subject,
(D) Guidance specific to that product as provided by the
manufacturer,
(E) Repeated failure to meet the requirements of Clause 7.5
(F) Illness or physical inability to participate on the day of the
test, and
(G) Inability to remain attentive during instruction or testing
sessions.
Subjects shall not be retested or dismissed as the result of the
attenuation they obtained during the testing process.''
(iii) For subpart B, the following new provisions shall be in
addition to Clause 8.3 of ANSI/ASA S12.6-2008:
(A) ``For the occluded tests, the subject shall fit the hearing
protector without the experimenter present in the test chamber. The
fitting noise shall be introduced into the test chamber and the subject
shall be told to manipulate the hearing protector to obtain the lowest
level of perceived noise. The experimenter shall observe the subject
during the fitting test from outside the chamber. Once the subject is
satisfied with the fit, and after observing the quiet period specified
in Clause 7.6 and the waiting period specified in Clause 7.7 of ANSI/
ASA S12.6-2008, the test shall begin.
(B) Adjustments of the fit of the hearing protector during the
occluded threshold tests are not allowed. However, the subject shall be
instructed to inform the experimenter if, during the test, a change in
fit of the device is noticed, and if so, the test shall be stopped. The
subject shall refit the device and the occluded threshold test
restarted from the beginning. If this occurs a second time the occluded
threshold testing shall be completed without refit and the attenuation
data shall be used in the computation of the rating.''
(9) For subpart B, Clause 9 of ANSI/ASA S12.6-2008 is not
applicable.
14. Section 211.206-2 is revised to read as follows:
Sec. 211.206-2 Active noise reduction (ANR).
The provisions of this section shall apply to all Active Noise
Reduction hearing protection devices as defined in Sec. 211.203(u)(7).
(a) The measurement of active sound attenuation requisite to the
Noise Reduction Rating for Active Noise Reduction hearing protection
devices shall be in accordance with the methods defined in this section
and only those clauses of ANSI S12.42-1995 (R2004), incorporated by
reference at Sec. 211.213 of this subpart, stated below. The octave
band attenuation shall be calculated using one-third octave band
insertion loss measurements as described in paragraph (m)(2) of this
section.
(b) The definitions given in Sec. 211.203 shall be used.
(c) Acoustic Environment of Test Room: The requirements of this
subpart shall be applicable to measurements of all Active Noise
Reduction devices.
(1) Sound Field Generation Equipment: For subpart B, Clause 6.1 of
ANSI/ASA S12.6-2008, shall be applicable.
(2) Sound Field Characteristics: For subpart B, Clauses 6.2.1 and
6.2.2 and Table 1 of ANSI S12.42, shall be applicable.
(3) Sound Field Frequency Characteristics: The sound field shall be
a broad band noise incorporating frequencies from 100 to 10000 Hz. The
difference between the maximum and minimum one-third octave band levels
within the specified frequency range shall not exceed 10 dB. The
difference between adjacent one-third octave band levels shall not
exceed 3 dB.
(4) Sound Field Integration Time: The integration time shall not be
less than 32 seconds using linear spectral averaged third octave band
analysis.
(5) Sound Field Reference Levels (LREF(f)): The signal
generation equipment shall be capable of producing a continuous sound
field of 105 dB SPL without a subject in the room. The field shall be
measured with an ANSI Type I Pressure Microphone. The attenuation
settings shall be recorded to permit replication.
(6) Ambient Noise Floor of Test Room: The noise floor of the test
chamber, with all external equipment operating and no sound field
present, shall be at least 60 dB less than sound field levels measured
at each third octave band.
(7) Fitting Noise: The fitting noise shall be as specified in
paragraph (c)(3) of this section and presented at a level of 85 dB SPL.
(d) Measurement Equipment:
(1) For subpart B, Clauses 6.3.1, 6.3.2, and 6.3.4 of ANSI S12.42,
shall be applicable.
(2) For subpart B, the following new provision shall be in addition
to Clause 6.3.6 of ANSI S12.42: ``A spectrum analyzer using a third-
octave band analog or digital filter bank or a Type I sound level meter
with a third-octave band filter set shall be used for measuring the
sound pressure levels. The measurement system shall have sufficient
dynamic range such that all measurements are a minimum of 10 dB above
the instrumentation noise floor and test chamber's ambient background
noise level. When using a Fast Fourier Transform (FFT) analyzer, it
shall have internally generated digital pseudorandom white and pink
noise sources with known statistical characteristics, i.e., wide sense
stationary, and shall be used for the third-octave band calculation of
true random noises. All decibel measurements shall be referenced to 20
x 10-6 N/m\2\ (20 [mu]Pa).''
(3) Signal to Noise Ratio of the measurement microphone in the test
chamber: The difference in microphone output levels with and without
the sound field present shall be at least 10 dB in each third-octave
band from 80 to 12500 Hz.
(e) Active Attenuation Method for ear muffs using Microphone In
Real Ear (MIRE).
(1) MIRE Microphone: For subpart B, a microphone that fulfills the
requirements set forth in Clause 8 of ANSI S12.42, is required.
(2) For subpart B, the following new provision shall be in addition
to Clause 8.1.2 of ANSI/ASA S12.6-2008: ``The microphone may be
wireless or wired. If wired, the wires from the microphone, including
insulation, shall not be more than 0.3204 millimeters (0.0126 inches)
in diameter to minimize leakage of sound into the protector cavity.''
(3) For subpart B, the following new provision shall be in addition
to Clause 8.1.3 of ANSI/ASA S12.6-2008: ``The experimenter shall fit
appropriate ear plugs into the subject's ear canals such that their
external surfaces are flush with the base of each ears conchae. The
subject shall be instructed that removal of any hearing protector is
prohibited during the test without permission from the experimenter.''
(4) Position of microphone: The MIRE microphone shall be positioned
by the experimenter on the external surface of the ear plug at the
entrance of the ear canal, as shown in Figure 1 of this section. The
sensing surface shall be perpendicular to the axis of the ear canal,
centered in the ear canal and directed away from the center of the
subject's head.
[[Page 39188]]
[GRAPHIC] [TIFF OMITTED] TP05AU09.012
(f) Product selection:
(1) Ear muffs: A minimum of one pair of ear muffs for every two
test subjects shall be provided. Subjects shall use the same ear muff
as for the REAT testing. When a specific product is available in
different sizes, one pair of each product size shall be provided for
every two test subjects.
(2) Ear muffs attached to a hardhat: The hardhat sample shall be
specified by the manufacturer of the hearing protection device. A
minimum of one pair of ear muffs for every two test subjects shall be
provided. When an ear muff is available in different sizes, one pair of
each size shall be provided for every two test subjects. For each size
of hard hat, two samples shall be provided in each size.
(3) Helmets: A minimum of one sample for each size helmet to be
tested shall be provided. Helmets incorporating ear muffs shall be
tested as a system. The integral ear muffs for a helmet shall be
provided by the manufacturer of the helmet. If the ear muffs are
removable, the minimum number to be used in combination with the helmet
shall be as specified in Sec. 211.206-1(b)(6)(i)(D).
(g) Measurement Procedure:
(1) Subject Selection: Only those subjects who completed the REAT
tests with protectors specified in Sec. 211.206-1(a)(3) shall be used
for the MIRE tests set forth in this section.
(2) Subject Position: A head-positioning device, such as a plumb-
bob to the nose or the forehead of the subject, shall be used to
maintain the subject's head at the reference point. The head
positioning device shall not transmit to the head vibrations that
affect the threshold measurements, and shall not measurably affect the
uniformity of the sound field of the room as specified in Clause 6.2.1
of ANSI S12.42. The use of a headrest or bite bar is not permitted.
(h) Fitting the protectors:
(1) The subject shall fit the protector as instructed for the REAT
testing. No additional fitting training shall be given. However, the
experimenter shall ensure that the integrity of the MIRE microphone and
its wires is maintained during the fit process.
(2) The fitting noise shall be introduced into the test chamber and
the subject shall be told to adjust the hearing protector to minimize
the level of the perceived noise.
(3) To allow hearing protectors to conform to the subject's ears
and/or head, MIRE measurements shall begin a minimum of two minutes
after the hearing protectors have been fitted unless the manufacturer's
standard instructions state otherwise.
(4) Adjustments of hearing protector fit during the test are not
permitted. The subject shall be told to inform the experimenter if a
change in the fit of the device is noticed. If the experimenter is so
informed, the occluded test shall be stopped. The subject shall refit
the device and the experimenter shall confirm the integrity of the MIRE
system, after which the test shall be restarted from the beginning. If
change in the fit occurs a second time but the MIRE system is
unaffected, the test shall be completed without refit and the
attenuation data shall be used in the computation of the active noise
reduction.
(i) MIRE Sound Levels with Protectors Activated
(LTOTAL(f)):
(1) The experimenter shall verify that the device is activated as
specified by the manufacturer's standard instructions.
(2) The sound field shall be presented in the test chamber at the
reference level of 105 dB SPL as specified in paragraph (c)(5) of this
section.
(3) The MIRE output signal shall be measured in one-third octave
bands (LTOTAL(f)) using linear spectral averaging and an
integration time of no less than 32 seconds.
(j) MIRE Sound Levels with Protectors Deactivated
(LPASSIVE(f)):
(1) The experimenter shall verify that the device is deactivated as
specified by the manufacturer's standard instructions.
(2) The sound field shall be presented in the test chamber at the
reference level
[[Page 39189]]
of 105 dB SPL as specified in paragraph (c)(5) of this section.
(3) The MIRE output signal shall be measured in one-third octave
bands (LPASSIVE(f)) using linear spectral averaging and an
integration time of no less than 32 seconds.
(4) The measurements in paragraph (i)(j) of this section shall be
repeated and the LPASSIVE(f) and LTOTAL(f) levels
for each measurement recorded.
(5) Verification of MIRE microphone position: Upon completion of
the measurements in paragraph (i)(j) of this section, the experimenter
shall confirm the position of the MIRE has not changed. If the position
has changed, the measurements shall be repeated.
(k) Active Attenuation Method for ear plugs using Acoustic Test
Fixture (ATF).
(1) Acoustic Test Fixture:
(i) The ATF shall incorporate two ear canal couplers and ear
simulators.
(ii) The ATF ear simulators shall comply with the International
Electrotechnical Commission (IEC) specification 60711--``Occluded-ear
simulator for the measurement of earphones coupled to the ear by ear
inserts,''
(iii) The length of the ear canal couplers shall provide a residual
volume of between 0.5 and 2.0 cubic centimeters after insertion of the
ear plug.
(iv) The ATF microphones shall meet or exceed the following minimum
specifications.
(A) Frequency range 20 to 12500 Hz.
(B) Dynamic range: 40 to 130 dB SPL.
(v) The insertion loss of the ATF shall not be less than 60 dB for
a sound field as specified in Sec. 211.206-2(c)(5).
(2) Product selection:
(i) Custom Ear plugs:
(A) The testing lab shall provide the manufacturer with impressions
of the ATF ear canal that provide a residual volume between 0.5 cubic
centimeters (cc) and 1.0 cc.
(B) The manufacturer shall provide the testing lab a minimum of
five ANR electronic control units and five pairs of ANR ear plugs that
are custom fitted to the ATF ear canal coupler.
(ii) Non-custom Ear plugs:
(A) The manufacturer shall provide the testing lab a minimum of
five ANR electronic control units and five pairs of ANR ear plugs.
(B) Alternatively, the ear plugs from the REAT test may be reused
for this ATF test.
(3) Measurement Procedure for Active Noise Reduction Performance of
ear plugs.
(i) Fitting the protectors:
(A) The experimenter shall fit the protectors into the ear couplers
of the ATF such that their respective residual volumes are not less
than 0.5 cc and no greater than 1.0 cc.
(ii) ATF Sound Levels with Protectors Activated
(LTOTAL(f)):
(A) The experimenter shall activate the device as specified by the
manufacturer's standard instructions.
(B) The sound field in the test room shall be at the reference
level of 105 dB SPL as specified in paragraph (c)(5) of this section.
(C) The output signals of the ATF microphone(s) shall be measured
in one-third octave bands (LTOTAL(f)) using linear spectral
averaging and a minimum integration time of 32 seconds.
(iii) ATF Sound Levels with Protectors Deactivated
(LPASSIVE(f)):
(A) The experimenter shall deactivate the device as specified by
the manufacturer's standard instructions.
(B) The sound field in the test room shall be at the reference
level of 105 dB SPL as specified in paragraph (c)(5) of this section.
(C) The ATF microphone(s) output signal shall be measured in one-
third octave bands (LPASSIVE(f)) using linear spectral
averaging and a minimum integration time of 32 seconds.
(D) The measurements in paragraphs (k)(3)(ii) and (iii) of this
section shall be repeated for a total of forty trials. Each ANR control
unit and each pair of ear plugs shall be used an equal number of times.
The LPASSIVE(f) and LTOTAL(f) levels for each
measurement shall be recorded.
(l) ANR performance for helmets with integral ear plugs or ear
muffs or both ear plugs and ear muffs.
(1) The tests set forth in paragraph (k)(3) of this section for ANR
muffs and plugs shall be used singularly or in combination as
appropriate.
(m) Calculation of Attenuation of ANR devices:
(1) The passive attenuation for each subject shall be the average
of the individual REAT attenuation measurements for octave band
frequencies from 125 to 8000 Hz.
(2) The octave band active attenuation for each trial shall be
calculated using the third octave band insertion loss measurements
(from 100 to 10000 Hz), as follows:
(i) LACTIVE (one-third octave band insertion losses) for
each trial for each one-third octave band shall be calculated as:
(A) LACTIVE (\1/3\ OB) = LTOTAL -
LPASSIVE
(B) LACTIVE (octave band insertion losses) for each
trial shall be calculated as the median of the one-third octave band
active attenuations, described in Sec. 211.206-2(k)(3)(ii) and (iii),
measured for both the right and left ears.
(C) An example calculation is presented in Table 1 of this section.
The six (6) insertion losses for the active mode have a median of 11.4
dB. The six values are sorted first (10.4, 10.8, 11.1, 11.7, 12.1 and
12.6). The values 11.1 and 11.7 bracket the 50th percentile and their
average is 11.4 dB.
Table 1--Example of the Median Octave Band Insertion Loss Combined With REAT for Active Mode
----------------------------------------------------------------------------------------------------------------
-\1/3\ octave Center band +\1/3\ octave
----------------------------------------------------------------------------------------------------------------
REAT Attenuation................................................ .............. 25.4 ..............
Right Ear Active Insertion Loss................................. 10.4 12.1 11.7
Left Ear Active Insertion Loss.................................. 10.8 11.1 12.6
Median Insertion Loss........................................... .............. 11.4 ..............
REAT + Median Insertion Loss.................................... .............. 36.8 ..............
----------------------------------------------------------------------------------------------------------------
(3) The total octave band attenuation for each trial in the Active
mode (electronics turned on) shall be the sum of the REAT octave band
attenuations and the LACTIVE octave band insertion losses as
computed in paragraph (m)(2) of this section. These total octave band
attenuation values (REAT + LACTIVE) shall be used in the
computation of the NRR and the NRRG as specified in ANSI
S12.68-2007. If the total octave band attenuation values exceed 50 dB
in any band then a cautionary note must be provided regarding the
influence of bone conduction according to Sec. 211.204-5(j).
15. Section 211.206-3 is added to read as follows:
[[Page 39190]]
Sec. 211.206-3 Reduction of Peak Impulsive Noise.
Hearing protection devices sold or offered on the basis of
providing protection from impulsive noises in excess of 130 dB peak
sound pressure level shall be tested in accordance with this section.
(a) Product Selection.
(1) Custom Ear plugs:
(i) The manufacturer shall provide the testing lab a minimum of
five pairs of ear plugs that are custom fit to the ear canal couplers
of the ATF.
(ii) The testing lab shall provide the manufacturer with
impressions of the ATF ear canals such that the residual volume is not
less than 0.5 cubic centimeters (cc) or greater than 1.0 cc.
(2) Ear plugs:
(i) The manufacturer shall provide the testing lab a minimum of
five pairs of ear plugs selected at random from production lots.
(ii) Alternatively, the ear plugs from the REAT test may be reused
for this ATF test.
(iii) The testing lab shall insert the ear plug such that the
residual volume is not less than 0.5 cc or greater than 1.0 cc.
(3) Ear muffs:
(i) The manufacturer shall provide the testing lab a minimum of
five pairs of ear muffs selected at random from production lots,
appropriately sized for the ATF.
(ii) Alternatively, the ear muffs from the REAT test may be reused
for this ATF test if they meet the ATF size requirements.
(4) Ear muffs attached to a hardhat:
(i) The manufacturer shall provide the testing lab a minimum of
five pairs of ear muffs attached to a hardhat selected at random from
production lots, appropriately sized for the ATF.
(ii) Alternatively, the hard hat(s) and ear muffs from the REAT
test may be reused for this test if they meet the ATF size
requirements.
(5) Helmets incorporating ear cups:
(i) Helmets incorporating ear cups shall be tested as a system for
impulse noise reduction. The manufacturer shall provide the testing lab
a minimum of one helmet and five pairs of ear cups selected at random
from production lots, appropriately sized for the ATF.
(ii) Reserved.
(6) Combination of ear plugs, ear muffs and/or helmets:
(i) The manufacturer shall provide the testing lab five (5) pairs
of each protector. The device shall be tested as a system in
combination as appropriate.
(ii) Reserved.
(b) Impulsive Noise Characteristics.
(1) Three different peak impulse noise levels shall be used. The
peak impulse levels shall be in the following ranges 130-134 dB, 148-
152 dB and 166-170 dB. Manufacturers may elect to test at levels in
excess of the required 170 dB, in which case notice must be given on
both the primary and secondary labels as required in Sec. 211.204-1(c)
and Sec. 211.204-6 and the information reported to the EPA on the
required test report per Sec. 211.212-5.
(2) The minimum permissible A-duration shall not be less than 0.5
milliseconds and the maximum shall not be greater than 2.0
milliseconds.
(3) The peak level and A-duration of the impulse noise shall not be
affected by acoustic reflections.
(c) Measurement Equipment.
(1) Impulsive Acoustic Test Fixture or Dummy Head (IATF).
(i) The hearing protection device shall be tested on an IATF which
meets the requirements of ANSI S12.42-1995, Section 9.1--Acoustic Test
Fixture Method.
(ii) The insertion loss of the IATF shall not be less than 65 dB
for impulses in the ranges described in paragraph (b)(1) of this
section.
(iii) The IATF shall include two identical simulated ears,
including representative pinnas, conchas, and ear canal coupler, and
identical instrumentation. The ear canal coupler shall be in accordance
with IEC 60711 (1984) but incorporate a 6.35 mm (0.25 inch) pressure
microphone to satisfy the required dynamic range of 130 db to 170 dB.
(2) Free-Field Pressure Probe/Microphone.
(i) A free-field pressure probe/microphone capable of accurately
measuring impulse levels of 180 dB peak SPL shall be used as the
external microphone.
(ii) The free-field pressure probe shall be a cylindrical body as
depicted in Figure 1 of this section, having a minimum length, d3, of
40.64 cm (16 inches), a maximum diameter of 5.08 cm (2 inches) and a
taper from the tip, d1, of 5.08 to 10.16 cm (2 to 4 inches). The
pressure transducer shall be flush with the side of the cylindrical
body and located a distance d2, from the tip, of between 15.24 and
20.32 cm (6 and 8 inches).
(iii) The free-field pressure probe/microphone shall be positioned
as shown in Figure 2 of this section, equidistant and at the same
elevation as the microphone(s) of the IATF from the impulse noise
source.
[[Page 39191]]
[GRAPHIC] [TIFF OMITTED] TP05AU09.013
[GRAPHIC] [TIFF OMITTED] TP05AU09.014
(3) Impulsive Noise Measurement Instrumentation
(i) Sampling rate: The data acquisition system shall be capable of
simultaneously sampling the acoustic response of the two ears of the
IATF and the free-field pressure probe/microphone with a minimum
sampling rate of 96,000 samples per second (96 kHz) for each channel.
(ii) Signal to Noise Ratio: The Signal to Noise Ratio of any
captured signal must be greater than 10 dB from 100 to 10000 Hz.
(iii) Sampling Resolution: The resolution of the data acquisition
system shall be a minimum of 16-bits.
[[Page 39192]]
(4) Instrumentation layout for Measurement of Reduction of Peak
Impulsive Noise.
(i) The instrumentation shall be arranged such that each ear of the
IATF and the free-field pressure probe/microphone are located
equidistant from the impulse noise source as shown in Figure 2 of this
section.
(5) Measurement Procedure for the Impulsive Noise Reduction Rating.
(i) Calibration of the Free-field to ear canal transfer function.
(ii) Five impulses shall be produced in the range of 148 to 152 dB
peak impulse sound pressure level. The measurement of the free field to
ear canal transfer function is not required if impulse peaks are within
0.5 dB.
(iii) The complex free-field to ear canal transfer functions
(HFF-Right-i and HFF-Left-i) shall be calculated
for each impulse and each ear.
(iv) The free-field to ear canal transfer functions
(HFF-Right and HFF-Left) shall be the average of
the five respective individual calculated transfer functions.
(A) HFF-Right, i(f) = F(PEAR-Right,i(t))/
F(PFF, i(t))
(B) HFF-Left, i(f) = F(PEAR-Left,i(t))/
F(PFF, i(t))
(6) Measurement of the Peak Impulsive Noise Reduction for a hearing
protection device.
(i) For each sample of the hearing protection device, a minimum of
one impulse at each of the three pressure ranges shall be produced as
specified in paragraph (b)(1) of this section. The peak pressure can be
adjusted by varying the acoustic impulse source and/or altering the
distance from the source to the test fixture.
(ii) Each impulse shall be recorded from the free-field, IATF left
and right ear canal microphones by the data acquisition system. The
total duration of the captured signal shall not be less than 50
milliseconds. The time duration from the beginning of the captured
signal to its peak amplitude shall be a minimum of 1.0 millisecond. The
time waveforms from the IATF and the free-field pressure probe/
microphone shall be sampled simultaneously.
(iii) The measured time waveforms shall be labeled as
PFF, j, k for the free-field pressure probe/microphone and
as PATF-RIGHT, j, k and PATF-LEFT, j, k for the
acoustic test fixture/dummy head ear microphones, where j = 1 to 5 for
the protector samples, and k=1 to 3 are the respective impulse noise
peak ranges, respectively.
(iv) The hearing protector shall be removed and refitted to the
IATF for each impulse noise trial.
(v) If an acoustic impulse or HPD fitting is unacceptable, the HPD
shall be refitted and the impulse trial shall be repeated. The data
from an unacceptable trial shall be discarded.
16. Section 211.206-4 is added to read as follows:
Sec. 211.206-4 Consideration of alternative test procedures.
The Administrator may approve applications from manufacturers of
hearing protectors for the approval of test procedures which differ
from those contained in this subpart so long as the alternative
procedures have been demonstrated to correlate with the prescribed
procedures. To be acceptable, alternative test procedures must be such
that the hearing protector test results obtained will fulfill all test
and data requirements prescribed in Sec. 211.206 when the product is
tested in accordance with the specified methodology. After approval by
the Administrator, testing conducted by manufacturers using alternative
procedures may be accepted by the Administrator for all purposes
including, but not limited to, production verification testing and
selective enforcement audit testing.
Sec. 211.207 [Amended]
17. Section 211.207 is amended by removing the introductory text
and Figure 2.
18. Section 211.207-1 is added to read as follows:
Sec. 211.207-1 Computation of NRR based on statistical and graphical
methods.
(a) The Noise Reduction Rating (NRR) in this subpart shall be
determined in accordance with the procedures set forth in Clauses 5, 6
and 7 of ANSI/ASA S12.68-2007, incorporated by reference at Sec.
211.213 of this subpart, except as stipulated in paragraphs (b)(1)
through (4), (c)(1) and (2), (d), and (e) of this section.
(b) ANSI Clause 5: The computation of the NRR, as set forth in this
clause, shall be used to determine the ``PASSIVE mode'' noise reduction
performance of all hearing protector devices subject to this
regulation.
(1) The ``Noise Level Reduction Statistic for use with A-weighting
(NRSA)'' shall be replaced by the ``Noise Reduction Rating
(NRR)'' as used in this subpart.
(2) For subpart B, ANSI Clause 5.1 shall be replaced by the
paragraph (b)(3) of this section.
(3) ``The NRR for a hearing protector, as used in this subpart, is
comprised of a pair of values representing the lower and upper A-
weighted noise level reductions that can be expected when the device is
used as directed by the manufacturers' instructions.''
(4) ANSI Clause 5.2: The value of [alpha] as used in this subpart
shall be for the 80% and 20% protection performance and equal to 0.8416
and -0.8416 respectively.
(c) ANSI Clause 6: The computation of the NRR, as set forth in this
clause, shall be used to determine the ``ACTIVE mode'' noise reduction
performance of all hearing protector devices that rely in whole or in
part on either mechanical, electronic and/or acoustically variable
(with respect to sound pressure level) methods of increasing their
noise reduction performance.
(1) For subpart B, ANSI Clause 6.0: the ``Noise Level Reduction
Statistic, Graphical (NRSG) shall be replaced by the ``Noise
Reduction Rating, Graphical (NRRG).
(2) This method shall not be used to compute either the ``PASSIVE
mode'' or the ``ACTIVE mode'' performance of hearing protectors
intended for protection from high level impulsive noise. The
appropriate computation is given in paragraph Sec. 211.207-4.
(d) ANSI Clause 7--Octave-Band Method: The computation of the mean
attenuation, the standard deviation of attenuations and the Assumed
Protection Values (APVs) as a function of frequency, as set forth in
this clause, shall be used for all hearing protectors for the ``PASSIVE
mode'' and for active noise reduction hearing protectors in the
``ACTIVE mode.''
(e) For subpart B, ANSI Annex A of ANSI/ASA 12.68-2007--``Noise
Spectra Used in Calculating the NRRA and NRRG,''
shall be applicable.
19. Section 211.207-2 is added to read as follows:
Sec. 211.207-2 Computation of the Passive Noise Reduction Rating.
The PASSIVE Noise Reduction Rating shall be calculated using the
REAT data obtained in Sec. 211.206-1.
(a) Noise Reduction Rating: For each subject, the attenuations from
both trials at each octave band frequency (125, 250, 500, 1000, 2000,
4000, and 8000 Hz) shall be averaged, yielding seven attenuations. The
averaged attenuation data shall be used for the Rp f(k) in
Equation 1 of ANSI S12.68-2007. The Noise Reduction Rating shall be
determined according to Equations 1, 2, 3, 4, 5 and 6 as specified in
Clause 5.2 of ANSI/ASA S12.68-2007, incorporated by reference at Sec.
211.213 of this subpart, using the alpha ([alpha]) values of 0.8416 and
-0.8416, corresponding to the 20th and 80th percentiles.
(b) Variability of Noise Reduction Rating with Spectral Levels: The
variability of the Noise Reduction Rating with the spectral level of
the
[[Page 39193]]
noise environment in which the hearing protector is worn shall be
determined according to Equation 8 in Clause 6 of ANSI S12.68-2007 and
shall use the noise spectra as specified in Annex B of ANSI S12.68 for
determining the variability. For the variability of passive devices,
the Estimated Noise Level Reduction shall be determined at the spectral
balance values of LC-LA = [-1, 2, 6 and 13 dB].
The variability shall be determined for the 20th and 80th percentile
assumed protection values. The variability results shall be reported in
the supporting information specified in Sec. 211.204-4.
(c) Mean attenuations and standard deviations: The mean
attenuations and standard deviations across subjects as a function of
octave band frequency (f) from 125 to 8000 Hz are determined as
follows:
(1) The mean attenuations are:
[GRAPHIC] [TIFF OMITTED] TP05AU09.000
Where Rpf is the averaged attenuations for each subject
and octave band frequency, P is the total number of subjects tested,
p is the subject index.
(2) The standard deviations of the mean attenuation are:
[GRAPHIC] [TIFF OMITTED] TP05AU09.001
Where Rpf is the averaged attenuations for each subject
and octave band frequency, P is the total number of subjects tested,
p is the subject index.
(d) Assumed Protection Values: The assumed protection values
(APVf) for the ``passive mode'' of a hearing protector as a
function of octave band frequency (f) from 125 to 8000 Hz are
determined as follows:
(1) The assumed protection values are
APVf = mf[alpha]sf
Where the 20th percentile APV is determined when [alpha] = +0.8416
and the 80th percentile APV is determined when [alpha] = -0.8416 is
used.
(2) [Reserved]
20. Section 211.207-3 is added to read as follows:
Sec. 211.207-3 Computation of the Active Noise Reduction Rating.
The Active Noise Reduction Rating shall be calculated using total
octave band attenuation determined in Sec. 211-206-2(m).
(a) Noise Reduction Rating: The total octave band attenuation (the
sum of the REAT octave band attenuations and the LACTIVE
octave band insertion losses) shall be used for the Rp f(k)
in Equation 1 of ANSI S12.68-2007. The Noise Reduction Rating shall be
determined according to Equations 1, 2, 3, 4, 5 and 6 as specified in
Clause 5.2 of ANSI S12.68-2007, using the alpha ([alpha]) value of
0.8416 and -0.8416, corresponding to the 20th and 80th percentiles.
(b) Variability of Noise Reduction Rating with Spectral Levels: The
variability of the Noise Reduction Rating with the spectral level of
the noise environment in which the hearing protector is worn, shall be
determined according to Equation 8 in Clause 6 of ANSI S12.68-2007 and
shall use the noise spectra as specified in Annex B of ANSI S12.68 for
determining the variability.
(1) For the variability of passive devices, the Estimated Noise
Level Reduction shall be determined at the spectral balance values of
LC-LA = [-1, 2, 6 and 13 dB]. The variability
shall be determined for the 20th and 80th percentile assumed protection
values. The variability results shall be reported in the supporting
information specified in Sec. 211.204-4.
(2) The Estimated Noise Level Reduction (20th and 80th percentiles)
determined for the spectral balance value of LC-
LA = 13 dB shall be used to identify the performance of an
active noise reduction hearing protection device in a low frequency
noise environment.
(c) Mean attenuations and standard deviations: The mean total
attenuations (REAT + LACTIVE) and standard deviations across
subjects as a function of octave band frequency (f) from 125 to 8000 Hz
are determined as follows:
(1) The mean attenuations are
[GRAPHIC] [TIFF OMITTED] TP05AU09.002
Where Rpf is the averaged total attenuation for each
subject and octave band frequency, P is the total number of subjects
tested, p is the subject index.
(2) The standard deviations of the mean attenuation are
[GRAPHIC] [TIFF OMITTED] TP05AU09.003
Where Rpf is the averaged total attenuation for each
subject and octave band frequency, P is the total number of subjects
tested, p is the subject index.
(d) The standard deviations of the mean attenuation are
[GRAPHIC] [TIFF OMITTED] TP05AU09.004
Where Rpf is the averaged total attenuation for each
subject and octave band frequency, P is the total number of subjects
tested, p is the subject index.
(1) The assumed protection values are
APVf = mf[alpha]sf
Where the 20th percentile APV is determined when [alpha] = +0.8416
and the 80th percentile APV is determined when [alpha] = -0.8416 is
used.
(2) [Reserved]
21. Section 211.207-4 is added to read as follows:
Sec. 211.207-4 Computation of the Impulsive Noise Reduction Rating.
(a) The equivalent ear canal time waveform shall be calculated from
the measured free-field waveform, PFF,j,k, and the free
field to the ear canal transfer function HFF for each ear.
(b) These waveforms shall be referred to as
PFF-EAR-Left,j,k and PFF-EAR-Right,j,k and shall
be computed by applying the average free-field to ear canal transfer
functions (HFF-Right and HFF-Left) to the free-
field waveforms (PFF). The corrected waveforms shall be
computed as:
PFF-EAR-Right, j, k (f) = PFF, j, k(f) *
HFF-Right(f),
PFF-EAR-Left, j, k (f) = PFF, j, k (f) *
HFF-Left(f),
PFF-Right, j, k (t) =
F-1(PEAR-Right, j, k (f)),
PFF-Left, j, k (t) =
F-1(PEAR-Left, j, k (f)),
Where:
F-1( ) is the inverse Fourier transform function. The
respective waveforms and transfer functions are represented as
linear quantities in the frequency domain.
(c) The reduction of the peak impulse, as affected by the hearing
protection device, shall be:
(1) [Delta]PImpulse-Right, k = [Sigma]j = 1 to 5
[max(PFF--EAR-Right, j, k)--
max(PATF-Right, j, k)]/5
(2) [Delta]PImpulse-Left, k = [Sigma]j = 1 to 5
[max(PFF--EAR-Left, j, k)--max(PATF-Left, j, k)]/
5,
Where:
Max( ) is the maximum positive peak pressure of the impulse.
(d) The average impulse noise reduction for each pressure range (k)
shall be the average impulse noise reduction for each pressure range
(k) shall be:
[Delta]PImpulse, k =
[avg([Delta]PImpulse-Right, k) +
avg([Delta]PImpulse-Left, k)]/2
(e) The three average impulse noise reductions shall be used to
provide the data points for Sec. 211.204-6, Table 2. The three average
impulse noise reduction values shall be graphed with a range for the
abscissa of 130 to 180 dB (re 20 [mu]Pa) and a range for the ordinate
of 0 to 50
[[Page 39194]]
dB with the symbols connected by a solid line.
(f) The minimum of the three impulse noise reduction values
calculated in paragraph (d) of this section shall be the lower endpoint
in the impulse noise reduction rating as required in Sec. 211.204-1(c)
Figure 3.
(g) The maximum of the three impulse noise reduction values
calculated in paragraph (d) of this section, shall be the upper
endpoint in the impulse noise reduction rating as required in Sec.
211.204-1(c) Figure 3.
22. Section 211.209 is added to read as follows:
Sec. 211.209 Maintenance of records.
(a) The manufacturer, as defined in Sec. 211.203(aa), of any
hearing protective device subject to this regulation must establish,
maintain and retain the following adequately organized and indexed
records.
(1) General records.
(i) Identification and description by category parameters of
protectors comprising the manufacturer's product line;
(ii) A description of any procedures, other than those contained in
this regulation used to perform noise attenuation tests on any test
protector, and the results of those tests;
(iii) A record, signed by an authorized representative of the
laboratory, of any calibration that was performed during testing by the
test laboratory; and
(iv) A record of the date of manufacture of each protector subject
to this regulation, keyed to the serial number or other coded
identification contained in the supporting information required by
Sec. 211.204-4.
(2) Individual records for the test protectors. A complete record,
or exact copies of the complete record of all noise attenuation tests
performed (except tests performed by EPA directly) which includes all
individual worksheets, and other documentation relating to each test
required by subpart B.
(3) The manufacturer may fulfill this record retention requirement
by keeping a copy of the labeling verification report that he has
submitted to the EPA in the format recommended by the Administrator
(see Appendix A of this part) and by establishing a record of the
information required by Sec. 211.212-5.
(4) The manufacturer must retain all required records for the life
of each specific product line. Records may be retained as electronic or
hard copy or reduced to microfilm, or other forms of data storage
depending on the record retention procedures of the manufacturer.
22a. Section 211.209-1 is added to read as follows:
Sec. 211.209-1 Reporting requirements.
(a) The manufacturer must submit to the EPA, in hardcopy or
electronic format, a completed coversheet according to Annex A, a copy
of all authorized measurement information, including test results and
calculated NRR values, obtained from the testing laboratory for each
product or product category, within ten (10) business days of
completion of the required test. The test results are to be in the
format recommended in Appendix A and sent to: U.S. Environmental
Protection Agency, Attn: Docket Center, Docket Number EPA-HQ-OAR-2003-
0024, Mail Code--2822T, 1200 Pennsylvania Avenue, NW., Washington, DC
20460.
(b) On request by the Administrator, the manufacturer must submit
to the Administrator information regarding the number of protectors, by
category, produced or scheduled for production during the time period
designated in the request.
23. Section 211.210-1 is revised to read as follows:
Sec. 211.210-1 General requirements.
(a) Each manufacturer of hearing protectors for distribution in
commerce in the United States, which are subject to the requirements of
this regulation as specified in Sec. 211.201.
(1) Must affix a label to each product, as specified in Sec.
211.204, that is readily visible at the point of sale to the ultimate
purchaser or distribution to the prospective user.
(2) Must assure that each product meets or exceeds the sound
attenuation values determined by the procedures in Sec. 211.206 and
explained in Sec. 211.207.
(b) Product manufacturers who introduce protectors into commerce
for sale to another manufacturer, as defined herein, for packaging and
sale to ultimate purchaser or user, must provide to that manufacturer
the attenuation values and standard deviations of each of the one-third
octave band center frequencies as determined by the test procedures in
Sec. 211.206. The product manufacturer must also provide the Noise
Reduction Ratings calculated according to the appropriate product as
specified in Sec. 211.207.
24. Section 211.210-2 is amended as follows:
a. Revise paragraphs (a)(1) and (a)(2).
b. Revise paragraph (b)(1).
c. Add and reserve paragraph (b)(2).
d. Revising paragraph (c).
e. Designate the undesignated paragraph at the end of the section
as paragraph (d).
Sec. 211.210-2 Labeling requirements.
(a)(1) A manufacturer responsible for labeling must satisfy the
requirements of this subpart for a category of hearing protectors, as
defined in Sec. 211.203, before distributing that category of hearing
protectors in commerce.
(2) A manufacturer may apply to the Administrator for an extension
of time to comply with the labeling requirements of this subpart for a
category of protectors that are currently being distributed in
commerce. The Administrator may grant the manufacturer an extension of
up to 60 days from the date of distribution. The manufacturer must
provide reasonable assurance that the protectors will equal or exceed
their currently labeled NRR range, and that testing and labeling
requirements of this subpart will be satisfied before the extension
expires. Requests for extension shall go to the Administrator, U.S.
Environmental Protection Agency, Washington, DC 20460. The
Administrator will respond to a request within ten (10) business days
from receipt of request. Responses may be either written or electronic.
* * * * *
(b) * * *
(1) Testing hearing protectors according to Sec. Sec. 211-204
through 211-206. The hearing protectors must have been assembled by the
manufacturer's normal production process and must have been intended
for distribution in commerce.
(2) [Reserved]
(c) Each category of hearing protectors is determined by one or a
combination of the following parameters. Manufacturers may use
additional parameters as needed to create and identify additional
categories of protectors.
(1) Ear muffs.
(i) Head band tension (spring constant);
(ii) Ear cup volume or shape;
(iii) Mounting of ear cup on head band;
(iv) Ear cushion;
(v) Material composition.
(2) Ear plugs.
(i) Shape;
(ii) Size;
(iii) Material composition.
(3) Custom ear plugs.
(i) Manufacturing Method;
(ii) Acoustic Filter(s);
(iii) Material composition.
(4) Semi-insert Devices.
(i) Hand band tension (spring constant);
(ii) Mounding on pod or tip on head band;
(iii) Shape;
[[Page 39195]]
(iv) Size;
(v) Material composition.
(5) Active Noise Reduction Devices.
(i) Protector Style;
(A) Ear plug;
(B) Ear muff.
(ii) Circuitry;
(A) Feed-forward control circuit;
(B) Feed-back control circuit;
(6) Amplitude-Sensitive Devices.
(i) Active design;
(A) Level-limiting;
(B) Compression circuit;
(C) Peak-clipping.
(ii) Passive design.
(A) Nonlinear resistive orifice.
(B) Physical control valve.
(iii) Protector Style.
(A) Ear plug.
(B) Ear muff.
* * * * *
Sec. 211.211 [Removed and Reserved]
25. Section 211.211 is removed and reserved.
26. Section 211.211-1 is added to read as follows:
Sec. 211.211-1 Compliance with labeling requirements.
(a) All hearing protection devices manufactured after the effective
date of this regulation, and meeting the applicability requirements of
Sec. 211.201, must be labeled according to this subpart, and must
comply with the range of Noise Reduction Ratings as determined by the
appropriate test procedure as specified in Sec. 211.204 through
211.206 of this subpart.
(b) A manufacturer must take into account both product variability
and test-to-test variability when labeling his devices in order to meet
the requirements of paragraph (a) of this section. A specific category
is considered when the attenuation value at the tested one-third octave
band is equal to or greater than the Labeled Value, or mean attenuation
value, stated in the supporting information required by Sec. 211.204-
4, for that tested frequency. The attenuation value must be determined
according to the test procedures of Sec. 211.206. The range of Noise
Reduction Ratings for the label must be calculated using the mean
attenuation that will be included in the supporting information
required by Sec. 211.204-4.
27. Section 211.211-2 is added to read as follows:
Sec. 211.211-2 Transition testing and labeling requirements.
All hearing protection devices manufactured on or after the
effective date of this subpart, and meeting the applicability
requirements of Sec. 211.201, must be tested with the appropriate
procedure specified in Sec. 211.206 and labeled as specified in Sec.
211.204. Manufacturers shall complete testing and labeling of all
categories within thirty (30) months from the effective date of subpart
B.
28. Section 211.211-3 is added to read as follows:
Sec. 211.211-3 Recurrent testing requirements.
All hearing protection devices manufactured after the effective
date of this subpart, and meeting the applicability requirements of
Sec. 211.201, must be retested periodically, following their initial
transition testing and labeling pursuant to Sec. 211.210-2.
Manufacturers shall retest their products every five (5) years
commencing from the date of a categories transition test.
29. Section 211.211-4 is added to read as follows:
Sec. 211.211-4 Product change retesting requirement.
(a) Any product that meets the applicability requirements of Sec.
211.201, must be retested prior to entry into commerce if the
manufacturer alters the product design, product materials,
manufacturing process or takes any action that may alter the noise
reduction performance of the product from its previous test state. In
the event the NRR values (lesser and/or greater) are a minimum of 3 dB
less than the current labeled NRR values, the manufacturer must relabel
as specified in Sec. 211.211-3.
(b) The recurrent testing of such product shall commence in
accordance with the appropriate schedule in Sec. 211.211-3.
30. Section 211.212-1 is amended as follows:
a. Revise paragraph (a).
b. Revise paragraph (b).
c. Revise paragraphs (e)(2) and (e)(3).
d. Revise paragraph (f).
Sec. 211.212-1 Test request.
(a) The Administrator will request all compliance audit testing
under this section by means of a written request addressed to the
manufacturer listed on the product label. The test request will be
signed by the Assistant Administrator for Enforcement or his designee.
(b) The test request will be delivered by an EPA Enforcement
Officer or sent by certified mail to the plant manager or other
responsible official as designated by the listed manufacturer.
* * * * *
(e) * * *
(2) The manufacturer must complete the required testing within ten
(10) business days following commencement of the testing.
(3) The manufacturer will be allowed five (5) business days to send
test hearing protectors from the assembly plant to the testing
facility. The Administrator may approve more time based upon a request
by the manufacturer. The request must be accompanied by a satisfactory
justification.
(f) Failure to comply with any of the requirements of this section
will not be considered a violation of these regulations if conditions
and circumstances outside the control of the manufacturer render it
impossible for him to comply.
* * * * *
31. Section 211.212-5 is amended by revising paragraph (a)(1) and
removing paragraph (c).
The revision reads as follows:
Sec. 211.212-5 Reporting test results.
(a)(1) The manufacturer must submit in electronic format within
five (5) business days of completion of testing, to the Administrator
or his designated enforcement representative, a copy of the Compliance
Audit Test report for all testing conducted under Sec. 211.212. A
suggested compliance audit test report form is included as Appendix B
of this part.
* * * * *
32. Section 211.212-6 is amended by revising paragraph (a)(2) to
read as follows:
Sec. 211.212-6 Determination of compliance.
(a) * * *
(2) The Noise Reduction Rating values (lesser and/or greater), as
determined by Compliance Audit Test, are equal to or greater than the
Noise Reduction Rating values as stated on the label required by Sec.
211.204.
* * * * *
33. Section 211.213 is revised to read as follows:
Sec. 211.213 Incorporation by Reference.
The American National Standards Institute/Acoustical Society of
America standards are incorporated by reference into subpart B with the
approval of the Director of the Federal Register under 5 U.S.C. 552(a)
and 1 CFR part 51. The materials are incorporated as they exist on the
date of approval, and notice of any change in these materials will be
published in the Federal Register. They are available for inspection at
the HQ Air Docket Center, EPA/DC, EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC, and at the
[[Page 39196]]
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.go/federal_register/code_of_federal_regulations/ibr_locations.html.
(a) The following materials are available for purchase from:
Acoustical Society of America, Standards Secretariat, 35 Pinelawn Road,
Suite 114E, Melville, New York 11747. Phone: (631) 390-0215; e-mail:
[email protected]; and Web: http://asastore.aip.org.
(1) ANSI/ASA S12.6-2008, ``Methods for Measuring the Real-Ear
Attenuation of Hearing Protectors,'' incorporated by reference (IBR)
approved for Sec. 211.206-1(b)(1), (b)(2), (b)(3), (b)(4), (b)(5),
(b)(6)(i)(A)(B)(C)(D)(E)(F), (6)(ii), (6)(iii), (7)(i), (7)(ii),
(8)(i)(A)(B), (8)(ii)(A)(B)(C)(D)(E)(F)(G)(H), (8)(iii)(A)(B), and (9).
(2) ANSI S12.42-1995 (R2002), ``Microphone-in-Real-Ear and Acoustic
Test Fixture Methods for the Measurement of Insertion Loss of
Circumaural Hearing Protection Devices,'' IBR approved for Sec. Sec.
211.206-2(a), (c)(1), (c)(2), (d)(1), (d)(2), (e)(1), (e)(2), (e)(3),
(g)(2), and 211.206-3(c)(1)(i).
(3) ANSI/ASA S12.68-2007, ``Methods of Estimating Effective A-
weighted Sound Pressure Levels When Hearing Protectors are Worn,'' IBR
approved for Sec. 211.206-2(l)(3) and Sec. Sec. 211.207-1(a), and
211.207-2(a), (b), and 211.207-3(a)(b).
(4) ANSI S1.11-2004, ``Specification for Octave-Band and
Fractional-Octave-Band Analog and Digital Filters'' incorporated by
reference (IBR) approved for Sec. 211.206-1(b)(4).
(b) The following material is available for purchase from: American
National Standards Institute, Customer Service Department, 25 W. 43rd
Street, 4th Floor, New York, New York 10036. Phone: (212) 642-4980; e-
mail: [email protected]; and web: http://webstore.ansi.org.
(1) International Electrotechnical Commission (IEC) standard 60711,
Occluded-ear simulator for the measurement of earphones coupled to the
ear by ear inserts,'' incorporated by reference (IBR) approved for
Sec. Sec. 211.206-1(k)(1)(ii) and 211.206-1(c)(1)(iii).
(2) [Reserved]
Appendix A to Part 211 [Redesignated as Appendix B to Part 211]
34. Appendix A is redesignated as Appendix B to Part 211 and a new
Appendix A is added to read as follows:
Appendix A to Part 211--Reporting Requirements--Attenuation Test
Results and Label Verification
1. Date of Report.
2. Manufacturer's Name.
3. Manufacturer's Address.
4. Name of original equipment manufacturer (OEM), if different
from above.
5. OEM address if different from above.
6. Name and position of responsible individual for manufacturer.
7. Product country of origin if other than U.S.
8. Product Name.
9. Product Model.
10. Date of Manufacture.
11. Date of last test.
12. Name of Testing Laboratory.
This coversheet must be accompanied by the authorized
attenuation test measurements and calculated NRR values obtained
from the testing laboratory for each product of product category.
[FR Doc. E9-18003 Filed 8-4-09; 8:45 am]
BILLING CODE 6560-50-P