United States
Environmental Protection
Agency
Office of
Noise Abatement Control
Washington, D.C. 20460
EPA 550/9-79-256
August 1979
NOISE
Regulatory Analysis
Supporting the
Noise Labeling
Requirements for
Hearing Protectors
-------
EPA 550/9-79-256
PRODUCT NOISE
LABELING REQUIREMENTS
REGULATORY ANALYSIS
SUPPORTING THE
LABELING OF HEARING PROTECTORS
August, 1979
U.S. Environmental Protection Agency
Office of Noise Abatement and Control
Washington, D.C. 20460
-------
FOREWORD
This Regulatory Analysis has been prepared by the Environmental Protec-
tion Agency in support of Noise Labeling Requirements for Hearing Protectors.
The regulation is promulgated under the authority of sections 8, 10, 11 and
13 of the Noise Control Act of 1972.
-------
CONTENTS
Page
INTRODUCTION 1
PART I. The Development of the Noise Labeling of Hearing
Protectors 13
Section I. DESCRIPTION OF HEARING PROTECTIVE DEVICES
AND THEIR PERFORMANCE CHARACTERISTICS 15
1.1 Description of Available Devices 15
Ear Insert Devices 15
Ear Cap Devices 17
Ear Muff Devices 18
Combination Devices 19
1.2 Factors Affecting Selection of Hearing
Attenuation Capability 21
Use Requirements/Environment 21
Fitability 22
Comfort 23
Biological Compatibility 24
Durability-Useful Life 24
Summary of Advantages and Disadvantages ... 25
1.3 Attenuation/Effectiveness of Devices 27
Factors Affecting Attenuation 27
Techniques of Evaluating Attenuation 31
Standardization of Attenuation Measurements . 35
Current State-of-the-Art of Hearing Protector
Attenuation 38
Simplified Methods of Expressing Hearing
Protector Performance 39
Section II. THE HEARING PROTECTOR INDUSTRY 45
Economic Effect of Labeling 47
First Year Costs 50
Annual Costs 53
Summary 55
REFERENCES FOR INTRODUCTION AND PART I 58
SELECTED BIBLIOGRAPHY FOR PART I 59
-------
CONTENTS (Cont'd)
Part II. Docket Analysis 61
INTRODUCTION 63
Section 1. GENERAL ISSUES 65
1.1 Statutory Authority 65
1.2 Interagency Coordination 69
1.3 Audience Addressed 70
1.4 Definition of Party Responsible for Compliance. . . 73
1.5 Need for a Public Education Campaign 75
1.6 Comments on Language in the NPRM 75
1.7 Exports and Imports 77
1.8 Miscellaneous Remarks 79
Section 2. LABEL CONTENT 83
2.1 Comparative Acoustic Information 85
2.2 Descriptor 87
2.3 Product and Manufacturer Identification 91
2.4 Date of Manufacture 92
2.5 Logo 93
2.6 Supporting and Additional Information 93
2.7 Alternative Media 97
Section 3. SPECIAL CLAIMS AND EXCEPTIONS 99
3.1 Exceptions 99
3.2 Exemptions 102
Section 4. LABEL PLACEMENT, SIZE REQUIREMENTS AND RELATED
CONCERNS 105
4.1 Placement and Type of the Label 105
4.2 Industrial vs. Retail Market 107
4.3 Size of the Label 108
4.4 Character Type and Color 109
Section 5. RATING SCHEME AND TEST METHODOLOGY 112
5.1 The Noise Reduction Rating (NRR) 113
5.2 Selected Standard 119
5.3 Laboratory Facilities 124
IV
-------
CONTENTS (Cont'd)
Section 6. ENFORCEMENT,
6.1 Label Verification
6.2 Compliance Audit Testing
6.3 Reporting Requirements
6.4 Remedial Orders and Product Recall
6.5 Effective Date of Regulation. . .
Section 7. ECONOMIC EFFECT.
7.1 Costs of Testing
7.2 Administrative Costs
7.3 Label Size Requirements: Costs . .
7.4 Effective Date and Associated Costs
129
129
131
133
135
137
139
139
141
143
144
APPENDICES
Appendix A.
Appendix B,
Appendix C.
Appendix D.
DEFINITION OF ISSUES FROM EACH DOCKET ENTRY
Hearing Protector Docket #77-5 A-l
Relevant Comments: General Provisions Docket #77-8 . . A-34
Oral Testimony A-40
Docket Summary for Public Meeting A-41
INDEX OF WRITTEN DOCKET SUBMISSION AND PUBLIC
HEARING TESTIMONY
Index of Written Docket Submissions B-l
Index of Relevant Submissions from Docket #77-8 . ... B-5
Index of Oral Comments Delivered at 13 December
1977 Public Meeting B-6
Public Meeting Attendees B-7
ABBREVIATED LIST OF PARTIES CONTACTED
THROUGH PUBLIC PARTICIPATION PROGRAM.
MANUFACTURERS AND DISTRIBUTORS OF
HEARING PROTECTORS
C-l
D-l
-------
CONTENTS (Cont'd)
TABLES
1.1 State of the Art of Hearing Protector Attenuation
vs. Frequency 38
1.2 Computation of the Noise Reduction Rating 43
1.3 Number of Protector Models 51
1.4 Cost of Preparation of Labeling Verification
Reports 52
1.5 Total Annual Administrative Costs 54
1.6 Total Industry Costs 55
FIGURES
1.1 Noise Paths to the Inner Ear 28
1.2 Practical Protection Limits for Plugs and Muffs. ... 29
2.1 Revised Label 84
VI
-------
INTRODUCTION
In the Noise Control Act of 1972 (86 Stat. 1234) Congress declares that
"it is the policy of the United States to promote an environment for all
Americans free from noise that jeopardizes their health or welfare." Con-
gress further declares that one purpose of this Act is "to provide informa-
tion to the public respecting the noise emission and noise reduction charac-
teristics of products (distributed in commerce)."
Section 8 of the Act (Labeling) requires that the Administrator of the
Environmental Protection Agency shall by regulation designate any product
or class of product "which emits 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." Further, the Administrator must
require by regulation that "notice be given to the prospective user (of a
product) of the level of the noise the product emits, or of its effective-
ness in reducing noise, as the case may be." The regulation must specify:
"...whether such notice should be affixed to the product or to the outside
of its container, or to both, at the time of its sale to the ultimate pur-
chaser or whether such notice shall be given to the prospective user in some
other manner,"; "the form of the notice"; and "the method and units of mea-
surement to be used (in the notice)."
The Agency has as its basic objectives in the development and the
implementation of Federal noise labeling requirements for specific products
under Section 8 of the Noise Control Act, the following elements:
1. To provide accurate and understandable information to prospective
users of products regarding the acoustic properties of designated
-------
products so that meaningful comparisons with respect to noise
emission or noise reduction can be made as part of a product
purchase or use decision.
2. To provide accurate and understandable information to prospective
users with minimal Federal involvement. Minimal Federal involve-
ment is to be achieved by ensuring that the Federally-imposed
labeling requirements are carefully analyzed and structured so as
to reduce the administrative, economic and technical impacts of
the Federal program as much as possible.
Therefore, under the authority of and as required by Section 8 of the
Noise Control Act of 1972, on December 5, 1974, the Agency published an
Advanced Notice of Proposal Rulemaking (ANPRM) (39 FR 42380) [1] which stated
that, in the first rulemaking under Section 8, the Agency intended to desig-
nate hearing protective devices as products sold wholly or in part on the
basis of their effectiveness in reducing noise, and to require them to be
labeled according to their noise reducing capability.
RATIONALE
The Agency initiated this regulatory development action because of the
recognized usefulness of hearing protectors in certain noise environments.
Every noise environment contains three basic characterisitics: a noise
source, a path along which the noise travels, and a receiver of the noise.
Typically, control of noise which adversely affects people is limited to
reducing noise at its source, controlling its paths of propagation, or
limiting --at the ear—the noise entering the ear.
In many instances, these controls of noise at the source or along the
propagation path are either lacking or are inadequate to reduce the level of
the noise sufficiently to protect the hearing of someone exposed to the
noise.
2
-------
In these situations, the use of hearing protectors may be the only practical
means of noise control on a short-term basis.
Hearing protectors are principally sold on the basis of their ability
to attenuate the level of sound entering a person's ear. The amount of sound
attenuation provided by the broad range of insert and muff type protectors,
currently on the market varies widely. There are devices designed primarily
to prevent water from entering a swimmer's ears that are frequently misused
as hearing protectors. There are devices that can be purchased merely to
reduce annoying sounds in a person's environment to levels that may permit
sleep, study or relaxation. While these devices may afford a measure of
sound reduction, their effectiveness in high noise environments may be
marginal. Users of devices which give insufficient hearing protection for a
particular noise environment can sustain permanent hearing loss because of
exposure to levels of noise from which they believe they are protected.
For a prospective user of hearing protective devices to make an informed
choice of a protector that will provide adequate protection in a particular
noise environment, that person must be able to determine the level of hearing
protection offeree* by a given hearing protector, and its effeciveness
relative to other protectors. This information is not now available to an
ultimate purchaser or a prospective user in a easily understood and readily
visible manner.
While manufacturers have measured the effectiveness of their products,
they in general do not convey this information to prospective users. Those
few that do, do not relay effectiveness information in a uniform manner for
similar categories of protectors; nor is comarative range information avail-
able upon which protector selections adequate for a users need can be made.
-------
The Agency's intent in initiating the development of a regulation
concerning the labeling of hearing protectors, was to provide information
to prospective users on the noise reducing effectiveness of these products
at the point of sale or at the point of distribution (e.g., industrial users).
This information will provide the basis for selection of a protector best
suited to the user's needs.
To fulfill the Agency's own objectives of providing accurate and under-
standable information, and that any labeling requirements be carefully
analyzed and structured so as to reduce administrative, economic and tech-
nical impacts as much as possible, the Agency established a public comment
period for 60 days, and solictied information relative to all aspects associ-
ated with the labeling of hearing protectors, specifically:
1. Information on the different types, makes and model of hearing
protectors being sold, their packaging, manufacturing costs, and
wholesale prices;
2. What information is now being provided to purchasers regarding the
effectiveness of hearing protectors, and the manner and techniques
used to to relay that information;
3. Discussions of recommended methods for classifying hearing
protectors and other parameters which could be used as descriptors
in a classification scheme;
4. The test procedures currently in use or under development to deter-
mine noise attenuation capabilities of hearing protectors, and the
test procedures which could be used;
5. Information on the shelf life and use life of hearing protectors;
6. Hazards asssociated with the improper use of hearing protectors, or
-------
devices or products inappropriately used as hearing protectors;
7. Information and suggestions in the form a label for hearing
protectors should take, and what information should appear on the
label in order to meaningfully convey the noise attenuation
capability of the hearing protector to the prospective user; and
8. Information regarding the number of hearing protectors produced
for distribution per year in the United States, the number of
hearng protectors imported for distribution in commerce, the
number of manufacturers or importers involved in the total market,
and relative market shares.
We received a total of 9 written comments to the ANPRM docket from: the
hearing protector industry and trade associations; laboratories involved in
acoustic testing; and government agencies that use protectors or specify pro-
tector effectiveness, construction, composition or packaging requirements.
These commenters recommended measurement standards, label placement and
content, questioned the validity of single number rating schemes, and sub-
mitted examples of various protector characteristics and packaging.
Because of the limited data received from comments to the ANPRM, the
Agency sent letters to selected manufacturers of hearing protectors in an
effort to obtain information on manufacturing costs, manufacturing processes,
marketing processes, extent of the market, numbers and types of protectors
manufactured, and each manufacturer's share of the market to adequately
assess the effects of a labeling requirement on the industry and the public.
-------
LABELING APPROACH
The approach the Agency took in developing its Section 8 noise
labeling requirements was to study product labeling in general and then
labeling with respect to a product to noise-emitting or noise reducing
capabilities. Hearing protectors were then studied specifically. The
study of the aspects of product labeling in common use, and their appli-
cability to Agency regulatory requirements, led the Agency to conclude that
certain elements of labeling can be applied uniformly when regulating all
product classes. These common elements are format and content of the
label, label location, and basic regulatory enforcement procedures. These
"general provisions" were published as a Notice of Proposed Rulemaking (NPRM)
on June 22, 1977 in the Federal Register (42 FR 31722) [2].
By proposing the General Provisions for Product Noise Labeling, the
Agency intended to provide guidance to the general public, and to all poten-
tially affected parties, on the general nature and intent of the product
noise labeling program, and set forth the general approach the Agency would
follow when regulating specific products or classes of products. Product
manufacturers and suppliers potentially affected by noise labeling require-
ments would then have substantial lead-time to either formulate voluntary
labeling programs that would satisfy EPA's labeling requirements or to pre-
pare for possible Federal noise labeling regulatory action. The general
labeling requirements would apply to all noise-producing and noise-reducing
products, and would eliminate the need to re-propose many of the same regula-
tory requirements in each product-specific labeling action. Each regulation
specific to a product would clearly delineate any exceptions to the general
provisions, modifications of the general provisions or additional provisions
-------
necessary to adequately regulate a product. Thus, a complete Section 8
labeling action by the Agency would consist of those general provisions that
are applicable to a specific product and the product-specific regulation.
The NPRM proposed the Product Noise Labeling program as a new Part 211
of Title 40 of the Code of Federal Regulations (40 CFR) with the General
Provisions to be Subpart A.
The Agency, at the same time, published the Notice of Proposed Rulemak-
ing (NPRM) on the labeling requirements for hearing protectors (42 FR 31730)
[3], which would be included in 40 CFR Part 211 as Subpart B.
The NPRM on the labeling of hearing protectors proposed to require:
that all manufacturers of hearing protective devices label each device as to
its effectiveness in reducing noise entering the ear; a uniform test method-
ology for determining the noise reducing effectiveness of hearing protectors;
and a uniform scheme - the Noise Reduction Rating (NRR) - for rating the
effectiveness of all hearing protectors. The NPRM also proposed to require
that noise attenuating information, statements on fit, and a cautionary note
supporting the label NRR be included in the protector packaging. It
presented the detailed enforcement procedures that would be used by the
Agency to assure manufacturers' compliance with the labeling requirements,
and the conditions under which special claims or exceptions could be
requested.
PUBLIC PARTICIPATION;
At the time of publication of the proposal, EPA solicited written public
comment by means of direct mailings of information about the regulation to
manufacturers, trade associations, other Federal Agencies, State and local
governments, test laboratories, educational institutions, users of hearing
protectors, and others.
7
-------
The information provided was in the form of fact sheets, copies of
the proposed regulation, and press releases generally dexcribing the pro-
posal.
A public comment period on the NPRM extended from June 22, 1977 to
September 22, 1977; public hearings were defered pending public response.
During this period, the Agency received 52 written comments. It also
received 3 oral and 7 written comments pertaining to hearing protectors
which had been directed to the concurrently established public comment
period for the proposed General Provisions (Subpart A) for Product Noise
Labeling (40 CFR Part 211).
The Agency decided that a public meeting was in the best public interest
in order to fully understand problems the hearing protector industry
expressed in their written comments, and to better clarify certain elements
of the proposed rule.
The public meeting was announced in the Federal Register on December
2, 1977 (42 FR 61289) and held on December 13, 1977, at the Office of Noise
Abatement and Control in Arlington, Virginia. Attendees included manufac-
turers, the industry trade association, several members of the user industry,
and Federal representatives. Oral comments were received from 10 speakers.
A transcript of the proceedings of this meeting along with the listing of
attendees has been made available at EPA's office of Public Information,
401 M Street, SW, Washington, DC 20460.
Comments from private citizens and industrial users for the most part
supported the labeling of hearing protectors as to their noise reducing
effectiveness. Comments from manufacturers and related groups were critical
of certain elements of the program, but were not generally opposed to
placing an effectiveness rating on their hearing protectors.
8
-------
The Agency carefully reviewed and considered all information received
from the manufacturing industry and related organizations, the user indus-
tries, government organizations, and the general public on the potential
impact a Federal labeling requirement might engender on the cost of hearing
protectors on manufacturers' production processes and on their packaging
procedures. The Agency reassessed the designated test methodology, avail-
ability of test facilities, enforcement procedures, and labelng responsibil-
ities and made various changes and clarifications in response to the public
comments.
The Agency published the final rule, Noise Labeling Requirements for
Hearing Protectors, in Volume 44 of the Federal Register, in August of 1979.
To provide adequate notice to the public on the provisions of the final
rule, the Agency developed explanatory material in the form of letters of
introduction, fact sheets, questions and answers, press releases, a "Back-
grounder" and reprints of the Federal Register. These items were mailed to
manufactures, distributers, retailers, consumer groups, unions, trade associ-
ations, educational institutions, import/export interests, State and local
governments, newspapers and consumer oriented media, and any other interested
parties the Agency was able to identify. An abbreviated list of parties
contacted is included in Appendix C of this document.
-------
OUTLINE AND SUMMARY OF THE REGULATORY ANALYSIS
This regulatory analysis presents the results of studies carried
out by the United States Environmental Protection Agency during its develop-
ment of a proposed regulation requiring the labeling of all hearing pro-
tectors with respect to their effectiveness in reducing the level of noise
entering a user's ear.
This document also contains a detailed descussion of all comments the
Agency received during the Public Comment Period and the basis for resol-
ution of all issues raised.
This analysis is divided into two parts:
PART I. The Development of the Noise Labeling of Hearing Protectors.
Section 1. Includes a description of hearing protective
devices, performance characteristics of these
devices, and a review of testing methodologies
for measuring attenuation characteristics of
hearing protectors.
Section 2. Includes an overview of the hearing protector
industry, and the estimated economic affects
associated with the labeling of hearing pro-
protectors.
PART II. Docket Analysis
The docket is the record of the comments received from all
interested parties concerning the proposed regulation on the labeling of hear-
ing protectors. Respondents are identified in the analysis by a docket number
assigned to their entry when received into the docket. The primary function
10
-------
of the Docket Analysis is to present the public's view and comments relative
to this rulemaking action and the Agency's reponse to all comments and issues
raised.
Section 1. Addresses issues concerning the Agency's statutory
authority, and other general issues concerning the
labeling of hearing protectors.
Section 2. Addresses issues that concern the information the
label will contain.
Section 3. Addresses exceptions to the labeling requirement.
Section 4. Addresses placement and size of the label, and
related concerns.
Section 5. Addresses the effectiveness rating, test metho-
dology, and laboratory facilities.
Section 6. Addresses issues pertaining to enforcement proce-
dures.
Section 7. Addresses issues related to an economic analysis
of noise labeling of hearing protectors.
Appendix A. Presents the definition of issues from each docket
entry, both written comments and oral testimony.
Appendix B. Is an index of all docket submissions, written and
oral, which allows one to identify the sources of
comments not specifically mentioned in the text.
Appendix C. Is an abbreviated list of the parties contacted
through the Agency's public participation program.
Appendix D. Is a list of the manufacturers and distributors
of hearing protectors.
11
-------
PART I
THE DEVELOPMENT OF THE NOISE LABELING OF HEARING PROTECTORS
-------
SECTION I
DESCRIPTION OF HEARING PROTECTIVE DEVICES
AND THEIR PERFORMANCE CHARACTERISTICS
1.1 DESCRIPTION OF AVAILABLE DEVICES
A wide variety of devices that can fit in or over the ear, such as
cigarette filters, dimes, pencil erasers, and cigar butts, have been used
to keep noise from entering the ear. Cotton wadding inserted into the ear
was used widely during World War I. In the 1940's, cotton was found to be
ineffective and considerable attention was devoted to developing truly effec-
tive devices. The product of these early efforts was an earplug known as the
V51R.
Industrial and commercial hearing protectors presently available may be
classified as:
o ear insert devices;
o ear cap devices;
o ear muff devices; and
o combination devices.
EAR INSERT DEVICES
These devices are designed to fit into the ear canal. A variety of dif-
ferent types of insert devices have been developed. They may be conveniently
discussed as a) pre-molded, b) malleable, and c) custom molded.
a) Pre-Molded Inserts
These devices are molded of soft, flexible rubber or plastic compounds
into uniform shapes. They are often flanged and come in various sizes to
accommodate the wide range of ear canal geometry. Some of these inserts are
straight and symmetrical while others are shaped to conform more to curved
15
-------
ear canals. Most pre-molded devices are designed for substantial re-use and,
therefore, are washable. Some pre-molded devices are intended to be dis-
carded after limited use.
Pre-molded insert devices are relatively inexpensive. However, the
prices per pair can vary considerably between those devices purchased in bulk
quantities and those devices purchased as a single pair. Disposable insert
devices may cost 10 cents when purchased in bulk quantities from a distri-
butor, while a single pair of reusable devices may cost up to $7.00 if pur-
chased from a retail store. Often the carrying case or the display packaging
costs more than the device itself.
These devices, when properly cared for, are capable of providing hearing
protection for extended periods of time. The the useful life of the protector
is governed primarily by the materials used to make the device, which may
shrink, crack, or, with time, lose the resiliency needed to assure proper,
comfortable fit. Ear wax will cause some molded plugs to shrink and harden
after a period of time, because the wax tends to extract from the plug the
chemical constituents that keep it soft and pliable; this chemical reaction
varies from person to person. The typical life of a reusable device can be as
low as 5 to 6 weeks, but for most, it is about 6 months.
b) Malleable Inserts
These devices are, for the most part, intended to be disposable. Their
use may range from 1 to 3 days before replacement is necessary. They are
made from materials such as plastic foam, fine glass fibers, and wax-impreg-
nated cotton. Malleable inserts are not pre-sized, but rather are personally
molded to conform to each individual's ear canal. This is an advantage over
pre-molded devices. However, the limited useful life of this type of device
16
-------
develops into a cost drawback if the user intends to use them on a continuing
basis. The cost per pair ranges from 5 to 30 cents. Again, the price depends
upon the quantity purchased, bulk purchase being the most economical.
Since the material must be kneaded before it is inserted in the ear,
proper hygiene is required to prevent introducing dirt into the ear canal.
c) Custom Molded Inserts
Custom molded insert devices are permanently molded to the exact shape
of an individual's ear. The fitting process can be somewhat complex, but it
basically involves fitting the ear canal and outer ear with some pliable
material to obtain the exact shape of the ear. This shape is then hardened
to yield a permanent custom mold.
Typical materials used are plastic and silicone compounds. Hardeners
that are added to these compounds to retain their custom fit, make the
material remain pliable long enough for it to be inserted in the ear, make
the mold, and then set permanently. Setting may require a few minutes to a
full day.
With proper care custom molded devices may last from 2 to 3 years, and
cost from $3.00 to $30.00 depending upon the materials used, quantities
desired and the fabricator. These devices are generally more comfortable,
but are not necessarily more effective than other devices; the materials
occasionally contract while hardening, resulting in a slightly undersized
protector.
EAR CAP DEVICES
These devices consist of two ear caps, designed to contact the outer
edges of the ear canal. The caps are fastened to a headband that provides
17
-------
a compressive force on the caps to form a seal with the ear. Part of the
cap fits slightly into the ear canal and the remainder spreads around the
edge of the canal. They are generally molded from soft rubbery material and
fit a large range of ear sizes. The caps last about 12 months and may be
replaced for about $2.00 a pair. The initial cost of the device is from
$3.00 to $5.00. Ear caps are intended to bridge the gap between inserts and
ear muffs, having some of the advantages and disadvantages of each; for
example, they are more expensive but more consistently effective than
inserts, and are less expensive than ear muffs but do not fit as large a range
of ear sizes. They do not seem to be in widespread use at the present time.
EAR MUFF DEVICES
These devices fit over the entire outer ear as opposed to within the ear
canal. They consist of hard molded plastic cups held in place by a spring-
loaded headband. The cups surround and cover the ear completely, forming a
tight seal around the ear with a flexible vinyl sealing cushion filled with
air, liquid or foam. Foam fillings are the most commonly found. In addi-
tion, the cups are lined with an acoustically absorbent material, usually
foam sponge. The spring tension of the headband is critical in that it must
allow minimum sound leakage between the muff and the ear, while accomodating
varying head shapes. Many devices are designed to allow the headband to be
worn over, under and/or behind the head to suit different personal prefer-
ences and use situations.
All parts of the ear muff that contact the skin can be washed with soap
and water. The ear cups require periodic inspection for cracks or other
18
-------
damage. The ear seals are usually the first component to deteriorate, gen-
erally from perspiration. Most ear muffs have replaceable seals which can
extend their useful life indefinitely.
The price of ear muffs varies in the range of $5.00 to $15.00.
COMBINATION DEVICES
There are a number of noise environments in which the need to protect
hearing is only one of many important requirements. For example, the need
for concise communication, the use of hard hats, and the use of welder
shields would all require that, if hearing protective devices are to be
worn, the devices must be made compatible with work requirements and safety
precautions.
Any of the different types of hearing protective devices mentioned,
ear inserts, caps or muffs, may be suitable for various use circumstances;
however, special modifications and designs may be necessary to satisfy cer-
tain user needs. For example, ear muffs or inserts may be fitted with
communication gear; helmets may be designed with built-in ear muffs or in-
serts; or hardhats may have muffs fastened directly to them with variously
shaped headbands.
19
-------
1.2 FACTORS AFFECTING SELECTION OF HEARING PROTECTIVE DEVICES
Two significant factors to be considered in selecting the proper hearing
protective device for an in-use environment are the noise attenuating capa-
bility of the device and whether or not it will be worn. User acceptance to
wearing the device is paramount to its effectiveness in reducing noise; obvi-
ously, the protectors cannot reduce noise if they are not worn.
In a work environment employers often must seek employee acceptance to
wearing hearing protection, and then must further provide acceptable hearing
protectors.
In a situation where an individual is purchasing a protector for his or
her personal use, the need to wear hearing protection has already been
accepted, and only selection of the appropriate protector remains.
For the individual or the employer to be able to choose the correct pro-
tector(s) for specific situations, the factors of overall noise attenuation
capability and attenuation at specific frequencies are generally of primary
importance. Factors such as use requirements/environment, fitability,
comfort, care requirements, cost, biological compatibility, and durability
must also be considered. However, some of these factors are subjective, so it
is desirable to have a choice among hearing protective devices capable of
adequate attenuation, but also capable of suiting different individual wear-
ing preferences, or physiological constraints. These latter factors are not
within the scope of the Agency's labeling authorities and therefore have not
been considered in any detail in the studies presented here. They are,
however, presented for general information.
20
-------
ATTENUATION CAPABILITY
Since attenuation of noise is the purpose for which hearing protectors
are used, special care must be taken to ensure that the measured attenuation
is, in fact, indicative of that realized by the user. Virtually all tests of
attenuation capability are conducted under strictly controlled laboratory
conditions. Recently there has been concern that results obtained under
these laboratory conditions are not truly indicative of the attenuation
that is realized under in-use conditions. The National Institute for
Occupational Safety and Health (NIOSH) has developed a field test procedure
and conducted several field surveys to determine the difference between
laboratory and in-use attenuation measurements. Early results [4] show a
very poor correlation due, in part, to improper fit and user modifications.
Because of the importance of attenuation, it is treated separately in
detail in Section 1.3.
USE REQUIREMENTS/ENVIRONMENT
The ultimate effectiveness of a hearing protector is not only dictated
by its attenuation but also by the type of environmental conditions and use
patterns in which hearing protectors will be needed. Such items as tempera-
ture and humidity, intermittent or continuous use, the need for compatibility
with other personal safety devices, and workspace constraints play key roles.
For example, wax-impregnated cotton inserts may be unsuitable for high
temperature environments due to the softening or melting of the material;
ear muffs may be best for intermittent use where the individual must
go in and out of the noise environment frequently; ear muffs may not be
21
-------
suited to use with other equipment such as goggles or respirators; and
inserts may be desirable where use is anticipated in very close quarters,
such as might be required for machine repair and maintenance.
FITABILITY
Few devices, if any, will provide an optimum fit for everyone. However,
proper fit is essential to realize the full attenuation potential of a device.
Much of the developmental efforts for hearing protectors have been
directed to broadening the range of persons that a particular protector can
fit properly. An example is the V51R ear insert which was originally manu-
factured in small, medium and large sizes, but later broadened to include
extra-small and extra-large sizes to fit up to 95% of the population [4]. An
extra-extra-large size would be necessary to obtain fit for 98% of the popu-
lation. Another example is the triple-flanged insert, which was designed
to fit everyone by providing three progressively larger concentric flanges.
However, manufacture of three distinct sizes of this type of device was
necessary to provide adequate fit for the large range of ear canal sizes. A
final example is the expandable foam insert which is squeezed into a small
cylinder, inserted into the ear canal, and allowed to expand to the indi-
vidual shape of each canal. With this moldable device, reducing the original
diameter of the foam cylinder provided an even greater range of ear canal
fit.
In addition to initially providing a satisfactory fit, the hearing pro-
tective device must be able to maintain its fit during a variety of activi-
ties such as talking, chewing, and head movement. For inserted devices, this
requires adequate depth of penetration and pressure on the ear canal. For
devices employing muffs, flexible joints, proper ear cushions, and adequate
headband tension are needed.
22
-------
Fit is less of a problem for ear muff devices, but still requires
special consideration. First, the device must necessarily cover the entire
ear comfortable while allowing a minimum circumference for the cushion seal.
Next, there must be a loose joint between headband and earcup to accommodate
the range of skull curvatures encountered. Finally, the headband must be
adjustable to allow for different sized heads and ear location. This is ac-
complished either by an adjustable headband, a movable ear cup, or both.
COMFORT
The major cause of discomfort is pressure exerted either on the ear
canal by inserts or on the side of the head by muffs. However, pressure is
required to create and maintain the seal that reduces noise leaks and allows
the device to produce its intended attenuation. Thus, a major objective in
the design of protective devices is to obtain a good fit in the canal or
about the ear, while creating minimum discomfort for the wearer. This is
accomplished by using soft, pliable materials and through various other de-
sign features. For inserts, the important factor in maintaining the proper
fit of the protector in the ear is the sizing of the insert to the canal.
For ear muffs, the critical factors required for a good fit are the ear
cushion design and the pressure of the cushion against the head. Some in-
serts seal by assuming the shape of the ear canal while others use multiple
soft flanges. Ear muffs use foam, air-filled, or liquid-filled cushions to
comfortably seal the sound absorbing material with the contours of the head.
Another factor which can cause discomfort to the wearer is the weight of
the device, thus introducing another design constraint. Since attenuation is
related to the mass (or density) or materials used in constructing a device,
23
-------
a trade-off may be required between the attenuation capability of the device
and the comfort to the wearer.
BIOLOGICAL COMPATIBILITY
This factor is primarily a design consideration by the manufacturer.
Before certain materials are used in the construction of hearing protective
devices, tests are conducted to determine their compatibility with the chem-
istry of the human body. Some people can be particularly sensitive to
certain materials used in protectors. In such cases irritation may result,
making continued use of the protector difficult.
An inserted protector may tend to push ear wax inward toward the ear
drum, causing a poor acoustic seal in addition to discomfort.
The tragus, which is the projection found in front of the external ear,
in many individuals extends backwards over the ear canal opening, and may
prevent the insertion of an insert device to its intended depth. The tragus
may produce unequal pressure against the protective device, forcing the de-
vice backward and outward, thus displacing it enough to cause an acoustic
leak which will reduce the potential noise reducing effectiveness of the
device.
DURABILITY-USEFUL LIFE
The ability of a device to maintain its noise reducing effectiveness
for a satisfactory period of time is an important consideration in terms of
economical and effective hearing protection. How long will a device provide
the rated attenuation? How long will it remain comfortable and maintain the
proper fit? How long will it reamin hygienically acceptable? Devices age
and deteriorate to varying degrees over varying spans of time. There is a
lack of specific information regarding the real useful life of hearing
24
-------
protective devices. The useful life depends in large part upon the materials
of which the device is made, environment in which it is used, and the care a
person gives the device. Manufacturers can give general guidance, but it is
necessary for the user to be sensitive to the physical changes that can occur
in hearing protectors.
The National Institute for Occupational Safety and Health is field
testing, for evaluation purposes, the practical hearing protection provided
by various devices in actual use. Such testing permits evaluation of the
actual attenuation provided by the devices (for comparison with stated
attenuation values), and may, with time and repeated testing, develop some
data on durability.
SUMMARY OF ADVANTAGES AND DISADVANTAGES
Some of the advantages and disadvantages of the currently available
hearing protectors are summarized as follows:
Insert Type Devices
Advantages:
o small and easily carried;
o can be worn conveniently and effectively with other personally worn
safety items;
o relatively comfortable to wear in hot environments;
o convenient for use where the head must be maneuvered in close
quarters;
o the cost of pre-molded inserts is significantly less than that of
all other protective devices; although inserts such as custom-molded
devices may be comparable in price to other types of protectors such
as muffs or ear caps.
Disadvantages:
o inserts require more time and skill to properly fit them than do muffs;
25
-------
o the amount of attenuation provided at different frequencies by different
plugs is more variable;
o proper hygiene is more difficult to maintain when devices must be
removed and re-inserted;
o inserts can be worn only in healthy ear canals.
Muff Type Devices
Advantages:
o attenuation at different frequencies by different products is less
variable;
o one size muff accommodates a large range of head sizes and shapes;
o muffs are more convenient when use is intermittent;
o muffs can be worn in spite of minor ear infections;
o muffs are not lost as easily as inserts.
Disadvantages:
o muffs can be uncomfortable in hot and/or humid environments;
o muffs are not easily carried or stored;
o muffs are not as compatible with other personally worn safety items;
o headband spring force may diminish with use, and reduce the protec-
tion provided;
o length of hair around the ear and use with eye glasses can diminish
effectiveness.
o muffs may be awkward when used in close quarters;
o muffs are more expensive than most insert devices.
Ear Cap Devices
These devices seal the outer edge of the ear canal, and are the middle
ground between inserts and muffs. As such, they have many of the disadvant-
ages and advantages of each. They do not seem to be in widespread use at
this time.
26
-------
1.3 ATTENUATION/EFFECTIVENESS OF DEVICES
FACTORS AFFECTING ATTENUATION
Hearing protective devices are used, on a short-term basis, to reduce
the level of noise entering the ear. Therefore the ability to attenuate
noise is a major consideration in the selection of a device. Other factors
pertinent to the selection of a protector for use in a specific environment
may be balanced one against the other, but of primary concern is the amount
of hearing protection required and the ability of a device to provide the
necessary attenuation.
Noise may reach the inner ears of persons wearing protectors by four
different paths: (1) transmission through bone and tissue, thus by-passing
the protector; (2) vibration of the protector which, in turn, transmits a
sound into the external ear canal rather than blocking it; (3) passing
through air leaks in the protector; and (4) passing through noise leaks
around the protector. These paths are illustrated in Figure 1.1 [5].
If the device permits no noise leaks through or around it, some noise
will reach the inner ear by the first two paths if the noise levels are suf-
ficiently high. The practical limits set by the bone and tissue conduction
threshold, and the vibration of the protector itself, vary considerably with
the design of the device and the individual 's physical structure. However,
approximate limits of attenuation for inserts and muffs have been determined
and are illustrated in Figure 1.2 [6],
In order to approach these limits, the hearing protector must minimize
loss of attenuation due to noise leaks. The following design criteria are
useful in accomplishing this goal:
27
-------
Cartilage and Flesh
ro
00
Bone and
Tissue Conduction
(c) Schematic Representation
Figure 1.1. Noise Paths to the Inner Ear
-------
CD
T3
O
«
1
10
Limitation Set By
Earplug Vibration
Range of Bone and
Tissue Conduction
Limitation Set By
Earmuff Vibration
50
60
70
1000
Frequency in Cycles Per Second
10000
Figure 1.2. Practical Protection Limits for Plugs and Muffs
29
-------
1. Hearing protectors are generally made of dense material. If it
is possible for air to pass through a material, noise will also.
2. Protectors are designed to conform readily to the head or to the
ear canal configuration so that an efficient acoustic seal can
be achieved, and the device can be worn with reasonable comfort.
3. Protectors generally have a means of support on or about the head
or within the ear, or a means of completing the acoustic seal that
will minimize protector vibration.
It is interesting to note the relationship between the tradeoffs made by
manufacturers of protectors after considering those factors that affect the
selection of protectors, and those criteria that affect the design of hearing
protectors and the attenuation to be achieved from certain designs; and how
those design criteria have been applied to the current generation of hearing
protective devices.
Ear muffs use a stiff plastic cup containing sound absorbing material
to reduce the transmission of sound. The greater the mass (hence weight) of
this cup, the greater is the attenuation available. Weight is a comfort
factor, and, therefore, a potential design tradeoff for weight arises between
the noise attenuation capability of the device, and the comfort for the
wearer.
In a similar example, muff-type devices use headbands as a means of at-
tachment to the head. The greater the pressure that the headband exerts on
the head, the better is the seal of the muff with the head. This force is a
comfort factor and selection of optimal headband force entails a potential
design tradeoff between providing an effective acoustic seal between the muff
and the head and minimizing the discomfort for the wearer. The need to ac-
commodate a wide range of head sizes frequently leads to the use of a loose
30
-------
joint where the ear cup meets the headband. This permits alterable headband
tension in order to obtain a satisfactory seal with various head shapes.
Therefore, there is a design tradeoff between the fitting of relatively few
heads perfectly or fitting relatively more heads less perfectly. A suitable
material is needed for the ear cup cushions in order to achieve durability,
comfort, cleansibility and a good airtight seal. These qualities cannot be
expected to be optimized in any one material, consequently there is further
potential for tradeoff. The ear cup volume necessary for good low frequency
attenuation is balanced against the size limitations of the device so that
comfort and maneuverability can be maintained.
The criteria necessary in the design of ear insert devices that perform
well in terms of attenuation of noise are balanced against those factors that
affect the selection of those devices.
Comfort for the wearer and fit of the device in the ear canal are criti-
cal for inserts. A plug must be soft and pliable for comfort and proper fit,
yet firm and dense for good noise attenuation. A protector may be designed
of relatively low density material and yet provide good noise attenuation by
fitting very tightly in the ear. A tight fit is necessary to avoid vibration
of the device and subsequent transmission of the noise by the device itself.
Therefore, by selecting this type of protector, a comfortable fit may be
sacrificed.
TECHNIQUES OF EVALUATING ATTENUATION
A variety of different methods have been tested over the years in an
effort to yield meaningful information regarding the attenuation capability
of hearing protectors. These techniques may be classified as either subjec-
tive or physical (objective). Subjective methods measure a test subject's
31
-------
psychoacoustical responses to noise(s) with and without a protector in place.
Physical (objective) methods are those which measure directly the sound pres-
sure level differences developed by a protector placed in the propagation path
of a known level of sound. A brief discussion of various methods reported in
the literature is presented below. In the "STANDARDIZATION OF ATTENUATION
MEASUREMENTS" subsection, close attention is given to the American National
Standards Institute standard Z24.22-1957 subjective method which has been
widely adopted at this time as the standard method for reporting the perform-
ance of most presently available devices.
Subjective Methods
One of the subjective (psychoacoustic) methods, used to evaluate the
attenuation potential of protectors, measures the differences in the level of
intensity at which the test subject just detects the presence or absence of
an audio signal. This is done with the subject's ears unprotected, and then
with the subject wearing the protector being tested. This is called the
Threshold Shift method. The threshold shift is determined for both ears
simultaneously, using pure tones in a free or nearly free sound field.
Narrow and broad band noise have also been used. However, broad band
stimuli have been given little attention due to the frequency-dependent
nature of attenuation.
A Japanese standard (JISB9904-1598) describes a threshold shift method
testing one ear at a time. It requires the subject to press the side of his
head against a foam-rubber bordered hole in a loudspeaker box in which the
stimulus is presented.
32
-------
A "masked threshold shift" method has also been used. A miniature
transducer is used as a sound source, inserted under an ear muff, and an
audio signal is presented to the subject. The intensity level at which the
subject is able to detect that signal is determined with high ambient noise
present. The same signal is again presented to the subject, but without high
ambient noise present. The intensity level at which the signal is detected
is determined. The difference in the intensity levels at which the signal
was detectable provided a measure of the amount of masking noise excluded by
the ear muff.
Another method called loudness balance has been used. The procedure
requires the subject to match the loudness of an auditory stimulus perceived
while wearing a hearing protector with the loudness of the same stimulus
after removing the protector. This method used pure tones in a free field
and half-octave band noise in a diffuse field.
The difference in sound pressure level necessary to elicit action of an
individual's acoustic reflex (involuntary contraction of muscles of the mid-
dle ear in response to acoustic or mechanical stimuli) with and without hear-
ing protectors, has been measured and used to indicate a threshold of hearing
shift. Conversely, the difference in temporary threshold shift (TTS) (that
elevation in the threshold of hearing which shows a progressive reduction
with the passage of time) observed with and without protectors in continuous
and impulsive noise environments has been used as an indicator of protector
performance.
Articulation or intelligibility testing in a quiet environment, with and
without hearing protectors, provides an indication of the degree of degrada-
tion of speech by protectors.
33
-------
The most subjective method is simply to allow an individual to sample
the noise reducing effectiveness of a variety of different devices, and to
choose the one judged best. Experiments of this nature have shown that
unless the attenuation capabilities of the protectors differ considerably,
effectiveness ranking by the subjects is not useful.
Physical Methods
Direct physical measurement of hearing protector attenuation is attrac-
tive because of the relative simplicity and objectivity of the test as com-
pared to subjective measures. Unfortunately, developing a test fixture which
accurately simulates the human ear and surrounding head structure, in terms
of acoustic response throughout the audible frequency range, is a difficult
task.
At present, a standard method for ear muff measurements exists using a
"dummy" head fixture. The method is intended to supplement a subjective test
for such purposes as product design and quality control.
A variety of experiments use different means, artificial ears and heads
among others, to determine the effectiveness of devices is reducing noise.
One system uses a small passive microphone (as opposed to the "masked thres-
hold shift" method which uses a transducer inserted under or through an ear
muff. This permits sound pressure level measurements at the ear opening as
the protector is worn by human subjects. The attenuation of the protector is
determined by comparing the sound pressure level exterior to the muff with
that at the interior microphone. This method has produced data agreeing
with subjective measurements at middle and high frequencies, but low fre-
quency results diverge by from 3 to 10 decibels. One problem with this
34
-------
method is the placement of the monitoring microphone. Displacements as small
as one millimeter can cause changes in the measured sound pressure level at
the interior microphone of six decibels or more at high frequencies.
STANDARDIZATION OF ATTENUATION MEASUREMENTS
The need for a standardized method for determining and reporting hearing
protector attenuation is apparent when the variety and sensitivity of these
measurements are considered.
The American National Standards Institute (ANSI) published the "American
Standard Method for the Measurement of the Real-Ear Attenuation of Ear Protec-
tors at Threshold" (ANSI STD Z24.22-1957). The subjective threshold shift
method was the only technique which, at that time - 1957 - received suf-
ficient unanimity of expert opinion to be standardized.
The Foreword to this standard states that the original intention was
to establish psychological and physical procedures for evaluating hearing
protectors, but that the scope was reduced to that of specifying procedures
for evaluating the real-ear attenuation of protectors on the basis of audi-
tory thresholds of human observers. The Foreword further states that the
standard-writing group was aware of the simplicity of purely physical me-
thods, but felt that comparison of human subjective results to the purely
physical methods was questionable. Lastly, the Foreword recommends the need
for continued efforts in the field, and recognizes the possibility that there
might need to be subsequent revisions to the standard.
The standard specifies that the hearing thresholds of at least ten
randomly selected, normal hearing subjects be measured with and without the
protector worn. This is to be done on no less than three separate occasions
35
-------
for each individual, at a minimum of nine pure-tone test frequencies (125,
250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 cycles per second (Hertz
(Hz)). The difference between the thresholds with and without protectors, at
each test frequency, is reported as the protector's attenuation characteris-
tics.
This standard, Z24.22-1957, has been used extensively in determining
and reporting the attenuation performance of hearing protectors.
The technical community determined that there are several problems with
this procedure. First, pure-tone signals are not characteristic of the
broad-band noises which are normally encountered in real-world noise environ-
ments. Second, the use of threshold-level test tones may not accurately
represent performance of protectors in high noise fields. Third, test
tones are introduced only from the front position. Attenuation has been
observed to vary up to ten decibels with the angle of incidence (the direc-
tion from which a sound wave approaches the ear). Finally, the time required
to perform this procedure is very lengthy and the test room requirements are
strict.
Recognizing the impact of these factors, the U.S. Department of Health,
Education and Welfare [7] supported research which was intended to serve as a
foundation for revisions to this standard. The most important conclusion of
this research was that ". . . . measurement of hearing protector noise atten-
uation by a threshold shift technique in a diffuse sound field using one-
third octave bands of noise as stimuli is a desirable technique and is amen-
able to attenuation standardization. This technique eliminates the problems
associated with pure tone stimuli and a fixed angle of incidence, and also
more closely approximates the noise exposure conditions in which hearing
protectors are usually worn."
36
-------
Based on research performed at the Pennsylvania State University,
supported by HEW, a revision was approved by the American National Standards
Institute in August, 1974 as ANSI STD S3.19-1974. It was also published by
the Acoustical Society of America in 1975 as ASA STD 1-1975. This revised
standard is titled the "Method for the Measurement of Real-Ear Protection of
Hearing Protectors and Physical Attenuation of Earmuffs." It is this stand-
ard that the Agency has adopted as the test method for measuring the noise
reducing effectiveness of hearing protectors.
The primary improvements over the previous standard are the use of a
diffuse sound field and one-third octave band test tones. The diffuse field
eliminates the influence that the angle of incidence has on the attenuation
developed by a protector, since diffuse sound impinges randomly from all
directions. The diffuse field also facilitates creation of the proper test
conditions since a free field is more difficult and costly to produce. The
use of one-third octave bands of noise is more realistic than the use of
pure tones, and enhances the reproducibility of the test results by reducing
the possible variations in protector response due to excitation of resonance
in the devices. In ANSI Z24.22-1957, small differences in the absolute fre-
quency of pure tones could cause disproportionately larger differences in the
measured attenuation between investigations.
In addition to these revisions to the subjective threshold methodology,
a supplemental physical test for ear muff devices is included in the stan-
dard. A "dummy head" covered with material that simulates human flesh is
specified as a means for obtaining attenuation measurements. However, as
stated in the Foreword to the standard, "the physical measurement method is
intended for production test and engineering design of ear muffs ... it is
not suitable for earplug testing."
37
-------
CURRENT STATE-OF-THE-ART OF HEARING PROTECTOR ATTENUATION
Most hearing protector manufacturers have determined the attenuation
capability of their devices according to ANSI Z24.22-1957, and report the
attenuation value at each discrete test frequency. Some manufacturers have
obtained data using the ANSI STD S3.19-1974 methodology, but do not report
it because the results generally indicate somewhat less attenuation than the
ANSI Z24.22-1957 test. Performance testing is usually conducted by an
independent testing laboratory to insure unbiased evaluations.
A report by the National Institute for Occupational Safety and Health,
HEW Publication No. (NIOSH) 76-120 [8], contains attenuation data compiled
for a wide variety of hearing protectors. NIOSH collected the data in
response to a letter survey of manufacturers. NIOSH does not claim that the
list of protectors is complete nor does it endorse the data submitted by the
manufacturers. The data includes the standard deviation of the measurements
at each frequency, and thereby provides an indication of the variability in
performance to be expected from protectors with the same model designation.
The data present the current state-of-the-art of hearing protector at-
tenuation. The range of attenuation at the test frequencies is indicated
below.
Table 1.1
State-of-the-Art Hearing Protector
Attenuation vs. Frequency
(ANSI STD Z24.22-1957)
Frequency (Hz) 125 250 500 1000 2000 3000 4000 6000 8000
Maximum
Attenuation (dB) 33 35 37 46 46 48 50 48 52
Minimum
Attenuation (dB) 3 4 5 13 22 28 25 27 19
38
-------
SIMPLIFIED METHODS OF EXPRESSING HEARING PROTECTOR PERFORMANCE
The attenuation data obtained from the present standardized threshold
shift method of rating hearing protector effectiveness (ANSI STD S3.19-1974)
is very useful for performance information, provided that it is interpreted
and applied correctly. However, it may be difficult for prospective users
of a hearing protector to relate octave band attenuation values to the overall
protection that would be provided in terms of reduction of the "A"-weighted
sound level at the ear. The "A"-weighted sound level (or noise level) in
decibels (frequently abbreviated as dB) is a frequency-weighted measure
which represents the human response to the sound. This sound level is sym-
bolically represented as "U".
Recognition of the difficulty of relating the attenuation data from
the ANSI standard to the reduction of noise in terms of L., has led to the
development of various techniques for rating the effectiveness of hearing
protectors by using octave band attenuation data to calculate an estimate
of the reduction of noise entering the ear in terms of L«. These tech-
niques are similar to one another and, generally, trade accuracy for sim-
plicity.
The primary difficulty in estimating the reduction in LA resides
in the fact that performance of hearing protective devices depends upon
the frequency spectrum of the noise. Hearing protectors provide different
amounts of attenuation at different sound frequencies depending on their
design. Therefore, a specific hearing protector, selected because of its
ability to attenuate a particular noise with specific dominant frequencies,
may provide the wearer with potentially widely different amounts of attenua-
tion of noises with different frequency components because of the differ-
ences in attenuation at the various frequencies of interest. Consequently,
39
-------
specifying a constant value of expected attenuation generally does not give a
reliable indication of protector performance. Also, there is a significant
variation in hearing protector performance observed from individual to indi-
vidual. This variation is accounted for in the calculation procedures by
using the "standard deviation" calculated at each frequency from the 30
measurements required by the standard test procedure.
There are two basic calculation procedures [9] for relating octave band
attenuation to L. attenuation. The distinctions between the procedures lie
in the type of data required in the calculations and the relative accuracy of
the estimated attenuation value obtained.
Method One
Data Required: Octave band sound pressure levels at the location where
the protector is to be used, at center frequencies of
125, 250, 500, 1000, 2000, 4000, and 8000 hertz (Hz).
Hearing protector mean attenuation data for 1/3-octave bands
of noise centered at 125, 250, 400, 1000, 2000, 3000, 4000
6000, 8000 Hz.
Description: This procedure uses the band attenuation values (test data),
adjusted for the observed standard deviation values, to
calculate the "A"-weighted octave band levels under the
hearing protector (at the ear) for the specified environmental
sound levels. Logarithmic addition of these octave band
levels yields the effective "A"-weighted sound level at the
ear; the difference between this calculated level and the
"A"-weighted environmental sound level is the attenuation
rating of the protector.
Comments:
This is the more precise method for determining protector
effectiveness in an environment with a known frequency
spectrum. Attenuation value will vary for different noise
spectra but not for different levels of the same noise
spectrum.
40
-------
Method Two
Data Required:
Description:
Comments:
Mean values of hearing protector attenuation for 1/3-octave
bands of noise centered at 125, 250, 500, 1000, 2000, 3000,
4000, 6000, 8000 Hz.
This procedure also uses the observed band attenuation values,
adjusted for standard deviation. It differs from Method
One in that a hypothetical environmental sound field is
assumed - "Pink" noise with sound pressure level of 100 dB in
each octave. The adjusted band attenuation values for the
protector are subtracted from the "A"-weighted levels in
the corresponding bands to yield the "A"-weighted octave
band levels at the ear. The overall "A"-weighted sound level
at the ear (logarithmic sum of the band levels) is adjusted
upward by 3 dB to account for variations in the spectrum and
the result is subtracted from the "C"-weighted environmental
noise level to obtain the Noise Reduction Rating (NRR).
Not as precise as Method One for any specific noise spectrum,
but more reliable as a general indication of protector
effectiveness in an unknown noise spectrum.
Requires that the noise reduction factor be subtracted from
the "C"-weighted sound level to obtain "A"-weighted sound
level at the ear.
Noise Reduction Rating is independent of the environmental
spectrum to which the user of the hearing protector is
exposed.
Method One is the more accurate if the local noise spectrum is known and
constant. It requires the use of a Type 1 sound level meter with octave band
filters to obtain the needed environmental noise data. The reduction factor
is applied to the "A"-weighted level of the noise in the workplace to yield
the "A"-weighted level entering the ear.
41
-------
Method Two provides a reduction rating which, when subtracted from the
"C"-weighted sound level of the noise, yields the approximate "A"-weighted
sound level entering the ear. This method, developed empirically, requires a
3 dB adjustment factor to allow for the range of environmental noise spectra
that may be encountered. A variation on Method Two allows some simplification
of the calculation procedure; this is done by providing a tabular format for
adding decibels. Use of this table allows addition without resorting to the
conventional process of converting to antilogarithms, adding and converting
back to decibels. This latter process, however, is accomplished conveniently
with a pocket "scientific" calculator.
Both methods use the mean attenuation and standard deviation data
determined for a protector by the ANSI STD S3.19-1974 (ASA STD 1-1974) pro-
cedure. In each case, the mean attenuation value at each test frequency is
adjusted by twice the appropriate standard deviation to insure that 98%
(because of the "one-tailed" statistical distribution) of the population that
uses hearing protectors realizes at least that amount of noise attenuation.
Method Two is the procedure the Agency adopted in the final rule for
calculation of the Noise Reduction Rating that is required for all hearing
protectors; either of the methods for adding decibels may be employed.
42
-------
TABLE 1.2
COMPUTATION OF THE NOISE REDUCTION RATING
Octave Band Center
Frequency (Hz) 125 250 500 1000 2000 3000 4000 6000 8000
1 assumed Pink
noise (dB) 100 100 100 100 100 100 100
2 "C" weighting
corrections (dB) -.200 0 -.2 -.8 -3.0
3 unprotected ear "C"-
weighted level (dB)...99.8 100 100 100 99.8 99.2 97.0
(The seven logarithmically added "C"-weighted sound pressure levels of Step #3 =107.9 dB)
4 "A"-weighting
corrections (dB) -16.1 -8.6 -3.2 0 +1.2 +1.0 -1.1
5 unprotected ear "A"-
weighted level
(step fl-step #4)
(dB) 83.9 91.4 96.8 100 101.2 101 98.9
6 average attenuation (43 + 47)/2 (41 + 36)/2
in dB at frequency 21 22 23 29 41 =45 =38.5
7 standard deviation
in dB at frequency.... 3.7 3.3 3.8 4.7 3.3 (3.3 + 3.4) (6.1 + 6.5)
x2 x2 x2 x2 x2
774" ~%Jo 7TF ~tt FT =6.7 =12.6
8 step #5-(step #6-
step #7) develops
the protected ear "A"
weighted levels (dB)..70.3 76.0 81.4 80.4 66.8 62.7 73.0
(The seven logarithmically added "A"-weighted sound pressure levels of Step #8 using
this sample data = 85.1 dB)
9 NRR = Step #3 - (Step 18+3 dB*)
= 107.9 dB - (85.1 dB + 3 dB*)
= 19.8 dB (or 20) (Round values ending in .5 to next lower whole number)
*Adjustment factor for spectral uncertainty
The value for Step #3 is constant. Use logarithmic mathematics to
determine the combined value of protected ear levels (Step #8) which is used
in Step #9 to exactly derive the NRR.
43
-------
An alternative method of calculating the NRR is to use the following
table as a substitute for logarithmic mathematics to determine the value
of Step #8 and thus very closely approximate the NRR.
Difference Between Any Two Sound
Pressure Levels Being Combined (dB)
0 to Less than 1.5
1.5 to Less than 4.5
4.5 to 9
Greater than 9
Add This Level to the Higher
of the Two Levels (dB)
2
T
0
44
-------
SECTION II
THE HEARING PROTECTOR INDUSTRY
When the Agency published the Advanced Notice of Proposed Rulemaking
(ANPRM) in the Federal Register (39 FR 42380), quantitative and qualitative
data regarding the hearing protector industry were requested. The Notice
of Proposed Rulemaking (NPRM) (42 FR 31730) stated the regulatory approach
the Agency intended to pursue when labeling hearing protectors, and solicited
comments.
The Agency used information received from the industry association,
manufacturers, private citizens and government agencies responding to both
the ANPRM and NPRM, and its own research, in order to assess the effect of
noise labeling on the hearing protector industry.
The size of the industry and the means it uses to distribute its prod-
ucts are two areas that must be considered when determining the effect that
Federally required product labeling will have on an industry.
The Industrial Safety Equipment Association (ISEA) [10], in its response
to the ANPRM, estimated that the hearing protector industry was comprised of
25 to 30 major manufacturers. The ISEA claims 17 of these major manufac-
turers of protectors as members, and stated that these manufacturers repre-
sented approximately 80% of the sales volume of all protectors.
The Agency has further determined from safety equipment catalogues, re-
view of the Thomas Register [11], and others, that, in addition to the larger
companies, there are small companies that represent themselves as manufac-
turers of protectors, and "individuals" who produce custom-molded ear plugs
for very limited markets.
45
-------
The chain of distribution used by the hearing protector industry is re-
latively complex. Distributors generally repackage protectors supplied by
manufacturers, and put their own brand names on the packaging. Therefore, a
given device may be marketed under several different private labels. For
example, a manufacturer who produces a line of ear-muff type protectors may
purchase another manufacturer's insert-type protector in order to have a
complete line of hearing protectors to offer to customers. Therefore, the
manufacturer listed on the label may not (and in the majority of cases does
not) actually produce the protectors packaged and marketed under that manu-
facturer's brand name. The Agency has carefully considered the chain of
distribution within the industry in order to assess the economic effects of
the provisions of the regulation as they pertain to responsibility for the
label, product testing, and for overall compliance with the regulatory
requirements.
Another factor that is relevant to the effect of labeling on the indus-
try, based on information supplied by manufacturers, is that hearing protec-
tor manufacturers often have supplies used in producing, packaging, and
labeling their products on-hand months in advance of the time they actually
need them. This is generally the result of lead-time procurements necessary
within this industry. The Agency has considered this facet of the industry
because making industry on-hand supplies prematurely obsolete by requiring
an early effective date for the regulation could cause the economic effect
of labeling to be significantly greater than necessary.
46
-------
Another factor of importance in assessing the potential effect labeling
will have on costs to the consumer is the size of the market. Information
furnished the Agency by manufacturers, the industry association, and others,
indicates that there is no reliable estimate of the total number of hearing
protectors manufactured or sold in the United States each year.
However, the Agency has determined from statements made by manufac-
turers and the industry association that, presently, the major consumption
of hearing protectors is in the military and industrial segments of the
market, where hearing protectors are used to protect individuals from noise
levels in the work situation which can damage hearing permanently. Most of
these bulk purchasers are reached either by the manufacturers themselves or
by distributors of personal safety equipment.
The present consumption of hearing protectors by single unit purchase
is relatively small. The variety of choice is usually limited, with ear-
muff type devices predominating, since these minimize problems encountered
with fit.
ECONOMIC EFFECT OF LABELING
The quantitative and qualitative data requested in the ANPRM relevant
to the labeling of hearing protectors included data on the number and types
of hearing protectors sold, test methods, existing labeling practices, etc.
The 9 responses to the ANPRM did not provide sufficient data for the
Agency to adequately describe the hearing protector industry, and the eco-
nomic effect of a labeling regulation on it.
47
-------
Additional requests for production and marketing data (manufacturing
costs and processes, marketing procedures, size of the market, numbers and
types of protectors manufactured, and market share) were sent to selected
manufacturers and distributors. The Agency did this in an attempt to increase
the amount of information obtained in response to the ANPRM so it could
adequately assess the economic effects of various hearing protector labeling
schemes.
The National Institute for Occupational Safety and Health (NIOSH) sub-
mitted information listing forty (40) manufacturers and suppliers [HEW Publi-
cation (NIOSH) #76-120, September 1975]. Manufacturers and distributors
listed in the Thomas Register were also considered for this analysis. In
all, the Agency determined that there are approximately seventy (70) manu-
facturers and distributors who may be affected economically by a labeling
regulation.
Additional data were submitted to EPA during the public comment period
following publication of the proposed rule (NPRM). These included responses
from two of the larger manufacturers of hearing protectors [13, 14]. Their
estimates of cost increases per unit were based on promulgation of the rule
as it was proposed, which would require that previously bulk-packaged pro-
tectors be individually packaged and labeled. A third manufacturer [15]
supplied estimates of costs entailed in the preparation of labels.
The Agency has revised its estimates of the costs of this regulation,
based in part on this new cost data, and due to other changes which it has
deemed appropriate from public comments.
In the absence of an extensive economic data base, the Agency developed
what it believes to be a "worst case" estimate of potential industry costs
to label hearing protectors. The Agency has assumed that every manufacturer
48
-------
and distributor (wholesale or retail) identified in both the NIOSH publica-
tion [6] and the Thomas Register [11], would be affected equally regardless
of company size, or contractual agreements with other manufacturers or
distributors. Distributors ("manufacturers" as defined in the Noise Control
Act) are included within the seventy (70) manufacturers the Agency has deter-
mined to comprise the total industry. However, they are not likely to
incur the costs of complying with the regulation to the same extent that
manufacturers will.
Distributors generally repackage protectors supplied by manufacturers,
and put their brand names on the packaging. Therefore, a single device may
be marketed under several different private labels.
The final regulation states that a manufacturer's Noise Reduction Rating
and Mean Attenuation data may be used when packaging and labeling protectors.
Therefore, the only costs likely to be incurred by distributors in complying
with the labeling requirements would be those associated with repackaging; not
the testing, recordkeeping or reporting costs.
However, since it has been virtually impossible to accurately determine
the number of distributors who change their packaging and the average costs
associated with such changes, the Agency has developed its best estimate of
costs based, in part, on one manufacturer's estimate for label preparation,
and the Agency's own assessment of potential labeling costs. The Agency has
applied these estimated costs equally to every manufacturer and distributor.
There are two costs to be considered when assessing the economic effect
of this regulation: A) first year (start-up) costs; and B) annual costs.
49
-------
A. FIRST YEAR COSTS
The first year, or start-up, costs to the industry to comply with the
Federal labeling requirements for hearing protectors include:
1. Label verification testing
2. Preparation of the labeling verification reports
3. Direct costs of label preparation 1.
1. Label Verification Testing
The cost of testing to develop data to support the values with which
manufacturers will label their products, using the required American National
Standards Institute Standard S3.19-1974 test procedure, ranges from $1500 to
$2000 per test, based on rates quoted to manufacturers by test facilities.
These rates include costs for three test runs on each of ten (10) test sub-
jects, and processing and analyzing the resultant data. Each model of hear-
ing protector will need to be tested as well as each position of multi-
position devices (e.g., ear muffs).
According to the National Institute for Occupational Safety and Health
(HEW Publication (NIOSH) #76-120, Sept. 1975), there are currently 175
models/use positions that should initially be tested (see Table 1.3).
First year costs for labeling verification testing of 175 product
test configurations are estimated to be between $262,000 and $350,000 (for
per-test costs ranging from $1500 to $2000).
50
-------
TABLE 1.3
NUMBER OF CURRENT PROTECTOR MODELS AND
REQUIRED TEST CONFIGURATIONS
Ear Inserts
o Premolded 49
o Moldable 7
o Non-Linear 4
60"
Ear Muffs
o One-position 53
o Two-position 1 x (2) 2
o Three-position 18 x (3) 54
109-
Ear Caps 6
TOTAL REQUIRED TEST CONFIGURATIONS 175
2. Preparation of the Label Verification Reports
The Agency estimates that preparation and reproduction of the label
verification reports, of the type required in the regulation, will entail
the following workload. This estimate is based on the assumption that manu-
facturers will average five categories of protectors for which reports will
be necessary (using data in NIOSH pub. #76-120).
o Technician 2 days
o Clerical 1 week
Based on comparable Federal Government salaries (Civil Service General
Schedule wage scales) the salary/wage costs for a technician (GS-05) and
51
-------
for a clerical worker (GS-04) would be $78 and $181 respectively. An average
overhead rate of 110% was assumed based on the values included in contrac-
tors' proposals for work recently received by the Agency. Taking into
account initial printing of the label verification reports, and 20 cents per
page for copying, $100.00 was included for printing/reproduction. Therefore,
based on 70 manufacturers, the Agency estimate of the total industry costs
associated with the label verification reports is $45,080. (See Table 1.4).
TABLE 1.4
COST OF PREPARATION OF LABELING VERIFICATION REPORTS
o Technical $ 78
o Clerical +181
"239"
o Overhead at 110% +285
"54~4~
o Printing/reproduction +100
o Estimated cost per manufacturer $644
3. Direct Costs of Label Preparation
The estimated costs for label preparation for the first year include
new or revised product graphics, packaging, literature, drafting of labels,
and personnel. Of eight replies from hearing protector manufacturers to
the ANPRM on the cost of labeling preparation, four were estimated "minimal
costs," two said the information was not available, one estimated $0.10 per
unit for muff-type devices, and one estimated $1000 for typesetting and art-
work. One manufacturer estimated the total costs of label preparation for
camera-ready copy and graphics (based on purchasing 100,000 labels) to be
52
-------
$10,000, of which $7500 were for non-recurring costs. The Agency estimates
that the direct cost to the industry for label preparation for the first year
would, therefore, not exceed $525,000 ($7500 X 70 manufacturers).
ANNUAL COSTS
The annual costs to the industry to comply with the regulation include
compliance audit testing by not more than 15% of the manufacturers in any one
year after the first year; label verification testing of new classes of pro-
tectors or classes of protectors that have undergone changes which result in
decreased noise reducing effectiveness (this is not expected to exceed 10% of
the various models of protectors in any one year); and annual administrative
costs for reporting and recordkeeping. The Agency's estimate of annual
Compliance Audit Testing costs industry-wide is that they will not exceed
$21,000 (.15 X 70 X $2000 per test).
Labeling verification testing costs for new products or products changed
from a preceding year are not expected to exceed $35,000 (.10 X 175 X
$2000).
Annual administrative costs (exclusive of the preparation of labeling
verification reports) include costs for maintenance of records and adminis-
trative costs of compliance audit testing. The personnel requirements are
estimated to be:
o Senior level official - 1 week
o Mid-level official - 2 weeks
o Technical/clerical - 2 weeks
Again, the Agency has, in the absence of industry-furnished data, developed
cost estimates based on comparable government wage scales for these posi-
tions. These estimated costs are: senior level official (GS-14 - $32,402/yr)
53
-------
approximately $650 for one week; mid level official (GS-12 - $23,100/yr)
approximately $888 for 2 weeks; technician/clerical (GS-05 - $10,500/yr)
approximately $420 for 2 weeks. Assuming an overhead rate of 110% from
previous experience, we estimate that first year costs should not exceed
$4,038.
Costs for annual changes to artwork and graphics are estimated at 10%
of the $2500 that one manufacturer estimated as recurring graphic expenses;
and the cost of preparing label verification reports for those protectors
new or changed in the year, is 10% of the first year report preparation costs
of $644.
Total industry administrative costs are therefore estimated to be no
more than $304,710; see Table 1.5.
TABLE 1.5
TOTAL ANNUAL ADMINISTRATIVE COSTS
o Personnel
1 senior level $ 650
1 mid-level 888
1 technician/clerical 420
o Overhead at 110% 2,115
$4,112
o Cost of Preparing Label Verification
Reports (10% of $644) $ 65
o Artwork and Graphics (10% of $2500) 250
$
X 70 manufacturers = $309,890
54
-------
SUMMARY
Total costs of labeling to the entire industry, based on the "worst
case" estimates presented in this analysis, are summarized in Table 1.6.
The Agency considers these figures to be the maximum the industry should
experience, since both manufacturers and distributors were considered as
being affected equally by the labeling requirements. Distributors are not
likely to incur costs to the extent assumed in this analysis because, in many
cases, they can rely on the data and reports supplied by the producers of the
hearing protectors.
TABLE 1.6
TOTAL INDUSTRY COSTS
FIRST YEAR COSTS (Maximum anticipated)
o Label Verification Testing $350,000
o Label Preparation 525,000
o Label Verification Reporting 45,080
TOTAL FIRST YEAR COSTS: $930,080
ANNUAL COSTS
o Compliance Audit Testing $ 21,000
o Annual Testing 35,000
o Annual Administrative Costs 309,890
TOTAL ANNUAL COSTS: $365,890
It is the practice of this industry to pass 100% of production costs
through to the ultimate purchaser. We believe this practice will continue.
While the potential percent price increase per pair of protectors is
impossible to determine in the absence of market size information, the Agency
55
-------
estimates, based on limited data, that prices may increase between $0.03 and
$0.05 per pair of insert devices (if previously bulk-packaged protectors
are required to be individually packaged and labeled), and $0.10 for "muff"
devices.
The Agency determined from safety equipment catalogues and checks of
retail outlets, that the current prices for typical ear insert devices
(plugs) range from approximately ten cents per pair of disposable inserts
in bulk industrial quantities to as much as seven dollars per pair for
individually packaged plugs typically offered to the consumer. Customized
plugs can cost as much as thirty dollars per pair but they are the exception
in terms of insert devices. Ear-muff type protectors range in price from
several dollars when purchased in commercial bulk quantities to approximately
fifteen dollars per pair when individually packaged for consumers.
The Department of Defense and several major industries that are affected
by the Occupational Safety and Health Administration's (OSHA) rules have been
requesting effectiveness data on hearing protectors. Therefore, a majority
of the manufacturers already include in their prices the costs of testing
protectors to develop effectiveness ratings.
The Agency has had no indication that this labeling rule would impose
appreciable burdens on any manufacturer within the hearing protector ind-
ustry, nor that a regulation in itself would result in any business closures.
Our economic analysis did not attempt to predict potential market shifts or
potential adverse economic effects that might occur as a result of labeling
requirements which would identify some protective devices as being low in
effectiveness. Since the intent of labeling under Section 8 of the Noise
56
-------
Control Act is to provide information to prospective users of noise-producing
or noise-reducing products, the Agency believes that any market shifts or
other economic effects beyond the direct costs of labeling would be solely
related to the competitive nature of the industry. We believe that this
industry will adjust itself to reflect purchasers' and users' selections
made as the result of any newly available information that may result from
noise labeling requirements; not as a result of restrictions that may be
imposed by command and control regulations.
57
-------
REFERENCES FOR INTRODUCTION AND PART I
1. Federal Register, Vol. 39, December 5, 1974, p. 42380.
2. Federal Register, Vol. 42, June 22, 1977, p. 31722.
3. Federal Register. Vol. 42, June 22, 1977, p. 31730.
4. U.S. Department of Health, Education and Welfare: National Institute
for Occupational Safety and Health, (NIOSH) Publication Number 79-115.
5. (Figure l.l(c))
Michael, Paul L. and Sataloff, Joseph, Hearing Conservation, (Charles C.
Thomas, Springfield, Illinois, 1973), p. 291.
6. Michael and Sataloff, 1973, p. 292.
7. Michael, P.L. and Bolka, D.F., An Objective Method for Evaluating Ear
Protectors. U.S. Department of Health, Education, and Welfare, 1972.
8. U. S. Department of Health, Education and Welfare: National Institute
for Occupational Safety and Health, HEW (NIOSH) Publication Number
76-120.
9. (First three Methods): HEW (NIOSH) Publication Number 76-120.
(Fourth Method): Environmental Protection Agency, simplification of
Method #2 (above), 1978.
10. Wilcher, Frank, for Industrial Safety Equipment Association, Docket
entry 74-3-005.
U. Thomas Register, 69th edition, Volume No. 11, G through J.
12 Draft Background Document for the Labeling of Hearing Protectors.
' EPA 550/9-//-252. April 19//.
13. Plasmed, Inc. Docket 77-5-031.
14. Letter to EPA from Wilson Products Division, ESB Inc.
15. Woods, Thomas J., for Aural Technology Oral Testimony, September 22,
1977, San Francisco, California. Docket entry 77-5-061.
58
-------
SELECTED BIBLIOGRAPHY FOR PART I
1. Paul L. Michael, Pennsylvania State University, Personal Protective
Devices and Hearing Conservation Programs.
2. Donald C. Gasaway, Personal Ear Protection, Aeromedical Review, USAF
School of Aerospace Medicine, August 1971.
3. David F. Bolka, Methods of Evaluating the Noise and Pure Tone Attenua-
tion of Hearing Protection, Thesis Abstract, Pennsylvania State Univer-
sity, December 1972.
4. P.S. Veneklasen, Methods of Noise Control: Personal Protection, Noise
Control, _]_, 29-33, September 1955.
5. U.S. Department of Health, Education, and Welfare, National Institute
for Occupational Safety and Health, HEW (NIOSH) Pub. No. 76-120.
6. Acoustical Society of America Standard (American National Standards
Institute S3.19-1974) 1-1975, Method for the Measurement of Real Ear
Protection of Hearing Protectors and Physical Attenuation of Earmuffs.
59
-------
PART II
DOCKET ANALYSIS
-------
INTRODUCTION
On June 22, 1977, the Environmental Protection Agency published in the
Federal Register a proposed rule (42 FR 31730) [1] to require the labeling of
hearing protectors under the authority of Section 8 of the Noise Control Act
of 1972, 42 U.S.C. 4907. At the same time, the Agency proposed the general
provisions for product noise labeling (42 FR 31722) [2].
At the time of publication, the Agency solicited written comments on the
proposed rule on the labeling of hearing protectors, and established a public
comment period extending 90 days, to September 20, 1977.
After initial review of the public comment on this proposed regulation,
the Agency decided that, in order for the Agency to fully understand the
problems the hearing protector industry expressed in their written comments
and to clarify certain elements of the proposed rule, a public meeting was
in the best public interest. Notice of the meeting was published in the
Federal Register on December 3, 1977 (42 FR 61289), and the meeting was
held in the Office of Noise Abatement and Control on December 13, 1977 with
representatives of Federal agencies, the hearing protector industry, and
interested parties attending.
A third opportunity for public comment on the proposed regulation of
hearing protectors was the public comment period established for the Notice
of Proposed Rulemaking on the General Provisions for product noise labeling.
This public comment period ran concurrently with the comment period for
hearing protectors. Some comments submitted to the beneral Provisions
referenced the hearing protector proposed regulation, and are included in
this analysis.
63
-------
This analysis of public submissions to the docket has attempted to iden-
tify and group together common issues to facilitate Agency resolution and
response. We believe that to the extent possible all substantive issues have
been identified, considered and responded to by the Agency.
Each comment referring to the labeling of hearing protectors was given
a "docket" number, prefixed by 77-5. Thus, comment 77-5-19 refers to the 19th
comment (numbers were assigned according to order in which they were received
by the Agency). Comments numbered 77-5-1 through 52 refer to public comments
received concerning the NPRM for hearing protectors. Comments numbered
77-5-60 through 69 refer to comments pertinent to the hearing protector
proposal but addressed to the docket concerning the general provisions.
Comments numbered 77-5-101 through 110 refer to oral statements made at the
public meeting on December 13, 1977. For simplicity, only the last 3 digits
of the docket numbers are used in this analysis. The number or numbers in
parentheses at the end of each comment, or issue raised, refers to the
docket number(s) of particular commenter(s).
Appendix A presents a delineation of the issues from each written and
oral commenter. Appendix B is an index of all docket submissions which
allows one to identify the source of different comments where they are not
specifically mentioned in the text.
64
-------
Section 1: General Issues
1.1 Statutory Authority
Several commenters questioned the Agency's statutory and constitutional
authority to proceed with the proposed rule. Other commenters challenged the
legal grounds for the noise labeling program in general, as well as specific
aspects of the labeling program.
The Industrial Safety Equipment Association (ISEA) (38 and 109) took
issue with the proposed rule on various items. ISEA quoted Section 10 of the
Administrative Procedures Act [U.S.C. S4907(b)] to support its contention
that the proposed rule exceeded the Agency's statutory authority, constituted
an abuse of its discretion and was otherwise arbitrary and capricious.
Response:
The Agency maintains that the basis of the proposed rule is the non-dis-
cretionary mandate of Section 8 of the Noise Control Act of 1972, which
requires, in part, that notice oe given to prospective users of products sold
wholly or in-part on the basis of their effectiveness in reducing noise; and
that the requirements within the proposed rule as to the type of notice to be
given are wholly in keeping with EPA's authority, discretion and responsi-
bility to the public.
The proposed rule was developed through extensive discussions with all
affected parties. Ample provisions were made to receive substantive writ-
ten and oral public comment. In view of the careful development of this
final rule by considering the comments from, and participation of, affected
parties, and the non-discretionary requirement in Section 8 of the Act, the
Agency believes that the proposed rule was not capricious or arbitrary.
There is detailed response in later sections of this document to other
specific aspects of ISEA contentions in this regard.
65
-------
1.1.1 Label Content
ISEA (38, 109) felt that Section 8 of the Noise Control Act of 1972
required only a label giving notice of the hearing protector's effective-
ness in reducing noise. The requirement that the label contain information
such as the EPA logo or the removal prohibition statement was viewed as lack-
ing statutory foundation, for Congress usually expressly included such other
information requirements in its Acts.
Response;
The Agency maintains that the Section 8 requirement to give notice of a
hearing protector's effectiveness in reducing noise does not limit the Agency
from requiring that additional information be available on the label to
immediately supplement and give meaning to the notice.
Section 8 of the Act requires that notice be given to a prospective
user of the effectiveness of a product in reducing noise. As part of the
notice given by the label, the Agency has developed, and will supply to
the industry with periodic updating, the comparative range for hearing
protectors as a complement to the effectiveness rating on the label. The
effectiveness rating, by itself, would not indicate to the prospective user
the available range of effectiveness ratings offered by other hearing pro-
tectors, nor would it show the effectiveness of a specific protector relative
to the noise reducing effectiveness available from other protectors. The
comparative range information is intended to give support to the use of the
NRR as a means of choosing an adequate hearing protector for a given noise
environment. We believe that comparative range information on the label
is a key element to the total notice of a protector's noise reducing
effectiveness that is supplied by the label.
66
-------
The Agency addressed in detail, within the General Provisions for
Product Noise Labeling, the requirement tor the EPA logo on the label.
In brief, the appearance of the logo on the label is intended to notify
an ultimate purchaser or the prospective user that the label is Federally
mandated across the industry, its contents are uniform and that the
ratings are credible.
The statement prohibiting removal of the label prior to sale to the
ultimate purchaser is based on the prohibition of Section 10(a)(4) of
the Act. Removal of the label from a protector before it is sold to the
ultimate purchaser is a violation of the Act, and the person who removes
the label is subject to a remedial order that the Administrator may issue
under Section ll(d) of the Act. This restriction is important for the
public to know.
1.1.2 Relationship between General Provisions and Hearing Protectors
ISEA (38,109) stated that the proposed Hearing Protector labeling
rule (the proposed Subpart B of the new Part 211 of 4U CFR (as proposed
in the NPRM for Product Noise Labeling - General Provisions (42 FR 31722)))
was contrary to the preamble of the proposed beneral Provisions (Subpart A
of 4U CFR Part 211) in that administrative, economic, ecological and tech-
nical impacts of the program were "substantially detrimental" to the
hearing protector industry. The ISEA position was based on the perceived
necessary alterations in bulk packaging and the resultant increased costs
that the proposed rule would impose on the industry and the consumer it the
rule were implemented without change.
Flents Products Company (60) objected to the lack of distinction
given to the concurrently proposed Subparts A and B of the new Part 211 of
67
-------
40 CFR, and the limited opportunity for comment on Subpart B. Bilsom Inter-
national and others (17, 19, 60) argued that a separate public hearing should
be conducted in connection with Subpart B.
Response;
After reviewing comments from ISEA, manufacturers and industry related
concerns with respect to packaging and cost issues, the Agency decided to
modify the proposed rule to take into account the special circumstances
of the packaging and marketing of hearing protectors for various markets.
These modifications, discussed in detail in Section 4 of the Regulatory
Analysis, minimize the economic impact of the final rule and answer the con-
cerns addressed by ISEA and others.
The Agency maintains that the purposes and contents of both Subpart A
and Subpart B of the proposed regulatory category - Product Noise Labeling -
of the Code of Federal Regulations [40 CFR Part 211] were clearly distin-
guished. Subpart A contains the general provisions of the regulatory
program applicable to all products for which noise labeling requirements
will be developed under the authority of Section 8 of the Act, unless modi-
fications are made in product-specific regulations. Subpart B contains the
requirements for the labeling of hearing protective devices and includes any
modifications to the general provisions, alternative or additional provisions
necessary to adequately regulate hearing protectors.
Concerning the lack of public hearings on this proposed regulation
initially, the Agency did not schedule public hearings for the proposed
Hearing Protector regulation, as significant additional public participa-
tion was not anticipated. However, in response to several requests for
68
-------
meetings with the Agency from manufacturers of hearing protectors, the Agency
held a public meeting on December 13, 1977 in an effort to better understand
the effects of the regulation on the industry and to certain elements of the
regulation. We believe that the general public and the affected industry have
had the opportunity to express their views effectively and completely.
1.2 Interagency Coordination
Four industry commenters cited possible conflict between the proposed
rule and other government programs and requirements. Aural Technology (61)
expressed a general concern regarding the lack of interagency coordination
and the consequent difficulty of satisfying different regulations. ISEA (38
and 109) questioned the compatibility of the proposed regulatory requirements
with the National Institute for Occupational Safety and Health (NIOSH)
voluntary certification program; and NIOSH (51) commented on several aspects
of the proposed requirements. Plasmed, Inc. (31 and 106) asserted that there
was conflict between the Department of Defense medical purchase packaging
requirements and our labeling requirements.
Response:
From the beginning of the program, the Agency has worked closely with
other Federal agencies in an effort to coordinate the hearing protector
regulation with other government programs and their requirements. Several
relevant agencies, including NIOSH, the Federal Aviation Administration,
and the Mining Safety and Health Administration (formerly MESA) either
participated in our December, 1977 public meeting on the proposed rules,
provided helpful written comments to the public docket, or both.
69
-------
The Agency has worked closely with representatives of the Department
of Defense (Air Force), specifically the Aerospace Medical Research Labora-
tory at Wright-Patterson Air Force Base. This facility has extensive data
on, and knowledge of, hearing protectors, and establishes the specifica-
tions for hearing protectors used by the Department of Defense.
The Federal Agencies were also consulted concerning the resolution
of issues that developed from public comments to the proposed regulation,
and we have received concurrence from all parties.
The Agency worked closely with NIOSH in the development of its require-
ments for the labeling of hearing protectors to ensure that the two programs
would be complementary.
We will continue to coordinate activities with NIOSH to assure that
the two programs work together, and produce no conflict or redundancy.
The Agency explored the possibility of conflict with Department of
Defense Military Specifications (DOD MIL. SPEC.) on product and product
package labeling. DOD MIL. SPEC, experts assured us that there were no
apparent conflicts, and that if conflict should develop, the specifications
would be changed to incorporate the Agency's regulatory requirements.
1.3 Audience Addressed
A major concern of many manufacturers was the audience addressed by
the labeling requirements. The differences between the individual con-
sumer and the industrial market for protectors, and between purchasers
and users of protectors, were frequently mentioned. These issue areas
are related, since in the industrial market there is often a distinction
between purchaser and user, whereas in the consumer market there is
frequently no distinction.
70
-------
Most manufacturers appeared to do more business with the industrial
market than with the individual consumer market. While acknowledging the
existence of an individual consumer market, the manufacturers felt that
the "realities" (the packaging, labeling and use requirements) of the two
markets differed. ISEA (38 and 109) asked whether the labeling rule would
be made to apply to both industrial and consumer markets and questioned the
propriety of such an action. Two manufacturers (40 and 107) recommended that
EPA consider different regulations for the industrial and consumer markets.
Bilsom International (44) felt that EPA's regulations confused the
identity of the purchaser and user of hearing protectors. They noted
that in the industrial market the two are seldom the same: the purchaser
is usually the procurement officer or safety engineer of an industry, and
not the worker who uses the device. Therefore, the labeling regulations
do not represent an effective means for reaching the user of each device.
Two manufacturers (1 and 101) felt since the end user is not necessarily
the buyer, supplying the NRR to the user would not serve the stated purpose
of the program.
The North Carolina Department of Labor (34) doubted that individual
consumers would be able to use the NRR to make comparisons, but felt that
industrial users would benefit from the NRR. A representative of Reynolds
Metals Company (110) felt that employees should have some opportunity to
choose their own protectors and recommended a labeling plan which would
inform the ultimate user rather than only the industrial buyer. A major
characteristic of the industrial market is the prevalence of bulk sales.
Since hearing protectors are sold in large quantities to industries, ISEA
(38) suggested that the NRR be reported in technical literature and
71
-------
on product cartons rather than on each device and/or its packaging. Bilsom
International (44) suggested that there was no need for effectiveness label-
ing since commercial or industrial buyers do not inspect the product. In
general, manufacturers expressed disenchantment over the requirement that
devices sold in bulk be treated the same for labeling purposes as devices
sold over the counter (38, 46, 106, 101). E-A-R Corporation (104) felt that
disposable or semidisposable protectors sold in bulk should be labeled
differently than other protectors sold in other ways. A manufacturer of
insert type protectors (106) stated that the label was not appropriate for
those instances when the device was purchased for swimming protection.
Response:
The major issue raised in these previous comments concerned the impact
of the regulations on a major method of marketing hearing protectors: bulk
sales. The Agency, because of the many oral and written comments received
from hearing protector manufacturers, has given careful and thorough conside-
ration to the production and marketing dynamics of the industry.
The Agency modified the regulation, and now requires the labeling of
protectors according to the method by which they are displayed for ultimate
purchase or use. Section 4 of this Docket Analysis discusses this labeling
method in much greater detail.
Concerning hearing protectors bought by swimmers, the Agency notes
that packaging for the device is not directed primarily at the swimmer
but rather implies a broader audience including those persons meant to
72
-------
be addressed by the proposed label. Therefore, if protectors are sold
In part on the basis of their effectiveness in reducing noise, they are
clearly subject to the labeling requirement.
1.4 Definition of Party Responsible for Compliance
NIOSH (51) stated that the term "manufacturer" is not sufficiently
defined in Section 211.2.1 of the proposed rule to clarify the party ulti-
mately responsible for compliance with the labeling regulations. A manufac-
turer (107) suggested that the last handler of the product before a retail
sale, rather than the manufacturer, bear the responsibility for meeting the
requirements of label accuracy and visibility at point of ultimate purchase.
ISEA (38) also questioned whether these responsibilities would rest with the
manufacturer of the device or the packager/distributor. ISEA inquired as to
how the Agency planned to handle the matter of the private label manufactur-
ers and their responsibilities.
One manufacturer (106) supported the previous comments by describing
the difficulty of determining whether some of his products were destined
for the domestic market or for the foreign market, because they were often
packaged three or four times. Another manufacturer (107) commented that
if he purchased protectors from a manufacturer that had performed the
required tests and had provided him with a copy of the test results, his
intentions would not be to conduct any additional tests. Does this use
of someone else's data satisfy the manufacturer's responsibility for meeting
the labeling requirements and, if so, under what conditions? The basic
question from these manufacturers is at what point the responsibility for
protector and package labeling correctly rests.
73
-------
Response:
Considering these points, the Agency believes that the statutory defini-
tion of "manufacturer" adequately identifies the party responsible for
label verification of the protector, for labeling the protector or its
packaging, for assuring the accuracy of the information on the label, and
for assuring the visibility of the label at the point of sale to the
ultimate purchaser or distribution to the prospective user. We have,
therefore, simply required that the "manufacturer", as defined in the Act,
be identified on the label. The manufacturer packaging the protector
for ultimate purchase or use is to be named on the label, is to assure
that the information that must accompany the protector as supporting
information, and from which the NRR is determined, is provided in the
packaging, and is to assure the accuracy of the information on the label.
The "manufacturer" who packages and/or distributes the product may elect
to either use the information provided by the product "manufacturer" that
label verified the protector, or to retest the protector.
Where a device is comprised of component parts or is changed in some
way such that the effectiveness may have been altered, the final assembler
of the protector is the manufacturer as defined, and acquires the testing
responsibility for the purposes of this rule.
Private labeling firms might be employed by hearing protector manufac-
turers or marketers to produce and/or affix the required labels for the
program. Such firms are outside the chain of hearing protector commerce
and are charged with no compliance responsibility under the program. in
74
-------
the event of labeling errors or misrepresentations by such label-producing
firms, responsibility for label compliance with the Federal labeling require-
ments remains with the manufacturer that introduces the product into commerce.
'1.5 Need for a Public Education Campaign
A private citizen (5), ISEA (38, 109), and an official in the North
Carolina Department of Labor (34), directed their comments at the need
for consumer education to allow purchaser/users an understanding of various
aspects of the labeling program. For example, ISEA (38) recommended that
EPA begin a large-scale education program to provide the public with a
better understanding of the Noise Reduction Rating scheme.
Response:
The Agency recognizes the need for consumer education if the public
is to effectively use the labeling information when selecting products
for purchase or use; and intends to provide a public awareness campaign
on hearing protectors in order to educate those parties concerned with
hearing protection and the provisions of this regulation.
1.6 Comments on Language in the NPRM
1.6.1 Perceived Negative Bias
A major manufacturing company (41) objected to Paragraph 4 of the
Notice of Proposed Rulemaking (NPRM) Introduction [1] concerning the effi-
ciency of hearing protective devices. Paragraph 4 states, in part, that the
effectiveness of hearing protectors in high noise environments "may be
marginal at best." The company cited Air Force testimony at OSHA's Proposed
Noise Standard hearing of October 24, 1974, as well as HEW materials and
75
-------
Army publications, in an attempt to dispel what they perceived as a negative
bias against the effectiveness of hearing protectors in the statement.
Response;
The language of the statement referenced by the company was chosen
only after Agency consultation with experts in the scientific community
and accurately reflects the situation. The wide range in noise reduction
ratings demonstrates the variations in the attenuation capabilities of
hearing protective devices. Some protectors might not be adequate for
any high noise environments.
A fundamental reason for the uniform rating method and the require-
ment that the supplemental information report a protector's mean attenua-
tion and standard deviation at the specified testing frequencies is that
protectors provide varying amounts of attenuation in varying noise environ-
ments, depending on the frequencies present. Therefore, the statement
in the NPRM Introduction is correct and appropriate in the context of this
regulation.
1.6.2 Impulsive Noise
ISEA (38) took exception to the statement in Section 211.2.4-4(e)
that "... hearing protectors are recommended for protection against
the harmful effects of impulsive noise." ISEA contended that there was
no empirical data to support such a statement; they therefore suggested
that it be removed.
Response;
After discussions with hearing protector experts and review of ISEA's
comment, EPA determined that a modification to the wording was in order.
76
-------
The first part of the statement now reads "Although hearing protectors
can be recommended for protection against the harmful effects of impulsive
noise, . . ." This modification renders the statement more accurate while
preserving the important concept it intends to convey.
1.7 Exports and Imports
The proposed hearing protector labeling regulation elicited several
comments concerning problems associated with the exporting or importing
of finished devices or components. One manufacturer (44), especially
concerned that the Agency failed to consider the problems of an inter-
national company, felt that the costs of a company satisfying different
legal requirements in different nations should be reflected in our economic
analysis. Another manufacturer (101) was concerned that imported products
might be treated somewhat differently than domestic products, depending
on the implementation of Section 9 of the Noise Control Act (IMPORTS).
A comment concerning exportation of products was also received. A
manufacturer (106) of an insert-type protector which is both exported and
sold domestically through brokers stated that it is not possible to know
whether a given device will reach a foreign market or remain in the domestic
market. Another problem with labeling devices to be exported, he maintained,
is that they are often repackaged, as many as four times, by a broker.
His company felt that it was virtually impossible to determine if one of
these devices was actually destined for export and therefore not subject
to the regulations.
77
-------
Response;
The Agency maintains that those items known to be destined for export
will not be required to be labeled for noise-reducing effectiveness.
This was proposed in the NPRM and has not been changed. Whatever costs
are incurred by a company in testing and labeling protectors that may
be exported are costs that cannot be construed as other than necessary
to assure compliance of the protector should it not be exported, but entered
into commerce within the United States. The cost-impact of this program on
firms doing business internationally cannot be a consideration of this rule,
for costs and problems associated with compliance of products exported and
subject to other country's regulations are the responsibility of the company
engaging in that international commerce.
In response to the comment concerning Section 9 (IMPORTS) requirements
of the Act, the Agency position is that imported products in violation
of the labeling requirements cannot be sold in the United States, regard-
less of whether separate import regulations have been promulgated. Section
9 simply involves the establishment of an enforcement program that would
detect imported products in noncompliance with Subpart B, and its status
does not affect the applicability of the labeling requirements to imported
products. As noted above in paragraph 1-3, the domestic assembler of foreign-
made hearing protector components is considered to be the manufacturer
with responsibility for testing the protectors for labeling verification
and compliance under the regulation. In the case of exclusively foreign-made
devices that are imported and introduced without change into commerce by
a domestic firm, the foreign manufacturer shall bear testing responsibility
78
-------
while the domestic marketer shall assume responsibility for label accuracy,
visibility, and testing if the test results or testing procedure are suspect.
Concerning the need to know whether a device will be exported or sold
domestically, the regulation pertains to "categories" of protective devices
in a manufacturer's product line, not the individual protectors. Therefore,
if a category of devices is to be marketed at all within the United States,
that category needs to be tested and label verified. Individual devices
within the category may be exported. The responsibility for packaging
and labeling for export lies with the manufacturer that packages the
protector(s) for export.
Devices manufactured for the export market exclusively are exempt
from the testing and NRR labeling requirements.
1.8 Miscellaneous Remarks
A few problems were mentioned by one or two commenters and could not
be easily categorized in one of the major sections of the report. These
comments are reported in this sub-section.
Issue:
One question raised at the public meeting was whether manufacturers'
quality control procedures were sufficient to detect if and how
content variations between batches of material affect the device's
acoustic performance. A manufacturer present at the meeting (106)
explained that his firm had no routine acoustical quality control
checks.
Response:
One of the parameters for defining "category" for purposes of label
verification is the material composition of the protector; therefore, if
79
-------
content variations between batches of material affect the device's acoustical
attenuation, the manufacturer has created a new category subject to label
verification. It is up to the manufacturer to determine when a change
in one of the parameters changes the acoustic attenuation of the device
thus creating a new category.
Issue:
At least two commenters (26, 31) suggested that the labeling require-
ments apply to other products used in hearing protection, such as
cotton and Swedish wool, even though that might not be their primary
function.
Response:
In determining what products will be considered personal hearing
protectors for the purposes of this regulation, we rely on the statutory
language of Section 8 of the Noise Control Act of 1972. If a device to
be used in or about the ear is sold wholly or in part on the basis of its
effectiveness in reducing noise entering a person's ear, it is a personal
hearing protector under the testing and labeling requirements of this regu-
lation. If, on the other hand, the devices are sold without reference to
their noise attenuation potential and are simply adopted for hearing protec-
tion purposes on an individual basis by the user, they do not come under
the language of Section 8, and are not subject to this regulation. Deter-
mining the applicability of the regulation in circumstances such as those
described above will occur on a case-by-case basis.
Issue:
The Forging Industry Association (FIA), (21) which expressed
support for the program, felt that EPA should require that
80
-------
testing results, certified by EPA, be provided by the manufacturer
upon request from a customer.
Response:
The major objective of this regulation is to provide the prospective
user with valid, reliable and useful information on the effectiveness of
personal hearing protectors in attenuating noise. To this end, the Agency
is requiring that the composite Noise Reduction Rating (NRR) in decibels,
and other essential items, appear prominently on the primary label of
a protector's packaging. We are also requiring that the supporting infor-
mation to the label include the mean attenuation values and standard devia-
tions derived for a category of protectors (obtained according to ANSI
STD S3.19-1974), in the table showing the computation of the NRR.
81
-------
SECTION 2: LABEL CONTENT
Two sections of the proposed regulation, Section 211.2.4-1 (Information
content of primary label) and Section 211.2.4-4 (Supporting information),
dealt with label content. We received many comments on these sections
from both private individuals and the affected industry. A copy of the
revised label is shown in Figure 2.1. For analytical purposes, the comments
were organized as follows:
o Comparative acoustic information
o Descriptor
o Product and manufacturer identification
o Date of manufacture
o Logo
o Supporting and additional information
o Alternative media
In addition to statements which focused specifically on particular
aspects of the proposed requirements for label information, there were
also general comments on label content from affected manufacturers (38,
60). Their major concerns were with what they perceived as excessive and
redundant information requirements. Noting that Section 8 of the Noise
Control Act only requires that the label give notice of the product's "effec-
tiveness" in reducing noise, ISEA (38) thought the inclusion of such items of
information as company name, EPA logo, and a prohibition of removal statement
(among other things) were beyond EPA's statutory authority. The manufac-
turers particularly felt that the proposed label requirements for
83
-------
Noise
Reduction 2 3 DEC'BELS
ndll HQ (WHEN USED AS DIRECTED)
THE RANGE OF NOISE REDUCTION RATINGS
FOR EXISTING HEARING PROTECTORS
IS APPROXIMATELY 0 TO 30.
(HIGH NUMBERS DENOTE GREATER EFFECTIVENESS.)
(Manufacturer) (Modal No.)
Federal law prohibits / f% \ LABEL REQUIRED BY
removal of this label i ^MK; 1 U.S. E.P.A. REGULATION
prior to purchaae. V •*""*/ 40 CFH Part 211, Subpart B. i
^ ^-f /
Figure 2.1. Revised Label
84
-------
company name, company location and product identification number were
redundant since this information is already provided on the product packag-
ing.
Response:
The Agency addressed questions on our statutory authority to require
label information beyond the NRR in Section 1.1.1 above. We maintain
that the additional information on the label is necessary to give full
meaning to the notice of a protector's effectiveness in reducing noise
as required by Section 8 of the Noise Control Act. Items such as the
company name and location and product identification number are needed
on the label to fix responsibility for the label to facilitate EPA enforce-
ment. The regulation requires the minimum amount of information on the
label needed to provide effective notice.
2.1 Comparative Acoustic Information
The criticisms of general label content and the inclusion of infor-
mation beyond the NRR were also in part criticisms of the inclusion of
the comparative acoustic information.
Few comments, however, actually opposed the concept of comparative
acoustic range.
There were, however, three manufacturers (38, 40, 44) who commented
negatively on the proposed limits of the "0 to 31" range for hearing pro-
tectors. They felt that the range should not be tied precisely to the
performance of "existing" devices because of future developments which
may result in more effective protectors, and therefore require a change
in the range values.
85
-------
ISEA (38) recommended the use of a theoretically "perfect" NRR as
an alternative to fixing the upper limit of the range at a specific number
They maintained this would resolve any problems caused by the addition
to the market of a new device with an NRR exceeding 31, or by the removal
from the market of the best - performing protector thereby lowering the
actual upper limit of the range. ISEA also noted that the range was computed
from ANSI Z24.22-1957 data, and felt that the Agency should wait until all
new ANSI STD S3.19-1974/ASA STD 1-1975 data are collected.
One manufacturer (104) asserted that the range developed by using
ANSI S3.19-1974 data would be more on the order of 0 to 35. However another
manufacturer (44) disagreed with this statement because their tests, using
that standard, showed the best protector would develop a rating of less than
25 dB. Two commenters (40, 44) suggested that the Agency require reporting
of an approximate range.
Response;
In order to respond to the valid points made by the commenters, and
to take account of any uncertainty that exists regarding the effects of
the new standard and new products on the size of the range, EPA has decided
to modify the comparative range statement required on the label. The revised
range statement reads as follows [Sec. 211.2.4-l(c)]:
The range of Noise Reduction Ratings for existing hearing
protective devices is approximately 0 to 30 (higher numbers
denote greater effectiveness).
86
-------
2.2 Descriptor
The use of a descriptor on the label to communicate information about
the effectiveness of hearing protectors in reducing noise received few
critical comments. Of greater concern were issues such as the type of
descriptor and its name.
2.2.1 Possible Misinterpretations
There were a number of comments about the proposed Noise Reduction
Rating (NRR). ISEA (38) expressed concern that the consumer may confuse
the meaning of the descriptor and the range, and think that a device with
a rating of 29 is effective in 94 percent of all noise exposure (i.e.,
29/31). ISEA also feared that exclusive reliance on the NRR would lead
potential consumers of hearing protective devices to overlook other impor-
tant factors such as comfort, durability, or cost, when selecting a pro-
tector. With these considerations in mind, ISEA recommended language
for the label, or its supporting information, which qualified the meaning
of the NRR. ISEA was also concerned that the NRR might not be appropriate
for devices which have special application. One private citizen (5),
similarly concerned about misinformation, emphasized that the rating scheme
should be explained, particularly such characteristics as whether it is
linear or logarithmic. Another person (43) simply expressed his opposi-
tion to any system which required the consumer to consult other materials
to understand the primary label, while a third individual questioned the
meaning of the rating number (66).
87
-------
Response:
The NRR is based on a methodologically sound procedure developed by
acknowledged scientific experts in the field of hearing. The hearing
protector industry was itself involved in the development of the NRR com-
putation procedure. It is a simple, reliable numerical indicator of a
hearing protector's relative effectiveness in attenuating noise entering
the ear. The NRR, as with any such indicator, cannot measure all factors
affecting the effectiveness of a device. It will not eliminate other factors
such as cost, comfort and durability from prospective users' consciousness
when selecting the protective device adequate to their needs. Rather, the
NRR provides the prospective user with quantified and comparative information
through which that person can consider the noise reducing performance of
hearing protectors.
The Agency understands the need for the prospective user to comprehend
the NRR in order to use it effectively. The public awareness campaign
should provide an ultimate purchaser or prospective user with sufficient
background on the NRR, which in fact has been developed so that the purchaser
or user need not be familiar with the complexities of its calculation, in or-
der to use it as an aid in protector selection.
2.2.2 Single Number Descriptor
The fact that the rating system employs a single-number descriptor
drew a few comments. One commentor (49) knowledgeable on hearing protective
devices, felt the single-number rating system could provide practical
information for comparing the attenuation characteristics of different
devices and determining their effectiveness in given noise hazard areas.
On the other hand, the DuPont Company (41) claimed that the single number
88
-------
rating should never be used in such a way that it obscures the effectiveness
of a device over individual frequencies.
A professor of environmental acoustics (9) implied that the single-
number rating was exceedingly difficult to understand, at least if the
user wanted to know about the given procedures. He also commented negatively
on the choice of the designation of "Noise Reduction Rating", because NRR
might be misinterpreted to mean Noise Regulation Reporter, and because
increasingly "sound" is being used in the terminology instead of "noise."
The suggested alternative was "Sound Level Difference."
Response:
While the Agency recognizes the importance of looking at a protector's
attenuation capabilities at different frequencies, it also recognizes the
physical and conceptual limitations on the amount of information that
can be provided on the primary label. Therefore, we decided to require
this kind of data in the supporting information.
Use of any acronym or abbreviation has the problem of possible conflict
with any other acronym or abbreviation. Since only a highly specialized
audience is familiar with the Noise Regulation Reporter, and since the
Noise Reduction Rating (NRR) is an accepted designation in the scientific
community, the Agency believes it is justified in retaining the NRR designa-
tion as the proper descriptor for hearing protector labeling. Finally,
"noise" is a well-accepted term in the scientific community and does not have
any debilitating, negative connotations that affect the utility of the rating
scheme.
89
-------
2.2.3 Classification
Another issue relating to the descriptor is whether or not to employ
a classification scheme that assigns a symbolic or integer value to a set
of personal hearing protectors falling within a certain range of attenuation
effectiveness. There existed a difference of opinion on this issue. One
commenter (43) emphatically opposed any indirect means of rating the noise
reduction capabilities; he desired a descriptor that directly communicated
the amount of decibels reduced rather than a system of classes. A scientist
for the Civil Aeromedical Institute (FAA) (30) held the opposite view.
He believed that a decibel rating could put into competitive disadvantage
those devices that offer adequate protection under most noise exposures,
but are not listed at the upper end of the NRR range. Other reasons he
gave in support of product classes were the "arbitrary" sounding and measure-
ment error that accompanies the decibel rating, the precedent already estab-
lished by the system of grades of agricultural products, and the ease of
comparison afforded by product classes.
Response:
It is the view of the Agency that the positive benefits of the NRR
descriptor, including its uniformity, objectivity, precision, and under-
standability, fully justify its retention for the program over a descriptor
system involving product classes. The NRR will provide the ultimate purcha-
ser or prospective user with a precise, numerical indication of the protec-
tor's relative attenuation effectiveness. Any classification scheme, how-
ever, entails the loss of information since protectors with differing attenu-
ation levels are grouped into the same categories. The result is that bet-
ter performing devices in the same class as poorer ones are penalized, with
90
-------
little market incentive provided for the manufacturer of the latter devices
to improve his product. Furthermore, since the NRR is based on a decibel
scale, the descriptor has the advantage of a base of public knowledge about
decibels, unlike a protector classification scheme. Finally, using the NRR,
and possessing some knowledge of the given noise level in an area, the
prospective user could reasonably estimate the effective resultant noise
level entering the ear when different protectors are used. Such an estima-
tion would not be feasible if a classification scheme were adopted.
2.3 Product and Manufacturer Identification
From the comments submitted by several manufacturers (51, 38, 106,
107), there appeared to be some confusion about what entity constituted
the manufacturer for purposes of identification on the label. One company
(61) suggested that the name of the company introducing the product into
commerce should be on the label, while the original manufacturer could be
identified in the records of the named company.
An industry spokesman (101) commented on protectors that combine hel-
mets or some other head gear, and muff attachments. These two components,
he stated, are often marketed together even though they are produced by
different manufacturers. Finally, the opinion was expressed that even to
include the manufacturer's name and the product number on the label was
unnecessary because the information was already on the product or packaging
(38).
91
-------
Response:
As was explained in Section 1.4 of this docket analysis, the manu-
facturer packaging the protector for sale to the ultimate purchaser or
distribution to the prospective user is to be named on the label. EPA
will maintain the requirement that the manufacturer's name and product
number appear on the label in order to properly fix accountability for the
label.
2.4 Date of Manufacture
None of the manufacturers commenting on the proposed inclusion of
the date of manufacture were in favor of placing this information on the
label. The Industrial Safety Equipment Association (38) asserted that
lot control numbers would serve the same purpose as the date of manufacture
and that the placement of this information should be left to the discretion
of the manufacturer. Another manufacturer (37) also recommended the use of
lot numbers.
The E-A-R Corporation (40), while of the opinion that code numbers
on bulk packaging would be sufficient identification, stated that the
date of manufacture, if required, would be better located on the bulk
dispenser box.
Response:
The Agency agrees with the suggestion that manufacturers be allowed
to place their own code on the label which would identify a group of pro-
tectors and the time period during which they were produced. We have
revised the regulation accordingly.
92
-------
2.5 Logo
There were only two comments about the placement of the EPA logo on the
proposed label. Aural Technology, Inc. (61) felt the logo should be placed
on the label but stressed that it would seem to be an explicit endorsement
by EPA of the validity of the information on the label. The Industrial
Safety Equipment Association (38) gave no opinion about the logo per se but
said that there was no statutory basis for the requirement of its inclusion,
as well as other information, since Section 8 of the Noise Control Act of
1972 requires only a label giving notice of the hearing protector's effec-
tiveness in reducing noise.
Response:
The Agency addressed in detail, within the General Provisions for
Product Noise Labeling, the requirement for the EPA logo on the label.
In brief, the appearance of the logo on the label is intended to notify
an ultimate purchaser or the prospective user that the label is Federally
mandated across the industry, its contents are uniform and that the ratings
are credible.
2.6 Supporting and Additional Information
This section reports those comments which focused on the regulation's
supplemental information requirements or which suggested the inclusion of
additional information within the program's scope.
2.6.1 Flexibility
Two manufacturers (40, 44) appeared concerned that the labeling
provisions were not flexible enough to meet the industry's legitimate
needs. One company (40) suggested that overall flexibility govern the
93
-------
regulation dealing with both the label information and the supporting data.
The E-A-R Corporation felt only the NRR need be printed on each package, and
the octave band data could be "prominently" lettered on the dispenser or
master package (40).
Response:
EPA has, during all stages of the regulatory process, integrated the
needs of the industry into the final action. Industry representatives,
including spokesmen for large and small hearing protector manufacturers
and the relevant trade associations, have been consulted in a variety of
forums. However, the Agency believes that the provisions requiring the
label and supporting information meet the reasonable interests of industry
and the primary goals of the program. In response to E-A-R1s suggestion,
it should be pointed out that octave band data must be reported only in
supporting information and need not appear on the primary label.
2.6.2 Consumer Education
As far as suggestions for additional information are concerned, there
were a few individuals who adopted a fairly broad perspective and stressed
the need for a consumer education program (24, 109, 51, 29, 38, 34, 5).
Several industry commenters pointed out the need to educate the public
on how to use the NRR system (29, 51, 38, 109). The Bethlehem Steel
Corporation (29) said this information, which could be on the label or
in the supplementary information, would help industry to comply with
Federal workplace noise exposure regulations. A NIOSH official (51)
suggested wording for the supporting explanation of the NRR system.
94
-------
Response:
EPA's planned public awareness campaign will include an explanation
of the descriptor. The details and format of this campaign are being
reviewed by the Agency.
2.6.3 Suggested Information for Inclusion
Other kinds of additional information were recommended for inclusion
either on the label or in the supporting information.
ISEA and NIOSH representatives (38, 51) emphasized the importance
of providing attenuation data on each wearing position for protective de-
vices with headbands (multiposition devices). The ISEA spokesman stated that
such information was required so that the wearer does not underestimate the
protection offered by the device at different wearing positions.
Instructions on proper use, maintenance, and fit were recommended
for inclusion by several conmenters (62, 51, 1, 68). A State public offi-
cial (68) thought a disclaimer was needed to inform purchasers that actual
attenuation of devices was affected by improper use; he offered specific
language for this purpose. Two commenters (1, 61) addressed the need to
inform the consumer about the likely degradation of the attenuation capabili-
ties of hearing protectors.
Three commenters (14, 26, 49) suggested the inclusion of information
on the hearing protector's noise reducing capability at individual frequen-
cies. Finally, NIOSH (51) suggested that the supporting information ref-
erence methods to predict noise exposure to the user of the protector, when
the noise field is being described in different ways (e.g., "A"-weighted level
or "C"-weighted level).
95
-------
Response:
With respect to multiposition devices, the NRR to be put on the label
of a hearing protector that uses a headband as its primary means of attach-
ment to the head, and which can be worn in several positions, will be the
NRR of the position that yields the lowest effectiveness rating with the
position(s) noted on the label. The supplementary information will contain
the NRRs for the other wearing position(s) (Section 211.2.4-4(a)).
The Agency recognizes the importance of proper care and fit in achieving
the maximum attenuation from the protector. Instructions as to the "proper
placement" of a device, as well as a warning on the importance of fit
in realizing the stated effectiveness, are required as part of the supple-
mentary information (Section 211.2.4-4(d),(e)). However, the inclusion
of information on the "likely" degradation of attenuation is inappropriate
at this time because of the lack of useful-life data. The work that the
National Institute for Occupational Safety and Health is doing on the actual
protection supplied by ear inserts may develop some useful-life data in
the future.
Data on sound attenuation values at different frequencies are part
of the supporting information (Section 211.2.4-4(a)), as recommended oy
several commenters.
The ability to use the NRR in different noise fields (e.g., "C" and
"A") is explained in the supporting information by showing how to determine
the "A"-weighted noise reducing ability of the protector(s) from the "C"-
weighted Noise Reduction Rating (NRR).
96
-------
2.7 Alternative Media
Most industries did not explicitly reject the idea of providing infor-
mation about hearing protector effectiveness to the public, but felt that
there were other ways besides the proposed label to provide consumers
with the appropriate data. Bilsom International, Inc. (44) suggested that
the information be provided "at a location defined flexibly enough to
relate to the product, its package, and the reality of the sales trans-
action," which was perceived as primarily oriented toward bulk sales to
industry. This company and other manufacturers of hearing protectors,
many of whom shared Bilsom's criticisms about the label location require-
ments, recommended alternative ways to supply consumers with the attenua-
tion data.
Four manufacturers (44, 40, 101, 38) felt that the "label" informa-
tion should be placed in technical and/or sales literature so that the
information reaches the proper audience, the industrial consumer. Two of
these manufacturers (38, 40) also mentioned another location for the label
information that they viewed as appropriate - namely, the dispenser or
master cartons containing the insert-type protectors.
Flents Products and E-A-R Corporation (101, 36, 104) both suggested
that package inserts might be preferable to labels, either small inserts
placed with individual insert protectors or 8 1/2" x 11" sheets of paper
contained in larger cartons of several hundred protectors. The cost
effectiveness of transmitting information in this manner was thought to
be much better than through the labeling program, according to two com-
menters (101, 106).
97
-------
Response:
The concerns of these manufacturers are substantially addressed through
the Agency's decision to require labeling based on the method of display at
the point of sale to the ultimate purchaser, or the point of distribution
to the prospective user. This is discussed in detail in Section 4 of this
analysis.
98
-------
SECTION 3: SPECIAL CLAIMS AND EXCEPTIONS
3.1 Exceptions
There were a number of comments on the proposed regulation regarding
special claims and exceptions. The NPRM stated that, if a manufacturer
believes the NRR is not applicable to a given device, the manufacturer
may apply for an exception to certain provisions of the regulation (i.e.,
test methodology and effectiveness rating). The manufacturers request
must offer a "suitable alternate effectiveness rating" for the device,
and "be supported by conclusive scientific test data." (Sec. 211.2.5(b)).
Most of the comments dealing with special types of protectors were
from two manufacturers, The Norton Company (21, 107) and Aural Technology
(39). The Norton Company cited what they viewed to be the advantages of
non-linear hearing protectors, expressed concern that these devices may
not be testable using ASA STD 1-1975/ANSI S3.19 testing procedures, and
felt the resulting NRR of 0 would represent an unfair competitive dis-
advantage for non-linear protectors. At the same time, they indicated
their intention to file for an exception and commented on the related
requirement for submitting information on a "suitable alternative effective-
rating," supported by "conclusive scientific test data" (Sec. 211.2.5(5)).
They noted that the word "suitable" is not defined and maintained that
a "suitable" alternative rating system for a device for which the NRR is
not an accurate indicator can be independent of and unrelated to the proposed
NRR system. They also asserted that the regulation does not define what
constitutes "conclusive scientific test data" and suggested language for this
purpose.
99
-------
Aural Technology (39) also requested an exception from the proposed
NRR testing system for its vented device, because of the inappropriateness
of the test for that particular type of protector. It urged that "an
objective evaluation" developed in the Health Sciences Center of the Univer-
sity of Oregon be approved by EPA as a suitable alternative since the pro-
posed subjective method is inappropriate. Otherwise, Aural Technology feared,
its vented device would be subjected to an unjustified competitive disadvan-
tage since it would receive an NRR value of 0. In other entries to the
docket, Aural Technology supplied supporting data to further recommend
adoption of this objective testing alternative.
Norton Company (27) criticized the fact that the exception require-
ments applied to devices already on the market, which meant that products
for which exceptions were being sought could not be sold until an atten-
uation rating was approved. Specifically, they objected to the second
sentence of Section 211.2.5(a), which they felt should be altered to restrict
application of the rules to devices not already on the market as of the
effective date of the final regulation. The Norton Company (27) commented
further that alternative procedures should be established for devices on the
market, suggesting that a period of at least a year after the effective date
of the rules should be allowed to prepare for the application of an exception
ISEA (38) also maintained that there were hearing protectors for which an NRR
may not represent the true protective quality of the device.
100
-------
Response:
The Agency will maintain the provision for special claims and exceptions
for those devices for which the manufacturer believes the NRR is inappli-
cable, since it is not the intent of the Agency to place any special protec-
tors at a competitive disadvantage. EPA will consider these requests for
exception on a case-by-case basis, and will notify the manufacturer within
thirty (30) days if the exception is approved, if additional data is needed,
or if the Agency needs additional time to properly consider the request.
The clear need for uniformity in the testing methodology used in the
program demands that a "suitable alternative effectiveness rating" must
demonstrate not only scientific validity but also a consensus of use and
acceptability in the scientific and industrial communities. Such an
acceptable effectiveness rating must display qualities similar to those
which led to adoption of the NRR, as for example, standardization, quantifi-
cation, validity, reliability and understandability. Until a request is
presented with rating schemes which, in the Agency's judgment, reflect
these qualities, the exception will not be granted.
At present, for example, there exists no widely accepted testing
methodology which rates the noise attenuation effectiveness of non-linear
protector devices. Since these devices are marketed as hearing protectors,
they must be rated with a NRR, until an exception is presented accompanied
by a suitable effectiveness rating scheme having a consensus of all non-
linear protector manufacturers, which meets the above qualifications. This
would allow non-linear devices to be properly rated and compared among
themselves.
101
-------
To set aside the current product line from the requirements of the
program pending an exception request, as the Norton Company suggested,
would work against the primary goals of the program. The industry will
be alloted ample time in the one-year period between the promulgation of
the regulation and the effective date to file exception requests for EPA
review. It should be noted that only protectors manufactured on or after
the effective date of the regulations are subject to its requirements.
The recordkeeping and reporting requirements proposed for special
claims of acoustic effectiveness have been reduced. The Agency is not
requiring manufacturers to obtain Agency approval of their suggested special
claims before presenting them to the public. However, manufacturers wishing
to make special claims about the noise reducing effectiveness of their
devices, other than the Noise Reduction Rating (NRR), must be prepared to
demonstrate the validity of those claims.
3.2 Exemptions
There was also a comment focusing on the particular stage of develop-
ment of a protection device and the need for an exemption (from the labeling
requirements). Bilsom International (1) requested that the regulations
not be applicable to new products (prototypes, unmarketed new designs) for
a period of twelve months after their entry into the market in order to
avoid discouraging product innovation.
Response:
The rule applies to new products (the equitable or legal title of
which has never been transferred to an ultimate purchaser) manufactured
on or after the stated effective date. Exemptions from the requirements
102
-------
can be requested for prototype devices according to Section 211.1.10 of
Subpart A. Products that enter commerce before the effective date of this
rule are not required to comply with the labeling requirements of this
regulation. The manufacturer may label protectors produced up to 6 months
before the effective date of the regulation, as stated in Section 211.1.10-3
(f) of the regulation, if the Agency is allowed to monitor the early label
verification testing, and the testing is done with production-line pro-
tectors.
103
-------
SECTION 4: LABEL PLACEMENT, SIZE REQUIREMENTS
AND RELATED CONCERNS
Two of the more prominent concerns related to the labeling require-
ments were label placement and label size. Also discussed in this section
are comments pertaining to label color and character or type specification.
4.1 Placement and Type of the Label
The comments concerning label placement were directed mostly toward
where to place the label. Commenters indicated confusion over the term
"product packaging," as described in Section 211.2.4-3. Wilson Products
and Bilsom International (103, 1) requested clarification as to the unit
which must be labeled.
Outlining the difficulties of adopting strict labeling standards
governing all devices, Flents Products (101) emphasized that a given product
is often packaged in several ways, each having its own limitations in terms
of labeling (101), while Bilsom International (1, 44) recommended that
the regulations be flexible so as to relate to the individual product, its
packaging, and the sales environment.
Several comments (1, 36, 38, 61, 101, 106) concerned alternative
means of presenting label information, such as sales literature and package
inserts. (See also Section 2.7.) E-A-R Corporation (40) urged that only
the NRR rating be included on each package and that the remaining infor-
mation be supplied through other media. The Mine Safety and Health Admin-
istration (formerly Mining Enforcement Safety Administration) (16) suggested
a permanent NRR on the device itself. J. I. Case Company (32) also had
as its first choice a reasonably permanent label on the hearing protector.
105
-------
Another manufacturer of protectors (40) pointed out that the printing of
information on an individual protector, as opposed to its package, was
not practical in terms of hygiene, legibility, or cost effectiveness. The
Mine Safety Appliances Company (102) suggested that the embossing of informa-
tion on individual inserts was inappropriate for monetary reasons. The
Industrial Safety Equipment Association and Flents Products (38, 109, 60)
requested clarification of the latitude to either affix labels or print them
on packages; Flents Products also requested clarification with regard to the
acceptability of "hang tags" (4); labels that are affixed to the protector
by way of a string.
Response:
The language of Section 211.2.4-3 of the regulation has been modified to
clarify the intent of the Agency. It is up to the manufacturer that packages
the protector to choose the type of label for his products (i.e., permanent,
embossed, stick-on, hang tag, among others). The purpose of the label, as
stated in the regulation and in Section 8 of the Act, is to give notice to the
prospective users of hearing protectors concerning the noise reducing effec-
tiveness of the product. This is to be accomplished by making the information
available before actual sale or use. It is the element of visibility of the
label at the point of purchase or use that is of paramount importance. If the
label is not visible to the ultimate purchaser or prospective user prior to
purchase or use, then the information on the label will be of limited prac-
tical value.
Manufacturers may use any labeling means available as long as the
labeling requirements are met.
106
-------
4.2 Industrial vs. Retail Market
Bilsom International and Flents Products (44, 101) asserted that the
EPA regulations confuse the product purchaser and the product end-user in
those cases where the user-industries purchase protectors in bulk quantities.
Label information supplied to the end-user would not serve the purposes
of the program acccording to two commenters (1, 101) since the end-user has
no control over the purchase decision. Along the same line, a manufacturer
(44) stated that the commercial buyer does not inspect the individual product
package.
The Industrial Safety Equipment Association (38,109) questioned whether
the labeling regulations applied to both the industrial and consumer markets,
and how EPA intended to regulate the labeling of devices sold unpackaged in
bulk quantities. Two manufacturers (107, 40) felt there should be different
labeling requirements for industrial and consumer products.
Flents Products (60, 101) objected to any requirement for labels
affixed to individual protectors or their carrying cases when they are
sold in bulk, and to the labeling of both boxes and packaging inserts. (See
also Section 1.3 for a discussion of industrial vs. retail market.)
Response:
Because of the two markets that hearing protector manufacturers and
distributors serve, the Agency is requiring labeling according to the method
of presentation of a protector at the point of sale to the ultimate purchaser
or distribution to the prospective user. This method, explained in subsec-
tion 4.3, labels protectors for both bulk and consumer markets while continu-
ing the industry's present marketing practices and packaging methods.
107
-------
4.3 Size of the Label
The size of the required label was a major issue. Section 211.2.4-2(a)
of the regulation states that the label shall have minimum dimensions of 3.8
centimeters x 5.0 centimeters (approximately 1 1/2" x 2"). Strong recommenda-
tions for flexibility in the size requirements were made by Flents Products,
the Industrial Safety Equipment Association, and Bilsom International (36, 38,
44). Also noting problems with the label size were the Charles Machine Works,
a professor of environmental acoustics, and E-A-R Corporation (37, 9, 40).
Commenters (36, 60, 101, 38, 40, 44) used such adjectives as "excessive,"
"unreasonable," and "impractical" to describe label dimensions which exceed
both the size of the product and its package.
Related concerns had to do with costs associated with package redesign
(36, 60). Flents Products (36, 101) indicated that hearing protectors should
not require more stringent labeling requirements as to size than those
required by the Mine Safety and Health Administration (formerly MESA) on
respirators. Wilson Products (103) expected no problem with label size for
the muff-type protector.
Response:
While packaging changes may result from the requirement that protectors
be labeled with a minimum sized label, labels of a size smaller than 3.8 x 5.0
centimeters (cm) (approximately 11/2x2 inches) with correspondingly smaller
print are practically non-informative because of their illegibility. There-
fore, the Agency maintains that the label must be no smaller than 3.8 x 5.0
cm.
However, in requiring that the minimum label size be 3.8 x 5.0 cm, the
Agency has developed the following labeling criteria based on the means
108
-------
used to display the protector at the point of ultimate purchase or distribu-
tion to the prospective user.
(1) If the protector is individually packaged and so displayed at the
point of ultimate purchase or distribution to users, the package must
be labeled as follows:
(a) If the "primary panel" of the package, as defined in Section
211.2.3 of the regulation, has dimensions greater than 3.8 x
5.0 cm the label must be presented on the primary panel.
(b) If the primary panel of the package is equal to or smaller than
3.8 x 5.0 cm, a label at least 3.8 x 5.0 cm must be affixed to
to the package by means of a tag.
(2) If the protector is displayed at the point of ultimate sale or
distribution to users in a permanent or disposable bulk container
or dispenser, even if the protector is individually packaged within
the dispenser and labeled as above, the container or dispenser itself
must be appropriately labeled. The label must be readily visible to
the ultimate purchaser or prospective user.
Labeling of the "Dispenser," as defined in Section 211.2.3 of the
regulation, requires, that the accompanying protectors NOT be separated from
the dispenser before ultimate purchase. Separation is tantamount to removal
of the label, which is prohibited by Section 10(a)(4) of the Act.
4.4 Character Type and Color
The Industrial Safety Equipment Association (38) suggested that con-
trasting colors on the label were unnecessary if the label were legible. They
also recommended that choice of size and type be left to the manufacturer for
109
-------
cost-related reasons. E-A-R Corporation (104) submitted a mock-up label
which suggests that the required label size cannot accommodate the required
type size.
Response:
EPA believes that the consistent requirements for color contrast,
minimum size, and type specifications are essential not only to insure the
overall legibility of the label but also to provide a uniform label format
and appearance. This uniformity is needed to assist the ultimate purchaser
or prospective user in identification of the label for comparative purposes.
A misprint in the proposed rules was published in the Federal Register
on page 31734, column 3, paragraph 3, line 3; the minimum type size required
for Area B of the label should have read "24 point." E-A-R Corporation
correctly noted that the printed "42 point" requirements could not be accom-
modated on the label, given the other area specifications and the minimum
label dimensions. However, the Agency has determined that to avoid confusion
in the printing of labels, and to be technically accurate in stating the
size of the type to be used, we have stated the "type face" sizes for a 3.8 x
5.0 cm label as follows:
Area A - 2.8 millimeters (mm) or 8 point.
Area B - 7.6 mm or 22 point for the Rating.
1.7 mm or 5 point for "Decibels".
Area A-B - 1.5 mm or 4 point.
Area C - 1.5 mm or 4 point.
Area D - 0.7 mm or 2 point.
Area E - 0.7 mm or 2 point.
110
-------
Area F - 0.7 mm or 2 point.
Area H - 0.7 mm or 2 point.
These type face sizes apply to the 3.8 cm x 5.0 cm label; type face
sizes for larger labels must be in the same approximate proportion to the
label as those specified for the 3.8 cm x 5.0 cm label.
Ill
-------
SECTION 5. RATING SCHEME AND TEST METHODOLOGY
5.1 The Noise Reduction Rating (NRR)
The docket contains a number of entries which address overall apsects
of the NRR as conceived in the proposed rules. Few commenters objected
to the principle of the NRR when it was feasible for the protectors in
question, although several persons raised objections to narrow, discrete
aspects of the NRR. Alternative ratings or test methodologies were also
suggested. (Some of the comments reported here are also discussed in Section
2.2.)
5.1.1 Criticisms of the NRR
Dr. Paul Michael (107), a Pennsylvania State University Professor
of Environmental Acoustics (9), sought to clarify language in the NPRM (42
FR 31731, para. 4) [1] by noting that NIOSH does not employ the single-number
designation "Noise Reduction Rating" (NRR). He viewed the single-number
rating system as needlessly complex, claiming that it emphasizes magnitude
rather than reliability of performance. Dr. Michael also pointed out
that many Federal agencies, such as the Department of Labor, use the term
"sound" rather than the "more pejorative" "noise" whenever possible.
Response:
The NRR required in the regulation is a reliable accepted approach
for expressing the attenuation effectiveness of a hearing protector in a
readily understandable single-number format. Although the Agency recognizes
that there are other characteristics of a protector that also relate to its
attenuation performance, we have determined that the NRR is the best avail-
able descriptor to give notice to the prospective user of a protector's
113
-------
potential effectiveness in reducing noise. For the sake of simplicity and
greater understandability in the calculation of the NRR, we have simplified
the method of calculation.
In response to the concern about terminology, the Agency views "noise"
as unwanted sound. In this respect, "noise" is the appropriate term for use
in this regulation, since it is the intent of this regulation to provide
information to the prospective user which will assist that person in select-
ing a device adequate to attenuate the level of unwanted sound.
Issue:
NIOSH (51) suggested wording for the supporting explanation of the
NRR, and urged that the manufacturer be required to provide the
exact mean attenuation and standard deviation on which the labeled
NRR is based.
Response:
The regulation requires that the mean attenuation and standard deviation
for a category of protectors be reported in the supporting information in-
cluded in the packaging.
Issue:
A spokesman for the Australian Department of Health (47) suggested
that EPA re-examine the need for the 3 dB "spectrum" correction in
the NRR calculation since it might not be imperative for adequate
protection.
Response;
The "spectrum" correction is based on firm data originating from the
scientific community concerned with hearing protection. Its appropriateness
114
-------
for the goals of the program can be readily documented through scientific
evidence. EPA has therefore determined that it should be retained.
Issue:
The DuPont Company (41) recommended comparison testing of one-third
octave band measurements and standard octave band measurements to determine if
the costly one-third octave band method is needed for the program.
Response:
The use of the one-third octave band method was adopted after close
consultation with the protector industry community. This methodology is fully
accepted in both scientific and industrial communities, and is essential for
evaluating protector effectiveness at various frequencies.
Issue: Another commenter (3U) particularly commended EPA's selection of
the method of the mean attenuation value minus two standard devia-
tions, and included a paper he wrote pointing out the value of such
an approach. However, an official of the Mine Safety and Health Ad-
ministration (formerly MESA) (16) felt that the NPRM was incorrect in
stating that the subtraction of two standard deviations from the mean
attenuation values "assures applicability of the attenuation est-
imates to 98 percent of the population." He claimed that the con-
fidence level would be 95 percent.
Response:
Since the calculation is based on a one-tailed statistical test in that
the values exceeding the upper confidence limits are safe, the 98 percent
figure is the correct one. To clarify the meaning of the statement, it
should state that 98 percent of the population will be at or above the stated
value and therefore on the "safe" side of the rating.
115
-------
5.1.2 Other Purchase Considerations
ISEA (38) feared that exclusive emphasis on the NRR could lead consumers
to overlook other important factors such as comfort, cost, durability and
compatibility with other protective equipment and suggested that certain
language be added to the label, master carton, or sales literature which
would encourage use of protector selection criteria in addition to the
NRR.
A spokesman for the Australian Department of Health (47) expressed
the opinion that, under the proposed NRR, the user would be overprotected
with unnecessarily heavy and uncomfortable hearing protectors.
Response:
The NRR--far from replacing other factors such as comfort, cost and
durability that figure into the selection of a protector for a particular
situation—augments their use by providing an objective, reliable source of
information in the most vital area of protector performance, i.e., its actual
effectiveness in reducing noise. Furthermore, the regulation does not re-
strict manufacturers from including in their marketing literature, packaging
etc., any other factural information.
The Agency believes that the requirements of this regulation are un-
likely to cause the prospective user to be burdened with unnecessarily
cumbersome protectors. In the protector industry, comfort and fit of the
devices are afforded strong emphasis in product development. Better perform-
ing protectors are not necessarily less wearable or comfortable than other
protectors.
5.1.3 Objective Test Methods
The ISEA (38) suggested that physical measurement methods should not be
applied to the evaluation of hearing protector performance until adequate
procedures are fully developed.
116
-------
Plasmed (31) urged EPA to develop a less costly objective test method to
replace the proposed subjective test. However, other commenters expressed
reservations about objective test methodologies for hearing protectors.
One manufacturer (1) pointed out the limitations of objective testing, while
a second commenter (1U1) asserted that no satisfactory or reliable objective
tests for insert protectors exist. In response to questions about the
possibility of using an objective test as a screening device to identify
significant labeling inaccuracies, an E-A-R Corporation representative
(1U4) noted that tests conducted by his firm indicated no correlation between
a given decibel change in an objective test using an artificial "ear" and a
given decibel change measured in a standard subjective test. A Norton
Company official (108) suggested that artificial objective testing is inap-
propriate for purposes other than quality control.
Response:
There is a consensus within the scientific and industrial segments
of the protector community that no suitable objective test of protector
attenuation effectiveness is currently available for general use. Should the
industry find a correlation between the results of the required methodology
and some objective test, and wish to use the objective test internally for its
own purposes, the Agency would have no objections. The American National
Standards Institute Standard S3.19-1974 procedure remains the required method
for compliance with the testing and labeling requirements of the regulation.
If a breakthrough should occur, such that a national or international standard
is developed for an objective method that permits reliable testing of all
hearing protectors to the accuracy of the present subjective test method, the
Agency will consider it as a candidate to replace the present method.
117
-------
5.1.4 Alternative Approaches
Eleven commenters offered suggestions or observations on possible
alternative approaches to the proposed NRR. A NIOSH official (51) pointed
out that his agency's certification program takes into account other impor-
tant performance characteristics of protectors beyond those reflected in the
NRR, and the DuPont Company (41) suggested that EPA adopt the original NIOSH
rating system contained in Section I of Criteria for a Recommended Standard
in Occupational Exposure to Noise (NIOSH, 1972).
A citizen (64) cited a possible alternative to the NRR contained in
the following publication: Selection Uuide to Hearing Protectors for Use on
Firing Ranges, National Institute of Law Enforcement and Criminal Justice,
LEAA, April 1976. He noted that its effectiveness rating number ranged
from 6 to 47.
An expert in the area of hearing protection devices (3U) objected to
the use of the decibel-number NRR instead of a rating system using product
classes. To demonstrate the possibility of a classification scheme he
submitted a paper describing his Protector-Attenuation Rating (P-AR). He
mentioned that the P-AR takes into account three major factors determining
protector effectiveness and arrays protectors in six classes based on the
difference between a protector's score and the mean attenuation in units of
standard deviation.
Response:
As previously explained, the Agency has given due consideration to
other performance characteristics and rating schemes, and has adopted the
118
-------
composite NRR for its qualities of reliability, validity, ease of quantifica-
tion and usefulness.
The reasons for not choosing a classification scheme were discussed in
Section 2.2. Briefly, the Agency has determined that a product classifica-
tion scheme is disadvantaged by its inherent loss of information in compari-
son with the accepted precision of the NRR as adopted.
5.2 Selected Standard
EPA's selected standard for determining the value of the sound attenua-
tion level, the American National Institute Standard (ANSI STD) S3.19-1974,
"Method for the Measurement of Real-Ear Protection of Hearing Protectors
and Physical Attenuation of Earmuffs", attracted a significant number of
comments which centered on questions of the variability of test results under
the standard, the use of C-weighting, fitting considerations and possible
alternative standards.
5.2.1. Miscellaneous Comments
A Professor of Environmental Acoustics at Pennsylvania State University
(9) suggested the typographic correction from Z22.540-1957 to ANSI Z24.22-
1957 in Section 211.2.3 (b) and (c). Another commenter (3) noted that the
ASA STD 1-1975 (ANSI STD S3.19-1974) calls for a band force report but fails
to specify how a hardhat hearing protector attachment can be measured for
force.
Response:
The Agency gave careful consideration to a comment that the test method
requires a report of the force that the headband procedures, and its effect
on the noise reducing effectiveness of protectors that use headbands as
119
-------
their principal means of attachment. The test method does not state how
the data is to be derived for hardhat hearing protectors. EPA concluded,
after conferring with technical experts, that the "band force", as derived in
the standard, was designed to measure only "muff" type protectors that actu-
ally employ a band as the means of clamping the protectors to the user's
head. Hearing protectors combined with hardhats do not normally depend on a
headband for clamping force. However, until another measurement method is
devised that adequately measures the clamping procedure used by hardhat
protectors and relates this to their noise reduction rating, the mean attenua-
tion levels at the test frequencies and the NRRs for this type of protective
device must be derived according to the designated measurement method. When a
validated procedure is available, an exception may be requested, and the
Agency will review the request.
5.2.2 "C" vs. "A" Weighting
While Flents Products (4) had no serious objections to the selected
standard, it did urge EPA to exercise caution in the use of this relatively
new and unproven procedure. E-A-R Corporation (104) pointed out that certain
test results for a given protector differed between the old and new standard.
E-A-R estimated that the likely range of the NRR under ANSI S3.19-1974 would
be an approximate range of zero to 30 or 35.
The requirement for "C"-weighting under the selected standard drew
comment from four respondents (9, 16, 38, 41). Taking exception to page
31731, Col. 1, Para. 2, Lines 1-5 of the proposed rules, Dr. Paul Michael
(9) argued that "A"-weighting does not "approximate the human threshold
of hearing curve" while "C"-weighting is "relatively unweighted (as stated
120
-------
in the regulations)" only at the center frequencies. Three commenters,
including the Mine Safety and Health Administration (MSHA) (formerly
MESA)(16), reflected concern about the NRR's reliance on "C"-weighting and
generally preferred "A"-weighting, partially because of the "A" weighted
sound level meters commonly used in industry. The comment by the MSHA
expressed a concern about the implied need to measure the "C"-weighted noise
level in the workplace in order to calculate the "A"-weighted noise level
entering the ear of a hearing protector user, if the protector is rated by a
rating factor derived from "C"-weighted noise.
Response:
EPA consulted with representatives of the industry and of the scientific
community and has determined that the Noise Reduction Rating (NRR), derived
from a hypothetical noise level that is "C"-weighted, will provide the best
descriptor currently available for the uniform rating of hearing protectors
for use in all noise enviornments.
The MSHA concern is pertinent if the environmental noise spectrum is
dominated by low frequencies (below 500 Hz). However, in many industrial
noise environments, the spectrum is not dominated by low frequencies, and the
"A"-weighted noise level closely approximates the "C"-weighted level; conse-
quently, subtracting the NRR from the "A"-weighted environmental noise level
yields a good approximation to the "A"-weighted level entering the user's ear,
and a "C"-weighted measurement is not essential.
It also is pertinent that, at high noise levels, the spectral response of
the ear is similar to "C"-weighting, so that the degree of protection afforded
the user is indicated reliably by the NRR which is the difference between
121
-------
the "C"-weighted noise level of the environment and the "A"-weighted noise
level at the ear less 3 dB for spectral uncertainty,
5.2.3 Proper and "Best" Fit
Many comments addressed the issue of the difficulty of achieving the
proper fit and wearing position for ear protectors, which affects a major
reduction in real attenuation (versus the attenuation values yielded under
test conditions with the selected standard). This raises the question of
whether or not the real-life environment should be sought in the test con-
ditions outlined in the standards. NIOSH (51 and 105) reported that its
research indicated that protectors provide 50 to 65 percent less attenuation
in actual use than under laboratory conditions, probably because of improper
or variable fit and improper use of the devices by the field-tested subjects.
Four other individuals (62, 68, 69, 108) offered similar observations on the
effects of improper fit and individual subject variability in protection
afforded by a device.
Dr. Michael (9) contended that all protector sizes should simply be
available for the ten test subjects (rather than randomly selecting the test
subjects and expecting the selected people to require all sizes of the protec-
tor under testing).
A comment was made about the type of fit permitted in the testing, with
one manufacturer claiming that results from "best fit" subjects should not be
used for labeling or advertising because of the potential for variability
between subjects (18). This individual advocated complete randomness in the
choice of test subjects and, most importantly, the reporting of all test
results.
122
-------
Response:
EPA recognizes the proolem of the variation between attenuation test
values obtained under laboratory conditions and those obtained in the field.
This variation can be explained through individual wearing differences and
through improper use and fit of the devices in the field. Therefore, the
regulations require that the supporting information contain a statement
on the negative effects of improper fit on the attenuation performance of
protectors, as well as instructions on proper fitting of the device.
The Agency, following discussions with appropriate experts and a thor-
ough review of the issue, agrees with Dr. Michael that having all sizes of
the protector available for the ten test subjects reasonably fulfills the
requirement of randomness. The requirement at Section 211.2.10-2(c) has
been modified accordingly.
b.2.4 Alternative Standards
Three commenters made remarks related to possible alternative standards.
Bilsom International (1) called for a testing standard that reflects both
noise reduction and wearability factors. Aural Technology (7) submitted
comments on the selected standard in support of its contention that its
vented device should oe tested under an alternative standard developed at the
University of Oregon. An agency of the Government of Austria (22) requested
the reason why EPA did not adopt International Standards Organization (ISO)
Standard 4869 for the program.
Response:
The Agency is aware of no testing standard that objectively quantifies
wearability of hearing protectors that might be adopted for this regulation.
The acceptability of alternative standards through exceptions, such as that
123
-------
suggested by Aural Technology, is discussed in detail in Section 3 of this
docket analysis. In response to the inquiry from the Government of Austria,
the Agency decided that ANSI S3.19-1974 was preferaole to the ISO Standard
4869 based on the evaluation obtained from the scientific community. It
should be noted that ISO 4869 was in fact developed from the chosen ANSI
S3.19 standard.
The Agency tries to use measurement standards from voluntary standard-
setting organizations that have been developed, validated and are in use.
The Agency encourages the development of improved subjective and objec-
tive test methodologies. Procedures that have been demonstrated to correlate
with the prescribed procedure should be submitted to the Agency for considera-
tion as alternate methodologies or replacements to the procedure specified
under Section 211.2.5 of the regulation.
5.3 Laboratory Facilities
There were numerous comments, in both the written submissions to the
docket and at the public meeting on December 13, 1977, about the laboratory
facilities that would be needed to conduct the testing. Three major concerns
reflected in those comments were the availability of laboratories capable of
performing the required test, the possibility of obtaining biased results
from some testing firms, and the variability in test results between differ-
ent laboratories.
5.3.1 Availability of Testing Laboratories
Representatives of several affected manufacturers (102, 101, 38) ques-
tioned whether or not there were sufficient laboratories available to permit
nationwide implementation of the program. One commenter (101) reported that
there were no more than three laboratories currently able to perform the
124
-------
required tests, while another commenter (102) stated that only one of the
three laboratories found to do psychoacoustic testing did contract work for
manufacturers. An I SEA spokesman (38) asked if the Agency knew the number of
laboratories presently equipped to conduct the ANSI S3.19-1974 test.
A related concern of manufacturers was the possibility of lengthy delays
in testing due to excessive demands placed upon the few laboratories thought
to be capable of performing the tests. Because of this limited capacity, one
commenter (101) thought the six-month period from promulgation of the regu-
lation to the effective date should be extended to no less than twelve months
and preferably to eighteen months.
Response:
The Agency consulted with experts in the field of hearing protection
and laboratory management and was assured that adequate facilities would
exist given adequate lead time before the effective date of the regulation.
The Agency further determined that those laboratories presently capable
of testing hearing protectors according to the required test method are:
the Pennsylvania State University (Environmental Acoustics Laboratory, State
College, PA), the Worcester Polytechnic Institute (Worcester, MA), the
U.S. Naval Air Station, (Pensacola, FL), the U.S. Aviation Center (Ft.
Rucker, AL), and the National Institute for Occupational Safety and • Health
(Morgantown, WV).
Partly in order to allow greater availability of laboratory facili-
ties, the Agency is requiring the regulation to be effective one (1) year
from promulgation of the final rule. This should be ample time to perform
the initial product testing required.
125
-------
5.3.2 Possibility of Biased Results
Several comments (51, 62, 101) dealt with the potential for biased test
data resulting from manufacturers using their own laboratory facilities or
working in collaboration with test firms. One commenter (62) was especially
concerned about the possibility of fraudulent activities practiced by test
labs (62). A spokesman for NIOSH (51) said that his agency's experience with
using test facilities that are either manufacturer-owned, or manufacturer-
selected, indicated that both approaches result in inadequate enforcement.
He suggested EPA rely on NIOSH test data once their certification program is
established. On the other hand, one manufacturer (40) thought that each
industry should be allowed to choose the lab it uses for compliance audit
testing.
Response:
The enforcement procedures within this regulation are specifically
designed to effectively handle cases of improper labeling. The provisions
for monitoring the accuracy of test results and of labeled values, the
possibility of Federally-supervised compliance audit testing, and the poten-
tial for recall or relabel are considered adequate deterrents to testing
fraud. However, should the Agency receive evidence of widespread improprie-
ties with respect to product testing, it will consider alternative measures.
5.3.3 Test Variability
Test variability between different laboratories was a concern mentioned
by three commenters (44, 103, 104). One manufacturer (44) felt that the
regulations do not recognize the influence of laboratory conditions on test
results, and therefore it would be unfair to hold manufacturers liable for
these limitations. A representative of the E-A-R Corporation (104), also
126
-------
commenting on variability between laboratories, recommended that any retest
be done at the same laboratory which did the original testing, assuming that
the facility was on a government-certified list of laboratories. He also
suggested that, if the new mean was not more than one standard deviation
lower than the prior reported mean, the product should be judged to be in
compliance.
Response:
The responsible parties must take into account testing variability and
the influence of laboratory conditions when reporting test results or label-
ing products. Some variation because of testing conditions enters into any
scientific measurement procedure.
However, the Agency concluded, after conferring with both private and
government testing laboratory technical experts, that "experimenter fit",
(i.e., the hearing protector is fitted to the test subject by the experi-
menter) rather than "subject fit" (where the test subjects fit themselves
with the protectors) should be required.
While "subject fit" results in a more subjective rating of a protector,
it also produces values of noise attenuation that spread much more widely
about the "mean" (average) attenuation value for a test frequency. Conse-
quently, enforcement procedures based on a test using "subject fit" would
have to allow greater variability in the values derived from the test. This
dispersion of values about the "mean" reduces the possibility of reproducing
the attenuation values from test-to-test, and thus the test is less strictly
enforceable.
127
-------
"Experimenter fit", however, ensures greater consistency in the "fit" of
the protector to all subjects, which tends to reduce the test-to-test
variability.
We have examined the potential for variability in the test between
facilities, and agree that there may be variations in measured attenuation
from facility to facility as a result of slight differences in the physical
facilities or in the way the facility implements the test. However, because
of the modification of the test procedure to require "experimenter fit", we
believe these variations to be small. Furthermore, the procedure, of itself,
will reduce variations between test facilities because of the thirty (30)
tests required during labeling verification to obtain a single NRR for a
category of protectors. The consensus of technical experts was that manufac-
turers will take possible variations between test facilities into account in
designating NRRs for their protectors.
128
-------
SECTION 6: ENFORCEMENT
The label verification and enforcement scheme of the program drew a wide
variety of comments, many of them specific and technical. A few entries did
address the general enforcement approach. The Forging Industry Association
(FIA) (26) stated a preference for voluntary compliance by the hearing pro-
tector manufacturers, and a state government official from North Carolina
(34) suggested that EPA provide testing as a service rather than requiring it
by regulation. Industry spokesmen for ISEA (38) and E-A-R (40), expressed
the opinion that the compliance system creates a gambling situation for the
manufacturer, in that he is forced to calculate the degree of risk he is
willing to take in assigning his product an NRR.
Response:
None needed.
6.1 Label Verification
6.1.1 General Issues
One manufacturer (31) asked if separate label verification tests would
have to be conducted for each of the firm's customers, resulting in prohibi-
tive testing costs. Another manufacturer (44) expressed opposition to what
he perceived as a requirement for the pre-approval of labels in 211.2.10-3,
viewing it as a costly delay in the distribution of products.
The Industrial Safety Equipment Association (ISEA) (38) concurred with
EPA's decision that only production model protectors be required to undergo
verification testing, but also suggested that the requirement for samples of
products for compliance audit testing in Section 211.2.12-l(c)(5) should be
consistent with accepted practices for the type of device being tested. They
129
-------
recommended the testing of ten circumaural devices and possibly 30 pairs in
the case of ear inserts.
A hearing protector manufacturer (106) wondered if both the manufacturer
and distributor would each have to conduct separate tests. The DuPont
Company (41) recommended that only new products be subject to the require-
ments of the program.
Response:
Separate label verification tests are not required for each of a firm's
customers. Label verification is the testing of categories of hearing
protectors to determine their effectiveness in reducing noise--the NRR.
Protectors introduced into commerce must be labeled with the NRR for the
category to which they belong. The manner of distribution of protectors is
not pertinent to the rating of protectors for effectiveness.
There is no requirement for advance approval of compliance labels under
this regulation.
The manufacturer who physically assembles or produces the hearing pro-
tector must satisfy the label verification test requirements. The manufac-
turer who packages the device for display at the point of sale to an ultimate
purchaser or distribution to a prospective user is responsible for all elements
related to the labeling of the device. It is expected that a formal chain of
liability will be developed between manufacturers of protectors and those who
package and market the device.
6.1.2 Annual Testing
Several commenters focused on the requirement that labeling verifica-
tion occur at the beginning of each calendar year, subject to certain ex-
ceptions. Another commenter (9) noted that the concept of once-a-year
testing would impose heavy burdens on manufacturers. ISEA (38)
130
-------
questioned whether the wording of Section 211.2.10-8 could be construed to
allow the Administrator to require annual testing for any chosen protector.
ISEA (38, 109) also inquired about the conditions under which the previous
year's label verification data would not be accepted for the current year's
production. Bilsom (44) recommended that label verification be required only
if there is a negative change in the level of protection (from a device)
rather than on an annual basis.
Response;
The proposed annual Label Verification (LV) test requirement has been
modified to require a manufacturer to test each category of protector once
and retest only where changes are made to the category which could affect
its noise attenuation. Newly introduced categories, of course, must be tested
and labeled in accordance with the regulation.
The Agency's decision to drop the annual test requirement was based, in
part, on its plan to conduct tests on products selected "off-the-shelf" to
determine whether they are labeled correctly. Where they are not, we would
follow-up with an enforcement action to remedy the situation.
6.2 Compliance Audit Testing (CAT)
6.2.1 Circumstances Leading to CAT
A number of commenters inquired about the circumstances under which EPA
would mandate compliance audit testing. Three spokesmen for the hearing
protector industry (38, 40, 61) felt that EPA should not order compliance
audit testing in the absence of evidence of probable cause that a manufac-
turer had violated the labeling regulations. ISEA (38) asked EPA to spell
131
-------
out clearly the parameters leading to a compliance audit testing order.
The Tasco Corporation (3) requested clarification of whether the compliance
audit testing itself would be performed by a government agency or each manu-
facturer.
Response;
The Act does not require that the Agency have probable cause before
issuing a Compliance Audit Test (CAT) order. This authority will not be
limited by regulation. In most cases, however, the Agency would issue
compliance audit test requests where there is reason to believe there is non-
compliance, but it reserves the right to issue requests on a random basis.
The Agency expects to conduct tests of the effectiveness of all categor-
ies of protectors on the market, using the designated test methodology,
through a laboratory contracted to randomly or selectively, at our direction,
test hearing protectors. This would test all manufacturers' products at
least once every two years. Those manufacturers perceived by the Agency to
be having a problem meeting their labeled values may then be required to
perform Compliance Audit Tests more often than others.
Specific criteria have not been developed to select manufacturers for
testing in any particular order.
6.2.2 Time and Cost Requirements
ISEA (38) had other objections concerning the section on Compliance
Audit Testing (211.2.12). The Association objected to the 24-hour require-
ment [Section 211.2.12-l(e)(3)] for shipping devices to a testing facility
as unreasonable and suggested the period be extended to at least one week.
ISEA also proposed that a minimum of 30 days be granted for completion of
132
-------
compliance audit tests with provision for automatic extensions if the labor-
atory is unable to meet established guidelines.
Two other commenters (34, 44) suggested that EPA and not the manufac-
turer bear the cost burden of compliance audit testing.
ISEA (38) and the E-A-R Corporation (40) challenged the requirement for
two Federal tests (Section 211.2.12-l(c)) as unreasonable and unnecessary.
Response:
The Agency is confident that the regulation can be complied with by all
manufacturers. Shipment to the laboratory can be accomplished within the
24-hour time period. There are a number of shipping services which are
capable of accomplishing rapid shipment of goods. Extensions can be granted
on a case-by-case basis. However, extensions are not expected to be needed
in the vast majority of CAT orders.
Subject to the exceptions discussed in the preamble to the General
Provisions (40 CFR, Part 211 Subpart A, §211.1.10), EPA will absorb the cost
of testing when EPA conducts tests under Section 211.1.11 of the General
Provisions, Testing by the Administrator. The manufacturer only pays for LV,
CAT or other tests that the manufacturer may be ordered to conduct. When EPA
conducts the tests, the manufacturer pays for the shipment of products to EPA
for testing by EPA.
6.3 Reporting Requirements
Several industry representatives raised objections to the reporting
requirements in the proposed rules. Bilsom (1 and 44), the Industrial Safety
Equipment Association (ISEA) (38) and E-A-R Corporation (40) contended that
Section 211.2.9-(4)(b) should be stricken since the production volume in-
formation required is confidential, proprietary, and irrelevant to the
133
-------
purposes of the rules. Bilsom International also indicated that the informa-
tion called for falls outside EPA's statutory authority for the program.
ISEA (38) believed that the enforcement provision greatly magnified the
requirements of the manufacturers as stated in Section 13 of the Noise
Control Act.
Response;
The U.S. Court of Appeals of the District of Columbia in the case of
Atlas Copco., Inc., et al. vs. Environmental Protection Agency ruled on April
27, 1978 on a production schedule information request made by EPA to the
portable air compressor industry. The court indicated that the Agency is
entitled to request a reasonable amount of information concerning production
scheduling and ordered the Agency to keep such information confidential. The
Agency believes that the rationale of this ruling carries over to other
product areas.
The Agency believes that reporting requirements are reasonable and
necessary to assure compliance with the regulation since manufacturers con-
trol label verification testing and will do most of any Compliance Audit
Testing.
6.2.3 Compliance with Label Values
An official of NIOSH (51) suggested alteration of the procedural re-
quirements for compliance of verification testing with labeled information.
The major complaint was that the manufacturer is "not given a statistically
rational basis for labeling his devices." He is required to present mean
attenuation values that will never be higher than the results of future
compliance audit tests. NIOSH feels that a better approach is to require the
manufacturer always to provide the exact attenuation and standard deviation
134
-------
from tests used in the calculation of the NRR. Then a hearing protection
device will be considered out of compliance if the attenuation values arrived
at through compliance test procedures are significantly less than the labeled
mean attenuation values at the respective frequencies. A method of deter-
mining significance was suggested by NIOSH. ISEA (38) recommended that EPA
develop a data base for determining the appropriate statistical test for
compliance, and suggested procedures for consideration in developing such a
data base.
Response:
In response to these and similar comments, the Agency has included a
3 dB variability factor that will be used in comparing the mean attenuation
values at the one-third octave bands as stated in the supporting information
supplied with each protector, with those determined from Compliance Audit
Testing (CAT). We will take enforcement action only in those cases where the
CAT values are lower than the labeled one-third octave band values minus the
3 dB variability factor. For example, if at one of the one-third octave
bands, the attenuation value is 20 dB, we will take action only when the
CAT test result shows that the attenuation value at that one-third octave
band is less than 17 dB (20 dB minus 3 dB).
6.4 Remedial Orders and Product Recall
The provisions for remedial orders and product recall attracted consid-
erable attention from commenters. Two of these offered suggestions for an
expanded program. The French Laboratory (18) recommended that hearing pro-
tectors which fail to meet the label performance standards be removed from
the market, and the Forging Industry Association (26) urged EPA to prohibit
135
-------
all advertising and marketing claims not substantiated through the testing
program.
Most commenters, however, were negative about these provisions, believ-
ing them to be too burdensome on manufacturers. One industry spokesman (37)
felt that the Agency lacked the authority under the Noise Control Act to
order a product recall, regardless of how serious the violation. Also ob-
jecting to the product recall remedy, the E-A-R Corporation (40) suggested
that in the event of non-compliance, the manufacturer be required only to
label the offending products within a reasonable period of time. A similar
position was taken by ISEA (38), which argued that relabeling should only be
required on devices manufactured after Compliance Audit Testing. Finally,
ISEA, seeking clarification of many of the enforcement provisions, requested
the Agency to specify the situations that would result in a product recall
order.
Another manufacturer (60) proposed revisions in the rules circumscribing
EPA cessation of production orders by vesting such authority only in the
Administrator, and then only in writing with a copy sent to the manufacturer
by registered mail.
Plasmed, Inc. (31 and 106) pointed out that remedial orders under Sec-
tion ll(d)(l) of the Noise Control Act of 1972 would result in substantial
costs to the manufacturer, which would be passed on to the consumer, and also
noted that the court costs incurred in contesting an EPA remedial order would
impose a heavy burden on a small company.
Response:
Protectors will be recalled in the event of a relabeling order, and
will involve those products reasonably available to the manufacturer for
136
-------
relabeling. Recall will not entail tracing a product to the ultimate pur-
chaser or user as is done with some medical supplies.
Traceability to the ultimate purchaser or user is not required in this
rule. However, the Agency maintains the position that it is reasonable
to require relabeling of protectors in a manufacturer's possession or in the
distribution chain, or to take other steps to remedy non-compliance. The
reasonableness of a remedy, of course, will depend on the facts of the parti-
cular case. The manufacturer subject to a remedial action has the right to a
hearing under section ll(d)(2) of the Act. At the hearing, held according
to 5 USC Section 554, the manufacturer can challenge both the existence of
the violation and the appropriateness of the remedy.
6.5 Effective Date of Regulation
The time period between the date of promulgation of the Final Rule and
the effective date of the regulation drew a considerable number of comments,
most of which urged an extension of the six-month time limit.
The Industrial Safety Equipment Association (ISEA) (38) cited five
reasons why it felt the proposed six-month effective date should be extended
to an 18- to 24-month period: (1) low number of adequate test facilities;
(2) time requirement for testing; (3) required packaging, art work and
tooling changes; (4) long lead times for plastic packaging; and (5) the need
to deplete inventories of non-complying items.
Other manufacturers (44, 52) suggested that the implementation period
be extended to at least 12 months. E-A-R (52) noted that the additional costs
for a six-month period, as opposed to a 12- to 18-month period, would be "sub-
stantially greater than $50,000", consisting mainly of repackaging, scrapping
137
-------
or modifying current inventory, conversion to new packaging, and lost sales.
Flents Products (60 and 101) suggested that sufficient implementation lead
time be provided to allow for importation and manufacturing difficulties; a
F'lents representative noted that containers and other packaging materials are
often ordered 15 months ahead of time.
Response;
The Agency, after carefully considering the industry's comments, has
decided that the effective date of the regulation should be extended to one
year after the date of promulgation of the Final Rule. This change is incor-
porated into the regulation in Section 211.2.2. Many of industry's other
concerns relating to the effective date of the regulation, such as the time
needed for packaging changes, are essentially eliminated through the Agency's
modified approach to labeling requirements for bulk protector sales to indus-
try, discussed in Section 4 of this Docket Analysis.
138
-------
SECTION 7: ECONOMIC EFFECT
7.1 Costs of Testing
The majority of submissions to the public docket dealing with the eco-
nomic effect of the labeling regulation focused on industry concerns. The
Industrial Safety Equipment Association (ISEA) (38) contended that the pro-
posed regulations, contrary to the Preamble of Subpart A, were economically
detrimental to the industry. Flents Products (104) and Plasmed (31) ex-
pressed the opinion that the proposed rules could pose impossible economic
burdens on smaller companies. Similarly, several firms (44, 101, 106, 33)
felt that the regulations would place an unfair economic burden on producers
of insert protectors, making them less competitive with producers of muff
protectors.
There appeared to be agreement, on the part of the protector industry,
that EPA underestimated the cost to the industry of implementing the regula-
tory requirements (28, 40, 44, 106). E-A-R Corporation stated that their
estimates for implementation total nearly one-fourth of that which EPA esti-
mates for the entire industry (40). Many comments addressed the issue of
testing costs. The ISEA (38) suggested that label verification testing alone
could nearly consume the EPA estimate of $400,000 to $500,000.
Wilson Products, Flents Products, and Plasmed (103, 60, 101, 106) each
estimated a testing cost approaching $2,000 per product. Comments by Plasmed
and Wilson Products (106, 103) raised the problem that each size of insert,
and each ear muff configuration might require its own test, resulting in sig-
nificant costs per design. Plasmed (38) estimated that testing alone would
contribute an 8/10 of a cent increase per unit.
139
-------
Response:
As was stated earlier in the economic analysis (Section II, Part I of
this analysis), the Agency has revised upward its original economic analysis
based, in part, on industry's cost estimates and the Agency's additional
research.
In the Draft Background Document for the Labeling of Hearing Protectors
April, 1977 [4] the cost to the industry was based on the previously deter-
mined size of the industry to be 40 manufacturers. The economic information
presented in this revised analysis is based on having determined the industry
to be 70 manufacturers and distributors.
However, distributors in this industry are not likely to incur the costs
of complying with these requirements to the same extent that manufacturers
will. They generally repackage protectors supplied by manufacturers, and
put their brand names on the packaging. Therefore, a single device may be
marketed under several different private labels.
With this aspect of the industry in mind, the regulation states that
distributors may use a manufacturer's previously developed Noise Reduction
Rating and Mean Attenuation data when packaging and labeling protectors.
Therefore, in these situations, the only costs incurred for complying with
the requirements of this regulation would be the labeling costs as a result
of repackaging, not the testing, and recordkeeping.
The Agency based its estimates of first-year testing costs on the test-
ing of all models of protectors in each of their use-positions (as many as
three positions for muff-type protectors) - these costs are not expected to
exceed $350,000. The Agency's best estimate of first year testing costs range
from $262,500 (175 model configurations x $1500 per test) to $350,000 (175 x
$2000 per test).
140
-------
The annual cost estimate of this regulation for testing is based on
including: costs for Compliance Audit Testing by not more than 15% of the
industry in one year (approximately $21,000); and label-verifying of new
classes of protectors or classes of protectors that in one year have undergone
changes which result in decreased noise reducing effectiveness (this is not
expected to exceed 10% of the models of protectors in one year with a result-
ant cost of approximately $35,000).
7.2 Administrative Costs
Charles Machine Works, Inc. (37) noted difficulty in understanding Sec-
tion 211.2.12-7(a), which appeared to be a costly testing process. Bilsom
International (44) pointed out a conflict between the section in the General
Provisions on Testing by the Administrator and the section in the Hearing
Protector provisions on Compliance Audit Testing, and suggested that EPA bear
the cost of this testing. Plasmed (31) suggested that EPA develop a less
costly objective test.
Several industry spokesmen (31, 38, 106, 44) mentioned additional ad-
ministrative costs required for implementation. These included costs for
such things as clinical, legal, and managerial support. Plasmed (30) esti-
mated an additional 4/10 of a cent increase per unit for clerical and legal
support (31).
Response:
Section 211.2.12-7(a) applies to additional testing required only if a
protector is found to not comply with its label as a result of Compliance
Audit Testing. This cost will not be incurred for protectors that comply
with their labels.
141
-------
In response to the perceived conflict between the General Provisions
and the Hearing Protector regulations with respect to who will bear the costs
of testing, there is no conflict.
Section 211.1.11 of the General Provisions, Testing by the Administra-
tor, reserves to the Agency the ability to test products as a part of its en-
forcement strategy. The manufacturer submits products to EPA upon request,
and EPA conducts the test. The Administrator may test at any facility and
will use Agency equipment. This will assure the Agency that testing is being
conducted properly. The cost of testing under this section is borne by the
Agency. The cost of shipment is borne by the manufacturer.
Section 211.2.12 of this regulation, Compliance Audit Testing, details
a specific procedure which the Agency will use to assure itself that manufac-
turers are continuing to produce complying products after the label verifi-
cation test. This section is designed to minimize the number of tests that a
manufacturer will have to perform while still providing assurance to EPA that
only complying products are being distributed in commerce. The manufacturer
bears the cost of Compliance Audit Testing.
In short, subject to the exceptions discussed in the preamble to the
General Provisions, EPA will absorb the cost of testing when EPA conducts
tests under Testing by the Administration. The manufacturer pays for Label
Verification, Compliance Audit Testing, or other ordered tests. The manufac-
turer pays for the shipment of products for testing, including shipment of
products to EPA where EPA conducts the test.
As for additional administrative costs required for implementation of
these requirements, the Agency considered these costs in detail (see Section
II, Part I of this analysis for details).
142
-------
7.3 Label Size Requirements: Cost
Factors associated with the actual labeling operation were mentioned by
many commenters. Such things as label design (38), label printing (38),
materials (61), loss of existing inventory that has been made obsolete (38,
40), and labor for attaching labels (38) were given as specific factors con-
tributing to increased costs. Industry representatives (31, 106, 102) sug-
gested that, for monetary reasons, pasting labels is preferable to emboss-
ing or labeling done in the process of molding protectors.
Many industry representatives (38, 40, 106, 44, 103, 60, 36) suggested
that the label size requirements would dictate packaging changes. Specific
aspects of the packaging process mentioned by the commentators as affecting
costs include tooling costs for manufacturing new containers (38), modifi-
cations to or replacement of containers (38), increased shipping costs (38,
40), obsolete inventories (44), and storage costs (44). Wilson Products
(103) indicated that the cost of packaging could exceed the cost of the
product. Flents Products (36, 60) estimated that labeling might add 83 per-
cent to container costs.
Other commenters (38, 101) addressed the costs of designing and print-
ing supplemental information sheets or inserts. Other specified costs
included training of sales force and distributors (38) and revisions to
promotional literature (38). Bilsom International (44) emphasized that
the additional costs associated with satisfying nation-by-nation labeling
requirements were also being neglected.
Response:
The Agency considered the costs associated with the actual labeling
operation and revisions to promotional literature in Section II of Part I
of this document.
143
-------
With respect to label size requirements and the costs associated with
changes in packaging, the Agency is requiring the labeling of protectors
according to the method by which they are displayed at the point of sale to
the ultimate purchaser or distribution to the prospective user (see Section
4.3 of this Docket Analysis for further explanation). Therefore, any costs
that would have been attributable directly to changes in packaging to accom-
modate a label have been essentially eliminated.
Costs associated with the compliance of products exported to other coun-
tries and subject to their regulations are the responsibility of the company
engaging in that international commerce.
7.4 Effective Date and Associated Costs
Time factors associated with the regulation were mentioned as having an
influence on cost. Bilsom International (1) suggested that advance approval
of labels could be a source of costly delay. E-A-R Corporation (52) esti-
mated that the additional costs for a 6-month period as opposed to a 12- or
18-month period of compliance could be substantially greater than $50,000.
Factors contributing to this were: purchases of supplies in small amounts;
scrapping or modifying present inventory, lost sales; and covering down-time
with sufficient inventory.
Plasmed (31) estimated that the overall cost for meeting the regulations
would be three cents per unit. Aural Technology (61)' also estimated a few
cents per unit, and suggested that this was reasonable for a unit otherwise
costing $5.00. Plasmed (106) asserted that the manufacturing costs to produ-
cers selling in bulk to other firms would more than double. Flents Products
indicated that the cost of package inserts, depending upon the information
required, would be under three cents a piece (101).
144
-------
Comments by certain manufacturers (44, 36) indicated concern that the
proposed regulations would have serious economic impact on the industry with-
out a corresponding benefit to the consumer. Mott Corporation (23) expressed
opposition to the labeling program because of, among other things, the higher
cost to both taxpayers and consumers. The Department of Labor of North Caro-
lina suggested that the cost of the regulations might increase price beyond
the public's willingness to pay, and warned about the possible decrease in
use of hearing protectors because of cost. Finally, the Industrial Safety
Equipment Association (38) suggested that the costs might deter development
of new or improved protectors by both old and potential manufacturers.
Response:
The modification of Section 211.2.2 extends the effective date to one
year after promulgation of the Final Rule. This change is intended to allow
manufacturers to minimize the obsolescence of packaging and literature sup-
plies that they may have on-hand due to the lead-time procurements necessary
in this industry. The extension provides a longer phase-in period for the
testing requirements, and also allows extra time for greater availability of
testing laboratories, thereby reducing a potential supply/demand imbalance
that might cause an increase in test cost.
Advance approval of labels is not required in this regulation, so it
will not "be a source of costly delay".
It is the practice of the industry to pass 100% of production costs
through to the ultimate purchaser. We believe this practice will continue.
While the potential percent price increase per pair of protectors is
impossible to determine in the absence of market size information, the Agency
estimates, based on limited data, that prices may increase between $0.03 and
145
-------
$0.05 per pair of insert devices (if previously bulk-packaged protectors are
required to be individually packaged and labeled), and $0.10 for "muff"
devices.
These final hearing protector labeling requirements reflect the Agency's
overall sensitivity to the costs that accompany regulation, and our policy,
with respect to product labeling, of minimizing the economic impact of a
regulation. The Agency is requiring that labeling of protectors be done in a
method compatible with current marketing practices, which reduces the proba-
bility of packaging changes and associated cost increases.
The Agency has had no indication that this rulemaking would impose
appreciable burdens on any manufacturer within the hearing protector indus-
try, nor that the regulation in itself will result in business closure. Also,
our economic analysis did not attempt to predict potential market shifts or
potential adverse economic effects that might occur as a result of labeling
requirements which would identify some protective devices as being low in
effectiveness. The Agency believes that any market shifts or other economic
effects beyond the direct costs of labeling are solely related to the com-
petitive nature of this industry. We believe that the industry will adjust
itself to reflect purchasers' and users' selections made as the result of
newly available information from these noise labeling requirements; not as a
result of the restrictions of command and control regulations.
146
-------
REFERENCES FOR PART II
1. Federal Register, Vol. 42, June 22, 1977, p. 31730.
2. Federal Register, Vol. 42, June 22, 1977, p. 31722.
3 Regulatory Analysis Supporting the General Provisions for Product Noise
" Labeling, LPA 550/3-79-255, August 1979.
CONSULTANTS AND EXPERTS
Department of Defense, Robins Air Force Base, GA
National Institute for Occupational Safety and Health (Department of Health,
Education and Welfare)
Mine Safety and Health Administration (Department of Labor) (Formerly
Mining Enforcement and Safety Administration)
Aerospace Medical Research Laboratory, Wright-Patterson Air Force Base, OH
Civil Aeromedical Institute (Federal Aviation Administration - DOT)
Environmental Acoustics Laboratory, Pennsylvania State University
147
-------
APPENDIX A
DEFINITION OF ISSUES FROM EACH DOCKET ENTRY
-------
HEARING PROTECTOR DOCKET 77-5:
Docket Number, Name,
Affiliation
Comments
77-5-001
Roland Westerdal
President
Bilsom International, Inc.
(letter dated 5/10/77)
1. Suggested that the inclusion of required information
in sales literature would be a more effective means
of reaching the persons who make the purchase
decisions in industrial settings.
2. Recommended that consideration be given to the
development of standards that reflect the factor
of wearability.
3. Maintained that a rating scheme which defines
classes of hearing protectors offers no advantage
to either the consumer or the manufacturer and
should not be adopted.
4. Pointed out the limitations of objective testing.
5. Suggested that the Administrator's analysis of
costs should reflect the additional costs associated
with satisfying nation-by-nation requirements.
6. Pointed out that, due to variability in test results,
manufacturers could not guarantee even a very
conservative NRR value.
7. Indicated that since the end user is not necessarily
the buyer, reporting the NRR and supporting informa-
tion to the end user would not serve the stated
purposes of the program.
8. Suggested that the information provided to the end
user emphasize proper use instructions.
9. Requested that the regulation be flexible in its
labeling requirements to reflect reasonable
realities of marketing and manufacturing.
10. Requested clarification as to the unit which "must
be labeled to include this information and to contain
enclosures with supporting information."
11. Asked that the regulations consider the impact of
aging in evaluating a device's effectiveness.
12. Pointed out that production volume information
cannot be requested pursuant to the authority
vested in the Administrator by the Act.
A-l
-------
Docket Number, Name,
Affiliation
Comments
77-5-001 (continued)
13. Requested the opportunity to examine and comment
on regulations concerning imported hearing pro-
tective devices.
14. As a means of not discouraging product innovation,
requested that regulations not be applicable to new
products for a period of 12 months after their entry
into the market.
15. Suggested that the advance approval of labels could
become a source of costly delay in the distribution
of devices, and indicated that the annual verifica-
tion requirement is unnecessary.
16. Enclosed:
a. Bilsom International study regarding the rela-
tionship between wearing time and effect of
personal hearing protectors.
b. Dennis Else, The University of Aston in Birmingham,
Great Britain, "A Note on the Protection Afforded
by Hearing Protectors-Implications of the Energy
Principle."
c. Bilsom suggested resale price lists showing mini-
mum quantities offered for sale to end users.
-002
Marlene K. Olinger
Administrative Assistant
Bilsom International, Inc.
1. Resubmitted Bilsom's letter of 5/10/77 (77-5-
001), reordering the enclosures and placing them
on Bilsom paper, but including no new information.
-003
Thomas A. Scanlon
President
Tasco Corporation
1. Requested clarification on the question of whether
compliance testing would be done by a government
agency or each manufacturer.
2. Noted that ASA STD-1-1975 calls for a band
force report but fails to specify how a hardhat
hearing protector attachment is to be measured
for force.
-004
Stuart M. Low
President
Flents Products Company
1. Wrote to confirm a phone call to EPA to clarify
certain points in the proposal rather than to
submit a formal response.
A-2
-------
Docket Number, Name,
Affiliation
Comments
77-5-004 (continued)
4.
Noted that the EPA official informally stated that
printing in the specified manner on the packaging
could satisfy the labeling requirement.
Noted that the EPA official informally stated that
information printed on "hang cards" would not
be acceptable, and that each small earplug container
would have to display the labeled information.
Asked confirmation of his understanding of the
above responses.
-005
Elizabeth Platt
1. Suggested that the scaling system used in the
program be explained.
2. Noted that the consumer should be informed if
the scale used is linear, logarithmic, or otherwise,
to assure that the labels be properly understood
by the intended audience.
-006
Phil!is H. Rosenthal
1. Though referred to this docket, comment called
for abatement of detrimental lawnmower and
grass and leaf blower noise.
-007
Thomas J. Woods
Aural Technology, Inc.
1. Expressed thanks to EPA for information on
the program provided to ATI.
2. Enclosed literature on the firm's "Protectear"
product, and noted that it should be tested only
by Jack Vernon 's attenuation method and not
by ANSI 3.19-1974.
3. Enclosed a typical letter sent in response to
inquiries about the firm's product, which describes
the features of "Protectear."
4. Enclosed vita of Jack Vernon and a note of his
comments on ASA-STD-1-1975.
-008 (omitted)
A-3
-------
Docket Number, Name,
Affiliation
Comments
77-5-009 1.
Paul L. Michael, Ph.D.
Professor of Environmental
Acoustics 2.
Pennsylvania State
University
3.
5.
6.
8.
9.
10.
11,
Noted that NIOSH does not use the single-number
designation "NRR."
Warned that "NRR" might be construed as
"Noise Regulation Reporter" and suggested
"SLD" (Sound Level Difference) be used
instead.
Pointed out that many Federal agencies (e.g.,
DOL) use the term "sound" rather than "noise."
Noted, re: page 31731, Col.l, Para. 2, Line
1-5, that the "A" weighting does not approximate
the threshold of hearing, and that "C" weighting
is relatively unweighted only at the center
frequencies.
Expressed the opinion that the procedure for a
single-number rating method is needlessly complex,
suggesting a simpler approach expounded in his
paper for DOL (attached). Also suggested citation
of the long method of calculation as discussed in
the attachment. ("OSHA Methods for Determining
the Effectiveness of Ear Protector Devices.")
Noted that the minimum label size may have a signv
ficant economic impact on the manufacturers of
insert-type hearing protectors.
Re: page 31733, Col. 1, Para. 1, Line 7-12,
suggested that for consistency, the means minus
two standard deviations rather than just the
mean attenuations be compared.
At 211.2.3(b) and (c), suggested changing ANSI
Z22.540-1957 to read ANSI Z24.22-1957.
Proposed a standard definition for impulsive
sound.
Noted that re: page 31734, Col. 1, Para, m,
the NRR symbol is not used in NIOSH Publication
No. 76-120 and, at Para, n, the heading should
read "one-third octave band."
Expressed support for an NRR rating for
each wearing position.
A-4
-------
Docket Number, Name,
Affiliation
Comments
77-5-009 (continued)
12. Mentioned that it would not be feasible to
randomly select ten test subjects who would
require all protector sizes. Suggested wording
should be changed to "all sizes must be available
in conducting the required test."
13. Noted the heavy economic and testing burden
of the requirement for once-a-year testing.
-010
R.A. Smith
1. Expressed strong support for EPA's hearing
protector labeling proposal.
-Oil
David Rankin
1. Urged EPA to move ahead with the program,
pointing out that it would pressure companies
into the competitive market.
-012
Kenneth R. Freitas
1. The respondent, an employee with the United
States Postal Service, described the noisy environ-
ment in which he worked.
2. Reported that he had written a letter of complaint
to his supervisor but that he had not received a
reply.
3. Questioned whether the United States Postal
Service was subject to the standards and regulations
administered by the EPA.
4. Asked what recourse he had to protect his personal
interest.
5. Asked what EPA could do to his employer to
rectify the situation.
6. Asked whether an on-site investigation of the
situation could be made.
-013
Jane A. Baran, Director
Audiology/Aural
Rehabilitation
Indianapolis Speech and
Hearing Center
Expressed support of labeling regulations for
hearing protectors on behalf of audiological staff
at the Center, citing noise pollution as a prominent
problem in society.
Asked to be kept informed of any further
developments in this area.
A-5
-------
Docket Number, Name,
Affiliation
Comments
77-5-014
H.E. Douglas, President
H.E. Douglas Engineering
Sales Co.
1. Wholeheartedly endorsed the proposed ruling.
2. Suggested that the label should state the noise
reducing capability at the following nominal
frequencies: .125; .25; .5; 1; 2; 3.15; 4; 6.3; 8.
3. Felt that 0 to 31 did not mean much since there
are very few manufacturers, if any, that have a
reduction in the low figures below 125.
4. Pointed out that there are also very few devices
that show a 31 on any of the first four figures.
5. Suggested that labeling should be in the 500 to
3,000 range, which is the area most critical for
protection of one's ears in the speech field.
6. Pointed out that very few people who have been
exposed to noise are able to hear efficiently in the
high frequencies.
7. Pointed out that as long as protection is used in
the 3,000 Hertz and lower range, noise doesn't
interfere with speech conversation.
-015
Margaret R.A. Paradis
Leboeuf, Lamb, Leihy &
MacRae (Attorneys)
Requested, pursuant to the Freedom of Information
Act, the data received by EPA in response to a
request made of nine hearing protector manufacturers,
referred to on page 38 of the Background Document,
with proprietary information masked.
Attached a copy of the first page of a letter of
request from EPA to one of the nine aforementioned
firms, Mine Safety Appliances Company.
-016 1.
Robert G. Palaso, for
Donald P. Schlick,
Ass 't. Administrator, 2.
Technical Support
Mining Enforcement and
Safety Administration
(MESA)
U.S. Department of the 3.
Interior
Expressed agreement with EPA's intent and
action in the program.
Noted that the inclusion of two standard deviations
actually applies 95% confidence levels to the atten-
uation values, while the 98% figure refers to NIOSH
3dB adjustment factor.
Pointed out that the use of NIOSH Method 2 will be
a confusing factor by requiring measurement in "C"
weighted decibels.
A-6
-------
Docket Number, Name,
Affiliation
Comments
77-5-016 (continued)
Noted MESA's revision of regulations to allow use
of the dosimeter in measuring worker noise exposure
and stated its preference for a method reliant
on "A" weighted decibels (dB(A)) alone.
Since many Type 2S sound level meters are in use in
industry, he pointed out that requiring Method 2
with its C-weighting would render such devices
obsolete.
Suggested a permanent NRR on the device itself,
an especially important feature for MESA enforce-
ment officers.
Expressed a preference for an exclusively dBA-
based method with a conservative underestimation
of the R factor rating for the sake of simplicity.
-017
Stuart M. Low
Flents Products Company,
Inc.
(dated 8/23/77)
1. Expressed no quarrel with Public Law 92-574, the
Noise Control Act of 1972, nor with the intent
of the proposed rules.
2. Suggested that allowing comments to be made in
writing was not a satisfactory substitute for a
public hearing.
3. Suggested that the future of his business would
be seriously affected if the proposed regulations
were put into effect.
4. Strongly urged the holding of public hearings.
-018
Hugh Crozier
French Laboratory
3.
Stated that an agency of the Government should
be set up for testing all attenuators.
Pointed out that the agency doing the testing
should not have a conflict of interest where they
are attempting to develop a device of their own
such as the V51R.
Suggested that tests be conducted for attenuation,
comfort, wearability, personal hygiene, acceptance,
required maintenance, length of time for wearing
comfort, length of time the product remains as
initially tested, and whether the product remains in
place during various mouth maneuvers.
A-7
-------
Docket Number, Name,
Affiliation
Comments
77-5-018 (continued)
4. Suggested that the only true guarantee is to test
the product on the individual who is to wear it.
5. Suggested that test results obtained from best fit
subjects and subjects whose test results vary too
much should not be used for any publication, adver-
tising, or labeling.
6. Suggested that test results obtained from best fit
subjects and subjects whose test results vary too much
should be used solely to determine the percent of
people that may be able to use such a protector.
7. Suggested that a true test would select subjects at
random and use all test results, and that the reporting
of test results without including all subjects should
be considered fraudulent.
8. Suggested tests of protector material to determine
how readily it would accept bacteria and foreign
objects and to determine its potential irritation to
users under normal use.
9. Pointed out that the seal on muffs depends on the
skin and hair contact made, the actual head and
bone structure, and the stiffness of the seal.
10. Pointed out that most seals begin to stiffen in
three to four months and should be replaced at
that time.
11. Took exception to the inference that custom
fitted protectors may not be used in ears that have
problems and pointed out that they have made ear
protectors for many post-operative ear cases.
12. Suggested that ear protectors not meeting required
standards should be removed from the market place.
-019 1.
Frank E. Wilcher
Executive Director
Industrial Safety Equip-
ment Association 2.
Requested an extension of the period for comment on
Subpart B to coincide with that of Subpart A (that
is, October 28, 1977).
Requested a public hearing on the hearing protector
provisions.
A-8
-------
Docket Number, Name,
Affiliation
Comments
77-5-020
David Fishken, Ph.D.
Department of Psychology
Northeastern University
1. Expressed interest in acquiring all available infor-
mation on the proposed noise labeling program,
specifically requesting information pertaining to
hearing protector labeling.
2. Stated that his interests concerned the methods used
to establish label values, test methodologies, and
the role that private industry can play in promoting
the program.
-U21
Singapore Institute of
Standards and Industrial
Research
1. Requested a copy of the proposed regulations on
hearing protector labeling and asked to be informed
of future developments.
-022
Rudolf Donninger
Osterreichisches
Normungsinstitut
(Standards Institute for
Government of Austria)
1. Noted the intention of the Austrian government
to propose hearing protector labeling requirements
and requested reasons why EPA did not choose
International Standard 4869 as the measurement of
sound attenuation.
2. Included draft of Internatinal Standard 4869.
a. Test signals consist of white noise filtered
through one-third octave bands with ten
center frequencies reported.
b. Ten listeners are used per test, with statist-
ical results reported for each subject.
-U23
E.S. Mott
Mott Corporation
1. Expressed opposition to the labeling program
because of excessive Federal regulations, higher
costs for consumers and taxpayers, and the
ability of the public to make wise purchasing
decisions in the absence of noise labels.
2. Suggested that bureaucrats be required to have
five years of practical experience in private
industry.
-U24
John T. Hughes
State Lobster Hatchery and
Research Station (Mass.)
1. Expressed approval of proposed actions taken by EPA
under authority of Section 8 of the Noise Control
Act.
A-9
-------
Docket Number, Name,
Affiliation
Comments
77-5-024 (continued)
2. Suggested that public education material be dis-
tributed which describes dBA's, their measurement,
and the required equipment.
-025
Katherine M. Reilly
Audiologist
Marin General Hospital
1. Requested current and future information on
labeling standards and requirements for hearing
protectors.
-026
Michael N. Winn
Director of Industrial
Relations and Government
Affairs
Forging Industry
Association
1. Gave background information on Forging Industry
Association.
2. Pointed out that not quite half of the 89,000 per-
sons employed in the forging industry were exposed
to noise levels above 90 dBA.
3. Supported efforts to standardize the testing and
performance claims of devices marketed as hearing
protection equipment since this equipment is
essential to the Forging Industry.
4. Stated preference for voluntary compliance by all
manufacturers.
5. Suggested that the labeling requirements apply
to all products marketed in interstate commerce
as personal hearing protection devices including
plugs, muffs, Swedish wool, etc.
6. Suggested that the regulation should require that
a manufacturer provide separate testing for devices
which may be worn in a variety of ways.
7. Suggested that EPA should prohibit all advertising
or marketing claims not substantiated by the
required testing program.
8. Suggested that EPA should require that testing results
as certified by EPA be provided by the manufacturer
upon request from a customer or potential customer.
9. Urged that the regulations include a rating system
which states the attenuation factor for each
frequency, and that the labeling system make pro-
visions for reporting attenuation factors at each
individual frequency.
A-10
-------
Docket Number, Name,
Affiliation
Comments
77-5-027
Frederick G. Crocker, Jr.
Vice President and
General Manager
Safety Products Division
Norton Company
2.
1. Asserted that two of Norton's products-SONIC
EAR VALVS and the SONIC II protectors-cannot
be tested using ASA STD 1-1975/ANSI STD S3.19-1974
and thus cannot be assigned an NRR number. Norton
therefore expects to file for an exception to
certain Subpart B regulations under the proce-
dures outline in Sec. 211.2.5.
Approved of Sec. 211.2.5 in principle, subject
to the following comments:
a. "Second sentence of Sec. 211.2.5(a) should
be limited to apply only to devices not
already on the market as of the effective
date (or the date of promulgation) on the
final regulation."
b. Alternative procedures should be established
for devices already on the market, as it is
unfair to force discontinuance of an effective
product simply because there has not been the
time (nor opportunity) to submit an applica-
tion containing a "suitable alternative rating
system" supported by "conclusive scientific
test data." A period of at least a year after
the effective date of the rules should be
allowed to prepare the application.
c. "Suitable" is not defined in phrase "suitable
alternative effectiveness rating." Submitted
that a "suitable" alternative rating system for
a device for which NRR is not an accurate indi-
cator can be independent and unrelated to NRR
system.
d. Sec. 211.2.5(c) does not define what con-
stitutes "conclusive scientific test data"
(suggests language).
3. Changes proposed are designed to permit continued
marketing during testing and processing of applica-
tion.
4. Noted that other views of the Norton Company will
be reflected in the comments of the Industrial
Safety Equipment Association.
A-11
-------
Docket Number, Name,
Affiliation
Comments
77-5-028
H.J. Wise
W.H. Brady Co.
As a manufacturer of nameplate and labeling
products, Mr. Wise expressed interest in reviewing
all proposed labeling regulations and requested a
copy of those pertaining to hearing protectors.
-029
David M. Anderson, Ph.D.
Manager, Environmental
Quality Control
Bethlehem Steel Corporation
Suggested that information be required on the
label or in the supporting information about
how the NRR should be used to determine the
A-weighted level at the eardrum.
-030 1,
Jerry V. Tobias, Ph.D.
Civil Aeromedical Institute
U.S. Federal Aviation
Administration 2.
3.
Respondent found the proposals sensible and
responsible, particularly commending use of the
attenuation value minus two standard deviations.
Objected to the use of the decibel number (rather
than the rating number in product classes) as not
in the public interest because of:
a. Arbitrary rounding and measurement error.
b. The greater benefit to consumers of classi-
fication numbers.
c. The precedent for agricultural product
classification by the Federal government
(e.g., eggs, butter and meat).
d. The ease of product comparison that such
a classification allows.
e. The likelihood that most hearing protectors
would rank in the higher classes while a
decibel rating could hurt good products in
marginal cases.
Submitted (a) paper presented by the respondent
to the International Congress on Acoustics which
sets forth an approach to hearing protector class-
ification, and (b) two other selected papers,
entitled
(1) The Typical Noise: First step in the Develop-
ment of a Short Procedure for Estimating Per-
formance of Hearing Protectors (Jerry V7 Tobias
and Daniel L. Johnson).
A-12
-------
Docket Number, Name,
Affiliation
Comments
77-5-03U (continued)
(2) Earplug Rankings Based on the Protector-Attenua-
tion Rating (P-AR). (Jerry V. Tobias)
4. Respondent's ILA paper, "Statistically Based Rating
System for Hearing Protectors" stated that hearing
protector effectiveness is determined by the statisti-
cal distributions of:
a. The noise spectra in which the device is used.
b. The variability of attenuation characteristics
of each device for a variety of potential users
in a given noise environment.
c. The attenuation variability for a variety of
hearing protectors used by a given population
in a given noise environment.
5. The paper noted that hypothetical noises must be
developed for a valuable average rating.
6. The paper pointed out the value of the "mean minus
one or two standard deviations" approach.
7. The paper proposed a Protector-Attenuation Rating
(P-AR) derived from previously calculated attenua-
tions for many types of protectors. Those protec-
tors scoring at least two standard deviations above
the mean form Class 1; one standard deviation above,
Class 2; those at the mean, Class 3; and so on to
Classes 4, 5, and 6. The P-AR takes account of all
three factors determining protector effectiveness.
-031
John M. Ruffner
President
Plasmed, Inc.
1. Expressed concern over meeting Plasmed's labeling
responsibility as an original ear-plug manufacturer,
through the complexities of the distribution process.
2. Inquired if test would have to be conducted separately
for each customer, which would result in prohibitive
testing costs for the firm.
3. Noted that the proposed rules conflict with Armed
Forces' requirements for packaging.
4. Pointed out that the firm has never sold a pair of
earplugs to an individual customer, specializing
instead in bulk sales.
A-13
-------
Docket Number, Name,
Affiliation
Comments
77-5-Q31 (continued)
5. Inquired about EPA's intention for labeling of
cotton given its use as a major competitor to
earplugs in hearing protection.
6. Ranked customer priorities for earplugs as comfort
first, freedom to work second, and noise suppres-
sion third.
7. Suggested that EPA develop an objective test at
a lower cost than the proposed procedure.
8. Pointed out that the rules would entail an esti-
mated cost of 3 cents per unit, a substantial
portion of the earplug's selling price. The
figure consists of 8/10 cents for initial com-
pliance testing, 4/10 cents for clerical and
legal support, and 1-8/10 cents for actual label-
ing operations.
9. Added that if mold changes were necessitated for label
ing, an additional cost of approximately $100,000 for
the firm's production line would result.
10. Pointed out that the cost impact for ear muff
manufacturers would be fractional compared to that
for bulk earplug manufacturers.
11. Noted that remedial order under Section ll(d)(l) of
the Act would result in further substantial costs
to be passed on to the customer.
12. Pointed out that as a small firm with a net worth
of less than $100,000, the proposed rules, aimed
at the individual rather than bulk consumer, could
pose impossible economic burdens.
-032
Lawrence H. Hodges
Vice President, Technical
Affairs
J.I. Case Company
1. Explained the manufacturing scope of the J.I. Case
Company.
2. Explained that some of their employees used hear-
ing protectors.
3. Agreed, in principle, with the proposed regulations,
A-14
-------
Docket Number, Name,
Affiliation
Comments
77-5-032 (continued)
4. Recommended a reasonably permanent label as opposed
to a label which remains intact only until the time
of first retail sale.
5. As a first choice, recommended that the label be
placed on the hearing protector and, as a second
choice, on the carrying case.
6. Felt that the continuing availability of attenua-
tion data would allow future comparisons with
improved protectors to determine whether replace-
ment was cost-justified for the protection of
employees.
-033
Thomas J. Woods
President
Aural Technology, Inc.
1. Submitted a request for an exception to test proce-
dures (for a vented device).
-034
L. A. Weaver
Department of Labor
Acting OSHA Director
State of North Carolina
1. Expressed doubts about the individual consumer's
ability to properly use the NRR to make product
comparisons, although industrial users would benefit
from the NRR.
2. Noted that the costs of the regulations might
increase the price of hearing protectors beyond
the public's willingness to pay.
3. Noted the need for proper consumer education and
fit of the protector.
4. Expressed a preference for performance regulations
rather than the testing specification standards in
the proposed regulations.
5. Suggested that EPA, and not the manufacturers, bear
the cost burden for testing.
6. Warned about the possibility of decreased use of
protectors because of increased costs under the
regulations, and urged EPA to provide product test-
ing as a service rather than requiring it as a
regulation.
A-15
-------
Docket Number, Name,
Affiliation
Comments
77-5-035
Edwin W. Abbott, Manager
Operational Facility
Requi rements
Air Transport Association
of America
1. Stated that the Air Transport Association has no
additional information to offer regarding the
effectiveness rating, or facilitation of the enforce-
ment of the labeling requirements for hearing pro-
tectors, as requested by the Environmental Protec-
tion Agency.
-036
Stuart M. Low, President
Flents Products Company,
Inc.
1. Gave some company background and pointed out that
approximately 95 percent of their sales are in
anti-noise devices.
2. Pointed out that many of the proposed noise label-
ing requirements were impractical, would raise costs
substantially, and would provide only limited benefit
to the potential user of hearing protectors.
3. Pointed out that the required 1-1/2" x 2" primary
label would not fit any of the containers currently
marketed by their company and would require containers
two or three sizes larger than those currently used.
4. Elaborated on the issue of container size and pointed
out that the cost increase of a container capable of
accepting a 1-1/2" x 2" label for one item alone would
amount to $10,000 a year, an 83 percent increase.
5. Suggested that the Agency allow some flexibility in
the dimensions of the required labeling.
6. Pointed out that respirator labels required by the
Mining Enforcement and Safety Administration and the
National Institute for Occupational Safety and Health
have no minimum dimensions. Questioned the need for
substantially more severe labeling requirements on
hearing protectors, not used for protection in life
endangering conditions, than those required for
respirators.
7. Strongly urged that the rules be redrafted to allow
Noise Reduction Ratings and other information
required by Section 211.2.4-1 to appear in a package
insert for products sold at retail, as permitted
under Section 8(b) which gives the Administrator
considerable latitude in specifying the manner in
which information is to be disseminated to the
potential user.
A-16
-------
Docket Number, Name,
Affiliation
Comments
77-5-037
Gerald A. Stangl, Ph.D.
Design Engineer
The Charles Machine
Works, Inc.
1. Noted marketing problems in requiring date of pro-
duction on the label and suggested a production
lot number or code instead.
2. Noted the size problem of the label for hearing
protectors.
3. Pointed out difficulties in finding test subjects
to test the full-size range of insert-type protec-
tors.
4. Expressed difficulty in understanding Section
211.2.12-7(a), indicating a very costly testing
process.
5. Suggested that finding one protector in violation
of its noise attenuation value is an unreasonable
basis for the application of penalties, arguing
that noncompliance should be limited to serious
jeopardizing of the public health and welfare.
6. Argued that EPA had no authority under the Act for
a product recall, however gross the violation of
the regulations.
7. Suggested that EPA adopt an "Acceptable Quality
Level" for compliance audit testing and establish
guidelines for the violations jeopardizing public
health and welfare.
-038
Frank E. Wilcher, Jr.
Executive Director
Industrial Safety
Equipment Association
1. Expressed fear that exclusive emphasis on the NRR
would lead potential buyers to overlook factors of
equal or greater importance such as comfort, cost,
durability, and compatibility with other protective
equipment.
2. Expressed concern over possible misinterpretation
of the NRR and the comparative acoustic range.
3. Pointed out the existence of hearing protective
devices for which an NRR may not represent the
true protective quality of the device.
4. Suggested that physical measurement methods should
not be applied to the evaluation of hearing protec-
tor performance until adequate procedures are
developed.
A-17
-------
Docket Number, Name,
Affiliation Comments
77-5-038 (continued) 5. Felt that EPA's estimates of the economic impact of
the proposed rulemaking were grossly underestimated,
both for initial testing and maintenance requirements.
6.
Outlined in detail some of the elements which would
increase manufacturing costs and suggested that many
of these had been neglected by EPA.
7. Suggested that label verification testing alone would
nearly consume the EPA estimate of $400,000 to $500,000.
"NIOSH Document 76-120 lists 175 separate protector
configurations which, at $2,000 per test, would cost
$350,000; there are many protectors not listed in this
publication."
8. Suggested that small manufacturers would bear an even
larger relative burden when trying to cope with the
significant fixed costs.
9. Felt that the costs and complexities of the proposed
rulemaking would deter the development of new and
improved hearing protectors by both existing companies
and those wishing to enter the field.
10. Agreed with EPA that only production devices should
be used for testing.
11. Suggested a phase-in period of 18 to 24 months since
the proposed six-month effective date for the final
rule is not adequate.
12. Reasons given for longer period were: (1) low number
of adequate testing facilities; (2) time requirement
for test; (3) required packaging, artwork and tooling
changes; (4) long lead-times for plastic packaging;
and (5) need to deplete inventories of non-complying
items.
13. Suggested language which should be added to preclude
concentration on the NRR as the only selection
criterion for hearing protective devices. (Section
211.2.4-1, page 31734)
14. Pointed out that the existing range of NRRs was
calculated under ANSI Z24.22-1957 and that the
range under ANSI S3.19-1974 has not been computed.
(Section 211.2.4-l(c), page 31734)
A-18
-------
Docket Number, Name,
Affiliation
Comments
77-5-038 (continued)
15. Suggested that EPA establish a theoretical "perfect"
NRR for the upper limit of the range in order to
avoid changes in the range values in the future.
16. Suggested that ear muffs with multi-position head-
bands be labeled for each wearing position, to ensure
the wearer does not underestimate the protective
quality of the device due to his choice of wearing
position.
17. Suggested that EPA drop its mandatory label size
requirement in favor of a requirement that the
label be of sufficient size to be legible. The
primary label size requirement of 1-1/2" x 2" will
necessitate expensive packaging changes. (Section
211.2.4-2, page 31734)
18. Suggested that EPA consider removal of redundant
information, such as manufacturer's name and model
number, from the label.
19. Maintained that those making the selection decision
would be better informed of a device's NRR through
sales or technical literature. Therefore, Mr.
Wilcher recommended the NRR be required on the master
carton only, as opposed to the container of each
device, since the purchase decision is more often
made by someone other than the user in the industrial
situation.
20. Submitted that the proposed regulations are contrary
to the Preamble of Subpart A in that the administra-
tive, economic, ecological, and technical impacts
of the program are substantially detrimental to the
industry.
21. Recommended that manufacturers be permitted to place
the NRR on the display portion of consumer packages
in a visible, legible manner "in a size and type of
their own choosing."
22. Recommended that EPA begin a large-scale educational
program, before the rules go into effect, to give the
public an understanding of the NRR and other facets
of the Noise Control Act.
A-19
-------
Docket Number, Name,
Affiliation
Comments
77-5-038 (continued)
23. Suggested that lot control numbers would serve the
same purpose as the month and year of manufacture
and that the placement of this information should
be left to the discretion of the manufacturer pro-
vided that it can be readily found. (Section
211.2.4-4(b), page 31734)
24. Took exception to the statement recommending hearing
protection against the harmful effects of impulsive
noise and suggested new wording (Section 211.2.4-4(b),
page 31734).
25. Asked if EPA knew the number of laboratories pre-
sently equipped to perform testing in accordance
with ANSI S3.19-1974, and if the Agency intended to
publish a list of these laboratories.
26. Strongly recommended that Section 211.2.9-4(b)
(page 31735) be stricken since the information
required is confidential, proprietary to the
manufacturer, and irrelevant to the laboratory
requirements proposed.
27. Pointed out that the wording of Section 211.1.10-8
was unclear and could be construed to mean that
the Administrator could require label verification
testing on an annual basis for any product.
28. Strongly disagreed with the methods for determin-
ing compliance since each company is able to deter-
mine what risk of non-compliance it wishes to incur,
and then derate accordingly.
29. Recommended that EPA develop a data base suitable
for determining the appropriate statistical test
for determining compliance and suggested a list
of procedures for consideration in developing that
data base.
30. Suggested that EPA establish field testing proced-
ures to be used prior to requiring a Compliance
Audit Test and that probable cause be demonstrated
prior to invoking this requirement. (Section
211.2.12-l(a), page 31737)
31. Questioned the need for two tests given that ANSI
S3.19-1974 was developed to provide meaningful data
from one test. (Section 211.2.12-l(e), page 31737)
A-20
-------
Docket Number, Name,
Affiliation
Comments
77-5-038 (continued)
32. Suggested that EPA furnish manufacturers with a list
of certified laboratories and that manufacturers have
the opportunity to select the facility to perform
the tests. (Section 211.2.12-l(c)(4), page 31737)
33. Suggested that the requirement for samples under
Section 211.2.12-l(c)(5) should be consistent with
usual practice for the type of device being tested.
34. Suggested a wording change in Section 211.2.12-l(e)(l)
making it a requirement for the Administrator to
extend the time requirement if the certified test
facility is not available to conduct such testing.
35. Suggested a minimum 30-day requirement for comple-
tion of Compliance Audit Tests and automatic exten-
sions if the laboratory is unable to meet the estab-
lished deadlines. (Section 211.2.12-l(e)(2), page
31737)
36. Pointed out that a 24-hour requirement for shipping
devices to a test facility was impossible to comply
with and suggested that this be extended to at least
one week. (Section 211.2.12-l(e)(3), page 31737)
37. Suggested that relabeling be required only on devices
manufactured after Compliance Audit Testing. (Sec-
tion 211.2.12-8, page 31738)
38. Requested clarification on a number of issues: Nos.
38-50. Questioned whether the proposed rulemaking
would apply to both the industrial and consumer
markets.
39. Questioned the manner in which EPA intended to
regulate the labeling of devices sold unpackaged,
in bulk quantities.
40. Questioned EPA's plans for developing an educational
program to make purchasers aware of the NRR system.
41. Questioned whether the responsibility for label
verification testing and Compliance Audit Testing
was with the manufacturer of a device or the
packager/distributor.
42. Asked about what situations would result in product
recall.
A-21
-------
Docket Number, Name,
Affiliation
Comments
77-5-038 (continued)
43. Questioned how the conflict between NIOSH certifica-
tion of sound level meters (Type 5-2A), which do not
provide C-scale readings, and the use of NRR to deter-
mine compliance, would be resolved.
44. Requested information on the status of NIOSH 's volun-
tary certification program and the compatibility of
the two programs.
45. Asked for clarification on Section 211.2.4-3 concern-
ing the latitude to either affix labels or print on
packages.
46. Asked what parameters were being considered for
requiring Compliance Audit Testing.
47. Questioned the conditions under which prior year's
label verification data would be accepted for cur-
rent year 's production.
48. Questioned how EPA plans to handle the matter of
private label manufacturing, as it relates to label-
ing requirements.
49. Suggested that the amount of information proposed
for the label is excessive and that EPA should
design a label that would not require redesign and
enlargement of the product package.
50. Gave examples of redundant label information, such
as company name, location, and product model number.
51. Felt that color contrast is unnecessary if the label
is legible.
52. Quoted Section 10 of the Administrative Procedures Act
5 U.S.C. S706(2), and suggested that the proposed regu-
lations were legally as well as technically unsound.
53. Suggested that regulations concerning specification
of label content, EPA's inspection authority and
recordkeeping requirements of manufacturers exceed
the authority conferred on EPA by Congress.
54. Pointed out that Section 8 of the Noise Control Act
of 1972, 42 U.S.C. S4907(b), requires only a label
giving notice of the hearing protector's effective-
ness in reducing noise.
A-22
-------
Docket Number, Name,
Affiliation
Comments
77-5-038 (continued)
55. Stated that there is no statutory basis for the
requirement that the label contain information
beyond the noise-reducing effectiveness notice,
such as the EPA logo and especially the removal
prohibition statement, noting that Congress usually
expressly specifies such requirements.
56. Suggested that the proposed enforcement provisions
magnify the manufacturer's requirements as stated
in Section 13 of the Noise Control Act.
57. Cited specifics in the proposed rulemaking which
exceed the requirements of Section 13 by requiring
manufacturers to admit EPA inspection officials to
their private facilities for inspection and monitor-
ing activities.
58. Cited examples of proposed noise labeling regula-
tions which, in ISEA's opinion, lack a rational
basis and constitute an abuse of discretion.
59. Pointed out that the proposed regulations may be
unconstitutionally vague, noting that the grounds
for a cessation order are ill-defined, particularly
the term "substantial." (211.1.9(f)(2))
60. Indicated that a public hearing on Subpart B is
constitutionally required.
-039
Thomas J. Woods
President
Aural Technology, Inc.
(9/19/77)
1. Requested exception to the method of testing under
Subpart B as the methodologies in Sec. 211.1.3(b)
and (c) are not appropriate for the device vented
through a patented Resonance Decay Acoustical Filter.
2. Reported that the vented device has been tested
under a procedure described as "An Objective
Evaluation" by the University of Oregon, Health
Sciences Center.
3. Requested that the objective evaluation method
be approved for vented devices to avoid competitor
discrimination.
4. Expressed support for the noise labeling requirements
and offered full cooperation to EPA.
5. Attached promotional literature for the vented device.
A-23
-------
nocket Number, Name,
Affiliation
Comments
77-5-039 (continued)
6. Attached correspondence with Dr. Jack A. Vernon,
Director, Department of Otolaryngology, Kresge
Hearing Research Laboratory, University of Oregon
Health Sciences Center. Dr. Vernon (a) strongly
objected to EPA reliance on ASA STD 1-1975 as the
only way to measure the effectiveness of hearing
protectors; (b) supported objective testing pro-
cedures; and (c) reported on the disadvantages of
ASA STD 1-1975.
7. Attached Dr. Vernon's vita.
8. Attached report, authored by Dr. Jack Vernon,
evaluating the product by the objective evaluation
method.
9. Attached ANSI Z24.22-1957 test data for the unvented
model of the custom molded ear protector.
-040
Charles S. Shoup
General Manager
E-A-R Corporation
1. While agreeing with the principle of the program,
Mr. Shoup noted that E-A-R 's costs for its implemen-
tation total nearly one-fourth of EPA 's estimates
for the entire industry.
2. Pointed out that E-A-R 's NRR rating under ANSI S3.19-
1974 is 29, but requested the report of an approximate
range to avoid changes in printing.
3. Felt that the label size and information requirements
proposed pose extremely unreasonable demands on the
manufacturers of insert devices, because of the
small size of the packaging.
4. Urged that only the NRR rating be included on each
package and that the label and octave band data
be prominently lettered on the dispenser or master
package and on technical and/or sales literature.
5. Proposed that consideration be given to different
regulations concerning industrial and commercial
sales.
6. Suggested that month and year of production informa-
tion is not useful and that codes on dispenser
boxes should be sufficient for EPA's purposes.
A-24
-------
Docket Number, Name,
Affiliation
Comments
77-5-040 (continued)
(letter of 1/27/77)
7. Disagreed with methods for determining compliance
in that derating becomes a measure of the risk the
manufacturer is willing to take.
8. Suggested that manufacturers be able to choose the
lab used for compliance audit testing.
9. Felt that the requirement for two Federal tests and
potential repeated tests is extremely unreasonable
and arbitrary.
10. Suggested that protectors be considered in compliance
if the one-third octave bands were within one stand-
ard deviation of the Federal Compliance Audit Test.
11. Reported no suggestions for the error boundaries
applicable to the NRR.
12. Suggested that if non-compliance occurs, the manu-
facturer be required only to relabel all new pro-
tectors produced, allowing a reasonable time for
conformance.
13. Pointed out that Part 211.2.9-4(b) should be
stricken since the information is confidential
and proprietary.
14. Pointed out that more than six months would be
required to comply with the regulations as they
currently stand.
15. Felt that EPA should show due cause when requiring
Compliance Audit Tests.
16. Pointed out that the printing of information on
an individual protector was not practical in terms
of hygiene, legibility, or cost-usefulness.
17. Provided several points of information on their
protectors requested by EPA.
-041
John F. Dickey, Attorney
Energy and Environment
Division
DuPont Company
1. Cited references to dispel the negative bias con-
tained in the fourth paragraph of the NPRM Introduc-
tion concerning the efficiency of hearing protec-
tive devices.
A-25
-------
Docket Number, Name,
Affiliation
Comments
77-5-041 (continued)
2. Suggested adoption of the original rating system
proposed by NIOSH, contained in Appendix A of
Section I of "Criteria for a Recommended Standard
in Occupational Exposure to Noise" (NIOSH 1972).
3. Pointed out that the EPA program will require a
large amount of redundant effort, and suggested
that new testing and labeling be limited to new
products.
4. Recommended that the simplicity of a single number
rating should never be used to obscure the per-
formance effectiveness of a device over individual
bands of frequency.
5. Recommended that the NRR be based only on differ-
ences between A-scale weighted levels rather than
C-scale levels.
6. Pointed out that annoyance factors should be con-
sidered separately from "potential impairment"
factors in the rating system.
7. Recommended comparison testing of third octave
band measurements and standard octave band measure-
ments to determine if costly third octave band
requirements are needed.
8. Attached a document entitled "Real-Ear Sound
Attenuation Characteristics of Hearing Protective
Devices Available Through Federal Supply Channels"
as coordinated with the U.S. Army Technical Bulletin
TB MED251, 25 January 1975.
9. Attached pages 19 through 113 of Section I in
"Criteria for a Recommended Standard in Occupational
Exposure to Noise" (NIOSH, 1972).
10. Attached pages 1 and 2 of HEW Publication No.
(NIOSH) 76-120, "List of Personal Hearing Protec-
tors and Attenuation Data" (Sept, 1975).
11. Attached selected pages of articles appearing in
trade and safety journals. These include: "Hearing
Protection and the Employee," "Personal Ear Protec-
tion," and "Getting Employees to Wear Hearing Pro-
tection."
A-26
-------
Docket Number, Name,
Affiliation
Comments
77-5-042
Julian Pawlina
Chief Engineer
Taylor Products
1. Requested further information on the proposed
regulations.
-043 1.
Michael J. Percy
Senior Urban Planner
City of Mountain View,
California 2.
(Also 77-8-172)
Opposed the use of a numerical or symbolic rating
scheme which required consumers to refer to addi-
tional materials to interpret its meaning.
Suggested that the label be direct and "state the
amount of decibel reduction that would be achieved
by a given noise protection device or the number
of decibels that the machinery produced."
-044
Roland Westerdal
President
Bilsom International,
(letter dated 9/7/77)
Inc.
1. Asserted that the EPA regulations confuse the
identity of the purchaser and the end user, who
are seldom the same in the hearing protector market.
2. Noted that the commercial buyer does not inspect the
individual product package and for that reason, there
is no need for labels on the product package and the
product or its carrying case. In addition, if the
carrying case is not the package and is therefore
not visible or accessible at the time of purchase,
the issue is how the label can be of use to consumers,
3. Recommended that the necessary information be pro-
vided at a location defined flexibly to relate to
the product, its package, and the reality of the
sales transaction.
4. Claimed the minimum label size requirement is rigid
and impractical, in that it exceeds the size of
many of the products and their packages.
5. Recommended flexibility in label size requirement,
because of the range in size of products and the
need to vary the label location to suit the sales
transaction.
6. Suggested there was no logical distinction between
supporting information and label information and
that they should be treated with equal flexibility.
A-27
-------
Docket Number, Name,
Affil iation
Comments
77-5-044 (continued)
7. Stated that the proposed regulations do not recog-
nize the influence of a variety of laboratory con-
ditions on the test results and that it would be
unjustified and unfair to impose on manufacturers
liability for test variations due to these limita-
tions.
8. Maintained that submittal of information from manu-
facturers concerning actual and planned production
volume should not be required, due to its sensitivity
and irrelevance to the Agency's goals.
9. Pointed out that pre-approval of labels is unneces-
sary and would result in delays (211.2.10-3).
10. Recommended that manufacturer's verification of label
information be required only if there is a negative
change in the level of protection afforded and not on
an annual basis. Therefore, deletion of 211.2.10-8
was suggested.
11. Criticized the choice of a 0 to 31 dB range, noting
that according to their calculations the best pro-
tector tested in accordance with S3.19-1974 had less
than 25 dB attenuation. He indicated that the docu-
mentation for whatever range is used should be dis-
cussed at a public hearing.
12. Outlined several factors contributing to the cost
of the program and suggested that nation-to-nation
requirements should also be reflected in any analysis
of costs.
13. Pointed out a conflict between the general provisions
and the proposed hearing protector labeling regula-
tions with respect to who will bear the cost of Com-
pliance Audit Testing and suggested that these costs
should be borne by the Administrator and so stated
in the final regulations or an accompanying statement.
14. Requested a 12-month rather than a 6-month effective
date.
15. Pointed out the need for coordination with respect
to the impact of the program on imported products.
A-28
-------
Docket Number, Name,
Affiliation
Comments
77-5-044 (continued)
16. Complained about lack of consideration of special
problems facing an international company and
suggested the scheduling of a public hearing to
discuss the hearing protector regulations and
related general provisions.
17. Resubmitted to the public docket Mr. Westerdal 's
letter of May 10, 1977, which was originally
assigned docket number 77-5-001 and is summarized
therein.
-045
Thomas J. Woods
President
Aural Technology, Inc.
1. Expressed thanks to EPA in connection with his
appearance as a witness at the San Francisco hearing.
2. Expressed confidence that the industry would support
a reasonable labeling requirement from a single
agency such as EPA rather than numerous requirements
from many agencies.
3. Cited an enclosed copy of a competitor's catalog
advertising a protector in an allegedly unsubstanti-
ated and misleading manner.
-046
Stuart M. Low, President
Flents Products Company,
Inc.
1. Expressed pleasure at having the opportunity to
testify at the September 16 public hearing.
2. Expressed concern about the labeling of products
sold in bulk and some of the special packaging
they use in consumer markets.
3. Expressed concern about the proposed rules as they
would affect imported hearing protectors.
4. Suggested a meeting in the future.
-047 1.
R. Waugh
Psychoacoustics Section
National Acoustic
Laboratories 2.
Australian Department
of Health
Expressed opinion that under the proposed method
of calculating the NRR, user will be overprotected
with unnecessarily heavy and uncomfortable devices.
Using a hypothetical method described in an enclosed
paper, he calculated that the NRR has an overall
protection rate of 99.7 percent instead of 98 per-
cent, but removal of the 3 dB "spectrum" brings
this figure to 97.5 percent.
A-29
-------
Docket Number, Name,
Affiliation
Comments
77-5-047 (continued)
4.
Noted that the objective of 97-98 percent is much
greater than the objectives set by the U.K., W.
Germany or Australia, which have adopted a mean-
minus one standard deviation for a protection rate
of around 80 percent.
Suggested re-examination of the need for the 3 dB
"spectrum" correction in the NRR calculation.
5. Included two of his papers entitled:
a. "Investigation of South Level Conversion as a
Means of Rating Ear Protector Performance,"
American Industrial Hygiene Association Journal.
April 1976, 239-245.
b. "Calculated In-Ear A-Weighted Sound Levels
Resulting from Two Methods of Hearing Protector
Selection," Ann. Occup. Hyg.,19, 1976, 193-202.
-048
D. Lambert
Naval Ocean Systems
Center
1. Cited a number of suggested changes and typographical
errors in the NPRM (42 FR 31730).
2. At p. 14, suggested that EPA may want to include
"desire" for protection under "comfort."
3. At p. 27, 1.6, suggested use of a term other than
"displacements" to avoid confusion.
4. Stated, re: p. 31, bottom line, that "the dB(A)
noise reduction" is an incorrect phrase, suggesting
"the A-weighted noise-reduction in decibels" instead.
-049
Dr. 6. L. Cluff, Director
Tri-Utility Hearing
Conservation Program
Salt River Project
1. Endorsed use of a single number label for personal
hearing protectors.
2. Suggested that the single number label would pro-
vide practical information for comparing attenua-
tion characteristics of hearing protectors.
3. Suggested that the single number label could also
find practical field use in cases where individuals
needed to determine whether a given protector model
would provide adequate protection in a given noise
hazard area.
A-30
-------
Docket Number, Name,
Affiliation
Comments
77_5_049 (continued)
4. Asserted that the level of protection afforded the user
of a given PHP model could be obtained by subtracting
the "R" value, determined through procedures defined
in the NIOSH 76-120 report, from the dBA sound level.
5. Suggested that the R value be used as the product label.
6. Reported on calculations of the R value for personal
hearing protectors as a function of nine different
idealized noise spectra.
7. Attached data supporting the notion that the scope
of the noise spectra significantly affects the R
value achieved by the personal hearing protector.
8. Recommended that the reported R represent the worst
case performance of the personal hearing protector
and that, according to their data, this would be
a -12 dB per octave slope.
9. Suggested that a negative slope in the neighborhood
of -6 to -12 dB be adopted as the standard slope
for the determination of the R value of the personal
hearing protector.
10. Expressed the opinion that PHP manufacturers' publi-
cation of octave attenuation characteristics, along
with the standard deviation for the attenuation at
each octave, was highly desirable.
-050
Thomas J. Woods
President
Aural Technology, Inc.
1. Requested status of ATI 's 9/19/77 request for excep-
tion from testing for its vented device that cannot
be tested under ANSI S3.19-1974 (ref: 77-5-033) since
the firm was about to proceed on qualification for
a new product.
-051L
Kenneth Bridbord, M.D.
Director, Office of
Extramural Coordination
and Special Projects
NIOSH, Public Health
Service, Center for
Di sease Control, DHEW
1. Noted that "manufacturer" is not defined (211.2.1)
2. Based on its experience with manufacturers' testing,
NIOSH felt "that relying on test facilities which
are manufacturer-owned or manufacturer-selected is
an inadequate enforcement technique. NIOSH certifi-
cations or approvals are based on test data generated
in NIOSH laboratories. We therefore suggest that EPA
rely on NIOSH test data once we have established a cer-
tification program for hearing protective devices."
A-31
-------
Docket Number, Name,
Affiliation Comments
77-5-051L (continued) 3. Pointed out a typographical error at 211.2.4-l(c),
replacing "to" with "is" before the numeral "0".
4. Suggested that attenuation for each position of
headband device use should be provided to the user.
5. Listed a number of items for inclusion with support-
ing information, consisting mainly of instructions
for proper use and fit, expected attenuations, and
methodology, including a reference of where methods
could be found to predict the wearer's noise exposure
when the noise field is described in different ways.
6. Noted that NIOSH is considering other important
performance characteristics of protectors beyond
attenuation for its certification program.
7. Suggested wording for a supporting explanation of
the NRR.
8. Suggested that the manufacturer provide the exact
mean attenuation and standard deviation on which
the labeled NRR is based.
9. Suggested use of a one-sided, two sample t-test
applied at each 1/3 octave band to determine
"significantly less" at 211.2.6 for compliance
purposes and recommended rewriting of 211.2.12-6
and 7 based on this point and point 8 above.
10. Noted NIOSH testing indicates less (50-65 percent)
attenuation for three protectors under field condi-
tions than under laboratory conditions, implying
inadequate fits.
11. Pointed out NIOSH requirements for quality control in
its certification program (Subpart B of 42 CFR 82).
-052L 1. Responded to requests for information from EPA
Elliot H. Berger arising from meeting.
Acoustical Engineer
E-A-R Corporation 2. Enclosed data on an obsolete protector comparing
results of Z24.22 and S3.19 testings, and enclosed
test result data for a test conducted on an obsolete
protector by four different laboratories.
A-32
-------
Docket Number, Name,
Affiliation Comments
77-5-052L (continued) 3. Noted additional cost estimates for a six-month
period as opposed to a "more reasonable 12-18
month compliance period," as "substantially greater
than $50,000." These costs consist mainly of packag-
ing, scrapping or modifying existing inventory,
conversion to new packaging, and lost sales.
4. Enclosed copies of current consumer information
literature.
A-33
-------
RELEVANT COMMENTS:
GENERAL PROVISIONS DOCKET 77-8
77-5-060 Oral Statement at Washington, D.C. Public
Mr. Stuart Low, President Hearing -- 9/16/77
Flents Products Company
(Also 77-8-904-WH) 1. Mr. Low objected to the handling of Subparts A and
B by EPA with particular reference to the lack of
distinction given them by EPA and the time obstacles for comments on Subpart B,
directly affecting his firm as a manufacturer of hearing protectors. (129-130)
2. Mr. Low maintained that labeling for retail hearing protectors would not accom-
plish the desired results because of the small size of the devices, the public's
lack of awareness and the public concern with comfort rather than a technical
acoustic rating descriptor. (131-133)
3. Although Mr. Low had no objection to ASA's test No. 1, Standard of 1975, per se.
he did urge caution about the use of such a relatively new procedure. (134-135)
4. With reference to Sections 211.1.1 and 211.1.9 Mr. Low noted that the definition
of "manufacturer" for the purposes of importation remains unclear; does "manufac-
turer," for example, encompass "assembler"? In addition, rules for importers have
yet to be articulated. (135-137)
5. Mr. Low suggested allowances for sufficient lead time in the implementation of
the labeling program to account for importation and manufacturing difficulties.
(137-138)
6. Referring to Section 211.1.4, Labeling Content, Mr. Low pointed to excessive infor-
mation requirements for earplugs, much of it duplicating contents on the product's
packaging, and also objected to the large size of the proposed labels, requiring
larger and costlier packaging for the earplugs. These requirements, Mr. Low
concluded, are unduly burdensome to the industry, given the low cost of making
ear plugs.
7. Referring to Section 211.1.5-8, Mr. Low objected to the requirement to affix labels
on each individual product, since many of his firm's sales are in bulk lots in cost-
saving packages. Mr. Low also inquired about what could be pasted on as opposed
to less costly printing of a label. (141-143)
8. Referring to Section 211.1.9, Inspection and Monitoring, Mr. Low objected in light
of unpleasant experiences with New York State regulations, to the "extraordinary"
inspection powers afforded to EPA, and suggested two paragraphs (pp. 146-147)
be appended to the regulations circumscribing EPA cessation of production orders
(144-147)
9. Mr. Low objected to the lack of hearings on the hearing protector proposals,
Subpart B, and urged a dialog with EPA and his industry leading to a more
voluntary program. (147-149)
A-34
-------
Responses to Questions from EPA Panel: Mr. Thomas
10. Mr. Low commented that he did not oppose the new ANSI S3.19-1974 standard test
but rather was concerned about its relative novelty for testing purposes.
(150-156)
11. Mr. Low expressed concern over placing rating labels on both his product's
packaging insert and on the box itself, which he felt would be a costly pro-
cedure. (156-158)
12. Mr. Low suggested that EPA consider the differences for labeling purposes in
hearing protectors marketed for individuals versus those sold in bulk packages
to industry. (159-164)
Dr. Shutler
13. Mr. Low suggested more highly articulated enforcement language in the regulation,
vesting cessation-of-production authority clearly in the Administrator, to inform
enforcement offices of the limits of their discretion. (165-168)
Mr. Kozlowski
14. Mr. Low pointed out differences in costs, marketing and packaging of ear muffs
and ear plugs for labeling purposes but preferred to defer to Industrial Safety
Equipment Association's comments on the ear muff matters. (168-170)
Mr. Cerar
15. Mr. Low received clarification from Mr. Cerar that a domestic assembler of
imported components would be considered a domestic manufacturer for purposes of
the regulations. (170-171)
16. Mr. Low expressed concern over possible delays in implementing Import Section 9
through Treasury Department regulations, which have yet to be issued. (171-173)
Mr. Feith
17. Mr. Low pointed out that a 12-422 attenuation test costs around $2,000, and
labeling might add 80 percent to his container costs. (173-176)
A-35
-------
77-5-061 Oral Statement at San Francisco Public Hearing — 9/22/77
Thomas Moods
President of Aural 1. Mr. Woods, manufacturer of protective hearing devices,
Technology expressed support for the labeling program and
Also 77-8-949-SH described a case where a person exposed to noise at
a recording company suffered extreme hearing loss.
(178-179)
2. Mr. Woods expressed concern about the lack of interagency coordination and thus
the difficulty of satisfying different regulations. He also expressed concern
about the economic impact of the testing costs and objected to the authority of
the Administrator to order a compliance audit even when there was no evidence of
noncompliance. (180-183)
3. Mr. Woods described the content of his company's proposed brochure. He stated
that a pressure-sensitive label which could be peeled off would cost about 3 cents
per unit -- a reasonable price for a device costing $5.03/unit. The cost of
printing the sample brochure he showed to the panel would be less than 1 1/2 cents
per unit, based on printing 100,000. Costs for preparing camera-ready copy and
graphics would be about $10,000, of which $7,500 would be nonrecurring expenses.
The label could be done economically, he asserted. His label also contained
information on how to properly use the ear protectors. (183-187)
Responses to Questions from EPA Panel: Mr. Thomas
4. Mr. Woods suggested that most companies in the hearing protective device industry
would not be reluctant to publish the noise attenuation properties of their pro-
ducts on a label, though he admitted some would hesitate to do so. (190-192)
5. Mr. Woods suggested that the "label" information be required in advertisements
directed at industrial consumers of hearing protectors. (193)
6. Mr. Woods said the name of the company which introduces the product into com-
merce should be on the label and not the original manufacturer. Annual reports
represent a means of tracking down the true manufacturer. Mr. Woods did not
see any problem in repeating the company's name both on the packaging and on
the label. (196-200)
7. Mr. Woods felt the EPA logo should be on the label but noted that this carries
with it an explicit endorsement of the validity of the information by EPA.
(201-202)
8. He suggested that it is important for EPA to require on the label information
about the likely degradation of the attenuation capabilities of hearing protec-
tive devices. (204-206)
A-36
-------
77-5-062 Remarks from the Floor at San Francisco Public
Mr. and Mrs. Crozier Hearing — 9/22/77
French Laboratory
(Also 77-8-954-SH) 1. Mr. Crozier, a manufacturer of custom-molded hearing
protectors, suggested that labeling take into account
factors like comfort, hygiene properties, and the appropriate fit. He noted that
an attenuation rating based on laboratory subjects is meaningless (and misleading
to consumers), since there are variations in the structure of the human ear and
protectors will not function properly unless they are built to correspond to these
variations. (325-326)
2. Mr. Crozier suggested a statement for the label (or brochure) which emphasizes
that the amount of attenuation an individual will derive from the product is
based on a proper fit. Factors affecting the "fit" are ear canal configuration,
haircut, eyeglasses, etc. (330-332)
3. Throughout Mr. Crozier's discussions with EPA panel members, questions were
raised about the validity and reliability of test procedures used by laboratories
to rate hearing protectors (e.g., ASA 1-1975). (326-334)
4. Mr. Crozier explained that even if certain information cautions the user about
the need for a proper fit, there are serious problems because of the average
person's ignorance about what constitutes a "proper fit." (336)
5. Mrs. Crozier suggested there may be a serious problem raised by fraudulent
activities of test labs, working in collaboration with manufacturers. (341)
6. Mrs. Crozier cited the problem of an inaccurate label remaining on a product
which has undergone repairs affecting its noise properties. (343)
A-37
-------
77-5-063
Mary 0 'Neal Broida
(Also 77-8-047)
Requested information on the availability or future
development of ear protectors which will substan-
tially reduce noise at all frequencies.
Commented that she is trying to find "ear protectors
which will eliminate or reduce noise for people who
are trying to sleep in noisy environments."
77-5-064
Morris Tenenbaum
(Also 77-8-051)
1. Expressed approval of product noise labeling program.
2. With respect to the effectiveness of hearing protec-
tors, Mr. Tenenbaum cited the following publication
and noted that the quoted effectiveness rating numbers
ranged from 6 to 47:
National Institute of Law Enforcement and Criminal Justice, Law Enforcement
Assistance Administration, U.S. Department of Justice (NILE-CJ-0101.00,
April 1976), Selection Guide to Hearing Protectors for Use on Firing Ranges.
77-5-065
John Connolly
(Also 77-8-052)
1. Expressed support for labeling of hearing protectors.
2. Noted effects of noise on the tuning of musical
instruments and professional musicians.
77-5-066
James Bogar
(Also 77-8-058)
1. Expressed strong opposition to the labeling provv
sions for hearing protectors.
2. Questioned the meaning of the rating number and
asserted that noise-reducing products and noise-
producing products cannot be labeled in the same
manner.
77-5-067
Mrs. Vernon Wall
(Also 77-8-069)
1.
2.
3.
Expressed interest in and support of the program.
Requested assistance in identifying effective hear-
ing protectors and their marketing source.
Complained about the ineffectiveness of certain
materials and earplugs in reducing noise.
77-5-068
Larry W. Potter
Standards Officer
Kentucky Department of Labor
Occupational Safety and
Health
1. Commented on the problem of evaluating hearing pro-
tectors, noting that studies have indicated that manu-
facturers ' attenuation values are seldom accurate in
the actual work environment. Possible reasons for the
discrepancy include improper fitting or wearing and the
determination of attenuation values under ideal condi-
tions.
A-38
-------
77-5-068 (Continued) 2. Recommended therefore that hearing protector labels
contain a disclaimer informing potential purchasers
"that the actual attenuation values as listed by the
manufacturers can be affected by improper fitting or
wearing ..." and "that the manufacturer's values
represent the maximum attenuation under ideal condi-
tions, with the insert-type hearing protectors fitted
by individuals trained in this procedure ..."
77-5-069 1. Asserted that the sound attenuation of custom-molded
K. 0. looker, President ear protectors will vary from one individual to
Plasticast Laboratories, another depending on stiffness of ear tissue and
Inc. other factors. Tests have indicated attenuation
varying from 18 to 22 decibels in the range of 300
to 1000 Hertz and from 28 to 35 decibels in the range
of 3000 Hertz and beyond.
A-39
-------
Docket No.
77-5-101
77-5-102
77-5-103
77-5-104
77-5-105
77-5-106
77-5-107
77-5-108
77-5-109
77-5-110
ORAL TESTIMONY
PUBLIC MEETING ON LABELING REGULATIONS
FOR HEARING PROTECTORS
(Crystal Mall, Crystal City, Virginia, 13 December 1977)
Person
Stuart M. Low, President
Frank J. Lotlo
Ronald J. Cox
Elliot Berger
Roy Fleming
John M. Ruffner, President
Earl W. Broker
William Newcomb
Frank E. Wilcher, Jr.
James T. McCallum, Jr.
Organization
Flents Products, Inc.
Mine Safety Appliances Company
Wilson Products Division of ESB
EAR Corporation
NIOSH
Plasmed, Inc.
Norton Company, Safety Products
Division
Norton Company, Safety Products
Division
Industrial Safety Equipment
Association
Reynolds Metals Company
This public meeting was less structured than a formal public hearing in that
commenters were allowed to make more than one statement. There were free exchanges of
ideas between commenters and Agency panel members, as well as exchanges of ideas among
commenters. Therefore, all statements from commenters and panel members are listed as
they occurred. Docket numbers were assigned to commenters in their order of initial
appearance.
The page number of the transcript of the public meeting on which the statement
occurs is noted in parentheses at the end of the statement.
A-40
-------
DOCKET SUMMARY FOR PUBLIC MEETING
Commenter (Doc. No.)
Mr. Low (101)
Mr. Lotlo (102)
Mr. Low (101)
Mr. Lotlo (102)
Mr. Cox (103)
Pointed out that the requirements place a burden on the
manufacturers of hearing protectors in terms of labels,
printing costs, and higher costs for larger boxes, particu-
larly for the insert type of protectors. (17)
Pointed out that the labeling requirements for hearing pro-
tectors are more severe than those required by the Mining
Enforcement Safety Administration on respirators, which are
often used in life and death situations. (18)
Pointed out that in the industrial market, which is different
from the consumer market, the ultimate user does not purchase
the hearing protector and therefore questioned that the users
need to have this information, given that they have no control
over the purchase decision. (18-19)
Questioned the need for labeling information on earplugs used
by some swimmers. (20)
Questioned whether imported products would be given treatment
equal to that of domestic products under Section 9. (20-21)
Questioned regulations concerning the importation of hearing
protector components. (24)
Reported that, according to his informal survey of laboratories,
there are no more than three laboratories in the country cur-
rently able to perform the required test. (25)
Due to the limited number of, the limited capacity of, and the
scheduling within testing agencies, Mr. Low suggested that the
6 month compliance period be extended to no less than 12
months and possibly to 18 months. (25-26)
Reported on a survey of psychoacoustic laboratories conducted
by the National Bureau of Standards and suggested that only
one of the three laboratories found to do psychoacoustic
testing did contract work for manufacturers. (27)
Mentioned that testing requires laboratories which are well-
versed in psychoacoustics. (29)
Expressed the opinion that testing laboratories require
trained listeners in addition to appropriate facilities.
(30)
A-41
-------
Commenter (Doc. No.)
Mr. Low (101)
Mr. Cox (103)
Mr. Low (101)
Mr. Berger (104)
Mr. Cox (103)
Noted the distinction between overall capacity to do
testing and ability to do testing in a reasonable time
period. (30-31)
Indicated that the cost of testing which could range from
$1200 to $2000, weighs more heavily on the smaller company.
(31)
Suggested that consideration be given to the possibility of
using small package inserts to give notice to the potential
users of the insert-type hearing protectors. (31-32)
Citing bad experiences in New York, Mr. Low felt that
manufacturers deserved protection against inexperienced
and perhaps unreasonable inspectors. (33-35)
Suggested provisions which grant only the Administrator the
authority to order a manufacturer, distributor, or user to
cease distribution or use of a product, and then only in
writing with a copy sent to the manufacturer by registered
mail. (34)
Mr. Low mentioned that the cost of inserts to packaging would
vary according to the amount of information provided on the
insert, but that they would be under three cents apiece.
(35)
Interjected that the cost of packaging changes, which
depends upon the rigor of packaging requirements, could con-
ceivably exceed the cost of the product in the package. (36)
Emphasized that a given product is often packaged in several
ways, each having its own limitations in terms of labeling.
(38)
Objected to any requirement for labels affixed to individual
protectors or their carrying cases when they are sold in
bulk. (41)
Asserted that the size requirements for the labels make
impossible their application on one particular transparent
insert-type protector box currently produced. (42)
Suggested that disposable or semi-disposable hearing pro-
tectors packaged in bulk be treated differently from other
hearing protectors with respect to labeling. (43)
In response to a question, Mr. Cox agreed that there would
be no "label size" problem with respect to the muff-type
protector. (44)
A-42
-------
Commenter (Doc. No.)
Mr. Low (101)
Mr. Berger (104)
Mr. Fleming (105)
Mr. Cox (103)
Mr. Fleming (105)
Mr. Berger (104)
Mr. Cox (103)
In response to questions by EPA panel members, Mr. Low
reported on his testing costs and his procedures for
testing imported products. (47-50)
Mr. Low discussed educational and sales literature as a
substitute for labels in the industrial market. (51-52)
Mr. Low indicated that he knew of no satisfactory or
reliable objective tests for the insert-type protector.
(54-55)
In response to questions by EPA panel members, Mr. Low
provided information about the kinds of products he
imports and the means through which he obtains test
data on these products. (55-57)
Submitted a mock-up label which suggests that the 1-1/2 x
2 inch label cannot accommodate the required type size.
(57)
Reported on a NIOSH study which compared the attenua-
tion values of hearing protectors obtained through
a field test at four industrial sites in Kentucky with
those obtained in the laboratory under the old ANSI
standard. According to the study, workers were not
getting the dBA reduction that would be predicted through
the ANSI laboratory test procedures. The implications of
the study were that these workers were not wearing
the protectors the way trained test subjects do and/
or that they had significantly different ear canal
structure.(59-68)
Mr. Fleming reported that NIOSH was in the process of
developing a certification program for hearing protectors.
(69)
Reported that Wilson Products had data comparing products
under the old and new test standards. (69)
Mr. Fleming briefly discussed a short, subjective test
which was used as a check on the ANSI test system.
(77-78)
In a discussion concerning criteria for trained subjects,
Mr. Berger said that trained subjects were those who had
experience with the program. (79)
Mr. Cox reported that while he couldn't quantify the
variability, the results of tests by different labora-
tories on similar devices were not the same. (80)
A-43
-------
Commenter (Doc. No.)
Mr. Fleming (105)
Mr. Berger (104)
Suggested an adjusted NRR which takes into account the
variability of the mean itself. (81)
In response to a question, Mr. Fleming suggested that the
adjusted NRR would be even lower if the larger standard
deviations found in field tests were taken into account.
(82)
A 10 dB range of means was obtained on one type of plug
tested at several laboratories three to four years ago.
(83-84)
Pointed out that the NRR range of 1 to 31 would more
likely be on the order of 0 to 35 using ANSI S-3.19-1974
data. (84)
Reiterated that a differentiation should be made between
disposable and reusable insert protectors. (85)
Felt that the regulations, rather than standardize the
reporting of data, create a gambling situation for the
manufacturer in that the manufacturer determines the risk
he is willing to take for noncompliance. (85-86)
Suggested that some standardized method for comparing govern-
ment certification test results and reported data be adopted.
He felt that if the government test and the reported data
were within one standard deviation, then probably the data
should be determined to be in compliance." (86)
Emphasized the need to consider the problem of determining
the variability of the NRR rating. (86)
Suggested that Section 211.2.9(4)(b) concerning EPA's
right to know about production data for any particular
period of time be stricken from the document since the
need for such data is not demonstrated. (86-87)
Suggested that code numbers be substituted for the dating
of protectors, given that presumably the purpose of the
dating requirement is to allow the manufacturer the ability
to recall a specific product that has been determined to be
out of compliance. (87)
Suggested that information on an 8-1/2 x 11 inch sheet of
paper contained in each carton of 200 units would supplement
the short form instructions on each individual protector
package and would be a suitable means of supplying data to
the end users of the products -- both individual protector
users and industrial safety officers. (87-88)
A-44
-------
Commenter (Doc. No.)
Mr. Berger (104)
Mr. Berger (104)
Mr. Berger (104)
Mr. Ruffner (106)
Mr. Low (101)
Mr. Ruffner (106)
Has found no correlation in decibel changes between an
objective test using an artificial ear and a subjective
test. (88)
Suggested that any NRR derating brought about by studies
showing difference between laboratory and field tests be
done on a protector-by-protector basis. (88-89)
In response to a question by a member of the EPA panel,
Mr. Berger suggested that it would be inappropriate to
provide production data since it would then be available
to competitors. (90-91)
Expressed the opinion that additional testing would be
required to determine the correlation between objective
and subjective tests. (91-92)
Suggested that one method for discounting the variance
between laboratories would be to retest the product at
the laboratory which did the original testing, assuming
that the laboratory was on a government certified list of
laboratories. The product would be found in compliance if
its new mean was not more than one standard deviation
lower than the prior reported mean. (95)
Reiterated that the cost of going to court to contest
the Agency's remedial action is a staggering sum for a
small manufacturer. (97-98)
Expressed concern about adopting an objective test for the
muff-type protector since this would give the muff-type
protector an advantage in the market place in the future.
(99-100)
Expressed concern over potential bias resulting from manu-
facturers using their own test laboratories instead of
independent laboratories. (100-101)
Maintained there was a conflict between the defense medi-
cal purchase description and the EPA labeling requirement.
(103-104)
Stated that the manufacturing costs to manufacturers sell-
ing in bulk to other firms will more than double under the
proposed regulations and discussed some label ing-related
manufacturing costs. (104-105)
Pointed out that ear plugs may go through four levels of
distribution before they reach the ultimate consumer.
(104-105)
A-45
-------
Commenter (Doc. No.)
Discussed the costs involved in the change of an etching
on a molded earplug and reported that the total cost would
be about $1600 per mold. (105-106)
Asserted that his insurance premiums for product liability
would increase to about $50,000 with the implementation of
labeling requirements. (106)
Noted that there was no way to determine whether the ulti-
mate user of a given earplug produced by his firm was using
it for swimming protection or hearing protection. (107)
Questioned whether tests would have to be duplicated by
both manufacturing and distributing firms or whether one
test would satisfy the Agency. (108-109)
Pointed out that exported earplugs are often repackaged by
a broker prior to export, and that contracts with various
foreign governments could not be met if the regulations
governing exported products were implemented. (109)
Objected to the perceived unfair advantage given to ear
muff protectors because the cost of labeling ear muffs
relative to the cost of the ear muff itself is inconse-
quential. (109-110)
Suggested that information provided on an 8-1/2 by 11 inch
sheet of paper would be cheaper than box imprinting or
adhesive labels and would pose no problems. (110)
Expressed "no inhibition on (his) part to supply any test
data to any user." (110)
Feels strongly that the $300,000 figure calculated by EPA
as the regulation's cost to the manufacturer is totally
unreasonable. (Ill)
Mr. Ruffner described the system by which earplugs are
exported and indicated the problems involved in knowing
whether a given earplug will reach a foreign market or
remain in the domestic market. Mr. Ruffner also explained
that his products may be repackaged three or four times.
(112-114)
In response to a series of questions, Mr. Ruffner explained
that he provides his purchasers with photocopies of test
results carried out on five sizes of randomly-selected
earplugs, and that these tests have been run five times in
seven years. (115)
A-46
-------
Commenter (Doc. No.)
Mr. Broker (107)
Mr. Low (101)
Mr. Ruffner (106)
Mr. Low (101)
Mr. Ruffner (106)
Mr. Low (101)
In response to questions by EPA panel members, Mr.
Ruffner explained that his firm has no routine quality
control checks to determine if and how content varia-
tions between batches of plastic affect the acoustic
properties of his earplugs. He noted that the specifi-
cation sheet distributed with the earplugs relates to
the technical performance of an arbitrary batch and not
the batch from which they were produced. (117-118)
Mr. Broker suggested that the labeling requirements
be placed on the last handler of the product prior to
the end user or consuming company. (119-120)
Indicated that if he purchased protectors from another
manufacturer (e.g., Mr. Ruffner) who already performed
the required tests and provided him with a Xerox copy
of the results, he would not run any additional tests
(assuming he was satisfied with their accuracy). (121)
Raised the issue of whether the person doing the testing
would allow his customer to release the results to another
manufacturer for use by that manufacturer. (121)
Raised a question as to the professional ethics of photo-
copying original-source data and sending it to another
manufacturer. (121)
Reiterated the idea that the earplug is able to compete
with the earmuff because of its low price and that a
substantial price increase because of labeling would
render it less competitive. (121-122)
Pointed out that the label would not necessarily iden-
tify the actual manufacturer, given current marketing
practices. (123)
Mr. Low indicated that he was inclined to use original
test results rather than subject a product to additional
testing, provided the results are available. (123-124)
Explained batch-to-batch quality control procedures run
according to Military Standard. (126-127)
In relation to problems with the Defense Supply Agency
and other government agencies, Mr. Low commented that the
change of a specification is often a 2 or 3 year job and
that contracts are often held up for this reason. (128)
A-47
-------
Commenter (Doc. No.)
Mr. Newcomb (108)
Mr. Broker (107)
Mr. Lotlo (102)
Mr. Low (101)
Mr. Newcomb (108)
Mr. Cox (103)
Suggested that artificial objective testing is inappro-
priate for anything other than quality control, even for
the muff-type protector. (129-130)
Responding to questions from the EPA panel, he indicated
that hairstyles and the wearing of glasses affect test
results but are not taken into account systematically in
the subjective testing. (130)
Expressed concern over the use of a single number rating
system which emphasizes magnitude of performance as
opposed to the reliability of performance. (132)
Pointed out the advantages of non-linear hearing pro-
tectors and expressed concern over the fact that these
would have an NRR of zero. (133)
Supported different labeling requirements for the consumer
product as opposed to the industrial product. (133)
Mr. Broker explained that the nonlinear protector was
packaged differently for different markets and that the
information provided to consumers differed according to
the particular market. (138-139)
Expressed concern about requirements for embossing infor-
mation on individual inserts, given the fact that differ-
ent products come off the same hard tools. He suggested
that, for monetary reasons, the labeling scheme should
allow for something added to the product after the mold-
ing process so that the expensive process of repeatedly
inserting different molds could be avoided. (139-140)
Pointed out that helmets and special muff attachments
are often marketed together even though they are not
made by the same manufacturer. (141)
Mr. Newcomb explained that he tests his ear muffs on
his own company's hats, but that other manufacturers
make ear muffs that fit on several different companies'
hats. (This situation raises the issue of whether or
not a test is required for each combination of helmet
and muff.)
Summarized chains of distribution in both the industrial
and consumer markets for his product. (143-147)
Reported that the testing of one muff potentially worn in
three positions with two different ear cushions, with or
without a crown strap, could cost $24,000. (147)
A-48
-------
Commenter (Doc. No.)
Mr. Ruffner (106)
Mr. Wilcher (109)
Mr. Lotlo (102)
Mr. Fleming (105)
Mr. Wilcher (109)
Cited market research studies which mentioned the reasons
for buying hearing protectors as (1) comfort, (2) freedom
in the work environment and (3) noise suppression effec-
tiveness. (154-155)
Questioned whether the proposed rule making would apply
to both consumer and industrial markets. (156-157)
Questioned how EPA would regulate the labeling of devices
sold unpackaged in bulk quantities. (157)
Asked about EPA's specific plans for developing an educa-
tional program to make purchasers aware of the NRR system,
its purpose, applications and significance. (158)
Inquired as to who would have responsibility for label
verification testing and audit and compliance testing in
the case of a device manufactured by one company and
packaged or distributed by another. (160)
Inquired about what situations would result in an order
by the Administrator to recall or buy back products
from purchasers. (160-161)
Questioned the means by which EPA plans to resolve the
conflict between pre-NIOSH certification of sound level
meters, type S2A, which do not provide C-scale ratings,
and the use of NRR to determine compliance. (161)
Pointed out that an arbitrary scheme would not provide
the customer with information as to whether a given
protector would provide enough protection in his envi-
ronment. (162)
Pointed out that it was possible to calculate the effec-
tive dBA level given knowledge of the NRR, the dBA level
and certain correction factors. (163-164)
Expressed concern about the compatibility of the EPA pro-
gram with the pending NIOSH certification program. (166)
Questioned whether manufacturers would, under Section
211.2.4-3, have the latitude to either affix a label
or print the required information on the package itself.
(167)
Inquired as to the parameters being considered for requir-
ing compliance audit testing. (168)
A-49
-------
Commenter (Doc. No.)
Mr. McCallum (110)
Mr. Low (101)
Asked about the conditions under which EPA would not
accept prior year's label verification data for current
year's products. (169)
Inquired about how EPA planned to handle labeling respon-
sibility. (170)
Emphasized the importance of getting the information to
the user. (170-171)
Mr. McCallum explained his preference for offering
employees a choice of protectors and cited his company's
policy on this issue. (171-172)
Requested consideration of a 12-month implementation date
since containers and other packaging materials are often
ordered 15 months ahead of time. (173)
A-50
-------
APPENDIX B
INDEX OF WRITTEN DOCKET SUBMISSION
AND PUBLIC HEARING TESTIMONY
-------
INDEX OF WRITTEN DOCKET SUBMISSIONS
Title: Noise Labeling Requirements-Hearing Protectors
Authority: Federal Register. June 22, 1977, Part IV, p. 31730
Number Date
77-5-
001 5/10/77
002
5/12/77
003
004
005
006
007
008
009
010
Oil
012
013
014
015
6/28/77
7/13/77
7/18/77
7/21/77
7/8/77
8/1/77
7/12/77
7/17/77
8/4/77
7/25/77
8/12/77
Company/Address
Bilsom International, Inc.
Bilsom International, Inc.
Tasco Corporation, Inc.
Flents Products Company, Inc.
Aural Technology, Inc.
(omitted)
Pennsylvania State University
Indianapolis Speech and
Hearing Center
H.E. Douglas Engineering
Sales Co.
Leboeuf, Lamb, Leihy & MacRae
(Attorneys)
Writer
Roland Westerdal
President
Marlene K. Olinger
Administrative Assistant
Thomas A. Scanlon
President
Stuart M. Low
President
Elizabeth Platt
Phillis H. Rosenthal
Thomas J. Woods
Paul L. Michael, Ph.D.
Professor of Environ-
mental Acoustics
R.A. Smith
David Rankin
Kenneth R. Freitas
Jane A. Baran, Director
Audiology/Aural
Rehabilitation
H.E.Douglas
President
Margaret R.A. Paradis
B-l
-------
Number Date
77-5-
016 8/11/77
017
018
019
020
021
022
023
024
025
026
027
028
029
030
8/23/77
8/15/77
8/19/77
9/2/77
8/18/77
8/26/77
8/23/77
8/22/77
8/17/77
9/6/77
9/20/77
9/7/77
9/12/77
9/12/77
Company/Address
Mining Enforcement and Safety
Administration (MESA), U.S.
Department of the Interior
Flents Products Company, Inc.
French Laboratory
Industrial Safety Equipment
Association
Northeastern University
Singapore Institute of Standards
and Industrial Research
Osterreichi sches Normungsi nsti tut
(Standards Institute for
Government of Austria)
Mott Corporation
State Lobster Hatchery and
Research Station (Mass.)
Marin General Hospital
Forging Industry Association
Norton Company
Safety Products Division
W.H. Brady Co.
Bethlehem Steel Corporation
Civil Aeromedical Institute
U.S. Federal Aviation
Administration
Writer
Robert G. Palaso, for
Donald P. Schlick, Ass't.
Administrator, Technical
Support
Stuart M. Low
Hugh Crozier
Frank E. Wilcher
Executive Director
David Fishken, Ph.D.
Department of Psychology
Rudolf Donninger
E.S. Mott
John T. Hughes
Katherine M. Reilly,
Audiologist
Michael N. Winn
Director of Industrial
Relations and Govern-
ment Affairs
Frederick G. Crocker, Jr,
Vice President and
General Manager
H.J. Wise
David M. Anderson, Ph.D.
Manager, Environmental
Quality Control
Jerry V. Tobias, Ph.D.
B-2
-------
Number Date
77-5-
031
032
9/9/77
9/15/77
033 9/20/77
034 9/14/77
035 9/16/77
036
037
038
039
040
041
042
043
(Also
77^172)
9/14/77
9/13/77
9/20/77
9/19/77
1/27/77
9/16/77
9/27/77
9/25/77
044
045
046
9/7/77
9/28/77
9/29/77
Company/Address
Plasmed, Inc.
J. I. Case Company
Aural Technology, Inc.
State of North Carolina
Department of Labor
Air Transport Association of
America
Operational Facility Requirements
Flents Products Company, Inc.
The Charles Machine Works, Inc.
Industrial Safety Equipment
Association
Aural Technology, Inc.
E-A-R Corporation
DuPont Company
Energy and Environmental
Division
Taylor Products
City of Mountain View,
California
Bilsom International, Inc.
Aural Technology, Inc.
Flents Products Company, Inc.
Writer
John M. Ruffner
President
Lawrence H. Hodges
Vice President,
Technical Affairs
Thomas J. Woods
President
L.A. Weaver
Acting OSHA Director
Edwin W. Abbott
Manager
Stuart M. Low, President
Gerald A. Stangl, Ph.D.
Design Engineer
Frank E. Wilcher, Jr.
Executive Director
Thomas J. Woods
President
Charles S. Shoup
General Manager
John F. Dickey, Attorney
Julian Pawline
Chief Engineer
Michael J. Percy
Senior Urban Planner
Roland Westerdal
President
Thomas J. Woods
President
Stuart M. Low, President
B-3
-------
Number Date
77-5-
047 9/29/77
048 9/26/77
049 10/21/77
050 10/28/77
051L 12/14/77
052L 12/10/77
Company/Address
Australian Department of Health
Psychoacoustics Section
National Acoustic Laboratories
Naval Ocean Systems Center
Tri-Utility Hearing Conservation
Program
Salt River Project
Aural Technology, Inc.
NIOSH, Public Health Service
Center for Disease Control, DHEW
E-A-R Corporation
Writer
R. Waugh
D. Lambert
Dr. G.L. Cluff
Di rector
Thomas J. Woods
President
Kenneth Bridbord, M.D.
Director, Office of
Extramural Coordination
and Special Projects
Elliot H. Berger
Acoustical Engineer
B-4
-------
INDEX OF RELEVANT SUBMISSIONS FROM
DOCKET 77-8:
NOISE LABELING STANDARDS/GENERAL PROVISIONS
Number
77-5-060
(Also 77-8-904;
Washington, D.C.
Public Hearing)
77-5-061
(Also 77-8-949;
San Francisco
Public Hearing)
77-5-062
(Also 77-8-954;
San Francisco
Public Hearing)
77-5-063
(Also 77-8-047)
77-5-064
(Also 77-8-051)
77-5-065
(Also 77-8-052)
77-5-066
(Also 77-8-058)
77-5-067
(Also 77-8-069)
77-5-068
(Also 77-8-414)
77-5-069
(Also 77-8-444)
Company/Address
Flents Products Company, Inc.
14 Orchard Street, P.O. Box 2109
Bel den Station
Norwalk, Connecticut 06852
Aural Technology, Inc.
12722 Riverside Drive
North Hollywood, California 91607
French Laboratory
1938 Marconi Avenue
Sacramento, California 95815
290 South Ashland Avenue
Lexington, Kentucky 40502
155 Honness Lane
Ithaca, New York 14850
6 Centre Place
Boston, Massachusetts 02119
(not available)
310 West Liberty Street
Rome, New York 13440
Kentucky Department of Labor
Occupational Safety and Health
Frankfort, Kentucky 40601
Plasticast Laboratories, Inc.
711 Penn Avenue
Pittsburgh, Pennsylvania 15222
Writer
Stuart M. Low
President
Thomas J. Woods
President
Mr. and Mrs. Hugh Cozier
Mary 0 'Neal Braida
Morris Tenenbaum
John Connolly
James Bogar
Mrs. Vernon Wall
Larry W. Potter
K.O. Tooker, President
B-5
-------
INDEX OF ORAL COMMENTS DELIVERED AT
13 DECEMBER 1977 PUBLIC MEETING
Number
77-5-
101
102
103
104
105
106
107
108
109
110
Company/Organi zati on
Flents Products Company, Inc.
Mine Safety Appliances Co.
Wilson Products Division of ESB
E-A-R Corporation
NIOSH
Plasmed, Inc.
Norton Company, Safety Products
Division
Norton Company, Safety Products
Division
Industrial Safety Equipment
Association
Reynolds Metals Company
Speaker
Stuart M. Low
President
Frank L. Lotlo
Ronald J. Cox
Elliot Berger
Roy Fleming
John M. Ruffner
President
Earl W. Broker
William Newcomb
Frank E. Wilcher, Jr.
James T. McCallum, Jr.
B-6
-------
PUBLIC MEETING ATTENDEES
(December 13, 1977)
Angela Bannon
3M Company
1101 15th Street
Washington, D.C.
331-5581
Elliot Berger
EAR Corporation
7911 Zionsville Road
Indianapolis, Indiana 46224
(317) 293-1111
Earl W. Broker
Norton Company
2000 Plainfield Pike
Cranston, Rhode Island 02920
(401) 943-4400
Ronald J. Cox
Product Manager
Wilson Products Division of ESB
P.O. Box 622
Reading, Pennsylvania 19603
(215) 276-6161
G.C. Croushore
Mine Safety Appliances Company
600 Penn Center Boulevard
Pittsburgh, Pennsylvania 15235
(412) 273-5149
Roy Fleming
NIOSH
(617) 357-9500, x 3051
Richard P. Flynn
Marketing Manager
American Optical Company
14 Mechanics Street
Southbridge, Massachusetts
(617) 765-9711, x 2822
Bruce D. Johnson
Lab Manager
American Optical Corporation
100 Canal Street
Putnam, Connecticut
(203) 928-6554
Frank J. Lotlo
Mine Safety Appliances
201 North Braddock Avenue
Pittsburgh, Pennsylvania 15205
(412) 273-5540
Stuart M. Low, President
Flents Products, Inc.
14 Orchard Street
Norwalk, Connecticut 06850
(203) 866-2581
James T. McCallum, Jr.
Reynolds Metals Company
6603 West Broad
Richmond, Virginia 23261
William Newcomb
Norton Company
Safety Products
2000 Plainfield
Cranston, Rhode
(401) 943-7735
Division
Pike
Island 02920
Margaret Paradis
LeBoeuf, Lamb, Leihy, and MacRae
(Counsel for Bilsom International,
Inc.)
1757 N Street, N.W.
Washington, D.C. 20036
457-7500
B-7
-------
John M. Ruffner, President
Plasmed, Inc.
145 North Plains Road
Wallingford, Connecticut 06492
(203) 265-6761
Robert L. Strain
1231 25th Street, N.W.
Washington, D.C. 20037
F.C. White
Glendale Optical Company
130 Crossways Park Drive
Woodburg, New York
(516) 261-5800
Frank E. Wilcher, Jr.
Industrial Safety Equipment Association
1901 North Moore Street
Arlington, Virginia 22209
(703) 525-1695
B-8
-------
APPENDIX C
ABBREVIATED LIST OF PARTIES CONTACTED
THROUGH PUBLLIC PARTICIPATION PROGRAM
-------
This Appendix contains an abbreviated list of all the organizations,
associations, and individuals, both domestic and international, that the
Agency was able to identify as potentially affected by, proponents of, users
of, or in any way affected by the Noise Labeling Requirements for Hearing
Protectors.
The Agency has actively contacted the parties on this list by direct
mailings of information to them about the Hearing Protector regulation.
C-l
-------
PUBLIC PARTICIPATION THROUGH
DIRECT MAILING HEARING PROTECTORS
CATEGORY
Acoustical Associations
NUMBER OF ENTRIES
Aerospace Association 22
Association of Airlines/Airports
Audiological Associations 26
Business Associations 122
Citizens Associations 7
Construction Industry Associations 17
Consumer Associations 19
Environmental Associations 126
Health/Medical Associations 29
Hospital Associations 11
Associations of Importers/Exporters 19
EXAMPLES
Acoustical Society of America
National Council of Acoustical
Consultants
American Astronautical Society
American Institute of Aeronautic
and Astronautics
Air Transport Association of
America
Aviation Development Council
American Academy of Ophathalmology
and Otolaryngology
Council on Education of the Deaf
American Chamber of Commerce
Jaycees International
Citizen Action Group
Call for Action
American Building Contractors
Association
Associated General Contractors
of America, Inc.
Center for Consumer Affairs
Consumers' Union of United States
John Muir Institute for Environ-
mental Studies
National Environmental Develop-
ment Association
American Medical Association
American Public Health Associa-
tion
Catholic Hospital Association
Surgeon General (Military
Hospitals)
Association of Private Hospitals
World Trade Centers Association
National Federation of Export
Management Companies
C-2
-------
CATEGORY
NUMBER OF ENTRIES
EXAMPLES
Industry Associations
73
Insurance Associations
Legal Associations
Retailer's Associations
Shipbuilding Associations
Sports Associations
Standards Organizations Associations
Trade Associations
Associations of Vocational Schools
Wholesalers Associations
Acoustical Consultants/Testing Labs
Congress
Congressional Committees
Environmental Research Centers
11
4
9
15
6
32
13
3
300
535
11
48
Western Forest Industries
Air Conditioning and
Refrigeration Institute
Association of Steel Dis-
tributors
Health Insurance Association
of America
International Claim Associa-
tion
American Bar Association
Special Committee on
Environmental Law
National Retail Merchants
Association
Boating Industry Associations
Boat Manufacturers Association
National Rifle Association
American National Standards
Institute
National Beauty and Barber
Manufacturers Associa-
tion
Northwestern Lumbermen, Inc.
American Council on Industrial
Arts Teacher Education
American Vocational Associa-
tion
Farm Equipment Wholesalers
Association
Acoustical Consultants, Inc.
Institut de Recherche Des Tran
Senate and House of Representa-
tives
Senate Committee on Energy
and Natural Resources
Environmental Sciences
Institute
C-3
-------
CATEGORY
NUMBER OF ENTRIES
EXAMPLES
Federal Agencies 43
International Organizations 2
Law Firms with Environmental Interests 332
Manufacturers of Hearing Protectors 70
Manufacturers of Noise Pollution
Control Products
Major Manufacturers and Distributors
Media: Environmental Publications
Media: General
Media: Industry Specific
Public Interest Groups
State and Local: Attorneys General
State and Local: Departments of
Transportation
State and Local: Governors
State and Local Users of Hearing
Protectors (e.g. State
Procurement Offices)
State and Local Law Enforcement
134
554
92
70
14
133
50
50
50
50
General Services Administration
Occupational Safety and Health
Administration
Department of Defense
Organization for Economic
Cooperation and Develop-
ment
Abutano and Chisholm
Flents Products
Excel-Silenta, Inc.
Acoustics Manufacturing Corp.
Acoustiflex Corp.
National Gypsum Corp.
Eastman Kodak Co.
General Electric Co.
Journal of The Acoustical Society
of America"
Archives of Environmental Health
Cry Californian
U.S. News & World Report
Better Homes & Gardens
Heavy Trucking
National Council of Senior
Citizens
American Association of
Retired Persons
Purchasing Bureau, State of
Maryland
Material Management Bureau,
District of Columbia Division
National Sheriffs Association
C-4
-------
CATEGORY NUMBER OF ENTRIES EXAMPLES
State and Local: Mayors, 893 L.A. Banda, City of Fremont,
Local Noise Officials California Planning
and Health Department Department
Zoning Administrator,
Tuscon, Arizona
Mrs. Jane Byrne, Chicago
Hawaii State Department of
Health
Unions 167 United Steelworkers of America
United Farm Workers of America
Universities 515 Texas A&M
Manufacturers/Industries: 160 Dupont
Users of Hearing Protectors The Boeing Company
Docket Entries—Hearing Protectors 48
C-5
-------
APPENDIX D
MANUFACTURERS AND DISTRIBUTORS
OF HEARING PROTECTORS
-------
Adcotone-Adcomold
1558 California St.
Denver, CO 80202
American Optical Safety Products
14 Mechanic St.
Southbridge, MA 01550
Bausch & Lomb
1400 N. Goodman St.
P.O. Box 450
Rochester, NY 14602
Belmar Safety Equipment, Inc.
Trenton Avenue
Barrington, NO
Bilsom International, Inc.
1930 Isaac Newton Square, East
Reston, VA 22090
Binky Baby Products Co., Inc.
519 Patterson Avenue
Wallington, NJ
Doug Biron Associates
P.O. Box 413
Buford, GA
Blackhawk Gasket, Corp.
218 Mill St.
Rockford, IL
Bowman Distribution
Barnes Group, Inc.
852-T E. 72 St.
Cleveland, OH
E. D. Bullard, Co.
2682 Bridgeway
Sausalito, CA
CSE Corporation
600-T Seco Road
Monroeville, PA
Clark Caster, Co.
7312 W. Roosevelt Road
Forest Park, IL
H. E. Douglass Engineering
Sales Company
2700 West Burbank Blvd.
P.O. Box 7209
Burbank, CA 91505
Dunn Products, Inc.
33 S. Sangamon St.
Chicago, IL
E. I. duPont de Nemours
& Co.
Applied Technology Div.
Wilmington, DE 19898
E-A-R Corporation
376 University Avenue
Westwood, MA 02090
Eagle Druggists Supply, Co.
P.O. Box 3307
Wallington, NJ
Eastco Industrial Safety
Corporation
26-15A 123rd St.
Flushing, NY
Eastern Safety Equipment
Co., Inc.
45-17 Pearson St.
Long Island City, NY 11101
Environmental Acoustical
Research, Inc.
Insta-Mold Western Head-
quarters
P.O. Box 2146
Boulder, CO 80302
Erb Plastics, Inc.
P.O. Box 156
Woodstock, GA 30188
Feeder Corporation of
America
4429-T James Place
Melrose Park, IL
D-l
-------
Cesco Safety Products
100 East 16th St.
Kansas City, MO 64108
David Clark Co., Inc.
360 Franklin St.
P.O. Box 155
Worcester, MA 01613
Curtis Safety Products Co.
P.O. Box 61
Webster Square Station
Worcester, MA 01608
Foam Products, Inc.
York Haven, PA
French Laboratory
1938 Marconi Avenue
Sacramento, CA 95815
General Scientific Equipment
Company
N. Limekiln Pike and Williams
Avenue
Philadelphia, PA
Hal-Hen Company
36-14A llth St.
Long Island City, NY
Hechler Brothers, Inc.
22-19 37th Avenue
Long Island City, NY 11101
Industrial Noise Control, Inc.
785-T Industrial Dr.
Elmhurst, IL
3M Company
Occupational Health and Safety
Products Department
3M Center
St. Paul, MN 55101
Martindale Electric, Co.
1365 Hird Avenue
Cleveland, OH
The Fibre-Metal Products
Company
Baltimore Pike at Brinton
Lake Road
Concordville, PA 19331
Firesafe, Inc.
1202 Monroeville Avenue
Turtle Creek, PA
Flents Products Co., Inc.
14 Orchard St.
P.O. Box 2109
Belden Station
Norwalk, CN 06850
Dr. Frank Corporation
P.O. Box 232
Cape Coral, FL
Frontier Industrial
3521 Sunset Blvd.
Los Angeles, CA 90026
Glendale Optical Co., Inc.
130 Crossways Park Dr.
Woodbury, NY 11797
Hearing Conservation Ltd.
Amplivox House
Beresford Avenue
Wembley, Middlesex
England HAO IRU
Hocks Laboratories
935 N.E. Couch St.
Portland, OR 97214
Industrial Products, Co.
21 Cabot Road
Langhorne, PA
Marion Health and Safety,
Inc.
9233 Ward Parkway
Kansas City, MO 64114
D-2
-------
Mediprint, Inc.
2510 Sutton Blvd.
St. Louis, MO 63143
Mine Safety Appliances, Co.
400 Penn Center Blvd.
Pittsburgh, PA 15235
New Jersey Safety Equipment, Co.
1680 Stuyvesant Avenue
Union, NO
Ocean Pool Supply Co., Inc.
17 Stepar Place
Huntington Station, NY
Perfection Supply, Co.
6434 N. Central Avenue
Chicago, IL
Pure Rubber Products, Co.
3 Ray Place
Fairfield, NJ
Safety Clothing and Equipment, Co.
4900 Campbell Road
Willoughby, OH
Safety Ear Protector, Co.
5356 West Pico Blvd.
Los Angeles, CA 90019
Sellstrom Manufacturing, Co.
Palatine, IL 60067
Sigma Engineering
Norton Safety Products Division
11320 Burbank Blvd.
North Hollywood, CA 91601
Sound Master Corporation
1530 Broadway
Oakland, CA 94612
Surgical Mechanical Research, Inc.
900 W. 16th St.
P.O. Box 1185
Newport Beach, CA 92663
Material Flow, Inc.
835 N. Wood St.
Chicago, IL 60622
Morse Safety Products, Co.
18103 Roseland Avenue
Cleveland, OH 44112
Norton Company
Safety Products Division
2000 Plainfield Pike
Cranston, RI
Ohio Valley Safety Co., Inc.
523 N. Commerical Dr.
Steubenville, OH
Pulmosan Safety Equipment,
Corporation
30-48 Linden Place
Flushing, NY
Rye Industries, Inc.
125 Spencer Place
Mamaroneck, NY
Safety Direct
P.O. Box 8907
Reno, NV 89507
Scintrex Audio Division
Scintrex, Inc.
400 Creekside Drive
Amherst Industrial Park
Tonawanda, NY 14150
Russ Simpson, Co.
21908 Schoenherr Road
Warren, MI
Southern First Aid Supply, Co.
1120 Piedmont Drive
Lexington, NC 27292
Talon Industries, Inc.
55-T Knickerbocker Avenue
Bohemia, NY
D-3
-------
Titan Abrasive Systems, Inc. Tasco Corporation
P.O. Box 3-T 22 Alemida Avenue
Furlong, PA East Providence, RI
Wade Products, Co. United States Safety
12 Arlington Drive Service Company
Croton, NY 1535 Walnut St.
Kansas City, MO 64108
George W. Warner & Co., Inc.
252-A Lafayette St. Welsh
New York, NY A Textron Company
2000 PI ainfield Pike
Will son Products Division Cranston, RI
ESB Incorporated
2nd and Washington Streets
P.O. Box 622
Reading, PA 19603
D-4
-------
TECHNICAL REPORT DATA
(Please read Instructions on the reverse before completing}
REPORT NO.
EPA 550/9-79-256
2.
3. RECIPIENT'S ACC
5. REPORT ONhlEJ'J 1 ?fi PH '7Q
T\,,~,~.i- i mr> «iii | j
TITLE AND SUBTITLE
Regulatory Analysis Supporting the Noise Labeling
Requirements for Hearing Protectors
August, 1979
6. PERFORMING ORGANIZATION CODE
AUTHOR(S)
I. PERFORMING ORGANIZATION REPORT NO.
. PERFORMING ORGANIZATION NAME AND ADDRESS
Environmental Protection Agency
Office of Noise Abatement and Control
401 M Street, S.W.
WaHhincri-nn. n.C!. 2D4fif)
10. PROGRAM ELEMENT NO.
11. CONTRACT/GRANT NO.
12. SPONSORING AGENCY NAME AND ADDRESS
Environmental Protection Agency
Office of Noise Abatement and Control
Washington, D.C. 20460
13. TYPE OF REPORT AND PERIOD COVERED
14. SPONSORING AGENCY CODE
EPA 200/02
15. SUPPLEMENTARY NOTES
16. ABSTRACT
Ijhis document contains information used by EPA in developing the Noise Labeling
Requirements for Hearing Protectors] including: a description of hearing protector
devices, factors affecting selection, and a discussion of the various methods for
measuring protector effectiveness; the procedure used to calculate single-number
effectiveness ratings; an overview of the industry; the Agency's response to
comments, and resolution of issues raised during the public comment period; and
the participation of the public throughout the development of the regulation.
17.
KEY WORDS AND DOCUMENT ANALYSIS
a.
DESCRIPTORS
b.lDENTIFIERS/OPEN ENDED TERMS
c. COSATI Field/Group
Compliance Audit Testing, Docket Analysis,
economics, hearing protectors, label con-
tent, Label Verification Testing, Noise
Reduction Rating (NRR)
enforcement, measurement
methods, public partici-
pation, selection
factors, the industry
18. DISTRIBUTION STATEMENT
Release unlimited
19. SECURITY CLASS (This Report/
ified
21. NO. OF PAGES
20. SECURITY CLASS (This page)
Unclassified
22. PRICE
•PA Form 2220-1 (9-73)
------- |