Recommendations for Hearing Protector Labeling

Ted K. Madison, M.A., CCC-A

## 3M Occupational Health & Environmental Safety Division

March 27, 2003

Comments presented at the EPA Workshop on Hearing Protector Devices,
Washington, D.C.

Today I would like to speak to 3 main points.

1.  Based on my observations of and conversations with hearing protector
    users and hearing conservation program administrators, I am
    convinced that packages of hearing protectors need to bear labels
    that communicate more clearly and accurately the product performance
    characteristics and the use conditions that impact the effectiveness
    of that product in the workplace or in non-occupational settings.

2.  Secondly, there is widespread agreement within the hearing
    conservation professions that the hearing protector labeling
    currently required by the United States EPA, under federal
    regulation 40 part 211, is inadequate and misleading.

3.  Thirdly, 3M believes that users of hearing protectors and employers
    who provide hearing conservation programs for their employees will
    benefit from improved hearing protector labeling, should the EPA go
    forward with changes to the rules contained in 40 part 211.

In order to understand the needs of hearing protector users, we need to
understand the intended use. In the occupational noise setting, the
person who selects the hearing protector needs to know whether or not a
particular hearing protection device is capable of reducing the noise
exposure of employees to levels below the exposure limit. Typically, the
employer has measured or at least estimated employee noise exposure
levels relative to exposure limits established by OSHA or company
policy. In industries where noise-exposed employees participate in a
hearing conservation program, includes annual training and hearing
testing, one can assume that the user has some level of understanding of
how to properly use hearing protection and the risks of failing to do
so.

However, the needs of the non-occupational hearing protector user are
quite different. The consumer who purchases a pair of hearing protectors
to use while operating a chainsaw, hunting, or attending a NASCAR event
often does not know his/her noise exposure level or hearing level.
Likewise, these consumers are typically not trained on proper use of
hearing protection. Labeling HPDs for these consumers is a more
challenging task.

It was apparently this non-occupational hearing protector user that the
EPA had in mind in 1979 when the hearing protector labeling rules were
implemented. An EPA press release that year stated that the agency
intended to put "Primary emphasis on ...labels on products used in and
around the home". The press release described how the new EPA hearing
protector labels would allow the consumer, "...to tell at a glance the
relative noise characteristics of a specific brand of product by
comparing its...Noise Reduction Rating to those of other brands." I
suspect that this emphasis on home use of hearing protectors influenced
the EPA to require the use of an ostensibly simple single number rating,
the NRR.

The premise behind the Noise Reduction Rating system was, according to
the EPA, "The higher the rating, the more effective the product should
be" If that were true, few of us would be here today to urge EPA to
modify its labeling rules.

In fact, we have learned since 1979 that a high NRR is a weak predictor
of hearing protector effectiveness. As we heard previously today,
research conducted over the last 20 years has shown that effectiveness
of a given hearing protector varies widely within the population of HPD
users in the real world. Even more concerning is the evidence suggesting
that the NRR fails to provide the consumer with an accurate indicator of
the effectiveness of a device compared to other devices with higher or
lower ratings. Regrettably, we have come to realize that the NRR reveals
only the *capability* of the device to attenuate sound under controlled
conditions, not it's effectiveness when worn under field conditions.
And, yet, it is the effectiveness of the device that is of primary
concern to users.

An effective hearing protector is one that helps reduce noise exposure
when used according to instructions. Reducing noise exposure involves
much more than the capability of the device to attenuate sound. The
effectiveness of the hearing protector is influenced by the attributes
of the noise itself, a host of user variables, including fit, and,
perhaps most importantly, wear time.

3M has concluded that the existing HPD labeling rules set forth by the
EPA are inadequate. If you read all of the EPA-required text on a
hearing protector package, you may come away with the idea that noise
reduction is the most important characteristic of a hearing protector in
determining its effectiveness. Few, if any other factors that influence
HPD effectiveness are even mentioned in the EPA-mandated text. Given the
weight of evidence suggesting that these other factors influence HPD
effectiveness as much or more than laboratory attenuation
characteristics, it is imperative that changes be made to the labeling
rules to provide consumers with better information about hearing
protector selection. The omission of valid criteria for selecting
hearing protectors in the current EPA labeling rules is compounded by
the lack of accurate information concerning how much the performance of
a given device varies within a population of users. A single number
rating based on average performance, such as the NRR, fails to
communicate the tremendous range of attenuation that may be achieved by
individual in the field.

3M is also concerned that portions of the EPA-mandated text, which we
and other manufacturers must print on packages of hearing protectors, is
misleading to consumers. This misleading information has led OSHA to
require employers to discount or derate the NRR when evaluating the
protection offered by hearing protectors relative to noise controls.
Likewise, 3M and other manufacturers, in response to misleading
statements on the EPA label, have modified their packages to include
cautions and use limitations. The end result is confusion for the
consumer. I'd like to show you a couple of examples.

On a box of 3M ear plugs, the consumer may read this statement required
by the EPA,

"The level of noise entering a person's ear... is closely approximated
by the difference between the... noise level and the NRR".

However, on the same package, the consumer will read,

> "Research suggests that the NRR may overestimate the protection
> provided by hearing protectors during typical use. 3M recommends
> reducing the NRR by 50% for estimating the amount of noise reduction
> provided."

In another example, the consumer will read these two contradictory
statements on the same package:

> "Higher (NRR) numbers denote greater effectiveness"

"Differences between hearing protector ratings of less than 3 dB are not
important. Far more important is the amount of time you wear the hearing
protector relative to the amount of time you are exposed to noise."

Clearly, we are sending mixed messages to consumers. By modifying its
rules for labeling hearing protectors, the EPA can reduce much of this
confusion and help consumers make better informed choices about hearing
protection.

I would like to share with you, now, some specific recommendations for
improving hearing protector labeling.

3M supports changing the laboratory test method that manufacturers must
use to measure the real-ear attenuation of hearing protectors for
labeling purposes to ANSI S12.6, method B. It appears that method B, a
subject fit test method, yields a better estimate of real-ear
attenuation that is "achievable" by groups of users under field
conditions. Because it appears that subject fit data correlate well with
the "field attenuation" data measured in numerous studies, using method
B to measure hearing protector performance may reduce or eliminate the
need to apply safety factors or derate the labeled rating. If the use of
subject fit testing yields hearing protector ratings that can be used at
face value, the process of estimating the adequacy of hearing protection
relative to noise controls would be simplified. Occupational hearing
protection users and those who administer hearing conservation programs
would directly benefit from such simplification.

3M recommends that the NRR be converted from a single number rating to a
two number Noise Reduction *Range*. By providing the user with an NRR at
two different performance levels, the EPA can help consumers better
understand the range of noise reduction that is achievable depending on
use conditions. Such a range of noise reduction provides a clear
illustration of the importance of wearing the devices properly and
consistently during noise exposure periods. While critics of this
approach have argued that a noise reduction range would be too confusing
for consumers, 3M believes that a simple explanation of the range can be
developed. We support the ANSI S12 working group 11 in its efforts to
define the methods for calculating such a noise reduction range and
efforts by the EPA to develop a label to communicate a Noise Reduction
Range to consumers.

With regard to the so-called secondary label, 3M encourages the EPA to
review and incorporate into a revised labeling rule recommendations made
by the NHCA Task Force on Hearing Protector Effectiveness on the topics
of "Selecting Hearing Protection" and "Estimating Noise Reduction for
Individual Users". We agree with the intent of the task force
recommendations to de-emphasize the NRR as the primary criterion for
selecting hearing protectors.

One statement in the NHCA task force report, shown here, very clearly
summarizes the most important information consumers need to know when
selecting hearing protectors.

> "The most critical consideration in selecting and dispensing a hearing
> protector is the ability of the wearer to achieve a comfortable
> noise-blocking seal which can be consistently maintained during all
> noise exposures."

3M encourages the EPA to require that this statement, or one similar to
it, be printed on every hearing protector package sold in the United
States.

Should the EPA develop and implement new rules for labeling hearing
protection devices, 3M favors a transition period of at least 3 years,
during which time manufacturers would be allowed to sell products
labeled according to the 1979 rules. This would allow sufficient time
for manufacturers to test and label their products in accordance with
the new rules. Re-testing of hearing protectors should not be required
by EPA unless the manufacturer has modified the product substantially,
resulting in a change to the product form, fit, or function. With regard
to laboratory testing, 3M and a significant number of other
manufacturers encourage the EPA to require, in any new hearing protector
labeling rule, that manufacturers of hearing protectors use independent,
third-party laboratories for the purpose of measuring the real-ear
attenuation values and calculating the performance rating(s) that are to
be printed on packages sold in the United States. We believe that this
requirement will help boost consumer confidence in the validity of
hearing protector performance ratings.

One challenge faced currently by HPD manufacturers is the test-retest
variability of real-ear attenuation measurements. In cases where a
single product is tested more than once, and the test data yield
different ratings, the EPA needs to provide clear rules for determining
which NRR is to be printed on the label. Given the "bigger is better"
mentality in the industry, with regard to NRR, it is conceivable that
HPD manufacturers have, in the past, or may, in the future, attempt to
obtain a desired NRR, not by improving the product in a meaningful way,
but by retesting a product repeatedly; rolling the dice, if you will, in
hope that the variability of test data will eventually yield a higher
number. EPA should discourage this practice by including in revised
labeling rules specific criteria for when and if a manufacturer must
modify its published NRR to reflect newly acquired performance data. By
defining these criteria carefully, the EPA can help protect consumers
from false claims of "improved product performance" that are based on
statistically insignificant variations in test results.

Finally, 3M urges the EPA to seek full funding for the Office of Noise
Abatement and Control to assure that hearing protector labeling
regulations are kept up-to-date and to enforce those regulations in a
meaningful way. If funding for ONAC cannot be obtained, 3M recommends
that the EPA consider granting permission to other Federal agencies,
such as NIOSH for example, to regulate certain aspects of hearing
protector labeling by means of a memorandum of understanding or similar
agreements.

Thank You