Document ID: EPA-HQ-OAR-2003-0024-0063
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-08-05T04:00Z

January 23-24, 2007 Meeting on Hearing Protector Labeling

EPA Headquarters, Washington, DC

Rule Making Schemes: Two number system 

Method Comparison

Method

	A	B

Within Lab

	X

	Between Lab

X

Cost

	X

	Speed 

	X

	Realism

X

Rank Order

X

Explanation

	X

	De-rate

X

Dual Number	X	X

Device’s inherent performance	X

	International Issues	X

	X

International testing is more complicated due to country specific
requirements. 

	Standards are one consideration

	Measurement methods is the area of most debate international

	International harmonization is very important for future

	Reciprocity is also important 

EU now has expanded and many of the new counties are compromising on
testing. It is easier to pass tests for certification to standards in
some EU counties. At the same time EPA is open to regulations that may
help US business in over seas markets.

ISO Standard

One approach could be to adopt ISO standards with some exceptions.  If
changes were made in the vague sections in ISO with more stringent US
requirements it would – should be accepted certification for selling
internationally. There still were concerns by industry whether this
would be accepted internationally. 

Industry perspective for business development

 What is the industry’s market strategy for business development?

Most see US market as close to saturation. Looking over seas for market
growth

Generally business will follow areas of growth internationally

The are mow large international conglomerates that are exploiting world
markets

One focus is to prevent products that are not tested and certified to
meet labeling requirements from coming into US. If there is a foreign
standard and test procedure the US may accept it for use in US.  

No one internationally is using a range of numbers in labeling. There is
no clear trend in world for method A or B. 

Working Group 11

Working group 11 results could be useful for this EPA effort.

“A” weighted worked in most cases

In areas of more “C” weighted it may call for modification

Look at the handout from yesterday

Noise Statistic not level

Used 20% , 80% rating points as best

See page 6 as example of label

NSRG is a four number rating, HML other method.  NSRG is simpler to
calculate and understand. Both used for low frequency. 

The proposed standard is about ready to go to ANISE for balloting and
approval. It could be out by this summer.

Evaluation of methods A and method B

Is there an overlap between method A and method B?

Suggest that even the primary label should be graphical not numerical
value. Example of method B was illustrated in the slide shown in the
meeting. Group liked the bar chart approach to show the performance of
hearing protector. There was some discussion of the size of the range
shown. Some questioned OSHA acceptance of the bar approach. Would this
label be subject to de-rating by OSHA? There should be some dialog
between EPA and OSHA on this approach before this would be finalized.
Current OSHA de-rating was based on marginal analysis. EPA would not
want their labeling to be modified in some way by OSHA. Take the
position that EPA has developed a leading new approach based on detailed
technical review and analysis.  This would then take president over the
OSHA approach of de-rating in any way. Ken noted that discussions within
EPA have been positive on graphic standard vs. numbers. Ken asked if
this approach would apply to all devices. 

This approach could be used to describe passive performance of active
devices. It was noted that there should be some explanation of what the
bars mean. Could have two bars for devices that are designed to perform
two functions? For example, example ear plugs used in the military for
passive noise reduction and for weapon firing events.

There were questions about the two bar approach shown on Bill’s
slides. The concern was about treatment of active vs. passive ear muffs.
 The effect of automatic noise reduction (ANR) is very different at
different frequencies.   Note that some felt that ANR devices should be
only rated in the on position because that is what they were designed
for.  Suggest that the guidance on page 8 (applying the NRS graph) is
something that could be used to guide user on which graphs to use. 	

Ken suggested that the full range of performance of a single device
could be shown on the label graph.  The example of aviation and
industrial noise was used. Why not one bar over the full range of all
frequencies. Note the use in NIOSH 100 for industry exposure test. Other
frequencies are used to test for sound more dominated in low
frequencies. Suggest that more examples of appropriate application be
used on the red or blue bars. 

Note the bar approach should not be used to do more than intended.
Suggest that products be labeled for specific markets (i.e. still only
one bar for designated customer base by manufacturer). Note that the
test/measurement environment is the same for both red and blue. The
difference is how the values are calculated. A different value and range
is calculated for the red and blue. Bose feels that there is a need if
not a requirement for educating people so they can understand the double
bar label.  For Air Force the spectral content is most important for
aviation.  Comment made that in this case may not have design for the
Air Force! 

KISS principle:

Best rating is 40 to 50

Sample two numbers 10 and 25

Show some sample applications on the scale (feel to complex to show the
differences)

It is possible to have two different packaging approaches for the
consumer vs. professional market. Under this concept there could be just
one bar on the package label. Should this be mandated or left to
manufacturer? 

Ken now feels that the two bars can not be combined and make sense. 
Should the designed product user be designated as part of the label? 
Specify, the label would state that this devise is intended to be used
to listen to music or in the operation of an aircraft. 	

PM Session: Primary and Secondary Labels

Focus on what should go on primary and secondary label

Federal agencies want numbers

Maybe a range of values

Rating using graphic

Time frame for implementing labeling regulations

Should we package according to anticipated customer or use

Home applications are often as high as industrial environment, example
is home depot now the source power tools for contractors

Separate by bulk packaging for industry and home use

Military maybe exempt from labeling

Limited production maybe exempted, provided not be offered at large
retail outlets (Wal-Mart). Do not want to shift markets i.e. Play
helmets with ear devise. Manufacture may choose to just make helmet and
let others make ear piece. 

Military exemption may not be as applicable since now buy off shelf
concept

Double protection items. How to label these products. Double labeled?
Use secondary label to do more education about the product and the use
and suggestions for different application environments

Important to provide information on assessing the effectiveness of the
device after using it and suggestions for better use and alternative
devices for better protection

Industry questioned if it should be EPA or manufacture to provide
educational information on use etc. 

Secondary label maybe shorter with just short instruction on use and a
web site link or other link like phone, fax, email etc.

There should be contractor help desk support for major retail outlets.
Right now there is not that kind of support at the home depot etc. Now
must go to manufacturer to get this kind of information. Manufacturer
should have some incentive to provide this kind of information to the
retail level. 

Dispenser box is an other location for additional information

Require the manufacture to identify an intended use statement and what
it is not intended for other stated uses. Problem is that space is
limited for the identification of all uses or the time of exposure
factor that has to be considered.

Note: noise accumulates so the approach of separating out home vs. other
use locations is counter to real life accumulative noise exposure.

OSHA: the communication challenge is similar for the small contractor
and home user.

Consider separation by occasional user vs. the industrial user with the
idea of simpler information for occasional user class.

For consumer enhancement products i.e. listening to music etc. these
should not be labeled with numbers etc. but just labeled as not intended
as a hearing protector. Suggest that the language be not for use in
hazardous noise environments.

What about ear devices to protect swimmers from water in the ear.

Put hearing protector words on the primary label. For example, this
device is designed to protect you ears from hazardous noise and other
high sound levels.

Ken interested in word changes that could be used on label. To include
consideration of liability chain relative to federal enforcement of
labeling regulation.  Who provides the information on the label 

Should the information developed by the manufacturer be submitted to EPA
as data base for the labeling program? 

 EPA is working with NIOSH for a calculator that will automatically send
information to EPA and post on official record. The data base would be
available to everyone but could not be changed once entered into data
base.

Putting icons on label to identify use application may help communicate
information. Many of the people liked the simplicity of the icon
approach.

Ken supported the development of a set of hearing protect icons for
different applications. 

Three categories: 1) recreational/industrial continuous noise, 2)
Impulse noise and 3) Low-frequency noise 

What information should be on bulk shipment products?

Ken’s summary at 3:00pm

Two numbers better than one

Bar approach good

Icon also has merits

Suggest secondary label be small and simple with contact link to
manufacture (prevent waste etc)

NIOSH: When product is put on the market all labeling information is
sent to official data base site. Most seemed this was reasonable. 

Ken: Primary label will have manufacturer contact information.

Suggest that if icon used also show bar. Majority seemed to like one
with bar or a bar with symbol.

Icons: airplane, round bomb with fuse

When manufacturers send to second party provider to private label
situation is created. The private labeler is held responsible to have
all records to verify testing etc of the product including any
applicable manufacturer information.

Adding color will add a lot of cost of labeling. Consider this carefully
in the regulation.

NIOSH Calculator

Standardized NIOSH Calculator: Does this have merit

generally very supportive

Discussion of what data would go into the calculator (i.e. using
averages)

Attendees would like some time to review in detail the calculator

Generally seemed to be a lot of interest in this tools and potential
enhancements to it

Some felt it was too much to put this amount of data into the tool

The standard will have the details of the data base input and may
include the detail of an ANSI standard if by reference or modification
and reference

Greatest benefit is to manufactures that are not doing the full testing
that the representatives here today are doing

There was multiple support for no decimal places in the report

Wrap up Comments on Testing

Duration of exposure to noise will not be part of the EPA regulation.
The will be left to manufacture to define their product and
differentiate from others.  Same for third octave band information.

Implementation by Manufacturers should have up to 32 weeks for testing
to properly label. Considering everything else (labeling, inventory,
etc.) it may require up to 18-24 months to be in compliance.

Bootstrap Model: Bootstrapping the NRR

See Bill’s slides on the process for estimating NRR

Doing this to get understanding to get an understanding of the standard
error on individual measurements

If there is a two number labeling system then both would have to be
tested.

For determining retest: If second test falls outside confidence interval
consider retesting.

Everyone will retest periodically: test is usually at same lab as the
first test.  Under regulation, however, EPA can do testing at any lab
for compliance with regulation. If another lab test was significantly
different may result in retesting with witness in same lab as originally
tested. 

Six lab test results showed (method B) the variation of test results.
These test results showed a large variation in results. Method A in
similar lab tests showed much better clustering of results. 

If went to third party testing would method B be more successful?  But
example showed better results using method A (with training). The factor
of subject attention to details is not well measured or assessed and
this may be a factor in the variation. Suggest the subject to read aloud
the instructions to assure instructions were understood.  

Ken: have a variable with subject and variable of the tester.  May have
recording to get uniform instruction and the reading aloud instruction
by the subject to reduce variance.

This should improve the out come of the test.  Training the testers is
most effective use of resources vs. training the subjects based on
number people involved.  

Method B is measuring the ability to learn and understanding by the
subject in addition to testing the device. There are different methods
used across the board by different industry representatives in testing
under both Method A and B. 

History of regulation is not to look to detail requirements of testing
in depth.  In auto regulations it was more the competition that raised
an issue that then was investigated by EPA. Better to come with
forthright, honest testing and sharing of lessons learned.