range information and new label content; applicable to both primary and
secondary labels.
     Recurrent testing for all HPDs at either 3 or 5 year
intervals.
     Changing the label to reflect a new NRR range of any
product for which the recurrent testing yields NRRs that are
significantly lower or higher than previously stated on the products
label.
     Additional recordkeeping and reporting costs attendant to
the periodic retests.
a. Transition Testing and Labeling Costs
    Seven HPD manufacturers and two testing laboratories provided a
range of estimates of the unit costs to test and label each of their
HPD product lines. Some companies provided cost estimates based on
their in-house test facilities. Others provided estimates based on
historic charges from independent testing laboratories. Most companies
provided cost data based on the existing test method; however, some,
including one independent test laboratory, provided estimates based on
their experience using the new ANSI method.
    Table C-1 summarizes the ranges of cost estimates for the existing
test method and the new ANSI/EPA test methods. The table also presents
the range of unit cost estimates developed from the information
collected by this study to analyze the impacts of the proposed rule
changes. Testing costs for earmuffs are given for each potential
headband position. This means that if a particular earmuff can be worn
with the headband in three different positions (behind-the-head, over-
the-head, or under-the-chin), then three tests may be required--this
analysis provides a conservative evaluation of costs since many
manufacturers are expected to identify a preferred headband position.
The testing cost estimates reflect the costs of testing using an
outside laboratory, although several major manufacturers are expected
to use their in-house testing facilities.
    The costs of testing using the new ANSI/EPA methods are estimated
to be somewhat higher than the costs of testing using the 1979 standard
for a number of reasons, the principal one being the requirement for
twice as many test subjects. Testing costs are somewhat higher for
earplugs and inserts than for earmuffs because of the need to train
subjects on how to correctly insert the plugs into their ears.
    In addition, the table presents the cost estimates provided by the
sampled companies for creating an entirely new product label to reflect
the change from

a single number NRR to a range of two NRRs.
    The ranges of cost estimates are quite broad, even for the existing
test methods. This may be the result of changes in the unit cost of
testing depending on the number of products tested at a given time;
costs do not reflect potential savings afforded by the use of test
subjects for multiple product tests. Further, the relatively large cost
range for testing electronic noise cancellation (ANR) systems stems, in
part, from uncertainties about the entirely new test method that is
proposed here for those devices. The Agency is soliciting comment and
cost estimates based on the proposed test protocols.

Table C-1--Estimated Costs of Testing and Labeling for Each Product Line
------------------------------------------------------------------------
                                      Range of cost
                                    estimates given by      Range of
           Device type               industry sources    estimates used
                                           ($)           in analysis ($)
------------------------------------------------------------------------
Testing:
    Existing test methods:
        Earplugs and semi-aural    2,000-3,000........       2,000-3,000
         inserts.
        Earmuffs and headsets      1,700-4,000........       1,700-4,000
         (per headband position,
         excluding electronic
         noise cancellation
         systems).
    Revised test methods:
        Earplugs and semi-aural    2,800-4,000........       2,800-4,000
         inserts.
        Earmuffs and headsets      2,000-4,000........       2,000-3,000
         (per headband position,
         excluding electronic
         noise cancellation
         systems).
        Electronic noise           2,500-10,000.......      2,500-10,000
         cancellation systems
         \32\.
        Impulse noise reduction    2,000-4,000........       2,000-4,000
         \33\.
Labeling:
    Initial label design and       5,000-10,000 to          5,000-10,000
     printing setup.                25,000-48,000.
    Modification of a label to     one manufacturer          2,700-5,000
     change the NRR.                estimated this
                                    cost at 2,700-
                                    3,700, while
                                    others indicated
                                    that it would be
                                    the same as a
                                    complete label
                                    change.
------------------------------------------------------------------------

    The proposed changes in the labeling rule are expected to result in
a substantial increase in the volume of product testing. First, all
HPDs are to be tested in accordance with the newly proposed ANSI and
EPA/NIOSH standards. A transition-testing period of thirty (30) months
following the effective date of this proposed regulation is expected to
reduce the workload on existing testing facilities. Second, the Agency
is proposing that all products must be retested periodically at five
(5) year intervals from the completion of the respective transition
test; the current regulation does not require such recurrent testing
and label verification. As explained above, EPA is proposing a
recurrent test period of 5 years was selected to (a) provide a uniform
testing period for all parties, (b) allow a longer time between
transition test and first recurrent test for the less than three
product line manufacturers, (c) provide manufacturers with more than
two product lines adequate time to complete transition testing before
first recurrent tests become necessary and (d) to amortize near-term
testing costs over a reasonable period of time.
---------------------------------------------------------------------------

    \32\ This cost figure includes the expense for both passive and
active testing.
    \33\ This cost is in addition to the required passive testing.
---------------------------------------------------------------------------

    The Agency believes the increase in testing volumes may result in
lower per product testing costs than the current industry estimates in
Table C-1 for two reasons. First, the Agency anticipates additional
testing laboratories will enter the marketplace to satisfy the
increased and continuing testing demand resulting from the recurrent
testing requirement, thereby increasing price competition that may
result in lower fees. Second, the increased volume may provide
opportunities for improved testing efficiency due to economies of
scale. However, for the purpose of this analysis, we have used the
average cost estimates from Table C-1 to develop a conservative
assessment.
    The Agency has also considered the required redesign of the label
to display the results of transition testing using the new ANSI/EPA
test methods and two-value NRR effectiveness range. Most companies
responding to the Agency's questionnaire estimated the cost of
developing new product labels to be between $5,000 and $10,000 per HPD
model; one company estimated these costs at $25,000-48,000 (Table C-1).
These estimates reflect design costs and fabrication of the necessary
printing plates and the preparation of required revised secondary
labels. The main source of variation in the cost estimates is the
estimated time to develop the label design. However, since the EPA is
specifying the design, format and content of the new label, the cost
estimates for ``creative'' label designs are believed to be on the high
side. Discussions with an independent source in the public relations
field indicated the cost of label design can be expected to be the
lower range of estimates given by industry representatives, i.e.,
$5,000-10,000.\34\
---------------------------------------------------------------------------

    \34\ Personal Communication. Battye, W., EC/R Incorporated, with
Erika Schmidt, The Frause Group. August 15, 2007.
---------------------------------------------------------------------------

    The Agency was particularly concerned with labeling costs that may
be incurred by very small manufacturers and repackagers (one or two
product lines). In assessing the marketing methods of this segment of
the industry, the Agency believes that their point of sale is
principally via the internet. Further, their customer base is primarily
individuals or small groups that purchase their products for personal
use only. It is primarily for this segment of the industry that the
Agency has developed and is proposing the concept of ``electronic
labeling.'' We believe that an electronic reproduction of the EPA label
will eliminate the costs of art work and printing plates requisite to
producing paper labels or printing on packaging for organizations that
sell exclusively on the internet. The Agency also believes that
electronic labeling will greatly simplify and reduce any future costs
that would be incurred should recurrent testing dictate new NRR ratings
for these small manufacturers.
    In light of the proposed recurrent testing requirement, we believe
that NRR effectiveness ranges may require change from time to time. In
that regard

we have attempted to quantify the associated cost of relabeling. One
company estimated the costs of relabeling to present a revised NRR
range would be somewhat lower than the costs of developing the initial
new label but was unable to quantify without a definitive cost estimate
for the initial new label. However, other manufacturers believed the
costs would be roughly the same as those associated with the new
transition label.
    Table C-2 presents estimates of the nationwide costs of carrying
out the transition testing in accordance with ANSI/EPA test methods.
The table also presents cost estimates related to changing all existing
product labels to reflect the new test results and label information.
These estimates are derived using the unit costs given in Table C-1 and
the estimated nationwide numbers of HPD currently being sold. The
estimates are conservative in that they do not include any estimates of
cost savings that may be realized through electronic labeling. The
Agency identified approximately 1,029 different HPDs currently for sale
in the U.S. The HPD population is believed to consist of 403 earplugs
or semi-aural passive devices, 572 passive earmuffs sold either alone
or incorporated into communication headsets, 2 active noise reduction
(ANR) earplugs and 52 active noise reduction (ANR) earmuffs.
    As required in subpart B, Sec.  211.206-1, all HPDs must be tested
in their ``passive'' mode which yields 1029 separate tests. In
addition, those 54 products identified as ANR will require a second
test in their ``active'' mode. Finally, those 156 products identified
as ``impulsive'' will require a second test in a high intensity impulse
noise environment where human test subjects are replaced by a test
fixture. Consequently, 1239 separate tests must be carried out on the
1029 products. The difference between the number of HPDs given above
and the actual number of tests given in Table C-2 represents products
which are tested by the manufacturer and are labeled for sale by
another entity which relies upon the manufacturer's effectiveness data.
Foreign manufacturers that export to the U.S. are included in our
estimations. Even though the testing and manufacturing costs are
incurred outside the U.S., any effects on prices due to the revised
regulation may be passed along to the distributors in the U.S. These
distributors, as previously mentioned, may pass along the price changes
to the buyer.

         Table C-2--Estimated Nationwide Costs of Transition Product Effectiveness Testing and Labeling
----------------------------------------------------------------------------------------------------------------
                                                                                Estimated
                         Product type                           Number of HPD    Unit cost per   nationwide cost
                                                                    tests         HPD test ($)       ($1000)
----------------------------------------------------------------------------------------------------------------
Testing
    Earplugs and semi-aural inserts..........................              375      2,000-4,000        750-1,500
    Earmuffs and headsets....................................              550  \a\ 2,540-3,810      1,400-2,100
    Active Noise Reduction systems...........................              108      1,250-5,000          140-540
    Impulse noise reduction..................................              156      2,000-4,000          310-620
                                                              --------------------------------------------------
        Subtotal.............................................            1,189  ...............      2,600-4,760
----------------------------------------------------------------------------------------------------------------
                                                                Number of HPD    Unit cost per      Estimated
                                                                   products     HPD product ($)  nationwide cost
                                                                                ($1000)
----------------------------------------------------------------------------------------------------------------
Labeling
    Earplugs and semi-aural inserts..........................              375     5,000-10,000      1,880-3,750
    Earmuffs and headsets....................................              550     5,000-10,000      2,750-5,500
    Electronic noise cancellation systems....................               54     5,000-10,000          270-540
                                                              --------------------------------------------------
        Subtotal.............................................              979  ...............      4,900-9,790
                                                              --------------------------------------------------
            Grand total......................................  ...............  ...............    7,630-15,090
----------------------------------------------------------------------------------------------------------------
\a\ Based on a testing cost of $2,000-3,000 per headband position, and an average of 1.27 headband positions per
  product.

    The number of HPD products was estimated from reviews of
manufacturer's catalogs and advertisements (as published on the
Internet). In addition, the NIOSH ``Hearing Protection Device
Compendium'' provided significant information on the HPD products sold
in the U.S.\35\
---------------------------------------------------------------------------

    \35\ Franks JR, Graydon PS, Jeng C, Murphy WJ, ``NIOSH Hearing
Protector Device Compendium,'' http://www2d.cdc.gov/hp-devices/hp_
srchpg01.asp (2003). as of July 6, 2008.
---------------------------------------------------------------------------

    Because earmuffs may sometimes be manufactured to be worn in
different head band positions, the product must be tested in each
position to determine whether their performance/attenuation is changed
due to the position. When we account for the positions, and consider
that each position requires another test, an average of 1.27 potential
headband positions per product-line was used to estimate the number of
headband position tests required for earmuffs. This factor is based on
the average number of headband positions per product-line for all
earmuff models included in the NIOSH Hearing Protector Device
Compendium.
b. Costs of Recurrent Testing and Relabeling
    Table C-3 presents estimates of costs for recurrent testing and
potential relabeling of products due to measured changes in product NRR
range. Unit costs of testing each HPD are the average industry
estimates shown in Table C-1. Costs have been estimated for a three (3)
and five (5) year recurrent testing interval. In each case we have
assumed that testing will be spread evenly over the respective time
period. Thus, for the 3-year interval we assumed that one third of the
HPD models will be tested each year, and for the 5-year interval, we
assumed that 20 percent of HPD models would be tested each year.
    Based on analysis of inter and intra laboratory variations of
product recurrent tests in a recent inter-laboratory test program
carried out by EPA and NIOSH,\36\ we estimate twelve

(12) percent of all HPD products will require relabeling based on
recurrent tests every five years. The agencies commissioned parallel
tests of six different HPD products at six different laboratories. The
study provided 180 laboratory-to-laboratory comparisons of the test
results; 30 for each of the six products tested. For each of these
comparisons, the average test results and the 95 percent confidence
intervals for two tests of a single HPD model were determined. If the
second test was lower than the first test to the extent that the two 95
percent confidence intervals did not overlap, then it was assumed that
the product would need to be relabeled. This occurred in 12 percent of
the comparisons. The fraction was the same for earplugs and earmuffs.
However, for reasons stated above, the Agency has selected a  3dB criteria rather than the 95 percent confidence interval to
initiate relabeling. Therefore, for this analysis the 12 percent
represents a conservative assessment of the potential cost impact.
---------------------------------------------------------------------------

    \36\ Murphy W.J., Byrne D.C., Gauger D., Ahroon W.A., Berger E.,
Gerges S.N.Y., McKinley R., Witt B., Krieg E.F. (2009). ``Results of
the National Institute for Occupational Safety and Health--U.S.
Environmental Protection Agency Interlaboratory Comparison of
American National Standards Institute S12.6-1997 Methods A and B.''
J. Acoust. Soc. Am. 125(5):3262-3277.

                       Table C-3--Estimated Nationwide Annual Costs of Product Recurrent Testing and Relabeling for Manufacturers
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Estimated number of HPD tests                       Estimated nationwide costs
                                                                                per year                                         ($1000/year)
                            Product type                            ----------------------------------  Unit Cost per  ---------------------------------
                                                                     3-Year interval  5-Year interval    HPD test ($)
                                                                           \a\              \b\                         3-Year interval  5-Year interval
--------------------------------------------------------------------------------------------------------------------------------------------------------
Periodic Recurrent Testing
    Earplugs and semi-aural inserts................................            125.0             75.0      2,000-4,000          250-500          150-300
    Earmuffs and headsets..........................................            183.3            110.0  \c\ 2,540-3,810          470-700          280-420
    Electronic noise cancellation systems..........................             36.0             21.6       \d\ 2,500-           90-360           54-216
                                                                                10,000
    Impulse noise reduction........................................             52.0             31.2      2,000-4,000          100-210           60-120
        Subtotal...................................................            396.3            237.8  ...............        910-1,770        544-1,056
--------------------------------------------------------------------------------------------------------------------------------------------------------
Relabel as Necessary                                                 Estimated number of HPD products
                                                                                per year
--------------------------------------------------------------------------------------------------------------------------------------------------------
        \e\ Subtotal...............................................             39.2             23.5  ...............          106-196           63-117
                                                                    ------------------------------------------------------------------------------------
            Grand total............................................  ...............  ...............  ...............      1,016-1,966       607-1,173
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Under the 3-year recurrent test interval, one third of all HPD models are assumed to be retested each year.
\b\ Under the 5-year recurrent test interval, 20% of all HPD models are assumed to be retested in a given year.
\c\ Based on a testing cost of $2,000-3,000 per headband position, and an average of 1.27 headband positions per product.
\d\ This cost figure includes both the expense for passive and active testing.
\e\ Based on NIOSH/EPA inter-laboratory testing, a change in the label NRR may be required for 12% of products tested in periodic effectiveness tests.
\f\ Based on the cost of making a simple modification to the label to change the NRR (Table 3-1).

c. Manufacturers' Costs of Reporting and Recordkeeping
    Pursuant to Sec. 13 (a)(1) of the Noise Control Act, manufacturers
are required to provide the EPA Administrator reports of the laboratory
test results for each HPD model. The cost of generating these reports
is incorporated in the cost of product testing (as summarized in Table
C-1). However, we believe manufacturers may incur limited additional
costs to track and retain periodic recurrent testing reports. Table C-4
presents estimates of the nationwide costs of these recordkeeping and
reporting requirements. We have estimated that 30 minutes per product
may be required for record keeping and reporting.

                                        Table C-4--Estimated Annual Ongoing Costs of Recordkeeping and Reporting
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Estimated number of HPD tests                                    Estimated nationwide costs
                                                                     per year             Clerical labor                           ($1000/year)
                      Product type                       --------------------------------   per product   Labor cost  ($/-------------------------------
                                                              3-Year          5-Year       line (hours)      hour) \c\        3-Year          5-Year
                                                           interval \a\    interva l\b\                                      interval        interval
--------------------------------------------------------------------------------------------------------------------------------------------------------
Earplugs and semi-aural inserts.........................             125            75.0             0.5              31             1.9             1.2
Earmuffs and headsets...................................           183.3           110.0             0.5              31             2.8             1.7
Electronic noise cancellation systems...................            18.0            10.8             0.5              31             0.3             0.2
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................           326.3           195.8  ..............  ..............             5.0            3.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Under the 3-year recurrent testing interval, about one third of all HPD models are assumed to be retested each year.
\b\ Under the 5-year recurrent testing interval, about 20% of all HPD models are assumed to be retested in a given year.
\c\ Estimate based on Bureau of Labor Statistics information for the medical supplies manufacturing industry, hourly rates include an overhead factor
  (including benefits) of 100%.

d. Costs for Relabelers
    Companies that relabel products manufactured by other companies for
sale under their own label or under the labels of brand name retailers
may also incur labeling costs. These companies, identified as
``relabelers'' typically use the results of NRR tests carried out by
the products manufacturers, and therefore, are not expected to incur
costs for product testing. However, they are

expected to incur costs for redesigning product labels to incorporate
new NRR values and required labeling information. Table C-5 summarizes
the estimated costs of compliance for these relabelers. However, no
adjustments have been made for those relabelers that sell exclusively
via the internet and adopt electronic labeling. In this latter case the
costs of relabeling are expected to be significantly less than those of
Table C-5 since no changes will be required for artwork or packaging.
The Agency has not quantified these costs savings. Consequently, we
believe the costs presented in Table C-5 to be very conservative (i.e.
likely overestimated).

   Table C-5--Estimated Nationwide Labeling Costs for Companies Which Do Not Manufacture HPD, but Only Relabel
                                                    Products
----------------------------------------------------------------------------------------------------------------
                                   Estimated number of  products                      Estimated nationwide costs
                              --------------------------------------  Unit cost per            ($1,000)
         Product type                                                  HPD product   ---------------------------
                                3-Year  interval   5-Year  interval      test ($)        3-Year        5-Year
                                      \a\                \b\                            interval      interval
----------------------------------------------------------------------------------------------------------------
Transition Label Costs                                               ...............
    Earplugs and semi-aural                     46                     5,000-10,000             230-460
     inserts.
    Earmuffs and headsets....                   32                     5,000-10,000             160-320
    Electronic noise                            83                     5,000-10,000             420-830
     cancellation systems.
                              ----------------------------------------------------------------------------------
        Total................  .................  .................  ...............           810-1,610
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                    Products per
              Recurrent label costs                     year                                Cost per year
----------------------------------------------------------------------------------------------------------------
    Earplugs and semi-aural inserts.............         1.8 1.1      2,700-5,000                       5-9 3-6
    Earmuffs and headsets.......................         1.3 0.8      2,700-5,000                       4-7 2-4
    Electronic noise cancellation systems.......         3.3 2.0      2,700-5,000                     9-17 5-10
                                                 ---------------------------------------------------------------
        Total...................................  ...............  ...............                 18-33 10-20
----------------------------------------------------------------------------------------------------------------
\a\ Under the 3-year recurrent test interval, one third of all HPD models are assumed to be retested each year.
\b\ Under the 5-year recurrent test interval, 20% of all HPD models are assumed to be retested in a given year.
\c\ Based on NIOSH/EPA inter-laboratory testing, a change in the label NRR may be required for 12% of products
  tested in periodic effectiveness tests.

D. Summary of Nationwide Costs of Revised HPD Labeling Rule

    Table D-1 summarizes the estimated nationwide costs of the proposed
revisions to the HPD labeling rule. The initial or capital costs will
be primarily transition testing of all HPD products in the U.S. market
on the effective date of this proposed rule. In addition, we have
incorporated the amortized costs of transition product labeling to
reflect the new NRR range presentation and revised user information. In
the latter case, the transition labeling costs have been amortized over
a 20-year period using an interest rate of 7 percent. The transition
testing costs are estimated to be between $2.5 million and $4.6 million
and are expected to be spread over a period of 30 months from the
effective date of the regulation. New labeling costs are estimated to
be between $5.1 and $10.1 million to produce product labels with the
new NRR range presentation and mandated statements. The industry
provided cost estimates associated with the required secondary labels
are incorporated in the total cost of labeling.
    Annualized costs of the revised rule depend, in large part, on the
recurrent product testing intervals. Two options have been evaluated: A
3-year interval and a 5-year interval. As stated previously, after
evaluating the two approaches, the Agency is proposing the 5-year
interval for all manufacturers. Recurrent testing of products would
commence 5 years from the date of completion of their respective
transition test. The annualized costs include the costs of changing
product labels to reflect the new NRR range of the 12% of products that
fail their recurrent test and costs of reporting and recordkeeping.

            Table D-1--Total Costs Compared With Total Sales
------------------------------------------------------------------------
                                              Estimated nationwide costs
                Cost element                         ($1000/year)
------------------------------------------------------------------------
Manufacturers:
    Transition costs
        Product model testing\ a\..........                  2,600-4,760
        Initial revisions to labels\ a\....                  4,900-9,790
------------------------------------------------------------------------

                                                 3-Year        5-Year
                                                recurrent     recurrent
                                                  test          test
                                                interval      interval
------------------------------------------------------------------------
    Annualized costs
        Periodic product effectiveness           910-1,770     544-1,056
         tests\ b\..........................
        Changing product labeling, as              106-196        63-117
         necessary\ c\......................
        Recordkeeping and reporting.........           5.0           3.1
        Amortized cost of initial labeling         462-924       462-924
         e, f...............................

        Total annualized costs for             1,484-2,896   1,073-2,101
         manufacturers......................
                                             ---------------------------
Relabelers:\ g\
    Initial revisions to labels.............           810-1,610
                                             ---------------------------
    Annualized costs........................
        Amortized cost of initial labeling e        76-152        76-152
         f..................................
        Label changes as necessary from              18-33         10-20
         recurrent ftesting.................
        Total annualized costs for                  94-185        86-172
         relabelers \g\.....................
Total annual cost...........................   1,578-3,081   1,159-2,273
Annual cost as a fraction of total                0.3-0.7%     0.3-0.5%
 industrial product sales\ f\...............
------------------------------------------------------------------------
\a\ Table C-2 provides additional details on initial testing and
  labeling costs for manufacturers.
\b\ Product tests are assumed to be carried out at a uniform rate over
  the recurrent test period. (See Table C-3).
\c\ Based on NIOSH/EPA inter-laboratory testing, a change in the label
  NRR may be required for 12% of products tested in periodic
  effectiveness tests. (See Table C-3)
\d\ Costs of developing product labels to reflect the revised test
  methods are amortized over a 20 year period using an interest rate of
  7%.
\e\ Annualized costs do not include the amortized costs of the initial
  tests, since this would double-count the first round of recurrent
  testing costs.
\f\ Total industrial product sales were obtained from Frost & Sullivan
  (see Table A-2). Consumer sales are believed to be minor in comparison
  with industrial sales.
\g\ Table C-5 provides additional details on costs for relabelers.

     Table D-1 presents the total annualized costs of complying with
the proposed labeling rule changes. These are estimated to be 0.3-0.5
percent of total industrial product sales for the 5-year interval.
Industrial product sales were obtained from the Frost & Sullivan market
research report, totaling $242.9 million. Estimates developed by EPA
from limited information obtained from site visits for consumer and
military sales are $216.2 million. Therefore, the estimated costs of
compliance with the proposed labeling rule changes may range from 0.16
to 0.4 percent of total combined industrial, consumer and military
sales.

E. Economic Impacts

    Based on the results of analyses in the previous section,
compliance costs associated with the proposed labeling rule changes are
expected to be on average 0.3 to 0.6 percent of the total wholesale
price. As noted earlier, seven HPD manufacturers were interviewed on
the potential costs and economic impacts of the new labeling rule. The
larger companies indicated they did not plan to pass along the costs of
compliance in the prices of their products. However, some of the
smaller companies indicated that they would probably pass on a portion
or all of the costs of compliance to distributors and consumers.
    In the event that prices are increased to cover the cost of
compliance, industrial and other occupational sales of HPDs are not
expected to change. These uses are generally mandated by occupational
safety regulations and are not an optional purchase. Consumer purchases
of HPDs are also not expected to be significantly impacted, since the
overall impact of compliance costs is a relatively small fraction of
the wholesale price.
    HPD manufacturers indicated they do not expect to close any
operations as a result of increased compliance costs. However, most
indicated they would probably discontinue some marginally profitable
product lines rather than incur the associated cost of transition
testing and labeling. In particular, the companies indicated that
product lines which are not selling well on the current market due to
their effectiveness rating, comfort, or competition may be discontinued
when the new labeling rules are implemented.

F. Impacts on Small Business

    Please see paragraph XI--C (Statutory and Executive Order Reviews)
below.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under terms
of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under that Order
    Although a Regulatory Impact Analysis was not required or
conducted, EPA did carry out a cost impact analysis, as just set forth
in the previous section. The annual effect on the economy resulting
from the proposed compliance costs is estimated to be less than
$2,800,000. A copy of the ``Cost Analysis for Proposed Labeling
Regulation of the Hearing Protection Device Industry'' is available in
the docket for this action.

B. Paperwork Reduction Act

    The information collection requirements in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document prepared by EPA has been
assigned EPA ICR number 2341.01.
    Section 13 of the Act, ``Records, Reports and Information,'' states
that manufacturers of products which emit noise capable of adversely
affecting the public health or welfare, or which is sold wholly or in
part on the basis of its effectiveness in reducing noise, shall
establish and maintain such records, make such reports, provide such
information, and make such tests, as the Administrator may reasonably
require to enable him to determine whether such manufacturer has acted
or is acting in compliance with the Act.
    Pursuant to this provision, the Agency proposes to collect
information to ensure compliance with the provisions in this rule. EPA
is also proposing recurrent testing requirements, as discussed
previously. In order to establish reliable baseline performance
information for each device, against which future performance can be
compared, the EPA is proposing that manufacturers provide the Agency
with their product test information following each required product
test.
    The 1979 regulation required manufacturers to establish and retain
adequately organized and indexed records of the testing protocols that
provide the basis for the claimed Noise Reduction Ratings (NRR) that is
placed on the mandated label. The regulation also required
manufacturers to submit

hearing protector test data reports for the attendant NRR to the EPA.
In 1982, 40 CFR Part 211 was amended to suspend the submittal of test
data reports to the EPA due to the closure of the Agency's Office of
Noise Abatement and Control. However, manufacturers were still required
to retain all pertinent test data reports for recordkeeping purposes.
EPA is proposing to reinstitute the requirement for manufacturers to
submit to the Agency test data reports following each required product
test. The reports would have to include measurement information, test
results and calculated lesser and greater NRRs obtained from the
testing laboratory for each product or product category. Manufacturers
would continue to retain such records for a period of two (2) testing
periods. However, if a manufacturer elects to alter the product design
or materials prior to expiration of the 5 year recurrent testing cycle,
the manufacturer would be required to test and submit the product's new
test data report to the EPA.
    The annual reporting burden for this collection of information for
the initial test data report for approximately 81 respondents is
estimated to be 185 labor hours per year [555 total hours] at a total
annual cost of $5,735 [$17,205 total cost]. This burden estimate
includes time to complete the cover sheet per Annex A of the proposed
regulation, time to convert the results into a PDF document, and time
to submit the test data report(s) to the EPA. Burden is defined at 5
CFR 1320.3(b).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR Part 9.
    To comment on the Agency's need for this information, the accuracy
of the provided burden estimates, and any suggested methods for
minimizing respondent burden, EPA has established a public docket for
this rule, which includes this ICR, under Docket ID number EPA-HQ-OAR-
2003-0024. Submit any comments related to the ICR to the EPA docket
noted above and to OMB. See `Addresses' section at the beginning of
this notice for where to submit comments to EPA. Send comments to OMB
at the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW., Washington, DC 20503,
Attention: Desk Office for EPA. Since OMB is required to make a
decision concerning the ICR between 30 and 60 days after August 5,
2009, a comment to OMB is best assured of having its full effect if OMB
receives it by September 4, 2009. The final rule will respond to any
OMB or public comments on the information collection requirements
contained in this proposal.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's proposed rule on
small entities, small entity is defined as: (1) A small business
engaged in manufacturing, distributing, relabeling and/or importing of
hearing protection devices having NAICS codes presented in Table A-2;
(2) a small governmental jurisdiction that is a government of a city,
county, town, school district or special district with a population of
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The small
entities directly regulated by this proposed rule are manufacturers,
distributors, repackagers and importers of hearing protector devices.
We have determined that fewer than 100 U.S. small businesses are
expected to be subject to the planned rule changes and using
conservative assumptions only 1 or 2 of those potentially affected face
significant adverse impacts.
    In its analysis of the impacts of the rule, EPA made a significant
effort was made to ensure that we identified as many as possible of the
companies that manufacture or distribute HPDs, including any that are
small businesses. A number of steps were taken to identify these
companies, including reviews of the NIOSH Hearing Protection Device
Compendium and the membership directory of the National Hearing
Conservation Association (NHCA). Further, the NHCA was contacted to
obtain a listing of small companies engaged in the manufacture or
relabeling of HPDs. The NHCA assisted by providing information on some
companies which obtain HPD from manufacturers for sale under their own
labels. We also reviewed a number of directories of HPD and safety
equipment vendors, including the Noise Pollution Clearinghouse, the
International Safety Equipment Association Buyer's Guide, the Thomas
directory, the Business Internet, Hoover's Online, and Mergent Online.
    It is possible that some manufacturers or distributors were not
identified in these efforts. Because of the classification of HPD
manufacturers in the Census, it is particularly difficult to identify
all HPD manufacturers. As discussed in paragraph X (A), HPD
manufacturers are generally in a miscellaneous manufacturing category
(NAICS Code 339113) along with manufacturers of surgical appliances and
supplies because many HPD manufacturers also produce other products. In
addition, many of these companies classify themselves under other NAICS
categories. Therefore, the Census does not provide an explicit count of
HPD manufacturers. We believe that most of the small manufacturers and
distributors of HPDs have been identified, but we invite reviewers to
submit any additional relevant data in this regard.
    For most categories applicable to HPD manufacturers, a small
business is defined as any company which employs fewer than 500
employees (and which is not owned by another large business). The small
business size threshold is 750 employees for firms which also produce
electronic or communications equipment, as is the case with most
manufacturers of active HPDs. For distributors that merely relabel
HPDs, the small business size threshold is 100 employees.
    Using the applicable NAICS size thresholds, 54 of the 96 identified
HPD manufacturers and relabelers would be classified as small
businesses. However, it must be noted that the NAICS thresholds
overstate the number of truly small businesses. This is because most
passive HPD manufacturers fall into a catch-all miscellaneous
manufacturing category which was primarily designed to characterize the
manufacturers of surgical equipment. Thus, the 500 employee threshold
used for this category probably does not reflect the conditions of the
HPD manufacturing industry. Nevertheless, we have analyzed the costs of
compliance for all of the companies that would be classified as small
under the applicable NAICS threshold. However, we have also paid
special attention to a subset of ``very small'' companies, which
produce only one or two HPD product lines. Of

the 96 identified HPD manufacturers and relabelers, 34 would fall into
this ``very small'' business category.
    After identifying the small businesses likely to be subject to the
rule, we estimated the potential economic impacts of the proposed rule
on small entities. For this proposed rule, we evaluated the compliance
costs as a percentage of total sales for any small businesses affected
by any proposed regulatory action. Costs of compliance were identified
for each of these small and very small companies based on the numbers
of HPD models they sell and using the calculation methods and
assumptions outlined in paragraph X (C) above. Some of these companies
were interviewed as part of the effort to develop background
information to estimate the costs and economic impacts of labeling rule
changes; these companies gave information on the number of HPD models
sold.\37\ We estimated the numbers of product models sold by other
small businesses from catalogs and other advertising materials
published on the Internet.
---------------------------------------------------------------------------

    \37\ The referenced interviews can be found in the Federal
Docket at http://www.regulations.gov, docket number EPA-HQ-OAR-2003-
0024.
---------------------------------------------------------------------------

    Table F-1 summarizes the estimated impacts of the proposed labeling
rule changes on U.S. small businesses, including the initial costs of
compliance and the ongoing annualized costs for the 3-year and 5-year
recurrent test options. Therefore, we have analyzed small business
impacts for both ends of this range. In addition, we have analyzed
impacts for the ranges of testing and labeling costs identified in
Table F-1, and the ranges of labor requirements shown in Table C-4 for
reporting and recordkeeping. The table gives ranges of costs, depending
on which underlying unit cost estimates are used for testing, labeling,
and recordkeeping.
    We have estimated that the initial testing and labeling costs would
average 1.1-2.1 percent of sales during the initial compliance period
for all 54 U.S. small businesses affected by the rule. For the 3-year
recurrent test interval, we have estimated that the average annual
compliance costs for all 54 U.S. small businesses affected by the rule
would be 0.5-0.7 percent of annual sales. The estimates of ongoing
annual costs include the amortized initial compliance costs. The
majority of small businesses (44 to 47) are expected to incur ongoing
annual costs of less than 1 percent of the total annual sales. However,
between 7 and 10 small businesses are expected to incur annual ongoing
compliance costs exceeding 1 percent of their total annual sales. (Of
these small businesses, we estimate that one or two are very small
businesses (produce less than 3 types of product)). It is possible that
one or more small businesses may experience costs exceeding 3 percent
of sales. However, our data set is limited for sources in this size
range (generally facilities with very low annual sales volume).

            Table F-1--Summary of Impacts on Small Businesses
------------------------------------------------------------------------
                                   3-Year recurrent    5-Year recurrent
          Cost element                  testing             testing
------------------------------------------------------------------------
Total number of small businesses                  54
 affected by the rule in the U.S
Initial testing and labeling:
    Estimated initial costs of
     compliance:
        Lowest cost for a small               <1,000
         business...............
        Average cost for a small       47,000-94,000
         business...............
        Maximum cost for a small     298,000-620,000
         business...............
Ongoing annual costs of
 compliance
    Estimated annual costs
        Lowest cost for a small                  500                 500
         business...............
        Average cost for a small       10,000-14,000        8,000-11,000
         business...............
        Maximum cost for a small       63,000-90,000       49,000-68,000
         business...............
    Estimated annual cost as a
     fraction of annual sales: a
     b
        Lowest cost for a small               <0.01%              <0.01%
         business...............
        Average cost for a small            0.5-0.7%            0.4-0.6%
         business...............
        Maximum cost for a small              11-17%               9-12%
         business...............
    Number of small businesses
     with estimated annual
     compliance costs greater
     than:
        1% of annual sales......                7-10                 4-8
        3% of annual sales \c\..                   1                   1
------------------------------------------------------------------------
\a\ Sales figures used in these calculations are from market databases,
  such as Dun and Bradstreet, and include not only HPD, but all products
  sold by the companies, such as other safety equipment.
\b\ Annualized costs of compliance include amortized costs of initial
  testing and labeling.
\c\ One or more companies may experience costs above 3% of sales, but
  our data set is limited in this size range.

    At the 5-year recurrent test interval, the average annual
compliance costs for all 54 U.S. small businesses affected by the rule
is estimated to be 0.4-0.6 percent of annual sales. The majority of
small businesses (46 to 50) are expected to incur ongoing annual costs
of less than 1 percent of the total annual sales. However, between 4
and 8 small businesses are expected to incur ongoing annual compliance
costs above 1 percent of their annual sales. This means that 7 to 15
percent of the small businesses subject to the rule are expected to
face economic impacts greater than 1 percent. (Of these small
businesses, we estimate that one or two are very small businesses
(produce less than 3 types of product)). It is possible that one or
more small businesses may experience costs that exceed 3 percent of
sales. Once again, we note that our data set is limited for sources in
this size range (generally facilities with very low annual sales
volume).
    Given that there are some impacts on small businesses, we looked
for ways to mitigate these impacts. One step we have taken, as
discussed earlier, is to exempt companies that sell exclusively over
the Internet from the requirement to provide hard copy labels on their
product packaging; an electronic label is being proposed as the
exclusive labeling requirement for such entities. Additionally, after
considering

regulatory options to require retesting every 3 years versus every 5
years, we have selected the 5-year option. This option will allow
manufacturers to time-stream the testing of their product categories.
Finally, we think that companies will take steps on their own to reduce
compliance costs by reviewing their product slates and reducing the
number of HPD models that are low sales products and/or older products
that have updated versions. These actions would reduce their costs of
compliance with the revised testing and labeling requirements. We
continue to be interested in the potential impacts of this proposed
rule on small entities and solicit comments on issues related to such
impacts.
    Small governments are not affected since enforcement of the
proposed regulation would continue to be carried out by the federal
EPA. Further, not-for-profit enterprises engaged in the distribution of
hearing protectors do not assume responsibility or incur the costs of
testing and labeling of a product and therefore, are not impacted by
the rule.
    Although this proposed rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities through the
means described above. When developing the proposed rule, we took
special steps to ensure that the burdens imposed on small entities were
minimal. We continue to be interested in the potential impacts of this
proposed rule on small entities and solicit comments on issues related
to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. This action imposes no enforceable duty on any State, local or
tribal governments or the private sector.
    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires the Agency to
identify and consider a reasonable number of regulatory alternatives
and to adopt the least costly, most cost-effective, or least burdensome
alternative that achieves the objectives of the rule. The provisions of
section 205 do not apply when they are inconsistent with applicable
law. Moreover, section 205 allows EPA to adopt an alternative other
than the least costly, most cost-effective, or least burdensome
alternative if the Administrator publishes with the final rule an
explanation why that alternative was not adopted. Before we establish
any regulatory requirements that may significantly or uniquely affect
small governments, including tribal governments, a small government
plan must be developed under section 203 of the UMRA. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
    We have determined that this proposed action does not contain a
Federal mandate that may result in expenditures of $100 million or more
for State, local, and tribal governments, in the aggregate, or to the
private sector in any one year. Thus, this proposed action is not
subject to the requirements of sections 202 and 205 of the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism,'' (64 FR 43255,
August 10, 1999), requires EPA to develop an accountable process to
ensure ``meaningful and timely input by State and local officials in
the development of regulatory policies that have federalism
implications.'' ``Policies that have federalism implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.''
    This proposed rule does not have federalism implications. It will
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This proposed rule applies to
manufacturers and distributors of hearing protection devices and has no
association with State and local governments. Thus, Executive Order
13132 does not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). Executive Order
(EO) 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' This proposed
action will have no substantial direct effects on tribal governments,
on the relationship between the Federal government and Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes as specified in EO 13175. Thus,
Executive Order 13175 does not apply to this proposed action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying
to those regulatory actions that concern health or safety risks to
children, such that the analysis required under section 5-501 of the
Order has the potential to influence the regulation. This action is not
subject to EO 13045 because it is based solely on technology
performance.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law No. 104-113 (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards (VCS) in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. VCS are technical standards
(e.g., materials specifications, test methods, sampling procedures, and
business practices) that are developed or adopted by VCS

bodies. NTTAA directs EPA to provide Congress, through OMB,
explanations when the Agency decides not to use available and
applicable VCS.
    This proposed rulemaking involves technical standards. Therefore,
EPA conducted a search to identify potentially applicable VCS. We
identified several that have direct or partial applicability to the
technical requirements specified in the rule. To the extent possible
the Agency has incorporated by reference the principal elements of the
American National Standards Institute (ANSI) standard S12.6 (2008). In
addition, we have also incorporated by reference various elements of
ANSI S12.68 (2007) and S12.42. The Agency also gave careful
consideration to all relevant standards of the International Standards
Organization (ISO) and the International Electrotechnical Commission
(IEC) and determined that the above mentioned ANSI standards and the
IEC standard 60711 were the most appropriate for this action.
    EPA welcomes comments on this aspect of the proposed rulemaking
and, specifically, invites the public to identify potentially-
applicable VCS and to explain why such standards should be used in this
regulation.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because hearing
protectors provide protection to the human health of all affected
populations without having any disproportionately high and adverse
human health or environmental effects on any population, including any
minority or low-income population.

List of Subjects in 40 CFR Part 211

    Environmental Protection, Incorporation by reference, Noise
Abatement Programs, Product Noise Labeling, Hearing Protection Devices.

    Dated: July 21, 2009.
Lisa P. Jackson,
Administrator.
    For the reasons stated in the preamble, title 40, chapter I of the
Code of Federal Regulations is proposed to be amended as follows:

PART 211--PRODUCT NOISE LABELING

    1. The authority citation for part 211 continues to read as
follows:

    Authority:  Sec. 8, Noise Control Act of 1972, (42 U.S.C. 4907),
and other authority as specified.

Subpart B--[Amended]

    2. Section 211.201 is revised to read as follows:

Sec.  211.201  Applicability.

    (a) Unless this part states otherwise, the provisions of subpart B,
part 211, apply to all devices or materials sold as ``hearing
protection devices'' on the basis of their ability to reduce the level
of sound entering the user's ears and thus claim to protect the users
hearing. The proposed regulation also applies to devices of which
hearing protection may not be their primary function, but which are
nonetheless sold in-part as providing protection to the user's hearing.
    (b) To the extent that a product manufacturer, importer, packager
or any other party introduces into U.S. commerce any product that
incorporates an explicit or implicit claim that said product can
protect the hearing of the user, or stipulates the level of sound
reduction offered by such product, then it shall be subject to the
requirements of this proposed regulation (See 211.203(u) for definition
of ``hearing protection device.'')
    (c) This rule does not apply to those devices or materials that are
designed to fit over or into the user's ears to, for example, preclude
the entrance of water during swimming, reduce the level of annoyance
from snoring or to enhance listening to music or video dialogue
presentations.
    (d) This regulation is also applicable to those devices or
materials that while not designed for or intended to be used as hearing
protection devices can, due to their similarity in appearance or
function, be easily mistaken for products that are hearing protection
devices. To the extent that a product manufacturer, importer, packager
or any other party introduces into U.S. commerce any product that
incorporates an explicit or implicit claim that said product can
protect the hearing of the user, or stipulates the level of sound
reduction offered by such product, then such product shall be subject
to the requirements of this proposed regulation.
    (e) The provisions of subpart A apply to all products for which
regulations are published under part 211 and manufactured after
[EFFECTIVE DATE OF FINAL RULE], unless they are made inapplicable by
product-specific regulations.
    3. Section 211.202 is revised to read as follows:

Sec.  211.202  Effective Date.

    Manufacturers of hearing protection devices must comply with the
requirements set forth in this subpart for hearing protective devices
manufactured on or after [date TBD]. All hearing protection devices
that are manufactured on or after the effective date of this subpart
must be tested and labeled in accordance with the applicable procedures
set forth herein.
    4. Section 211.203 is revised to read as follows:

Sec.  211.203  Definitions.

    As used in subpart B, all terms not defined here have the meaning
given them in the Noise Control Act of 1972 (the Act) (42 U.S.C. 4907),
or in subpart A of this part.
    (a) A-Duration. The duration of an impulsive sound from its initial
sharp increase in positive sound pressure to the point where the sound
pressure becomes negative.
    (b) A-Weighted Sound Level. A single number representing the
overall sound level of a noise that emphasizes sounds containing
frequencies between about 500 and 5000 Hz and deemphasizes frequencies
outside that range. The resultant sound level is referred to as A-
weighted units in dB, generally indicated as dBA and considered to be
representative of the human ears frequency response to sounds.
    (c) Acoustic Test Fixture (ATF). A device that approximates the
size and shape of a human head and which includes acoustic elements to
simulate the acoustic response of the ear canal. An ATF with ear canals
approximates the cross sectional area and length of the human ear
canal.
    (d) Active Noise Reduction. The reduction of sound transmission
based on the use of electronic elements (e.g. circuits and transducers)
to produce acoustic signals of approximately equal and opposite phase
and amplitude to reduce the transmitted sound.

    (e) ANSI/ASA S12.6-2008. ``American National Standard--Methods for
Measuring the Real-Ear Attenuation of Hearing Protectors.'' A procedure
for measuring the hearing protector sound attenuation values at various
frequencies using one-third octave band noise stimuli presented to
subjects in a diffuse sound field.
    (f) ANSI S12.42-1995 (R2002). ``American National Standard--
Microphone-in-Real-Ear and Acoustic Test Fixture Methods for the
Measurement of Insertion Loss of Circumaural Hearing Protection
Devices.'' A procedure for measuring the acoustical insertion loss of
earmuff using a miniature microphone positioned in the ear canal.
    (g) ANSI/ASA S12.68-2007. ``American National Standard--Methods of
Estimating Effective A-weighted Sound Pressure Levels When Hearing
Protectors are Worn.'' Procedures for calculating Noise Reduction
Ratings.
    (h) Assumed Protection Value (APVfx). The protection in a given
octave band computed as the mean attenuation, minus the standard
deviation of that octave band multiplied by a constant.
    (i) Attenuation. The reduction of sound pressure level provided by
a hearing protection device by either structural elements, acoustic
pathways, electronic or mechanical means.
    (j) Carrying Case. The container used to store reusable hearing
protectors.
    (k) Category. A group of hearing protectors which are identical in
all aspects to the parameters listed in Sec.  211.210-2(a)(3).
    (l) Claim. An assertion made by a manufacturer regarding the
intended purpose, general performance and the sound attenuating
effectiveness of his product.
    (m) Decibel (dB). Unit of measure of sound level used in this
regulation for both sound pressure level and hearing threshold level.
    (n) Dispenser. The permanent or disposable container designed to
hold more than one complete set of hearing protector(s) for the express
purpose of display to promote sale or display to promote use or both.
    (o) Disposable Device. A hearing protection device that is intended
to be discarded after one or otherwise specified period of use.
    (p) Effective A-weighted Sound Pressure Level (L'A). The sound
pressure level, A-weighted and referred to an equivalent diffuse sound
field condition, that is estimated to be experienced by users when the
hearing protector is worn.
    (q) Effective Peak Sound Pressure Level (L'P). The estimated peak
sound pressure level underneath the hearing protection device.
    (r) Estimated Noise Level Reduction (ENR). The value in decibels
derived from the variability of noise reduction as a function of noise
spectra.
    (s) Fitting Instruction. Guidance on the demonstration and fitting
of a hearing protection device that is provided to the testing
laboratory and included with the product as entered into commerce.
    (t) Headband. A component of a hearing protection device that
applies force to, and holds in place on a person's head, the sound
attenuating component that is intended to acoustically seal the ear
canal. The headband can be positioned over-the-head, behind-the-head or
under-the-chin of the user.
    (u) Hearing Protection Device (HPD). Devices or materials intended
to reduce the level of sound entering a user's ears. Such devices
include those of which hearing protection may not be the primary
function, but which are nonetheless sold partially as providing hearing
protection to the user. This term is used interchangeably with the
terms, ``hearing protective device'', ``hearing protector'', ``device''
and ``HPD'' in subpart B. The following list, although not all
inclusive, presently represents products that are subject to this part.
    (1) Passive Hearing Protection Device. A device that relies solely
on its structural elements to block or otherwise control the
transmission of sound into the ear canal and that does not use
electronic circuits or fluid dynamic means to reduce the entry of
external sound.
    (2) Active Hearing Protection Device. A device that contains
electronic components including transducers (i.e. speakers and
microphones) to increase or decrease the transmission of sound into the
ear canal. Also referred to as an electronic hearing protection device.
    (3) Ear plug. A hearing protection device that is designed to be
inserted into the ear canal and held in place principally by virtue of
its fit inside the ear canal.
    (4) Ear cap. See ``Semi-insert Device''.
    (5) Ear cup. The combination of the hard shell, soft cushion and
sound attenuating material that encloses the external ear or pinna in
ear muff applications.
    (6) Ear muff. A hearing protection device usually comprised of a
headband which applies spring-like force/pressure to two ear cups with
soft cushions to seal against the external ear or pinna (supra-aural)
or the sides of the head around the pinna (circumaural). The ear cups
may also be held in position by attachment arms mounted on a hardhat or
hardcap.
    (7) Active Noise Reduction Hearing Protection Device. A device that
uses single or in combination, electrical components and structural
elements to reduce the sound transmitted to the ear canal through
acoustic cancellation of the air-conducted and/or bone-conducted
external sound.
    (8) Amplitude-Sensitive Hearing Protection Device. A device that is
designed to produce a change in sound attenuation as a function of the
external sound level. Amplitude-sensitive hearing protection devices
include passive devices, active devices, and impulsive noise devices.
    (9) Communication Headset. A voice communication device (ear plug,
ear muff, semi-insert device or helmet) that is also designed to reduce
the level of sound at the users' ears by either structural elements
and/or electronic means.
    (10) Custom-molded Hearing Protection Device. A device that is made
to conform to a specific person's ears (pinnas) and ear canals.
    (11) Electronic Hearing Protection Device. See ``Active Hearing
Protection Device.''
    (12) Helmet. A hearing protection device that provides impact
protection to the head or skull and designed with ear cups to reduce
the external sound from entering the ears through either structural
elements and/or electronic means.
    (13) Level-Dependent Hearing Protection Device. See Amplitude-
Sensitive Hearing Protection Device.
    (14) Semi-insert Device. An ear plug-like hearing protection device
consisting of soft pods or tips that are held in place by a lightweight
band. The pods are positioned in the conchae covering the entrances to
the ear canals, or fitted to varying depths within the ear canals.
Semi-inserts that cap the ear canal require the force of the band to
retain their position and acoustic seal. Semi-inserts that enter the
ear canal behave more like ear plugs; they seal the ear to block noise
with or without the application of band force. Also referred to as
canal cap or banded hearing protector.
    (v) Impulsive Acoustic Test Fixture (IATF). A device that
approximates the size and shape of a human head, simulates the acoustic
response of the human ear canal, and includes a microphone(s) and
electronic circuitry to detect acoustic signals.
    (w) Impulsive Noise. A sound or series of sounds that are
characterized

by a sharp rise and rapid decay in sound pressure level and have
duration of less than one second.
    (x) Impulsive Noise Reduction. The reduction of peak impulse sound
transmission based upon the single or combined use of passive and/or
active noise reduction elements.
    (y) Insertion Loss. The arithmetic difference in decibels between
the sound pressure levels measured at a reference point (i.e. the ear
canal or microphone of the acoustic test fixture) with and without a
hearing protection device in place.
    (z) Label. A notice, as described in this subpart, which is
inscribed on, affixed to or appended to a product, its packaging, or
both for the purpose of giving the purchaser or product user
information regarding the products designed use, noise reduction
effectiveness, operating or fitting instructions and other information
appropriate to the product.
    (aa) Manufacturer. Any person engaged in the manufacturing or
assembling of products, or the importing of products for resale, or who
purchases products from an original equipment manufacturer (OEM) for
the purpose of repackaging or relabeling or who acts for, and is
controlled by any such person in connection with the distribution of
such products in U.S. commerce.
    (bb) Microphone in Real Ear (MIRE). A testing method where
miniature microphones are positioned at the entrance to the subject's
blocked ear canals to measure the sound pressure level underneath a
hearing protection device.
    (cc) Noise. Undesired or unwanted sound. For the purpose of this
subpart, noise and sound are used interchangeably.
    (dd) Noise Reduction Rating (NRR). A single number metric used to
describe noise reduction in decibels.
    (ee) Noise Reduction Variability Data Points. The values of the
noise reductions calculated for the spectral balances given by
LC-LA = (-1, 2, 6 and 13 dB).
    (ff) Occluded Threshold of Hearing. The minimum level of sound
heard at a specific frequency when a hearing protection device is worn.
    (gg) Octave Band Attenuation. The amount of sound reduction
determined according to the measurement procedure of Sec.  211.206 for
one-third octave bands of noise.
    (hh) Open Threshold of Hearing. The minimum level of sound heard at
a specific frequency when a hearing protection device is not worn. Also
referred to as ``unoccluded'' threshold of hearing.
    (ii) Package. The container in which a hearing protection device is
presented for purchase or use. The package in some cases may be the
same as the carrying case.
    (jj) Passive Noise Reduction. The reduction of sound transmission
based solely on the use of materials and/or structural elements.
    (kk) Pink Noise. Noise for which the spectrum density varies as the
inverse of frequency.
    (ll) Primary Panel. The surface of the product package that is
considered to be the front surface or that surface on the package which
is intended for initial viewing at the point of ultimate sale or the
point of distribution for use.
    (mm) Random Incident Field. A sound field in which sound waves are
incident from all directions with equal probability.
    (nn) Real-Ear Attenuation at Threshold (REAT). The mean value in
decibels of the occluded threshold of hearing minus the open threshold
of hearing for all trials of each test subject under otherwise
identical test conditions.
    (oo) Real-Ear Attenuation at Threshold (REAT). The mean value in
decibels of the occluded threshold of hearing minus the open threshold
of hearing for all trials of each test subject under otherwise
identical test conditions.
    (pp) Residual Volume. The volume of air between the termination of
an ear plug and the sensing surface of the microphone when an ear plug
is inserted into an acoustic test fixture.
    (qq) Reverberation Time. The time, in seconds, required for a sound
produced in an enclosure to decay to a designated level once the sound
source is turned off.
    (rr) Spectral Balance (B). The difference in decibels between the
C-weighted and A-weighted levels of a sound spectrum (LC -
LA), indicating the proportion of energy at low frequencies
in the spectrum.
    (ss) Sound pressure level (dB SPL). Ten times the logarithm to the
base 10 of the ratio of the time mean square sound pressure to the
square of the reference sound pressure, given by: Lp = 10
log10 (p\2\/p0\2\), where p is the root mean
square value of sound pressure in pascals, and the reference sound
pressure p0 is 20 micropascal (20 x 10-6 Newtons
per meter squared) for measurements in air. Unit: decibel (dB).
    (tt) Spectral uncertainty. Variation in the attenuation provided by
a hearing protector due to the frequency content of the noise in which
a device is worn.
    (uu) Subject uncertainty. Variation in the attenuation provided by
a hearing protector due to the effect of different subjects fitting the
device when the attenuation is assessed.
    (vv) Tag. Stiff paper, metal or other hard material that is tied or
otherwise affixed to the packaging of a protector.
    (ww) Test Facility. A laboratory that tests hearing protection
devices in accordance with the requirements of this subpart.
    (xx) Test Hearing Protector. A hearing protector that has been
selected for testing to determine the NRR value(s) to be put on the
label, or which has been designated for testing to verify the labeled
value(s) and determine compliance of the protector with this subpart.
    (yy) Test Request. A request submitted to the manufacturer by the
Administrator of the Environmental Protection Agency (EPA) that will
specify the hearing protector category, and test sample size to be
tested according to Sec.  211.212, and other information regarding the
audit.
    (zz) Test Subject. Any person of any gender, ethnicity or age who
is selected from a group of candidates that exhibit physical and mental
characteristics requisite to the conduct of testing in accordance with
Sec.  211.206-1(b)(5) and other requirements of this subpart.
    (aaa) Third-octave band microphone free-field rejection. The
variation in sound field (decibels) of the microphone polar response
(front to back for cardioid and front to side for cosine) for each
measured third-octave band.
    (bbb) Threshold of Hearing. For a specified signal, the average
minimum sound pressure level as indicated by the test subject's
responses.
    (ccc) Trial. A complete series of occluded and unoccluded hearing
threshold measurements on a single test subject for a single hearing
protector.
    (ddd) White Noise. Noise for which the spectrum density is
independent of frequency over a specified frequency range.
    5. Section 211.204-1 is revised to read as follows:

Sec.  211.204-1  Information content of primary label.

    The information to appear on the primary label must be according to
Sec.  211.104 of Subpart A except as stated here and prescribed in
Figures 1, 2 and 3 of Sec.  211.204-1.
    (a) Primary Label for all PASSIVE Hearing Protection Devices
(Figure 1):
    (1) Area A must state ``Noise Reduction Rating''.
    (2) Area B must contain the range(s) of the Noise Reduction Ratings
(NRR) in

decibels for the designed mode(s) of use of that model hearing
protector.
    (i) The range shall be depicted by a bar-graph that shall include a
numeric scale from 0 to 50 decibels in equal increments of 10 decibels.
    (ii) A solid color bar, as presented in Figure 1 of this section,
shall be superimposed on the bar-graph scale indicating the lesser and
greater Noise Reduction Ratings from the 80th and 20th percentiles.
    (iii) The lesser and greater NRR values shown on the numeric scale
shall be determined in accordance with Sec.  211.207-2.
    (iv) For devices with headbands that may be used in different
positions, the labeled NRR shall represent the 80th and 20th
percentiles for the manufacturers recommended position as determined in
Sec.  211.207-2.
    (v) The word ``PASSIVE'' shall be placed and centered below the
bar-graph. For multi-positional head band protectors, the tested
position shall be indicated by the words, ``OVER HEAD'', ``BEHIND
HEAD'' or ``UNDER CHIN'' placed immediately following ``PASSIVE''.
    (3) Area C must state ``PASSIVE NRR values indicate range of noise
reduction when used as instructed by the manufacturer. When used in
steady and intermittent noise environments, the difference between the
noise level and respective NRRs is the user's estimated exposure level.
This protector was not tested for impulse noise.''
    (4) Area D of the primary label must state the manufacturers' name,
city and state of principal office and may include a primary web
address.
[GRAPHIC] [TIFF OMITTED] TP05AU09.005

    (b) Primary Label for ACTIVE Noise Reduction Hearing Protection
Devices (Figure 2):
    (1) Area A must state ``Noise Reduction Rating''.
    (2) Area B must contain the range(s) of the Noise Reduction Ratings
(NRR) in decibels for the designed mode(s) of use of that model hearing
protector.
    (i) There shall be two bar-graphs with numeric scales from 0 to 50
decibels in equal increments of 10 decibels. The two bar-graphs shall
be aligned one above the other as shown in Figure 2 of this section.
    (ii) The word ``ACTIVE'' shall be placed and centered above the
upper bar-graph.
    (iii) The word ``PASSIVE'' shall be placed and centered below the
lower bar-graph.
    (iv) A solid color bar shall be superimposed on the respective bar-
graphs indicating their lesser and greater Noise Reduction Ratings from
the 80th and 20th percentiles.
    (v) The lesser and greater NRR values shown on the upper bar-graph
shall be determined in accordance with Sec.  211.207-3.
    (vi) The lesser and greater NRR values shown on the lower numeric
scale shall be determined in accordance with Sec.  211.207-3.
    (vii) For devices with headbands that may be used in different
positions, the labeled NRR shall represent the 80th and 20th
percentiles for the manufacturers recommended position(s) as determined
in Sec.  211.207-3. The tested position shall be indicated by the
words, ``OVER HEAD'', ``BEHIND HEAD'' or ``UNDER CHIN'' placed
immediately following ``PASSIVE'' and ``ACTIVE''.
    (2) Area C must state ``ACTIVE and PASSIVE NRR values indicate
range of noise reduction with and without electronic activation when
used as instructed by the manufacturer. In steady and intermittent
noise environments, the difference between the noise level and
respective NRRs is the user's estimated exposure level. This protector
was not tested for impulse noise.''
    (3) Area D of the primary label must state the manufacturers' name,
city and state of principal office and may include a primary web
address.

[GRAPHIC] [TIFF OMITTED] TP05AU09.006

    (c) Primary Label for IMPULSIVE Noise Hearing Protection Devices
(Figure 3):
    (1) Area A must state ``Noise Reduction Rating''.
    (2) Area B must contain the range(s) of the Noise Reduction Ratings
(NRR) in decibels for the designed mode(s) of use of that model hearing
protector.
    (i) There shall be two bar-graphs with numeric scales from 0 to 50
decibels in equal increments of 10 decibels. The two bar-graphs shall
be aligned one above the other as shown in Figure 3 of this section.
    (ii) The word ``IMPULSIVE'' shall be placed and centered above the
upper bar-graph.
    (iii) The word ``PASSIVE'' shall be placed and centered below the
lower bar-graph.
    (iv) A solid color bar shall be superimposed on the respective
scales indicating their lesser and greater Noise Reduction Ratings from
the 80th and 20th percentiles.
    (v) The lesser impulsive NRR values shown on the upper numeric
scale shall be determined in accordance with Sec.  211.207-4(f).
    (vi) The greater impulsive NRR values shown on the upper numeric
scale shall be determined in accordance with Sec.  211.207-4(g).
    (vii) The lesser and greater passive NRR values shown on the lower
numeric scale shall be determine in accordance with Sec.  211.207-2.
    (viii) For devices with headbands that may be used in different
positions, the labeled NRR shall represent the 80th and 20th
percentiles for the manufacturers recommended position as determined in
Sec.  211.207-2. The tested position shall be indicated by the words,
``OVER HEAD'', ``BEHIND HEAD'' or ``UNDER CHIN'' placed immediately
following ``IMPULSIVE'' and ``PASSIVE.''
    (3) Area C must state ``IMPULSIVE and PASSIVE NRR values indicate
the range of noise reduction in impulsive and continuous noise
environments when used as instructed by the manufacturer. The
difference between the noise level and respective NRRs is the user's
estimated exposure level.''
    (4) Area D of the primary label must state the manufacturers' name,
city and state of principal office and may include a primary web
address.

[GRAPHIC] [TIFF OMITTED] TP05AU09.007

    6. Section 211.204-2 is amended as follows:
    a. Revise paragraphs (b)(2) and (b)(3).
    b. Revise (c) and (d).
    c. Add new paragraphs (e) through (l).
    Sec.  211.204-2 Primary label size, print and color.
* * * * *
    (b) * * *
    (2) Area B--2.1 mm or 6 point for numerals and
    (3) Area A and B--1.7 mm or 5 point for words.
* * * * *
    (c) The use of upper and lower case letters and the general
appearance of the label must be similar to the example in Figure 1 of
Sec.  211.204-1.
    (d) The color of the EPA logo shall be a solid color with
sufficient contrast with surrounding information or if it is printed in
full color, it must be the colors of the official EPA logo.
    (e) The minimum dimensions of the scale shall be 2.2 (cm) (0.87
inch) long and 0.3 (cm) (0.12 inch) high.
    (f) The minimum font size of the labels for the bar shall be 4
point type.
    (g) The values depicted on the bar shall be at least 6 point in
bold type face.
    (h) The solid range bar shall be a minimum of 0.2 (cm) (0,079 inch)
high, vertically centered in the bar-graph scale and of sharply
contrasted solid-color with the endpoints positioned at the respective
numeric limits.
    (i) For all PASSIVE hearing protection devices the layout shall be
according to Figure 1 of Sec.  211.204-1.
    (j) For ACTIVE hearing protection devices the layout shall be
according to Figure 2 of Sec.  211.204-1.
    (k) For IMPULSIVE hearing protection devices the layout shall be
according to Figure 3 of Sec.  211.204-1.
    7. Section 211.204-3 is amended by revising paragraphs (a)
introductory text and (a)(2) and by adding paragraph (a)(3) to read as
follows:

Sec.  211.204-3   Label location and type.

    (a) The manufacturer or entity that introduces the product into
commerce is responsible for labeling the product for ultimate sale or
use. Such manufacturer or entity shall select the primary product label
in accordance with Sec.  211.204-1 and locate it as follows:
* * * * *
    (2) Affixed to the primary panel of the product packaging if the
label complying with Sec.  211.204-1 is not visible at the point of
ultimate purchase or the point of distribution to users.
    (3) Products that are sold exclusively over the Internet and thus
constitute the point of sale to ultimate purchasers or users, shall
present the requisite primary and secondary labels as readily visible
electronic images for each product category offered for sale. Such
electronic labels shall contain all information that is required for
labels that are required to be affixed to and contained within the
package of products with a point of sale outside the Internet. Such
labels must be automatically downloaded to the purchaser along with
confirmation of acceptance of payment from the purchaser. Electronic
labels shall not be used for bulk container sales or for non-Internet
resale.
* * * * *
    8. Section 211.204-4 is revised to read as follows:

Sec.  211.204-4  Supporting information.

    The following minimum supporting information must accompany all
hearing protection devices in a manner that ensures its availability to
the perspective user in an easily readable format. In the case of bulk
packaging and dispensing, such supporting information must be affixed
to the bulk container or dispenser in the same manner as the label, and
in a readily visible location. Such information shall be presented in
tabular form except where specified otherwise.
    (a) The mean sound attenuation for each octave band test frequency
as determined from the measurements prescribed in Sec.  211.206-1.
    (b) The standard deviation of the mean sound attenuation across
subjects for each octave band test frequency as determined from the
measurements prescribed in Sec.  211.206-1.

    (c) The Assumed Protection Values (APV) for the 80th and 20th
percentiles of the sound attenuation for each octave band test
frequency as determined from the measurements prescribed in Sec.
211.206-1.
    (d) The noise reduction as a function of spectral balance shall be
presented as shown in the example given in Table 1 of this section.

                            Table 1--Example--Noise Reduction Variability Data Points
                                               [spectral balance]
----------------------------------------------------------------------------------------------------------------
                                                       -1 dB           -2 dB           6 dB            13 dB
----------------------------------------------------------------------------------------------------------------
                                                                       Noise Reductions (dB)
                                                 ---------------------------------------------------------------
20th Percentile.................................            30.6            24.0            18.7            11.9
----------------------------------------------------------------------------------------------------------------
80th Percentile.................................            26.8            19.2            13.7             8.1
----------------------------------------------------------------------------------------------------------------

     (e) The variability of attenuation as a function of noise spectrum
shall be presented in a graphical format as shown in Figure 1 of this
section.
    (1) The figure caption shall be ``Variability of Noise Reduction as
a function of Noise Spectra.''
    (2) The dimensions of the body of the graph shall be no smaller
than 5.0 cm wide by 3.8 cm high (1.97 x 1.5 inches).
    (3) The dimensions of the body of the graph shall be no smaller
than 5.0 cm wide by 3.8 cm high (1.97 x 1.5 inches).
    (4) The ordinate scale shall be linear from -2 to 16 decibels with
increments of 2 decibels. The axis label shall be ``Spectral Balance B
= LC - LA (dB)''.
    (5) The abscissa scale shall be linear from 0 to 50 decibels with
increments of 5 decibels. The abscissa scale shall be labeled
``Estimated Noise Reduction (dB)''.
    (6) The use of a grid is optional to facilitate interpolation of
values.
    (7) The symbols for the 80th percentile shall be filled and
connected by solid lines.
    (8) The symbols for the 20th percentile shall be unfilled and
connected by solid lines.
    (9) A legend shall be placed in the body of the graph as shown in
the example of Figure 1 of this section.
[GRAPHIC] [TIFF OMITTED] TP05AU09.008

    (f) For hearing protection devices with a headband that can be worn
in multiple positions (over head, behind head and/or under chin) the
mean sound attenuation values, standard deviations and APV, as
prescribed in paragraphs

(a), (b), (c), (d) and (e) of this section, shall be provided for each
tested position.
    (g) The following statement, ``When this device is worn as
directed, the level of noise entering a person's ear is approximated by
the differences between the A-weighted environmental noise level and
the lesser and greater NRRs.'' except as stated in Sec.  211.204-5 for
ACTIVE devices and as stated in Sec.  211.204-6 for IMPULSIVE devices.
    (h) The following example shall be included except as stated in
Sec.  211.204-5 for ACTIVE devices and in Sec.  211.204-6 for IMPULSIVE
devices:
    ``Example:
    (1) X: the sound pressure level as measured at the user's location
in decibels A-weighted (dBA).
    (2) Lesser and greater NRRs: the PASSIVE NRR ratings obtained from
the primary label or from the graph of noise reduction variability with
spectral balance.
    (3) The approximate range of sound pressure levels at the user's
ears with hearing protection:
    (X -- lesser NRR) = the greater sound pressure level.
    (X -- greater NRR) = the lesser sound pressure level.
    The sound pressure level at the user's ears will depend upon the
fit of the protector.''
    (i) The following cautionary note shall be included except as
stated in Sec.  211.204-5 for ACTIVE devices and as stated in Sec.
211.204-6 for IMPULSIVE devices.
    ``Caution: For predominantly low frequency noise environments in
which the difference in the measured C-weighted and A-weighted noise
levels (dBC--dBA) exceeds 3 dB, the user is directed to the enclosed
graph of the variability of noise reduction with noise spectra to
determine the level of protection.''
    (j) The month and year of production of the device shall be printed
on the outside of the package using a minimum font size of 8 point.
    (k) Instructions as to the proper use, fitting technique and care
of the device.
    (l) The following statement: ``Improper fit or improper use of this
device will decrease noise reduction effectiveness and increase the
risk of hearing damage.
    9. Section 211.204-5 is added to read as follows:

Sec.  211.204-5  Supporting information for Active Noise Reduction
Hearing Protection Devices.

    In addition to the supporting information required in Sec.
211.204-4, the following minimum supporting information must accompany
all ACTIVE devices in an easily readable format.
    (a) The mean total sound attenuation for each octave band test
frequency as determined from the measurements prescribed in Sec.
211.206-2.
    (b) The standard deviation of the mean total sound attenuation
across subjects for each octave band test frequency as determined from
the measurements prescribed in Sec.  211.206-2.
    (c) The Assumed Protection Values (APV) for the 80th and 20th
percentiles of the sound attenuation for each octave band test
frequency as determined from the measurements prescribed in Sec.
211.206-2.
    (d) The passive, active and total noise reduction data points as a
function of spectral balance shall be presented as shown in the example
in Table 1 of this section.

   Table 1--Example--Combined Active and Passive Noise Reduction Variability as a function of Spectral Balance
----------------------------------------------------------------------------------------------------------------
                                                       -1 dB           2 dB            6 dB            13 dB
----------------------------------------------------------------------------------------------------------------
                                                                       Noise Reductions (dB)
----------------------------------------------------------------------------------------------------------------
20th Percentile Passive.........................            21.0            14.0             9.0             5.0
80th Percentile Passive.........................            27.0            21.0            15.0            10.0
20th Percentile Active..........................            -1.0             0.7             6.2            12.5
80th Percentile Active..........................             0.0             0.0             7.5            14.0
20th Percentile Total...........................            20.0            14.7            15.2            17.5
80th Percentile Total...........................            27.0            21.0            22.5            24.0
----------------------------------------------------------------------------------------------------------------

     (e) The variability of attenuation as a function of noise spectrum
shall be presented in a graphical format as shown in Figure 1 of this
section.
    (1) The figure caption shall be ``Variability of Noise Reduction as
a Function of Noise Spectra.'' The dimensions of the body of the graph
shall be no smaller than 5.0 cm wide by 3.8 cm high (1.97 x 1.5
inches).
    (2) The font size for the title, ordinate and abscissa scales, and
the legends shall be no smaller than 4 point.
    (3) The ordinate scale shall be linear from -2 to +16 decibels with
increments of 2 decibels. The axis label shall be ``Spectral Balance B
= LC--LA (dB)''.
    (4) The abscissa scale shall be linear from 0 to 50 decibels with
increments of 5 decibels. The abscissa scale shall be labeled
``Estimated Noise Reduction (dB)''.
    (5) The use of a grid is optional to facilitate interpolation of
values.
    (6) The symbols for the 80th percentile passive noise reductions
shall be filled and connected by solid lines.
    (7) The symbols for the 20th percentile passive noise reductions
shall be unfilled and connected by solid lines.
    (8) The symbols for the 80th percentile total noise reductions
shall be filled, distinctly different from the passive symbols and
connected by dashed lines.
    (9) The symbols for the 20th percentile total noise reductions
shall be unfilled, distinctly different from the passive symbols and
connected by dashed lines.
    (10) A legend shall be placed in the body as shown in the example
given in Figure 1 of this section.

[GRAPHIC] [TIFF OMITTED] TP05AU09.009

    (f) The following statement, ``When this device is worn as
instructed and operated in its PASSIVE mode, the level of noise
entering a person's ear is approximated by the differences between the
A-weighted sound pressure level at the user's location and the lesser
and greater PASSIVE NRRs. When this device is operated in its ACTIVE
mode, the level of noise entering the person's ear is approximated by
the difference between the A-weighted sound pressure level at the
user's location and the lesser and greater ACTIVE NRRs.''
    (g) The following example shall be included for ACTIVE devices:
``Example:
    (1) X: The sound pressure level as measured at the user's location
in decibels A-weighted (dBA).
    (2) Lesser and greater NRR: The ACTIVE or PASSIVE ratings obtained
either from the primary label or from the graph of noise reduction
variability with spectral balance.
    (3)(I) The approximate range of sound pressure levels at the user's
ears with the HPD in either its ACTIVE or PASSIVE mode:
(A) (X-lesser NRR) = the greater sound pressure level.
(B) (X-greater NRR) = the lesser sound pressure level.

    (ii) The sound pressure level at the user's ears will depend upon
the fit and operating mode of the protector.''
    (h) The following cautionary note shall be included in the
secondary label for active noise reduction hearing protectors:
``Caution: For the ACTIVE mode in predominantly low frequency
environments in which the difference in the measured C-weighted and A-
weighted sound pressure levels (dBC-dBA) exceeds 3 dB, the user is
directed to the enclosed graph of the variability of noise reduction
with noise spectra to determine the level of protection.''
    (i) The following statement shall be included: ``This device, in
ACTIVE mode, is recommended for use in environmental noise levels from
X to Y dBA.'' The manufacturer shall designate the values of X and Y.
    (j) If the total combined attenuation of REAT and
LACTIVE, as calculated in Sec.  211.206-2, for any octave
band exceeds 50 dB, the following cautionary statement shall be
included: ``The combined attenuation of this device has been measured
to be in excess of 50 dB at XXX Hz. Sound energy transmitted through
the head or oral/nasal cavities to the inner ear may be greater than
the level of sound when attenuated by the hearing protection device.''
The manufacturer shall designate the frequency band(s) where the
attenuation exceeds 50 dB.
    (k) The battery type, number of batteries and expected use time for
the product.
    10. Section 211.204-6 is added to read as follows:

Sec.  211.204-6  Supporting information for Amplitude-Sensitive Hearing
Protection Devices.

    In addition to the supporting information required in Sec.
211.204-4, the following minimum supporting information must accompany
all Amplitude-Sensitive hearing protection devices in an easily
readable format. In the case of bulk packaging and dispensing, such
supporting information must be affixed to the bulk container or
dispenser in the same manner as the label, and in a readily visible
location. The information

resulting from the measurements prescribed in Sec.  211.206-3 shall be
presented in tabular and graphical form as shown in Table 1 and Figure
1 of this section for PASSIVE Amplitude-Sensitive hearing protection
devices and as shown in Table 2 and Figure 2 of this section for ACTIVE
Amplitude-Sensitive devices.
    (a) The mean peak sound pressure levels.
    (b) The mean impulsive noise reduction at each mean peak sound
pressure level.
    (c) The minimum and maximum impulsive noise reduction values at
each mean peak sound pressure level.

                  Table 1--Example--Variability of Impulsive Noise Reduction for ABC Protector
                                                 [Passive mode]
----------------------------------------------------------------------------------------------------------------
                 Mean peak sound pressure level                       131 dB          150 dB          167 dB
----------------------------------------------------------------------------------------------------------------
Mean Impulse Noise Reduction....................................            23.2            22.9            23.4
Maximum Impulse Noise Reduction.................................            24.0            23.1            24.4
Minimum Impulse Noise Reduction.................................            21.5            22.4            22.7
----------------------------------------------------------------------------------------------------------------

                  Table 2--Example--Variability of Impulsive Noise Reduction for XYZ Protector
                                           [Active and passive modes]
----------------------------------------------------------------------------------------------------------------
                 Mean peak sound pressure level                       133 dB          150 dB          167 dB
----------------------------------------------------------------------------------------------------------------
Mean Impulse Noise Reduction (Passive)..........................            32.2            32.8            33.9
Maximum Impulse Noise Reduction (Passive).......................            32.6            33.4            34.2
Minimum Impulse Noise Reduction (Passive).......................            31.2            31.7            33.7
Mean Impulse Noise Reduction (Active)...........................            32.0            31.6            32.7
Maximum Impulse Noise Reduction (Active)........................            32.1            32.3            33.8
Minimum Impulse Noise Reduction (Active)........................            30.5            31.2            30.6
----------------------------------------------------------------------------------------------------------------

                                                                                [GRAPHIC] [TIFF OMITTED] TP05AU09.010

[GRAPHIC] [TIFF OMITTED] TP05AU09.011

    (d) The battery type, number of batteries and expected operating
time for the product as appropriate.
    (e) The following statement: ``This device is recommended for use
in impulsive noise environments having peak levels between 130 to X dB
SPL.'' (X dB is equal to 130 dB plus the mean passive impulsive noise
reduction)
    (f) The following cautionary note shall be included for ACTIVE
noise reduction hearing protectors. ``Caution: This device is not
intended for use in impulsive noise environments exceeding Y dB peak
sound pressure levels. The risk of hearing loss increases with multiple
exposures to high level peak impulses.'' (Y dB is equal to 130 dB plus
the mean active impulsive noise reduction)
    (g) The following statement: ``The PASSIVE Noise Reduction Rating
is based on the attenuation of continuous noise and is not an accurate
indicator of the protection attainable against impulsive noise. The
IMPULSIVE Noise Reduction Rating is based on the attenuation of high-
level impulsive noise and is not an accurate indicator of the
protection attainable for continuous noise.''
    (h) The following example shall be included for amplitude-sensitive
devices:
    ``Example:
    (1) X: the peak sound pressure level as measured at the user's
location in decibels A-weighted (dBA).
    (2) Lesser and greater NRR: the IMPULSIVE ratings obtained from the
primary label.
    (3)(i) The approximate range of sound pressure levels at the user's
ears with hearing protection:

(A) (X-Lesser NRR) = the greater effective peak sound pressure level.
(B) (X-Greater NRR) = the lesser effective peak sound pressure level.

    (ii) The peak sound pressure level at the user's ears will depend
upon the fit and operating mode of the protector. For a more accurate
estimate of the impulsive noise reduction the user is directed to the
graph of Figure 2 of this section.''
    11. Section 211.204-7 is added to read as follows:

Sec.  211.204-7  Supporting information for Amplitude-Sensitive Hearing
Protection Devices with Active Noise Reduction.

    Devices that incorporate both ACTIVE noise reduction and ACTIVE
amplitude-sensitive noise reduction shall comply with both sections
Sec.  211.204-1(b) and Sec.  211.204-1(c) for primary labeling and with
both sections Sec.  211.204-5 and Sec.  211.204-6 for supporting
information.
    12. Section 211.205 is revised to read as follows:

Sec.  211.205  Special claims and exceptions.

    (a) Any manufacturer wishing to make claims regarding the acoustic
effectiveness of a device, other than its Noise Reduction Ratings, must
demonstrate the validity of such claims, including the presentation of
test data and the specific methods used to validate the claims.
    (b) Any request concerning an exception must be supported by
scientific test data that establishes the exception without doubt, and
must be submitted for consideration and approval to: The Administrator
or his designee at U.S. EPA, Office of the Administrator. The Agency
will notify the manufacturer within thirty (30) business days of
receipt of the request if: the special claim or exception is approved,
disapproved, additional information is needed, or the Agency needs
additional time to consider the request.
    13. Section 211.206-1 is revised to read as follows:

Sec.  211.206-1  Real ear attenuation at threshold (REAT).

    (a) The provisions of this section shall apply to the following
devices:
    (1) Passive Hearing Protection Devices;
    (2) Active Hearing Protection Devices in their ``off'' mode of
operation;
    (3) Active Noise Reduction Hearing Protection Devices in their
``off'' mode of operation; and
    (4) Amplitude-Sensitive Hearing Protection Devices in their ``off''
mode of operation (if they incorporate electronics).
    (b) The sound attenuation to be used in the calculation of the
Noise Reduction Rating shall be determined in accordance with all
clauses of ANSI/ASA S12.6-2008 ``Methods for Measuring the Real-ear
Attenuation of Hearing Protectors,'' incorporated by reference at Sec.
211.213 of this subpart, except as stipulated in the identified ANSI
clauses below:
    (1) For subpart B, the word ``requester'' as used in ANSI/ASA
S12.6-2008 shall be replaced with the word ``manufacturer'' as defined
in Sec.  211.203.
    (2) For subpart B, only those requirements addressing Method A of
ANSI/ASA S12.6-2008 shall be applicable.
    (3) Clause 3 of ANSI/ASA S12.6-2008. Terms and Definitions. The
definitions given in Sec.  211.203 shall be used in this subpart.
    (4) Clause 4 of ANSI/ASA S12.6-2008. Physical Requirements of Test
Facility. For subpart B, the following new provision shall be in
addition to that of Clause 4.3.1: ``The electrical test signals
measured at the input terminals of the speaker or speakers shall
consist of one-third octave bands of pink or white noise, with a
spectrum shape equivalent to that which would be created by a filter
meeting the requirements of Class O of ANSI S1.11-2004, incorporated by
reference at Sec.  211.213 of this subpart. The mode of operation in
changing from one band to another shall be a discrete step function; a
gradual continuously adjustable mode of change shall not be used.''
    (5) Clause 5 of ANSI/ASA S12.6-2008--Test Subjects.
    (i) For subpart B, the following new provision shall be in addition
to Clause 5.3. ``Prior to audiometric qualification and participation
in attenuation testing, the dimensions of both the right and left ear
canals, and the bitragion width and head height of the test subject
shall be measured in accordance with the procedure of ANSI 12.6-2008,
Annex B.
    (6) Clause 6 of ANSI/ASA S12.6-2008. Product Samples.
    (i) For subpart B, the following new provisions shall be in
addition to Clause 6.1 of ANSI/ASA S12.6-2008:
    (A) Formable ear plugs: a minimum of three pairs of ear plugs per
test subject shall be provided. A new pair shall be used for training
and for each subsequent occluded trial. When a specific product is
available in different sizes, three pairs of each product size shall be
provided per test subject.
    (B) Premolded ear plugs and semi-insert devices: a minimum of one
pair of ear plugs per test subject shall be provided. When a specific
product is available in different sizes, one pair of each product size
shall be provided per test subject.
    (C) Custom ear plugs: One pair of custom ear plugs for each test
subject shall be provided.
    (D) Ear muffs: a minimum of one pair of ear muffs for every two
test subjects shall be provided. When a specific product is available
in different sizes, one pair of each product size shall be provided for
every two test subjects.
    (E) Ear muffs attached to a hardhat: The hardhat sample shall be
specified by the manufacturer of the hearing protection device. A
minimum of one pair of ear muffs for every two test subjects shall be
provided. When an ear muff is available in different sizes, one pair of
each size shall be provided for every two test subjects. For each size
of hardhat, two samples shall be provided in each size.
    (F) Helmets: a minimum of one sample shall be provided for each
size helmet to be tested. Helmets incorporating other hearing
protection devices (e.g. ear plugs, ear muffs) shall be tested as a
system. The hearing protection device(s) incorporated in a helmet shall
be provided by the manufacturer of the helmet. The minimum number of
samples of the hearing protection device(s) to be used in combination
with the helmet shall be as specified in paragraph (b)(6)(i)(A) through
(E) of this section.
    (ii) For subpart B, the following new provisions shall be in
addition to Clause 6.2 of ANSI/ASA S12.6-2008: ``Ear muffs and semi-
insert devices with bands or attached to hardhats, which include
adjustment mechanisms allowing the band force to be varied, shall be
initially set to the minimum application force of their adjustment
range prior to being provided to each subject. During fitting, the
devices may be readjusted per the provisions of Clauses 8.1 of ANSI/ASA
S12.6-2008.''
    (iii) For subpart B, Clause 6.3 of ANSI/ASA S12.6-2008, shall not
be applicable.
    (7) Clause 7 of ANSI/ASA S12.6-2008--Psychophysical Procedure.
    (i) For subpart B, Clause 7.1.1 of ANSI/ASA S12.6-2008, shall not
be applicable.
    (ii) For subpart B, Clause 7.5 of ANSI/ASA S12.6-2008, shall read
as follows: ``If the range of open threshold measurements at any
frequency exceeds 6 dB during a test session, the threshold at that
frequency shall be retested until two open thresholds are obtained
within 6 dB of each other.''
    (8) Clause 8 of ANSI/ASA S12.6-2008--Method A: Trained-subject Fit:
    (i) For subpart B, the following new provisions shall be in
addition to Clause 8.1 of ANSI/ASA S12.6-2008:
    (A) ``The experimenter shall give each subject precise directions
and practice in fitting the hearing protector in accordance with the
instructions that are provided by the manufacturer with the product to
all users. The manufacturer's instructions shall not be modified by the
experimenter's own knowledge in fitting the same or similar devices. No
indicators, marks, or lubricants shall be utilized unless supplied or
recommended by the manufacturer as a part of normal use. No alterations
shall be made to the device to facilitate fitting. When applicable the
experimenter shall assist the subject in selecting the appropriate size
hearing protector, and in adjusting products with variable band force.
Subjects can select the size appropriate to fit their right and left
ears. The selected size(s) must be used throughout the two product
trials.
    (B) The experimenter may provide demonstrations of the
manufacturer's fitting instructions during the training period. The
experimenter may personally fit the device to the test subject as part
of the training process. The experimenter shall train the subject in
the use of the fitting noise (Clause 4.3.6 of ANSI/ASA S12.6-2008) to
assist in fitting the protector. There is no limitation on either the
duration of the training or the number of practice fittings that may be
performed. Trial sound attenuation measurements during the training
period are prohibited. Once the experimenter has determined the subject
can properly fit the hearing protector, the test shall begin.''
    (ii) For subpart B, the following new provisions shall be in
addition to Clause 8.2 of ANSI/ASA S12.6-2008: ``After training, a
subject shall be dismissed if the subject cannot obtain an acceptable
product fit based on any one of the following criteria:
    (A) Subjects assessment of the quality of the hearing protector fit
based on

listening to the loudness of the fitting noise,
    (B) Visual evaluation by the experimenter,
    (C) Tactile evaluation by the experimenter working in conjunction
with the subject,
    (D) Guidance specific to that product as provided by the
manufacturer,
    (E) Repeated failure to meet the requirements of Clause 7.5
    (F) Illness or physical inability to participate on the day of the
test, and
    (G) Inability to remain attentive during instruction or testing
sessions.
    Subjects shall not be retested or dismissed as the result of the
attenuation they obtained during the testing process.''
    (iii) For subpart B, the following new provisions shall be in
addition to Clause 8.3 of ANSI/ASA S12.6-2008:
    (A) ``For the occluded tests, the subject shall fit the hearing
protector without the experimenter present in the test chamber. The
fitting noise shall be introduced into the test chamber and the subject
shall be told to manipulate the hearing protector to obtain the lowest
level of perceived noise. The experimenter shall observe the subject
during the fitting test from outside the chamber. Once the subject is
satisfied with the fit, and after observing the quiet period specified
in Clause 7.6 and the waiting period specified in Clause 7.7 of ANSI/
ASA S12.6-2008, the test shall begin.
    (B) Adjustments of the fit of the hearing protector during the
occluded threshold tests are not allowed. However, the subject shall be
instructed to inform the experimenter if, during the test, a change in
fit of the device is noticed, and if so, the test shall be stopped. The
subject shall refit the device and the occluded threshold test
restarted from the beginning. If this occurs a second time the occluded
threshold testing shall be completed without refit and the attenuation
data shall be used in the computation of the rating.''
    (9) For subpart B, Clause 9 of ANSI/ASA S12.6-2008 is not
applicable.
    14. Section 211.206-2 is revised to read as follows:

Sec.  211.206-2  Active noise reduction (ANR).

    The provisions of this section shall apply to all Active Noise
Reduction hearing protection devices as defined in Sec.  211.203(u)(7).
    (a) The measurement of active sound attenuation requisite to the
Noise Reduction Rating for Active Noise Reduction hearing protection
devices shall be in accordance with the methods defined in this section
and only those clauses of ANSI S12.42-1995 (R2004), incorporated by
reference at Sec.  211.213 of this subpart, stated below. The octave
band attenuation shall be calculated using one-third octave band
insertion loss measurements as described in paragraph (m)(2) of this
section.
    (b) The definitions given in Sec.  211.203 shall be used.
    (c) Acoustic Environment of Test Room: The requirements of this
subpart shall be applicable to measurements of all Active Noise
Reduction devices.
    (1) Sound Field Generation Equipment: For subpart B, Clause 6.1 of
ANSI/ASA S12.6-2008, shall be applicable.
    (2) Sound Field Characteristics: For subpart B, Clauses 6.2.1 and
6.2.2 and Table 1 of ANSI S12.42, shall be applicable.
    (3) Sound Field Frequency Characteristics: The sound field shall be
a broad band noise incorporating frequencies from 100 to 10000 Hz. The
difference between the maximum and minimum one-third octave band levels
within the specified frequency range shall not exceed 10 dB. The
difference between adjacent one-third octave band levels shall not
exceed 3 dB.
    (4) Sound Field Integration Time: The integration time shall not be
less than 32 seconds using linear spectral averaged third octave band
analysis.
    (5) Sound Field Reference Levels (LREF(f)): The signal
generation equipment shall be capable of producing a continuous sound
field of 105 dB SPL without a subject in the room. The field shall be
measured with an ANSI Type I Pressure Microphone. The attenuation
settings shall be recorded to permit replication.
    (6) Ambient Noise Floor of Test Room: The noise floor of the test
chamber, with all external equipment operating and no sound field
present, shall be at least 60 dB less than sound field levels measured
at each third octave band.
    (7) Fitting Noise: The fitting noise shall be as specified in
paragraph (c)(3) of this section and presented at a level of 85 dB SPL.
    (d) Measurement Equipment:
    (1) For subpart B, Clauses 6.3.1, 6.3.2, and 6.3.4 of ANSI S12.42,
shall be applicable.
    (2) For subpart B, the following new provision shall be in addition
to Clause 6.3.6 of ANSI S12.42: ``A spectrum analyzer using a third-
octave band analog or digital filter bank or a Type I sound level meter
with a third-octave band filter set shall be used for measuring the
sound pressure levels. The measurement system shall have sufficient
dynamic range such that all measurements are a minimum of 10 dB above
the instrumentation noise floor and test chamber's ambient background
noise level. When using a Fast Fourier Transform (FFT) analyzer, it
shall have internally generated digital pseudorandom white and pink
noise sources with known statistical characteristics, i.e., wide sense
stationary, and shall be used for the third-octave band calculation of
true random noises. All decibel measurements shall be referenced to 20
x 10-6 N/m\2\ (20 [mu]Pa).''
    (3) Signal to Noise Ratio of the measurement microphone in the test
chamber: The difference in microphone output levels with and without
the sound field present shall be at least 10 dB in each third-octave
band from 80 to 12500 Hz.
    (e) Active Attenuation Method for ear muffs using Microphone In
Real Ear (MIRE).
    (1) MIRE Microphone: For subpart B, a microphone that fulfills the
requirements set forth in Clause 8 of ANSI S12.42, is required.
    (2) For subpart B, the following new provision shall be in addition
to Clause 8.1.2 of ANSI/ASA S12.6-2008: ``The microphone may be
wireless or wired. If wired, the wires from the microphone, including
insulation, shall not be more than 0.3204 millimeters (0.0126 inches)
in diameter to minimize leakage of sound into the protector cavity.''
    (3) For subpart B, the following new provision shall be in addition
to Clause 8.1.3 of ANSI/ASA S12.6-2008: ``The experimenter shall fit
appropriate ear plugs into the subject's ear canals such that their
external surfaces are flush with the base of each ears conchae. The
subject shall be instructed that removal of any hearing protector is
prohibited during the test without permission from the experimenter.''
    (4) Position of microphone: The MIRE microphone shall be positioned
by the experimenter on the external surface of the ear plug at the
entrance of the ear canal, as shown in Figure 1 of this section. The
sensing surface shall be perpendicular to the axis of the ear canal,
centered in the ear canal and directed away from the center of the
subject's head.

[GRAPHIC] [TIFF OMITTED] TP05AU09.012

    (f) Product selection:
    (1) Ear muffs: A minimum of one pair of ear muffs for every two
test subjects shall be provided. Subjects shall use the same ear muff
as for the REAT testing. When a specific product is available in
different sizes, one pair of each product size shall be provided for
every two test subjects.
    (2) Ear muffs attached to a hardhat: The hardhat sample shall be
specified by the manufacturer of the hearing protection device. A
minimum of one pair of ear muffs for every two test subjects shall be
provided. When an ear muff is available in different sizes, one pair of
each size shall be provided for every two test subjects. For each size
of hard hat, two samples shall be provided in each size.
    (3) Helmets: A minimum of one sample for each size helmet to be
tested shall be provided. Helmets incorporating ear muffs shall be
tested as a system. The integral ear muffs for a helmet shall be
provided by the manufacturer of the helmet. If the ear muffs are
removable, the minimum number to be used in combination with the helmet
shall be as specified in Sec.  211.206-1(b)(6)(i)(D).
    (g) Measurement Procedure:
    (1) Subject Selection: Only those subjects who completed the REAT
tests with protectors specified in Sec.  211.206-1(a)(3) shall be used
for the MIRE tests set forth in this section.
    (2) Subject Position: A head-positioning device, such as a plumb-
bob to the nose or the forehead of the subject, shall be used to
maintain the subject's head at the reference point. The head
positioning device shall not transmit to the head vibrations that
affect the threshold measurements, and shall not measurably affect the
uniformity of the sound field of the room as specified in Clause 6.2.1
of ANSI S12.42. The use of a headrest or bite bar is not permitted.
    (h) Fitting the protectors:
    (1) The subject shall fit the protector as instructed for the REAT
testing. No additional fitting training shall be given. However, the
experimenter shall ensure that the integrity of the MIRE microphone and
its wires is maintained during the fit process.