Summary of comments from 3M Company for EPA
40 CFR Part 211 Product Noise Labeling Hearing Protection Devices;
Proposed Rule EPA–HQ– OAR–2003–0024
3M supports the efforts by EPA to update and improve its rule on hearing protection device labeling. Extensive written comments on the proposed rule have been prepared and will be submitted to the docket prior to the close of the comment period, November 4, 2009. At the hearing on October 7, 2009, 3M Senior Scientist, Elliott Berger, will provide an overview of 3M’s primary questions, concerns and recommendations. This document presents, in a prioritized order, an outline of those oral comments.
1. Transition to New Label §211.211–1 and 211.211–2
3M Comments
a. 30 months is not enough time for manufacturers to complete transition testing and labeling of all products according to the proposed rule.
b. Customer confusion is likely during the 30–month transition period following the effective date if products bearing the old labels and those bearing the new labels are in the market side–by–side.
3M Recommendations
In order to provide more time for manufacturers to complete testing and labeling of hearing protectors according to the proposed rule and to minimize confusion in the marketplace caused by an extended transition period, 3M recommends a 24–month interim period followed by an 18–month transition period (42 months total) as follows:
a. 24–month interim: Set the effective date at 24 months following the date of the publication of the final rule. During this interim time, only packages bearing the old NRR labels are allowed to be sold. Manufacturers will use this time to begin testing products using the new test methods.
b. 18–month transition: Shorten the transition period following the effective date to 18 months during which time manufacturers will begin introducing into commerce products with the new labels. Products bearing the old labels may also be sold during this transition. All hearing protectors manufactured after the end of the transition period shall be labeled with the new label only.
2. Recurrent Testing and Relabeling Requirements §211.211–3 and 211.211–4
3M Comments
a. A 3–dB change in NRR values is not a significant enough change to warrant relabeling a product given the variability of the test methods required in the proposed rule.
b. Recurrent testing is unnecessary unless the product design, materials or manufacturing processes have changed in a manner affecting the form, fit or function of the HPD.
c. 5 years recurrent test interval is too short.
i. It is unlikely that manufacturers will be able to adequately stagger transition tests and recurrent tests within the 5 year time frame resulting an unmanageably large block of testing in years 4 and 5.
ii. Such a short retest interval is inconsistent with EPA’s stated objective to ensure that “…the labeling requirements are structured to minimize administrative, economic, and technical impacts on manufacturers, distributors, and other interested parties.” [II. Introduction pg 39151]
3M Recommendations
a. The requirements for relabeling a hearing protector when a change in NRR values occurs should be based on the method defined in ANSI/ASA S12.68–2007 Annex D.
b. If EPA requires recurrent testing, the retest interval should be no fewer ten years from the date of the transition test.
3. Reporting of Test Data to EPA §211.209–1
3M Comments
a. It would be inappropriate to ask manufacturers to disclose test data for products not yet introduced into commerce since such data could be obtained by competitors or others.
b. The ten–day reporting requirement is too short.
c. The timing of reporting requirements in the proposed rule is unclear.
3M Recommendations
a. Manufacturers should be required to report attenuation test data to the EPA within 30 days following:
i. Introduction of the hearing protector into commerce, and
ii. Completion of an attenuation test for products already in the market.
b. Further specificity should be inserted into the rule identifying the trigger for reporting requirement timelines (i.e., date the testing is completed, date the testing report is received by the manufacturer).
4. Test Procedures §211.206–2, 211.206–3
3M Comments
a. Manufacturers are unable to comply with the requirements for testing the reduction of peak impulsive noise because:
i. No laboratory facilities can perform these tests, and
ii. The feasibility and consistency of these new test methods have not been established.
b. The methods do not conform with the soon–to–be–adopted ANSI S12.42 standard that provides improved and more explicit methodology.
3M Recommendations
a. New test procedures for evaluating the performance of active noise reduction hearing protectors and devices designed to protect against impulsive noise should refer to published consensus standards and proven/valid test methodologies.
b. Delay effective date of the rule until after:
i. The publication of ANSI S12.42 pertaining to the test methods required in the rule, and
ii. The establishment of test facilities that can conduct those tests.
5. Information Content of Primary labels §211.204–1
3M Comments
a. The three types of primary labels proposed by EPA use inconsistent and misleading terminology which misinforms hearing protection users and may lead to confusion.
3M Recommendations
a. Expand the number of different types of primary labels from three to five to better distinguish different types of HPDs, and
b. Reword the labels for clearer indication of the capabilities of different types of hearing protectors.
6. Computation of the two–number range §211.207–2
3M Comments
a. Using the 80th percentile of the attenuation test data as the basis for the lesser NRR value appears to yield values that are higher than the existing single–number NRR values. As a result, this proposal fails to address the concern about “unrealistically high sound reduction” raised by EPA in the discussion of the test methodology in the preamble to the proposed rule [III. Background, pg. 39152].
b. If the 80 / 20 NRR proposal is implemented by EPA, it will still be necessary for hearing protection users to apply a safety factor to the rating (derating) in order to use the NRR to approximate the average noise reduction obtained by groups of hearing protection users.
3M Recommendations
a. Establish the lesser and greater NRR values for passive hearing protectors based on the 90th and 20th percentile attenuation test results, respectively. Using the 90th percentile rather than the 80th percentile is likely to yield lesser NRR values that are more consistent with the existing single–number NRR value.
7. Label dimensions and location §211.204–3, 211.204–4
3M Comments
a. The requirement to place the primary label on the primary surface of the package is difficult to implement. This is especially problematic with retail packages that are as small as the minimum size of the primary label itself.
b. New, more extensive primary and secondary labels will not fit on existing packaging (see mock–up of multi–lingual package to be submitted with 3M’s formal written comments).
c. Supporting information regarding noise reduction as a function of noise spectra is complex enough that few will ever choose to use it.
3M Recommendations
a. Allow the label to be affixed to any outside surface of the packaging that is readily visible (but not the bottom panel of boxes that stand on their own).
b. Allow manufacturers to make seldom–used information on noise reduction as a function of spectra available to users online rather than printing this information on every package.
8. “Safe to use” statement for amplitude–sensitive HPDs §211.204–6(e)
3M Comments
a. It is inappropriate to require manufacturers to make the claim: ‘‘This device is recommended for use in impulsive noise environments having peak levels between 130 to X dB SPL.’’
i. Claims concerning hazards associated with noise exposures are not consistent with the spirit of the Noise Control Act.
ii. This claim is unsupported by a scientific consensus.
b. Manufacturers cannot guarantee that devices will protect the user up to a certain noise exposure level because:
i. Manufacturers cannot know the conditions in which the device will be used, and
ii. Manufacturers cannot predict the quality of fit of their hearing protectors for individual users.
3M recommendation
a. Remove the “recommended for use” statements from the labeling requirements.
9. Accreditation of Test Facilities Preamble X B.1
3M Comments
a. The proposed rule does not require HPD testing facilities to be accredited. However, accreditation of testing facilities can provide greater credibility and consistency to the test data and, therefore, the product labels.
3M Recommendation
a. Test facilities used to conduct tests related to hearing protector labeling should be required to be accredited for the S12.6 and S12.42 tests that they will conduct in conformance with policies of ISO/IEC 17025:2005.
b. The accrediting body may be the U.S. Department of Commerce’s National Voluntary Laboratory Program (NVLAP), a laboratory participating in the American Association for Laboratory Accreditation (A2LA), or an equivalent foreign agency or organization.
c. This approach should make it easier for manufacturers to locate satisfactory test facilities while balancing the need for assuring that quality results are being provided to HPD users.
10. Supporting information on using NRR to predict noise reduction of individual users §211.204–3
3M Comments
a. HPD ratings, regardless of how they are derived, are only able to describe the average noise reduction obtained by groups of users in the laboratory and cannot predict the noise reduction obtained by individuals in practice.
b. The only way to predict the noise reduction for individuals with reasonable accuracy is to conduct individual fit testing.
3M Recommendation
a. Add to the supporting information this phrase: “The NRR is based on the average noise reduction obtained by groups of wearers in a laboratory. Your actual noise reduction may vary. For improved accuracy in predicting your noise reduction, an individual fit test is recommended.”