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 September 4, 2001 Docket Officer Re: Docket No. R-02A, Response to Notice of Proposed Delay and Request for Comments Regarding the Final Rule Revising 29 CFR 1904 To Whom It May Concern: The Society of the Plastics Industry, Inc. (SPI) is submitting these comments to the Occupational Safety and Health Administration (OSHA) in response to the Notice of Proposed Delay of Effective Date and Request for Comments published at 66 Federal Register 35113 on July 3, 2001. Founded in 1937, SPI is the trade association representing one of the largest manufacturing industries in the United States. SPI's approximately 1,500 members represent the entire plastics industry supply chain, including processors, machinery and equipment manufacturers and raw material suppliers. The U.S. plastics industry employs 1.5 million workers and annually produces goods with an approximate aggregate value of $304 billion. For more information on SPI, please visit our web site at www.plasticsindustry.org . I. INTRODUCTION The Final Rule revising 29 CFR 1904 was published in the Federal Register on January 19, 20011. The objective of the Final Rule, pursuant to Sections 8(c) and 24(a) of the Occupational Safety and Health (OSH) Act, was to require employers to record and report serious work-related fatalities, injuries and illnesses. In its July 3rd Notice (referenced above), OSHA proposed to delay for a period of one year, two sections of the Final Rule to allow for reconsideration and possible revision of those provisions to ensure they were consistent with Sections 8(c) and 24(a) of the OSH Act. Those sections are: 1) Section 1904.10 establishing new rules for recording occupational hearing loss cases; and 2) Section 1904.12 establishing new rules for defining the term "musculoskeletal disorder" (MSD) and recording MSDs. The criteria adopted by OSHA for recording MSDs and hearing loss under 29 CFR 1904 are likely to influence the nature of future OSHA interventions that have the potential to significantly affect the plastics industry. Therefore, SPI appreciates this opportunity to provide further input on the selection of these criteria. There are two aspects to this proceeding: 1) addressing the merits of the proposed delay or stay to allow adequate time for reconsideration and revision of Sections 1904.10 and 1904.12; and 2) providing the agency with our recommendations on an approach for recording hearing loss that is consistent with the OSH Act. II. REQUEST FOR DELAY TO ALLOW FOR RECONSIDERATION This section of our comments deals with the merits of, and need for the delay to allow reconsideration. Based on a careful and detailed analysis of the issues, SPI believes that the requirements of Sections 1904.10 and 1904.12 of the Final Rule go beyond OSHA's authority under Sections 8(c) and 24(a) the OSH Act as well as the Paperwork Reduction Act (PRA). In addition to their legal invalidity, those requirements are of particular concern because their implementation would cause confusion and skew the data collected by OSHA and the Bureau of Labor Statistics. OSHA reliance on that data is likely to have a substantial adverse economic impact on the plastics industry and the U.S. economy. For those reasons, as explained in greater detail below, SPI strongly supports the proposed delay to allow for reconsideration and revision of Sections 1904.10 and 1904.12. A. Hearing Loss Under the OSH Act Section 1904.10 of the Final Rule would require that any work-related Standard Threshold Shift (STS)2 of 10 decibels (dB) or more (after allowing for age adjustment) be recorded as a work-related injury or illness. Under Sections 8(c) and 24(a) of the OSH Act, OSHA's authority to require the recording of work-related injuries and illnesses is limited to significant injuries and illnesses. See 66 Fed. Reg. 5932, col. 1-2. An STS of 10 dB, however, is simply a "sentinel event" or "action level" for purposes of OSHA's Noise Standard. Except where a worker already has experienced some hearing loss (resulting in a hearing level of +16 dB or more averaged over 2000, 3000 and 4000 hertz (Hz)), an age-adjusted STS of 10 dB would not be a significant work-related "injury or illness". Section 1904 and the OSHA Noise Standard have different objectives and were adopted under different statutory criteria. Early warning and intervention is the object of OSHA's occupational safety and health standards such as the OSHA Noise Standard. See Forging Industry Association v. Secretary of Labor, 773 F. 2d 1436, 1448 (4th Cir. 1985); 29 U.S.C. § 652(8) (defining safety and health standards); 29 U.S.C. § 655(b)(5) (authority to set standards). That is why monitoring is required and why precautions are taken in response to action levels (such as an 8-hour time-weighted average (TWA) of 85 dB) and to conditions that do not constitute significant injuries or illnesses (such as an STS of 10 dB). This is the structure of OSHA's Noise Standard, which requires employers to monitor noise levels, to provide annual audiograms to all workers exposed at 8-hour TWA levels of 85 dB or higher, to communicate the results to the affected employees, and to make medical referrals where appropriate. All of the hearing conservation measures necessary to minimize work-related hearing loss are contained in OSHA's Noise Standard. Early intervention is extremely important: it reduces workplace injuries; it improves the relationship between management and labor; it improves the relationship between OSHA and employers; and it reduces workers' compensation costs. The existence of all these benefits, however, does not justify setting aside the structure and mandates of the OSH Act to permit implementation of Section 1904.10. Early intervention, regardless of its merits, is not the function of the recordkeeping system under 29 CFR 1904. The recordkeeping provisions are intended to collect data on serious injuries and illnesses to help "accurately describe the nature of the occupational safety and health problem." 29 U.S.C. § 651(b)(12) Section 1904.10 would establish a presumption that any STS of 10 dB or more experienced by a worker with an 8 hour time-weighted-average (TWA) ambient noise exposure of 85 dB or higher was work-related. This presumption would apply regardless of the effectiveness of the employer's hearing conservation program and regardless of the frequency of exposure or time period between exposures. It appears that presumption could be rebutted only if a physician or other licensed health care professional (acting within the scope of his/her license) determined that the hearing loss was not work-related. B. Musculoskeletal Disorders Under the OSH Act For the reasons set forth below, we believe any rule that addresses the issues covered by Section 1904.12 of the Final Rule is premature. We also believe Section 1904.12 goes beyond OSHA's authority under Sections 8(c) and 24(a) of the OSH Act in that it would require the recording of conditions that may not be work-related, and may not be significant injuries or illnesses. Implementation of Section 1904.12 would result in a substantial overstatement of the number of such injuries and would likely result in a significant misallocation of resources toward efforts to reduce or eliminate those conditions. While there were some differences in scope, Section 1904.12, issued on January 19, 2001, was generally designed to record and provide an aggregate count of the conditions that would trigger coverage under Section 1910.900(e) of the Ergonomics Program Standard issued on November 14, 2000 and rescinded on March 20, 2001. The definition of the term "musculoskeletal disorder" (or MSD) in Section 1904.12 is substantially the same as the definition of that term in rescinded Section 1910.900(z). Following Congressional disapproval of OSHA's ergonomics standard (PL 107-5, Mar. 20, 2001), the Secretary announced her intent to develop a comprehensive plan to address ergonomic hazards and scheduled a series of forums to consider basic issues related to ergonomics (66 Fed. Reg. 31694, 66 Fed. Reg. 33578). One of the key issues to be considered in connection with the Secretary's comprehensive plan is the approach to defining an ergonomic injury and determining whether it is work-related. In light of these developments, we agree with the following publicly stated position of the Secretary on this issue (66 Fed. Reg. 35115, col. 1): [I]t is premature to define an MSD for recordkeeping purposes. Any definition of "musculoskeletal disorder" or other term for soft tissue injuries in the recordkeeping rule should be informed by the views of business, labor and the public health community on the problem of ergonomic hazards in the workplace, which the Secretary's forums are intended to elicit. Furthermore, to require employers to implement a new definition of MSD while the Agency is considering the issue in connection with the comprehensive ergonomics plan could create unnecessary confusion and uncertainty . . . . When the Department has progressed further in developing its comprehensive approach to ergonomic hazards, it will be in a better position to consider how employers will be required to report work-related ergonomics injuries. During the course of both the ergonomics rulemaking and the recent Ergonomics Forums, it was established that MSDs have many non-occupational causes and develop through a multifactorial process. In other words, there are numerous contributing factors in determining who, when and why someone develops an MSD. OSHA acknowledged this repeatedly during the ergonomics rulemaking in statements such as the following:
Contrary to Sections 8(c) and 24(a) of the OSH Act-- and the evidence introduced in the ergonomics rulemaking, the 1904 rulemaking, and the Ergonomics Forums--Section 1904.12 would require employers to record, as "musculoskeletal disorders", conditions that: 1) generally are poorly defined9 and subjective10 , 2) often are not serious, and 3) often are of unknown cause, and quite possibly more often than not are due to non-work causes.11 This would be accomplished by presuming that workplace exposures to activities that OSHA labeled as hazards must have caused, contributed to or significantly aggravated the reported condition. This presumption would be based on the fact that the condition was reported at work and the employer has not demonstrated that the condition qualifies for the exemption from recording established in Section 1904.5(b)(2)(ii) for "signs or symptoms that … result solely from a non-work related event or exposure that occurs outside the work environment." It is important to note that the scope of that exemption appears to be more narrow in scope than the corresponding work relationship test for pre-existing conditions-- i.e., whether an event or exposure in the workplace "significantly aggravated" the condition. In addition to the impact of the premature and, we believe, invalid criteria for recording MSDs found in Section 1904.12, we are particularly concerned by the use of an OSHA Form 300 column designed to provide an aggregate count of the conditions that would trigger coverage under Section 1910.900(e) of the rescinded Ergonomics Program Standard. The data generated by this column would cause confusion because the agency has not developed the criteria necessary to accurately and reliably: 1) identify a musculoskeletal disorder; and 2) determine whether it is work-related. Once the agency has properly resolved those issues, it will be necessary to develop criteria that effectively distinguish repetitive exposure cases from single incident events. Until those criteria are developed, we believe that Section 1904.12 is an invalid data collection tool that is neither necessary nor appropriate for the proper performance of agency functions. The proposed delay will prevent the confusion and misallocation of resources that is likely to result from implementation of Section 1904.12. C. The Paperwork Reduction Act Before OMB is authorized to approve the collection of information in the Final Rule pursuant to the PRA, OSHA must demonstrate that it has satisfied the applicable legal criteria contained in 5 CFR 1320. Under 5 CFR 1320, OSHA must demonstrate that each collection of information in the Final Recording Rule "is necessary for the proper performance of agency functions." A requirement that exceeds OSHA's statutory authority under the OSH Act is not necessary for the proper performance of agency functions. We believe it is clear that the provisions of 1904.10 of the Final Rule (requiring the recording of minor shifts in hearing and creating invalid presumptions of work relationships) and 1904.12 (requiring the recording of conditions that may not be serious or related to work) exceed OSHA's authority under the OSH Act and, therefore, are not permitted by the PRA. D. Need for Delay to Allow Reconsideration We believe the requirements of Sections 1904.10 and 1904.12 adopted by the Clinton Administration are contrary to Sections 8(c) and 24(a) of the OSH Act, and that their implementation is likely to generate data which is not only invalid but grossly misleading. Any rule that addresses the issues covered by Section 1904.12 of the Final Rule prior to their resolution in the context of the Department's comprehensive approach to ergonomic hazards would be premature. It is clear that OSHA has and plans to use the data generated by 1904.10 and 1904.12 in allocating its resources toward various interventions, be they outreach, consultation, rulemaking or enforcement. For that reason, it is particularly important that the data be accurate. Misplaced OSHA reliance on such data is likely to lead to unjustified OSHA rulemaking or enforcement activities, resulting in a potentially enormous misallocation of both private and government resources. Furthermore, interim adoption of these invalid requirements would lead to data which would damage the credibility of OSHA, the Bureau of Labor Statistics and the Department of Labor, and would make it impossible to make comparisons to data from prior years. E. Interim Recording Criteria In the July 3 Notice, OSHA states that the proposed one-year delay of the effective date of Section 1904.10 would have the following effect on an employer's recordkeeping obligations during the 2002 calendar year: Hearing loss cases: Employers would continue to record work-related shifts of an average of 25 dB or more at 2000, 3000, and 4000 Hz in either ear on the OSHA 300 Log. When a recordable hearing loss occurs, the audiogram indicating the hearing loss would become the new baseline for determining whether future additional hearing loss by the individual must be recorded. Employers would check either the "injury" or the "all other illness" column, as appropriate.With the clarification that the employer may adjust for presbycusis, we would agree with this formulation, which does not and should not contain any presumptions as to work relationship. However, it is not clear that OSHA has taken the necessary steps to make this formulation enforceable. Assuming the proposed delay of Section 1904.10 is implemented, the question is what language of the remaining text of Part 1904 properly could be cited if an employer failed to enter a case of hearing loss meeting the above formulation. As written, work-related hearing loss would be recordable under the new rule only when it meets one of the general recording criteria of 1904.7; the remainder of the special rules (Sections 1904.8 through 1904.12) would not be applicable. There appear to be two basic options. The first option, the straightforward approach, which we believe to be the only reliable and appropriate approach, is to adopt an interim version of Section 1904.10 based on and limited to the above formulation (including a presbycusis adjustment). The second option would be to state in the Federal Register notice formalizing the proposed delay that an age-adjusted STS of 25 dB or more meeting the above formulation (including a presbycusis adjustment) will be considered "a significant diagnosed illness" for purposes of Section 1904.7(b)(7). A significant problem with this approach is that it appears to pre-judge the issue. For example, we do not believe an individual whose average hearing level shifts from -10 dB to + 15dB (at 2000, 3000 and 4000 Hz) has experienced a serious injury or illness although it would represent a 25 dB STS. Based on the foregoing, we recommend that OSHA delay or stay the language of Section 1904.10 contained in the final rule and adopt an interim Section 1904.10 that reads as follows: §1904.10 Recording criteria for cases involving occupational hearing loss. This approach might be viewed as a partial delay of the disputed provisions of Section 1904.10 dealing with when a hearing loss is a significant illness-Section 1904.10(a)-- and the appropriateness of any work relationship presumptions-Sections 1904.10(b)(2) and (5)-while allowing the remainder of the Section to go into effect. III. THE APPROPRIATE CRITERIA FOR RECORDING HEARING LOSS A. Issues Raised by OSHA In addition to proposing to delay Section 1904.10, OSHA has requested comments on the following issues associated with the recording of hearing loss:
B. Summary of Position For the reasons set forth in the discussion below, SPI recommends that occupational hearing loss be recorded under 29 CFR 1904 in accordance with the following rules:
C. Classification of Hearing Loss There are two types of hearing loss: conductive and sensorineural. Conductive hearing loss is caused by anything that blocks the conduction of sound from the outer through to the inner ear such as middle ear infections, blockage of the outer ear (by wax), damage to the eardrum by infection or trauma, etc. Sensorineural hearing loss refers to damage to the pathway for sound impulses from the hair cells of the inner ear to the auditory nerve and the brain. The causes of this type of hearing loss can be caused by: 1) aging (presbycusis); 2) acoustic trauma (such as a loud noise) to the hair cells; or 3) use of drugs, including aspirin, quinine and some antibiotics. Sensorineural hearing loss due to noise (also known as noise induced hearing loss or NIHL) can be caused by both occupational and non-occupational noises. From the standpoint of early warning and as a guide to determining causation, a 'notch' or increase in the hearing level (HL) at 4000 Hz is unique to NIHL, although a similar increase in the hearing level may appear at 6000 Hz, depending on the frequency of the noise.12 With continued exposure to noise, hearing levels will increase at the frequencies around the initial increased frequency. When NIHL has expanded to frequencies on either side of 4000 Hz, it is very difficult to determine whether the hearing loss is due to the natural loss of hearing due to aging (presbycusis) or is due to exposure to noise without comparison to previous audiograms.13 However, as noted above, it is critical to remember that the selection of sound frequencies designed to serve as an early warning system, and bring about early intervention, is a function of the OSHA Noise Standard and not the recordkeeping system established under 29 CFR 1904. The recordkeeping provisions are intended to collect data on serious injuries and illnesses, not potential precursors. See, 29 U.S.C. § 651(b)(12). Hearing loss refers to a reduced ability to perceive sound at certain sound levels (measured in dB) and frequencies (measured in Hz). According to the American Medical Association and the American Academy of Otolaryngology-Head and Neck Surgery14 , Inc. (AAO-HNS), an adult is considered to have normal hearing if he/she has a hearing level (HL) less than +25 dB, averaged over 500, 1000, 2000, and 3000 Hz. We believe this is by far the most widely used approach for determining hearing impairment in the United States This hearing level of 25 dB is sometimes called a "fence" in that it provides a demarcation point along the continuum of hearing levels, above which a hearing loss is considered, in the language of the Occupational Safety and Health Act, a "material impairment of health or functional capacity."15 OSHA previously defined material impairment of hearing as an average hearing level, with respect to audiometric zero, that exceeds 25 dB over 1000, 2000, and 3000 Hz.16 OSHA's definition appears to be based on the 1972 NIOSH recommendation17 and we believe the 2000 AMA/AAO-HNS definition is more appropriate in that it reflects recognized medical practice.18 It is clear that the use of a 25 dB "fence" is a well-established practice as demonstrated by Table 1 below. Table 1. Hearing Impairment Calculators.19
The request for comments also asked for input on how subsequent hearing loss should be treated. Table 2, below, provides classifications of hearing loss which we believe would logically serve as additional "fences"--i.e., 25 dB, 40 dB, 55 dB, and 70 dB-- for recording additional levels of work-related hearing loss. Table 2. Classification of Hearing Loss.
In light of the hearing loss classifications described above and OSHA's own definition of hearing material impairment, it is clear that the recording trigger for hearing loss in Section 1904.10--any STS of 10 dB or more, averaged over 2000, 3000 and 4000 Hz-- in not an appropriate criterion. For a person with "normal" baseline hearing, a 10 dB STS does not represent a material impairment. On the other hand, for a person with a baseline hearing level (HL) of 16 dB, averaged over the frequencies of 500, 1000, 2000, and 3000 Hz, a 10 dB change in the HL may be significant. We use the word "may" because, as explained in Section III.E, below, there is substantial evidence that a "measured" change in the HL of up to 10 dB averaged over 2000, 3000 and 4000 HZ may simply reflect audiometric error or chance. 25 Assuming the focus of the approach governing the recordability of hearing loss was to shift from the magnitude of the shift to the resulting hearing level, there would still be a need to specify: a) the appropriate frequencies to be measured ( a matter already addressed); b) the minimum size of the work-related shift that would make the new hearing level recordable26; and c) how the magnitude of that shift would be determined. For example, it would not make sense to record a hearing loss case simply because the measured average shift of 3 dB over the four frequencies raises the individual's hearing level from the original baseline of 24 dB (above the 25 dB fence) to 27 dB averaged over those frequencies without regard to either the reliability of the measurement (i.e., audiometric error) or the effects of aging. D. Significance of an STS 1. Audiometric Testing Variability According to many articles in the scientific literature, audiometric error in field testing, as opposed to laboratory conditions, is up to approximately 10 dB27. Two large studies, including over 1000 workers, have now shown that test-retest standard deviations in industry range from 6-10 dB, about twice the amount seen in clinical audiometry28. Another paper by Hetu et al found that the "typical measurement error in field testing . . . is approximately double (+10 dB) the value obtained under laboratory conditions [i.e., + 5 dB]."29 Dr. Dobie further found that "on a one-year retest, over half of workers will have a 'shift' of 10 dB or more on at least one frequency on the basis of chance alone."30 (Emphasis added). In addition, Dr. Dobie found that, "even with averaging [which is the method used in OSHA's STS definition], about half the STSs seen on a one year test-retest comparison are probably spurious." Thus, Dr. Dobie concluded that "only about 25% of STS seen in good hearing conservation programs are both genuine and possibly attributable to noise-induced hearing loss ('NIHL')." A 1990 study by Robinson also examined the audiometric test-retest variation and found that 90% of tests were within 10 dB for all frequencies except at 500 Hz and 6000 Hz. A 10 dB variation at 1000, 2000, 3000 or 4000 Hz, in the opinion of Robinson, shows that audiometric testing is "reliable and repeatable."31 This conclusion indicates that a 10 dB STS averaged over 2000, 3000 and 4000 Hz may simply reflect the variability in audiometric testing and should not be considered conclusive proof of an STS, much less material impairment. Besides mechanical audiometric error, inconsistencies due to the patient's understanding of the test influence the audiometric test results and magnitude of shifts in the HL. In an article posted on the website of the International Hearing Society (2001), a researcher notes that a 10 dB to 15 dB increase in hearing levels can occur due to a patient who fails to respond to "barely discernible" tones and instead chooses instead to respond only at "comfortable" levels, thereby invalidating the threshold scores.32 In other words, any hearing shift obtained from such an audiogram may be completely inaccurate. And finally, OSHA stated in the 1983 Final Rule: Occupational Noise Exposure; Hearing Conservation Amendment (pg. 9760, Column 2) that "The criterion selected [for reliably identifying an action level] must be outside the range of audiometric error."33 An STS of less than10 dB clearly does not meet that criterion. 2. Temporary Threshold Shifts The frequent occurrence of temporary threshold shifts (TTS) among workers also weighs against the rule requiring the characterization of a 10 dB STS as a material impairment without consideration of the actual hearing levels, confirmed by a retest. A TTS is a rise in a person's hearing level (HL) or hearing threshold (HT) due to exposure to noise, whether occupational or non-occupational, and can be as great as 25 dB across all frequencies.34 Documented TTS has been observed in people who participate in leisure activities such as aerobics classes, jet-skiing, listening to portable music player at high volumes, woodworking, firearms target shooting, etc. as well as those people exposed to noise occupationally.3536, A TTS normally disappears within 24 hours but may last for days.37 Though the average TTS is seen at 4000 Hz, it has been noted that the band of frequencies between 3000 Hz and 5000 Hz is the last to return to normal from such a shift.38 Obviously, such temporary loss of hearing acuteness can directly impact audiometric testing results, possibly leading to recording of a TTS as a hearing loss under OSHA's recordkeeping criterion of a 10 dB STS. E. Appropriate Baseline Against Which to Measure Hearing Loss The appropriate baseline for identifying an initial recordable case of work-related hearing loss should be the original baseline taken at the time the person began work with the employer and should be age-adjusted as a means of excluding the effects of aging and more reliably limiting the cases to be recorded to those that are truly work-related. When a work-related case of hearing loss becomes recordable, the worker's baseline should be (adjusted) reset to the new HL. The appropriate baseline for identifying any subsequent recordable case of work-related hearing loss should be the most current adjusted baseline with the employer and should be age-adjusted as a means of excluding the effects of aging more reliably limiting the cases to be recorded to those that are truly work-related. The age adjustment is necessary to separate any noise induced hearing loss from hearing loss resulting from normal aging. F. The Presumption that a Hearing Loss is Work-Related Where the Ambient Noise Exposure is an Eight Hour TWA of 85 dB or Higher is Invalid Section 1904.10(b)(5) creates an unsubstantiated presumption 39 that an STS is work-related if the affected worker "is exposed to noise in the workplace at an 8-hour time-weighted average of 85 dB(A) or greater, or to a total noise dose of 50 percent, as defined in 29 CFR 1910.95." This language seems to say the presumption would apply as long as the ambient exposure level (without regard for the use of hearing protection) would be 85 dB or higher, although the worker is wearing effective hearing protection. As previously noted, Dr. Dobie found that "on a one-year retest, over half of workers will have a 'shift' of 10 dB or more on at least one frequency on the basis of chance alone."40 (Emphasis added). In addition, Dr. Dobie found that, "even with averaging [which is the method used in OSHA's STS definition], about half the STSs seen on a one year test-retest comparison are probably spurious." Thus, Dr. Dobie concluded that "only about 25% of STS seen in good hearing conservation programs are both genuine and possibly attributable to noise-induced hearing loss ('NIHL')," which may or may not be due to work-related noise. Section 1904.10(b)(5) also seems to say the presumption would apply even if the exposure is for as little as one day per year, despite studies performed by National Institutes of Health (NIH) concluding that most of the sounds in the environment that produce permanent hearing loss occur over a very long time--i.e., exposure to sound levels greater than 85 dB, for about 8 hours per workday over a period of 10 or more years. In the preamble to the Final Rule, OSHA asserted without any substantiation, that for any worker to experience a work-related STS, "the worker would have been exposed to levels of noise exceeding 85 dB(A) for at least a year, and possibly 18 months." 66 Fed. Reg. 6012, col. 2. While this 85 dB presumption may reflect OSHA's enforcement position, it is not supported by the science and there are no Review Commission or court decisions upholding that position. According to NIH, most studies of noise induced hearing loss (NIHL) are retrospective measurements (i.e., hearing sensitivities of numerous individuals correlated with their past noise exposures).41 Such studies have a large variability and thus, it is difficult to predict the precise magnitude of hearing loss that will result from a specific sound exposure. NIH concludes that most noise exposure that produces permanent hearing loss involves exposure to sound levels greater than 85 dB for about 8 hours per workday over a period of 10 or more years. Though OSHA infers that exposure to ambient noise levels above 85 dB in the workplace cause or contribute to any observed hearing loss, NIH stresses that hearing loss from non-occupational noise is common, but public awareness of the hazard is low. Therefore, an employee who normally wears hearing protection on the job may not realize that some leisure activities also require the same protection. Furthermore, an employee who wears hearing protection while exposed to workplace noise at ambient levels of 85 dB (8hr-TWA) is likely to have an actual noise exposure of no more than 70 dB, a level far below that identified as hazardous. Other studies suggest that hearing loss will occur after a minimum of five years exposure at 90 dB and after 3 years at 95 dB. However, the author cautions that determining whether such hearing loss is due only to occupational exposure requires knowledge of the intensity and duration of an employee's non-occupational exposure. Based on the foregoing, we believe it is clear that there is no basis for the 85 dB presumption. Consistent with the well-established principles applicable to OSHA enforcement, OSHA should be required to shoulder the burden of establishing that a condition is work-related rather than relying on unjustified presumptions (reflecting an undue emphasis on administrative convenience) and placing the burden of proving the absence of any work relationship on the employer. IV. CONCLUSION Based on the foregoing, and consistent with Sections 8(c) and 24(a) of the OSH Act as well as the Paperwork Reduction Act, we believe the proposed delays in the implementation of Sections 1904.10 and 1904.12 should be adopted. In addition, we believe OSHA should adopt the following criteria for recording hearing loss:
We recognize that adoption of our recommendation would result in the continued need for two sets of records to track hearing loss-one under the noise standard to identify all STS and a second under 1904 to identify all recordable cases of hearing loss. While it does require additional paperwork, we believe this is the necessary result and is far preferable to the consequences of re-characterizing a proactive action level as significant harm for the sake of administrative convenience. Should you have any questions regarding our comments, or if we can shed any further light on these issues, please contact us. Thank you for your consideration. Respectfully submitted, Maureen A. Healey Of Counsel:
1. 66 Fed. Reg. 5915-6135 (January 19, 2001). 2. A standard threshold shift or STS is a change in the hearing threshold relative to the baseline audiogram of an average of 10 dB or more over three frequencies-- 2000, 3000, and 4000 hertz. 29 C.F.R. 1910.95(g)(10)(i). .9. According to NIOSH, "Certain authors have noted the scarcity of objective measures . . . to define work-related MSDs, and the lack of standardized criteria for defining MSD cases." Musculoskeletal Disorders and Workplace Factors--A Critical Review of Epidemiologic Evidence for Work-Related Musculoskeletal Disorders of the Neck, Upper Extremity and Low Back. NIOSH, July 1997, p.1-7. 10. In their long-awaited report, the National Research Council and the Institute of Medicine recently defined a "disorder" as follows: A disorder is variously defined as an alteration in an individual's usual sense of wellness or ability to function. A disorder may or may not interfere with usual activities of daily living or work activities. A disorder may or may not be associated with well-recognized anatomic, physiologic, or psychiatric pathology.Musculoskeletal Disorders and the Workplace, Low Back and Upper Extremities, National Academy Press, January 18, 2001. Because musculoskeletal disorders have been associated with non-work activities (e.g., sports) and medical conditions (e.g., renal disease, rheumatoid arthritis), it is difficult to determine the proportion due solely to occupation. For example, in the general population, nonoccupational causes of low back pain are probably more common than workplace causes [Liira et al. 1996]. Elements of Ergonomics Programs - A Primer Based on Workplace Evaluations of Musculoskeletal Disorders, NIOSH, March 1997, p. 2. Data introduced in the ergonomics rulemaking indicated that the risk of experiencing either carpal tunnel syndrome or any lost workday MSD (an MSD which, for a worker, would have been severe enough to be classified as a lost workday case) was more than three times higher in the general population (U.S.) than for an employee in the private sector (U.S.) despite the fact that, according to the NRC, 80% of adults work. This determination was based on data in the scientific literature on the frequency of carpal tunnel syndrome in the general population, and the BLS lost workday injury MSD data for 1996. See Post Hearing Brief of Keller and Heckman LLP, OSHA Docket No. S-777, August 10, 2000, Neil Maizlish, et. al, Surveillance and Prevention of Work-Related Carpal Tunnel Syndrome: An Application of the Sentinel Events Notification System for Occupational Risks, 27 Am. J. Ind. Med. 715-729, 721 (1995). 12. "A guide to audiometric testing programmes". Health and Safety Executive. London: The Stationery Office, 1995 (Guidance note No. MS26). 13. McBride, D.I., Williams, S. "Audiometric notch as a sign of noise induced hearing loss". Occup Environ Med 2001; 58: 46-51. According to the author, a notch at 4000 Hz is often associated with exposure to continuous noise. A notch at 6000 Hz may occur in audiograms of people exposed to impulse noise and a notch at 3000 Hz with exposure to low frequency noise. 14. See Am. Academy of Otolaryngology, Comm. on Hearing and Equilibrium and the Am. Council of Otolaryngology, Comm. on the Medical Aspects of Noise, Guide for the Evaluation of Hearing Handicap, 241 JAMA No. 19, at 2055-59 (1979); American Medical Association Guides to the Evaluation of Permanent Impairment, (5th ed. 2000), Ch. 11, p. 250 ("The ability to hear everyday sounds under everyday listening conditions is not impaired when the average of the hearing levels at 500, 1000, 2000 and 3000 Hz is 25 dB or less.") 15. 46 Fed. Reg. 4082, col. 1-2. There was no indication that OSHA had changed its position on this point at the time it issued the Final HCA; nor is there any indication that the agency has subsequently changed its position or provided any justification for such a change. 16. 46 Fed. Reg. 4083, January 18, 1981; see Forging Industry Association v. Secretary of Labor, 773 F. 2d 1436, 1448 (4th Cir. 1985). 17. Criteria for a Recommended Standard: Occupational Exposure to Noise. NIOSH, 1972. 18. Kavanagh, K.T. Evaluation of Occupational Hearing Loss and Presbycusis Using a Microcomputer. Amer Acad Audiol 1992, May; Volume 3(3): 215-220. According to the author, the AAO-HNS 1979 equation is one of the most common equations for calculating hearing handicaps (impairment) in the United States. 19. These hearing impairment calculators are part of the Hearing Handicap Determination website designed and maintained by Dr. Kevin T. Kavanagh, Ear, Nose & Throat-USA, Cumberland Otolaryngology Consultants. http://www.entusa.com. Copyright 2001. 20. American Academy of Otolaryngology-Head and Neck Surgery, Inc. (AAO-HNS), originally part of AAOO (see next footnote) established as a separate professional organization in 1978. Headquarters of organization is located in Alexandria, VA. 21. American Academy of Ophthalmology and Otolaryngology (AAOO). Original association founded in 1896 with name changed to AAOO in 1903. 22. Degrees of hearing loss as classified by the American Academy of Family Physicians (AAFP) at any tested frequency. AAFP is a national association of more than 80,000 family physicians, family practice residents, and medical students. http://www.aafp.org. 23. Audiology Awareness Campaign (AAC). The Audiology Awareness Campaign (AAC) was organized by four professional audiology organizations with the goal helping persons with hearing loss. The participating organizations include: Academy of Dispensing Audiologists, Military Audiology Association, Academy of Rehabilitative Audiology, and American Academy of Audiology. http://www.audiologyawareness.com. 24. Report of the Informal Working Group on Prevention of Deafness and hearing Impairment Programme Planning, WHO, Geneva with adaptations form Report of the First Informal Consultation on Future Programme Developments for the Prevention of Deafness and Hearing Impairment, WHO, Geneva, 23-24 January 1. http://www.who.int/pbd/pdh/pdh_home.htm. 25. Dr. Dobie further found that "on a one-year retest, over half of workers will have a 'shift' of 10 dB or more on at least one frequency on the basis of chance alone." (Emphasis added). In addition, Dr. Dobie found that, "even with averaging [which is the method used in OSHA's STS definition], about half the STSs seen on a one year test-retest comparison are probably spurious." Dobie, R.A. "Industrial Audiometry and the Otologist," Laryngoscope Vol. 95, April 1985, 382-383. 26. For example, it would not make sense to record a measured average shift of 3 dB over the three frequencies that raises the individual's hearing level from the original baseline of 24 dB to 27 dB averaged over those frequencies without regard to either the reliability of the measurement or the effects of aging. 27. 48 Fed. Reg. 9760, col. 2. In a footnote to the discussion of audiometric error in the preamble to the Final HCA, OSHA states that variation in machine response (+ 5dB) was not the only source of variability of audiograms. Technician error, variation in subject response, and slight procedural changes from one test to the next "increases the variability greater than + 5dB." See 48 Fed. Reg. 9762, note 30 (1983). 28. Dobie, R.A. "Industrial Audiometry and the Otologist," Laryngoscope Vol. 95, April 1985, 382-383. 29. Hetu, R., Quoc, H.T., Duguay, P., "The Likelihood of Detecting a Significant Hearing Threshold Shift Among Noise-Exposed Workers Subjected to Annual Audiometric Testing," Ann. Occup. Hyg. 34, 361 at 364 (1990). 30. Dobie, R.A. "Industrial Audiometry and the Otologist," Laryngoscope Vol. 95, April 1985, 382-383. 31. Robinson, D.W. in "Repeatability of Results in Noise Exposure over Two Years," Br J Audiol 25:219-235 (1990). 32. Chartrand, M.S. "In Search of a True Threshold" on International Hearing Society website. http://ihsinfo.org/_old/index.html. 33. Federal Register Vol. 48, No. 46, March 8, 1983. 34. Hagner, H., Emmerich, E., Giesser, F., Haueisen, J., Nowak, H. Auditory Evoked Magnetic Fields Before and After a Stay of Four Hours in a Discotheque. Department of Neurophysiology and Biomagnetic Centre of the Friedrich-Schiller University Jena, Jenasensoric, Germany. 35. Nassar, G. The Human Temporary Threshold Shift After Exposure to 60 Minutes' Noise in an Aerobics Class. Br J Audiol 2001, Feb.; 35(1): 99-101. 36. Grant, P. Sensorineural Hearing Loss. Clinical Medicine Australia: Ear, Nose & Throat; http://216.94.9.122/home.html. 37. Audiology/Psychoacoustics. In: Handbook for Acoustic Ecology, 2nd Edition, Ed. Barry Traux. Cambridge Street Publishing, 1999. 38. Allen, B. Now 'Ear This! AMP Newsletter, 1995. The Newsletter of the Association of Motion Picture Sound. 39. OSHA simply makes the following unsupported assertion at 66 Fed. Reg. 6012, col. 2: For workers who are exposed to the noise levels that require medical surveillance under § 1910.95 (an 8-hour time-weighted average of 85 dB(A) or greater, or a total noise dose of 50 percent), it is highly likely that workplace noise is the cause of or, at a minimum, has contributed to the observed STS. 40. Dobie, R.A. "Industrial Audiometry and the Otologist," Laryngoscope Vol. 95, April 1985, 382- 383. 41. Noise and Hearing Loss. National Institutes of Health Consensus Statement; 1990 Jan; 8(1): 1-24. 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