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| |
| •
Publication Date: |
07/01/2002 |
| •
Publication Type: |
Final
Rules |
| •
Fed Register #: |
67:44037-44048 |
| •
Standard Number: |
1904;
1910.95;
1910.1020;
1952 |
| •
Title: |
Occupational
Injury and Illness Recording and Reporting Requirements -- Final Rule |
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1904
[Docket No. R-02A]
RIN 1218-AC06
Occupational Injury and Illness Recording and Reporting Requirements
AGENCY: Occupational Safety and Health Administration (OSHA), Department
of Labor.
ACTION: Final rule.
SUMMARY: The Occupational Safety and Health Administration (OSHA) is
revising the hearing loss recording provisions of the Occupational
Injury and Illness Recording and Reporting Requirements rule published
January 19, 2001 (66 FR 5916-6135), scheduled to take effect on January
1, 2003 (66 FR 52031-52034). This final rule revises the criteria for
recording hearing loss cases in several ways, including requiring the
recording of Standard Threshold Shifts (10 dB shifts in hearing acuity)
that have resulted in a total 25 dB level of hearing above audiometric
zero, averaged over the frequencies at 2000, 3000, and 4000 Hz,
beginning in year 2003.
EFFECTIVE DATE: January 1, 2003.
FOR FURTHER INFORMATION CONTACT: Jim Maddux, Occupational Safety and
Health Administration, U.S. Department of Labor, Directorate of Safety
Standards Programs, Room N-3609, 200 Constitution Avenue, NW.,
Washington, DC 20210. Telephone (202) 693-2222.
SUPPLEMENTARY INFORMATION:
I. Background
In January, 2001 (66 FR 5916-6135), OSHA published revisions to its rule
on recording and reporting occupational injuries and illnesses (29 CFR
parts 1904 and 1952) to take effect on January 1, 2002. On July 3, 2001,
the agency proposed to delay the effective date of §§ 1904.10
Recording criteria for cases involving occupational hearing loss, and
1904.12 Recording criteria for cases involving work-related
musculoskeletal disorders, until January 1, 2003 (66 FR 35113-35115). In
that notice, OSHA explained that the Agency was reconsidering the
requirement in § 1904.10 to record all cases involving an occupational
hearing loss averaging 10 decibels (dB) or more. OSHA found that there
were reasons to question the appropriateness of 10 dB as the recording
criterion, and asked for comment on other approaches and criteria,
including recording losses averaging 15, 20 or 25 dB. OSHA also stated
that it was reconsidering the requirement in § 1904.12 that employers
check the MSD column on the OSHA Log for a case involving a "musculoskeletal
disorder" as defined in that section.
OSHA received a total of 77 written comments on the July 3, 2001
proposal. After considering the views of interested parties, OSHA
published a final rule on October 12, 2001 (66 FR 52031 -- 52034)
delaying the effective date of §§ 1904.10(a) and 1904.12(a) and (b)
until January 1, 2003, adding a new paragraph (c) to § 1904.10
establishing a 25-dB recording criterion for hearing loss cases for
calendar year 2002, and modifying the regulatory note to paragraph
1904.29(b)(7)(vi) to delay the language referring to privacy case
consideration for MSD cases.
This final rule contains amended hearing loss recording criteria
codified at 29 CFR 1904.10(a) and 1904.10(b)(1)-(7). In a separate
Federal Register document published today, OSHA is proposing to delay
the effective date of § 1904.10(b)(7), which requires employers to
check the hearing loss column on the Log for hearing loss cases meeting
the revised recording criteria, as well as the MSD provisions addressed
in the October 12 final rule. Additional information about the proposal
to delay the effective date of the hearing loss column is contained in
the section of this rule titled Adding a column to the 300 Log, and in
the separate Federal Register publication Proposed Delay of Effective
Dates; Request for Comment, published today.
II. Recording Occupational Hearing Loss Cases
Section 1904.10 of the January 19, 2001 final recordkeeping rule
required employers to record, by checking the "hearing loss"
column on the OSHA 300 Log, all cases in which an employee's hearing
test (audiogram) revealed that a Standard Threshold Shift (STS) in
hearing acuity had occurred. An STS was defined as "a change in
hearing threshold, relative to the most recent audiogram for that
employee, of an average of 10 decibels or more at 2000, 3000 and 4000
Hertz (Hz) in one or both ears." The recordkeeping rule itself does
not require the employer to test employee's hearing. However, OSHA's
occupational noise standard (29 CFR 1910.95) requires employers in
general industry to conduct periodic audiometric testing of employees
when employees' noise exposures are equal to, or exceed, an 8-hour
time-weighted average of 85dBA. Under the provisions of § 1910.95, if
such testing reveals that an employee has sustained a hearing loss equal
to an STS, the employer must take protective measures, including
requiring the use of hearing protectors, to prevent further hearing
loss. Employers in the construction, agriculture, oil and gas drilling
and servicing, and shipbuilding industries are not covered by §
1910.95, and therefore are not required by OSHA to provide hearing
tests. If employers in these industries voluntarily conduct hearing
tests they are required to record hearing loss cases meeting the
recording criteria set forth in the final Section 1904.10 rule.
The former recordkeeping rule, which remained in effect until January 1,
2001, contained no specific threshold for recording hearing loss cases.
In 1991, OSHA issued an enforcement policy on the criteria for recording
hearing loss cases, to remain in effect until new criteria were
established by rulemaking. The 1991 policy stated that OSHA would cite
employers for failing to record work related shifts in hearing of an
average of 25 dB or more at 2000, 3000 and 4000 Hz in either ear.
Subsequently, OSHA released interpretations stating that the employer
could adjust the audiogram for aging using the tables in Appendix F of
the Noise Standard, and that the employer was to use the employee's
original baseline audiogram as the baseline reference audiogram for
determining a recordable hearing loss.
One of the major issues in the recordkeeping rulemaking was to determine
the level of occupational hearing loss that constitutes a health
condition serious enough to warrant recording. This was necessary
because the final rule no longer requires recording of minor or
insignificant health conditions that do not result in one or more of the
general recording criteria such as medical treatment, restricted work,
or days away from work (See, e.g., 66 FR 5931). In its 1996 Federal
Register notice OSHA proposed a requirement to record hearing loss
averaging 15 dB at 2000, 3000 and 4000 Hz in one or both ears (61 FR
4040). OSHA adopted the lower 10-dB threshold in the final rule based in
part upon comments that "(a)n age-corrected STS is a large hearing
change that can affect communicative competence" (66 FR 6008).
Comments on the Recording of 10-dB Shifts
Most commenters opposed the adoption of the 10-dB threshold for
recording hearing loss (Exs. 3-1, 3-13, 3-14, 3-19, 3-20, 3-22, 3-25,
3-26, 3-27, 3-29, 3-34, 3-35, 3-37, 3-43, 3-45, 3-48, 3-49, 3-50, 3-54,
3-57, 3-58, 3-59, 3-61, 3-62, 3-63, 4-3, 4-5, 5-5, 5-7). A number of
these commenters challenged the significance of a 10-dB shift, stating
that: 10-dB shifts are not significant -- only significant health
conditions should be captured (Exs. 3-14, 3-26, 3-48); the level
selected must amount to a significant alteration in an employee's
ability to hear (Exs. 3-50, 3-54, 3-59); a 10-dB shift from audiometric
zero is a virtually imperceptible loss in hearing -- 10-dB shifts at
higher levels become more important (Ex. 3-49); the medical community
and workers' compensation do not recognize a 10 dB shift as a
significant hearing loss (Exs. 3-19, 3-20, 3-25, 3-35, 3-43, 3-63); a
10-dB shift is not a material impairment, so it should not be a
recordable illness (Exs. 3-25, 3-26, 3-34, 3-50, 3-54, 3-59, 3-58,
3-61); and, 10 dB is an early warning mechanism that is appropriate for
the hearing standard but not for injury and illness recording -- the
1904 provisions are intended to collect data on serious injuries and
illnesses, not potential precursors (Exs. 3-25, 3-49, 3-50, 3-54, 3-59,
3-62). Organization Resources Counselors (ORC) remarked that:
[a] 10 dB shift from audiometric zero is a virtually imperceptible loss
in hearing * * * ORC understands that the finding of a Standard
Threshold Shift (STS) to be a "flag" for the implementation of
a series of actions required by the OSHA standard on exposure to noise.
It was not intended, of and by itself, to be an indicator of illness, or
impairment, but, rather, a sentinel event that triggers a series of
actions that will prevent illness or impairment from occurring. As such
a tool, it has been an effective indicator of employee hearing, but does
not, by itself, rise to the level of recordability (Ex. 3-49).
A number of the commenters objected to recording 10-dB shifts because
this recording level would result in the recording of too many
"false positive" cases, either because of audiometric testing
errors, because the hearing loss was temporary and not persistent, or
because the case was insufficiently work-related (Exs. 3-14, 3-19, 3-20,
3-25, 3-26, 3-27, 3-29, 3-35, 3-37, 3-43, 3-45, 3-49, 3-50, 3-54, 3-56,
3-58, 3-59, 3-61, 3-62, 3-63, 4-5). The issues of audiometric error,
persistence, and work-relationship are discussed in more detail below.
The commenters opposed to the 10-dB shift also remarked that using 10-dB
shifts will lead to overrecording (Ex. 3-37), 10 dB will result in a 5
to 10 fold increase in hearing loss recording (Ex. 3-49), too many
non-occupational (emphasis added) cases are captured by 10 dB (See,
e.g., Ex. 4-5), changing to 10 dB would make the past data useless and
make it difficult to establish trends (Ex. 3-19), and that if OSHA
adopts 10 dB, the states may be influenced to change their workers'
compensation standards, resulting in higher workers' compensation costs
(Ex. 3-34).
Some of the commenters opposed to the recording of all 10-dB shifts
recognized a critical difference between the 25-dB criteria contained in
the American Medical Association [AMA] Guides to the Evaluation of
Permanent Impairment and the 25-dB level OSHA has enforced since 1991 (Exs.
3-25, 3-49, 3-50, 3-54, 3-59, 3-62). The AMA Guides measure hearing loss
from a baseline of audiometric zero, which represents the statistical
average hearing threshold level of young adults with no history of aural
pathology (ANSI S3.6-1969). The 1991 OSHA recording level used the
individual employee's original baseline audiogram taken at the time the
worker was first placed in a hearing conservation program. If an
individual employee has experienced some hearing loss before being
hired, a 25-dB shift from the original baseline will be a larger hearing
loss than the hearing impairment recognized by the AMA as a disabling
condition. In a single comment submitted by both organizations, the
National Association of Manufacturers (NAM) and the Can Manufacturing
Institute (CMI) stated that:
[i]t is generally accepted in the medical community that an average
hearing level of more than 25 dB from audiometric zero (the hearing
level of healthy young adults never exposed to high noise levels) at
certain frequencies constitutes a material impairment. Accordingly, an
employee with near-perfect hearing (at or near audiometric zero) might
very well suffer a 10 or 15 dB shift in hearing yet continue to function
within the normal range of hearing with no impairment whatsoever.
Conversely, an employee with hearing on the outer edge of the normal
range who experiences a 15 dB shift would likely suffer a material
impairment. The NAM and CMI believe that a shift in hearing should not
be recorded unless it is confirmed and it results in hearing levels in
excess of 25 dB at the shift frequencies (Ex. 3-50).
Industrial Health, Inc, a mobile hearing testing vendor, added that:
[i]t is almost universally accepted in the profession that hearing
impairment starts when hearing levels exceed 25 dB * * *. We believe
there should be an "impairment fence" of 25 which must be
crossed before a shift in hearing is required to be recorded. We
recommend that to be recordable a shift must result in an average
hearing level at 2000, 3000, and 4000 Hz in excess of 25 dB. This fence
would not be adjusted for aging (however, the shift calculation itself
should retain OSHA's allowance for aging) (Ex. 3-62).
A number of commenters urged OSHA to adopt the 10-dB threshold for
recording occupational hearing loss, consistent with the January 19,
2001 Federal Register notice (Exs. 3-3, 3-4, 3-10, 3-11, 3-15, 3-17,
3-18, 3-21, 3-23-1, 3-24, 3-30, 3-36, 3-40, 3-47, 3-52, 3-53, 4-2, 5-2,
5-3, 5-6). Many of these commenters argued that an age-corrected 10-dB
shift is a large change in hearing that can affect communication ability
(Exs. 3-3, 3-21, 3-23-1, 3-53), that a persistent 10-dB shift represents
a permanent and irreversible loss of hearing acuity (Ex. 3-21), that a
10-dB shift is a material impairment (Exs. 3-17, 3-23-1, 3-53), and that
real and debilitating hearing loss may not be detected if a higher
threshold is selected (Ex. 3-3). The remarks of the Coalition to Protect
Workers Hearing are representative:
An age-corrected STS represents a significant amount of cumulative
hearing change from baseline, enough to affect communicative competence,
safety, and job productivity in the workplace. A confirmed, age
corrected STS is not a sensitive indicator of early hearing damage;
rather it reflects a very substantial permanent hearing change over
time. The appropriate sensitive indicator of early hearing damage is a
temporary threshold shift (TTS), which recovers quickly as the worker is
noise free. This indicator is currently used in hearing conservation
programs. (Ex. 2-23-1)
Commenters also stated that use of a 10-db shift reduces recordkeeping
and data management burdens for industry (Exs. 3-3, 3-10, 3-23-1, 3-47,
3-53, 5-2), reduces confusion for industrial managers and occupational
hearing conservation technicians --"[a] problem that occurred with
OSHA's 1991 policy" (Ex. 3-23-1), that current STS rates are not
sufficiently high to result in an undue or inappropriate number of
recordable events (Ex. 3-3), that many of the states (Michigan, North
Carolina, South Carolina, Puerto Rico and Tennessee) require the
recording of 10-db shifts with little detrimental effect on industry (Exs.
3-3, 3-4, 3-24), that a 10-db shift is comparable to other permanent
injuries that are recorded on the OSHA 300 Form, such as an amputated
finger (Ex. 3-23-1) or medical removal under the lead standard (Ex.
3-47), and that the 10-db shift is better for mobile and transient
employees because the original baseline may not follow employees when
they change jobs (Ex. 3-23-1).
Several of the commenters argued that recording 10-db shifts would be
more protective for workers (3-3, 3-10, 3-17, 3-18, 3-21, 3-23-1, 3-24,
3-30, 3-47, 3-53). In a representative comment, the AFL-CIO argued that:
"[t]he requirement to record a 10-db hearing loss on the Log would
aid in the early detection and prevention of occupational hearing
loss." It stated that "(r)ecording a 10-db STS on Form 300 is
a practical and reasonable means to assist in the early detection of a
loss in hearing so that workplace intervention measures can be
implemented to protect workers from the hazards of noise. Having
employers continue to record shifts in hearing of an average of 25 dB *
* * is too high a threshold of loss in hearing acuity to be sufficiently
proactive in preventing worker hearing loss" (Ex. 3-24).
Other commenters added that by recognizing disease earlier, employers
may take preventive measures to avoid potential workers' compensation
cases that are sometimes triggered at the 25-dB level (Ex. 3-10), that
recording triggers action on the part of employers (Ex. 3-23-1), that
10-db shifts provide consistency for construction employers who are not
required to test hearing (Ex. 3-10), and that the 10-db recording
criterion is more protective and reasonable for employers who are not
covered by the OSHA noise standard (Exs. 3-10, 3-17, 3-18, 3-24).
Alternatives Offered
Most of the commenters who objected to the recording of 10-db shifts
presented alternative recording thresholds. The American Chemistry
Council recommended a 15-db shift (Ex. 5-5), the Rubber Manufacturers
Association recommended a 20-dB shift (Ex. 3-27), and Abbott
Laboratories recommended recording second and subsequent 10-db shifts
(Ex. 3-13). By far, the most common alternative offered was a shift of
25 dB (Exs. 3-1, 3-14, 3-19, 3-20, 3-22, 3-26, 3-29, 3-34, 3-35, 3-37,
3-43, 3-45, 3-48, 3-50, 3-57, 3-58, 3-61, 3-63, 4-3, 4-5). The
commenters supporting a 25-dB shift argued that 25 dB was superior
because medical and health care professionals recommend using 25 dB (Exs.
3-29, 3-50, 3-54, 3-59), 25 dB is consistent with the American Medical
Association (AMA) guidelines (Exs. 3-50, 3-54, 3-59), 25 dB is used for
workers' compensation (Ex. 3-13), 25 dB is protective and provides an
easily identifiable measurement for determining injuries (Ex. 3-35), and
OSHA adopted 25 dB in 1991 because it is widely accepted as a meaningful
loss of hearing and is well documented (Exs. 3-37, 3-50, 3-54, 3-59).
The National Association of Manufacturers (Ex. 3-50), the Can
Manufacturing Institute (Ex. 3-50), and Industrial Health, Inc. (Ex.
3-62) recommended a system where 15-db shifts would be recorded, but
only when the shift crossed the disability boundary of 25 dB from
audiometric zero. These commenters argued that the 15-db difference
eliminated most shifts caused by audiometric error, and that by
requiring them to cross the 25-dB fence, they would also clearly involve
a hearing disability.
Organization Resources Counselors (ORC) urged OSHA to adopt a
"sliding scale" recording criteria whereby the employer would
record the first STS that exceeds 25 dB over audiometric zero, and all
subsequent STS cases (Ex. 3-49). ORC argued that "[t]here is no
single objective level of hearing loss that is uniformly identifiable
for every employee. Different employees enter the workplace with
different levels of hearing capability, and noise affects people
differently" and that this concept reflects the intent of the OSH
Act and the new rule in capturing significant injuries and illnesses.
The American Iron and Steel Institute (Ex. 3-54), the Society for the
Plastics Industry (Ex. 3-25) and the American Forest & Paper
Association (Ex. 3-59) encouraged the adoption of a similar recording
criteria where shifts would be averaged over the frequencies of 500,
1000, 2000, and 3000 Hz, and the first shift of 10 dB over the
disability fence of 25 dB would be recorded. This approach also set
forth thresholds for the recording of subsequent shifts when they
crossed boundaries used by various organizations for delineating mild,
moderate, and severe hearing disability at the 40, 55 and 70-dB levels
from audiometric zero.
OSHA's Decision
Following consideration of the comments received in response to the July
3, 2001 proposal to modify the hearing loss recording criteria, OSHA has
decided to require employers to record audiometric results indicating a
Standard Threshold Shift (STS) only when such STS cases also reflect a
total hearing level of at least 25 dB from audiometric zero. The STS
calculation uses audiometric results averaged over the frequencies 2000,
3000 and 4000 Hz, using the original baseline and annual audiograms
required by the OSHA noise standard § 1910.95. The rule also allows the
employer to adjust the employee's audiogram results used to determine an
STS to subtract hearing loss caused by aging, allows the employer to
retest the workers' hearing to make sure the hearing loss is persistent,
and allows the employer to seek and follow the advice of a physician or
licensed health care professional in determining whether or not the
hearing loss was work-related.
The approach adopted in the final rule has several advantages. By using
the STS definition from the OSHA noise standard § 1910.95, the §
1904.10 regulation uses a sensitive measure of hearing loss that has
occurred while the employee is employed by his or her current employer.
By requiring all STSs to exceed 25 dB from audiometric zero, the
regulation assures that all recorded hearing losses are significant
illnesses. OSHA received no comments suggesting that a shift of 25 dB
from audiometric zero was anything less than a serious hearing loss
case. While there is little consensus among the commenters concerning
the appropriate level that should be used to record hearing loss cases,
there is widespread agreement that a 25-dB shift from audiometric zero
is a serious hearing loss.
The hearing loss recording level is also compatible with the final
rule's definition of injury or illness, "an abnormal condition or
disorder" (§ 1904.46). Various scales used to rate hearing loss
consider hearing levels less than 25 dB to be within the "normal
range" (American Medical Association Guidelines to the evaluation
of Material Impairment, American Academy of Family Physicians, Audiology
Awareness Campaign). The recording level is also compatible with the
definition of material impairment used by OSHA and MSHA in the
development of standards for occupational noise exposure (64 FR 49548,
48 FR 9738).
The hearing loss recording requirements in § 1904.10 differ from the
requirements of the OSHA noise standard (§ 1910.95) because under the
noise standard the employer is required to take certain actions
(employee notification, providing hearing protectors or refitting of
hearing protectors, etc.) for all 10-db standard threshold shifts while
the part 1904 rule only requires the recording of STSs that also exceed
the total 25-db level. OSHA believes that this is an appropriate policy,
because 10-db shifts in hearing at higher levels (above 25 dB) are more
significant. Several commenters agreed that some shifts are more
significant than others. ORC stated that "(a) 10-db shift from
audiometric zero is virtually imperceptible, while 10-db shifts at
higher levels become more important" (Ex. 3-49). The American
Federation of Government Employees (Ex. 3-17) argued that "(h)earing
loss is not linear, but is exponential, and changes are incrementally
more serious and irreversible" and the American Federation of
State, County and Municipal Employees remarked that "(additional
shifts are progressively more serious in nature" (Ex. 3-21)).
When audiometric testing is done, test tones are presented at various
sound levels, usually increasing or decreasing in 5-dB steps. The
employee is asked to respond whenever a tone is heard, with the goal
being finding the lowest level at which the employee can consistently
hear. The standard measurement for measuring hearing level is decibels,
a logarithmic scale. For the first increase in hearing level from 0 to
10 dB, the sound intensity increases 10 fold. The next 10 dB is a
100-fold increase. By the time a person's hearing level changes from 0
to 30 dB hearing level, he or she needs 1,000 times more sound intensity
to just barely hear.
Although the part 1904 recordkeeping regulation and the § 1910.95 noise
standard treat the STS cases differently, this has no effect on the
noise standard's requirements and does not have any effect on the
requirement for employers to comply with § 1910.95. When employers
detect work-related STS cases, they are required to take all of the
follow-up actions required by the noise standard.
Additionally, the STS measure uses existing measurements and
calculations employers are already using to comply with the OSHA noise
standard, resulting in less paperwork burden for employers covered by
both rules. Employers are required to take one additional step to
determine if the STS has also resulted in a total hearing level of 25 dB
or more, and if so, to record it. The position taken in § 1904.10
provides a reasonable compromise between the commenters' highly
polarized views on the proper recording level. The final rule's hearing
loss recording provisions provide a reasonable "middle ground"
solution to reconcile the differences between a highly sensitive measure
of hearing loss (all 10-db shifts) and increasingly insensitive measures
(15, 20, or 25-db shifts).
The approach used in this final rule is a newly developed alternative
that was not considered in the January 2001 rulemaking because none of
the commenters to the 1996 proposed rule suggested it. The approach was
first suggested by Organization Resources Counselors in an unsolicited
post-promulgation submission following publication of the January 2001
rule (Ex. 1-6). OSHA then solicited comment on the approach in the July
3, 2001 Federal Register notice requesting comment on the hearing loss
recording issue (66 FR 35113 -- 35115).
OSHA believes that the § 1904.10 requirements will improve the nation's
statistics on occupational hearing loss and that more hearing loss cases
will be entered on employers' OSHA 300 Logs. However, OSHA recognizes
that the new requirements may not result in comprehensive statistics for
occupational hearing loss. Employees may experience significant hearing
loss in industries where audiometric testing is not required
(construction, agriculture, oil and gas drilling and servicing, and
shipbuilding industries), and is not provided voluntarily by the
employer, and thus never be entered into the records. Likewise, an
employee may experience gradual hearing loss while employed by several
employers, but never work for the same employer long enough to allow a
recordable STS to be captured. As to the effect on trend analysis,
caution must be used when comparing § 1904.10 hearing loss data that
span the effective date of this rule. The new hearing loss recording
rule will result in the recording of additional cases of hearing loss,
not as a result of a change in the number of workers who experience
hearing loss, but simply because of the recordkeeping change.
OSHA finds that recording only 25-dB shifts from the employee's baseline
audiogram is not an appropriate policy. If an employee had significant
hearing loss before being hired by the employer, additional hearing loss
would not be recorded until well beyond the point of disability. This
would not conform to the requirements of section 24 of the Act directing
the Secretary to "[c]ompile accurate statistics on work injuries
and illnesses which shall include all disabling, serious, or significant
injuries and illnesses * * *" (emphasis added) (29 U.S.C. 673). The
recording of 25-dB shifts in hearing acuity, measured from the
employee's original baseline audiogram would clearly understate the true
incidence of work-related hearing loss. Likewise, if the part 1904
regulation were to require only the recording of 15 or 20-dB shifts, or
categorically exclude the first STS case the rule would exclude many
legitimate and serious hearing loss cases that should rightfully be
entered into the records and the Nation's injury and illness statistics.
This approach would be especially deficient at capturing hearing loss in
those employees who change employers several times during their working
lives.
The Coalition to Protect Workers Hearing (Ex. 3-23) and the AFL-CIO (Ex.
3-24) specifically opposed the approach used in the final rule, which is
often referred to as a "sliding scale" approach because it
treats some STS cases as being more serious than others (Exs. 3-23,
3-24). These Commenters argued that a sliding scale approach was
rejected in 1981 because it was too complex (Exs. 3-23, 3-24), that
sliding scales are difficult to administer and do not provide uniform
protection for workers (Ex. 3-24), and that "(c)ategorizing
employers on the basis of hearing impairment is discriminatory. * * *
Women and African Americans, both of whom tend to have better hearing
sensitivity, might be placed in noise-hazardous jobs since they could
develop more hearing change without crossing the line" (Exs.
3-23-1, 3-53).
OSHA does not believe that these concerns are serious impediments to the
Section 1904.10 requirements. The two-part test, an STS combined with a
total hearing level in excess of 25 dB from audiometric zero, is not
overly complex, and is not nearly as complex as some of the sliding
scale approaches that were rejected during the revision of the OSHA
noise standard in 1981. In the years since 1981, computer technology has
become much more commonplace and is incorporated into most, if not all,
audiometric equipment. OSHA expects that most employers and contractors
who administer hearing tests under the provisions of the noise standard
will use computer software to make the needed calculations, so the
requirements will not be difficult to administer. OSHA has received no
evidence to show that the policies in the final rule will encourage
discriminatory behavior by employers. The suggestion that women or
African Americans may be selected for noise exposed jobs in order to
avoid a potential recordable hearing loss case is highly speculative.
OSHA has seen no evidence that such discrimination has occurred either
to avoid the requirements of the OSHA noise standard or to avoid
workers' compensation issues.
OSHA does not agree with the commenters who argued that because the
function of the OSHA standards and regulations, including the part 1904
regulation, is to protect workers, worker protection would be
compromised by any policy other than the recording of all STS cases.
OSHA encourages employers and employees to use the OSHA injury and
illness records to improve workplace safety and health conditions, and
this is one of the functions of the Part 1904 records. However, this is
not the only function of the records. They are also used to generate
injury and illness statistics for the Nation and for individual
workplaces. They are used by OSHA representatives to identify hazards
during workplace inspections, and are collected by OSHA to target its
intervention efforts to more hazardous worksites (See 66 FR 5916-5917).
As stated in the 2001 rulemaking, "[n]o new protections are being
provided by the recordkeeping rule". Further, the OSH Act does not
require the recording of all injuries and illnesses and specifically
excludes certain minor injury and illness cases. This exclusion, which
is discussed in the preamble to the January 19, 2001 final rule, applies
to both injuries and illnesses, including hearing loss (See 66 FR
5931-5932). It is thus entirely appropriate for the recordkeeping rule
to exclude certain minor illness cases while capturing more serious
cases.
The hearing loss recording requirements of Section 1904.10 will not
deprive employers and employees of information about noise hazards or
diminish workers' protection against the hazards of noise in the
workplace. The occupational noise exposure standard requires that
employees in general industry be tested for hearing loss when noise
exposure exceeds an 8-hour time-weighted average of 85dB, and that
employees be informed, in writing, if a 10-dB shift has occurred. The
audiometric test records must be retained for the duration of the
affected employee's employment. (See 29 CFR 1910.95(g), (m)). The noise
standard also specifies the protective measures to be taken to prevent
further hearing loss for employees who have experienced a 10-dB shift,
including the use of hearing protectors and referral for audiological
evaluation where appropriate. (See 29 CFR 1910.95(g)(8)). These
requirements, which apply without regard to the recording criteria in
the recordkeeping rule, will protect workers against the hazards of
noise. The modified requirements of Section 1904.10 will therefore not
deprive employers and workers of the means to detect and prevent hearing
loss.
Finally, section 4(b)(4) of the OSH Act provides that "[n]othing in
this Act shall be construed to supercede or in any manner affect any
workmen's compensation law or to enlarge or diminish or affect in any
other manner the common law or statutory rights, duties, or liabilities
of employers and employees under any law with respect to injuries,
diseases, or death of employees arising out of, or in the course of,
employment." 29 U.S.C. 653(b)(4). Accordingly, the OSHA
recordkeeping rule will have no legal effect on state workers'
compensation systems. There is no evidence that the states have modified
their systems to conform to OSHA's previous hearing loss recording
policies; in fact, the states are far from uniform in their treatment of
occupational hearing loss (Ex. 3-24-14). Therefore, OSHA does not expect
the 1904 regulation to have any effect on state workers' compensation in
the future.
Audiometric Error
In its July 3, 2001 proposal, OSHA asked the public to comment on the
variability of audiometric testing equipment and how testing variability
should be taken into account, if at all, in the recordkeeping rule (66
FR 35115). Many commenters questioned the accuracy of audiograms, and
some of them specifically questioned the accuracy of audiograms used to
compute 10-dB shifts in hearing acuity (Exs. 3-5, 3-13, 3-14, 3-19,
3-20, 3-25, 3-26, 3-27, 3-29, 3-30, 3-35, 3-37, 3-45, 3-48, 3-49, 3-50,
3-54, 3-56, 3-58, 3-59, 3-63). These commenters argued that 10 dB is the
lowest level of detection and is not reliable (Exs. 3-48, 3-63); at 10
dB the precision of the measurement becomes an issue (Ex. 3-49); 5 to
10-dB variability is common, which argues for 25 dB and against 10 dB
(Ex. 3-29); 10 dB is not effective because of the testing environment,
testing procedures, and error of audiometric equipment (Ex. 3-27); and
that at a 10-dB shift, there is significant uncertainty in measurement,
rendering a typical audiometric reading unreliable (Exs. 3-37, 3-56).
Verizon Communications, Inc., while supporting the recording of 10-dB
shifts, summarized the potential recording problem as follows:
The test-retest variability inherent in properly calibrated audiometric
equipment is +5 dB. * * * if a 10-dB recording threshold is
adopted, the following scenario is possible:
Baseline audiogram -- the threshold at 200 Hz is measured at 10 dB;
however, the equipment is off by -5 dB, so the threshold is really 15 dB
Follow-up audiogram -- the threshold at 200 Hz is measured at 20 dB;
however, the equipment is off by +5 dB, so the threshold is still 15 dB
This employee would have a recordable 10-dB loss, yet, in reality,
his/her hearing would be unchanged. This is the risk that is taken with
a 10-dB threshold -- too many false positives (Ex. 3-30).
The International Paper Company stated that "[a]pplying the 10-dB
STS criterion for recordkeeping purposes would have the effect of
recording large numbers of workers whose hearing losses may simply be
due to testing variability" (Ex. 3-14). The Society for the
Plastics Industry (Ex. 3-25) cited a number of articles in the
scientific literature to argue that measurement error in field testing
as approximately 10 dB and the measurement error under laboratory
conditions is +5 dB. The Specialty Steel Industry of North
America (SSINA) and the Steel Manufacturers Association (SMA), in a
combined comment, used information from the National Institute for
Occupational Safety and Health (NIOSH) to argue that typical audiometric
testing variability is 10 dB, stating that "(e)mployers will be
required to record each occurrence of an STS at 10 dB, using a test that
has a 10-dB measurement variability. This will generate an overwhelming
number of false positives" (Ex. 3-37).
In a single comment, the National Chicken Council and the National
Turkey Federation argued that "Lacking standardization in testing
methods and in testing equipment, this change will mean that employers
will likely be forced to record (or fail to record) STSs that are
inaccurately measured" (Ex. 3-19). The Hearing Conservation Team at
the Naval Submarine Medical Research Laboratory (Ex. 3-56) reviewed the
scientific literature on audiogram reliability and found that
methodology used by various researchers varied widely, making study
comparisons difficult. The Hearing Conservation Team recommended further
research into the test-retest reliability of various threshold levels
that could then be used to set an STS criterion that would minimize
false positives.
Another group of commenters argued that the accuracy of audiometric
testing equipment is not a major factor (Exs. 3-15, 3-22. 3-23-1, 3-24,
3-57, 3-58, 3-61, 5-2, 5-3). In a representative comment, the AFL-CIO
remarked that "The issue of audiometric test variability has been a
settled matter since the hearing conservation amendment was promulgated
nearly 20 years ago and is adequately addressed by the existing
provisions contained in 1904.10" (Ex. 3-24). The American Textile
Manufacturers Institute commented that: "Variability is a given in
audiometric testing as it can never be an exact process as long as it
relies on any given individual being tested to sense a signal and
respond. However, variability can be minimized if there are tight
quality controls on the test equipment, procedures, etc." (Ex.
3-15).
The Coalition to Protect Workers Hearing disagreed with OSHA's
suggestion that the 10-dB recordability criterion does not allow for
audiometric variability, stating that "The evaluation of
work-relatedness takes calibration shifts into account, and such
audiometric variability occurs infrequently. When random measurement
variability does occur, retesting reduces it", adding that "It
is true that audiometric data are vulnerable to calibration differences
between different audiometers. Calibration discrepancies may occur if
the employer changes service providers (e.g., mobile audiometric
testing, testing in an off-site clinic) or if the employer switches
audiometers for in-house testing. Such change can easily affect data by
5 dB. However, calibration discrepancies can be minimized through
careful procedural controls such as the use of bio-acoustic simulators
and proper professional supervision of the audiometric monitoring
program" (Ex. 3-23-1).
The Dow Chemical Company, which has voluntarily been using 10-dB shifts
for recording loss, stated that "In Dow's experience, following a
standardized testing protocol (using 29 CFR 1910.95), and including
adjustment for age and the use of a retest in 30 days, has provided
accurate, consistent results' (Ex. 5-2). The National Institute for
Occupational Safety and Health (NIOSH) argued that the variability of
testing should not be taken into account in the recordkeeping rule
because audiometric variability issues have been addressed in the OSHA
Noise Standard 29 CFR 1910.95. NIOSH stated that they believe that under
the OSHA Noise Standard the expected variability due to error will be +5
dB (Ex. 5-3).
OSHA agrees with NIOSH that the recordkeeping rule should not take any
actions to address the issues of audiometric variability, and finds that
there is no need to increase the recording loss threshold to 15 or 20 dB
to account for variability. The OSHA noise standard includes provisions
that standardize audiometric testing protocols. The requirements in §
1910.95 (g) Audiometric Testing Program, § 1910.95 (h) Audiometric Test
Requirements, Mandatory Appendix C to § 1910.95 Audiometric Measuring
Instruments, Mandatory Appendix D to § 1910.95 Audiometric Test Rooms,
and Mandatory Appendix E to § 1910.95 Acoustic Calibration of
Audiometers, and the incorporated provisions of American Standard
Specification for Audiometers S3.6-1969 provide standardized
methodologies for conducting hearing tests designed to assure, as far as
possible, that audiograms are accurate. As discussed in the preamble to
the January 2001 final rule (66 FR 6009), following these requirements
will result in audiometric test results with a variability of +5
dB. As the Medical Educational Development Institute argued in response
to the 1996 proposal, "(t)est/re-test reliability of 5 dB is well
established in hearing testing. For example, the Council on Accrediting
Occupational Hearing Conservationists maintain this range of reliability
in their training guidelines and this is recognized in American National
Standard Method for Manual Pure-Tone Threshold Audiometry, S3.21 -- 1978
(R1992)." At the 5+-dB reliability level, errors of 10 dB
will be infrequent. There is a low probability that the audiometer will
be incorrect by -5 dB on one test and +5 dB on a subsequent test because
many of the variables affecting reliability will remain the same from
year to year. The employer is likely to use the same audiometer, in the
same room, operated by the same technician from one test to the next.
When these variables are not held constant, or a 10-dB shift occurs due
to residual random variability, the allowance for retesting should
largely eliminate spurious shifts due to audiometric measurement errors.
Additionally, the use of an average shift at three frequencies reduces
the influence of random audiometric variability; this is one of the
reasons that a frequency averaged shift was adopted in the § 1910.95
STS definition.
It should be noted that it is impossible to eliminate audiometric errors
in their entirety. Any recording level, no matter how it is set, will be
subject to some level of false positive and false negative errors.
However, OSHA believes that the audiometric testing requirements of §
1910.95, if followed, will provide reasonably accurate audiometric data
for the administration of the OSHA noise standard, and for the recording
of occupational hearing loss. As the Dow Chemical Company (Ex. 5-2)
commented: "(f)ollowing a standardized testing protocol (using 29
CFR 1910.95), and including adjustments for age and the use of a retest
in 30 days, has provided accurate, consistent results." OSHA
believes that the provisions allowing the employer to age adjust
audiograms, seek advice from a physician or other licensed health care
professional for determining work-relationship, retest within 30 days,
and remove cases later found not to be persistent provide reasonable
checks against false positive results being recorded on the 300 Log.
Age Correction
The final rule carries forward the January 19, 2001 rule's conceptual
framework allowing, but not requiring, the employer to age adjust an
employee's annual audiogram when determining whether or not a 10-dB
shift in hearing acuity has occurred. There were no comments objecting
to the age-correction of audiometric results when evaluating Standard
Threshold Shifts in hearing. However, the American Iron and Steel
Institute (Ex. 3-54), the Society for the Plastics Industry (Ex. 3-25)
and the American Forest & Paper Association (Ex. 3-59), in support
of a recording criteria similar to that adopted in the final rule,
recommended that, "[b]ecause of the recognized contribution of
aging to hearing loss, all hearing loss determinations would be
age-adjusted in accordance with Appendix F to 29 CFR 1910.95".
While the final rule allows the employer to age-correct the STS portion
of the recording criteria, there is no allowance for age correction for
determining a 25-dB hearing level. The AMA Guides specifically state
that total hearing loss should not be age adjusted, and there is no
recognized consensus method for age adjusting a single audiogram. The
method used in Appendix F of § 1910.95 is designed to age correct STS,
not absolute hearing ability. The 25-dB criteria is used to assure the
existence of a serious illness, and reflects the employee's overall
health condition, regardless of causation. Age correcting the STS will
provide adequate safeguards against recording age corrected hearing
loss. Therefore, it would be inappropriate and unnecessary to age
correct the 25-dB hearing level.
Persistence
Although OSHA did not specifically ask for comment on the topic, several
commenters raised the issue of how to verify that recorded hearing loss
cases are persistent. The OSHA noise standard addresses the issue of
temporary hearing losses by allowing the employer to retest the
employee's hearing within 30 days (1910.95(g)(7)(ii)). The 2001 rule
adopted the same 30 day retest option at § 1904.10(b)(4) by allowing
the employer to delay recording if a retest was going to be performed in
the next 30 days.
A number of commenters stated that OSHA should record only permanent
shifts in hearing (Exs. 3-23-1, 3-25, 3-26, 3-37, 3-48, 3-50, 3-58,
3-61, 3-62). In a representative comment, Industrial Health Inc.
remarked that "[n]o shift, regardless of the number of dB, should
be recorded unless it is found to be persistent in a second audiogram
taken at a later time, which we believe should be no less than 60 days
and preferably 6 months or more after the initial audiogram which
revealed the shift" (Ex. 3-62).
The National Association of Manufacturers and the Can Manufacturing
Institute, in a combined comment, argued that 30 days does not allow
enough time to resolve transient conditions such as colds or allergies,
and the retest period should be extended to one year (Ex. 3-50). The
Coalition to Protect Workers Hearing recommended that "(a)t the
discretion of the reviewing professional, within 15 months of the
initial identification of the STS, any STSs which are not confirmed by
subsequent retesting or otherwise found not to be work related, may be
lined out on Form 300. Documentation justifying line outs must be
provided and should be retained with the employees' records'(Ex. 3-23).
OSHA agrees with these commenters that the goal of the rule is to record
only persistent hearing loss cases, and to help accomplish that goal,
the Agency has carried forward the 30 day retest provision. However,
OSHA has decided not to allow a longer retesting period. A longer
retesting period would increase the likelihood that the employer would
lose track of the case and therefore inadvertently fail to record the
case. These errors would have a detrimental effect on the accuracy of
the records and run counter to OSHA's goal of improving the quality of
the injury and illness data. The Agency also believes that using
different time periods for retesting in the part 1904 and § 1910.95
rules would result in increased confusion for employers.
The Agency has also rejected the suggestion that all hearing loss cases
must be confirmed prior to recording them. Waiting for one year or
longer to record an occupational hearing loss would move the recording
to a year in which the original hearing loss was not initially
discovered, would be administratively more complex for employers, and
would have a detrimental effect on the hearing loss data. Many
legitimate hearing loss cases could go unrecorded simply because the
employee did not receive a subsequent audiogram due to job changes or
some other circumstance that might occur before the next annual
audiogram required by the noise standard.
In order to make it clear to employers that they may remove any cases
that are found to be temporary, the final rule has adopted the removal
option recommended by the Coalition to Protect Workers Hearing, with
three modifications. First, the final rule does not include the 15 month
time limit. OSHA does not believe that a time limit is needed because
any future audiogram that shows an improvement in hearing and refutes
the recorded hearing loss would indicate a temporary hearing loss that
should be removed from the records. Second, the regulatory text does not
specify that the removal must be at the discretion of the reviewing
professional. The OSHA noise standard, at § 1910.95(g)(3), requires
that:
Audiometric tests shall be performed by a licensed or certified
audiologist, otolaryngologist, or other physician, or by a technician
who is certified by the Council of Accreditation in Occupational Hearing
Conservation, or who has satisfactorily demonstrated competence in
administering audiometric examinations, obtaining valid audiograms, and
properly using, maintaining and checking calibration and proper
functioning of the audiometers being used. A technician who operates
microprocessor audiometers does not need to be certified. A technician
who performs audiometric tests must be responsible to an audiologist,
otolaryngologist or physician.
Because the noise standard already requires audiograms to be conducted
by, or under the supervision of, a qualified professional, subsequent
audiograms that may refute the persistence of a recorded hearing loss
will be reviewed by the appropriate professional. The § 1904.10 simply
cross-references the need for the audiograms to be obtained pursuant to
the requirements of § 1910.95, so there is no need for the § 1904.10
rule to repeat the review requirement. Third, the rule does not require
the employer to maintain documentation concerning the removal of cases.
Section 1910.95(m)(2) of the noise standard requires the employer to
keep records of all audiometric tests that are performed, and those
records will be available, should they be needed for future reference.
As a result, there is no need to add a duplicative paperwork burden in
the § 1904.10 rule. Therefore, § 1904.10(b)(4) states that "If
subsequent audiometric testing indicates that an STS is not persistent,
you may erase or line-out the recorded entry". OSHA has added this
additional regulatory language to minimize the recording of temporary
hearing loss cases while capturing complete data on the incidence of
hearing loss disorders.
Frequencies
Some commenters urged OSHA to measure hearing loss at frequencies other
than 2000, 3000 and 4000 Hz (See, e.g., Exs. 3-25, 3-54, 3-57, 3-58,
3-59, 3-61). Alabama Power (Ex. 3-61) and the Southern Company (Ex.
3-58) recommended using 500, 1000, and 2000 because "these are the
frequencies where most communication occurs". Another group of
commenters recommended the use of 500, 1000, 2000 and 3000 Hz because
these are the frequencies specified by the American Medical Association
and the American Academy of Otolaryngology-Head and Neck Surgery, Inc. (Exs.
3-25, 3-54, 3-57, 3-59).
OSHA has decided to continue to use the frequencies used in the §
1910.95 OSHA noise standard (2000, 3000, and 4000 Hz). While
"most" communication occurs at lower frequencies, these are
clearly audible frequencies where some speech occurs, and where hearing
loss can have a significant impact on workers' lives outside of verbal
communication. Using these frequencies reduces the burden on employers
that would be created by requiring separate calculations of audiometric
results, and, as Industrial Health, Inc. stated "(w)ith regard to
the early effects of noise exposure, it seems reasonable to extend the
definition across the standard shift frequencies 2000, 3000, and 4000
Hz" (Ex. 3-62).
Baseline Reference and Revision of Baseline
In its July 3, 2001 Federal Register notice OSHA asked the public to
comment on the appropriate benchmark against which to measure hearing
loss, e.g., the employee's baseline audiogram, audiometric zero, or some
other measure (66 FR 35115). One commenter, Eric Zaban with the State of
Michigan, suggested using audiometric zero as the appropriate benchmark
(Ex. 4-1). The vast majority of the commenters who addressed this issue
supported using the employee's baseline audiogram (Exs. 3-15, 3-20,
3-21, 3-22, 3-23-1, 3-24, 3-25, 3-27, 3-29, 3-30, 3-37, 3-47, 3-49,
3-50, 3-53, 3-54, 3-57, 3-58, 3-59, 3-61, 3-62, 3-63, 4-2, 4-5, 5-2,
5-3, 5-5 ). Alabama Power remarked that:
[T]he appropriate benchmark against which to measure hearing loss is the
employee's original baseline. Using the employee's original baseline
ensures that employers are not held responsible for any prior hearing
loss the employee may have suffered. Comparing an employee's audiogram
to audiometric zero would not take into account any previous hearing
loss that may have occurred prior to employment (Ex. 3-61).
The AFL-CIO agreed, stating that "Using the original baseline takes
into account any hearing loss that a worker may have experienced while
employed by a previous employer" and "Using the baseline
ideogram (audiogram) will assist in preventing the recording of cases of
non-occupational hearing loss' (Ex. 3-24).
The two-part test for recording that is being adopted in the final rule
uses the baseline audiogram as the reference point for determining
whether or not the employee has had a change in hearing while employed
by his or her current employer, and then uses audiometric zero as the
reference point for determining the overall hearing ability of the
affected employee. OSHA agrees that the employee's baseline audiogram is
a superior reference point for measuring a change of hearing, a Standard
Threshold Shift. Using the baseline audiogram taken upon employment
reduces the effect of any prior hearing loss the employee have
experienced, whether it is non-occupational hearing loss or occupational
hearing loss caused by previous employment. Therefore, the final rule
uses the employee's original baseline audiogram as the reference for the
STS component of an initial hearing loss cases, and uses the revised
baseline audiogram from that initial case as the reference for future
cases.
The 25-dB total hearing level component of an OSHA recordable hearing
loss uses a reference of audiometric zero. This portion of the recording
criteria is used to assure that the employee's total hearing level is
beyond the normal range of hearing, so it does not exclude hearing loss
due to non-work causes, prior employment, or any other cause. The
measurement simply reflects the employee's current hearing ability as
reflected in the most recent audiogram. This comparison to audiometric
zero is a simple matter, because audiometers are designed to provide
results that are referenced to audiometric zero. The hearing level at
each frequency is oftentimes printed by the equipment, so there is
rarely a need to perform manual calculations.
Work Relationship
The final rule published on January 19, 2001 included a presumption of
work-relatedness when employees are exposed to loud noise at work,
relying on the OSHA noise standards criteria of an 8-hour 85 dBA
exposure level, or a total noise dose of 50 percent. The preamble
discussion of the work-relatedness presumption was that:
[I]n line with the overall concept of work relationship adopted in this
final rule for all conditions, an injury or illness is considered work
related if it occurs in the work environment. 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. It is not necessary for the workplace to be the sole cause, or even
the predominant cause, of the hearing loss in order for it to be
work-related (66 FR 6012).
Several commenters discussed the difficulties of determining the
work-relatedness of hearing losses, and many argued that the 8-hour 85
dBA presumption was invalid (Exs. 3-2, 3-3, 3-13, 3-20, 3-23-1, 3-25,
3-27, 3-29, 3-37, 3-43, 3-48, 3-50, 3-54, 3-63, 4-3). In a
representative comment, the Coalition to Protect Workers Hearing (Ex.
3-23-1) remarked that:
[W]ork relatedness should not be presumed solely on the basis of an
exposure to time-weighted averages (TWAs) of 85 dBA or higher; instead
it should be evaluated on a case-by-case basis. Presumption of
work-relatedness based on equivalent 8-hour exposure alone is
unsatisfactory because it presumes that the employer's hearing
conservation program is completely ineffective and does not take into
account other factors such as hearing protector fit and use compliance.
Presumption of work-relatedness is a disincentive for employers to
develop successful programs and to implement noise control because they
receive no credit for their efforts. The audiologist or physician
reviewing the audiometric record should make a determination regarding
whether the OSHA STS is work-related and should do so when the 10-dB STS
occurs.
Other commenters suggested that if an employer has an active and
enforceable hearing conservation program in effect, then the
recordkeeping rule should presume that a hearing loss case is
non-work-related (Exs. 3-37, 3-50); that the rule needs to take non-work
noise exposure into account (Exs. 3-29, 3-37, 3-50); and that the rule
should only consider a hearing loss to be work-related if work
contributed more than 50% (Ex. 3-63). Several commenters made the same
argument as the Coalition to Protect Workers Hearing, arguing that each
case should be evaluated on its merits (Exs. 3-29, 3-43, 3-50, 3-63).
The American Foundry Society argued that "[w]ork-relatedness should
be evaluated by a health care professional with experience in
occupational health. Low level occupational noise exposure or documented
regular use of hearing protection devices (HPDs) in noisy areas should
mitigate against the presumption of work-relatedness' (Ex. 3-63).
OSHA agrees with these commenters that it is not appropriate to include
a presumption of work-relatedness for hearing loss cases to employees
who are working in noisy work environments. It is possible for a worker
who is exposed at or above the 8-hour 85-dBA action levels of the noise
standard to experience a non-work-related hearing loss, and it is also
possible for a worker to experience a work-related hearing loss and not
be exposed above those levels. Therefore, the final rule states that
there are no special rules for determining work-relationship and
restates the rule's overall approach to determining work-relatedness --
that a case is work-related if one or more events or exposures in the
work environment either caused or contributed to the hearing loss, or
significantly aggravated a pre-existing hearing loss.
The final rule's approach to determining work-relatedness differs from
the January 2001 rule for three reasons. First, although it is likely
that occupational exposure to noise in excess of 85 dBA will be a causal
factor in hearing loss in some cases, a presumption of work-relatedness
is not justified in all cases. Further evaluation is needed to make this
determination. Second, the policy in the final rule is consistent with
the general principle in § 1904.5 that work-relatedness is to be
determined on a case-by-case basis. Third, the approach used in the
January 2001 rule is not supported by comments to the docket. None of
the commenters supported the presumption, while many opposed it.
The final rule also continues the 2001 rule's policy allowing the
employer to seek the guidance of a physician or other licensed health
care professional when determining the work-relatedness of hearing loss
cases. Paragraph (b)(6) of the rule states that if a physician or other
licensed health care professional determines that the hearing loss is
not work-related or has not been significantly aggravated by
occupational noise exposure, the employer is not required to consider
the case work-related, and therefore is not required to record it.
When evaluating the work relatedness of a given hearing loss case, the
employer should take several factors into account. The Coalition to
Protect Workers Hearing recommended that employers consider prior
occupational and non-occupational noise exposure, evaluation of
calibration records and the audiometric environment, investigation of
related activities and personal medical conditions, and age correction
before presuming that hearing loss is work related (Ex. 3-23-1). One
important factor to consider is the effectiveness of the hearing
protection program. When employees are exposed to high levels of noise
in the workplace, and do not wear appropriate hearing protection
devices, a case of hearing loss is more likely to be work-related. If an
employee's hearing protection devices are not appropriate for the noise
conditions, if they do not fit properly, or if they are not used
properly and consistently, they may not provide enough protection to
prevent workplace noise from contributing to a hearing loss case.
Adding a Column to the 300 Log
Section 1904.10(a) of the January 2001 rule required that employers
check a hearing loss column on the Log when recording a hearing loss
case. OSHA is issuing a separate Federal Register document proposing to
delay the effective date of the hearing loss column requirement until
January 1, 2004, and asking for comment on issues related to the hearing
loss column. The 1996 proposed recordkeeping rule did not contain a
hearing loss column requirement, and did not ask for comment on whether
a column should be added. In the 2001 final rule, OSHA explained that it
was adding a hearing loss column to the 300 Log so that BLS could
produce more reliable statistics on occupational hearing loss cases (66
FR 6005). OSHA's July 3, 2001 Federal Register notice sought comment on
alternative criteria for recording occupational hearing loss, but did
not mention the hearing loss column as an issue.
OSHA does not believe that the existing record provides an adequate
basis to determine the need for the hearing loss column. OSHA believes
that interested parties should be allowed to comment on the issue.
Accordingly, OSHA is publishing a separate Federal Register document
today, proposing to delay the effective date of the hearing loss
requirement until January 1, 2004 while the Agency reconsiders the
column requirement in light of public comment. To facilitate public
comment, OSHA has separated the requirement from § 1904.10(a) and
placed it in a separate paragraph at § 1904.10(b)(7), which asks
"How do I complete the 300 Log for a hearing loss case?" and
answers "When you enter a recordable hearing loss case on the OSHA
300 Log, you must check the 300 Log column for hearing loss
illnesses." To further help assure that the public is informed
about this additional rulemaking activity, OSHA is adding a regulatory
note to § 1904.10(b)(7) explaining that OSHA is delaying the
applicability of § 1904.10(b)(7) until further notice while the Agency
reconsiders the hearing loss column.
Miscellaneous Hearing Loss Issues
OSHA received one miscellaneous comment that is worthy of discussion.
The International Chemical Workers Union Council (Ex. 3-53) remarked
that "[i]t is difficult for workers and their representatives to
gain access to audiometric exams or summaries of those exams".
Several of OSHA's rules provide access rights to audiometric data.
Section 1910.95(g)(8) of the noise standard requires employers to inform
employees, in writing, that they have experienced a standard threshold
shift. OSHA's rule for access to employee exposure and medical records (§
1910.1020) requires employers to provide access to medical records,
exposure records, and analyses of records to employee's and their
designated representatives. Finally, the part 1904 regulation requires
employers to provide employee access to the OSHA injury and illness
data.
Economic Analysis
Costs of the Revisions to the Hearing Loss Recording Provisions
OSHA has determined that the total cost of this action is $1,049,650 per
year and, thus, that it is not an economically significant regulatory
action within the meaning of Executive Order 12866. The methodology that
OSHA has used for computing costs for the new rule is presented in the
next two sections.
Changes in Coverage
Under the 2002 rule, employers were required to record all hearing loss
cases that involved a work-related Standard Threshold Shift (STS) of an
average of 25 dB or more at 2000, 3000 and 4000 hertz (Hz) in either
ear, compared to the employee's original baseline audiogram. The new
rule requires recording all hearing loss cases that involve a
work-related STS of an average of 10 dB or more if the accumulated loss
of hearing is at least 25 dB above audiometric zero. (The use of the
tables in Appendix F of the Noise Standard to adjust for aging remains
unchanged.)
OSHA estimates that approximately 40,000 hearing loss cases would have
to be recorded under the 2002 rule, as opposed to approximately 145,000
hearing loss cases under the new rule. Thus, the new rule increases the
number of recordable hearing loss cases by approximately 105,000. (In
the Final Economic Analysis of the 2001 revisions to the rule, OSHA
estimated that there would be 275,000 additional hearing loss cases (66
FR 6121), but the new rule has a narrower definition of hearing loss
cases than the 2001 rule.)
Estimating the Number of Recordable Hearing Loss Cases
To estimate the number of cases that would be recorded, OSHA used the
same estimation methodology as in the January 19, 2001 final rule.
First, OSHA estimated the number of employees that would receive
audiometric tests. OSHA's noise standard § 1910.95 requires employers
to provide baseline and annual audiograms (and take other actions) when
employees are exposed to certain noise levels. OSHA believes that
approximately 23% of workers in the manufacturing sector are covered by
the OSHA noise standard. Therefore, the number of covered manufacturing
workers is 4,255,000 (18,500,000 manufacturing workers x .23). OSHA
estimates that an additional 10% of workers are covered in other general
industry sectors (such as transportation and utilities) or receive
audiograms in industries not required to perform audiometric testing
under the OSHA noise standard (such as construction and agriculture).
Therefore, the total number of covered workers is estimated to be
approximately 4,680,500 (4,255,000 x 1.1).
OSHA then reviewed a National Institute for Occupational Safety and
Health (NIOSH) database of audiograms to determine the proportion of
audiograms meeting the recording criteria. 3.09% of audiograms met the
final rule's criteria for recording hearing loss, and 0.83% met the 2002
recording criteria (25 dB). Applying this percentage to the number of
employees receiving annual audiograms results in 144,627 (4,680,500 x
0.0309) estimated hearing loss cases under the final rule, and 38,848
(4,680,500 x .0083) estimated hearing loss cases recorded under the 2002
rule.
Therefore, OSHA estimates 105,779 (144,627 - 38,848) additional cases of
occupational hearing loss will be captured by the final section 1904.10
regulation, and has rounded this figure to 105,000 for cost estimation
purposes.
Annual Costs of Maintaining Records
The additional hearing loss cases will require additional entries on the
OSHA Form 300 Log and Summary of Occupational Injuries and Illnesses and
the OSHA Form 301 Injury and Illness Incident Report. Access of
employees and their representatives to the additional Form 301s will
also involve costs.
OSHA estimates that employers will incur for each additional hearing
loss case a cost of 15 minutes for the Log entry.
As explained in the 2001 Final Economic Analysis, based on data
collected during approximately 400 recordkeeping audit inspections, OSHA
estimates that 82 percent of incidents will be recorded on forms other
than Form 301, such as workers' compensation forms. The remaining 18% of
additional hearing loss cases will take 22 minutes for the filling out
the Form 301.
Assuming that an individual with the skill level of a Personnel Training
and Labor Relations Specialist will do the recordkeeping required by
this rule, an hourly wage of $30.02 is used to compute cost. (The
average hourly wage for a Personnel Training and Labor Relations
Specialist as reported in the Bureau of Labor Statistics Occupational
Employment Statistics Survey for Year 2000 was $21.71; benefits are
computed at 38.3 percent of the hourly wage.)
Thus, employers will incur, for each additional hearing loss case, data
entry costs of 15 minutes for the Log entry plus, for 18% of the cases,
22 minutes for the Form 301. The total annual cost is estimated to be
$996,064 [= (105,000 Cases) x (15 Minutes/Case) x ($30.02/Hour) +
(18,900 Cases) x (22 Minutes/Case) x ($30.02/Hour)].
As in the Year 2001 Final Economic Analysis, OSHA assumes that (a) at
one-tenth of covered establishments, one employee would request access
to his or her own Form 301 (10,500 instances), and (b) at one percent of
covered establishments, a union representative would request access to
all Form 301s at the establishment. Using the same estimation method as
the 2001 Economic Analysis, OSHA estimates union representative access
will result in an additional 10,500 forms being provided by employers.
OSHA assumes that, for each of the 21,000 forms being provided (10,500 +
10,500), employers would require five minutes to pull, copy (at $0.05),
and replace the relevant Form 301.
The estimated total cost of providing access to additional hearing loss
records would thus be $47,110 [= (21,000 Forms) x (5 Minutes x
($30.02/Hour) + $.05/Copy)]. Thus, according to the above analysis, the
total annual cost of this regulatory action is $1,049,650.
Benefits
Hearing loss cases result in substantial disability and lead to safety
accidents as well. OSHA believes that aligning the recording threshold
for such cases with the STS criterion in the Agency's Noise Standard
will simplify recording for many employers who are already familiar with
this criterion and provide more opportunities for employers to intervene
to prevent other hearing loss cases.
As explained in the 2001 Final Economic Analysis, possession of
information about events and exposures will increase the ability of
employers and employees to identify hazardous conditions and to take
remedial action to prevent future illnesses. If this enhanced ability to
identify (and thus address) hazards translates into a reduction even as
small as 0.5 to 1 percent of the estimated number of additional
recordable cases, it would mean the prevention of 525 to 1,050 illnesses
per year [= (.005 to .01 x 105,000].
The revisions in the rule will also make the injury and illness records
more useful to OSHA, as well as to employers and employees. Improvements
in the records being kept by employers would enhance OSHA's capacity to
focus compliance outreach efforts on the most significant hazards;
identify types or patterns of illness whose investigation might lead to
regulatory changes or other types of prevention efforts, such as
enforcement strategies, information and training, or technology
development; and set priorities among establishments for inspection
purposes.
Employers and employees both stand to benefit from the more effective
use of OSHA's resources. The enhanced ability of compliance officers to
identify patterns of illness will enable OSHA to focus on more serious
problems. Identification of such patterns will also increase the ability
of employers to control these hazards and prevent other similar
illnesses. To the extent that employers take advantage of this
information, the burden of OSHA inspections should be reduced in the
long run. Employees clearly also will benefit from these reductions in
illnesses.
Regulatory Flexibility Certification
The 2001 revisions of the recordkeeping rule, which were much more
extensive, did not have a significant impact on a substantial number of
small entities (66 FR 6121). In the Final Economic Analysis for those
revisions, OSHA estimated that over the entire range of SICs affected,
the average cost per small firm was only $31.63. The impacts of those
revisions on sales and profits did not exceed 1 percent for small firms
in any covered industry (66 FR 6108).
Even if all the additional hearing loss cases estimated to result from
this year's revisions were distributed among the 541,988 small firms
that keep the injury and illness records (as OSHA identified in its Year
2001 Final Economic Analysis) the average cost of the current revisions
per small firm would be less than two dollars.
OSHA hereby certifies that the current revision to the hearing loss
recording provisions, with an estimated annual cost of just over a
million dollars, will not have a significant impact on a substantial
number of small entities.
Unfunded Mandates
For the purposes of the Unfunded Mandates Reform Act of 1995, as well as
Executive Order 12875, this rule does not include any Federal mandate
that may result in increased expenditures by State, local, and tribal
governments, or increased expenditures by the private sector of more
than $100 million in any year.
Federalism
This rule has been reviewed in accordance with Executive Order 13132 (52
FR 41685), regarding Federalism. Because this rulemaking action involves
a "regulation" issued under section 8 of the OSH Act, and not
a "standard" issued under section 6 of the Act, the rule does
not preempt State law, see 29 U.S.C. 667(a). The effect of the rule on
States is discussed in the State Plans section of this preamble.
Paperwork Reduction Act
OSHA will modify its previously approved information collection
requirements prior to the January 1, 2003 effective date.
State Plans
The 26 States and territories with their own OSHA-approved occupational
safety and health plans must adopt a comparable regulation within six
months of the publication date of this final regulation. These states
and territories are: Alaska, Arizona, California, Hawaii, Indiana, Iowa,
Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North
Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont,
Virginia, Virgin Islands, Washington, and Wyoming. Connecticut, New
Jersey, and New York have OSHA approved State Plans that apply to state
and local government employees only.
A few commenters urged OSHA to make sure that the State Plan States have
the same recording criteria as federal OSHA (see, e.g., Exs. 3-22, 3-30,
3-49, 3-55). During 2002, the State Plan States were allowed to maintain
their policies for the recording of hearing loss to maintain their
former requirements, while OSHA reconsidered what the appropriate
recording criteria should be. In the Federal Register document
announcing the one year delay and the interim policy for year 2002, OSHA
stated that when it issues a final determination for the recording of
occupational hearing loss for calendar years 2003 and beyond, the states
would be required to have identical criteria (66 FR 52033). Now that
OSHA has issued its final determination, the States are required to
promulgate identical criteria.
Executive Order
This document has been deemed significant under Executive Order 12866
and has been reviewed by OMB.
Authority
This document was prepared under the direction of John L. Henshaw,
Assistant Secretary for Occupational Safety and Health, U.S. Department
of Labor, 200 Constitution Avenue, NW., Washington, DC 20210. It is
issued pursuant to section 8 of the Occupational Safety and Health Act
of 1970 (29 U.S.C. 657).
Signed at Washington, DC, this 25th day of June, 2002.
John L. Henshaw,
Assistant Secretary of Labor.
For the reasons stated in the preamble, 29 CFR part 1904 is amended as
follows:
PART 1904 -- [AMENDED]
1. The authority citation for part 1904 continues to read as follows:
Authority: 29 U.S.C. 657, 658, 660, 666, 673, Secretary of Labor's Order
No. 3-2000 (65 FR 50017), and 5 U.S.C. 533.
2. Revise § 1904.10 to read as follows:
§ 1904.10 Recording criteria for cases involving occupational hearing
loss.
(a) Basic requirement. If an employee's hearing test (audiogram) reveals
that the employee has experienced a work-related Standard Threshold
Shift (STS) in hearing in one or both ears, and the employee's total
hearing level is 25 decibels (dB) or more above audiometric zero
(averaged at 2000, 3000, and 4000 Hz) in the same ear(s) as the STS, you
must record the case on the OSHA 300 Log.
(b) Implementation.
(1) What is a Standard Threshold Shift? A Standard Threshold Shift, or
STS, is defined in the occupational noise exposure standard at 29 CFR
1910.95(g)(10)(i) as a change in hearing threshold, relative to the
baseline audiogram for that employee, of an average of 10 decibels (dB)
or more at 2000, 3000, and 4000 hertz (Hz) in one or both ears.
(2) How do I evaluate the current audiogram to determine whether an
employee has an STS and a 25-dB hearing level?
(i) STS. If the employee has never previously experienced a recordable
hearing loss, you must compare the employee's current audiogram with
that employee's baseline audiogram. If the employee has previously
experienced a recordable hearing loss, you must compare the employee's
current audiogram with the employee's revised baseline audiogram (the
audiogram reflecting the employee's previous recordable hearing loss
case).
(ii) 25-dB loss. Audiometric test results reflect the employee's overall
hearing ability in comparison to audiometric zero. Therefore, using the
employee's current audiogram, you must use the average hearing level at
2000, 3000, and 4000 Hz to determine whether or not the employee's total
hearing level is 25 dB or more.
(3) May I adjust the current audiogram to reflect the effects of aging
on hearing?
Yes. When you are determining whether an STS has occurred, you may age
adjust the employee's current audiogram results by using Tables F-1 or
F-2, as appropriate, in Appendix F of 29 CFR 1910.95. You may not use an
age adjustment when determining whether the employee's total hearing
level is 25 dB or more above audiometric zero.
(4) Do I have to record the hearing loss if I am going to retest the
employee's hearing?
No, if you retest the employee's hearing within 30 days of the first
test, and the retest does not confirm the recordable STS, you are not
required to record the hearing loss case on the OSHA 300 Log. If the
retest confirms the recordable STS, you must record the hearing loss
illness within seven (7) calendar days of the retest. If subsequent
audiometric testing performed under the testing requirements of the §
1910.95 noise standard indicates that an STS is not persistent, you may
erase or line-out the recorded entry.
(5) Are there any special rules for determining whether a hearing loss
case is work-related?
No. You must use the rules in § 1904.5 to determine if the hearing loss
is work-related. If an event or exposure in the work environment either
caused or contributed to the hearing loss, or significantly aggravated a
pre-existing hearing loss, you must consider the case to be work
related.
(6) If a physician or other licensed health care professional determines
the hearing loss is not work-related, do I still need to record the
case?
If a physician or other licensed health care professional determines
that the hearing loss is not work-related or has not been significantly
aggravated by occupational noise exposure, you are not required to
consider the case work-related or to record the case on the OSHA 300
Log.
(7) How do I complete the 300 Log for a hearing loss case?
When you enter a recordable hearing loss case on the OSHA 300 Log, you
must check the 300 Log column for hearing loss.
Note to 1904.10(b)(7): The applicability of paragraph (b)(7) is delayed
until further notice.
[FR Doc. 02-16392 Filed 6-28-02; 8:45 am]
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