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I. Introduction
II. Back Supports Are PPE
III. Science
IV. Slips, Trips And Falls Should Be Part OfThe Definition
Of MSDs
V. OSHA Should Espand The Coverage Of The Final Rule To Include
Agricultural, Construction And Maritime Workplaces
VI. In Certain Industries, Back Supports Are As Effective
As Other Controls
VII. Conclusions
I. INTRODUCTION
Chase Ergonomics(r) Inc. is a ten year-old company formed
specifically to develop and market safety products applying disciplines
common to those required for success in the medical device segment
of healthcare. Back supports are a key component of Chase Ergonomics'
overall product line, and we firmly believe that they are safe
and effective.
We have worked constructively with both the National Institute
for Occupational Safety and Health (NIOSH) and the Occupational
Safety and Health Administration (OSHA) on issues related the
proper role of back supports in an overall ergonomic program.
As part of that effort, we have attempted to keep both agencies
informed about emerging scientific data demonstrating the effectiveness
of these products.
We contend that OSHA should recognize back supports as personal
protective equipment (PPE). There is enough epidemiological and
biomechanical evidence to answer convincingly past questions
about efficacy. In situations where it is appropriate to use
PPE, workers will benefit if employers provide them with equipment
proven to provide protection when worn and maintained according
to the manufacturers' instructions. While we recognize the importance
of education and training, effective PPE that takes advantage
of the body's inherent biomechanics is a plus. We have such a
product, and we trademarked the term "AccuPressure"
for the purpose of communicating this clinically proven benefit.
II. BACK SUPPORTS ARE PPE
A. OSHA's Proposed Definition of PPE Should Apply to Back
Supports
The proposed rule on ergonomics defines personal protective
equipment as "equipment employees wear that provides an
effective protective barrier between the employee and MSD hazards."1
The note to _1910.920 states that "[b]ack belts/braces and
wrist braces/splints are not considered PPE for the purposes
of this standard," but OSHA offers no explanation as to
why back supports are not covered by the proposed definition.
Back supports are "equipment employees wear that provides
an effective protective barrier between the employee and MSD
hazards." As detailed below, there are overwhelming epidemiological
data documenting the ergonomic value of these products and biomechanical
data demonstrating the mechanism that makes them effective. In
addition, there is a vast body of anecdotal data showing that
back supports have been used effectively in many ergonomic back
injury prevention programs. Much of this anecdotal data has been
provided to OSHA at stakeholders meetings and other public events
that formed the basis for the agency's rulemaking.
B. Back Supports Are a Critical Component of the Hierarchy
of Controls
Back supports should be recognized as an acceptable component
of an overall back safety program under the hierarchy of controls.
As with any PPE, back supports are not the first intervention
option. In many jobs, however, neither engineering controls nor
work practice or administrative controls are feasible or practicable.
In these circumstances, OSHA's PPE standard allows employers
to provide workers with protective equipment that is appropriate
for the hazards present. The PPE standard requires that employers
provide training on the proper use and limitations of the equipment
chosen.
The current ergonomics proposal is not clear on whether or
not employers can provide back supports to their workers. To
avoid confusion and potential misuse, employers need to understand
the proper role of back supports. In the final rule, OSHA should
clarify that employers may use back supports as a supplement
to their overall back injury prevention program.
C. Science shows that Back Supports Provide a Protective Effect
Clinical studies show that unexpected loading (stress) of
the spine plays a key role in many back injuries. An oft-cited
study of back injuries in general industry by Manning found that
slips, falls and sudden loading account for 78% of first events
leading to MSD injury to the back.2 Unexpected spinal loading
can occur regardless of the weight handled. It may occur simply
as a result of awkward body movements that involve no weight
at all. Almost any unexpected event-not just accidents-can result
in unexpected loading. Reengineering of the workplace and restricting
job duties can never totally eliminate this type of risk.
Researchers have identified this risk factor as a significant
"first event" contributor to lost time injuries. Unexpected
loading has been described as the involuntary response/over-response
of very strong back muscles to outside factors. The back muscles'
involuntary responses often exert harmful and potentially damaging
influence on the spinal column, which is relatively unstable.3
This mechanism is well understood and widely recognized. We
are submitting studies with these comments that quantify and
measure the role of unexpected loading and its effect on the
spinal column. One study demonstrated that during an accident,
muscles contract with 70% more force than they exert during a
planned lift.4 Another concluded that "a significant number
of low back pain problems attributed to sudden unexpected loads
could be avoided by wearing a properly fitted back support snugly
around the hips." 5 Independent laboratory tests at the
Iowa Spine Research Center,at the University of Iowa further
quantified this benefit.6
In light of the considerable scientific evidence explaining
the effect of unexpected loading on the spine, we submit that
any appliance proven to act as an effective barrier against this
hazard (uncontrolled, excessively strong contractions of the
large muscles supporting the spine) fits the proposed OSHA definition.
As explained in greater detail below, the body of science on
how back supports function demonstrates that they offer protection
against unexpected loading and therefore help protect wearers
against back injuries.
We believe that back supports are personal protective equipment
and that OSHA must recognize them as PPE in the final ergonomics
standard.
III. SCIENCE
A. OSHA's Proposal Does Not Reflect the Current Science
The preamble to the ergonomics proposal notes that "[I]n
developing this proposed rule, OSHA has carefully considered
[a] large body of scientific articles and studies."7 In
reading the proposal, however, it appears there is also a large
body of scientific articles and studies that OSHA has not considered.
We are enclosing a number of epidemiological and biomechanical
studies with these comments. These studies, only one of which
is addressed in the proposed rule8, provide convincing proof
of the effectiveness of back supports in protecting against back
injuries.
As support for its decision to specifically exclude back supports
from PPE in the ergonomics standard, OSHA cites a 1994 review
of the available literature on back belts conducted by NIOSH.9
The NIOSH review concluded that "the effectiveness of using
back belts to lessen the risk of back injury among uninjured
workers remains unproven." Unlike the documents we are submitting
to the record this NIOSH document was never subjected to outside
peer review.
Although it is not acknowledged in OSHA's preamble, NIOSH
has revised its position on back supports since 1994. This revision
was largely in response to the significant research done in the
interim. In June 1997, NIOSH issued a position paper noting that
"NIOSH believes [there is] limited evidence that back belts
may be effective in some settings for preventing back injuries."
10 Although the position paper cautioned that "NIOSH still
believes that evidence for the effectiveness of back belts is
inconclusive," the document reflected the strength of the
science published after completion of the 1994 literature review.
In particular, the updated NIOSH position paper mentioned
a very large epidemiological study conducted at a number of Home
Depot stores in California.11 The Home Depot study "found
compelling evidence that back supports . . . along with worker
training and proper ergonomic workplace design . . . can play
an important role in helping to reduce back injuries among workers
who do a lot of lifting."
In the Home Depot study, the researchers reviewed all documented
back injuries and divided workers into three categories of lifting/carrying
intensity: low, moderate and high. The study found "the
highest rates of low back injury were observed in employees less
than 25 years or more than 55 years old." For these same
employees, however, the percentage of injuries prevented was
also the highest: more than 50% for employees younger than 25
and 60% for those older than 55. For those in the under 25 category
who did not use back supports, this translated to an injury rate
that was twice as high as for those who did use them. In the
over 55 category, the injury rate for non-wearers was 2.5 times
as high as the rate of injury for those who wore back supports.
The researchers noted that the highest rate of back injuries
occurred in the group of employees in the low lifting/carrying
intensity group. The study found that the workers in this group
who did not use back supports had injury rates 4.2 times higher
than their counterparts who did use them. Similarly, those in
the high intensity group who did not wear back supports had an
injury rate 1.4 times that of those who wore supports. Based
on their observations, the authors concluded that "uniform
mandatory implementation of back-support-use policy significantly
reduces the incidence of acute low back injuries incurred in
the workplace." This conclusion applied equally to those
workers with low intensity and high intensity lifting/carrying
jobs.
The Home Depot study and other recent literature are not reflected
in OSHA's evaluation of elastic back support efficacy. We must
conclude, therefore, that the decision to exclude back supports
from recognition as PPE is based on the outdated 1994 literature
review. In light of this oversight, we request that OSHA review
the studies we are submitting and reconsider the decision not
to recognize back supports as PPE. We believe that if the agency
gives this information appropriate consideration, the final standard
will allow employers to use back supports as PPE. At the very
least, it should clearly state that neither OSHA nor NIOSH has
ever prohibited employers from providing back supports to their
employees.
In addition, we believe that NIOSH should update its literature
review. In the six years since the original document was published,
the body of research on back supports has increased exponentially.
We urge OSHA to work with NIOSH to update this influential document.
B. OSHA's Proposal Fails to Depict NIOSH's Research on
Back Supports Accurately
In explaining the exclusion of back supports from PPE, the
preamble notes that "NIOSH is currently studying the effects
of back belt use on employees engaged in manual handling jobs
in Wal-Mart stores."12 There is no reference to the many
studies on back support use in manual handling that have already
been performed, there is no further explanation of the pending
study, and there is no mention of a biomechanical study on back
supports that NIOSH has already completed. We have discussed
the failure to address the existing science. By glossing over
the NIOSH/Wal-Mart study and ignoring the NIOSH biomechanical
study, we believe that OSHA failed to provide an accurate depiction
of the current NIOSH research on back supports.
The reference to the pending results of the NIOSH/Wal-Mart
study implies that it will be the definitive study on back supports.
This is hardly the case. As NIOSH officials have repeatedly admitted
in conversation and at numerous public meetings and panel discussions,
there are serious flaws in the Wal-Mart protocol that risk compromising
the entire study. The control and study groups both have been
thoroughly contaminated, and NIOSH has lost the ability to track
data with any reliability. The study is years behind schedule
and is reported to have exceeded its million-dollar budget.
In addition, the degree of sensitivity built into the protocol
(30%) is so excessive that it could effectively exclude very
positive results. If an employer implemented a back injury prevention
program that included back supports and found that its back injuries
were reduced 25%, this would be viewed by the employer as a very
positive impact. Under the NIOSH protocol, however, this would
be discounted as an insignificant difference.
In the Home Depot study, the researchers saw the rate of acute
low back injuries fall from 30.6 per million worker hours to
20.2 per million worker hours: a 34% reduction. In human and
financial terms, this reduction is remarkable, but it is barely
enough to cross the sensitivity threshold in NIOSH's protocol.
In the Supporting Statement that accompanied the protocol
to the NIOSH/Wal-Mart study, NIOSH estimated that MSD injuries
to the lower back account for 400,000 work related injury incidents
annually. This document cited the mean cost per compensable,
work-related back injury as $8,321 and rising as far back as
1989. NIOSH noted that "the social and economic benefits
of even a modest reduction in low back injuries would have a
very large impact on work-related medical care costs, and losses
to productivity."
Applying the 30% degree of sensitivity built into the NIOSH
protocol to NIOSH's own statistics on back injuries, this means
that a minimum reduction of 120,000 MSD injuries to the lower
back per year would be required for NIOSH to recognize the efficacy
of the intervention. Not only is the sheer number of injuries
that must be prevented to satisfy NIOSH remarkable, but the workers
compensation cost of almost $100 million resulting from these
injuries is staggering.
We believe that the insensitivity built into the protocol-and
the sheer number of injuries that could be prevented and dollars
that could be saved by adjusting this factor-justify our skepticism
of the pending results of this study. Added to the significant
problems that NIOSH has had collecting and accurately tracking
data, we believe the NIOSH/Wal-Mart epidemiological study should
not be viewed as the definitive study on back supports. For purposes
of these comments to OSHA, we stress that the agency should not
plan to rely on this study to the exclusion of all others, particularly
those cited above that are already complete.
While OSHA does not state outright that it will base any future
back support decisions on the NIOSH research, this is certainly
a reasonable inference to make from the preamble's cryptic reference
to the study. In light of the failure to discuss the research
that currently exists, this is troubling. It undermines the very
credibility of the decision to exclude back supports from PPE.
In addition to reviewing the available literature, OSHA should
make clear that it is not making a regulatory decision regarding
back supports on the presumed outcome of an ongoing study.
The questionable credibility of the OSHA decision to exclude
back supports from PPE is exacerbated by the agency's failure
to reference the NIOSH biomechanical study. This study, we believe,
was recently sent out for peer review, and has yet to be shared
with the public. This is troubling in and of itself. OSHA's failure
to refer to this work in the preamble is surprising because these
two studies have been linked together by both OSHA and NIOSH
so many times in the past.
It is unclear why OSHA has suddenly decided to ignore the
NIOSH biomechanical study. We can only surmise that the results
were favorable to back supports, which means they are not in
line with the decision to exclude these products from recognition
as PPE. While we do not believe that OSHA would intentionally
ignore research that does not agree with its prior position,
we are wondering why the agency would refer to the NIOSH/Wal-Mart
study but not the NIOSH biomechanical study.
C. OSHA Confuses Flexible Wraps and Supports With Splints
and Braces
In the discussion of wrist splints and braces on page 65830
of the preamble, OSHA confuses these rigid immobilizing devices
with flexible wraps and supports. The two groups of products
operate in considerably different ways and should not be treated
as a single category of products.
Use of immobilizing splints may raise the concerns cited in
this section. For instance, they "keep the wrist straight
during work" and may require workers "to use more force
to work against the brace."13 These rigid products are intended
to facilitate recovery from injury; they are not intended for
use in the workplace. Flexible sewn elastic products, on the
other hand, are designed to be used during work. As a result,
they do not impose the same restrictions on the wearer's range
of motion. They do not require a greater amount of force to "overcome"
them. These products are intended to replace ACE14 bandages and
similar wraps that can either come loose and get caught in machinery
or that can be reapplied at excessive pressures after swelling
recedes.
OSHA should be careful in the final rule not to confuse rigid
devices that immobilize the affected area and limit the range
of motion with those flexible devices that provide support and
help reduce the risk of injury. By grouping these two distinct
product categories together, OSHA is confusing employers and
workers and may keep valuable products away from workers who
might otherwise benefit from their use.
IV. SLIPS, TRIPS AND FALLS SHOULD BE PART OF THE DEFINITION
OF MSDs
The proposed rule states that the definition of musculoskeletal
disorders does not include "injuries caused by slips, trips,
falls or other similar accidents."15 This decision was made
based on the belief that MSDs are "medical conditions that
generally develop gradually over a period of time, and do not
typically result from a single instantaneous event."16 We
strongly disagree with this presumption. There is a vast body
of scientific research demonstrating that the types of injuries
caused by slips, trips and falls-sudden loading injuries-are
often the events that trigger musculoskeletal disorders.
The OSHA definition itself specifically cites herniated spinal
discs and low back pain as examples of MSDs. These very injuries
are often directly attributable to slips, trips and falls. Excluding
injuries caused by slips, trips and falls is a serious mistake
that could put numerous workers at risk.
The findings of the Manning study were consistent with his
previous research and his twenty years of experience in the auto
industry. Manning expressed surprise that existing literature
on back pain gives the impression that the only cause of back
injuries is manual handling. While there is plenty of evidence
that manual handling is a leading cause of back injuries in the
manufacturing environment, Manning's study clearly shows that
slips, trips and falls play a significant role in these injuries
as well.
Rather than exclude slips, trips and falls from the definition
of MSDs, OSHA should recognize them as significant ergonomic
risk factors. The proposal itself identifies "[f]loor surfaces
that are uneven, slippery, or sloped" among the conditions
employers should look for in analyzing problem jobs.17 The paragraph
discussing these conditions presents the very argument we are
making here that these conditions can exacerbate the risk of
back injuries. Indeed, uneven floor surfaces can cause employees
to trip, slippery floor surfaces can cause them to slip, and
sloped floor surfaces can cause them to fall. When carrying heavy
or bulky objects over these surfaces, the risks of back injuries
caused by sudden loading are even greater.
We agree that these risk factors should be eliminated where
possible, but there are some workplaces where neither engineering
nor work practice or administrative controls are feasible or
practicable. In these situations, back supports can provide a
critical barrier against the impact on the back of sudden loading
caused by slips trips and falls.
In light of the discussion below regarding the industry sectors
excluded from the scope of the proposal, we note that in the
agriculture, construction and maritime industries, there are
a disproportionate number of MSDs caused by slips, trips and
falls.
We recommend that OSHA include back injuries caused by slips,
trips and falls in the final ergonomics standard. Specifically,
slips, trips and falls should be added to the list of risk factors
that appears on page 65808 of the proposed rules.
V. OSHA SHOULD EXPAND THE COVERAGE OF THE FINAL RULE TO
INCLUDE AGRICULTURAL, CONSTRUCTION AND MARITIME WORKPLACES
The proposed ergonomics standard excludes the agricultural,
construction and maritime industries from coverage. We believe
this is a mistake that unnecessarily prolongs the risks to thousands
of workers in those industries.
In the discussion of reasons for excluding these sectors from
the proposed rule, OSHA cites BLS data as evidence that "10%
of all reported lost-workday MSDs occurred in just [these] three
industry sectors."18 Nevertheless, OSHA has chosen to exercise
its discretion under _6(g) of the Occupational Safety and Health
Act and postpone efforts to address this significant portion
of MSD injuries. The proposal does not address the extent to
which these MSDs are back-related. On the basis of the seven
listed factors that differentiate the excluded sectors from general
industry, however, it seems likely that back injuries would be
more dominant in the excluded sectors than in general industry,
where engineering controls are ordinarily more feasible.
The preamble recognizes that OSHA's discretion under _6(g)
is limited. It cites a decision by the Third Circuit Court of
Appeals, which found that "Where OSHA has decided to promulgate
a standard to address an issue it is not enough for the agency
to declare that it has selected certain industries or jobs for
coverage because they present greater hazards . . .. Where significant
risk exists in other industries and a standard is feasible there
as well, OSHA may exclude those industries only if covering them
would 'seriously impede the rulemaking process'".19 We do
not believe that including the agriculture, construction and
maritime industries in this proposal would seriously impede the
rulemaking process.
Sufficient evidence exists of back injuries in the agriculture,
construction and maritime industries on which to base a standard
covering these sectors. From the discussion in the preamble,
it appears that OSHA chose not to include these sectors in the
proposal because of a mistaken belief that there is insufficient
understanding of the causes and solutions to MSDs in these workplaces.
While there may be fewer known engineering controls that address
the hazards in these industries, many employers have identified
and are successfully using other means to reduce injuries. In
many cases, that means providing back supports to their workers,
along with the necessary training and education. Where engineering
and work practice controls are not feasible, back supports can
function as a first line of defense against back injuries.
Too often, OSHA relies on engineering controls as the only
means of addressing MSD hazards. OSHA equates engineering controls
with increased productivity, but increased engineering also can
lead to increased repetition. Automation, the original engineering
control, was focused solely on increasing productivity. Repetition
was the byproduct of this enhanced productivity, and it ultimately
led to MSDs. A second round of engineering controls will not
necessarily increase productivity or its counterpart, profitability.
Because enhanced worker protection is not directly connected
to enhanced productivity, OSHA is having a difficult time promoting
ergonomics with the regulated community. The agency needs to
recognize the concerns that employers have about costs and allow
them the flexibility to implement cost-effective solutions. These
cost-effective solutions may not always be the most technologically
advanced, but they work.
In the fixed workplaces more common to general industry, OSHA's
emphasis on engineering controls makes sense. Although expensive,
these controls may eliminate most of the risk, rather than reduce
it. Many jobs in general industry, however, are similar to those
jobs in the agriculture, construction and maritime industries
that do not fall within the fixed workplace model. In fact, the
same "unique problems" cited by OSHA as justification
for excluding the agriculture, construction and maritime industries
are exactly the conditions of work that may trigger the application
of the ergonomics standard in general industry. Furthermore,
the most common MSDs in the excluded industries often result
from job tasks involving the same type of manual handling that
the proposed rule for general industry focuses on.
Non-fixed jobs in general industry are covered by the proposed
rule, however, and OSHA does not exclude them from coverage.
Because these jobs present the same sorts of hazards found in
the agriculture, construction and maritime industries, this undermines
any argument the agency makes for excluding the latter from coverage.
Excluding certain industry sectors for the very same reasons
that jobs in another industry sector trigger coverage is inherently
contradictory.
OSHA should correct this in the final rule by expanding its
coverage to include the agriculture, construction and maritime
industries.
VI. IN CERTAIN INDUSTRIES, BACK SUPPORTS ARE AS EFFECTIVE
AS OTHER CONTROLS
On Page 66062 of the proposal, OSHA asks whether there are
forms of PPE that "would be as effective as engineering,
administrative or work practice controls."
We are enclosing scientific evidence demonstrating the effectiveness
of back supports as PPE, and we believe that back supports can
function as well as engineering and administrative or work practice
controls in non-fixed workplaces where employees perform manual
handling tasks. The risks of sudden spinal loading in these jobs
is as great or greater than the seven risk factors listed in
the preamble: force, repetition, awkward postures, static postures,
vibration, contact stress and cold temperatures. The protective
effect of back supports is even more important in those areas
where traditional engineering and administrative controls are
neither practicable nor feasible, which is often the case in
non-fixed workplaces.
In the industries excluded from the proposal (agriculture,
construction, maritime), back supports are as effective as engineering,
administrative or work practice controls. Research we are submitting
to the record demonstrates that beneficial biomechanical responses
are achieved by wearing a properly designed back support in the
recommended manner. Research also shows that this positive protective
effect cannot be overridden by the worker wearing the support.
Specifically, the research by Manning, Marras and Lavender has
identified the mechanism by which these products work. Marras'
work has quantified the magnitude of over-contraction caused
by sudden spinal loading, and the work of Pope and Wilder has
shown the effectiveness of back supports at reducing this involuntary
over-contraction. This overwhelming evidence cannot be ignored
and should be reflected in the final ergonomics standard.
VII. CONCLUSION
For the reasons above, Chase Ergonomics recommends that OSHA
review the data on back supports that has been published since
NIOSH conducted its literature review. We believe that on the
basis of these biomechanical and epidemiological studies, there
is enough data to establish the efficacy of back supports. As
a result, we urge OSHA to recognize back supports as personal
protective equipment. By doing so, the agency would be directing
any employers who make back supports part of their back injury
prevention program to provide their workers with the necessary
training on proper use and education on the product's limitations.
In addition, we urge OSHA to recognize the role that slips,
trips and falls and sudden spinal loading have on the lower back
and the MSDs that result from these common workplace hazards.
Back supports have proven effective against these and other risk
factors, which are present not only in general industry but in
the agricultural, construction and maritime industries as well.
OSHA should expand the coverage of its proposed rule to include
these other industry sectors and extend the critical protections
of the proposed ergonomics standard to the workers in those industries.
We look forward to the public hearings on the proposal and
to seeing the changes we are recommending appear in the final
rule, In the meantime, we would be happy to participate in any
discussions the agency might have on the back support issue.
- 64 FR 66077.
- D.P. Manning, Spine, Volume 9, November 7, 1984.
- "Trunk Loading and Expectation," W.S. Marras, S.L.
Rangarajulu and S.A. Lavender, Ergonomics, 1987, Vol. 30, No.
3, 551-562.
- See Marras and Rangarajulu.
- "Evaluation of Various Lumbar Supports by EMG Signal
Analysis of Erector Spinae Muscle to Unexpected Load," David
G. Wilder, Jae S. Lee, Malcolm H. Pope, Marianne M. Magnusson,
Vijay K. Goel, presented at the 8th annual meeting of the European
Spine Society, September 1997 in Kos, Greece.
- See Wilder and Lee; "Does a Lifting Belt Reduce the
Spine Moments During Sudden Unexpected Loading?," S.A. Lavender,
K. Shakeel, G.B.J. Andersson, J.S. Thomas, presented at 45th
annual meeting of the Orthopaedic Research Society, February
1999 in Anaheim, California.
- 64 FR 65775.
- "The Influence of Prophylactic Orthoses on Abdominal
Strength and Low Back Injury in the Workplace," Walsh, N.E.
and Schwarz, R.K., which supports the notion of using education
and prophylactic bracing to prevent back injuries and reduce
time lost from work.
- "Workplace Use of Back Belts," DHHS (NIOSH) Publication
No. 94-127.
- "Back Belts," NIOSH Document #705004.
- "Reduction of Acute Low Back Injuries by Use of Back
Supports," J. Kraus, K. Brown, D. McArthur, C. Peek-Asa,
L. Zhou, International Journal of Occupational and Environmental
Health, 1996, pp. 264-273.
- 64 FR 65830.
- 64 FR 65830.
- Becton Dickinson Corporation, Franklin Lakes, New Jersey
- 64 FR 66076.
- 64 FR 65864.
- 64 FR 65820.
- 64 FR 65787.
- 64 FR 65786.
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