In a recent report on the performance of N95 filtering
facepiece respirators, published in the Morbidity and Mortality Weekly
Report, researchers from the National Institute for Occupational
Safety and Health (NIOSH) concluded that conducting a fit-test prior to
respirator assignment increases respirator performance.(1) This means
using a fit-test to select a respirator that fits appropriately can
increase the protection a respirator provides. This article describes the
NIOSH study and discusses the results. Laboratory vs. workplace
studies
NIOSH used a laboratory performance study (rather than a
workplace performance study) to evaluate the effects of fit-testing on
respirator performance. Researchers determined the total penetration of a
laboratory room aerosol into respirators with N95 filters while they were
being worn. A Portacount Plus fit-test apparatus was used to measure
particle penetration. The equipment utilizes ambient particles (room air
particles) as the challenge agent. However, the Portacount only measures
fit when a 100 level filter is used, because the 100 level filter
eliminates filter penetration so only faceseal leakage is measured. The
particle size distribution of ambient particles in room air contains many
particles in the most penetrating size range for respirator filters. Since
an N95 particulate filter is not 100% efficient in removing these
particles, the reported penetrations include both filter penetration and
faceseal leakage. In addition, particle size distribution in a workplace is very
different than that of a laboratory room. Workplace particles are
typically much larger. Consequently, it is difficult to extrapolate the
particular performance of these respirators to the workplace. However,
while these data may not indicate performance in the workplace, the study
allows one laboratory measurement to be compared to another. The NIOSH experiment had two parts. Part 1 measured laboratory
performance without fit-testing. Part 2 measured laboratory performance
only on those people who passed a fit-test. NIOSH study part 1
In this phase of the study, a test panel of 25 people wore 21 different
models of N95 filtering facepiece respirators. No fit-testing was
conducted to select appropriate-fitting respirators. Every person wore
each model of respirator regardless of fit. When a given model of
respirator was available in multiple sizes, the size with the best
subjective fit was used. User seal checks were performed according to the
manufacturers' instructions. Previous work has shown that user seal checks cannot be used as a
substitute for fit-tests.(2) Both the Occupational Safety and Health
Administration (OSHA) and American National Standards Institute (ANSI)
standards require fit-testing prior to respirator use in the workplace.
This is another reason the results of this test phase are not
representative of workplace performance.(3,4) After each respirator was donned and a user seal check performed, the
total penetration into the respirator was measured while the wearer
performed a test consisting of six exercises. The respirator was then
removed. Three more identical tests with the same model of respirator were
performed on each person. This provided four "performance" measurements on
each of the 25 people, yielding a total of 100 measurements for each of
the 21 respirator models. These performance measurements (% penetration) can be converted to a
simulated workplace protection factor (SWPF). The SWPF is the
inverse of penetration:
SWPF = The fifth percentile is the point in the data at which 95% of
the data lie above that point and 5% of the data fall below. Here, the
overall fifth percentile SWPF for all 21 respirator models was 3. This
corresponds to an overall penetration value of 33%. Therefore, 95% of
wearers of these respirators can expect respirator performance greater
than this value. These respirator performance measurements indicate
performance without fit-testing. The fifth percentile workplace protection
factor has typically been used to set the assigned protection factors
(APFs) for respirators.(5) Filtering facepiece respirators have typically
had an APF of 10.(4) NIOSH study part 2
The second part of the study evaluated the same "performance"
measurements after fit-testing had been done. Each respirator model was
assessed by removing the results from those people among the 25-person
panel who failed a surrogate fit-test with any of the respirator
models. NIOSH referred to the procedure as a surrogate fit-test because the
"fit-test" method used is: not commercially available; not one of the protocols in the OSHA respiratory protection
standard, 1910.134; and was never correlated to any accepted fit-test
method. In fact, this sample chamber procedure never passed the experimental
stage of product development and the manufacturer has since abandoned this
approach as a method of fit-testing respirators with N95 filters. A fit-test is a procedure for evaluating respirator faceseal
leakage and determining whether the respirator fits appropriately. Since
the fit test method used in this study allowed both faceseal leakage and
filter penetration, corrections were made for faceseal leakage. A
specially-designed sample chamber was used to measure the amount of filter
penetration. To make this correction, the sample chamber was clamped onto
the filter and the filter penetration was measured using the Portacount.
The Portacount pulled air through the filter into the chamber. It also
counted particles that penetrated the filter. In theory, the chamber was
sized so the airflow through the filter during the test was equivalent to
the airflow through the entire filter that would occur if a person were
breathing at a normal work rate. The researchers then calculated a "fit
factor." This can be accomplished by using the following two
equations:
Total Penetration - Filter Penetration Fit Factor = The 25 people were classified into passing or failing fits for each
model of respirator by determining if the initial test for each person had
a calculated "fit factor" greater than 100. A fit factor of 100 is the
standard value used by OSHA and ANSI to assess faceseal leakage of
half-facepiece respirators.(3,4) Then the total penetrations measured for
trials 2,3 and 4 were used to calculate the fifth percentile simulated
workplace protection factor for each person/respirator combination passing
the fit criterion. When only the results from those people who passed the fit-tests were
counted, the average fifth percentile SWPF increased to 25. This
corresponds to an overall penetration of 4%. These results indicate
respirator performance only on people passing a fit-test. As a result of
fit-testing, the fifth percentile SWPF increased from 3 to 25 while the
overall penetration decreased from 33% to 4%. It is important to note that
the fifth percentile is greater than the APF of 10 given to this
respirator type. NIOSH concluded that performing a fit-test has value in
identifying those wearers having poor fit. Discussion
This study did not measure actual workplace performance of N95
filtering facepiece respirators. Therefore, it is difficult to correlate
the results of the study directly to the workplace for several reasons.
These include the test aerosol, the fit-test method, the test panel and
the method of selecting the respirator. Test
aerosol Particle size distributions found in the workplace are typically larger
than those found in a room of a laboratory or office. Therefore, filter
penetration in the workplace would be lower than that measured in this
study. This would result in a lower value for total penetration and a
higher protection factor measurement. Fit-test
method Calculating a "fit factor" by subtracting filter penetration is
unproven. There are no data to indicate how the fit factor of 100
determined by this method compares with a fit factor of 100 determined by
other methods of quantitative fit-testing, or how this compares to passing
an accepted qualitative fit-test. This is not an OSHA-accepted method of
fit-testing. In addition, the accuracy of the device depends on several assumptions.
First, filter penetration is sensitive to airflow velocity. In turn,
airflow velocity through the respirator is dependent on the filter surface
area, which can be different for each respirator model. The airflow
velocity during the test is dependent upon the pump in the Portacount and
the size of the sample chamber. Therefore, each person must breathe at a
single rate and the rate cannot vary within or among tests or among
people. In addition, penetration through the filter must be uniform across
the entire surface. Both of these assumptions have been proven incorrect.
In our laboratory, we found the device used to measure filter penetration
was too variable to be useful in fit-testing. Measuring filter penetration with too low of a velocity compared to the
actual velocity when the respirator is worn results in allowing fits that
would not be acceptable using OSHA-accepted methods of fit-testing. This
would result in lower overall respirator performance being reported. Test panel The test panel consisted of 15 women and 10 men. NIOSH states that the
distribution of face lengths and face widths approximated the general
population. However, the general population may not represent the
workplace population. Some workplaces have a greater proportion of male or
female workers, or may have a higher proportion of one ethnic group than
another. In addition, the 25-person test panel typically used in studies
of this type is based on face measurements of United States Air Force
personnel in the 1960s. Today, the makeup of the U.S. workplace population
is nothing like that of the Air Force population of the 1960s. Many more
ethnic groups and females are found in the current U.S. work force. Size
of air force personnel compared to that of the workplace population is
another variable. This is why fit-testing on a multi-person panel does not
predict fit for a specific individual and why fit-testing is necessary in
the workplace. Respirator
selection Another factor that makes correlation difficult was the testing of each
person with each respirator. In a respiratory protection program, it is
recommended that if several respirators are available, a person be allowed
to choose the most comfortable respirator, then undergo a fit test. Some
respirators are obviously too small or large to fit. Testing each person
with each respirator means that marginally-fitting devices were included
in the tabulation. The researchers noted that several respirators did not
"fit" very many people. This is not surprising because it is expected some
respirators are designed for faces of specific size. Many manufacturers
make models of filtering facepiece respirators to fit different face sizes
instead of making one model of filtering facepiece respirator in three
sizes. For example, the 3M 8110S respirator is our smaller-sized version
of the 3M 8210 respirator. Instead of making the 8210 respirator in two
sizes, we make two different models. We expect the 8110S respirator to fit
a smaller percentage of the population, but we expect it to fit smaller
faces very well. In other words, if the best fit is obtained with the 8210
respirator, one would not choose to wear the 8110S respirator. Supporting data
Another way to measure respirator performance is through workplace
protection factor (WPF) studies. These studies directly measure
performance in the workplace by collecting samples inside and outside a
respirator while it is worn during work. A number of good workplace
protection factor studies have been reported around the world. In the
U.S., fit-testing is required, although in Europe it is not. Therefore,
some of these studies mandated a fit-test prior to measuring the
WPF,(6-18) while others did not.(19-22) Figure 1 shows the distribution of
data from these studies on half-facepiece respirators grouped according to
whether fit-testing was performed. When fit-testing was used to screen out
poor-fitting half-facepiece respirators, an improvement in performance was
found. The fifth percentile WPF without fit-testing is approximately 2 and
with fit-testing is approximately 25 to 30. These results are very similar
to those found in the NIOSH study.
Summary
While the NIOSH study may not predict actual workplace performance,
from a comparative viewpoint, it illustrates the benefit of fit-testing.
It indicates that screening people with a fit-test is useful for
identifying those with poor-fitting respirators. If an OSHA-accepted
method of fit-testing had been used, the increase in respirator
performance may have been even greater. Based on the data reviewed above, we can conclude it is beneficial to
perform fit-testing prior to respirator assignment. A decrease in total
filter penetration in the laboratory and workplace has been shown when
fit-testing is conducted. References
1. Centers for Disease Control. Laboratory Performance Evaluation of
N95 Filtering Facepiece Respirators, 1996. Morbidity and Mortality Weekly
Report 1998/47(48):1045-1049. 2. Myers, W. R., M. Jaraiedi, and L. Hendricks: Effectiveness of Fit
Check Methods on Half Mask Respirators. Appl. Occup. Environ. Hyg.
10(11): 934-942 (1995). 3. "Respiratory Protection," Code of Federal Regulations Title
29, Part 1910.134. 1998. pp. 412-437. 4. American National Standards Institute. American National Standard
for Respiratory Protection (ANSI Z88.2-1992). New York: American
National Standards Institute, Inc., 1992. 5. NIOSH Respirator Decision Logic. US Dept. of Health and Human
Services/National Institute for Occupational Safety and Health Pub. No.
87-108. pp. 29. 1987. 6. Gaboury, A., D. H. Burd, and R. S. Friar: Workplace Protection
Factor Evaluation of Respiratory Protective Equipment in a Primary
Aluminum Smelter. Appl. Occup. Environ. Hyg. 8(1):19-25 (1993). 7. Colton C. E. and J. O. Bidwell: "A Comparison of the Workplace
Performance of Two Different Types of High Efficiency Filters on Half
Facepiece Respirators." Paper presented at the 1995 American Industrial
Hygiene Conference, Kansas City, MO, May, 1995. 8. Colton, C. E. , J. O. Bidwell, and H. E. Mullins: "Workplace
Protection Factors of a Half-Facepiece High Efficiency Respirator in
Different Environments." Paper presented at the 1994 American Industrial
Hygiene Conference, Anaheim, CA, May, 1994. 9. Dixon, S.W. and T. J. Nelson: Workplace Protection Factors for
Negative Pressure Half-Mask Facepiece Respirators. J. Int. Soc. Respir.
Prot. 2(4):347-361(1984). 10. Galvin K., S. Selvin, and R. C. Spear: Variability in Protection
Afforded by Half-Mask Respirators Against Styrene Exposure in the Field.
Am. Ind. Hyg. Assoc. J. 51:625-639 (1990). 11. Colton, C. E., A. R. Johnston, H. E. Mullins, C. R. Rhoe and W.
Myers: "Respirator Workplace Protection Factor Study on a Half Mask
Dust/Mist Respirator." Poster presented at the 1990 American Industrial
Hygiene Conference, Orlando, FL, May, 1990. 12. Zhuang, Z. and W. R. Myers: Field Performance Measurements of
Half-Facepiece Respirators--Paint Spraying Operations. Am. Ind. Hyg.
Assoc. J. 57:50-57 (1996). 13. Nelson, T. J. and S. W. Dixon: "Respirator Protection Factors for
Asbestos, Parts I and II." Paper presented at the 1985 American Industrial
Hygiene Conference, Las Vegas, NV, May, 1985. 14. Gosselink, D. W., D. P.Wilmes, and H. E.Mullins: "Workplace
Protection Factor Study for Airborne Asbestos." Paper presented at the
1986 American Industrial Hygiene Conference, Dallas, TX, May, 1986. 15. Myers, W. R., Z. Zhuang and T. Nelson: Field Performance
Measurememnts of Half-facepiece Respirators--Foundry Operations. Am.
Ind. Hyg. Assoc. J. 57:166-174 (1996). 16. Myers, W. R. and Z. Zhaung: Field Performance Measurements of
Half-Facepiece Respirators--Steel Mill Operations. Am. Ind. Hyg. Assoc. J.
59:789-795 (1998). 17. Colton, C. E.and H. E. Mullins: "Workplace Protection Factors for a
Half Mask Dust/Mist/Fume Respirator." Poster presented at the 1992
American Industrial Hygiene Conference, Salt Lake City, UT, May, 1992. 18. Lenhart, S.W. and D. L. Campbell: Assigned Protection Factors for
Two Respirator Types Based Upon Workplace Performance Testing. Ann.
Occup. Hyg. 28(2):173-182 (1984). 19. Hery, M., J. P. Meyer, M. Villa, G. Hubert, J. M. Gerber, G. Hecht,
D. Franc and J. Herrault: Measurement of Workplace Protection Factors of
Six Negative Pressure Half-Masks. J. Int. Soc. Respir. Prot.
11(3):15-38 (1993). 20. Hery, M. V., G. Hubert and P. Martin: Assessment of the Performance
of Respirators in the Workplace. Ann. Occup. Hyg. 35(2):181-187
(1991). 21. Fergin, S. G.: Respirator Evaluation for Carbon Setters with
Beards. Am. Ind. Hyg. Assoc. J. 45(8):533-537 (1984). 22. Cohen, H. J.: Determining and Validating the Adequacy of
Air-Purifying Respirators Used in Industry Part I--Evaluating the
Performance of a Disposable Respirator for Protection Against Mercury
Vapor. J. Int. Soc. Respir. Prot. 2(3):296-304 (1984). Note: Fit-testing was
not conducted in the studies discussed in References
19-22.
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need
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cartridges
2.0 offers new features
Voluntary use and related issues
courses for 2000
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3M Service
Life Software Version 2.0 offers new features 3M has introduced new features and improvements to its
software that helps calculate end of service life for 3M organic vapor
respirator cartridges. 3M Service Life Software Version 2.0 is available in
web-based and downloadable
versions. It also is integrated with 3M Select Softwareฉ. Version 2.0 has these new features: Mixtures: Enter mixtures of organics,
inorganics or both User-entered contaminants: Enter your own
organic vapor contaminants New contaminants: Several inorganics and
organic gases are now available: - Ammonia - Hydrogen fluoride - Hydrogen sulfide - Methylamine - Sulfur dioxide Correction factors: Enter user-selected
correction factors to account for uncertainties Humidity: Access information about
humidity effects and suggested correction factors to account for the
effects. It also calculates service life based on workplace
conditions such as contaminant concentration, temperature, work rate and
atmospheric pressure. This software offers users an easy method for
calculating end of service life for 3M respirator cartridges. Cartridge
service life is the estimated period of time before breakthrough under
specific conditions. This information can be used to establish an
appropriate change schedule. The recently revised OSHA respiratory protection
standard, 29 CFR 1910.134, requires users of chemical cartridge
respirators to implement a cartridge change schedule based on "objective
information or data" to help prevent worker overexposure. OSHA believes
that chemical odor "breakthrough" is no longer an adequate indicator of
when to change cartridges. 3M's Service Life Software is based on a model
developed by G.O. Wood and published in the American Industrial Hygiene
Association Journal, January 1994. An appropriate cartridge change schedule is one that
is both convenient and assures that the concentration of the chemical
downstream does not exceed the exposure limit. For example, a cartridge
may have a breakthrough time of 15 hours for a given vapor. Changing
cartridges at the end of a normal work shift is convenient, and this
period of use is less than the breakthrough time. Several methods can be used to estimate breakthrough
times (i.e. service life). These vary in cost, complexity and precision.
All methods require professional judgment to establish an appropriate
change schedule and all require the same basic
information. Do I need
a respiratory protection program if...? By Larry L. Janssen,
C.I.H. Since it was first published in 1971, the Occupational
Safety and Health Administration (OSHA) respiratory protection regulation,
29 CFR 1910.134, has listed the elements of a respiratory protection
program. The program elements include: Proper respirator selection; Training; Fit-testing; Medical evaluation; Maintenance procedures, including cleaning,
inspection, repair and storage; Procedures for proper respirator
use; Breathing air quality assurance for atmosphere
supplying respirators; Program
evaluation. These elements are intended to maximize respirators'
ability to reduce air contaminant exposures and to assure that misuse of
respirators does not create hazards for users. Exposures below the PEL
OSHA has always required employers to have a complete
respiratory protection program when respirators are used to protect
employees from air contaminant exposures above the OSHA Permissible
Exposure Limit (PEL). However, respirators are often used in two
situations in which the PEL is not exceeded: 1. When employer policy requires respirator use for
specific operations; 2. When employees ask to wear respirators, and the
employer permits their use, i.e., voluntary respirator use. It should be emphasized that exposure assessment
(preferably air sampling) is necessary to determine whether overexposures
exist. OSHA specifies
requirements
OSHA's original respiratory protection regulation did
not identify respiratory protection program requirements for situations in
which there is no overexposure. However, the January 8, 1998 revision to
1910.134 specifies the respirator program elements that are necessary when
respirators are used for exposures below the PEL. When employer policy requires respirator use, the
program requirements are stated very simply: all elements of a respiratory
protection program must be in place. An employer's decision to require
respirator use indicates a belief that a hazard may exist although the
OSHA PEL is not exceeded. For example, the employer may decide to control
exposures to a lower, advisory exposure limit, such as the Threshold Limit
Value (TLVฎ). It clearly makes sense to maximize respirator effectiveness
with a complete respiratory protection program, since protection from a
perceived hazard is intended. Voluntary use
Before discussing OSHA's program requirements for
voluntary respirator use, it is important to state clearly what voluntary
use is and is not. Voluntary use means that: An exposure assessment has been
conducted; The PEL is not exceeded; No OSHA regulation requires that respirators be
provided by the employer (For example, 1910.1025, requires employers
to provide respirators upon request to employees exposed to lead at
any concentration); The employer does not believe it is necessary to
reduce exposures below their current levels, i.e., there is no
perceived hazard; The employer does not require, recommend,
encourage or suggest that respirators be used; Workers ask to wear
respirators; The respirators will not be used for emergency
response or escape. If one or more of these conditions are not met,
respirator use is not voluntary; a complete respiratory protection
program is required. If respirator use is permitted and all of the above
conditions are met, a voluntary use situation exists. Paragraph (c)(2) of
1910.134 requires a limited respiratory protection program in this case.
The only program elements specified are those that OSHA believes will
prevent respirator use from creating a hazard to the user. These
are: Medical evaluation, principally because the
breathing resistance associated with negative pressure respirators
may be intolerable to a few individuals; Cleaning, storage and maintenance, because a
respirator contaminated by improper storage and/or not cleaned could
promote skin irritation or similar problems; and Minimal training, i.e., the information found in
Appendix D of the regulation. A puzzling exemption
Interestingly, for voluntary use of filtering
facepiece respirators, which OSHA also calls dust masks, the regulation
contains an exemption from two of these program requirements. Workers who
wear filtering facepieces voluntarily need only be provided with the
information in Appendix D. This exemption is puzzling for the following
reasons: A filtering facepiece of a given class, e.g.,
P100, has approximately the same breathing resistance as the same
filter type used in an elastomeric facepiece; A filtering facepiece that is stored improperly
could become contaminated and cause the same problems that a
contaminated elastomeric facepiece can cause; When use of filtering facepieces is required
because of overexposure or employer policy, the situation is handled
in exactly the same manner as with any other respirator: a complete
respiratory protection program is
required. For these reasons, filtering facepieces and other
respirators should not be treated differently in voluntary use situations.
The same program elements that are appropriate for elastomeric respirators
should be implemented for filtering facepieces. Consider additional
program elements
Finally, employers must decide if OSHA's voluntary use
program requirements are sufficient for voluntary use in their workplaces.
Additional program elements should be considered in many situations. The
following two examples illustrate this point: 1. OSHA does not require procedures for proper
respirator use in voluntary situations. This omission permits
misuse, such as wearing a beard with a tight-fitting respirator.
This practice is prohibited when respirator use is required. At the
very least, allowing voluntary respirator users to have beards would
cause administrative problems if workers in another part of the
facility are required wear respirators and be clean-shaven. For this
reason, (and others; see example 2) many employers may choose to
require voluntary respirator users to be
clean-shaven. 2. Fit-testing is not required for voluntary use.
Employers must determine if waiving fit-testing is compatible with
their reasons for allowing respirators to be used voluntarily. If
the goal of voluntary use programs is enhancing employees' comfort,
with the full understanding that there is no real or potential
hazard present, employers may be comfortable not requiring
fit-testing. Specifically, a non-hazardous atmosphere leaking into
the facepiece is not a concern. Conversely, employers who believe
that exposures should be reduced to the lowest possible level, even
when there is no known hazard, will include fit-testing in their
voluntary use programs. Given the litigious nature of our society, many
employers will no doubt conclude that it is prudent to maximize
respirators' effectiveness whenever they are used. If so, they will elect
to implement complete respiratory protection programs for voluntary
use. TLV is a registered trademark of the American
Conference of Governmental Industrial
Hygienists. 3M
OH&ESD announces training courses for 2000 Are you interested in learning the latest available
information on establishing a cartridge change schedule? Do you want
hands-on experience in analyzing breathing air quality? Are you an
experienced respirator program administrator who just needs to know
"3M Canada Occupational Health and Safety What's New" in respiratory protection regulations and technology? 3M has
a unique program to respond to these and many more professional
development requirements. Two training courses are offered to provide
individuals involved with a respirator program the information they need
to operate their program effectively. The courses are unique among those
offered by respirator manufacturers in that they are based on the
technical and regulatory aspects of a sound respirator program rather than
specific products. In fact, a large equipment display from a number of
respirator manufacturers is used to supplement the classroom and workshop
presentations. Respiratory Protection is a comprehensive four
and one-half day course intended for anyone involved with managing all or
part of a respiratory protection program. All respirator types and each
element of a respirator program are thoroughly discussed. Workshop
sessions are used extensively to reinforce the course material.
Current Topics in Respiratory Protection is a
two-day course designed to provide the latest in technical and regulatory
information to experienced program managers. The schedule of course locations and dates for 2000 is
listed below. To find out more about these courses, do one of the
following: Contact your 3M Sales
Representative; Phone 1-800-659-0151, ext. 275; Visit our web site at www.3M.com/occsafety; Dial the 3M Fax On Demand system at
1-800-646-1655.
Respiratory Protection San Diego, CA January 24-28 Williamsburg, VA March 13-17 Nashville, TN April 10-14 Minneapolis, MN July 10-4 Seattle, WA September 11-15 Phoenix, AZ October 23-27
Current Topics in Respiratory Protection Nashville, TN April 17-18 Minneapolis, MN July 17-18
Tech
line To reach 3M's Technical Service staff with questions regarding
our products, you can call 1-800-243-4630. If you wish to contact
your local sales representative, you can leave a message by calling
1-800-896-4223.
Voluntary use and related
issues
Larry Janssen is a Certified
Industrial Hygienist with the 3M OH&ESD Laboratory.