United States Environmental Protection Agency Risk Reduction Engineering Laboratory Cincinnati OH 45268 Research and Development EPA/600/S2-89/014 Jan. 1990 v°/EPA Project Summary Evaluation of New In-Facepiece Sampling Procedures for Full and Half Facepieces Warren R. Myers and Richard W. Hornung The manufacture, handling, and use of new chemical substances often require a level of personal protection that includes respirators. Because of the need for these respiratory pro- tection devices, processes to eval- uate penetration of full and half facepiece, negative-pressure respira- tors were studied. The precision and bias were determined for five methods of sampling for inboard penetration through different areas of the face seal. The sampling procedures evalu- ated were: continuous, low sampling rate, flush on the respirator, mid- nose-mouth probing (CLF); continu- ous, high sampling rate, deep front- of-mouth probing (CHD); pulsed, exhalation, deep front-of-mouth prob- ing (FED); exhalation valve discharge (EVD); and pulsed, inhalation, deep front-of-mouth probing (PID). The CLF procedure represents current in-face- piece sampling practice in the United States. Based on evaluation with nine full facepiece respirators, the mean sam- pling biases were CLF: -21%; CHD: -3%; PED: 0.7%; EVD: -14%; and PID: -12.3%. For five half facepiece res- pirators, the mean sampling biases were CLF: -26%; CHD: -13%; PED: -4%; EVD: -2%; and PID: -24%. To some extent, the location of the face seal penetration, and the design of the respirator affected the bias of each method. This Project Summary was devel- oped by EPA's Risk Reduction Engi- neering Laboratory, Cincinnati, OH, to announce key findings of the research project that is fully documented In a separate report of the same title (see Project Report ordering information at back). Introduction A variety of protective clothing and equipment is often necessary to protect workers during the manufacture, hand- ling, and use of new chemical sub- stances. In most cases where a need for respiratory protection exists, air-filtering, negative-pressure, full and half facepiece respirators are recommended. Because of the inherent danger of exposure to such chemicals, extra care often must be taken to ensure worker protection. Various fit test procedures are used or have been suggested for evaluating the quantitative fit and protection of full and half facepiece, negative-pressure respira- tors. Recently published data has, however, demonstrated that the proced- ure commonly used in the United States is subject to large sampling biases. Factors that appear to contribute signifi- cantly to this bias include: location and depth of the sampling probe; location of the face seal leak; whether the wearer is breathing through the nose or the mouth; the aerosol size selectivity of different leak sizes; and the inspired air flow patterns and air mixing produced by ------- different facepiece designs. Consequent- ly, the presently used test provides less than the desired level of assurance that full protection is being achieved. This research sought to evaluate the bias and precision of alternative in- facepiece sampling procedures and compare them with the CLF procedure currently in wide use in the United States for both full and half facepiece respirators. The goal of the evaluation was to identify and recommend, if possible, an in-facepiece sampling procedure with lower bias and greater precision. Test System The system used to test the various respirators consisted of an acetone vapor generation and dilution system and an air/acetone feed line to one of the leak sites on the face seal of the respirator test setup. Each respirator, equipped with organic vapor cartridges, was mounted on a headform manikin with an airtight face seal. The headform could simulate nose or mouth breathing at a relatively constant rate between 18 and 19 cycles/ min, by the use of a breathing machine. Leaks simulated by a hypodermic sy- ringe needle were positioned in the various areas of the full and half masks. The syringe needle was connected to the acetone system, and inboard flow of acetone resulted from the negative pressure created during each inhalation cycle. For pulsed sampling during inhalation or exhalation, a pressure sensitive switch activates a three-way solenoid valve attached to the in-facepiece sampling line. A calibrated flame ionization detec- tor measured real-time acetone concen- tration in the collected samples. The "true" acetone concentration was meas- ured in the line between the headform and the breathing machine. The appa- ratus is shown schematically in Figure 1. Experimental Design The experimental design for the full facepiece respirators was a fixed effects factorial model that considered three leak sites, two leak sites, and five sampling methods on nine models. The nine selected models were those brands (with- out nose cups) currently certified by NIOSH: American Optical, Cesco, Glen- dale, MSA, North, Pulmosan, Scott, USD, and Willson. Based on preliminary testing, the (6) could best be measured as the of the difference between the in-f piece acetone concentration (C) and "true" concentration (CX): B = (6 - C/)C/ The experimental design was then si as an analysis of variance with B a dependent variable measured at d nated levels of the four factors: leak leak size, sampling method, and moc For half facepiece respirators, 5 c 16 NIOSH-certified respirators tested: American Optical, MSA, 5 USD, and Willson. Sampling Methods and Procedures CLF Sampling Procedure This is a continuous, low samplin (1 L/min, during inhalation and exhal procedure with the sampling i mounted flush on the body of the piece in the area between nose mouth. The manikin headform is sel simulate nose breathing. Solenoid Unbiased Sample Site Breathing Machine Dilution Air Flgun 1. Experimental test system used to evaluate the bias in different methods of sampling for inboard, face seal, penetration on h full facepieces. ------- 3HD Sampling Procedure This is a continuous, high sampling rate (5 L/min during inhalation and exhalation) procedure with the sampling probe extended into the facepiece cavity and located in front of the mouth. The manikin simulates mouth breathing. 'ED Sampling Procedure In this method, pulses of air (contam- nated with acetone) are collected from he facepiece only during exhalation jsing a deep probe location. The manikin imulates mouth breathing. It has been Jetermined that sampling through the srobe is not the same as sampling from he exhalation valve of the respirator. EVD Sampling Procedure This method employs high rate (5 ./min continuous sampling of the air discharged through the exhalation valve M the respirator whereas the manikin imulates mouth breathing. 3ID Sampling Procedure This procedure collects a pulse of air Juring inhalation, with the use of a deep Drobe location. Results and Discussion Because problems were encountered with the small leak size in the full acepiece respirators, data analysis was limited to the larger leak size. This reduced the number of variables to three. Note that the test system did not simulate any lung retention; this could increase average sampling bias values. Further, the test program was done with the use of a vapor challenge agent; very different results, with larger bias values, might be obtained with conventional oil mist or sodium chloride fit-tests or tests in workplace environments. Because the five methods of testing varied considerably, statistical analyses were computed separately for each method. This study confirmed earlier results that the sampling bias is influenced by the leak location. It also indicated that the design of the facepiece influences the effect of leak location. Of the five methods, the FED sampling procedure consistently gave the lowest sampling bias and the best precision in the full facepiece respirator tests. It also was less sensitive to the location of leak than was the CHD procedure. The EVD and PID procedures, although not as good as the RED and the CHD sampling procedures, still gave smaller (and ap- proximately equivalent) sampling biases than did the conventional CLF procedure. Based on a combined measure of pre- cision and bias in which each factor is given equal weight (see Table 1), the ranking of the five methods would be: RED > CHD > EVD > PID > CLF With the half facepiece respirators, the strongest interaction existed between sampling method and manufacturer (design). Three-way interactions among manufacturer, leak size, and leak location were also significant in all but the EVD procedure. Although not as clear as with the full face pieces, the RED procedure again produced better mean sampling biases than did the conventional CLF procedure or the CHD procedure. Sur- prisingly, the EVD procedure produced much smaller biases with the half facepieces than it had with the full facepieces and was approximately equiv- alent to the RED procedure. Both the PID procedure and the conventional CLF procedure produced poorer results in the statistical analysis. Table 2 summarizes the precision and bias for the half face- pieces. Based on the combined results, the methods would be ranked in the following order: EVD > RED > CHD > CLF > PID Based on the data with both half and full facepiece respirators, the RED sam- pling procedure appears to be signif- icantly more.precise and less biased than the conventional CLF sampling proce- dure now widely used in the United States. On that basis, it should be considered as a replacement for quan- titative fit testing. Before a procedure change is made, however, it may be necessary to learn more about the RED procedure. For example, whereas the testing in this study was done at a 5 L/min sampling rate during exhalation, the effect of lower flowrates on bias needs to be evaluated, as will the effect of relative humidity on test validity and the effect of lung retention. Conclusions and Recommendations Several alternative sampling methods for in-facepiece respirator testing were evaluated and compared with a method widely used in the United States. Based on these tests, two of the alternative methods are clearly superior to the conventional CLF (continuous sampling, low flow, flush probe) method in sam- pling precision and bias. Of these, the RED method (pulsed sampling, exhala- tion, deep probe) appears to be superior for both full and half facepiece respira- tors. The RED procedure, however, will require further validation and equipment modifications before it can be substituted for the current test method. Until that is done, another of the alternatives, the CHD sampling procedure (continuous sampling, high flow, deep probe), should replace the conventional method with the use of CLF equipment. Table 1. Test Results for Five Procedures on Nine Full Facepieces Procedure Precision SO Mean Bias § Combined Measure" Ft CLF CHD PED EVD PID 81 81 81 80 81 14.0 11.8 5.0 11.9 21.0 -21.3 -3.4 0.7 -14.2 -12.3 25.5 12.3 5.0 18.5 24.3 Table 2. "R = (SO2 + B2)112 Test Results for Five Procedures on Five Half Facepieces Procedure CLF CHD PED EVD PID n 60 60 60 60 60 Precision SO 74.0 11.7 5.0 3.0 29.2 Mean Bias 8 -25.9 -12.5 -3.7 -2.3 -24.1 Combined Measure' R 29.4 17.1 6.9 3.8 37.9 •R = (SD2 * 82; "2 ------- The full report was submitted in ful- fillment of Interagency Agreement No. DW 75931135-01-2 by The National Institute for Occupational Safety and Health, under the sponsorship of the U.S. Environmental Protection Agency. Warren R. Myers is now with West Virginia University, Morgantown, WV 26506; and Richard W. Hornung is with the National Institute for Occupational Safety and Health, Cincinnati, OH 45226. Raymond M. Frederick is the EPA Project Officer (see below). The complete report, entitled "Evaluation of New In-Facepiece Sampling Proce- dures for Full and Half Facepieces," (Order No. PB 89-181 2421 AS; Cost: $13.95, subject to change) will be available only from: National Technical Information Service 5285 Port Royal Road Springfield, VA22161 Telephone: 703-487-4650 The EPA Project Officer can be contacted at: Releases Control Branch Risk Reduction Engineering Laboratory—Cincinnati U.S. Environmental Protection Agency Edison, New Jersey 08837 United States Environmental Protection Agency Center for Environmental Research Information Cincinnati OH 45268 U-S.QFRCiALMAlL Official Business Penalty for Private Use $300 EPA/600/S2-89/014 000085B33 I0, ------- |