Respiratory Protection Newsletter August All rights reserved, Roy McKay, Ph.D.

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1 Respiratory Protection Newsletter August All rights reserved, Roy McKay, Ph.D. Featured Courses: Respirator Overview & Fit Testing Workshop: October 25-27, 2016 in Cincinnati Fit Testing Refresher & Advanced Topics: November 3, 2016 in Cincinnati Performance of Improperly Sized PAPR Facepieces Some manufacturers provide different size facepieces for Powered Air-Purifying Respirators (PAPRs). This is true for elastomeric and loose-fitting facepieces such as the one shown in the photo at right. Because an employee may select the wrong size facepiece, researchers at the University of Cincinnati studied the protection level offered by a PAPR equipped with an improperly sized loosefitting facepiece (see photo). In addition, studies were conducted on a stretched-out (damaged) loose-fitting facepiece to evaluate performance when a damaged facepiece is not removed from service. Improperly sized facepieces representing two models as well as a stretched-out facepiece were tested on a manakin using a variety of flow patterns and speeds. The facepieces were intentionally chosen to be larger than the optimal size for a respirator wearer. In other words, the study was intended to evaluate what might happen if a smaller sized person used a large facepiece or if a stretched-out facepiece was used. For this study, facepieces were donned onto a manikin and challenged with sodium chloride (NaCl) aerosols in an exposure chamber. Four cyclic flows with mean inspiratory flows (MIFs) of 30, 55, 85, and 135 L/min were applied using a breathing system. Results were expressed as manikin Fit Factor (mff), determined as the ratio of aerosol concentrations outside (Cout) to inside (Cin) of the facepiece. As expected, manakin fit factors (mff) decreased exponentially with increasing mean inspiratory flows (MIF). Manakin fit factors for the stretched-out (damaged) facepiece were significantly lower than those obtained for the undamaged ones. It was concluded that an improperly sized facepiece might potentially offer relatively low protection (mff < 250) at high to strenuous workloads. Acceptable levels of protection are likely to be achieved with mild to moderate work rates. Testing was also performed with constant inhalation flows with results similar to those obtained with cyclic flows. The findings suggest that program administrators need to equip employees with properly sized facepieces and remove stretched-out (damaged) facepieces from workplace. Manufacturers should emphasize the importance of proper sizing with their user instructions. Although not studied directly, the results provide some insight as to the performance of a loose fitting facepiece when worn with facial hair. Based on these findings, for the make and model studied, I would suspect that a well trimmed beard would have an effect similar to an improperly sized facepiece. For additional information, go to the original source: Gao, McKay, Yermakov, et.al. Performance of an improperly sized and stretched-out loose-fitting powered air-purifying respirator: Manikin-based study. J Occup Environ Hyg 13: , Respirator Program Administrator Training Attend at least four days of respirator training from three different training categories and earn a certificate for Respirator Program Administrators. For additional information, us at info@drmckay.com Fit Checks - Really??? Back on May of this year I conducted respirator training and fit testing for a new client. Prior to arrival, the client purchased a brand new respirators from a national distributor. I won t mention the brand name here. None of the boxes had been opened and respirators were in sealed bags. While reviewing manufacturer instructions, I was surprise to see the words Fit Checks rather than user seal or wearer seal checks. Nearly 20 years ago OSHA stopped using the term Fit Checks. Neither NIOSH 2016, All rights reserved, Roy McKay, Ph.D. Pg 1 of 11

2 or ANSI use this terminology. It s disappointing when instruction manuals don t use recommended terminology. Recently, the American Industrial Hygiene Association s Respiratory Protection Committee published new and revised respiratory protection terms. A sample of new terms is located towards the back of this newsletter. Fit Testing Refresher & Advanced Topics This 1-day course is specifically designed for the person who has been conducting fit testing, but needs a better understanding as to why poorly fitting respirators pass and why good fitting respirators fail. This class provides an opportunity to learn better donning techniques and discuss advanced topics not covered during a typical 2-day fit testing workshop due to time limitations. This course is also valuable for respirator program administrators who need a better understanding of fit testing procedures and assurance that their fit testing program is being run properly. Nov 3, 2016 Some N95 FFRs are Fluid-Resistant Laboratory testing by NIOSH and another independent testing laboratory found that four of six (4 of 6) models of N95 filtering facepiece respirators (FFRs) were resistant to fluid penetration by synthetic blood. These findings are interesting, since fluid resistance is a Food and Drug Administration (FDA) requirement for medical masks and surgical N95 respirators, but not a requirement for NIOSH approval. If all N95 FFRs had sufficient fluid resistance, this could potentially increase the supply of respirators for healthcare workers who need protection from occupational exposure to sprays and splashes of blood and other potentially infectious body fluids in public health emergencies, such as flu and other outbreaks. To test fluid resistance, synthetic blood was sprayed on six different NIOSH-approved N95 FFR respirator models at speeds designed to mimic those that may occur during medical procedures. They found that four of the six (66%) were resistant to the synthetic blood. Two of six respirator models (33%) did not to have sufficient resistance to synthetic blood. Consequently, just because an N95 FFR has NIOSHapproval, this alone doesn t ensure it has sufficient fluid resistance to be protective against infectious aerosols generated from splashes and/or sprays of body fluids for use by health care workers. Therefore, at the present time, employees who need this protection should use a surgical N95 FFR having both NIOSH and FDA approval. For additional information, go to American Journal of Infection Control, 43: , Crystalline Silica Final Rule On March 25, 2016 OSHA published it s final rule for occupational exposure to respirable crystalline silica. OSHA determined that employees exposed to respirable crystalline silica at the previous permissible exposure limits faced a significant risk of impairment to their health. OSHA reported the new rule will curb lung cancer, silicosis, chronic obstructive pulmonary disease and kidney disease in America's workers by limiting their exposure to respirable crystalline silica. OSHA estimates 2.3 million American men and women face exposure to respirable crystalline silica in their workplaces, including two million construction workers who drill and cut materials such as concrete and stone, and 300,000 workers in operations such as brick manufacturing, foundries and hydraulic fracturing. OSHA estimates that when the final rule becomes fully effective, it will save more than 600 lives annually and prevent more than 900 new cases of silicosis. This final rule establishes a new permissible exposure limit of 50 micrograms of respirable crystalline silica per cubic meter of air (50 mg/m 3 ) as an 8-hour time-weighted average in all industries covered by the rule. The new rule reduces the permissible exposure limit to half the current limit for general industry and five times more stringent than the current exposure limit for construction. It also includes other provisions to protect employees, such as requirements for exposure assessment, methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and record keeping. Remember, when exposure limits change, maximum use concentrations (MUC s) change! Therefore, this will trigger revisions to applicable written respirator programs. The final rule is written as two (2) standards, one for construction and one for general industry and 2016, All rights reserved, Roy McKay, Ph.D. Pg 2 of 11

3 maritime. In addition to reducing the permissible exposure limit (PEL) for crystalline silica, the rule includes employer requirements such as limiting worker exposure through work practices and engineering controls (such as water or ventilation); providing respiratory protection when controls are insufficient; training workers; limiting their access to high exposure areas and providing medical exams to highly exposed workers. The final rule is effective on June 23, The rule staggers compliance dates to ensure employers have sufficient time to meet its requirements. Start-up dates for specific provisions are set in (l) for general industry and maritime and in (k) for construction. Source and additional information. Federal Register Vol. 81, No. 58, March 25, 2016 / Rules and Regulations 29 CFR Parts 1910, 1915, and 1926 [Docket No. OSHA ], RIN 1218 AB70. Top 5 Violations within the Respirator Standard Violations of the Respiratory Protection Standard are routinely one of the top five violations of the OSHA Act. Each year I list the top five OSHA violations in my newsletter. However, one may wonder which sections of the Respirator Standard are most frequently cited. With the help from T. Paz (a reader of this newsletter), here s the top 5 sections cited within the respirator standard for fiscal year 2014 as reported in Safety + Health. #1) (e)(1) Medical evaluation general requirements #2) (c)(1) Establishing and implementing a written respiratory protection program #3) (f)(2) Fit testing prior to first use, whenever a different facepiece is used, and annually #4) (c)(2)(i) Permitting employees to voluntarily use their own respirators if such use will not create a hazard #5) (d)(1)(iii) Identifying and evaluating respiratory hazards Total respirator violations were 3,626. Source: Safety + Health, December 2015, by Kyle Morrison TB on the Rise For the first time in nearly a quarter century, the number of US tuberculosis (TB) cases increased according to a report published in the March 25, 2016 issue of Morbidity and Mortality Weekly Report (65(11); ). Twenty-nine states and the District of Columbia had more cases in 2015 than 2014, raising questions about a possible resurgence of tuberculosis, known as one of the world's deadliest diseases. Since the disease can be spread through the air, respiratory protection is often needed for those in close proximity to infected persons. Reader Questions: Question: Do hooded respirators require a fit test? If so, how can this fit test be performed? Answer: The issue regarding fit testing of hoods is somewhat controversial and/or confusing. However if the hood is approved as "tight fitting", because it relies upon a tight seal (such as a neck dam), then it must be fit tested. Keep in mind that not all neck dams require a tight seal. Fit testing tight fitting hoods usually requires special equipment, but can be done. I ve done it, but most fit testers will require manufacturer assistance. Remember, "loose fitting" hoods don't require a fit test. Some loose fitting hoods also have data to support an APF of 1,000. Question: Does OSHA require the employer to pay for respirator medical clearance evaluations? Answer: Yes. The employer must pay for respirator medical clearance evaluations. In addition, the questionnaire and/or any medical examinations must be administered confidentially during the employee s normal working hours or at a time and place convenient to the employee. Furthermore, although the employer pays for the evaluation, the employer is not permitted to review the employee s responses to the questionnaire. The 2016, All rights reserved, Roy McKay, Ph.D. Pg 3 of 11

4 responses and results of any medical testing are confidential. Spirometry Refresher Reminder If you took your initial NIOSHapproved spirometry training in 2011, you re due for a refresher in Respirator Use in Hospitals An article by Lisa Brosseau and colleagues reported respirator program compliance and respirator use in a rural and urban hospitals. For this study, they also observed donning and doffing procedures for 77 health care workers using filtering facepiece respirators (FFRs). They found the most frequent deficiencies were failure to correctly place respirator straps in accordance with manufacturer recommendations, perform user seal checks, and failure to properly remove the respirator facepiece. Failure to identify the respirator program administrator was reported to be a serious deficiency in many written respirator programs. Failure of respirator wearers to recognize their program administrator is a problem I ve identified in settings using elastomeric facepieces. In the Brosseau study, 7-9% of managers believed that health care workers could wear a respirator model or size to which they had not received a fit test. Compounding this problem is the fact that most health care workers wear respirators infrequently. Consequently, they may not remember which make, model and size respirator they were fitted to or remember how to put it on. In the hospitals evaluated by Brosseau, training was often too short in duration (often just 15 minutes) to provide an acceptable level of training. This suggests that inadequate attention is likely given to the range of training topics required by OSHA. One limitation of this study was that health care workers knew they were being observed. Consequently the donning and doffing procedures may not have been representative of actual use. If true, the deficiencies reported in this study may be underestimated. For additional detail, go directly to the source: L. Brosseau, et.al., Journal of Occ & Environ Hyg, 12:1-15, Is it Necessary to Fit Test N95 Respirators? Whenever respirators with tight fitting sealing surfaces are required to be worn, they must be fit tested to the individual. This is true for N95 Filtering Facepiece Respirators (FFRs), which are often called N95s by healthcare workers. Fit testing serves several purposes and is the only way an employer and employee can confirm that a specific make, model, style and size facepiece provides an acceptable fit. In addition, it verifies that the respirator wearer can correctly position the respirator on the face. There are other reasons for fit testing, such as, but not limited to the fact that subjects who pass a fit test are more likely to achieve a higher level of protection than those who don t. For example, a number of studies, including several published by NIOSH researchers have found that subjects passing a fit test had higher simulated workplace protection factors (SWPFs) than subjects who did not undergo fit testing. In one NIOSH study, an initial cohort of 229 subjects were fit tested twice a year over a 3 year period. The study found that the percent of workers whose respirator did not fit, increased with increasing length of time between fit tests. Additionally, twenty-four percent of subjects who lost more than 20 pounds no longer maintained an acceptable fit. Reduction in Respirator Related Fatalities In 1998, OSHA released the first major overhaul to the respiratory protection standard This revision to the original standard has many significant changes and improvements. However, one may question whether or not these changes had any significant impact on worker protection. To answer part of this question, Cowan and colleagues analyzed fatality reports from 1990 to 2012 to characterize historical trends in fatalities associated with respirator use. The study was designed to determine if revisions to the respirator standard had any measurable reduction in respirator associated fatalities. During the time span of study ( ) they identified 174 respirator related deaths. The majority of these fatalities were associated with using an airline respirator or the absence of using a respirator in respirator required spaces. They reported 79% of fatalities were associated with asphyxia. Reductions in fatality rates over time appeared to be associated with revisions to the respirator standard, although other variables may have influence these rates, such as control measures. Since this paper was published immediately before release of this newsletter, I haven t had the time to 2016, All rights reserved, Roy McKay, Ph.D. Pg 4 of 11

5 thoroughly evaluate and summarize their findings. I plan to do so in my next newsletter. In the interim, if you re interested ion this topic, go directly to the source: Evaluation of reported fatality data associated with workers using respiratory protection in the United States ( ), by Cowan, Benson, Cheng, et. al. Archives of Environmental & Occupational Health, Wanted: Damaged Fit Test Adapters Rather than throwing away damaged fit test adapters, consider donating them to our fit testing workshops. We strive to make our fit testing workshops as realistic as possible. Incorporating damaged along with mostly good fit testing adapters provides a valuable training experience. If you wish to make a donation, please us at info@drmckay.com Spirometry Refresher: September 13, 2016 in Cincinnati Interpretation of Spirometry: Beyond the Numbers September 14, 2016 in Cincinnati Go to for details. Announcements from NIOSH Respirator & PPE Database NIOSH recently developed an online database (PPE-INFO) to help determine which respirator and other PPE standards must be met by a specific type of equipment. The database compiles federal regulations and consensus standards (such as ANSI and others) for respirator and non-respiratory PPE. The database is a tool which can be useful for standards developers, certification organizations, manufacturers, purchasers, end users, safety and health professionals, and researchers. NIOSH claim the information in the database can be used to help determine whether a product meets a certain standard, and whether the performance requirements of that standard meet their need. Check it out at: Revised Respirator Certified Equipment List Based on previous comments and suggestions from stakeholders, NIOSH has recently updated the Respirator Certified Equipment List used to help respirator users, safety managers, industrial hygienists, and others. Reasons for using the certified equipment list are: 1) To determine if a given respirator is NIOSHcertified, 2) Assist with the selection of an appropriate respirator to protect against specific hazards 3) Locate correct replacement component parts The Certified Equipment List is regularly updated as respirators are approved, made obsolete, or the status changes in any way. Enhancements to the 2016 edition include expansion of searching capability to include TC (approval) number, type of respirator (i.e., filtering facepiece), manufacturer or brand, etc. Some features available on the original version, are still to be updated by NIOSH. Here s how to get to the new site: 2016 Reformatted Certified Equipment List ( Aftermarket Replacement Parts for Respirators NIOSH Fact Sheet (Publication number ): Use of Aftermarket Replacement Component Parts for NIOSH-Approve Respirators was released earlier this year. The fact sheet points out that worker safety can be compromised by using replacement component parts or accessories that are not NIOSH-approved for the specific respirator. Program administrators, employers, and users are reminded that the use of components which are not part of the approved assembly results in a respirator that has not been evaluated and certified by NIOSH. Unevaluated respirator assemblies may not function at the expected level of protection, putting the worker at risk for exposure to airborne hazards. NIOSH issues certificates of approval for specific and complete respirator assemblies. The approval is granted after the respirator has been evaluated, tested, and found to be in compliance with all of the applicable requirements of the NIOSH regulations in Title 42, Code of Federal Regulations, Part 84. Unapproved parts appear to be more common with industrial SCBA users who switch out cylinders with those from another manufacturer or switching atmosphere supplying hoses for airline respirators with those from a non-approved source. Switching something as simple as an inhalation valve from one manufacturer to another voids the NIOSH approval. Remember, 2016, All rights reserved, Roy McKay, Ph.D. Pg 5 of 11

6 when replacing respirator component parts, be sure to use manufacturer approved parts specific for that respirator. If unsure, check the respirator user manual or contact the respirator manufacturer. NIOSH CBRN Letter to Users and Manufacturers On May 20, 2016 NIOSH released a letter to inform both users and manufacturers of a recent interpretation regarding configuration of a newly developed full facepiece air purifying respirator with CBRN approval. In this particular case, the manufacturer (Avon Safety Systems, Inc.) was granted approval for a low profile CBRN APR respirator configuration with a novel canister connector. You may recall that after September 11, one problem for emergency responders was the inability to connect cartridges and canisters from one manufacturer with another. Therefore, in response to this problem, guidelines for CBRN respirators were implemented that permitted interchangeability. Unfortunately, this requirement may also impede innovative designs. For example, a low profile canister. The letter released by NIOSH is intended to inform users and manufacturers that the low profile design by this manufacturer meets the requirements of the CBRN APR statement of Standard. The innovative feature is a breakaway universal thread adapter supplied on every air-purifying canister. The as-supplied, air-purifying canister fully conforms to the standard and may be utilized for emergency interchange in the exact same manner as any of the other air-purifying canisters approved to date. Similarly, the as-supplied facepiece is capable of receiving any of the other approved air-purifying canisters. The unique aspect is that users who have both the Avon facepiece and Avon canister can achieve the low profile feature by removing the threaded adaptor piece and connecting the air-purifying canister directly to the facepiece. The May 2016 letter summarizes conditions critical for Maintaining conformance with CBRN standards. Firefighter Fatalities in the US: Calendar year 2015 The NFPA recently made available a report from a study it conducted on firefighter fatalities during 2015 (authors: R. Fahy, P LeBlanc & J. Molis). The 30+ page report is available on the NFPA web page and takes into consideration type of duty at time of fatal injury, cause and nature of injury, age, type of incident and type of property involved in fires. The study includes career and volunteer firefighters. Of interest are narrative descriptions of several of the fatal incidents that occurred during the year. Some highlights from this report are: * There were 68 on-duty firefighter deaths in * Sudden cardiac deaths accounted for a majority of the deaths (51%). * Crashes usually account for the second highest share of the deaths. * The number of volunteer firefighter deaths was the second lowest total ever reported. Respiratory Protection with Advanced Safety and Comfort The Asian Section of the International Society for Respiratory Protection (ISRP) will host the 18th International Conference in Yokohama Japan November 7th to 11th, The host location will be the Hotel New Grand Yokohama, in Yokohama Japan. The theme of the conference is "The Safe Use of Respiratory Protective Devices by More People who Need Respiratory Protection." Each section of the ISRP (Americas, Asian, Australian, European, and Korean) will present information on the activities of "Fit Testing and Education of Respirator Wearers'" in their respective section. An exhibition of respiratory protective devices and instruments will be displayed. Other sessions will present new technologies, standards, evaluation methods, and instruments. Detailed information on the conference and lodging is available on the website The Asian Section members look forward to welcoming specialists in respiratory protection to share valuable scientific and technical information in Yokohama. Mark the Date for ISRP 2018 Beginning Sunday, September 16, 2018 the International Society of Respiratory Protection (ISRP) 2018 International Conference will be held in Denver, Colorado. This is the premier conference 2016, All rights reserved, Roy McKay, Ph.D. Pg 6 of 11

7 dedicated to respiratory protection. Mark the date in your calendar now to avoid future conflicts. New Terminology for Respiratory Protection In 2016, the AIHA Respiratory Protection Committee completed a project to compile new and revised definitions for respirator terminology. In particular, protection factors and fit factors. Originally, the term protection factor was intended to express the level of protection a given type of respirator would provide when worn. Mathematically, it is commonly expressed as the ratio of challenge agent outside a respirator (Co) to that which would penetrate into the wearer s breathing zone (Ci). The latest revision of this project was undertaken to clarify and refine minor issues, account for new measurement technology, and add terms for research that did not fit within any of the previous terms. The revised and newly added terms are intended to expand and clarify the meaning of measurements made under a wider variety of conditions. Below is a sampling of new and revised terms developed by the AIHA Respiratory Protection Committee. In each case, Co represents the measured or estimated concentration of contaminant in the air outside the respirator. Ci represents the measured or estimated concentration of contaminant in the air inside the respirator. In addition to definitions, comments are provided to improve clarify. For additional information, go to the original source identified at the end of this article. Keep in mind that the following definitions and comments should be in quotations, as they ve been copied from the article published in The Synergist. However, the AIHA Respiratory Protection Committee and The Synergist wish to promote widespread use of these new and revised terms. Assigned Protection Factor (APF) The minimum expected workplace level of respiratory protection that would be provided by a properly functioning and used respirator or class of respirators to properly fitted and trained wearers when all elements of an effective respirator program are established and are being implemented. Comments: When sufficient data exist, APF is based on statistical analysis (usually the lower 5th percentile) of a population of workplace protection factor measurements. The APF should be achieved at least 95 percent of the time a respirator is properly worn. APFs have also been established using simulated workplace protection factors or other information. The APF takes into account all potential sources of facepiece penetration (for example, face seal penetration, filter penetration, valve leakage). It does not account for factors that degrade protection such as poor maintenance, failure to follow manufacturer s instructions, and failure to wear the respirator during the entire exposure period. Fit Factor A numeric expression of how well a tight-fitting respirator fits a wearer during a fit-test. Comments: Fit factor represents the ratio of a challenge agent outside the respirator to the challenge agent that leaks into the respirator. Fit factors are most commonly aerosol or gas concentration ratios expressed as Co/Ci, but can also be derived using air flows or other challenges. This definition is not meant to preclude the use of novel methods. Laboratory Protection Factor A laboratory measurement of respirator performance on test subjects when one or more of the conditions for a simulated workplace protection factor (SWPF) is not met. Comments: These studies can be used to examine individual aspects of respirator performance. Examples include evaluation of particle penetration through improperly selected filters, performance of tight-fitting respirators that are not fit-tested, and improper air flow to atmosphere-supplying respirators. Program Protection Factor (PPF) An estimate of the respiratory protection provided to a worker in the context of a specific respirator program. Comments: PPF represents the contaminant concentration that the wearer would inhale if the respirator were not worn (Co) divided by the contaminant concentration inside the respirator as the respirator is used in the context of the existing respirator program (Ci). The inside of the respirator concentration may be estimated indirectly from biological monitoring as the airborne concentration expected to produce the measured biological index (except for contaminants with significant risk of skin absorption or ingestion, or if there is a substantial background level in body fluids from nonoccupational sources). The program protection factor is a measure of the effectiveness of the site s respirator program. Factors that may affect the program protection factor are the activity of the wearer in that setting, the motivation of the wearer, the fit of the respirator, respirator selection, the respirator design, training, maintenance, storage, supervision, program administration and monitoring, and any other variable that affects program effectiveness. If any of these program elements are deficient, the program protection factor 2016, All rights reserved, Roy McKay, Ph.D. Pg 7 of 11

8 will be adversely affected. Qualitative Fit Factor (QLFF) An estimate of the minimum fit factor for a specific tight-fitting respirator to a specific individual when a validated qualitative fit-test is passed that is, the test agent is not detected by the subject s senses. Comments: A validated qualitative fit-test is one that meets the sensitivity criteria of ANSI standard Z88.10 or is listed in 29 CFR For example, currently accepted qualitative fit-tests provide an estimated fit factor of 100. Quantitative Fit Factor (QNFF) The fit factor established during a quantitative fit-test for a specific tight-fitting respirator to a specific individual. Comments: QNFF is intended to represent facepiece to face seal leakage. Leakage from other sources (for example, air purifying elements, damage, and so on) is intended to be essentially zero. QNFF is measured with specialized instrumentation while the subject performs prescribed test exercises. Simulated Workplace Protection Factor (SWPF) A measure of respirator performance that is done in a laboratory using test exercises designed to simulate work. The respirator must be properly selected, fittested, worn, and used. Comments: SWPF is determined by simultaneously measuring a test atmosphere concentration outside (Co) and inside (Ci) a properly functioning respirator. Immediately sequential Co and Ci samples are acceptable. If the test atmosphere concentration is well controlled, Co samples may be shorter than Ci samples. Filter and/or cartridge penetration may or may not contribute to the Ci measurement. It may also be desirable to match the exposure and environmental conditions (for example, temperature, humidity, and so on) to those of the workplace. Workplace Protection Factor (WPF) A measure of the protection provided in the workplace, under the conditions of that workplace, by a properly selected, fit-tested, and functioning respirator while it is correctly worn and used. Comments: WPF is a direct measurement of respirator performance in a specific work environment. It represents the workplace contaminant concentration outside the respirator (Co) divided by the contaminant concentration inside the respirator (Ci). Co and Ci must be measured simultaneously, only while the respirator is properly worn and used during normal work activities. Immediately sequential Co and Ci samples of similar duration are acceptable when integrated sampling methods are not available, but must be used with caution. Filter and/or cartridge penetration may or may not contribute to the Ci measurement. Ci measurements made using respirators that are poorly maintained, improperly used, or not worn during the entire exposure period are inappropriate for WPF determination. Manikin Fit Factor (mff) An expression related to the amount of leakage measured through the face or neck seal of a respirator mounted to a manikin under specified airflow and environmental conditions. If the challenge to the seal is an airborne substance, mff is the ratio of its airborne concentration outside the respirator divided by the concentration that enters the respirator through the seal. If the challenge is airflow or air pressure, conditions and assumptions for quantifying leakage must be specified. Leakage from other sources (for example, air purifying elements) must be essentially zero. The respirator may be mounted to the manikin without sealants; be partially sealed to the manikin; or be sealed to the manikin with artificially induced leaks. Note: The first article in this newsletter is one of the first to use this new term. For a complete list of new and revised terminology go to the following source: Larry Janssen and Roy McKay. What's in a Definition? New Terminology for Respiratory Protection. The Synergist, 27(4), April: 34-37, Kudos to University of Cincinnati Respirator Researchers: A selection of presentations, awards, and publications from University of Cincinnati researchers. Performance of an improperly sized and stretched-out loose-fitting powered air-purifying respirator: Manikin-based study. Gao, McKay, Yermakov, et.al. J Occup Environ Hyg 13: , 2016 Medical Complications from Respirator Use OSHA requires respirator medical clearance for persons required to wear respiratory protection. Researchers at the University of Cincinnati are collecting information on persons who: 2016, All rights reserved, Roy McKay, Ph.D. Pg 8 of 11

9 1) developed a medical complication while wearing a respirator, and 2) identify pre-existing medical conditions causally related to the complication that developed. If you have information (published or un-published) that establishes a link between a specific medical condition and a complication that developed as a result from wearing a respirator, please share this information with us. We are particularly interested in cases where a medical complication was induced by respirator use. Information such as the specific type of respirator worn, work environment, duration of use, level of physical exertion, underlying medical conditions that contributed to the complication, etc., is needed. You can send this information to Roy@DrMcKay.com UC Honors: Congratulations to Shuang Gao. Winner of the John White Award given by the American Industrial Hygiene Association s Respiratory Protection Committee for best respirator paper published during calendar year 2015 in the Journal of Occupational and Environmental Hygiene. Shuang was a graduate student in our department and earned her doctoral degree for her research in respiratory protection at the University of Cincinnati. The title of the winner paper was: Penetration of Combustion Aerosol Particles Through Filters of NIOSH-Certified Filtering Facepiece Respirators (FFRs). Congratulations once again. Share Your Respirator Experience Here s an opportunity to contribute your knowledge and experience to others. If you have an interesting respirator selection or other challenging respirator problem (and solution), please submit it to info@drmckay.com. I may use your real-life problem to help train students in our graduate and continuing education programs in respiratory protection. This transfer of information will benefit others, maybe even your children or grandchildren. Respirator Training Courses: The University of Cincinnati is pleased to announce the following programs on Respiratory Protection and Fit Testing that may be of interest to your staff. They are: Fit Testing Refresher & Advanced Topics Nov 3, 2016 Overview of Respiratory Protection: Oct 25, 2016 Fit Testing Workshop (2-day): Oct 26-27, 2016 Fit Testing Workshop Quantitative (1-day): Dates to Be Determined Respirator Selection & Cartridge Change Out Schedule Workshop. April 26 & 27, 2017 (tentative) All courses are held in Cincinnati, unless noted otherwise. On-site training is available. Respirator Selection & Change Out Schedules This workshop provides guidance on respirator selection and the development of OSHA compliant change out schedules for respirator cartridges. A combination of lecture with practice problem sessions is used. The course is designed to teach students how to select a respirator based on workplace conditions (exposure level, type of contaminant, length of time to be worn, etc.). The selection process goes beyond the typical recommendation to "use a NIOSH approved air purifying respirator". Students will learn how to select a specific respirator as well as a specific filter/cartridge (when appropriate). More than a dozen guidelines for development of an OSHA compliant cartridge change out policy will also be taught, including common computer models and how to use them. Partial Listing of Topics Respirator Selection * Review of facepiece definitions and modes of operation. * Practical and theoretical basis for respirator selection based upon: Assigned Protection Factors (APF) - MUC s, HR s, IDLH, etc. * OSHA guidelines for respirator selection. - IDLH and non-idlh atmospheres. * Selection steps and information gathering procedures. * Minimum respiratory protection versus practical alternatives. * Filter selection issues - How to select an N, R, or P filter. - Why filter selection is influenced by exposures 2016, All rights reserved, Roy McKay, Ph.D. Pg 9 of 11

10 below the exposure limit. - How to choose a 95 versus 100 filter. * Practical methods for handling unknown concentrations without defaulting to an SCBA. * Calculating MUC s for mixtures. * Saturated Vapor Concentrations (SVC s) and selection concerns. * When a particulate filter may be needed for organic solvents. * Equilibrium Vapor Concentrations. * Selection Workshop - Practical problems and solutions. Development of Cartridge Change Out Schedules * OSHA recommendations for a change out policy. * Factors that affect cartridge service life. * Learn how to develop an OSHA compliant change out schedule. * Understanding the breakthrough curve. * Common methods used to define breakthrough. * What level of breakthrough should be used? * Work rate tables. * Effect of high relative humidity. * Methods for determining service life (use, limitations, and practice problems) - OSHA recommendations - Rules of thumb - Using laboratory data - Using math models - Using computer (software) models - Cartridge testing methods (3 methods) Combining methods * Learn how to develop a change schedule when computer models are not available. * Recommendations for mixtures: - OSHA compliance method - mole fraction method - multi vapor model * How to confirm your change-out schedule. * Storage and migration concerns. * Immediate Breakthrough Upon Reuse (IBUR) concepts Gain confidence that your current procedure is correct! Former students have found this information to be extremely valuable. Even experienced students find the material useful as a way to verify their current procedures. Next dates are: April 26-27, 2017 in Cincinnati Overview of Respiratory Protection: This one day course provides a practical overview of respirators, standards, guidelines, use, and limitations of commonly used air purifying respirators. This class also provides an excellent overview of the OSHA Respirator Standard. Little or no prior formal training is required. The morning session includes lectures on the types and use of respirators and basic respirator selection procedures using APFs and MUCs. The advantages and disadvantages of different respirator facepieces, filters (N, R, & P), cartridges, PAPR's, and the physiologic effects of wearing a respirator will also be discussed. Respirator standards and program requirements will be reviewed to help the student comply with OSHA regulations. Discussion of qualitative and quantitative fit testing, user seal checks, worker training, and respirator medical clearance requirements will be provided. This course is essential for those individuals who oversee respirator users in their work place or new to respiratory protection. Fit Testing Workshop: This two (2) day workshop provides comprehensive lecture and "hands-on" training for students who need to learn how to conduct an OSHA accepted qualitative or quantitative respirator fit test. Students will have an opportunity to fit test a variety of different style facepieces, including filtering facepieces, half, & full. A combination of lecture and "hands-on" testing in the presence of a trained and experienced instructor will be used to help participants learn how to conduct respirator fit testing to satisfy regulatory requirements. Hands-on fit testing will include qualitative and quantitative methods. The following types of fit testing equipment will be available: Saccharin (sweetener) and Bitrex (bitter) qualitative fit test kits using squeeze-bulb nebulizers as well as powered pumps using Qfit. Quantitative fit testing with the TSI PortaCount (models 8020, N95 Companion, 8030 & 8038), and the OHD Fit Tester 3000/QuantiFit. Class size will be limited to ensure a favorable faculty to student ratio. Students will learn how to set-up, operate, maintain, troubleshoot, analyze, and interpret fit test results. Where appropriate, students will learn how to calibrate testing equipment and record results. All course materials, supplies, equipment, and reference manuals will be provided. Students will also learn how to disassemble, clean, reassemble, and inspect respirators for common problems. The workbook alone is a valuable reference for solving fit testing problems in the future. This course uses a combination of lecture and small practicum groups to ensure students have ample time to practice and learn fit testing techniques. The second day provides students sufficient time to 2016, All rights reserved, Roy McKay, Ph.D. Pg 10 of 11

11 concentrate on the particular methods of interest to them. The "Hands-On" approach is emphasized in this course. Students will have the opportunity to fit test several different make and model respirators. Individuals who plan to attend the fit testing workshop, but have little or no experience with respiratory protection should take the one day overview class in addition to the 2-day fit testing workshop. The fit testing workshop provides an opportunity to see and experience many different types of commonly used fit testing methods (qualitative and quantitative). A substantial discount is given when both courses are taken. Dr. McKay is the current chair of the ANSI Z88.10 Respirator Fit Testing sub-committee, a voting member of the full ANSI Z88 Respiratory Protection Committee, the AIHA Respiratory Protection Committee, and others. Fit Testing Refresher & Advanced Topics: This 1-day course is specifically designed for the person who has been conducting fit tests, but has not had formal training or needs a review. This course reviews OSHA fit testing requirements and helps the operator understand why poorly fitting respirators pass fit testing and why good fitting respirators fail. It is an excellent refresher for persons familiar with fit testing, but has limited formal training or needs a refresher. It also provides an opportunity to discuss advanced topics not covered during a typical 2-day fit testing workshop due to time limitations. This course is also valuable for respirator program administrators who need a better understanding of fit testing procedures and assurance that their fit testing program is being run properly. The emphasis of this course is on quantitative fit testing with the TSI PortaCount, although many of the concepts are applicable to other fit test methods. Partial Listing of Topics Review of fit test procedures Facial hair: issues & solutions Selection process Comfort assessment Interference with PPE Establishing pass/fail criteria Interpretation of fit test results Why user seal checks fail to detect leakage Why user seal checks create leaks not present Proper use of fit test adapters Selecting sample probe location Why leaking respirators pass fit testing Why good fitting respirators fail fit testing What does a high fit factor really mean? Wear time & non wear time issues Understanding fit factor vs protection When is quantitative fit testing required? Opportunity to get answers to your questions This course can also be given on-site. Respirator Training at Your Location: A variety of respirator training programs are available on-site. Courses available include: * Fit Testing Refresher & Advanced Topics * How to Develop a Cartridge Change Out Schedule (1 day) * Respirator Selection (1 to 1.5 days) * Fit Testing for Health Care Professionals (1 day) * Basics of a Respiratory Protection Program (2 days) * Overview of Respiratory Protection (1 day) * Respirator Fit Testing: Quantitative (1 or 2 days) * Respirator Fit Testing: Qualitative (1day) * Fit Testing at your workplace. Not a course, but a hands-on program with your staff and equipment. To Be Removed from List: If you wish to be removed from this list, please click "reply" and put "Remove" in the subject heading. If your address has recently changed or if you have more than one address, provide both addresses in the body of the . To be Added to our Newsletter: To be added to our Newsletter, go to There is no cost to subscribe. Your address is NOT given to any other source. Newsletters are sent 2-3 times per year. If you Receive Duplicate Newsletters: Click "reply" and put "Remove" in the subject heading of the address you wish to have removed as described above. Roy McKay, Ph.D. Course Director University of Cincinnati Dr. McKay does not receive any public or private funding for this educational service. The opinions in this newsletter are those of Dr. McKay and not the University of Cincinnati. 2016, All rights reserved, Roy McKay, Ph.D. Pg 11 of 11