Risk Assessment of Occupational Exposure from Peracetic Acid

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Peracetic acid (PAA), also known as peroxyacetic acid is widely used in healthcare, food preparation and food and beverage packaging among other industries as a disinfectant
and liquid sterilant. PAA is a strong oxidant and primary irritant and as with all chemical sterilants, there is a risk of occupational exposure.

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12. ®   © ChemDAQ Inc. 2012 Page 12 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 containing 53% acetic acid, 11% hydrogen peroxide and 36% peroxyacetic acid had an RD50 of 10.6 ppm, 3.8 ppm being peroxyacetic acid, which is 1.4 times lower than the theoretical value estimated from the fractional concentrations and the respective RD50s of the individual components. On the basis of a TLV-STEL (threshold limit value for short-term exposure limit) equal to 0.1 RD50, the TLV-STELs for acetic aci d, hydrogen peroxide and peroxyacetic acid should not exceed 20, 10 and 0.5 p.p.m. respectively. On the basis of a TLV-TWA (time-weighted average) equal to 0.03 RD50, the TLV-TWAs for these same chemicals should not exceed 5, 3 and 0.2 p.p.m. respectively. Finally, these values and existing TLVs in Europe and the USA are compared. 2) Case Study: Asthma Caused by Pe racetic Acid-Hydrogen Peroxide Mixture 50 Abstract: Thorough preventive meas ures against potential patient infections caused by endoscopic material has become a priority in hospitals and has pushed hospital care personnel to use increasingly more powerful disinfectant products with much longer contact periods, which has been responsible for a deterioration in their h ealth. Among chemical disi nfectants, formaldehyde and glutaraldehyde were the most widely used for reducing microbial contamination responsible for infectious accidents following invasive endoscopies. At present, oxidizing agents such as PA- HP, have replaced them but are known to be inef fective for the prion in activation cycle and to have toxic effects on patients, nursing staf f and the environment. PA-HP is officially recommended with respective concentrations of 0.08% and 1% for best sterilization of germs responsible for infections and on biofilm (org anic polymer sticking to a surface). Occupational asthma has been documented in nurses exposed to solvents such as formaldehyde but has not yet been described in workers exposed to PA-HP. We report the cases of two subjects who developed cough, wheezing and shortness of breath after being exposed to PA-HP vapors. 3) Evaluation of occupational exposure to high-level disinfectants in endoscopic services in an Italian hospital. 51 The aim of this study is the evaluation of exposure to airborne, high-level disinfectants to efficiently organize prevention of the risks due to the manipulation of these substances in the endoscopic units in medical facilities. In field and personal samples in the breathing zone of the workers were taken in 27 endoscopic units in a hospital during the replacement of high-level disinfectants in basins, tubes and lavaendoscopes. After a campaign of environmental monitoring of glutaraldehyde in nineteen endoscopic units (176 employees) of the hospital and considering the entity of glutaraldehyde problem, two substitu tes, peracetic acid and electrolyzed acid water, have recently been introduced. The level of glutaraldehyde was higher than the TLV-Ceiling in 13 out of 19 working units, while the value of per acetic acid resulted higher than TLV-TWA in 1 out                                                               50 Asthma Caused by Peracetic Acid-Hydrogen Peroxide Mixture; Emmanuelle CRISTOFARI- MARQUAND, Myriam KACEL, Francois MILHE3, Antoine MAGNAN and Marie-Pascale LEHUCHER-MICHEL. J Occup. Health (20 07) 49(2), 155-158. http://joh.med.uoeh- u.ac.jp/pdf/E49/E49_2_11.pdf; http://www.jst age.jst.go.jp/article/joh/49/2/155/_pdf 51 Pacenti M, Dugheri S, Boccalon P, Arcangeli G, Cupelli V.; Int J Immunopa thol Pharmacol. 2006 Oct-Dec;19(4 Suppl):73-7. http://www.ncbi.nlm.nih.gov/pubmed/17291411 . Retrieved 5/10/2012.

15. ®   © ChemDAQ Inc. 2012 Page 15 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 1) Event Description 58 The spring dislodged from the steris door latch during the beginning of the sterilization process. The rise in pressure forced the door latch to open, spewing peroxyacetic acid (epa reg. #58779-1) over the entire room. Vapors from the sterilant penetrated the operative suite with subsequent exposure to employees. One employee required emergency treatment. 2) Event Description 59 Steris was advised by (b) (6) that an employee was treated for breathing difficulty after opening the lid on a system 1 processor, and being exposed to sterilant use dilution that leaked from the processor during a processing cycle. She received a breathing treatment in the facility's emergency room and returned to work. The employee is currently on a steroid inhaler, but has missed no time from work. Manufacturer Narrative The hospital's biomedical department repaired the system 1 sterilizer. No further problems have been reported with the unit since the repair. According to the hospital, all employees have been trained on the use of system 1, including the procedures and precautions contained in the system 1 operator manual for spillage of steris 20 use dilution. These instructions require the use of appropriate personal protective equipment (ppe) and recommend increasing ventilation to the area to lessen the odor of peracetic acid. The employ ee did not increase ventilation to the area before opening the lid on the system 1 processor. The system 1 operator manual and material safety data sheet, provided with each shipment of sterilant, instruct operators on the proper precautions and practices to be employed when working with spillage of steris 20 use dilution. The steris account manager conducted a refresher in-ser vice training on december 9, 2008. 3) Sterilant steris corporation report # 557988 60 Steris received a call from the medical center repo rting that a hosp worker exposed to peracetic acid vapors was sent to the e.r. and was subsequently admitted to the hosp. The hosp reported that a system 1 operator noted that the chemical indi cator did not correctly ch ange color during the processing cycle, and that there was residual fluid remaining in the steris 20 cup. While disposing of the residual fluid in a room with the door opened and a large fan in the room, the peracetic acid odor/vapor reportedly tr aveled down a hallway to the e.r. re ception desk. The receptionist on duty, an asthma sufferer, experienced a reaction. The receptionist was sent to the er and later admitted to the hosp. The receptionist was treated and has return ed to work. No further details have been made available. Sterilant steris corporation report # 557988 Investigation by the steris account rep indicates th at the system 1 operator manual procedures for disposal of steris 20 sterilant concentrate were not followed completely by the operator. The steris 20 disposal instructions are specific with regard to the proper disposal method. After this incident, the steris account rep conducted training on-site at hosp on correct procedures for placement of                                                               58 FDA MAUDE Database, MDR 115135, http://www.accessdata.fda.gov/scripts/cdrh/cf docs/cfMAUDE/Detail.CFM?MDRFOI__ID=11513 5 , retrieved 5/10/2012. 59 FDA MAUDE Database, MDR 1282071, http://www.accessdata.fda.gov/scripts/cdrh/cf docs/cfMAUDE/Detail.CFM?MDRFOI__ID=12820 71 , Retrieved 5/10/2012. 60 http://www.patientsville.com/medical-device/ sterilant-steris-corporation-quality.htm , retrieved 5/9/2012

16. ®   © ChemDAQ Inc. 2012 Page 16 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 steris 20 in the processing chambe r and the proper disposal of ster is 20 sterilant concentrate when necessary. Steris operating instru ctions, correctly followed, provide for the safe and effective disposal of steris 20 sterilant c oncentrate. The material safety da ta sheet (msds) for peracetic acid notes that the inhalation of peracetic acid vapors or mist will cause irritation to the eyes, nose, and throat. Additional symptoms may include respir atory discomfort, headaches, dizziness, and nausea. These symptoms will usually subside wh en the exposure ceases. Due to the lack of additional specific info regarding the exact cause of the injury reported the treatment administered, and the seriousness of the injury, steris is filing this mdr. 4) Event Description 61 Steris was advised by (b)(6) that a clinic employee using a system 1 processor was treated for breathing difficulty after exposure to sterilant us e dilution that leaked fro m the processor during a processing cycle. This employee and others cleaned up the spill with towels. The employee has a history of allergies and reported experiencing breathing difficulties. She received a breathing treatment in the facility's emergency room, returned to work and did not require further medical treatment. The other employees who helped clean up the spill reported eye irritation and lightheadedness. They went outside for fresh air and did not need medical treatment. Manufacturer Narrative A steris service technician replaced the inflatable seal on the lid of the un it. No further problems have been reported with the unit since the repair. According to the clinic, all employees have been trained on the use of system 1, including the procedures and precautions contained in the system 1 operator manual for cleaning up spilled sterilant use dilution. These instruction requires the use of appropriate personal protective equipment (ppe) and recommended increasing ventilation to the area to lessen the odor of peracetic acid. The empl oyee(s) did not use ppe or increase ventilation to the area before or during clean-up of the spill. St erilant use dilution is a diluted mixture of steris 20 sterilant concentrate includ ing the active ingredient peracetic acid. The use dilution has a neutral ph, is non-toxic by oral and dermal administration and has no corrosive effects on skin, although dermal irritation may occur in sensitive individuals upon repeated exposure. The system 1 operator manual and material safety data sheet provided with each shipment of sterilant, instruct operators on the proper precautions and practices to be employed when cleaning up spilled use dilution. Steris recommended scheduling additional in -service training to the clinic staff provided by steris corporation. 5) Sterilant steris corporation report # 787513 62 Steris corporation received a report on october 20, 2006, that a system 1 sterile processing system had experienced sterilant fluid leakage due to a s eal that failed during processor operation. The sterilant use dilution leaked onto the counter and the floor of the gi lab. In response to the fluid spill, a hospital supervisor directed several hospital employees to assist in the cleanup efforts. The facility reports that several of the employees exposed to the sterilant use dilution vapor had symptoms of coughing, watery eyes, and itchy th roat, and these employees were treated by the hospital's occupational medicine department. One employee experienced vomiting and was treated in the facility emergency room.                                                               61 FDA MAUDE Database, MDR 1285940, http://www.accessdata.fda.gov/scripts/cdrh/cf docs/cfMAUDE/Detail.CFM?MDRFOI__ID=12859 40 , Retrieved 5/10/2012. 62 http://www.patientsville.com/medical-device/ sterilant-steris-corporation-quality.htm , retrieved 5/9/2012

18. ®   © ChemDAQ Inc. 2012 Page 18 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Sterilant steris corporation report # 884235 The operator's manual provides precautionary notes on handling steris 20 at the end of a cycle or when removing the sterilant cup from the unit. For reference, the steris system one operator's manual (p 2-17) specifically states the following: "the use of steris 20 has approximately a neutral ph, is non-toxic by oral and dermal administration, and has no corrosive effect on skin." the steris 20 sterilant cup is designed and manufactured to prevent user contact with the active ingredient, peracetic acid. Instructions in the operators manual, as well as labeling on the steris 20 product, include handling precautions to mitigate user contact with peracetic acid. Based upon the information received by steris, the root cause of this incident is mishandling of the product. 2) Sterilant steris corporation report # 884234 66 Steris received a complaint from hospital relating to an alleged burn on th e right forearm of an employee, who was disposing a system 1 sterilant cup. According to the account manager, the processor had a power failure, the previous evenin g and a note was left on the machine indicating that it was out of service. The employee came to wo rk in the morning, didn't read the note, pressed "cancel" twice on the machine & opened the cover. The employee took out the cup of s20 sterilant which was reported be full. Some liquid from the container came in contact with her arm. She felt an immediate burning sensation and quickly rinsed her arm in water. She sought treatment for the burn in the occupational health department. She reported a blister that was wrapped up by medical personnel. According to the steris account manage r no further visits to the attending physician were required. Sterilant steris corporation report # 884234 Based upon information received and documented, no adverse eff ect has resulted from the s20 exposure in this incident. For reference, the s2 0 cups, cartons and cases are all well labeled with instructions and precautionary statements on the use and handling of the sterilant, as is the ss1 operator manual. Steris provides regular in-service to personnel to avoid improper use and handling. The account manager indicat ed that the customer has been trained accordingly and that this was an isolated incident. 3) Sterilant steris corporation report # 884233 67 There have been no further reports of injury or required follow up medical attention. Steris made a follow up call to the manager of clinical services on 7/25/06. It was determined that the unit was functioning properly and that root causes of the event were, a kinked aspirator tube preventing total aspiration of peracetic acid and resulting in re sidue paa in the cup at the end of the cycle, and the hasty "flicking" motion to remove the aspirato r probe. The root cause of a failed chemical indicator strips was the operator failing to follow section 5-4, step 3, of the t6100 operator's manual requiring that the aspirator tubing not be kinked. Per the account manager's report, the customer has received in-depth training for s20 ha ndling before and after a sterile cycle. A query of steris's complaint data base over the last two years failed to identify any trends for issues associated with aspirator removal and paa exposure despite millions of sterilant cycles initiated on a daily basis worldwide.                                                               66 http://www.patientsville.com/medical-device/ sterilant-steris-corporation-quality.htm , retrieved 5/9/2012 67 http://www.patientsville.com/medical-device/ sterilant-steris-corporation-quality.htm , retrieved 5/9/2012

1. ®   © ChemDAQ Inc. 2012 Page 1 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Risk Assessment of Occupational Exposure from Peracetic Acid Sterilization and High Level Disinfection P. Richard Warburton 1 Introduction................................................................................................................... ...... 2 Risk Assessment ................................................................................................................ .3 Basic Information.............................................................................................................. .. 4 Hazards of Peracetic Acid................................................................................................... 4 Chemical Properties of Peracetic Acid ............................................................................... 4 Estimate of the Vapor Phase Concentration of Peracetic Acid ....................................... 6 Hazards of Peracetic Acid................................................................................................... 7 Exposure Hazard ............................................................................................................. 7 Fire and Explosion Hazard ............................................................................................ 10 Studies on the Effects of E xposure to Peracetic Acid....................................................... 11 Occupational Exposure Limits for Peracetic Acid............................................................ 13 Peracetic Exposure Incidents ............................................................................................ 14 Exposure to PAA Vapor................................................................................................ 14 Exposure to Liquid PAA ............................................................................................... 17 Analytical and Monitoring Me thods for Peracetic Acid................................................... 19 Analytical Methods ....................................................................................................... 19 Continuous Monitors..................................................................................................... 20                                                               1 Richard Warburton, Ph.D., J.D. is the CTO & General Counsel at ChemDAQ Inc.

6. ®   © ChemDAQ Inc. 2012 Page 6 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 hydrogen peroxide gas plasma sterilizers from Advanced Sterilization Product Inc, 22 and the Vapor Phase Hydrogen Peroxide st erilizers form Steris Corporation 23 ). Most disinfectants and sterilants are desi gned to destroy a wide range of biological organisms and so these compounds are usually toxic to humans and thus exposure in the workplace is often hazardous. OSHA has prom ulgated PELs for many common sterilants and disinfectants that have significant vapor pressure incl uding HP and AA, 1.0 ppm and 10 ppm respectively, calculated as an eight hour time weighted average. 24 Estimate of the Vapor Phase Co ncentration of Peracetic Acid One of the major ways that sterilant and high level disinfectant chemicals can pose hazards to workers utilizing them is through inhalation. In order to assess whether the potential atmospheric concentration is si gnificant an estimate of the atmospheric concentration at equilibrium over a peraceti c acid solution can be obtained from the vapor pressure. If there is no vapor phase pe racetic acid, then the risk of exposure by inhalation is very low. A typical concentrati on of peracetic acid used in a sterilizer is 0.2 %. 25 However, the sterilant solution is often supplied as a concentrate and so the vapor pressure over the concentration will be proporti onately higher. The concentration of the peracetic acid can be estimated using the Henry’s law constant 26 of 2.08 x 10 -6 atm m 3 /mole at 25 o C 27 to give a gas phase conc entration of about 50 ppm. Other estimates of the Henry’s law constant for peracetic acid in water are 660 and 830 mol/kg*bar, 28 (mean 745 mol/kg*bar) which on conve rting the units of the mean is equivalent to 1.4 x 10 -6 atm m 3 /mole. From this other estimate of the Henry’s Law constant, the head space peracetic acid concen tration over 0.2 % peracetic acid solution at 25 o C is 35 ppm.                                                               22 http://www.aspjj.com/us/products/sterrad-sterilization , retrieved 5/10/2012. 23 http://www.steris.com/vpro1plus/ , retrieved 5/10/2012. 24 29 CFR1910.1000 25 FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing; Reusable Medical and Dental Devices ; November 2003; http://www.fda.gov/cdrh/ode/germlab.html ; retrieved Aug 17, 2004. 26 Henry’s law constant is a proportionality consta nt between the concentration in the gas phase and the concentration in solution. Further details can be found in for example: P.W. Atkins, “Physical Chemistry”, 2 nd Ed. W.H. Freeman & Co., San Francisco (1982). 27 Hazardous Substances Data Bank (HSDB); Produced by : U.S. National Library of Medicine; Provided by : Canadian Centre for Occupational Health and Safety; Issue : 2000-2 (May, 2000); http://www.dialysisethics.org/fyi/canada%20oha.htm ; citing Gaffney JS et al; Environ Sci Technol 21: 519-24 (1987); retrieved 8/17/04.; 28 National Institute of Science and Technology – NIST Chemistry Web book, at http://webbook.nist.gov/cgi/cbook.cgi ?ID=C79210&Units=SI&Mask=10#Solubility ; retrieved 8/27/04

17. ®   © ChemDAQ Inc. 2012 Page 17 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Sterilant steris corporation report # 787513 The sterilant use dilution circulating in the system 1 processor during the sterilization phase of the cycle is produced by dilution and mixing of the components of the steris 20 sterilant concentrate. These include the active ingredient (peracetic acid), and powdered inactive salts/builders which mix to produce the sterilant use dilution. This sterilant use dilution has approx a neutral ph, is non- toxic by oral and dermal administration, and has no corrosive effects on skin although dermal irritation may occur in sensitive individuals upon repeated exposure. The steris system 1 processor operators manual provides info regarding use dilution clean up, including instruction to wear protective equipment and increase ventilation when a spill occurs. To date, steris has not been able to obtain further info from a health care professi onal at the hosp detailing the level, extent, and/or seriousness of any injuries that may have occurred. Due to the lack of detailed info regarding the potential injuries, the treatment administered, and th e seriousness of these potential injuries, steris is filling this mdr to be conservative. 6) A medical center was found liable for back wages for a pregnant dialysis technician who asked to be reassigned from her position because of conc erns about exposure to Rennalin vapors (PAA solution). The medical center argu ed that no exposures were above OSHA limits, but the court found that “that several employees experienced noxious physical reactions to working with Renalin.” 63 7) In 2009 NIOSH investigated reports of eye irritation, shortness of breath and loss of smell from employees using Steris equipment (Note System 1s not 1Es) at Kaleida Health, Buffalo General Hospital, but NIOSH lacked the ability to measure PAA concentrations. 64 Exposure to Liquid PAA 1) Sterilant steris corporation report # 884235 65 Hospital reported that an employee complained of a burning sensation on her hand after liquid splashed onto her hand, as she was discarding the sterilant cup from a steris system 1 unit at the end of a processing cycle. The employee was advise d to wash the affected area with water for at least 15 minuets and go to the er for treatment. In response to a follow-up cal from steris, the hospital reported that the employee was "ok" and that no further reports of additional medical attention were made. It was also noted that the employee was new and had just returned from training on steris equipment. The facility advise d the account manager that the sterilant cup was not totally empty at the end of the cycle, and a small amount of the liquid inside splashed on the employee's hand as she was discardi ng the cup. Steris offered to provide further in-service training to the employee, but she did not feel that this was required.                                                               63 Gretchen B. Maglich, Commissioner, Department of Labor and Industry,State of Minnesota, Complainant, v. Miller-Dwan Medical Center, Respondent. State Of Minnesota. Office Of Administrative Hearings. For The Minnesota Department Of Labor And Industry. April 1999. http://www.oah.state.mn.us /aljBase/190111970.FDG.htm , Retreived 5/9/2012. 64 Evaluation of Worker Exposures to Per acetic Acid-Based Sterilant during Endoscope Reprocessing. David Sylvain, MS, CIH, John Gi bbins, DVM, MPH, Hea lth Hazard Evaluation Report. HETA 2006-0298-3090. Kaleida Health–Buffalo General Hospital, Buffalo, New York, August 2009. http://www.cdc.gov/niosh/hhe/re ports/pdfs/2006-0298-3090.pdf , retrieved 5/8/2012 65 http://www.patientsville.com/medical-device/ sterilant-steris-corporation-quality.htm , retrieved 5/9/2012

19. ®   © ChemDAQ Inc. 2012 Page 19 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Sterilant steris corporation report # 884233 68 A complaint was received from facility relating a system 1 operator who experienced a burning sensation around her mouth, and lips after quickly removing the aspirator probe from the sterilant cup after a cycle. According to the facility, the chemical indicator strip for a cycle did not change color to indicate proper sterilization. The operator removed the instruments that were in the sterilizer and then quickly removed the aspirator probe from the sterilant cup. According to the operator, she "flicked" out the aspirator from the cup opening and was splashed with liquid resulting in exposure to, and a burning sensation around, her mouth and lips. The operator, who was wearing gloves, but not a face mask at the ti me, found a nearby sink to rinse and wash her mouth & lips with water. She then went to the emergency dept where first aid burn ointment was administered to her. Accordin g to the steris account manager' s report, the operator was not seriously injured, although some peeling of the skin on her lips occurred. It was also indicated that the staff was recently in-serviced on the unit and was given cd-rom otp training as well. According to a steris service tech, the unit was inspected and found to be functioning properly. Facility now supplies face masks & gloves at each ss1 unit throughout the building. Note: Most of the events described above i nvolved the Steris System 1, which has since been withdrawn from service. 69,70 Analytical and Monitoring Methods for Peracetic Acid Analytical Methods Despite the known hazards, monitoring for PA A has not been performed because until recently methods were not available. 71 The vapor pressure of PAA over the aqueous solutions used for disinfection and steriliza tion are significant for occupational health (discussed above) and there have been many reports of eye and respiratory irritation. A few industrial hygiene research papers have described chemical methods for sampling of PAA, 72 mostly by wet chemical analysis. FMC Corporation has a titration method for liquid PAA involving titration with cerium (IV) sulfate to measure hydrogen peroxide                                                               68 http://www.patientsville.com/medical-device/ sterilant-steris-corporation-quality.htm , retrieved 5/9/2012 69 Steris System 1 Processor: FDA Notice and Recommendations; http://www.fda.gov/safety/medwatch/safetyinform ation/safetyalertsforhumanmedicalproducts/ucm 192842.htm , Retrieved 5/10/2012 70 Stersi System 1 Customer Support. http://www.steris.com/ss1/ Retrieved 5/10/2012. 71 American National Standard; Chemical Steriliza tion and High-Level Disinfection in Health Care Facilities, ANSI/AAMI ST58:2005, sections E.4.1.3 and E.6 72 Simultaneous Sampling of Peroxyacetic Acid an d Hydrogen Peroxide in Workplace Atmospheres, G. Hecht et al, Annals of Occupational Hygiene,(2004), 48(8), 715-721; Air Monitoring and Assessment of Occupational Exposure to Peracetic Acid in a Hospital Envi ronment, M. Pacenti et al. Industrial Health (2010), 48, 217-221

20. ®   © ChemDAQ Inc. 2012 Page 20 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 and iodometirc titration to measure PAA, 73 and Enviro Tech uses a similar method. 74 Methods have also been developed using i odometric titration only, based on the different kinetics of reaction between PAA and HP. 75 Pasive sampling techniques have been developed, 76 but do not appear to have been commercialized. Spectroscopic methods for PAA vapor have been developed based on the oxidation of ABTS (2,2'-azino-bis(3-ethylbe nzothiazoline)-6-sulfonate) by PAA with formation of a radical cation which is charac terized by four strong absorp tion maxima between 405 nm and 810 nm; 77 and directly by absorption in the far UV. 78 Other methods include HPLC 79,80 but again none of these methods app ear to have been commercialized. Continuous Monitors The only continuous monitor for PAA is from ChemDAQ Inc. 81 The Steri-Trac Peracetic Acid Area Monitor displays real-time Per oxyacetic Acid values and alarms when exposure levels are too high. This monitor provide s a full range of features in state of the art gas detection. • Single point or Multi-Point/ Multi-Gas Systems provide versatility to meet worker safety requirements today and as your m onitoring needs change. Configurable to                                                               73 Analytical Method, Peracetic Acid and Hydrogen Peroxide Assay for 5% Peracetic Acid http://microbialcontrol.fmc.com/Portals/Mic robial/Content/Docs/PAA%20Analytical%20Met hod.pdf , retreived 5/9/2012. 74 DETERMINATION OF HYDROGEN PEROXIDE AND PERACETIC ACID IN SOLUTIONS; Enviro Tech Chemical Services, Inc. http://envirotech.com/pdf/PAA%20Analytical%20Method.pdf , Retrieved 5/9/2012. 75 The analysis of solutions of per-acids and hydrogen peroxide; B. Dudley Sully and P. L. Williams; Analyst, 1962,87, 653-657, http://pubs.rsc.org/en/content/articlelanding/1962/an/an9628700653 , retrieved 5/9/2012. 76 Passive Sampling of Airborne Peroxyacetic Ac id; Anal. Chem., Hartmut Henneken, Laura Assink, Joyce de Wit, Martin Vogel,*† and Uwe Karst†, 2006, 78 (18), pp 6547–6555. http://pubs.acs.org/doi/abs/10.1021/ac060668h , reteived 5/10/2012. 77 Spectrophotometric and direct-reading methods for the analys is of gas phase peroxyacetic acid. Effkemann S, Brødsgaard S, Mort ensen P, Linde SA, Karst U.; Fresenius J Anal Chem. 2000 Feb;366(4):361-4. Abstract available at http://www.ncbi.nlm.nih .gov/pubmed /11220319 , retrieved 5/9/2012. 78 Direct Determination of Peracetic Acid, Hydrog en Peroxide, and Acetic Acid in Disinfectant Solutions by Far-Ultraviolet Absorption Spectrosc opy; Noboru Higashi,† Hiroshi Yokota,† Satoru Hiraki,† and Yukihiro Ozaki. Anal. Chem., 2005, 77 (7), pp 2272–2277; http://pubs.acs.org/doi/abs/10.1021/ac0487045 , retrieved 5/9/12. 79 Simultaneous HPLC Determination of Peroxyacetic Acid and Hydrogen Peroxide; Ulrich Pinkernell, Stefan Effkemann, and Uwe Karst; Anal. Chem., 1997, 69 (17), pp 3623–3627, http://pubs.acs.org/doi/abs/10.1021/ac9701750 , Retrieved 5/9/2012. 80 Determination of Peroxyacetic Acid Using High-Performance Liquid Chromatography with External Calibration; U. Pinkernell, U. Karst, K. Cammann, Anal. Chem., 1994, 66 (15), pp 2599– 2602. http://pubs.acs.org/doi/abs/10.1021/ac00087a028 , Retrieved 5/9/2012. 81 http://www.chemdaq.com/g ases/Peracetic_Acid.html , retrieved 5/9/2012.

10. ®   © ChemDAQ Inc. 2012 Page 10 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 carcinogen; though the signi ficance to human health is not known. 42 The table below shows the carcinogenic, mutagenic and tumo rigenic for PAA and several other common sterilants and high le vel disinfectants. Summary of the Carcinogenicity Cla ssification and RTECS Description 43 Chemical Name Cancer Category IARC/ACGIH 44 Tumorigen Mutagen Reproductive Effector Hormone Primary Irritant Ethylene Oxide 1/A2 X X X X Formaldehyde 1/A2 X X X X X Hydrogen Peroxide 3/A3 X X X X Ozone N/A4 X X X X Peracetic Acid N/N X X X Glutaraldehyde N/A4 X X X X X OPA N/N N N N N N Fire and Explosion Hazard PAA is highly reactive, as are most sterilant chemicals. Chem ical sterilization is achieved by exposing the articles to be ster ilized to high concentrations of reactive gases. It is this reactivity that makes PAA a good sterilant. This reactivity can be seen in the propensity for PAA to react violently. Bretherick su mmarizes its properties are follows: “It is sensitive to impact but explodes violently at 110 o C. The solid acid has exploded at -20 o C. ... A case of explosion on impact has been recorded.” 45                                                               42 “Patty’s Toxicology,” 5th Ed., , E. Bingham, B. Cohrssen, C.H. Powel (eds), Publ. Wiley Interscience (2001) 43 The full RTECS report with citations to primary literature is available at http://www.cdc.gov/niosh/rtecs/sd8583b0.html , retrieved 7/10/09 [No longer available at this website address]. 44 IARC: 1 = Known, 2A = Probable, 2B = Suspected, 3 = Not a human carcinogen, N = not listed or no data. ACGIH: A1=Confirmed human, A2=Confirmed animal, A3=Confirmed Animal, unknown relevance to Humans, A4= Not a human carcinogen, N = not listed or no data. 45 Bretherick's Handbook of Re active Chemical Hazards, 4th Ed, L. Bretherick, Butterworths (1990)

11. ®   © ChemDAQ Inc. 2012 Page 11 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Sax lists the key flammability data for PAA as follows: 46 PAA (40% solution) BP 105 o C Explodes 110 o C Flash Point 105 o C Explosion hazard: Severe, when exposed to heat or by spontaneous chemical reaction. A powerful oxidizing agent. Vi olent reaction with acetic anhydride, olefins, organic matter Studies on the Effects of Exposure to Peracetic Acid Few health studies have been conducted with peracetic acid and lit tle is known of the effects of chronic exposure. Repeated exposur e to peracetic acid can cause rashes, liver or kidney damage and occupational asthma. It is not known if chronic exposure to peracetic acid will cause permanent lung damage , but in view of the similarity of its properties with hydrogen peroxide , it is a likely outcome, esp ecially since peracetic acid is destroyed at a much slower rate by the protective catalase enzyme than hydrogen peroxide. 47,48 Below are a few of the reports studying the effect s of PAA, with abstracts to allow a brief introduction to the work performed. 1) Sensory irritation of acetic acid, hydr ogen peroxide, peroxyacetic acid and their mixture in mice. 49 Abstract: The expiratory bradyp noea indicative of upper airway irritation in mice was evaluated during a period of 60 min of oronasal exposure to acetic acid, hydrogen peroxide and peroxyacetic acid vapours. The airborne concentration resulting in a 50% decrease in the respiratory rate of mice (RD50) was calculated for each chemical. The co ncentration–response curves of acetic acid, hydrogen peroxide and peroxyacetic acid had similar slopes. The results did however show that the three chemicals had different irritant potenc ies. The RD50 values of acetic acid, hydrogen peroxide and peroxyacetic acid were 227, 113 and 5.4 p.p.m. respectively. Moreover, a mixture                                                               46 Dangerous Propeties of Industrial Materials , N.I. Sx, 5th Ed, Van Nostrand Reinhold Company (1979) 47 The reaction of human erythrocyte catalase with hydroperoxides to form compound I.Palcic & Dunford , J.Biol. Chem . July 1980, 255 (13), 6128-32, . http://www.ncbi.nlm.nih.gov/pubmed/7391009 , retrieved 5/8/2012. 48 Selective peracetic acid determination in the presence of hydrogen peroxide using a label free enzymatic method based on catalase; Javier Galbán, Vanesa Sanz and Susana de Marcos. Analytical And Bioanalytical Chemistry; Volume 398, Number 5 (2010), 2117-2124. http://www.springerlink.com/content/k214611766m34019/ , retrieved 5/8/2012. 49 Sensory irritation of acetic acid, hydrogen peroxide, peroxyacetic acid and their mixture in mice. Gagnaire F, Marignac B, Hecht G et al. Ann Occup Hyg; 46: 97–102, (2002); http://annhyg.oxfordjournals.org/content/ 46/1/97.full.pdf, Retrieved 5/9/2012

2. ®   © ChemDAQ Inc. 2012 Page 2 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Introduction Peracetic acid (PAA), also known as peroxyacetic acid is widely used in healthcare, food preparation and food and beverage packagi ng among other industries as a disinfectant and liquid sterilant. PAA is a strong oxidant a nd primary irritant and as with all chemical sterilants, there is a risk of occupational exposure. Chemical sterilization and hi gh level disinfection (such as endoscope reprocessors) is achieved by exposing the items to be steril ized to high concentr ations of reactive chemicals and based on our common bioche mical heritage; excessive exposure of workers to broad spectrum steril ants and disinfectants presents the risk of injury. PAA is approved as a sanitizer for food use by the US Food and Drug Administration (FDA) 2 and for use as a high level disinfectant of sterilant for reusable medical and dental devices. Several patents have issued claiming use of peracetic acid as a biocide include for disinfecting work surfaces 3 , 4 , medical devices, 5 contact lenses, 6 fruit 7 , eggs, 8 the gastrointestinal tract of animals 9 ; as a water based pesticide. 10 Peracetic acid has been approved for us e in reducing microbial growth on meat carcasses 11 and on food processing equipment. 12                                                               2 21 CFR 178.1010 3 US Patent 6,593,283 ; July 15, 2003 ; Ecolab Inc. (St. Paul, MN) “Antimicrobial composition” Hei; Robert D. P.; Wei; Guang-jong J.; Halsrud; Da vid A. ; Smith; Kim R.; Podtburg; Teresa C. 4 US Patent 6,444,230; September 3, 2002; and 6,168,808; January 2, 2001 “ Synergistic composition of peracetic acid and amine oxide”; Godin; Catherine Hamon ; Gouges; Yves ; Le Rouzic; Daniel. 5 US Patent 6,468,472; October 22, 2002; “Cleaning and decontaminating dialyzers by per- compound solutions”; Yu; Zhi-Jian; Huth; Stanley William; Metrex Research Corporation (Orange, CA) 6 US Patent 4,986,963; January 22, 1991; “Method of disinfecting contact lenses with peracetic acid”; Corcoran; Richard A.; Whinston; James P. 7 US Patent 6,506,417; January 14, 2003; “Composition and process for reducing bacterial citrus canker organisms”; Siddle; John M.; FMC Technologies, Inc. 8 US Patent 5,756,139; May 26, 1998, “Egg washing and disinfection process”; Harvey; Anita Jane; Malone; Joseph William Gerard; Sanderson; William Ronald 9 US Patent, 6,518,307; February 11, 2003; “Control of microbial populations in the gastrointestinal tract of animals”; McKenzie; K. Scott Giletto; Anthony; Hitchens; G. Duncan; Hargis; Billy M. ; Herron; Kelly L. ; Assignees: Lynntech, Inc. (Co llege Station, TX); The Texas A&M University System (College Station, TX) 10 US patent 6,197,784; March 6, 2001; “Process for controlling and destroying pathogenic small creatures, in particular insects and worms”; Fuchs; Rainer; Huss; Michael 11 § 173.370 Peroxyacids. Peroxyacids may be safely us ed in accordance with the foll owing prescribed conditions: (a) The additive is a mixture of peroxyacetic acid octanoic acid, acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-hydroxyethylidene-1,1- diphosphonic acid. (b)(1) The additive is used as an antimicrobi al agent on meat carcasses, parts, trim, and organs in accordance with current industry practice where the maximum concentration of peroxyacids is 220 parts per million (ppm) as peroxyacetic acid, and the maximum concentration of hydrogen peroxide is 75 ppm.” 21 CFR § 173.370 , Current through July 27, 2004; 69 FR 44882

3. ®   © ChemDAQ Inc. 2012 Page 3 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 PAA is a relatively recent addition to the ster ilization and disinfection quiver and so the effects of occupational exposure are not widely known. The goal of this document is to summarize the published information about PAA in a manner that will assist industrial hygienists and other safety experts make info rmed decisions about the risks of exposure to PAA. One of the further advantages of using PAA as a sterilant is that the byproducts of the reaction, namely oxygen, acetic acid [acid found in vinegar] and water are relatively harmless to the environment. Even if PAA its elf is discharged into the environment, it will fairly quickly degrade in soil, water and in the air, 13 so it is not an accumulative pollutant. A chemical that reacts quickly ma y be environmentally safe, but that fast reactivity makes it hazardous to anyone exposed to it. 14 Risk Assessment Risk assessment for exposure to PAA is a combination of assessing the hazard presented by PAA and the probability of exposure to that hazard. The first part of the equation is fairly simple. As is described in more de tail below, PAA is a strong oxidant, primary irritant and can cause serious injury including fatal injury if the exposure is severe. The second part of the equation, the risk of expos ure is more difficult to assess. Even though PAA, like other sterilant and high level di sinfectant chemicals poses a severe risk, modern sterilization equipment is generally well engineered, made to very high standards and is designed to be safe to users of the equipment. However, we all know that any equipment has the potential for malfunction, en gineering controls can fail and of course it is impossible to completely design out human error. A gas monitoring system is like a fire alarm; it is not designed for the normal situation, it is there to warn in the rare abnormal case when potentially hazardous leaks of chemical vapor are released. Almost everyone has a fi re alarm in their home, but few houses burn                                                                                                                                                                                      12 § 178.1010 Sanitizing solutions. Sanitizing solutions may be safely used on food-processing equipment and utensils, and on other food-contact articles as specified in th is section, within the following prescribed conditions: (30) An aqueous solution containing hydrogen peroxide (CAS Reg. No. 7722-84- 1), peroxyacetic acid (CAS Reg. No. 79-21-0), acetic acid (CAS Reg. No. 64-19-7), and 1- hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4). 21 CFR § 178.1010, Current through July 27, 2004; 69 FR 44882 13 Hazardous Substances Data Bank (HSDB); Produced by : U.S. National Library of Medicine; Provided by : Canadian Centre for Occupational Health and Safety; Issue : 2000-2 (May, 2000); http://www.dialysisethics.org/fyi/canada%20oha.htm ; retrieved 8/17/04. 14    Environmentally Friendly ... To Whom? P.R. Warburton, Infection Control Today, January 2012, http://www.infectioncontroltoday.com/articles/2 012/01/environmentally-friendlyto-whom.aspx , retrieved 5/10/2012.  

7. ®   © ChemDAQ Inc. 2012 Page 7 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 This value is similar magnitude to the earlier estimate. However, sterilizers are usually operated at higher temperature (~ 50 o C) 29 and the vapor pressure of most compounds increases greatly with temperature. Two estimat es of the rate of change of the Henry’s law constant with temperature, expressed as d(ln(k H ))/d(1/T) are 5300 and 5900 K 30 (mean 5600 K) and so the Henry’s law constant for peracetic acid can be estimated at 50 o C are 3170 mol/kg*bar; i.e. the peracetic acid c oncentration is estimated to increase by 4.3 times on increasing the temperature to 50 o C compared to 25 o C. Similar estimates are obtained on consideri ng the temperature dependence of the vapor pressure of pure peracetic acid. The vapor pressure increases from 1.93 at 25 o C to 7.67 kPa at 50 o C 31 Therefore the potential concentr ation of peracetic acid will be approximately four times greater, or 200 ppm at 50 o C. This ball park figure of 200 ppm is only a very rough estimate, but it is three orders of magnitude greater than the ACGIH proposed STEL for PAA of 0.2 ppm. 32 Hazards of Peracetic Acid Exposure Hazard The NIOSH International Chemical Safety Cards for PAA indicates that all contact should be avoided and with respect to shor t term exposure “The substance [peracetic acid] is corrosive to the eyes, the skin and the respiratory tract. Co rrosive on ingestion. Inhalation of may cause lung oedema”, howev er the occupational exposure limits have not been established. Under inhalation risk, the card indicates that “ No indication can be given about the rate in which a harmful concentrati on in the air is r eached on evaporation of this substance at 20°C.” 33 The potential health effects of exposur e to peracetic acid are “Peracetic acid, peroxyacetic acid, is a strong skin, eye, and mucous membrane irri tant in both humans and animals. Continued skin exposure ma y cause liver, kidney, and heart problems. Peracetic acid has been observed to promote wart-like tumors, skin papillomas, in rats                                                               29 Hazardous Substances Data Bank (HSDB); Produced by : U.S. National Library of Medicine; Provided by : Canadian Centre for Occupational Health and Safety; Issue : 2000-2 (May, 2000); http://www.dialysisethics.org/fyi/canada%20oha.htm ; citing Gaffney JS et al; Environ Sci Technol 21: 519-24 (1987); retrieved 8/17/04.; 30 National Institute of Science and Technology – NIST Chemistry Web book, at http://webbook.nist.gov/cgi/cbook.cgi ?ID=C79210&Units=SI&Mask=10#Solubility ; retrieved 8/27/04 31 D.R. Lide (Ed.) CRC Handbook of Chemistry and Physics, 76 th Ed. 1995 – 1996; CRC Press, Boca Raton. 32 Peracetic Acid: TLV® Chemical Substances Dr aft Documentation, Notice of Intended Change ACGIH® http://www.acgih.org/store/ProductDetail.cfm?id=2199 , retrieved 5/10/2012. 33 NIOSH International Chemical Safety Card for peracetic acid is available at http://www.cdc.gov/niosh/ipcsneng/neng1031.html . Data retrieved on 8/17/04.

14. ®   © ChemDAQ Inc. 2012 Page 14 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 AEGL-1 is the airborne concentration, expresse d as parts per million or milligrams per cubic meter (ppm or mg/m3) of a substance above which it is predicted that the general population, including susceptible individuals, could experience notable discomfort, irritation, or certain asymptomatic nonsensory effects. However, the effects are not disablin g and are transient and reversible upon cessation of exposure. AEGL-2 is the airborne concentration (expressed as ppm or mg/m3) of a substance above which it is predicted that the general population, including susceptible individuals, could experience irreversible or other serious, long-lasting adverse health effects or an impaired ability to escape. AEGL-3 is the airborne concentration (expressed as ppm or mg/m3) of a substance above which it is predicted that the general population, including susceptible individuals, could experience life- threatening health effects or death. Peracetic Exposure Incidents In general 57 all of the equipment for sterilizati on and high level disi nfection equipment used in the US and other industrialized c ountries is made to very high engineering standards, at least in part because the e quipment would not receive the approval of the relevant government agencies (FDA in the US). This equipment is designed to minimize worker exposure and to allow the equipment to be used as safely as possible. However, even the best designed equipment can some times malfunction, engi neering controls can fail and of course user error can occur in any work environment involving humans. For PAA there is no OSHA PEL and the AC GIH proposal of 200 ppb ceiling is very recent (January 2012), and therefore may not have been considered by manufacturers who obtained their 510k approvals before 2012. A few examples of workplace exposure to PAA are given below. These cases are merely examples and do not represent in anyway a systematic survey of workplace injuries. Exposure to PAA Vapor The reports below are just a few of the ma ny reports in the FDA’s MAUDE database. It should be noted that there a large number of reports from Steris Corporation. Reporting non-fatal incidents to the FDA is voluntary and so the large number of reports from Steris is probably more a reflection of both the greater market sh are of Steris’s products and Steris’s philosophy of corporate responsibility full reporting ra ther than any indication of quality compared to Steris’ competitors.                                                               57 One notable exception was in the 1990s, Abtox sold two Plazlyte sterilizers that used 10% PAA outside of the scope of its FDA approval. Residual PAA caused injury to patients’ eyes and resulted in the closure of Abtox and jail time for some of its principles. http://www.justice.gov/usao/iln/pr/chicago/2003/pr020503_01.pdf , retrieved 5/10/2012.

13. ®   © ChemDAQ Inc. 2012 Page 13 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 of 15. EAW has recently been used in two units and the chlorine environmental concentrations resulted lower than the sensibility limit of the method (<75 microg/m3). The results obtained during this study of measurements allowed to identify those operations which have the highest degree of risk for employees; this serves for taking suitable measures for prevention and individual protection as well as for evaluating current prac tices and decisional pro cesses in the hospital. Occupational Exposure Limits for Peracetic Acid At present there are no OSHA permissible exposure limits (PELs) for PAA, though there are PELs for HP (1 ppm calculated as an eight hour time weighted average (TWA)) and AA (PEL 10 ppm 8 Hr TWA). 52 The ACGIH has proposed a short term exposure limit (STEL) of 0.2 ppm. 53 The EPA has issued acute exposure guidelines for PAA 54 Peracetic Acid 79-21-0 (Final) mg/m 3 10 min 30 min 60 min 4 hr 8 hr AEGL 1 0.52 mg/m 3 0.52 mg/m 3 0.52 mg/m 3 0.52 mg/m 3 0.52 mg/m 3 AEGL 2 1.6 mg/m 3 1.6 mg/m 3 1.6 mg/m 3 1.6 mg/m 3 1.6 mg/m 3 AEGL 3 60 mg/m 3 30 mg/m 3 15 mg/m 3 6.3 mg/m 3 4.1 mg/m 3 Converting the 8 hr TWA values to parts per million gives the following results. 55 EPA AEGL 1: 0.52 mg/m 3 (0.17 ppm) EPA AEGL 2: 1.6 mg/m 3 (0.51 ppm) EPA AEGL 3: 4.6 mg/m 3 (1.3 ppm) The definitions of the AEGLs are as follows: 56                                                               52 29 CFR 1910.1000 Table Z-1 53 Peracetic Acid: TLV® Chemical Substances Dr aft Documentation, Notice of Intended Change. http://www.acgih.org/store/P roductDetail.cfm?id=2199 , retrieved 5/9/2012. 54 http://www.epa.gov/oppt/aegl/pubs/results80.htm , retrieved 5/9/2012. 55 http://www.chemdaq.com/g ases/Peracetic_Acid.html , retrieved 5/9/2012. 56 http://www.epa.gov/oppt/aegl/pubs/define.htm , retrieved 5/9/2012.

5. ®   © ChemDAQ Inc. 2012 Page 5 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 even though there is no OSHA PEL for PAA, PAA is expected to be more hazardous than HP. PAA’s toxicity arises from its properties as a strong oxidant and the electrode potential is a measure of the oxidizing ability of a chemi cal species. The primary mode of action is oxidation, therefore the stronger the oxidizer, the faster the microorganism is inactivated or killed and the more hazardous the chemical. 18 The table below shows the electrode potential of peracetic acid toge ther with several other gases whose toxicity and biocidal activity derives primarily from their strong oxidizing ability. Comparison of Peracetic Acid with Other Strong Oxidizing Gases 19 Gas OSHA PEL (ppm) C NIOSH REL (ppm) Electrode potential 20 Chlorine 1 0.5 1.36 Chlorine Dioxide 0.1 0.1 1.28 Hydrogen Peroxide 1 1 1.78 Ozone 0.1 0.1 2.08 Peracetic acid 21 n/a n/a 1.81 Bromine 0.1 0.1 1.09 The oxidizing ability of peracetic acid at 1.81 V is greater than hydrogen peroxide and second only to ozone and comp arison of the exposure limits of ozone, hydrogen peroxide and the other oxidizing gases indicates that an exposure limit in the 0.1 to 1.0 ppm range would be reasonable. Peracetic acid (PAA) forms an equilibrium mixture with HP and acetic acid (AA) such that it is formed in solution if AA and HP ar e mixed together. PAA is almost always used in a mixture with HP and AA. CH 3 C(O)OH + H 2 O 2 Ù CH 3 C(O)OOH + H 2 O HP in aqueous solution is often used as a di sinfectant solution, a nd is widely used in healthcare as a sterilant gas to sterilize me dical equipment (see fo r example the line of                                                                                                                                                                                      17 E = 1.984 V vs. SHE, calc. from data in M.I. Awad, et al. J. Electroch emical Soc. (2004), 151(12), E358-363 18 http://www.ams.usda.gov/ nop/NationalList/TAPReviews/PeraceticAcid.pdf ; retrieved 8/17/04 19 OSHA PELs and NIOSH RELs from NIOSH Pocket Guide to Chemical Hazards, available at http://www.cdc.gov/niosh/npg/npgd0000.html#H , retrieved 8/19/04 20 E(V) vs. SHE, D.R. Lide (Ed.) CRC Handbook of Chemistry and Physics, 76 th Ed, (1995 – 1996), CRC Press, Boca Raton. 21 http://www.ams.u sda.gov/nop/NationalList/TAP Reviews/PeraceticAcid.pdf

9. ®   © ChemDAQ Inc. 2012 Page 9 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Effects of Inhalation of Pera cetic Acid on Test Animals 37 ORGANISM DOSE EFFECT Guinea pig lowest published toxic concentration: 186 mg/m 3 /1 hour/90 day- intermittent Liver: Fatty liver degeneration Lung, Thorax, or Respiration: Other changes Blood: Pigmented or nucleated red blood cells Mouse lowest published toxic concentration: 186 mg/m 3 /1 hour/90 day- intermittent Liver: Fatty liver degeneration Lung, Thorax, or Respiration: Other changes Rat lowest published toxic concentration: 350 mg/m 3 /30 day- intermittent Lung, Thorax, or Respiration: Other changes Liver: Other changes Kidney, Ureter, and Bladder: Other changes In animal studies, the lethal dose appears to vary greatly with species: LD50 (rat, oral) 1540mg/kg, Guinea pig 10 mg/kg. 38 PAA is not presently considered to be a carcinogen, though since hydrogen peroxide (PAA is in equilibrium with hydrogen peroxide) is a known animal carcinogen, 39 it should be at least suspected, especially si nce PAA is known to cause skin tumors in mice. 40 Even if PAA is not a carcinogen in its own right, there is the possibility it may promote the action of other carcinogens. As with hydrogen peroxide, low levels of peracetic acid have been found to be a cili a toxic and mucous coagulating agent thus inhibiting removal of lung contaminants 41 and Patty’s reported th at peracetic acid is a potent promoter of skin cancer in mice expos ed to dimethylbenz[a ]anthracene, a known                                                               37 The Registry of Toxic Effects of Chemical Substances; Peroxyace tic acid; RTECS #: SD8750000 CAS #: 79-21-0; http://www.cdc.gov/niosh/rtecs/sd8583b0.html ; Retrieved 8/17/04 {Web page no longer available] 38 Dangerous Properties of Industrial Materials , N.I. Sx, 5th Ed, Van Nostrand Reinhold Company (1979) 39 2007 guide to Occupation Exposure Values, ACGIH 40 The Registry of Toxic Effects of Chemical S ubstances; Peroxyacetic acid; RTECS #: SD8750000 CAS #: 79-21-0; http://www.cdc.gov/niosh/rtecs/sd8583b0.html ; Retrieved 8/17/04 41 Chemical Carcinogens, Searle, C. E. , ACS Monograph No. 173, Ameri can Chemical Society, Washington, D.C. (1976)

21. ®   © ChemDAQ Inc. 2012 Page 21 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 support 28 different gases including Ethyl ene Oxide, Hydrogen Peroxide and Ozone. • While some systems report gas concentra tions only at a central console, each Steri-Trac monitor displays its own gas readings so workers know what is happening in each particular area • Intuitive LED display of gas concentrations plus clear audible and visual alerts improve staff productivity because they will know when each area is safe • Each Steri-Trac area monitor can power up to three Remote Display Repeaters so users know it's safe before they enter a room • Supports Intrinsically safe installations (in conjunction with Remote Sensor) for Class 1, Division 1, • Zone 0 • Exchangeable EnviroCell™ Sensor Modul es ensure reliable and accurate gas readings through ChemDAQ’s SXP® Sensor Calibration / Exchange Program. • Dry contact relay outputs enable connecti ng the area monitors to existing facility maintenance and alarm systems for automatic notification and control. • Steri-Trac monitors can be tied to ChemDAQ’s DAQ™ Central Monitoring System to continuously

8. ®   © ChemDAQ Inc. 2012 Page 8 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 (NIOSH 1985). As a result, direct skin contact and exposure to vapors should be restricted. 34 For example, the Association of Pr ofessions in Infection Control and Epidemiology (APIC) warns that “There are several health hazard s associated with peracetic acid. Severe burns may result from dir ect skin contact, irreversible damage or blindness from direct contact of the chemical to the eyes, an d inhalation of peracetic acid vapor or mist will irritate the nose, throat, and lungs.” 35 The New Jersey Department of Health and Senior Service’s Hazardous Substance Fact Sheet for PAA 36 provides a short summary: • PAA can affect you when breathed in • PAA is a highly corrosive chemical • Eye contact can cause severe irritation and burns lead ing to permanent damage • PAA can severely irritate and burn the skin • Breathing PAA can irritate the lungs causi ng coughing and/or shortness of breath. Higher exposures can cause a build-up of fluid in the lungs (pulmonary edema), a medical emergency, with severe shortness of breath. • High or repeated exposure may affect the liver and kidneys • PAA is a highly reactive chemical and is an explosion hazard.                                                               34 Guidelines for Protecting the Health and Sa fety of Healthcare workers; 5. Recommended Guidelines for Controlling Noninfectious Health Hazards in Hospitals (Continued); § 5.1.10 Peracetic Acid PAA; from http://www.cdc.gov/niosh/hcwold5b.html ; retrieved 8/17/04 35 C. J. Alvarado; M. Reichelderfer, “APIC guide line for infection prevention and control in flexible endoscopy” Produced by the 1997, 1998, and 1999 APIC Guidelines Committees. American Journal of Infection Control 28(2), p 138; Available at http://www.apic.org/AM/Templ ate.cfm?Section=Home&TEMPL ATE=/CM/ContentDisplay.cfm &CONTENTID=1144 ; Retrieved 12/21/04 36 http://nj.gov/health/eoh/rtkweb/documents/fs/1482.pdf , retrieved 5/8/2012

4. ®   © ChemDAQ Inc. 2012 Page 4 of 21 SL-204-A-0.00 ChemDAQ Inc. • 300 Busi ness Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 down. Every hospital where there is a risk of sterilant chemical vapor leakage should have a monitor, even though most faciliti es will not experience major leaks. Despite the best efforts of the equipment manu facturers peracetic acid and other sterilant chemicals do sometimes leak and workers are some times exposed to these compounds. Examples of some of these leaks are included in this document. These examples illustrate that leaks, can occur. The frequency of PAA vapor leaks and exposure is not known because until recently there was no conti nuous monitor available for PAA and so no means to detect when PAA vapors were re leased from sterilization and high level disinfection equipment other than odor. Ma ny users of PAA ster ilants and high level disinfectants have experienced stinging eyes and other symptoms of exposure to PAA, but the concentration not known. With we ll maintained modern equipment, the probability of exposure to PAA should be sma ll but the risk of harm is significant. Basic Information on Peracetic Acid • Aliases: Peroxyacetic acid, Ethane peroxoic acid, Acetyl hydroperoxide • Formula: C2H4O3 / CH3COOOH • Molecular mass: 76.1 g/mol • CAS 79-21-0 • ICSC # 1031 • CAS # 79-21-0 • RTECS # SD8750000 • UN # 3105 • EC # 607-094-00-8 Chemical Properties of Peracetic Acid Sterilant chemicals typically fa ll into one of two groups, th e alkylating agents (ethylene oxide, formaldehyde, glutaraldehyde, o-phthala ldehyde (OPA)) and th e oxidizing agents (PAA, hydrogen peroxide (HP), oz one and chlorine bleach). HP is a strong oxidizing agent; 15 the strongly oxidizing propert ies of HP make its vapor very hazardous and consequently the Occ upational Safety and Health Administration (OSHA) has set a permissible exposure limit (PEL) for HP of 1 ppm calculated as an eight hour time weighted average. 16 PAA is a stronger oxidizing agent than HP 17 and so                                                               15 The standard potential for the half cell reaction H 2 O 2 + 2H + + 2e Ù 2H 2 O, is E = 1.776V vs SHE CRC Handbook of Chemistry and Physics, 76th Ed, 1995-1996, D. R. Lide Ed in Chief; CRC Press Boca Raton, SHE = standard hydrogen electrode 16 29 CFR 1910.1000, Table Z-1

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