1. EtO MONITORING REQUIREMENTS EtO MONITORING EQUIPMENT Michael D. Shaw Presented By

2. Anprolene Dihydrooxirene Dimethylene Oxide 1,2-Epoxyethane Oxacyclopropane Oxane Oxidoethane, -Oxidoethane Oxiran Oxirane ETHYLENE OXIDE

3. EtO HEALTH EFFECTS Although there are limited studies in humans to directly link EtO to human cancers, there is sufficient evidence in experimental animals to conclude that ethylene oxide is carcinogenic to humans Inhalation causes nausea, vomiting, neurological disorders and in some cases death Traces of gas in gloves or clothing may cause burns Residues in vascular catheters can cause thrombophlebitis whereas in endotracheal tubes, tracheitis

4. Mortality of workers exposed to ethylene oxide: extended follow up of a British cohort. Coggon D, Harris EC, Poole J, Palmer KT. MRC Environmental Epidemiology Unit, University of Southampton, UK. Occup Environ Med. 2004 Apr;61(4):358-62

5. EVENTOBSERVEDEXPECTED Deaths565607.6 All cancers 188184.2 Stomach cancer 1011.6 Breast cancer 1113.2 Non-Hodgkin's lymphoma 74.8 Leukemia54.6 AIMS: To obtain further information about the risks of cancer associated with occupational exposure to ethylene oxide METHODS: Follow up was extended by 13 years for a cohort of 2876 men and women with definite or potential exposure to ethylene oxide in the chemical industry or in hospital sterilizing units RESULTS: Analysis was based on 565 deaths, of which 339 had occurred during the additional period of follow up. Mortality was close to or below expectation for all causes

6. Occupational Exposure Standards

7. OSHA Standards The TWA (8-hour time-weighted average) is 1 ppm The Excursion Limit is 5 ppm, as averaged over a sampling period of 15 minutes The Action Level is 0.5 ppm, calculated as an 8-hour time-weighted average

8. OSHA Regulations per 29 CFR 1910.1047 1910.1047(d)(1)(i) Determinations of employee exposure shall be made from breathing zone air samples that are representative of the 8-hour TWA and 15-minute short-term exposures of each employee 1910.1047(d)(3)(i) If employee exposure action level but the 8-hour TWA, repeat monitoring for each such employee at least every 6 months 1910.1047(d)(3)(ii) If employee exposure > 8-hour TWA, repeat monitoring for each such employee at least every 3 months

9. 1910.1047(d)(6)(i) Monitoring shall be accurate, to a confidence level of 95%, to within ± 25% for airborne concentrations of EtO at the 1 ppm TWA and to within ± 35% for airborne concentrations of EtO at the action level of 0.5 ppm 1910.1047(d)(6)(ii) Monitoring shall be accurate, to a confidence level of 95%, to within plus or minus 35% airborne concentrations of EtO at the 5 ppm excursion limit 1910.1047(d)(7)(i) After 15 days, must notify affected employee of these results in writing 1910.1047(e)(1) Regulated area required wherever EtO may exceed the TWA 1910.1047(e)(2) Access to regulated areas shall be limited to authorized persons

10. 1910.1047(i)(1)(i)(A) Medical surveillance program required for all employees who are or may be exposed to EtO at or above the action level, without regard to the use of respirators, for at least 30 days a year 1910.1047(j)(1)(i) Signage required (regulated areas) DANGER ETHYLENE OXIDE CANCER HAZARD AND REPRODUCTIVE HAZARD AUTHORIZED PERSONNEL ONLY RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIRED TO BE WORN IN THIS AREA 1910.1047(j)(1)(ii)(A) And on containers DANGER CONTAINS ETHYLENE OXIDE CANCER HAZARD AND REPRODUCTIVE HAZARD

11. 1910.1047(k)(2)(iii) The employer shall keep an accurate record for 30 years IAW 29 CFR 1910.1020 of all measurements taken to monitor employee exposure to EtO The date of measurement The operation involving exposure to EtO which is being monitored Sampling and analytical methods used and evidence of their accuracy Number, duration, and results of samples taken Type of protective devices worn, if any Name, social security number and exposure of the employees whose exposures are represented This includes:

12. ACGIH (American Conference of Governmental Industrial Hygienists) Threshold Limit Values 8 hr Time Weighted Average (TWA): 1 ppm A2 Suspected human carcinogen

13. ACGIH EQUIVOCATION Threshold Limit Values (TLVs ® ) and Biological Exposure Indices (BEIs ® ) are determinations made by a voluntary body of independent knowledgeable individuals TLVs ® and BEIs ® are not standards. They are guidelines designed for use by industrial hygienists in making decisions regarding safe levels of exposure to various chemical substances and physical agents found in the workplace Since TLVs® and BEIs® are based solely on health factors There is no consideration given to economic or technical feasibility

14. NIOSH Recommendations RELs (Recommended Exposure Limit) 10 Hr Time-Weighted Average: <0.1 ppm 10 min/day ceiling value: 5 ppm NIOSH considers ethylene oxide to be a potential occupational carcinogen

15. MONITORING FOR ETHYLENE OXIDE

16. TOXIC GAS MONITORING PRECEPTS AS APPLIED TO ETHYLENE OXIDE The most important precept in ANY toxic gas monitoring application is protecting the employees First priorityyou must monitor where people are working Additional considerations Note that these precepts relate to CONTINUOUS monitoring Portable, survey monitoring has little applicability here, other than for initial testing or backup purposes The sterilizers and aerators Drain areas Gas cylinder storage area Ventilation characteristics Any other leakage or exposure possibilities

17. MONITORING METHODOLOGIES Semiconductor Sensor (Solid State) Inadequate sensitivity and no specificity Possible application for catastrophic leak detection Completely outmoded and outdated What about occupational health?

18. Photoionization Detector (PID) Responds to all organics so a chromatographic column must be used to remove interferences More commonly known as GC or gas chromatography method AdvantageExcellent interference rejection, but if used in the presence of isopropyl alcohol, will consume columns at an alarming rate DisadvantageNot true continuous monitoring DisadvantageExpensive AdvantageConventionally deployed stream-switching many points even if this precludes meaningful data collection

19. Electrochemical Voltammetric Sensor AdvantageExcellent sensitivity, and good interference rejection to all but isopropyl alcohol (IPA) Solution to this is replacement of IPA with phenol-based germicide or temporary analyzer pump shut-off while area is being wiped down with IPA AdvantageTrue continuous monitoring at all points, facilitating meaningful data acquisition AdvantageNot expensive for majority of applications DisadvantageCan become costly in those few industrial sterilization applications that really need to monitor scores of points

20. IMPORTANCE OF DATA ACQUISITION ARCHIVING/REPORTING Even if you've been a good corporate citizen, and have installed sensors for toxic compounds all around your facility, to protect your employees… Can you document long-term employee exposure? Do you have any idea how close their exposure is to the allowable levels? High concentration alarms are fine, but they're not enough!! You cant disregard long-term low level exposure Unless you have a documented record of exposure, if you're sued, you'll be scrambling for data, desperately trying to re-create the past the kind of exposure that lawsuits are based on

21. WHAT ABOUT BADGES? Badges only offer an appreciation of employee exposure retrospectively Inability to alarm at an instantaneous concentration value An absence of time-history A rounded "single number" value often insufficient to generate a realistic assessment of exposure levels To know what's happening in real time! Shortcomings include but are not limited to: Whats the solution?

22. SOME ETHYLENE OXIDE MONITORING PRODUCTS OFFERED BY

23. PORTABLE ANALYZER

24. CONTINUOUS MONITORING SYSTEM SINGLE POINT APPLICATION

25. CONTINUOUS MONITORING SYSTEM TWO POINT APPLICATION

26. CONTINUOUS MONITORING SYSTEM MULTI-POINT (THREE OR MORE) APPLICATION

27. ARC-MAX ® DATA ACQUISITION, ARCHIVING, AND REPORTING

28. ARC-MAX ® MAIN SCREEN

29. ARC-MAX ® SHIFT REPORT

30. ARC-MAX ® TRENDING

31. ARC-MAX ® ALARM LOG

32. CONCLUDING REMARKS IT WOULD APPEAR THAT ETHYLENE OXIDE CARCINOGENCITY HAS BEEN OVER-TOUTED REGULATIONS / RECOMMENDATIONS VARY BETWEEN OSHA, NIOSH, AND ACGIH MAINTAINING A GOOD RECORD OF EMPLOYEE EXPOSURE IS CRUCIAL FOR DEFENSE PURPOSES

33. SPECIAL THANKS TO JOE HADLEY AND THE MEMBERSHIP OF EOSA