EtO MONITORING REQUIREMENTS

EtO MONITORING EQUIPMENT

Michael D. Shaw

Presented By

AnproleneDihydrooxirene

Dimethylene Oxide1,2-Epoxyethane

Oxacyclopropane Oxane

Oxidoethane ,-Oxidoethane

Oxiran Oxirane

ETHYLENE OXIDE

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 thrombophlebitiswhereas in endotracheal tubes, tracheitis

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

EVENTEVENT OBSERVEDOBSERVED EXPECTEDEXPECTED

DeathsDeaths 565565 607.6607.6

All cancersAll cancers 188188 184.2184.2

Stomach cancerStomach cancer 1010 11.611.6

Breast cancerBreast cancer 1111 13.213.2

Non-Hodgkin's Non-Hodgkin's lymphomalymphoma

77 4.84.8

LeukemiaLeukemia 55 4.64.6

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

Occupational Exposure Standards

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

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

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

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)

DANGERETHYLENE OXIDE

CANCER HAZARD AND REPRODUCTIVE HAZARDAUTHORIZED PERSONNEL ONLY

RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIREDTO BE WORN IN THIS AREA

1910.1047(j)(1)(ii)(A)And on containers

DANGERCONTAINS ETHYLENE OXIDE

CANCER HAZARD AND REPRODUCTIVE HAZARD

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 measurementThe operation involving exposure to EtO which is being monitoredSampling and analytical methods used and evidence of their accuracyNumber, duration, and results of samples takenType of protective devices worn, if any Name, social security number and exposure of the employees whose exposures are represented

This includes:

ACGIH (American Conference of Governmental Industrial Hygienists) Threshold Limit Values

8 hr Time Weighted Average (TWA): 1 ppm

“A2” Suspected human carcinogen

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 physicalagents found in the workplace

Since TLVs® and BEIs® are based solely on health factors

There is no consideration given to economic or technical feasibility

NIOSH Recommendations

REL’s (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

MONITORING FOR ETHYLENE OXIDE

TOXIC GAS MONITORING PRECEPTS—AS APPLIED TO ETHYLENE OXIDE

The most important precept in ANY toxic gas monitoring application isprotecting the employees

First priority—you 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 aeratorsDrain areasGas cylinder storage areaVentilation characteristicsAny other leakage or exposure possibilities

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?

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

Advantage—Excellent interference rejection, but if used in the presence of isopropyl alcohol, will consume columns at an alarming rate

Disadvantage—Not true continuous monitoring

Disadvantage—Expensive

Advantage—Conventionally deployed stream-switching many pointseven if this precludes meaningful data collection

“Electrochemical” Voltammetric Sensor

Advantage—Excellent 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

Advantage—True continuous monitoring at all points, facilitating meaningful data acquisition

Advantage—Not expensive for majority of applications

Disadvantage—Can become costly in those few “industrial sterilization”applications that really need to monitor scores of points

IMPORTANCE OF DATA ACQUISITION ARCHIVING/REPORTING

Even if you've been a good corporate citizen, and have installed sensorsfor 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 can’t 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

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 insufficientto generate a realistic assessment of exposure levels

To know what's happening in real time!

Shortcomings include but are not limited to:

What’s the solution?

SOME ETHYLENE OXIDE MONITORING PRODUCTS

OFFERED BY

PORTABLE ANALYZER

CONTINUOUS MONITORING SYSTEMSINGLE POINT APPLICATION

CONTINUOUS MONITORING SYSTEMTWO POINT APPLICATION

CONTINUOUS MONITORING SYSTEMMULTI-POINT (THREE OR MORE) APPLICATION

ARC-MAX® DATA ACQUISITION, ARCHIVING,

AND REPORTING

ARC-MAX® MAIN SCREEN

ARC-MAX® SHIFT REPORT

ARC-MAX® TRENDING

ARC-MAX® ALARM LOG

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 EXPOSUREIS CRUCIAL FOR DEFENSE PURPOSES

SPECIAL THANKS TO JOE HADLEYAND THE MEMBERSHIP OF EOSA