1

Ethylene Oxide (ETO)

Stakeholder Meeting Agenda Topics

January 29, 2014

 Introductions

 ETO Usage Overview

 Industrial ETO Sterilization

o ETO Process Overview and Steps

o ETO Sterilization Emission Controls

o ETO Sterilization Worker Exposure Control Measures

 Hospital ETO Sterilization

o Typical Hospital EO Sterilization Process

o Hospital ETO Sterilization Emission Controls

o Hospital ETO Worker Exposure Control Measures

 ETO Preliminary Work Plan -- Anticipated Data Needs or Requested Comments

o Occupational Exposure

o Residential Post-Application -- Inhalation

o Ecological

o Water Quality

o Additional Information

 Open Discussion

Meeting Summary

EPA/Ethylene Oxide Stakeholders 

January 29, 2014, 1:00 PM to 2:30 PM

Room S-9100, 2777 S. Crystal Drive, Arlington, VA 22202

Participants

Stakeholders: Lynn L. Bergeson (Bergeson & Campbell, P.C. – counsel to The Ethylene Oxide Sterilization Association, 

Inc. (EOSA)), Joanne Cashin (ARC Specialty Products/ Balchem Corporation), Kathleen Hoffman (Sterigenics), Suzanne 

Leung (3M), David Ludwig (ARC Specialty Products/ Balchem Corporation), Edward M. Ruckert, (McDermott, Will & 

Emery – counsel to the American Spice Trade Association), Larry Talapa (3M), Jake Vandevort ( B&C Consortia 

Management)

*Mike Ebers (Steris), *Anita Kore (3M), *Resa Manson (Steris), *Randy Viscomi (ARC Specialty Products/ Balchem 

Corporation), *Ruey Dempsey (Advanced Medical Technology Association)

* Indicates participation by conference call

EPA: Sandra O’Neill, Susan Bartow, Cathryn Britton, Thurston Morton, Jessica Kidwell, Michelle Ranville, Sujatha Sankula, 

Gabe Rothman, He Zhong, Srinivas Gowda, Tim Leighton, Donna Randall, Rose Kyprianou, Donna Kamarei, Philip Ross, 

Jeffrey Dawson, Len Yourman, Elissa Reaves, Najm Shamim, Ivan Nieves, Ed Odenkirchen

EPA/Ethylene Oxide Stakeholders Meeting: On Wednesday January 29th, 2014, members of AD, PRD, HED, BEAD, EFED,

and OGC met with stakeholders of Ethylene Oxide (ETO) to discuss comments submitted by the stakeholders pertaining 

to the ETO Preliminary Work Plan (PWP). The stakeholders presented an overview on ETO usage and industrial and 

hospital ETO sterilization (typical ETO sterilization processes, emission controls and worker exposure control measures). 

Participants also discussed anticipated data needs, and comments on the ETO PWP and areas where the risk assessment 

could be refined with data from ETO stakeholders. (Donna Kamarei Kamarei.donna@epa.gov, Susan Bartow 

bartow.susan@epa.gov, Sandra O’Neill oneill.sandra@epa.gov)
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved. © 2014 B&C® Consortia Management, L.L.C. All Rights Reserved.

Jake Vandevort

B&C® Consortia Management, L.L.C.

Washington, D.C.

www.bc-cm.com

REGISTRATION REVIEW OF ETHYLENE OXIDE

Stakeholder Meeting

Arlington, VA

January 29, 2014
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Agenda

 Introductions 

 Summary of Key Points

 Ethylene Oxide (EO) Usage Overview

 David Ludwig, ARC Specialty Products/Balchem

 Industrial and Spice EO Sterilization

 Kathleen Hoffman, Sterigenics

 Hospital EO Sterilization

 Larry Talapa, 3M

 EO Preliminary Work Plan (PWP)

 Jake Vandevort, B&C® Consortia Management, L.L.C.

 Discussion

2
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Introductions

3
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Summary of Key Points

 The Ethylene Oxide Sterilization Association, Inc. 

(EOSA) believes the assumptions made concerning 

emissions do not reflect current usage and the 

perceived dangers due to those emissions are not 

reflective of the current situation

 EOSA is compiling industry data and wishes to 

provide it to the U.S. Environmental Protection 

Agency (EPA)

4
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Summary of Key Points (cont’d)

 Invitation to visit a sterilization facility

 EO sterilization plays a critical role in maintaining 

public health and we must get it right

 EOSA is committed to the registration review 

process and the products

 EOSA requests an opportunity to meet with EPA to 

discuss the PWP and anticipated data needs prior to 

the preparation of the Final Work Plan

5
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Usage Overview

 EO’s Essential Public Health Applications

 Sterilized Medical Products

 Sterilization Market

 Sterilization Capacity

6
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO’s Essential Public Health Applications

 Certain materials can only be sterilized using EO --

materials that are heat-sensitive, materials that 

cannot withstand exposure to steam or gamma 

radiation

 Sterilizes complex devices

 Long history of device compatibility

 Readily inactivates spores (most resistant life forms)

 Approximately 58% of medical products and 95% of 

surgical kits are processed with EO sterilization

7
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO’s Essential Public Health Applications (cont’d)

 EO sterilization is also vital to the spice industry

 Approximately 20% to 30% of spices in the U.S., most of 

which are imported, are treated with EO to reduce bioburden

 EO is an essential tool in protecting public health

 EO has consistently demonstrated its reliability in preventing 

the spread of dangerous pathogens, such as Salmonella and

E.coli, and it does so without adversely affecting the quality 

or conditions of the spices

8
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Total Sterilized Medical Products

(Cubic Feet Processed)

9

Source: ARC Specialty 

Products annual survey
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Historical Sterilization Market Trend

(Cubic Feet Processed)

10

Source: ARC Specialty Products annual survey
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Sterilization Market

(Cubic Feet Processed)

11

Source: ARC Specialty 

Products annual survey
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Contract and OEM EO Sterilization Capacity

12

Source: ARC Specialty Products annual survey
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Industrial EO Sterilization

 EO Sterilization -- Process Steps

 EO Worker Exposure -- Controls and Monitoring

 EO Emission Controls and Typical Emissions 

(compared to EPA’s PWP)

13
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Sterilization -- Product Flow

14
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Facilities Are Typically Split into Two Areas

15
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Receiving and Non-Processed Storage

 The first step in sterilization is the receiving of 

material and storage in the non-processed area

16
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Receiving (cont’d)

 Product is received on pallets and is traced 

throughout the process

 Material is moved through sterilization facilities with 

forklifts

17
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Facility Area Labeling

 All areas of the facility are clearly labeled

18
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Pre-conditioning

 Before being sterilized, the material needs to be preconditioned. This step brings the product up to the 

desired temperature and humidity. This is usually 

done in a separate pre-conditioning room or cell

19
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Pre-conditioning

 Product is stored in pre-conditioning room at 

elevated temperature and humidity for a prescribed 

time period

20
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Sterilization Chambers

 Following pre-conditioning, the material is ready to 

be sterilized and moved to an EO chamber

21
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Sterilization Chambers (cont’d)

 EO facilities typically have multiple sterilization 

chambers

22
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Multiple Chambers

 Sterilization work aisle for a 

plant with multiple chambers

 Note the physical 

separation of chambers from 

the rest of the plant and 

ventilation systems

23
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Sterilization Chambers (cont’d)

 Chambers are large, gas-tight, steel containers that are 

capable of holding vacuums

24
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Sterilization Chambers (cont’d)

25
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Sterilization Chambers (cont’d)

 Some chambers have 

conveyors to assist with the 

loading of product

26
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Delivery and Removal from Chambers

 EO is delivered to and removed from the chambers 

through gas-tight pipes

27
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Aeration Areas

 In conventional sterilization facilities, product is 

removed from chambers and put in an aeration room 

or cell

 Aeration rooms allow product to aerate safely. The 

product gives off small amounts of EO after it is 

removed from the chamber

28
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Aeration Room (cont’d)

 Aeration rooms undergo continuous air exchanges to 

provide a homogenous environment and route EO 

streams to emission controls

 Aeration rooms are considered restricted areas because 

of elevated EO concentrations. Operators are required to 

wear respirators when entering aeration rooms

 The elevated temperatures in aeration rooms helps speed 

the EO removal that is absorbed by the products

 Aeration is part of the sterilization process and subject to 

the same process control and Food and Drug 

Administration (FDA) validation as other sterilization 

steps

29
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Aeration

30
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Processed Storage and Shipping

 Following aeration, material is moved to processed 

storage. Once the product is released, it can be 

shipped

31
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Processed Product

32
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Shipping

33
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Drum Storage

 EO is stored in a special drum storage area

 Access to this area is restricted

34
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Connecting and Disconnecting Drums

 Special precautions are 

taken when EO drums are 

connected and disconnected

 All connections and piping 

are gas-tight and leakchecked

35
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Emission Controls

 EO emissions must be controlled

 EO vapors are piped from the chambers and aeration 

rooms to emissions control equipment

36
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Wet Scrubbers

 Wet scrubbers are often 

used to control emissions. 

These devices convert EO to 

ethylene glycol

 Sterilization facilities must 

comply with federal and 

state environmental air 

emissions regulations

37
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Control Room

 A control room and office area are also part of a 

facility

38
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Control Room (cont’d)

 A control room has 

computer equipment and 

instrumentation that allows 

operators to monitor and 

control every step of the 

sterilization process

 All computer software and 

control equipment must 

undergo FDA validation

39
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Cycle Designs

 EO vapor is exposed to product inside of a sealed 

chamber through a controlled and FDA validated 

“cycle”

 A cycle is composed of several steps, including removal of 

air by vacuum from the chamber, introduction of steam, 

nitrogen, and EO, and then the removal of EO

 The EO removal is conducted through the use of “gas 

washes,” where gas in the chamber is repeatedly removed by 

vacuum and replaced with nitrogen

40
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Typical EO Sterilization Cycle Phases

 Initial Vacuum

 Nitrogen Dilution

 Steam Injection and Conditioning

 EO Gas Injection

 EO Gas Dwell

 After Vacuum

 Air/Nitrogen Washes

 Final Release (ready for aeration)

41
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Cycle Design Considerations

 Cycle design has been used in recent years as an 

important tool to reduce employee exposures when 

the cycle is complete

 FDA’s EO residual requirements were recently 

reduced, which has also driven cycle designs that 

minimize EO left within the product

 The industry minimizes EO within the cycle

 All cycle design changes have resulted in lowering 

the number of employees potentially exposed

42
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Facilities Are Heavily Regulated

 The Occupational Safety and Health Administration (OSHA) EO 

Standard addresses worker exposure

 Association for the Advancement of Medical Instrumentation 

(AAMI)/American National Standards Institute 

(ANSI)/International Organization for Standardization (ISO) 

standards regulate the sterilization process

 An industry-specific National Fire Protection Association

(NFPA) Standard addresses EO fire hazards

 FDA Quality Systems Regulations address the operation of the 

entire sterilization process

 OSHA Process Safety Management applies to facilities that 

store more than 5,000 pounds of EO

 Homeland Security regulations regulate security requirements 

for EO facilities

43
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

OSHA Requirements

 Employee Exposure Monitoring

 Segregation of EO Regulated Area

 Respiratory Protection/Personal Protective 

Equipment (PPE)

 Emergency Planning

 Medical Surveillance

 Employee Communication

 Recordkeeping

44
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Worker Exposure Issues -- Solutions

 Heavily Regulated Industry

 Segregated Process Areas per OSHA Standards

 Segregated Product Storage Areas

 Well-Designed Ventilation Systems

 Properly-Designed Aeration Rooms

 Chamber Back Vents

 Effective Emission Controls

(EOSA Best Practice Sharing)

45
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Worker Exposure Issues -- Solutions (cont’d)

 Improved Sterilization Cycles

 Thorough EO Training for Employees

 Procedures for Handling EO and Drums

 Lower Explosive Limit (LEL) Detection Devices

 Continuous EO Monitoring Systems

 Door Interlock System (with EO Measurement)

 Respirator Requirements for Certain Tasks

46
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Few Employees Per Facility

 EO sterilization is a capital-intensive process, not 

labor intensive

 Industrial EO facilities typically have 5 to 30 EO employees

 Further minimized number of employees within the facility 

that are potentially exposed to EO

47
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Typical Respirator-Required Tasks

 Unloading Sterilization Chambers

 Entering an Aeration Room or Cell

 Maintenance Tasks on EO Pipes or Equipment

 Sampling or Accessing Processed Product

 Changing EO Drums Connected to the Process

48
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Types of Respirators Used

 MSA Canister Masks (phased out)

 Forced-Air Negative Fit Masks

 Self-contained Breathing Apparatus (SCBA)

49
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Safety-Limiting Worker Exposure

50
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Sterilization Emissions

51
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Emissions -- EPA Assumptions

 Appendix E (PWP) -- Modeling input based on EO 

release scenarios for spices and herbs

 Spices and herbs are processed in an industrial 

sterilization facility like medical devices

 EPA requires emission controls in almost all of these 

facilities

 The PWP assumptions should be corrected

52
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Emissions -- EPA Assumptions and Corrections

 Maximum Chamber Size is 10,000 5,200 cubic feet

 Maximum Application Rate is 500 mg/L

 Emission Rate is 312.2 162.3 lbs/hr. (without 

controls)

 Emission Rate is 1.62 lbs/hr. (with controls and 99% 

efficiency)

 Stack or Release Height is 5 25-30 feet

 Stack Diameter is 39.6 12 inches

 Distance between the stack and building center is 

22.3 100-300 feet

53
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

EO Sterilization Is Needed -- The Gold Standard

 Low temperature, moisture sensitive, device sterilization

 50+ years of EO use in U.S. hospital setting

 Efficacious -- inactivates spores, fungi, and viruses

 Superior ability to penetrate

 Long, large bore, multiple channel, flexible endoscopes

 Sterilizes complex geometries

 No lumen restrictions

 Materials compatibility

 Does not damage sterilized devices 

or materials

 Long history of compatibility

 Variety of packaging options

 Cost-effective

 Cycle to cycle basis

54
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Increasing Critical Need to Sterilize Complex 

Instruments

55
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Hospital EO Sterilization -- Usage Profile

 Reduced EO usage in U.S. health care facilities

 Approximately 1% of EO sterilization usage in the U.S.

 U.S. Clean Air Act -- Phase out of HCFC-based products

 Consolidation of hospital EO sterilization sites

 Long cycle times

 Sterile processing personnel

 Small ambulatory surgery centers

 1 - 2 operators 

 Large multi-system hospitals 

 1 - 3 operators

 Most cross train all on safety and procedures

56
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Recommended Practices

 ANSI/AAMI ST41:2008/(R)2012 -- Ethylene oxide 

sterilization in health care facilities: Safety and 

effectiveness

 Facility design

 Personnel training, continuing education, 

personnel health

 Sterilization and aeration

 Installation and maintenance of equipment

 EO PPE, storage, handling, leak, and spills

 Area and personnel monitoring

 OSHA (29 C.F.R. § 1910.1047)

57
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

FDA Cleared Sterilizers

 ANSI/AAMI ST24:1999/(R)2013 -- Automatic, generalpurpose ethylene oxide sterilizers and ethylene 

oxide sterilant sources intended for use in health 

care facilities

 Reaffirmed by AAMI in 2013

 Sterilizer design requirements

 Sterilant source requirements

 Sterilant emissions control systems

58
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

User Certification

 International Association of Healthcare Central 

Service Materials Management (IAHCSMM)

 Central Service Technical Manual (7th ed) Chapter 16 includes 

EO and Chapter 21 EO Special Safety Procedures

 Certification Board for Sterile Processing and 

Distribution (CBSPD)

 20% of Certification Exam Sterilization

Knowledge includes EO

 CE-credited EO In-services --

http://www.spdceus.com/tests.htm

59
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Existing Controls -- Facility Layout and Work Flow

 Signs demarcating regulated areas and entrances

 EO sterilizers located in containment area

 Traffic routed around or away

 Restricted personnel access in accordance with 

OSHA

60
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Existing Controls -- Facility Layout and Work Flow 

(cont’d)

61
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Existing Controls -- Engineering Controls

 Air flow away from operator’s breathing zone

 Minimum of 10 room air changes per hour (ACH)

62

(Ref. ANSI/AAMI/ST41:208)
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

High Level Procedure

 Hospitals must follow device and sterilizer

manufacturers instructions (IFU) created per 

obligations under FDA labeling regulations (21 C.F.R. 

Part 801)

63
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Typical 100% EO Cycle

 EO delivered in single dose cartridges

 Entire process maintained in a vacuum

 Sterilizer doors are interlocked until process complete

 Aeration of load begins automatically

64
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Typical 100% EO Cycle (cont’d)

 EO is delivered in single dose cartridges

65
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Existing Controls -- OSHA Occupational Exposure 

Standard for EO

 Employer required to monitor employee exposure

 What?

 Monitor for 8-hour time-weighted

average (TWA)

 15 minute sampling period

 How?

 Breathing zone air samples

 Who?

 Representative employee on each shift for each job classification

 If EO exposure  0.5 ppm AL, 8-hr TWA

 Monitoring of those employees can be discontinued

(ref. OSHA 29 C.F.R. § 1910.1047)

66
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Existing Controls -- OSHA Occupational Exposure 

Standard for EO (cont’d)

 Emergency planning

 Facilities using EO must have 

a written emergency plan

 Means to alert employees of 

emergencies promptly

 Area monitors in fixed 

locations with continuous 

sampling

 Alerts employees to leak or 

spill using visible and audible 

alarm

(ref. OSHA 29 C.F.R. §

1910.1047)

67
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Existing Controls -- EPA Reregistration Eligibility 

Decision (RED)

 RED: “determine that the 

benefits of continued use

outweigh the associated 

occupational risks, provided 

that risk mitigation measures 

specified by the Agency are 

adopted and reflected on 

product labeling”

 In hospitals, required risk 

mitigation, effective February 

28, 2010:

 Use of a single chamber 

process (i.e., sterilization and 

aeration occur in the same 

chamber)

68
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Existing Controls -- Emission Controls

 Small volumes vented directly to atmosphere

 Maximum 176 grams EO per cycle/day, typical 100 grams EO

 Abator option is available at 99.9% efficiency

 Maximum 0.18 grams EO per cycle/day, typical 0.10 grams EO

 Requirements vary by state and local regions

 Only run one cycle per day per sterilizer

 Must run in full chamber (unless abated)

69
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Existing Controls Emission Controls (cont’d)

70
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Existing Controls -- Emission Controls (cont’d)

 Maximum Chamber Size = 8 cubic feet

 Maximum Application Rate = 789 mg/L

 Maximum Emission Rate = 176 g/day/sterilizer (without 

controls)

 Maximum Emission Rate = 0.18 g/day/sterilizer (with 

Abator at 99.9% efficiency)

 Copper Vent Line or Release Height = no limit and protect 

from freezing

 Copper Vent Line Diameter = 3⁄4 - 1 inch with 180o 

downward bend

 Copper Vent Line Distance = >25 feet from any buildings

71
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Existing Controls -- Emission Controls

EPA Hospital Final Rule 

 Adopt a management practice

 Hospitals without an air pollution 

control device must sterilize full 

loads except under medically 

necessary circumstances

 Record date and time of each cycle

 Note any cycles that were not a full 

load

 Hospitals are NOT required to 

purchase an air pollution control 

device

 The use of an air pollution control 

device (abator) is an acceptable 

alternative

 Ref: 

http://www.epa.gov/fedrgstr/EPAAIR/2007/December/Day28/a25233.pdf

72
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Summary

 EO sterilization is still the gold standard in hospitals

 Public safety and patient care

 EO sterilization is adequately controlled in hospitals

 Recommended practices, training, education, certification, re-certification 

(FDA, AAMI, OSHA, manufacturers)

 Facility layout and work practices (AAMI, OSHA, manufacturers)

 Engineering controls (AAMI, manufacturers)

 Process controls (EPA, FDA, AAMI, manufacturers)

 Personal monitoring (OSHA)

 Available area monitors

 EO sterilization emissions are adequately controlled in hospitals

 Small single dose amounts in hospital settings (approximately 1% EO used 

for sterilization in U.S.)

 Emission is once per day per sterilizer (EPA -- full loads and aeration)

73
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

PWP for EO

 General Comments

 Usage Information

 Regulatory Requirements

 Anticipated Data Needs

 Water Quality Data

 Additional Information Request

74
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

PWP -- Usage Information

 Usage information may no longer be accurate

 Approximately 98% of the total pounds of EO sold for pesticidal 

purposes are used for sterilization of medical devices by 

contract sterilizers and medical device manufacturers

 The use of spice treatment and the number of hospitals 

performing in-house sterilization has declined since the 2008 

RED, and will continue to decline substantially

 Approximately 1% of the total pounds of EO used for pesticidal 

purposes will be used in hospitals or other medical facilities 

 Approximately 1% of the total pounds of EO sold for pesticidal 

purposes are used for fumigation of herbs and spices

 EOSA is reviewing industry data and has requested the 

opportunity to provide current reliable usage information

75
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Usage Information

 Typical usage is by large contract sterilization companies, 

medical device manufacturers, or spice processors

 All comply with EPA’s NESHAP and have OSHA restrictions

 EO usage is different than the typical agricultural field pesticide use as 

the process is performed in vacuum chambers

 The Exposure Analysis Plan used the AERSCREEN model 

results in Appendix F of the PWP

 Utilizes EO release assumptions from Appendix E

 Grossly overestimates the EO used in the typical EO process

 Does not account for the required emission controls

 The basis for the assumptions detailed in Appendix E is 

unclear

 Does not reflect current usage or release scenarios from the typical EO 

sterilization process

76
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Regulatory Requirements

 FDA has established several requirements for this 

sterilization process

 It regulates EO residual levels in the medical device products 

that contact the patient

 FDA requirements and the ISO 10993 Standard were modified in 

2008 such that allowable EO residual levels in the product were 

reduced

 Current requirements have contributed to reduced EO 

exposures in facilities as well as treated products

 OSHA 29 C.F.R. § 1910.1047 regulates EO usage

 Established a 1.0 ppm TWA requirement of an 8-hr period for all 

workers in the EO sterilization process

 All EO sterilization companies must comply

77
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Anticipated Data Needs

 Acute Inhalation Toxicity Study 

 Chronic Toxicity/Carcinogenicity Study (ECH)

 Inhalation Exposure Study for Applicators

 Product Use Information

 Post-Application Inhalation Exposure Study

 Monitoring Data on Fumigated Commodities

 Ambient Air Monitoring Study

 Avian Acute Inhalation Toxicity Study

 Honeybee Acute Vapor Exposure Toxicity Study

 Vegetative Vigor, Gas Chamber Exposure Study

78
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Acute Inhalation Toxicity

 Study intended to provide quantitative data on acute 

effect that would be used for separate acute 

inhalation risk assessments for EO

 The PWP identifies the availability of adequate subchronic 

data (PWP Table 8, page 18)

 These data should be deemed sufficient to support any shortterm inhalation risk

79
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Inhalation Exposure Study for Applicators

 Applies to all use sites

 2008 occupational risk assessments

 Contract sterilization

 Based on data for 21 facilities submitted by EOSA

 Hospitals and medical devices

 Based on information derived from the IMIS database

 Fumigation of herbs and spices

 Based on exposure study for two workers submitted by ASTA data for 21 facilities

 Approach

 Contract sterilization and medical facilities

 EPA can utilize OSHA data and observational monitoring data to update its risk 

assessment

 Fumigation of herbs and spices

 Given small proportion of total use (approximately 1%), such usage does not warrant 

imposition of a new exposure study

80
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Ambient Air Monitoring Study

 Proposing requirement for ambient air monitoring for 

“communities in proximity to treated facilities”

 The PWP grossly overestimates the emissions of EO 

from industrial facilities

 The PWP contains no rationale for this purported data 

need

 EPA indicates it does not expect significant post-application 

residential exposure from off-gassing of EO from sterilized items

 That computer modeling will be sufficient to confirm that there 

are no inhalation risks for residents located near fumigation or 

sterilization facilities that emit EO

 If there is not any significant risk for those residents who 

live near specific facilities that emit EO, there is no basis 

for concern about EO exposures in nearby communities

81
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Fumigated Commodities

 EOSA requests clarification of what is considered a 

fumigated commodity

 FDA regulates the residual levels in sterilized pharmaceutical 

and medical device products

 There are existing tolerances for EO and ECH

 What is the objective for requiring additional monitoring 

data?

 EPA already possesses monitoring data concerning the use on 

spices

 If required, it should be sufficient either to measure exposure of 

the affected workers or to monitor off-gassing in areas where 

those workers may be present

82
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Ecotoxicity Studies and Ecological Data

 The PWP identifies anticipated data needs regarding 

ecotoxicity data for several endpoints

 Avian acute inhalation

 Honeybee acute vapor exposure

 Vegetative vigor

 Such studies should not be needed once the EO 

emission data assumptions are corrected

83
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Water Quality Data

 EPA invites submission of water quality data 

 There are no water emissions from the typical EO sterilization 

or fumigation process

 There does not appear to be a need for additional water 

quality data associated with EO sterilization and fumigation 

processes

84
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Additional Information

 Label Information

 Use or Potential Use Distribution

 Use History

 Usage/Use Information for Non-agricultural Uses

 Typical Application Interval

 State or Local Use Restrictions

 Ecological Incidents Not Already Reported to EPA

 Monitoring Data

 Availability of Scrubber Technology for EO

85
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Confirmation of Label Information

 Application sites

 EO may be used only to sterilize medical or laboratory items, 

pharmaceutical, and aseptic packaging; or

 To reduce microbial load on cosmetics, whole and ground 

spices, or other seasoning materials; and

 Use of EO is only approved for industrial and hospital use

 Formulations

 23 active Federal Insecticide, Fungicide, and Rodenticide Act 

(FIFRA) registrations for products containing EO as the active 

ingredient (AI)

 8 products contain 100% EO

 15 products contain EO in percentages ranging from 8.5% to 98.06%

– All products are blended with inert ingredients, not other AIs

86
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Confirmation of Label Information (cont’d)

 Geographic limitations on use

 Products containing EO are registered in all 50 states and 

Puerto Rico and EPA-registered products are shipped to 

other countries

87
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Confirmation of Label Information (cont’d)

 Application methods and equipment

 EO may only be used in vacuum or gas-tight chambers

 Maximum application rates

 The concentration of EO is determined by the process used to validate 

the sterilization cycle in accordance with FDA requirements

 Method for treatment of spices and other seasoning materials is 

described on the label and specified a maximum EO concentration of 

500 mg/L

 Frequency of application, application intervals, and maximum 

number of applications 

 EO treatment facilities typically operate seven days per week

 Application intervals and the number of applications vary from site to 

site depending on the products to be treated

 FDA requirements control the maximum number of treatments for 

medical device sterilization

88
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Use or Potential Use Distribution and History

 Products containing EO are used at more than 80 

contract sterilization facilities, medical device 

manufacturing facilities, and spice treatment 

facilities

 Facilities currently exist in 31 states and Puerto Rico

 EO has been used for sterilization and fumigation 

purposes for decades

89
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Usage/Use Information for Non-Agricultural Uses

 Approximately 98% of the total pounds of EO sold 

for pesticidal purposes are used for the sterilization 

of medical devices by contract sterilizers and 

medical device manufacturers

 Use of EO to reduce microbial load on cosmetics, 

artifacts, archival materials, and library objects is 

increasingly rare

 Estimate that such uses comprise a fraction of a percent of 

the total annual pesticidal use

90
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Other Additional Information

 Typical application interval

 There are no “typical” application intervals for medical device 

sterilization 

 Spice treatment parameters are specified on the label

 State and local use restrictions

 New Jersey lists EO as a state Restricted Use Pesticide

 Ecological incidents not already reported to EPA

 None involving EO that we are aware of

 Monitoring data

 Facilities using products containing EO required to operate in 

compliance with OSHA EO Standard monitoring requirements

 Availability of scrubber technology for EO

 Many sterilization companies use acid scrubbers, catalytic oxidizers, 

absorbent systems, or a combination to meet NESHAP requirements

91
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Summary of Key Points

 EOSA believes the assumptions made concerning 

emissions do not reflect current usage and the 

perceived dangers due to those emissions are not 

reflective of the current situation

 Data is being compiled on use distribution and these 

data will be provided to EPA by ARC Specialty 

Products as confidential business information (CBI)

92
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Summary of Key Points (cont’d)

 Invitation to visit a sterilization facility

 EO sterilization plays a critical role in maintaining 

public health and we must get it right

 EOSA is committed to the registration review 

process and the products

 EOSA requests an opportunity to meet with EPA to 

discuss the PWP and anticipated data needs prior to 

the preparation of the Final Work Plan

93
© 2014 B&C ® Consortia Management, L.L.C. All Rights Reserved.

Thank You

David Ludwig

ARC Specialty Products/Balchem

52 Sunrise Park Road

New Hampton, NY 10958

dludwig@balchemcorp.com

Kathleen Hoffman

Sterigenics

2015 Spring Road

Suite 650

Oak Brook, IL 60523

khoffman@sterigenics.com

Larry Talapa

3M

3M Center

St. Paul, MN 55144

lmtalapa@mmm.com

Jake Vandevort

B&C® Consortia Management, L.L.C.

2200 Pennsylvania, Ave, N.W.

Suite 100W

Washington, D.C. 20037

jvandevort@bc-cm.com

http://www.bc-cm.com

94