EOSA

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P.O. Box 33361, Washington, D.C. 20033, PHONE: (866) 235-5030, FAX: (202) 557-3836, www.eosa.org

March 14, 2014

Via E-Mail

Ms. Donna Kamarei

Chemical Review Manager

Antimicrobials Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

Re: Ethylene Oxide Registration Review: Updated Emissions Date

Dear Ms. Kamarei:

On January 29, 2014, representatives of the Ethylene Oxide Sterilization 

Association, Inc. (EOSA) met with U.S. Environmental Protection Agency (EPA) staff regarding 

the Ethylene Oxide (EO) Registration Review. During the meeting, EOSA presented EPA with 

detailed information on EO usage and industrial, spice, and hospital sterilization. EOSA also 

identified inaccuracies with certain assumptions that EPA made in the Preliminary Work Plan 

(PWP) regarding emissions.

EPA staff requested additional information on actual emissions. In Appendix 1, 

EOSA presents information on the use of emissions controls and 2012 emissions data. Appendix 

2 provides additional information regarding anticipated data needs contained within the PWP.

We hope this information is helpful. Please do not hesitate to contact me at 410-

255-2773 or jvandevort@bc-cm.com if you have any questions.

Sincerely,

Jake Vandevort

The Ethylene Oxide Sterilization Association, Inc.
EOSA

Ms. Donna Kamarei

March 14, 2014

Page 2

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Appendix 1: Sterilization Industry Ethylene Oxide Emissions

In the Ecological Risk Assessment portion of the PWP for EO, several 

assumptions were made regarding emissions of EO from industrial sterilization facilities. During 

a meeting between EPA staff and industry representatives on January 29, 2014, members of 

EOSA detailed the inaccuracy of many of these assumptions and explained that industrial 

sterilization facilities are required to comply with federal, state, and local air emissions laws.

EOSA has confirmed that industrial EO sterilization facilities utilizing greater 

than 95% of the EO sold/used for pesticidal purposes currently have emissions controls in place. 

During the January 29, 2014, meeting, EPA staff requested that EOSA provide details about 

actual emissions. A search of the EPA Toxics Release Inventory (TRI) database confirmed that 

sterilization industry emissions of EO are being effectively controlled. The following analysis is 

based primarily on 2012 TRI data, supplemented by state reporting data:

2012 EO Emissions

Volume of EO sold/used*: 12,087,037 lbs

EO emissions: 79,844 lbs

Percent EO emitted: 0.66%

*These data represent approximately 91% of the volume of EO 

sold to/used by industrial sterilization facilities. Most of the 

emissions data were obtained from EPA’s TRI database. Some 

facilities do not report under TRI. For that reason, approximately 

15% of the emissions data were obtained from reports required to 

be provided under state air permits.

EO used for medical device and spice sterilization is a very minor use of the total 

product produced. Approximately 11 billion pounds of EO were produced nationwide in 2012. 

The volume of EO used for industrial sterilization purposes constitutes only 0.12% of total 

production. The emissions of EO from industrial sterilization facilities is approximately 0.007% 

of the total amount of EO produced.
EOSA

Ms. Donna Kamarei

March 14, 2014

Page 3

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Appendix 2: Anticipated Data Needs

Acute Inhalation Toxicity Study

This proposed data requirement is intended to provide quantitative data on acute 

effects that could be used for separate acute inhalation risk assessments. EOSA believes that 

short-term inhalation toxicity data (1-30 days) already exist and that the endpoints requested for 

this study are not likely to be measureable in the acute dosing period.

Inhalation Exposure Study for Applicator

EPA based its 2008 occupational risk assessment for contract sterilization 

facilities on applicator inhalation exposure data submitted by EOSA. EOSA believes the 2008 

data are sufficient to estimate conservatively industrial sterilization worker exposures. Since 

2008, there have been changes to the industrial sterilization process and cycles (such as less EO 

usage and increased number of gas washes at the end of the cycle) that would further reduce

worker inhalation exposures. Furthermore, the types of respirators used during this time period 

have changed from filter masks to forced air respirators, which would increase the workers’ 

protection factor and reduce their resulting inhalation exposures.

EPA based its 2008 risk assessment for hospitals and medical facilities on 

information from the Integrated Management Information (IMIS) database. Additional 

monitoring data for hospitals and medical facilities are being collected by 3M Health Care and it 

will submit further details under a separate cover. Given the small proportion of total use on 

herbs/spices, EOSA believes a new study for those use sites is not warranted.

Post-application Inhalation Exposure Study

EOSA believes this study is unnecessary once the corrected emissions data are 

taken into consideration. EPA states further inhalation data may be needed regarding the 

exposure of workers other than applicators resulting from off-gassing following commodity 

fumigation. During the January 29, 2014, meeting, EPA confirmed that “fumigated 

commodities” refers only to spices. In the PWP, EPA proposed to study this same route of 

exposure by downstream monitoring of the fumigated commodities.

Monitoring Data on Fumigated Commodities

As noted above, EPA confirmed that fumigated commodities refers to spices, 

however, the PWP indicates this anticipated data need applies to all use sites. If ultimately 

required, this requirement should apply only to sterilization of spices. Furthermore, if required, 
EOSA

Ms. Donna Kamarei

March 14, 2014

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EOSA believes 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.

Ambient Air Monitoring Study

EOSA believes this study is unnecessary once the corrected emissions data are 

taken into consideration. Although EPA is proposing monitoring for “communities in proximity 

to treated facilities,” the PWP contains no rationale for this data need. If there is not any risk for 

those residents who live near specific facilities that emit EO, it is unclear what basis could exist 

for concern about EO exposures in nearby communities.

Ecotoxicity Studies

The PWP includes anticipated ecotoxicity data needs for several endpoints, 

including avian acute inhalation, honeybee acute vapor exposure, and vegetative vigor. EOSA 

believes these studies are unnecessary once the corrected emissions data are taken into 

consideration.
EOSA

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P.O. Box 33361, Washington, D.C. 20033, PHONE: (866) 235-5030, FAX: (202) 557-3836, www.eosa.org

GLN Study Name Test 

Substance

Time 

Frame 

(Measured 

in months 

from Data 

Call In 

(DCI) 

Receipt)

Risk 

Assessments 

Data Will 

Support

Use Site(s) 

Triggering 

Anticipated 

Data 

Requirement

Applicable Exposure 

Scenario

Comments

Studies anticipated to be required through the Registration Review DCI

Special 

Study

Acute Inhalation 

Toxicity Study

ETO 24 Occupational/

bystander 

inhalation

All Worker/bystander 

acute inhalation 

exposures

Short-term inhalation toxicity data (1-

30 days) is currently available. 

Endpoints are not likely to be 

measureable in the acute dosing 

period.

870.4300 Chronic Toxicity 

/ Carcinogenicity 

Study

ECH 48 Occupational 

and 

Residential

All Chronic dietary 

exposure to ECH

Applicable to spices only.

875.1400 Inhalation 

Exposure Study 

for Applicator

ETO 12 Occupational All Applicator inhalation 

exposure

3M Health Care is collecting 

monitoring data for hospital use. 

Study not warranted for spice use due 

to minor proportion of overall use. 

The worker inhalation exposure data 

submitted by EOSA in 2008 should 

still be sufficient to conservatively 

estimate industrial worker exposures.

875.1700 Product Use 

Information

ETO 12 All All All To be provided by individual 

registrants.

875.2500 Post-application 

Inhalation 

Exposure Study

ETO 12 Postapplication 

(site specific)

All Emissions from 

specific facilities

Unnecessary with corrected EO 

emissions data. 

Special 

Study

Monitoring Data 

on Fumigated 

Commodities

ETO 24 Occupational All Emission from treated 

commodities/ 

materials and the 

potential for 

occupational exposure 

EPA confirmed “fumigated 

commodities” applies only to spices, 

however, all use sites are identified. 

If required, it should be sufficient 

either to measure exposure of the 
EOSA

Ms. Donna Kamarei

March 14, 2014

Page 6

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GLN Study Name Test 

Substance

Time 

Frame 

(Measured 

in months 

from Data 

Call In 

(DCI) 

Receipt)

Risk 

Assessments 

Data Will 

Support

Use Site(s) 

Triggering 

Anticipated 

Data 

Requirement

Applicable Exposure 

Scenario

Comments

due to those emissions 

in the channels of 

trade after fumigation 

activities are complete

affected workers or to monitor offgassing in areas where those workers 

may be present.

Special 

Study

Ambient Air 

Monitoring Study

ETO 36 Residential All Ambient air 

concentrations for 

communities in 

proximity to treated 

facilities

Unnecessary with corrected EO 

emissions data. For hospital use sites, 

modeling of levels in surrounding 

areas will be available separately from 

3M Health Care. The PWP contains 

no rationale for this data need.

Special 

Study

Avian Acute 

Inhalation 

Toxicity Study

ETO 24 Ecological All Inhalation of air 

emissions by nontarget wildlife

Unnecessary with corrected EO 

emissions data.

Special 

Study

Honeybee Acute 

Vapor Exposure 

Toxicity Study

ETO 24 Ecological All Inhalation of air 

emissions by nontarget wildlife

Unnecessary with corrected EO 

emissions data.

850.4150 Vegetative Vigor 

Gas Chamber 

Exposure Study

ETO 24 Ecological All Contact with air 

emissions by nontarget plants

Unnecessary with corrected EO 

emissions data.