# 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 1 4 , 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 Janu ary 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

detaile d 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 helpfu l. 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 1 4 , 2014 Page 2

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### Appendix 1: Steriliza tion 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 repre sentatives 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 emi ssions. 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 s terilization 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 1 4 , 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 a cute 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 estimat e 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 unnece ssary 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 a bove, 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 requir ed,

# EOSA

Ms. Donna Kamarei

March 1 4 , 2014 Page 4

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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 em issions 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 fa cilities 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 ac ute 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

Assess ments
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/ by stander

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 Post

application (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 1 4 , 2014 Page 6

{00606.002 / 111 / 00132486.DOC 4} GLN Study Name Test

Substance Time

Frame (Measured

in months

from Data

Call In (DCI) Receipt) Risk

Assess ments
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 compl ete affected workers or to monitor off

gassing 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 surroundi ng 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 non

target wildlife Unnecessary with cor rected EO

emissions data.

Special Study Honeybee Acute Vapor Exposure Toxicity Study ETO 24 Ecological All Inhalation of air emissions by non

target wildlife Unnecessary with corrected EO

emissions data.

850.4150 Vegetative Vigor

Gas Chamber Exposure Stu dy ETO 24 Ecological All Contact with air emissions by non

target plants Unnecessary with corrected EO

emissions data.