United States Prevention, Pesticides EPA 730-06-032
Environmental Protection and Toxic Substances July 24, 2006
v>EPA
Report of the Food Quality Protection
Act (FQPA) Tolerance Reassessment
and Risk Management Decision
(TRED) for Ethylene Oxide
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Report of the Food Quality Protection Act (FQPA) Tolerance
Reassessment and Risk Management Decision (TRED) for
Ethylene Oxide
Approved By:
' ^-i^^l
Debra Edwards, Ph.D.
Director, Special Review and
Reregistration Division
Date
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Abstract
The Environmental Protection Agency (EPA) has concluded its tolerance reassessment for
ethylene oxide (ETO) and has determined that with the exposure mitigation described in this
document, there is a reasonable certainty that no harm to any population subgroup will result from
exposure to ETO or its reaction products, ethylene chlorohydrin (ECH) and ethylene glycol (EG).
Therefore, the four tolerances established for residues of ETO are now considered reassessed as
safe under section 408(q) of the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act (FQPA).
This Tolerance Reassessment Decision (TRED) document considers dietary risk
associated with pending requests for voluntary cancellation of use on basil from Honeywell -
Fluorine Products NIC5 (Honeywell) and Balchem Corporation. In letters dated July 7, 2006, and
July 10, 2006, respectively, both Balchem and Honeywell corporations have requested irrevocable
voluntary termination of basil uses of its ethylene oxide products and requested label
amendments. These requests will be approved pending the completion of a 30 day public
comment period announced in the Federal Register.
This TRED also considers the exposure mitigation achieved through use of sterilization
methods which result in lower residues than the conventional method. The registrants have
agreed to amend their labels to mandate use of such methods.
The Agency is issuing this TRED document for ETO as announced in a Notice of
Availability published in the Federal Register. The Agency is providing a 60-day comment
period for stakeholders to respond to this risk management decision. If substantive information is
received during the comment period that indicates a need to reconsider the decisions presented in
this document, EPA may modify these decisions as appropriate through an amendment.
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I. Introduction
This is the Environmental Protection Agency's (hereafter referred to as EPA or the
Agency) "Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment and Risk
Management Decision for Ethylene Oxide." This document is also known as a Tolerance
Reassessment Decision, or TRED. This TRED reassesses the tolerances associated with ETO and
its reaction product ethylene chlorohydrin (ECH) to ensure the pesticide meets the standards of
FQPA. No residues of ETO per se are expected on food at the time of consumption. Therefore,
the dietary risk assessment focuses on the risks associated with ECH and another reaction product,
ethylene glycol (EG).
The Federal Food, Drug and Cosmetic Act (FFDCA), as amended by FQPA, requires
EPA to reassess all the tolerances for registered chemicals in effect on the day before enactment of
the FQPA on August 3, 1996. In reassessing these tolerances, the Agency must consider, among
other things, aggregate risks from non-occupational sources of pesticide exposure, whether there
is increased susceptibility to infants and children, and the cumulative effects of pesticides with a
common mechanism of toxicity. When a safety finding has been made that aggregate risks are not
of concern, and that there is no common mechanism of toxicity with other pesticides, the
tolerances are considered reassessed. Existing tolerances associated with ETO and its reaction
products must be reassessed in accordance with FFDCA, as amended by FQPA.
This TRED will be followed by a Reregistration Eligibility Decision (RED) for ETO,
scheduled for 2007. The RED will be prepared once the Agency's Office of Research and
Development (ORD) completes its assessment of ETO carcinogenicity. Once the ORD
carcinogenicity assessment is complete and publicly available, the results will be incorporated into
the Office of Pesticide Programs' (OPP) risk assessment for ETO and a RED will be prepared.
The RED will include an occupational assessment which is typically not included in a TRED.
The RED will also address ETO's special review status. ETO was placed in special review in
1978 based on predicted developmental toxicity, mutagenicity, and neurotoxic effects in workers.
In the early 1980s, the carcinogenicity of ETO emerged as an issue and was included as a special
review concern. After the RED is finalized in 2007, the Agency intends to complete the special
review for ETO later that year.
Readers should be aware that the current human health risk assessment reflects the
following exposure mitigation outlined in chapter IV of this TRED and agreed to by the
registrants.
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Voluntary Deletion of the Following:
Use Pattern: Basil
Label Amendments:
Manufacturing and end-use label language to read:
Manufacturing and end use products will be amended to (1) prohibit use on basil, and (2) require
the use of sterilization methods which have been demonstrated to result in residue levels which
are lower than those that result from sterilization using conventional sterilization methods.
Specific label language is included in Section V of this document.
II. Background
ETO is a fumigant/sterilant used to sterilize medical or laboratory equipment,
Pharmaceuticals, and aseptic packaging (21 CFR §201), or to reduce microbial load on cosmetics,
whole and ground spices or other seasoning materials, copra1, dried vegetables and black walnuts
(40 CFR § 180), and artifacts, archival material or library objects. Sterilization/fumigation with
ETO must be performed only in vacuum or gas-tight chambers designed for use with ETO. It is
applied by commercial applicators only; there are no residential uses of ETO. Tolerances for
residues of ETO and ECH in/on black walnuts, copra, whole spices and ground spices are
established under 40 CFR §180.151.
Agency estimates of ETO usage indicate that a major use of ETO in the U.S. is
commercial fumigation/sterilization. A majority of this fumigation is for sterilization of medical
and laboratory items/equipment. A much smaller portion of ETO annual usage is for fumigation
of herbs and spices. ETO treatment is the principal method used to reduce bacterial levels in
spices/herbs and black walnuts. All other uses account for less than 1 percent of the total annual
usage for pesticide purposes.
ETO residues decline rapidly after sterilization and are unlikely to be found in spices
available for consumption. ECH. and another reaction product, ethylene bromohydrin (EBH),
have been shown to result from fumigation of foods with ETO due to ETO interaction with
natural chlorides and bromides present in the crop. At high sterilization concentrations, ETO
reacts with moisture to form another reaction product, ethylene glycol (EG), and, in the presence
of sugars, glycol derivatives. Spice sterilization study data indicate persistent high levels of the
reaction products ECH and EG in treated spices and herbs and walnuts. Therefore, toxicological
The tolerance and/or use in/on coconut copra will be proposed for revocation as the registrant is not supporting this
use.
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endpoints were selected for dietary exposure to these reaction products. However, no tolerances
are required for EG because there is no acute toxicity endpoint and chronic dietary risk are well
below EPA's level of concern. EBH residues are also found in treated commodities, but are
minimal relative to ECH and therefore were not evaluated quantitatively in the risk assessment
and no EHB tolerances are required.
III. ETO Risk Assessments
Please refer to Appendices B and C, respectively, for the Revised Acute Dietary Exposure
Assessment for the Reregistration Eligibility Decision for ETO, dated June 21, 2006, and the
Addendum to Revised Residue Chemistry Chapter for Ethylene Oxide Reregistration
Eligibility Decision (RED) Document Issued July 12, 2006, for details on the risks associated
with dietary exposure to ETO. These documents are also available in the public docket EPA-
HQ-OPP-2005-0203, located on-line in the Federal Docket Management System (FDMS)
http://www.regulations.gov.
IV. Regulatory Determinations
A. FQPA Assessment Supporting Tolerance Reassessment Decision
EPA has evaluated the dietary risks from the supported registered uses of ETO and has
determined that there is a reasonable certainty that no harm to any population subgroup will result
from exposure to ETO or its reaction products.
The Agency's dietary risk assessments incorporate both exposure to and toxicity of a given
pesticide. Dietary risk is expressed as a percentage of a level of concern. The level of concern is
the dose predicted to result in no unreasonable adverse health effects to any human population
subgroup, including sensitive members of such population subgroups. This level of concern is
referred to as the population adjusted dose (PAD), which reflects the reference dose (RfD), either
acute or chronic, adjusted to account for the FQPA safety factor.
Estimated risks that are less than 100% of the PAD are below EPA's level of concern.
The acute PAD (aPAD) is the highest predicted dose to which a person could be exposed on any
given day with no adverse health effects expected. The chronic PAD (cPAD) is the highest
predicted dose to which a person could be exposed over the course of a lifetime with no adverse
health effects expected.
The acute dietary exposure estimates for ETO food uses, which includes whole and ground
spices (except basil), dried vegetables, and walnuts, for the general U.S. population and all
population subgroups, occupy less than 100 percent of the aPAD. The highest acute exposures at
the 99.9th percentile for ECH were for children 1 to 2 years old at 96 percent of the aPAD. This
assessment concludes that for the commodities listed above, the acute dietary exposure estimates
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for ECH are below the Agency's level of concern. An acute assessment for EG was not
conducted because an acute RfD for EG was not established since effects were seen only at high
doses (greater than 1,000 mg/kg/day) in oral studies including developmental toxicity studies.
The chronic dietary exposure estimates for both ECH and EG are below the Agency's
level of concern for the general population and all population subgroups and occupy less than 100
percent of the cPAD. The highest estimated chronic exposures for ECH were for children 1 to 2
years old at 38 percent of the cPAD. The highest estimated chronic exposures for EG were for
children 1 to 2 years old at 7 percent of the cPAD.
EPA has determined that risk from exposure to ETO and its reaction products is within its
own "risk cup." In other words, EPA is able to conclude that the tolerances for ETO meet the
FQPA safety standards. EPA has evaluated the dietary and drinking water risks from the
supported registered uses of ETO and has determined that there is a reasonable certainty that no
harm to any population subgroup will result from exposure to ETO and its reaction products.
Because drinking water exposures are not expected, there are no residential uses, and the acute
and chronic dietary exposure estimates for food are below the Agency's level of concern, the
tolerances for ETO established at 40 CFR §180.151 are now considered reassessed under Section
408(q)ofFFDCA.
The Agency has also assessed potential risk to residential bystanders resulting from the
commercial sterilization use of ETO. EPA's Office of Air and Radiation (OAR) conducted a
residential risk assessment which estimated cancer as well as acute and chronic non-cancer risk to
bystanders. The Agency concluded that potential cancer and non-cancer risks do not indicate any
further regulatory action is necessary at this time.
B. Cumulative Assessment
Unlike other pesticides for which EPA has followed a cumulative risk approach based on a
common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as
to ETO and any other substances, and ETO does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance action, therefore, EPA has not
assumed that ETO has a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and
to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's
Office of Pesticide Programs concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on EPA's website at
httir/'www.cpa.^ov-'pesticides/cumulative'.
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c.
Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program
to determine whether certain substances (including all pesticide active and other ingredients) "may
have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or
other such endocrine effects as the Administrator may designate." Following recommendations of
its Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA determined that there
was a scientific basis for including, as part of the program, the androgen and thyroid hormone
systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's
recommendation that the Program include evaluations of potential effects in wildlife. For
pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help
determine whether a substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations. As the science develops and resources allow, screening of additional
hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).
In the available toxicity database for ETO, there were possible testicular effects (altered
sperm counts and mobility) observed in a chronic monkey toxicity study. It should be noted that
this study had many deficiencies and no other toxicological study involving ETO exhibited any
potential endocrine disruption effects. Therefore, the Agency is confident that toxicity endpoints
chosen for risk assessment purposes are protective of any potential endocrine disruption effects.
When additional appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, ETO may be subjected to further screening and/or testing
to better characterize effects related to endocrine disruption.
D.
Tolerance Reassessment Summary
Tolerances for residues of ETO under 40 CFR §180.151 in/on food commodities currently
established and the proposed changes for ETO and ECH are summarized below.
(a) General. (1). Tolerances are established for the residues of the antimicrobial agent and
insecticide ethylene oxide, when used as a post-harvest fumigant in or on the following food
commodities:
Tablel. Tolerance Reassessment Summary for Ethylene oxide
Commodity
Current
Tolerance (ppm)
Tolerance
Reassessment (ppm)
Commcnt/f Correct Commodity Definition]
Tolerances Listed Under 40 CFR §180.151 a(l)
coconut, copra
spices, whole
walnut, black
50
50
50
revoke
7
50
should be revoked; treatment not used and
registrant is not supporting this use
[herbs and spices, group 19, dried (except basil)]
[walnut]
Tolerances Listed Under 40 CFR §180.151 a(2)
spices, processed
50
reassigned
Should be reassigned; ground spices included in
[herbs and spices, group 19, dried (except basil)]
Tolerances to Be Proposed under 40 CFR 180.151 For Ethylene oxide
vegetable, dried
none
~?
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EPA will propose to remove ail of section 151(a)(2) and replace with the following new
section (a)(2):
Tolerances are established for residues of the ethylene oxide reaction product, 2-
chloroethanol, commonly referred to as ethylene chiorohydrin, when ethylene oxide is used as a
post-harvest fumigant in or on the following food commodities.
TabieZ. Tolerance Reassessment Summary for Ethylene oxide
Commodity
Current
Tolerance
(ppin)
Tolerance Reassessment
(ppm)
Comment/fCorrect Commodity Definition/
Tolerances to Be Proposed under 40 CFR 180.151 For Ethylene Chiorohydrin
herbs and spices,
group 19, dried
(except basil)
vegetable, dried
none
none
940
940
Codex Harmonization. There are no Codex Maximum Residue Levels (MRLs) for
residues of ETC1 or ECH in/on spices/herbs. A Canadian MRL has been established for ECU at
1,500 ppm in/on spices. Canada does not have an MRL for ETO in spices/herbs. Since the U.S.
residue data showed slightly lower levels of ECH, the Agency is proposing a 940 ppm tolerance.
Consequently, the U.S. is not compatible with Canada in regards to ETO or ECH.
V. Data Requirements
These data requirements apply only to this TRED. Additional data requirements may be
identified upon completion of the RED. EPA will issue a DCI in the near future for the studies
listed below.
Product Chemistry Data Requirements. All pertinent data requirements are satisfied.
Toxicity Data Requirements. The database for ETO is found to be adequate and no
additional studies are required for the parent compound. However, the following studies are
identified as data gaps for the ETO reaction product ECH.
870.3700b Developmental Toxicity (rabbits)
870.3800 Two-generation Reproduction Toxicity (rats)
870.4300 Chronic/Oncogenicity - Oral (rats and mice)
870.41 OOb Chronic Toxicity Oral (nonrodent)
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Labeling Changes Summary Table
[Appendix A]
In order to be consistent with the mitigation requirements outlined in the ETO TRED, amend all product labels to incorporate the risk
mitigation measures outlined in Section IV. The following table describes how language on the labels should be amended.
Table 1: Summary of Labeling Changes for Ethylene Oxide (ETO)
Description
Amended Labeling Language
Placement onLabel
For all Manufacturing
Use Products
This product may only be used for formulation into a sterilant fumigation
for the following pesticidal uses: to sterilize medical or laboratory iterns,
Pharmaceuticals, and aseptic packaging, or to reduce microbial load on
cosmetics, whole and ground spices, ground vegetables or other seasoning
materials excluding basil, and artifacts archival material or library items.
"This product may not be used on or in any form of basil."
Directions for Use
One of these statements
may be added to a label
to allow reformulation
of the product for a
specific use or all
additional uses
supported by a
formulator or user
group
This product may be used to formulate products for specific use(s) not
listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of
such use(s).
This product may be used to formulate products for any additional use(s)
not listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of
such use(s).@
Directions for Use
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End Use Products
Application
Restrictions required
for Risk Mitigation
Product labeling must he amended to remove all instructions for
applications to Basil and the following statement must be added:
"This product may not be used on or in any form of basil."
Product labeling must be amended to restrict applications to use of the
following type of equipment and rneihods:
"After August 1, 2008. this product may only be applied to or on spices,
dried vegetables or seasonings utilizing an ETO sterilization method that
uses a single sterilization chamber to pre-condition and aerale with an
alternating vacuum and aeration purging procedure. If you wish to
employ an alternative method to that described below, you must contact
the Environmental Protection Agency Office of Pesticide Programs for
instruction on ho\v to receive authorization."
"Place spices in the treatment chamber. Assure that the mixture of
ethylene oxide and air is compatible with the chamber design, then,
introduce into the chamber a concentration of Ethylene Oxide not
to exceed 500 mg/L, with a dwell time not to exceed 16 hours.
Then evacuate the gas from the chamber using a sequence of not
less than 16 steam washes (injections and evacuations) between 1.0
PS1A (28" Hg) and 2.0 PSIA (26"Hg) while maintaining a
minimum chamber temperature of 120° F."
Directions for Use
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Ethylene Oxide Dietary Exposure Assessment
PC Code; 042301
[Appendix B]
DP Barcode: D316677
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\
a
'/
MEMORANDUM
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
OFFICE OF PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATE:
June 21,2006
SUBJECT: Ethylene Oxide/Ethylene Chlorohydrin Revised Acute Dietary Exposure
Assessment for the Reregistration Eligibility Decision
PC Code: 042301
DP Barcode: D316677
REVIEWER: Becky Daiss, Environmental Health Scientist
Reregistration Branch 4
Health Effects Division (7509P)
TH ROU GH: Thurston Morton
Dietary Exposure Science Advisory Council (DESAC),
and
Susan Hummel, Branch Senior Scientist
Reregistration Branch 4
Health Effects Division (7509P)
TO:
Susan Bartow, Chemical Review Manager
Special Review Branch
Special Review and Reregistration Division (7509P)
This document provides a revised acute probabilistic dietary risk assessment of exposures
to ethylene chlorohydrin (ECH) resulting from use of ethylene oxide as a food fumigarit using an
improved fumigation process. This document updates the January 6, 2006 dietary assessment (B.
Daiss, D325114). Only acute dietary exposures to ECH are assessed for this analysis because
that scenario only produced risk estimates above EPA's level of concern based on a previous
dietary assessment conducted for the Ethylene Oxide RED (B. Daiss, D313777, 3/30/05). This
analysis incorporates ECH residue data from a recently conducted ethylene oxide fumigation
study using the improved process which results in significantly reduced residues of ECH. The
analysis has also been revised to exclude basil as a fumigated commodity based on comments
submitted by McDermot, Will and Emmery regarding the registrant's intent to request deletion of
basil from product labels.
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Executive Summary
A refined acute dietary risk assessment of exposure to ethylene chlorohydrin was conducted
using the Dietary Exposure Evaluation Model (DEEM-FCID, Version 2.03) which uses food
consumption data from the USDA's Continuing Surveys of Food Intakes by Individuals (CSFII)
from 1994-1996 and 1998. Residue data for this assessment was provided in 2001 ethylene
oxide spice sterilization study submitted by the American Spice Trade Association (MRID
46635201). The submitted study describes a new ethylene oxide fumigation process that results
in substantially reduced residues over those reported in the previously submitted magnitude of
the residue study. For this assessment, it is assumed that basil is not fumigated with ethylene
oxide based on the registrant's intent to request deletion of basil from the ethylene oxide product
label. With the exception of basil, the entire distribution of fumigated commodity residues was
used for the acute assessment. Maximum percent crop treated (sterilized) was used for the acute
assessment.
Acute Dietary Exposure Results and Characterization
A refined probabilistic acute dietary exposure assessment was conducted for all supported
ethylene oxide food uses except basil for the general U.S. population and various population
subgroups. The assessment assumes commodities are treated with the improved fumigation
process.
This assessment concludes that for ail supported commodities, except basil, the acute
dietary exposure estimates for ethylene chlorohvdrin are below HED's level of concern.
The DEEM acute dietary exposure estimate at the 99.9th percentile for the highest
exposed population subgroup, children 1-2 years of age, is 96% of the aPAD. A critical
exposure contribution analysis for ethylene chlorohydrin indicates that marjoram and
savory commodities account for the largest percentage of dietary risk for the general
population as well as the highest exposed subgroup children 1-2 years old.
I. Introduction
Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute
and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose
(i.e.. the dose below which HED has concluded will result in no unreasonable adverse health
effects). This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent
to the Reference Dose (RfD) divided by the special FQPA Safety Factor.
For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk
exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in
more detail are available on the EPA/pesticides web site: "Available Information on Assessing
Exposure from Pesticides, A User's Guide," 6/21/2000, web link:
http://wvvv\ ena.u(n-/lcJruslr/HPA-PHST'2000/.lulv/Dav-l2/6061.pdf; or see SOP 99.6 (8/20/99).
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Ethylene Oxide Dietary Exposure Assessment
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II. Residue Information
The Biological and Economic Analysis Division (BEAD) provided a Quantitative Usage
Analysis (QUA) for ethylene oxide (Attachment 1). Percent crop sterilized data were available
and used for all treated commodities included in the dietary assessment. For the acute dietary
analysis, the estimated maximum % crop sterilized with ethylene oxide was used when available.
Available chemical specific data from cooking studies were used for cooked commodities.
Spices, herbs, and dried vegetables (garlic and onion) are treated as non-blended commodities for
this assessment because sterilization occurs post-application and therefore blending of treated
and non-treated spices, herbs, and dried vegetables is not likely to occur.
Existing and reassessed tolerances, assuming explicit deletion of basil from the product label, are
provided in Table 1. These tolerances are based on residue data from a residue study in which
the traditional sterilization process was used to treat spice/herb commodities. (J. Stokes,
D325 111, 1/25/06). If and when the improved ethylene oxide sterilization process as been fully
adopted, as reflected in the product label, the tolerances may be reassessed and likely reduced
based on the residue data from studies using the new process.
Table 1 - Tolerance Reassessment for Ethylene Oxide -- Tolerances Established Under 40 CFR §180.114
Commodity
spices/herbs (except basil)
dried bulb vegetables
Black walnut
Ethylene Oxide
Current Tolerance
(ppm)
50
--
50
Reassessed Tolerance
(ppm)
50
50
50
Ethylene Chlorohydrin
Current Tolerance
(ppm)
-
--
-
Reassessed Tolerance
(ppm)
2000
2000
50
Residue Data used for Acute Dietary Assessment:
Residues of Concern (residues included in dietary exposure analysis)
Residues of the ethylene oxide reaction product ethylene chlorohydrin only were included in this
dietary assessment for spices/herbs, dried vegetable and walnuts. Ethylene chlorohydrin is
considered a residue of concern for dietary exposure based on spice sterilization study residue
data which shows that this compound is consistently present at high levels and that the residues
persist.
Spice/Herb/Walnut Sterilization Study Data
Data from a 2001 ethylene oxide sterilization study were used to estimate residues of ethylene
chlorohydrin in spices, herbs, walnuts, and dried vegetables (J. Stokes, D325111). This study
was conducted in order to test the effect on ethylene oxide and ECH residue levels resulting from
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recent improvements in the control of fumigation conditions that have been developed for the
ethylene oxide sterilization process. Spice, herb, and walnut commodities were treated with
ethylene oxide in commercial treatment chambers under conditions representative of the
improved process and subsequently stored under conditions representative of actual handling
practices in the spice industry. A total of 29 whole and ground spices and herbs were evaluated
to represent three major categories of leaves, seeds and classical spices. Six whole and ground
spices were also evaluated for residues resulting from repeated (two) treatments with ethylene
oxide as representatives of the leaf, seed and classical spice categories. Spices were analyzed at
three different post-treatment sampling intervals 0 time, 24 hours and 72 hours. Residue data
from the 72 hour sampling interval was used in this dietary analysis. Based on information
provided by the registrant, this data is assumed to be representative of residue levels likely to be
found in treated spices.
HED assumes that herb and dried vegetable commodities identified as "fresh" in DEEM are not
sterilized with ethylene oxide. Therefore, these commodities were excluded in this dietary
analysis.
Residue Data Used for Acute Dietary Exposure Assessment
With the exception of the residue data for basil, all of residue data from the 2001 ASTA spice
sterilization study have been used to assess acute dietary exposures to ethylene chlorohydnn. For
individual commodities that are identified specifically in DEEM, commodity specific residue
data were used if such data is provided in the ASTA residue study. For example, ASTA study
residue data are provided for cinnamon and pepper and these spices are included as separate
commodities in CSFII, therefore, cinnamon and pepper-specific residue data were included in a
separate residue distribution file for these commodities. For commodities that are identified
categorically in CSFII (e.g., "other spices/herbs"), study residue data from all of the spices and/or
herbs provided for that category were used for the dietary assessment. For example, for the
category ''herbs other", all of the study data provided for specific herbs (i.e., oregano, sage) are
used. Similarly, for herbs/spices that are identified specifically in CSFII but do not have
corresponding commodity specific residue data from the sterilization study, all of the study
residue data provided for specific spices and/or herbs were used to assess that commodity. For
example, for the herb commodity chives, all of the study data provided for specific herbs (i.e.,
basil, oregano, sage) are used. Seeds are a subset of spices in CSFII. Therefore data from the
sterilization study for spices and seeds were combined for spice and seed commodities in the
dietary analysis. Study specific data for sesame seed which is identified as the food commodity
category "other" were included in the residue distribution file for spices and seeds residue data.
The ethylene oxide sterilization study provided no specific residue data for any commodities in
the category of dried vegetables (e.g., garlic and onions). Therefore, all of the 72 hour residue
data provided for all spice arid herb commodities were included in the residue distribution file for
dried onion and garlic commodities. Residues reported as non-detect were estimated at half the
level of detection (LOD) for the acute dietary exposure assessment.
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Ethylene Oxide Dietary Exposure Assessment
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A drinking water exposure assessment was not conducted for this assessment because the
Environment Fate and Effects Division expects that uses of ethylene oxide for indoor food and
nonfood uses will result in insignificant exposure to drinking water resources.
Processing Factors
No processing factors (e.g., drying, baking) have been used because ethylene oxide spice
sterilization is conducted post-processing.
Cooking Study
Cooking factors from a 1993 HC-ethylene oxide cooking study conducted by Agrisearch Inc.,
were used for the ethylene oxide dietary assessment. The cooking study was designed to
determine the effect of cooking foods following addition of spices previously fumigated with
i4C-ethylene oxide. The identity and total quantity of ethylene oxide and its reaction products
remaining in the foods after cooking was determined. Representative food types for the study
(baked goods, biscuit; sauce, tomato sauce; and meat; frankfurter) were uniformly mixed with
three representative spice types (leaves, seeds, and classical). The spices (9 total, 3 of each type)
were fumigated with 14C-ethylene oxide. The fumigated spice mixture was blended with the
three representative food types for cooking (baked biscuit, boiled sauce, and fried frankfurter)
and extracts were analyzed for quantitation of all observed radiocarbon materials. A more
detailed description of the study is provided in the residue chemistry chapter (J. Stokes,
D316652, 7/12/05). The study results demonstrated the magnitude and nature of the residue
resulting from the cooked foods. The cooking factors determined for baked, boiled and fried
foods were used for all EPA-defined food commodities specifically designated as baked, boiled,
or fried in DEEM and Lifeline . Cooking factors were averaged for food forms designated as
having undergone multiple methods of cooking i.e., baked/fried, baked/boiled, etc), Cooking
factors for ethylene chlorohydrin residues are provided in Table 2.
Monitoring Data
No PDF or FDA monitoring data are available for ethylene oxide treated spices. Data used in the
dietary analysis are provided in Tables 2 and 3.
Table 2. Data and Residue Estimates Used in Dietary Analyses
Commodity
Blended
Status
Data
Source
Max %CT
Process
Factors
ECH Anticipated Residue
Estimates
Acute
(Avg FT pprn)
Crop Group 19A: Herbs
Chive
NB
Field Trials (i;CH)
12 Samples
12 Detectable
Residues
61
..
RDF«
Herbs (6 1 % CT)
TO FALZ=8
TOTALNZ=I2
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Table 2. Data and Residue Estimates Used in Dietary Analyses
Commodity
Coriander, leaves
Coriander, leaves-bahyfood
Dillweed
Herbs, other
Lemongrass
Marjoram
M ;i rj oram -babyfood
Parsley, dried leaves
Parsley, dried leaves-
babytbod
Savot>'
Blended
Status
NB
NB
NB
NB
NB
NB
NB
NB
NB
NB
Data
Source
MR1D 46625301
,.
Max %CT
" "
Process
Factors
" "
" "
ECH Anticipated Residue
Estimates
Acute
(Avg fTppm)
.,
,.
" "
"
" "
Crop Group 19B: Spices
Cinnamon
Cinnamon-baby food
Spices, other
Spices, other-babyfood
Coriander, seed
Coriander, seed-babyfood
Dill, seed
Pepper, black and while
Pepper, black whitc-
babyfood
NB
NB
NB
NB
NB
NB
NB
NB
NB
Field Trials (ECU)
4 Samples
4 Detectable Residues
MR1D 46625301
field Trials (KCH)
44 Samples
42 Detectable
Residues
MRID 46625301
<< "
field Trials (ECU)
4 Samples
4 Detectable Residues
MRID 46625301
"
45
»
32
12
31
NA
,/
NA
/,
RDf#2 Cassia/Cinnamon
(45% CT )
TOTALZ-5
TOTAI.NZ=4
RDF#6
Spices ( 32% C'l)
TOTAI-Z=94
TOTAI.N/--44
"
RDf#5
Pepper (3 1%CT)
TOTAl./.=9
TOTAI.N/.-4
Crop Group 3: Bulb Vegetable
Garlic, dried
Garl.c. dtied-babytcod
NB
NB
field Trials (ECU)
56 Samples
56 Detectable
Residues
MRID 46625301
" "
5
n
RD1;#4
Onion/Garlic (5% CT)
TOT A LZ--- 1 064
7O1ALNZ=56
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Table 2. Data and Residue Estimates Used in Dietary Analyses
Commodity
Onion, dry bulb, dried
Onion, dry bulb, dried-
babyfood
Blended
Status
NB
NB
Data
Source
Max %CT
Process
Factors
ECH Anticipated Residue
Estimates
Acute
(Avg FT ppm)
" "
Crop Group 14: Tree Nuts
Walnut
NB
Field Trials (ECH)
3 Samples
3 Detectable Residues
MR1D 43218001
100
RDF#7
Walnut (1 00 %Cf)
TOT A 1.7=0
TOTALNZ-3
* not blended (NB) commodities are treated as non-blended commodities for this assessment because sterilization occurs post-application and
therefore blending of treated and non-treated spices, herbs, and dried vegetables is not likely to occur.
Table 3. Cooking Factors for Ethylene Chlorohydrin Residues
Type
Baking
Boiling
Frying
Factor
0.19
0.75
0.002
Used for
All Baked Commodities
All Boiled Commodities
All Fried Commodities
Source
MRID 42755401
MRID 42755401
MRID 42755401
Cooking factors Cor commodities identified as baked or boiled, baked or fried etc., were averaged, e.g. CF for baked or fried commodities - 0.1
III Program and Consumption Information
Several reasonable peer-reviewed softwares have recently been emerging for modeling dietary
exposure to pesticides. For a variety of technical, historical, and availability reasons, DEEMrM
was the program generally used by EPA's Office of Pesticide Programs for conducting its dietary
risk assessments. With the advent and current availability of a number of other exposure software
programs, OPP, registrants, and other interested parties have available to them the option of
selecting other peer-reviewed exposure software in conducting risk assessments for pesticides.
Dietary exposure assessments may also be performed with other, similar programs, and if
submitted, such results will be reviewed by EPA for acceptability and comparability to existing
peer-reviewed software being used by OPP.
Ilia. DEEM-FCID Program and Consumption Information
The ethylene chlorohydrin acute dietary exposure assessment was conducted using the Dietary
Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-
FCID, Version 2.03), which incorporates consumption data from USDA's Continuing Surveys
of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. The 1994-96, 98 data are based on
the reported consumption of more than 20,000 individuals over two non-consecutive survey days.
Foods "as consumed" (e.g., apple pie) are linked to EPA-defmed food commodities (e.g. apples,
peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using
18
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publicly available recipe translation files developed jointly by USDA/ARS and EPA. For acute
exposure assessment, consumption data are retained as individual consumption events. Based on
analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and
survey respondents, HED concluded that it is most appropriate to report risk for the following
population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children
3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.
For acute exposure assessments, individual one-day food consumption data are used on an
individual-by-individual basis. The reported consumption amounts of each food item can be
multiplied by a. residue point estimate and summed to obtain a total daily pesticide exposure for a
deterministic exposure assessment, or "matched" in multiple random pairings with residue values
and then summed in a probabilistic assessment. The resulting distribution of exposures is
expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating
relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant
commodities as well as those who did not) basis. In accordance with HED policy, per capita
exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, any significant
differences in user vs. per capita exposure and risk are specifically identified and noted in the risk
assessment.
IV. Toxicological Information
HED evaluated the toxicology data base of ethylene chlorohydrin and selected doses and
endpoints for acute dietary risk assessments. Acute toxicological endpoints for dietary exposure
assessment for ethylene chlorohydrin have been selected from a developmental toxicity study in
mice. Due to lack of developmental toxicity, reproduction toxicity and chronic combined
carcinogenicity study in rats and mice for ethylene chlorohydrin, lOx data base uncertainty factor
is deemed necessary when estimating dietary risk for ethylene chlorohydrin.
Based on the analysis of data regarding pre- and/or post-natal susceptibility, the FQPA Safety
factor is reduced from lOx to Ix for ethylene chlorohydrin. It is assumed that the exposure
databases are complete and that risk assessment does not underestimate the potential risks for
infants and children. Doses and toxicological endpoints selected for the acute and chronic dietary
exposure scenarios are summarized in Table 4.
Table 4 Summary of Toxicological Doses and Endpoints for Ethylene oxide for Use in Human Risk Assessments
Exposure
Scenario
Ethylene Chloroh
Acute Dietary-
Genera!
,
Dose Used in Risk
Assessment, UF
ydrin
NOAEL- 100
mg/kg/day
UF- 1000
Special FQPA SF*
and Level of
Concern for Risk
Assessment
FQPA SF- IX
aPAD -
acute RID
Study and Toxicological Effects
Developmental Toxicity Study- CD-I Mice (Courtney et aL
1982)
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Table 4 Summary of Toxicological Doses and Endpoints for Ethyiene oxide for Use in Human Risk Assessments
Exposure
Scenario
Population
Dose Used in Risk
Assessment, UF
Acute RfD =
0.1 mg/kg/day
Special FQPA SF*
and Level of
Concern for Risk
Assessment
FQPA SF
= 0.10 mg/kg/day
Study and Toxicological Effects
At 150 mg/kg/day, 75% mortality of maternal animals
observed after 2-4 treatments (days) of dosing.
i
V, Results/Discussion
As stated above, for acute assessments, HED is concerned when dietary risk exceeds 100% of the
PAD. The DEEM-FCID analyses estimate the dietary exposure of the U.S. population and
various population subgroups. The results reported in Table(s) 5-10 are for the general U.S.
Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19,
females 13-49, adults 20-49, and adults 50+ years.
Results of Acute Dietary Exposure Analysis
The results of the DEEM acute dietary exposure analyses for commodities treated using the
improved ethylene oxide fumigation process are reported in Table 5. This assessment concludes
that for all supported commodities, except basil, the acute dietary 99.9th percentile exposure
estimates for ethylene chlorohydrin are below HED's level of concern for the general U.S.
population and several population subgroups. The DEEM acute dietary exposure estimates for the
highest exposed population subgroup, children 1-2 years of age, is 96% of the aPAD. A more
detailed discussion and characterization of the results is provided in Section VI.
Table 5. Ethylene Chlorohydrin DEEM Tier 3 Acute Dietary Exposure Analysis - New Process - No Basil
Population Subgroup
Genera] U.S. Population
All Infants (< 1 year old)
Children 1.-2 years old
Children 3-5 years old
Children 6-12 years old
Youlh 13-19 years old
Adults 20-49 years old
Females 13-49 years old
Adults 50 -t years old
aPAD
(mg/kg/day)
0.1
0.1
0.!
0.1
0.1
0.1
0.1
0.1
0.1
95lh %ile
Exposure
(mg/kg/day)
0.0029
0.0002
0.0116
0.0086
0.0047
0.0030
0.0026
0.0025
0.0020
% aPAD.
(95th %)
3
<1
12
9
5
3
3
2
2
99th %ile
Exposure
(mg/kg/day)
0.0109
0.0110
0.0319
0.0260
0.0157
0.0095
0.0082
0.0079
0.0060
% aPAD
(99th %)
11
11
32
26
16
10
8
8
6
99. 9"' %ile
Exposure
(mg/kg/day)
0.0362
0.0611
0.0960
0.0630
0.0375
0.0312
0.0246
0.0273
0.0201
% aPAD
(99.9th %)
36
61
96
63
38
31
25
27
20
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VI. Characterization of Inputs/Outputs
In the course of conducting a refined dietary exposure analysis, decisions are made regarding the
residue data used in the analysis (e.g., field trials, monitoring data, etc.), refinements incorporated
in the analysis (such as percent crop treated and processing factors), and a variety of other issues
which may be chemical- or crop-specific. A discussion of uncertainties regarding assumptions
made for the refined acute dietary exposure analysis is provided below.
Data Limitations and Uncertainties
Residue Issues
Based on information provided by the registrants, the residue levels measured at 72 hours post
treatment are likely to be representative of residues found in treated spices.
Translation of Residue Data
The residue data from the spice sterilization study have been used to assess acute dietary
exposures to ethylene chlorohydrin. Date provided for the specific spice and herb commodities
included in the study were assumed to be representative of all spices and herbs (i.e., including
those for which no specific residue data were provided).
For individual commodities which are identified specifically in DEEM (i.e., individual
commodities for which CSFII consumption data are available) commodity specific residue data
were used. For example, study residue data are provided for pepper and pepper is included as a
separate commodity in DEEM; therefore, pepper-specific residue data was included in a separate
residue distribution file for that commodity. For commodities which are identified categorically
in DEEM (e.g., other spices/herbs), ASTA study residue data from all of the spices and or herbs
provided for that category are used for the dietary assessment. For example, for the category
"herbs other", all of the study data provided for specific herbs (i.e., oregano, sage) were included
in the residue distribution. Similarly, for herbs/spices that are identified specifically in CSFII but
do not have corresponding commodity specific residue data from the sterilization study, all of the
study residue data provided for specific spices and/or herbs were used to assess that commodity.
For example, for the herb commodity chives, which is included as a separate commodity in
DEEM, all of the study data provided for specific herbs (i.e., oregano, sage) were used. Seeds are
a subset of spices in CSFII. Therefore data from the sterilization study for spices and seeds were
combined for spice and seed commodities in the dietary analyses. Study specific data for sesame
seed which is identified as the food commodity category "other" were included in the residue
distribution file for spice commodities.
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The ethylene oxide sterilization study provided no residue data for any commodities in the
category of dried vegetables (i.e., garlic and onions). Therefore all of the residue data provided
for all spice and herb commodities were used in the residue distribution file for dried onion and
garlic commodities. ASTA defines spices as "any dried plant product used primarily for
seasoning purposes". Included are tropical aromatics (pepper, cinnamon, cloves, etc.), leafy herbs
(basil, oregano, marjoram, etc.), spice seeds (sesame, poppy, mustard, etc.) and dehydrated
vegetables (onions, garlic, etc.). Blends such as curry, chili powders, poultry seasoning, etc. are
part of the spice shelf, too. Only the dried vegetables, garlic and onion, were included in the
dietary assessment. Whether, and if so, to what extent other dried vegetables and other seasonings
not included in the assessment undergo ethylene oxide sterilization is uncertain. Exclusion of
other dried vegetable commodities may result in an underestimation of dietary risk.
While use of different groupings of the available residue data may be justifiable, different
arrangement of the data is unlikely to result in significantly different results.
As is standard practice for dietary assessments, residues reported as non-detect were estimated at
half the LOD. The LOD was reported as 10 ppm.
Level of Refinement
Residue data incorporated into the probabilistic assessment were comprised of sterilization data
for a subset of treated commodities. The commodities for which residue data are available were
assumed to be representative of all treated commodities. Use of additional commodity specific
data would improve the accuracy of the dietary assessment.
Incorporation of Monitoring Data
No PDF or FDA monitoring data are available for ethylene oxide treated spices. Data from a
spice/herb/walnut sterilization study were used for the Tier 3 acute dietary analysis. Ethylene
oxide sterilization is a post-harvest treatment, the sterilization study was conducted under
representative spice/herb sterilization conditions, and residues of ethylene chlorohydrin and
ethylene glycol did not show a consistent pattern of increase or decline indicating that
concentrations may tend to stabilize after the initial reaction. Therefore it cannot be assumed that
monitoring data would show significantly lower residues.
Processing Factors
Default Processing Factors
No processing factors have been used because ethylene oxide spice sterilization is conducted post-
processing.
Cooking Study
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Cooking factors from a 1993 HC-ethylene oxide cooking study conducted by Agrisearch Inc.,
were used for the ethylene oxide dietary assessment. The cooking factors determined for baked,
boiled and fried foods were used for all EPA-defined food commodities specifically designated as
baked, boiled, or fried in DEEM and Lifeline. Cooking factors were averaged for food forms
designated as having undergone multiple methods of cooking i.e., baked/fried, baked/boiled, etc).
Adequacy of %CT data
Data on percent of domestic and imported spice, herb, dried vegetable and walnut commodities
sterilized with ethylene oxide were provided by BEAD based on EPA data and American Spice
Trade Association data from 1989, 1996. More recent and refined data were not available. For
the acute dietary analysis, the estimated maximum % crop sterilized with ethylene oxide was used
when available. Percent crop sterilized data was available and used for all treated commodities
included in the dietary assessment.
Commodity specific percent crop sterilized data are used if such data are provided by BEAD and
the commodity is included separately in DEEM/Lifeline (i.e., specific % sterilized data were used
for pepper, cassia, and onion/garlic commodities). Specific % sterilized data was also used for
seed commodities separately identified in DEEM/Lifeline. For all other commodities, percent
sterilized data were used categorically for herb and spice commodities.
Significant Risk Contributors ("Risk Drivers")
A critical exposure contribution analysis for ethylene chlorohydrin indicates that marjoram, and
savory commodities account for the largest percentage of dietary risk for the general population as
well as the highest exposed population subgroup children 1-2 years old.
Sensitivity Analyses
No sensitivity analyses were performed because there were a number of commodities that
contributed to the estimated risk (i.e., there was no single driver).
Additional Information for Risk Managers
Sterilization study and/or monitoring data for spices/herbs not included in the available study
could be used to refine HED's risk estimates. Additionally, study/monitoring data for longer post-
sterilization periods may be used to refine the dietary assessment. More complete and more
refined % CT data could also be used to better estimate potential dietary risks.
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VII. Conclusions
Refined dietary exposure analyses were performed for acute exposures to ethylene chlorohydrin
using the DEEM model. When the residues associated with the improved ethylene oxide
fumigation process are used and the commodity basil is excluded from the analysis, acute
exposure estimates at the 99.9th percentile for ethylene chlorohydrin are below HED's level of
concern for all population subgroups for dietary (food) exposures. For ethylene chlorohydrin, the
DEEM model acute dietary exposure estimate for the highest exposed population subgroup,
children 1-2 years of age, is 96% of the aPAD.
VIII. List of Attachments
1 - Percent Crop Treated Data from BEAD
2 - Acute DEEM Residue Input Files
3 - Acute DEEM Results Files
4 - DEEM Residue Distribution Files
5 - DEEM CEC Summary Files
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Attachment 1 - Percent Crop Treated Data from BEAD
Ethylene Oxide Case #:2275 AI#:42301: Analyst: John Falkner 2001
EtO.wk4 EPA's QUANTITATIVE USAGE ANALYSIS Data years: 1988-94
Sites
Medical devices
Hospitals & Health Care
facilities
Cosmetics
Beekeeping, Beehives,
Equipment
Museums. Libraries
Black walnuts, processed
Spices
Domestic
Imported
Total Spices
Type of Spice
capsicum*
cassia & cinnamon
herbs*
onion/garlic
pepper-white & black
paprika, imported
roots-ginger, tumeric
seeds*
total
Million Ibs
Available
-
-
-
-
-
108
597
705
-
Million Ibs
Treated
Wtd
Avg
-
-
-
-
-
-
33
193
226
-
Percent Treated
Wtd
Avg
-
-
-
-
-
100%
30%
32%
32%
26%
32%
60%
4%
22%
45%
35%
7%
Est
Max
-
-
-
-
-
-
-
31%
45%
61%
. 5%
31%
51%
39%
12%
Lb ai (000)
Applied
Est
Avg
6.000
720
50
-
-
600
7370
Est
Max
6.560
800
55
1
1
-
800
8217
COLUMN HEADINGS
Wtd Avg = Weighted averagethe most recent years are weighted more heavily.
Est Avg = Estimated average, which is estimated from available data.
Est Max = Estimated maximum, which is estimated from available data.
NOTES ON TABLE DATA
Calculations of the above numbers may not appear to agree because they are displayed as rounded:
A dash (-) indicates that information is NOT available in EPA sources or is insufficient to make an estimate.
*Spices
capsicum ~ red, chili, & cayenne peppers, domestic paprika.
herbs = basil, bay, cheervil, chives, cilantro. dill weed, oregano, marjoram, mint, parsley, rosemary, sage, savory,
tarragon, thyme.
seeds = allspice, anise, annatto, caraway, cardamon, celery, cloves, coriander, cumin, dill, fennel, fenugreek, mace,
mustard,nutmeg, poppy, sesame.
SOURCES: EPA data; American Spice Trade Association (1989, 1996)
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Attachment 2 - Acute DEEM Residue File
U.S. Environmental Protection Agency Ver. 2.02
DEEM-FCID Acute analysis for ETO
Residue file name: C:\Documents and Settings\rdaiss\My Documents\RDAISS\DKEM-
FClD\ETO\etoacute-etoexpress-nobasi1-6-8-06.R98
Analysis Date 06-09-2006 Residue file dated: 03-15-2006/14:16:33/8
Reference dose (aRfD) = 0.1 mg/kg bw/day
RDL indices and parameters for Monte Carlo Analysis:
Index Dist Parameter #1 Param #2 Param #3 Comment
# Code
i
J
3
4
5
6
7
6
6
6
6
6
6
6
C
c
C
r
c
c
c
\rdaiss\ETO\basiletoexpress . rdf
\rdaiss\ETO\cassiaetoexpress . rdf
\rdaiss\ETO\herbsetoexpress2 . rdf
\rdaiss\ETO\onion-garlicetoexpress2 . rdf
\rdaiss\ETO\pepperetoexpress . rdf
\ rda i ss \ ETO\ spicesetoexpress . rdf
\rdaiss\ETO\walnut . rdf
EPA Crop Food Name
Code Grp
Def Res
(ppm)
Adj.Factors RDL Comment
#1 #2 Pntr
19011030 19A Chive
110-Uncooked; Fresh or N/S; Cook Meth N/S
0.000000 0.000 0.000
210-Cooked; Fresh or N/S; Cook Meth N/S
0.000000 0.000 0.000
211-Cooked; Fresh or N/S; Baked
0.000000 0.000 0.000
212-Cooked; Fresh or N/S; Boiled
0.000000 0.000 0.000
213-Cooked; Fresh or N/S; Fried
0.000000 0.000 0.000
221-Cooked; Frozen; Baked 1.000000 0.190 1.000
240-Cooked; Canned; Cook Meth N/S
1.000000 0.750 1.000
242-Cooked; Canned; Boiled 1.000000 0.750 1.000
19021050 19B Cinnamon
]10-Uncooked; Fresh or N/S; Cook Meth N/S
1.000000 1.000 1.000
130-Uncooked; Dried; Cook Meth N/S
1.000000 1.000 1.000
210-Cooked; Fresh or N/S; Cook Meth N/S
1.000000 0.310 1.000
211-Cooked; Fresh or N/S; Baked
1.000000 0.190 1.000
212-Cooked; Fresh or N/S, Boiled
1.000000 0.750 1.000
213-Cooked; Fresh or N/S; Fried
l.OCOCOO 0.002 1.000
214-Cooked; Fresh or N/S; Fried/baked
1.000000 0.100 l.COO
215-Cooked; Fresh or N/S; Boiled/baked
1.000000 0.470 1.000
221-Cooked; Frozen; Baked 1.000000 0.190 1.000
230-Cooked; Dried; Cook Meth N/S
1.000000 0.190 1.000
232-Cooked; Dried; Boiled 1.000000 0.470 1.000
240-Cooked; Canned; Cook Meth N/S
l.OGOOOO 0.750 1.000
19021051 19B Cinnamon-babyfood
211-Cooked; Fresh or N/S; Baked
1.000000 0.190 1.000
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230-Cooked; Dried; Cook Meth N/S
1.000000 0.190 1.000 2
240-Cooked; Canned; Cook Meth N/S
1.000000 0.750 1.000 2
19011180 19A Coriander, leaves
110-Uncooked; Fresh or N/S; Cook Meth N/S
0.000000 0.000 0.000
150-Uncooked; Cured etc; Cook Meth N/S
1.000000 1.000 1.000 3
210-Cooked; Fresh or N/S; Cook Meth N/S
0.000000 0.000 0.000
211-Cook.ed; Fresh or N/S; Baked
0.000000 0.000 0.000
212-Cooked; Fresh or N/S; Boiled
0.000000 0.000 0.000
213-Cooked; Fresh or N/S; Fried
0.000000 0.000 0.000
221-Cooked; Frozen; Baked 1.000000 0.190 1.000 3
230-Cooked; Dried; Cook Meth N/S
1.000000 0.190 1.000 3
232-Cooked; Dried; Boiled 1.000000 0.470 1.000 3
240-Cooked; Canned; Cook Meth N/S
1.000000 0.750 1.000 3
242-Cooked; Canned; Boiled 1.000000 0.750 1.000 3
250-Cooked; Cured etc: Cook Meth N/S
1.000000 0.310 1.000 3
252-Cooked; Cured etc; Boiled 1.000000 0.750 1.000 3
253-Cooked; Cured etc; Fried 1.000000 0.002 1.000 3
19011181 19A Coriander, leaves-babyfood 1.000000 1.000 1.000 3
19021190 19B Coriander, seed
110-Uncooked; Fresh or N/S; Cook Meth N/S
1.000000 1.000 1.000 6
150-Uncooked; Cured etc; Cook Meth N/S
1.000000 1.000 1.000 6
210-Cooked; Fresh or N/S; Cook Meth N/S
0.000000 0.000 0.000
211-Cooked; Fresh or N/S; Baked
0.000000 0.000 0.000
212-Cooked; Fresh or N/S; Boiled
0.000000 0.000 0.000
213-Cooked; Fresh or N/S; Fried
0.000000 0.000 0.000
214-Cooked; Fresh or N/S; Fried/baked
0.000000 0.000 0.000
221-Cooked; Frozen; Baked 1.000000 0.190 1.000 6
230-Ccoked; Dried; Cook Meth N/S
1.000000 0.190 1.000 6
231-Cooked; Dried; Baked 1.000000 0.190 1.000 6
240-Cooked; Canned; Cook Meth N/S
1.000000 0.750 1.000 6
242-Cooked; Canned; Boiled 1.000000 0.750 1.000 6
250-Cooked; Cured etc; Cook Meth N/S
1.000000 0.310 1.000 6
252-Cooked; Cured etc; Boiled 1.000000 0.750 1.000 6
253-Cooked; Cured etc; Fried 1.000000 0.002 1.000 6
19021191 19B Coriander, seed-babyfood 1.000000 1.000 1.000 6
19021430 19B Dill, seed
150-Uncooked; Cured etc; Cook Meth N/S
1.000000 1.000 1.000 6
210-Cooked; Fresh or N/S; Cook Meth N/S
0.000000 0.000 0.000
211-Cooked; Frer.h or N/S; Baked
0.000000 0.000 0.000
212-Cooked; Fresh or N/S; Boiled
0.000000 0.000 0.000
240-Cooked; Canned; Cock Meth N/S
1.000000 0.750 1.000 6
19011440 19A Dillweed
27
-------
Ethylene Oxide Dietary Exposure Assessment
PC Code: 042301
DP Barcode: D325114
Page: 28 of 23
03001650 3
03001651 3
150
210
211-
212
2.40
Garlic
110
130
210-
211
212
213
214
215
221
222
230
232
233
240
242
250
Garlic
240
19011840 19A Herbs,
110
150
210
211
212
213
215
221
230
232-
233
240
252-
2b3-
Uncooked: Cared etc; Cook Meth N/S
1.000000
Cooked; Fresh or N/S; Cook Meth N/S
0.000000
-Cooked; Fresh or N/S; Bilked
0.000000
-Cooked; Fresh or N/S; Boiled
0.000000
-Cooked; Canned; Cook Meth N/S
1.000000
, dried
--Uncooked; Fresh or N/S; Cook Meth N/S
1.000000
-Uncooked; Dried; Cook Meth N/S
1.000000
-Cooked; Fresh or N/S; Cook Meth N/S
O.OCOOOO
-Cooked; Fresh or N/S; Baked
0.000000
-Cooked; Fresh or N/S; Boiled
0.000000
-Cooked; Fresh or N/S; Fried
0.000000
-Cooked; Fresh or N/S; Fried/baked
0.000000
-Cooked; Fresh or N/S; Boiled/baked
0.000000
-Cooked; Frozen; Baked 1.000000
-Cooked; Frozen; Boiled 1.000000
-Cooked; Dried; Cook Meth N/S
1.000000
-Cooked; Dried: Boiled 1.000000
-Cooked; Dried; Fried 1.000000
-Cooked; Canned; Cook Meth N/S
1.000000
-Cooked; Canned; Boiled 1.000000
-Cooked; Cured etc; Cook Meth N/S
1 .000000
, dried-babyfood
-Cooked; Canned; Cook Meth N/S
1.000000
other
-Uncooked; Fresh or N/S; Cook Meth N/S
1.000000
-Uncooked; Cured etc; Cook Melh N/S
1 .000000
-Cooked; Fresh or N/S; Cook Meth N/S
0.000000
-Cooked; Fresh or N/S; Baked
0 ,000000
-Cooked; Fresh or N/S; Boiled
0.000000
-Cooked; Fresh or N/S; Fried
0.000000
-Cooked; Fresh or N/S; Boiled/baked
0.000000
-Cooked; Frozen; Baked 1.000000
Cooked; Dried; Cook Meth N/S
1.000000
-Cooked; Dried; Boiled 1.000000
Cooked; Dried; Fried 1.000000
Cooked; Canned; Cook Meth N/S
1.000000
Cooked; Canned; Boiled 1.000000
Cooked; Cured etc; Cook Meth H/3
1.000000
Cooked; Cured etc; Boiled 1.000000
Cooked; Cured etc; F'ried / .000000
28
i
0.
0.
0
0
1
1
0.
0.
0.
0.
0 .
0.
0.
0
0.
0.
0.
fl
0.
0.
0.
1 .
1 .
0.
0.
0
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.000
.000
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. 000
.000
. 000
.190
.750
190
750
002
,750
,750
,310
.750
000
000
000
000
000
.000
000
190
310
750
002
220
.220
.310
750
. 002
T^
0.
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000
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->
.J
3
4
4
4
4
4
4
4
4
4
4
4
1
3
3
3
3
3
3
3
3
3
3
-------
Ethylene Oxide Dietary Exposure Assessment
PC Code: 042301
DP Barcode: D325114
Page: 29 of 23
19011841 19A Herbs, other-babyfood
240-Cooked; Canned; Cook Meth N/S
1.000000
19012020 19A Lemongrass ].000000
J9012200 19A Marjoram
110-Uncooked; Fresh or N/S; Cook Meth N/S
0.000000
130-Uncooked; Dried; Cook Meth N/S
0.000000
210-Cooked; Fresh or N/S; Cook Meth N/S
0.000000
211-Cooked; Fresh or N/S; Baked
0.000000
212-Cooked; Fresh or N/S; Boiled
0.000000
213-Cooked; Fresh or N/S; Fried
0.000000
215-Cooked; Fresh or N/S; Boiled/baked
0.000000
221-Cooked; Frozen; Baked 1.000000
232-Cooked; Dried; Boiled 1.000000
233-Cooked; Dried; Fried 1.000000
240-Cooked; Canned; Cook Meth N/S
1.000000
242-Cooked; Canned; Boiled 1.000000
19012201 19A Marjoram-babyfood
240-Cooked; Canned; Cook Meth N/S
1.000000
03002380 3 Onion, dry bulb, dried
110-Uncooked; Fresh or N/S; Cook Meth N/S
0.000000
130-Uncooked; Dried; Cook Meth N/S
1.000000
210-Cooked; Fresh or N/S; Cook Meth N/S
0.000000
211-Cooked; Fresh or N/S; Baked
0.000000
212-Cooked; Fresh or N/S; Boiled
0.000000
213-Cooked; Fresh or N/S; Fried
0.000000
214-Cooked; Fresh or N/S; Fried/baked
0.000000
215-Cooked; Fresh or N/S; Boiled/baked
0.000000
221-Cooked; Frozen; Baked 1.000000
222-Cooked; Frozen; Boiled 1.000000
230-Cooked; Dried; Cook Meth N/S
1.000000'
231-Cooked; Dried; Baked 1.000000
232-Cooked; Dried; Boiled 1.000000
233-Cooked; Dried; Fried 1.000000
240-Cooked; Canned; Cook Meth N/S
1.000000
242-Cooked; Canned; Boiled 1.000000
250-Cooked; Cured etc; Cook Meth N/S
1.000000
03002381 3 Onion, dry bulb, dried-babyfood
211-Cooked; Fresh or N/S; Baked
O.OOOCOO
240-Cooked; Canned; Cook Meth N/S
1.000000
19012490 19A Parsley, dried leaves
liO-Uncooked; Fresh or N/S; Cook Meth N/S
0.000000
210-Cooked; Fresh or M/S; Cook Meth N/S
0.000000
211-Cooked; Fresh or M/S: Baked
29
0.750 1.000 3
1.000 1.000 3
0
0.
0.
0.
0.
0.
0.
0.
0.
0
0.
0.
0.
0.
1.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
.000
.000
000
.000
000
. 000
.000
190
.750
,002
750
.750
310
000
000
000
000
000
000
000
000
190
750
310
190
750
002
750
750
310
000
750
0
0.
0.
0.
0.
0.
0.
1 .
1.
1 .
1 .
1 .
0.
1.
0.
0.
0.
0.
0 .
0.
1 .
1 .
1 .
1 .
1 .
1 .
1 .
1 .
1 .
0.
1 .
.000
.000
.000
. 000
.000
. 000
.000
.000
. 000
. 000
.000
.000
,000
.000
000
000
000
,000
000
,000
000
000
000
000
000
000
,000
000
000
000
000
000
3
3
3
3
3
3
4
4
4
4
4
4
4
4
4
4
4
0.000 0.000
0.000 0.000
-------
Ethylene Oxide Dietary Exposure Assessment DP Barcode: D325114
PC Code: 042301 Page:30of23
0.000000 0.000 0.000
232-Cooked; Fresh or N/S; Boiled
0.000000 0.000 0.000
213-Cooked; Fresh or N/S; Fried
0.000000 0.000 0.000
221-Cooked; Frozen; Baked 1.000000 0.190 1.000 3
230-Cooked; Dried; Cook Meth N/S
1.000000 0.310 1.000 3
232-Cooked; Dried; Boiled 1.000000 0.750 1.000 3
240-Cooked; Canned; Cook Meth N/S
1.000000 0.750 1.000 3
242-Cooked; Canned: Boiled 1.000000 0.750 1.000 3
190]249i 19A Parsley, dried leaves-babyfood
211-Cooked; Fresh or N/S; Baked
0.000000 0.000 0.000
240-Cooked; Canned; Cook Meth N/S
1.000000 0.750 1.000 3
19022740 19B Pepper, black and white
110-Oncooked; Fresh or N/S; Cook Meth N/S
1.000000 1.000 1.000 5
130-Uncocked; Dried; Cook Meth N/S
1.000000 1.000 1.000 5
150-Uncooked; Cured etc; Cook Meth N/S
1.000000 1.000 1.000 5
210-Cooked; Fresh or N/S; Cook Meth N/S
1.000000 0.310 1.000 5
211-Cooked; Fresh or N/S; Baked
1.000000 0.190 1.000 5
212-Cooked; Fresh or N/S; Boiled -
1.000000 0.750 1.000 5
213-Cooked; Fresh or N/S; Fried
1.000000 0.002 1.000 5
214-Cooked; Fresh or N/S; Fried/baked
1.000000 0.100 1.000 5
215-Cooked; Fresh or N/S; Boiled/baked
1.000000 0.470 1.000 5
221-Cooked; Frozen; Baked 1.000000 0.190 1.000 5
222-Cooked; Frozen; Boiled 1.000000 0.750 1.000 5
230-Cooked; Dried; Cook Meth N/E
1.000000 0.310 1.000 5
231-Cooked; Dried; Baked 1.000000 0.190 1.000 5
232-Cooked; Dried; Boiled 1.000000 0.750 1.000 5
240-Cooked; Canned; Cook Meth N/S
1.000000 0.750 1,000 5
242-CooKed; Canned; Boiled 1.000000 0.750 1.000 5
250-Cooked; Cured etc; Cook Meth N/S
1.000000 0.310 1.000 5
252-Cooked; Cured etc; Boiled 1.000000 0.750 1.000 5
253-Cooked; Cured etc; Fried 1.000000 0.002 1.000 5
19022741 19B Pepper, black and white-babyfood
240-Cooked; Canned; Cook Meth N/S
1.000000 0.310 1.000 5
19013340 19A Savory
110-Uncooked; Fresh or N/S; Cook Meth N/S
0.000000 0.000 0.000
130-Uncooked; Dried; Cook Meth N/S
1.000000 1.000 1.000 3
210-Cooked; Fresh or N/S; Cook Meth N/S
0.000000 0.000 0.000
211-Cooked; Fresh or N/S; Baked
0.000000 0.000 0.000
212-Cooked; Fresh or N/S; Boiled
0.000000 0.000 0.000
213-Cooked; Fresh or N/S; Fried
0.000000 0.000 0.000
215-Cooked; Fresh or N/S; boiled/baked
O.OOOCOO 0.000 0.000
221-Cooked; Frozen; Baked 1.000000 0.190 1.000 3
30
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Ethylene Oxide Dietary Exposure Assessment DP Barcode: D325114
PC Code: 042301 ' Page: ?1 of 23
233-Cooked; Dried; Fried l.OOOCOO 0.002 1.000 3
240-Cooked; Canned: Cook Meth N/S
l.OOCOOO 0.750 1.000 3
95003360 0 Sesame, seed
110-Uncooked; Fresh or N/S; Cook Meth N/S
0.000000 0.000 0.000
210-Cooked; Fresh or N/S; Cook Meth N/S
0.000000 0.000 0.000
211-Cooked; Fresh or N/S; Baked
0.000000 0.000 0.000
212-Cooked; Fresh or N/S; Boiled
0.000000 0.000 0.000
213-Cooked; Fresh or N/S; Fried
0.000000 0.000 0.000
230-Cooked; Dried; Cook Meth N/S
1.000000 0.310 1.000 6
231-Cooked; Dried; Baked 1.000000 0.190 1.000 6
232-Cooked; Dried; Boiled 1.000000 0.750 1.000 6
95003361 0 Sesame, seed-babyfood 1.000000 1.000 1.000 6
19023540 19B Spices, other
110-Uncooked; Fresh or N/S; Cook Meth N/S
1.000000 1.000 1.000 6
120-Uncooked; Frozen; Cook Meth N/S
1.000000 1.000 1.000 6
130-Uncooked; Dried; Cook Meth N/S
1.000000 1.000 1.000 6
150-Uncooked; Cured etc; Cook Meth N/S
1.000000 1.000 1.000 6
210-Cooked; Fresh or N/S; Cook Meth N/S
1.000000 0.310 1.000 6
211-Cooked; Fresh or N/S; Baked
1.000000 0.190 1.000 6
212-Cooked; Fresh or N/S; Boiled
1.000000 0.750 1.000 6
213-Cooked; Fresh or N/S; Fried
1.000000 0.002 1.000 6
214-Cooked; Fresh or N/S; Fried/baked
1.000000 0.100 1.000 6
215-Cooked; Fresh or N/S; Boiled/baked
1.000000 0.470 1.000 6
221-Cooked; Frozen; Baked 1.000000 0.190 1.000 6
223-Cooked; Frozen; Fried 1.000000 0.002 1.000 6
230-Cooked; Dried; Cook Meth N/S
1.000000 0.310 3.000 6
231-Cooked; Dried; Baked 1.000000 0.190 1.000 6
232-Cooked; Dried; Boiled 1.000000 0.750 1.000 6
233-Cooked; Dried; Fried 1.000000 0.002 1.000 6
240-Cooked; Canned; Cook Meth N/S
1.000000 0.750 1.000 6
242-Cooked; Canned; Boiled 1,000000 0.750 1.000 6
250-Cooked; Cured etc; Cook Meth N/S
1.000000 0.310 1.000 6
252-Cooked; Cured etc; Boiled 1.000000 0.750 1.000 6
253-Cooked; Cured etc; Fried l.OOOCOO 0.002 1.000 6
19023541 19B Spices, other-babyfood
211-Cooked; Fresh or N/S; Baked
1.000000 0.190 1.000 6
230-Cooked; Dried; Cook. Meth N/S
1.000000 0.310 1.000 6
240-Cooked; Canned; Cook Meth N/S
l.OOCOOO 0.750 1.000 6
14003910 14 Walnut
110-Uncooked; Fresh or N/S; Cook Meth N/S
l.OOCOOO 1.000 1.000 7
130-Uncooked; Dried; Cook Meth N/S
1 .000000 1.000 1 .000 7
210-Cooked; Fresh or N/S; Cook Meth N/S
l.OOOOCO 0.310 1.000 7
211-Cooked; Fresh or N/S; Baked
31
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Ethylene Oxide Dietary Exposure Assessment DP Barcode: D325114
PC Code: 042301 ' Page: 32 of 23
1.000000 0.190 1.000 7
22]-Cooked; Frozen; Baked 1.000000 0.190 1.000 7
230-Cooked; Dried; Cook Meth N/S
1.000000 0.190 1.000 7
240-Cooked; Canned; Cook Meth N/S
1.000000 0.750 1.000 7
32
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Ethylene Oxide Dietary Exposure Assessment
PC Code: 042301
DP Barcode: D325114
Page: 33 of 23
Ver. 2.02
(1994-98 data)
Attachment 3
Acute Results File
DEEM ETO Express - Results with Basil zeroed out
U.S. Environmencal Protection Agency
DEEM-FCID ACUTE Analysis for ETO
Residue file: etoacute-etoexpress-nobasil-8-8-06.R98
Adjustment factor #2 used.
Analysis Date: 06-09-2006/13:18:37 Residue file dated: 06-09-2006/12:56:47/8
Daily totals for food and foodform consumption used.
MC iterations = bOOO MC list in residue file MC seed = 1128
Run Comment: ""
Summary calculations (per capita):
95th Percentile
Exposure % aRfD
99th Percentile
Exposure % aRfD
99.9th Percentile
Exposure % aRfD
U.s. Popu1a t i on:
AL1 infants:
Children 1-2 yrs :
Children 3-5 yrs:
Cnildren 6-12 yrs:
Youth 13-19 yrs:
Adults 20-49 yrs:
Adults 50+ yrs:
F'eina les 13-49 yrs:
0.
0.
0.
0.
0.
0.
0.
0.
0.
.002861
000239
011634
008580
004681
002999
002571
001897
002461
2
0
11
8
4
3 .
2 .
1 .
2 .
.86
.24
.63
. 58
.68
.00
.57
.90
.46
0
0.
0.
0.
0.
0.
0.
0.
0.
.010861
.011072
,031869
025981
.015666
009485
008193
.006061
007909
10
11
31 .
25,
15.
9.
8.
6.
7 .
.86
.07
.87
98
.67
48
19
06
91
0.
0
0.
0.
0.
0.
0.
0.
0.
. 036162
.061052
096002
063025
037446
031229
024606
020094
. 02'7307
36
61
96
63
37
31
24
20
27
. 16
.05
. 00
. 02
.45
.23
.61
.09
.31
33
-------
Ethyiene Oxide Dietary Exposure Assessment
PC Code: 042301
DP Barcode: D325114
Page: 34 of 23
Attachment 4 RDF table
~~ "-"- "" ' "
Spices(32% CT)
TOTALZ= 1 00
TOTALNZ=46
213
128
300
279
14
47
34
18
P5
185
200
143
5
18
86
86
45
58
143
79
49
69
62
5
303
182
284
295
880
668
72
46
149
1 08
194
134
227
458
296
174
11
17
73
34
30
34
Herbs(61%CT)
TOTALZ=5
TOTALNZ-8
195
292
208
128
207
327
334
242
Pepper (3 I%CT)
TOTALZ=9
TOTALNZ-4
213
128
300
279
Cassia/Cinnamon (45%
CT)
TOTALZ=5
TOTALNZ=4
14
47
34
18
Walnut (100%CT)
TOTALZ=0
TOTALNZ-3
50
50
50
Onion/Garlic (5% CT)
TOTALZ= 1 024
TOTALNZ=54
213
128
300
279
14
47
34
18
175
185
200
143
5
18
86
86
45
58
143
79
49
69
62
5
303
182
284
295
880
668
72
46
149
108
194
134
227
458
296
174
1 I
17
73
34
30
34
195
292
208
128
207
327
334
242
-------
Ethylene Oxide Dietary Exposure Assessment
PC Code: 042301
DP Barcode: D325114
Page: 35 of 23
Attachment 5 - Critical Exposure Contribution Analysis
Children 1-2 yrs
Low percentile for CEC records: 99.5 Exposure (mg/day) = 0.042827
High percent!le for CEC records: 100 Exposure (mg/day) = 0.548699
Number of actual records in this interval: 3620
Critical foods/foodforms for this population (as derived from these records
N=number of appearances in all records (including duplicates)
%-percent of total exposure for all records (including duplicates)
Food, FF, N , Percent, Food Name
240,
240,
130,
240,
240,
240,
211 ,
240,
240,
i 1 0
232!
242,
2272 ,
2295,
194,
209,
312,
1646,
194,
201 ,
159,
72,
122,
49,
24
24.
13
/
b
5.
3
2 .
2 ,
2 .
2.
_L ,
.41%,
.17%,
.01%,
.03%,
. 68%,
.10%,
.44%,
.82%,
.70%,
,51%,
.34%,
,60%,
Marjoram-Cooked; Canned; Cook Meth N/S
Savory-Cooked; Canned; Cook Meth N/S
Wai nut -Uncooked; Dried; Cook Meth N/S
Onion, dry bulb, dried-babyf ood-Cooked ; Canned;
Dil Iweed-Cooked; Canned; Cook Meth N/S
Herbs, otner-Cooked; Canned; Cook Meth N/S
"Walnut-Cooked; Fresh or N/S; Baked
Dill, seed-Cooked; Canned; Cook Meth N/S
Spices, other-Cooked; Canned; Cook Meth N/S
Spices, other-Uncooked; Fresh or N/S; Cook Meth
Parsley, drie^d leaves-Cooked; Dried; Boiled
Onion, dry bulb, dr led- Cooked; Canned; Boiled
Cook
N / S
Meth N/£
0. 016494
1.371348
U.S. Popu1a t i on
Low percentile for CEC records: 99.5 Exposure (mg/day) =
High percentile for CEC records: 100 Exposure (mg/day) --
Number of actual records in this interval: 87216
Critical foods/foodforms for this population (as derived from these records);
N=number of appearances in all records (including duplicates)
%-percer;t of total exposure for all records (including duplicates)
Food, FF, N , Percent, Food Name
46701,
46793,
10602,
10987,
3505,
37174,
1854,
5538,
3751,
375,
.1893,
Marjoram-Cooked; Canned; Cook Meth N/S
Savory-Cooked; Canned; Cock Meth N/S
Spices, other-Cooked; Canned; Cook Meth N/S
Dillweed-Cooked; Canned; Cook Meth N/S
Walnut-Uncooked; Dried; Cook Meth N/S
Herbs, other-Cooked; Canned; Cook Meth N/S
Onion, dry bulb, dried-babyfood-Cooked; Canned; Cook Meth
Dill, seed-Cooked; Canned; Cook Meth N/S
Walnut-Cooked; Fresh or N/S; Baked
Coriander, leaves-Uncooked; Cured etc; Cook Meth N/S
Parsley, dried ] eaves-Cooked; Dri-d; Boiled
35
-------
[Appendix C]
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFF1CI: OJ
PRhVF.N 1 ION, 1'F.STICIDFS
AND TOXIC SUBSTANCES
July 12,2006
MEMORANDUM
SUBJECT: Addendum to Revised Residue Chemistry' Chapter For Ethylene Oxide
Reregistration Eligibility Decision (RED) Document Issued July 12, 2005.
Tolerance Recommendations Based On Additional Residue Data In MRID
46625301.
DP Barcode: D330820
Chemical No. 042301
Reregistration Case No: 2275
FROM: Jerry B. Stokes, Chemist
Reregistration Branch 4
Health Effects Division [7509C]
THRU: Susan Hummel, Branch Senior Scientist
Reregistration Branch 4
Health Effects Division [7509C]
TO: Rebecca Daiss, Risk Assessor
Reregistration Branch 4
Health Effects Division [7509C1
New
Background
This memorandum is issued as an addendum to the Revised Residue Chemistry Chapter For
Ethylene Oxide Reregistration Eligibility Decision (RED) Document Issued July 12, 2005. It
does not supersede the previous document issued July 12, 2005. Tolerances for postharvest use
of ETO on spices (whole) are established at 50 ppm on each (40 CFR §180.151). Although the
current tolerance is expressed as" spices (whole) "and "ground spices", the historical use
includes herbs (whole and ground) and dried vegetables (unspecified). A study (MRID
36
-------
[Appendix C]
46625301) was conducted by the industry in order to test ETO and ECH residue levels resulting
from an improved fumigation process referred to as "ETO Express" using a 20% ETO: 80%
carbon dioxide formulation in the ETO sterilization of whole and ground spices and herbs.
"HED had previously recommended that the established 50 ppm tolerance (40 CFR 180.151) for
ETO residues in spices and herbs remain unchanged at 50 ppm. However, this new steam
process shows much lower residue levels after 72 hours. Therefore it is possible that the ETO
tolerance could be lowered based only if, the registrants, with a label statement, restrict all US
use of ETO to fumigate spices and herbs by this new process, and not allow any other treatment
processes. Likewise the proposed tolerances for the residues of ECH in/on spices/herbs, dried
(except basil), and basil could be adjusted downward but only if the new treatment method were
used in all fumigations". (See memo of 01/25/06, J. Stokes).
Conclusions/Recommendations:
In response to HED's comment, according to SRRD, the industry has now stated to the Agency
and to be documented in a 'terms and conditions" letter forthcoming that all food commodity
fumigations will be conducted only by the new procedure "ETO Express"as listed in MRID
46625301. They also have stated that basil will no longer be fumigated with any formulation of
ETO ( letters dated 07/07/2006, Honeywell International and 07/10/2006, ARC Specialty
Products).
Therefore, HED has reevaluated the tolerances previously proposed in the January 2006 Revised
Residue Chemistry Chapter. Thus, based on the results of HED's statistical tolerance generator
for NAFTA-harmonized tolerances, HED finds that tolerances of 7 ppm ETO and 940 ppm ECH
for spices/herbs fumigated with ETO are appropriate.
Note: Directions for use must be clearly defined on all labels that are allowed for the fumigation
of spices and herbs (and seasoning materials). Labels of all ETO formulations that are used to
sterilize commodities must include postharvest directions stating exposure time, temperature and
percent humidity, amount of active ingredient ETO, aeration time in treatment chamber,
additional storage conditions before treated commodities are released to market for consumption,
and any other parameters (i.e., equipment type, capacity, that are necessary to insure consistency
in each treatment). These parameters are needed so the established tolerances will always
adequately cover potential residues of concern from ETO fumigation of spices and herbs. In
addition, since ETO use will not be allowed for basil, then the label must prohibit application to
basil and all seasoning materials that contain basil.
Detail Considerations:
860.1200 Directions for Use
37
-------
[Appendix C]
The product used in this study was EPA # 36736-5 Sterilizing Gas 5 (20% ETO, 80% carbon
dioxide, w;w). The sterilization of the spices and herbs was performed using a new process. The
fumigation chamber was a commercial steel unit (1600 ft3) fitted with a airtight steel door. The
chamber was constructed with embedded steam jackets in all inside surfaces. All inside surfaces
were heated by passage of steam through jackets to achieve the desired temperature. Chamber
vacuum was produced with a large vacuum pump whose exhaust stream was connected to a gas
scrubber system. Temperature and pressures were monitored during the process. Approximately
150 Ib Sterilizing Gas 5 was delivered to the chamber during each treatment. The gas was
injected manually at the appropriate time by the operator.
860.1340 Residue Analytical Methods - Plants
Method No. RA 10.3 "Determination of Ethylene Oxide Residues in Spices by Headspace Gas
Chromatography". The Limit of Quantification (LOQ) was 1.0 ppm and the Limit of Detection
was 0.25 ppm. Details of the method and method validation are discussed in MRID 46625301.
Method No. RA 12.2 "Determination of 2-Chloroethanol Residues in Spices".
The Limit of Detection was 10 ppm for 25 of the 29 spices and herbs, but several were listed at
25 ppm (3), with 1 undefined. Details of the method and method validation are discussed in
MRID 46625301.
38
-------
[Appendix C]
860.1520 Processed Food and Feed
A study (MRID 46625301) was conducted by the industry in order to test ETO and ECH residue
levels resulting from an improved fumigation process referred to as "ETO Express" using a 20%
ETO: 80% carbon dioxide formulation in the ETO sterilization of whole and ground spices and
herbs.
"ElED had previously recommended that the established 50 ppm tolerance (40 CFR 180.151) for
ETO residues in spices and herbs remain unchanged at 50 ppm. However, this new steam
process shows much lower residue levels even after 72 hours. Therefore it is possible that the
ETO tolerance could be lowered based only if, the registrants, with a label statement, restrict ail
US use of ETO to fumigate spices and herbs by this new process, and not allow any other
treatment processes. Likewise the proposed tolerances for the residues of ECH in/on
spices/herbs, dried (except basil), and basil could be adjusted downward but only if the new
treatment method were used in all fumigations". (See memo of 01/25/06, J. Stokes).
In response to HED's comment, according to SRRD, the industry has now stated to the Agency
and to be documented in a "terms and conditions" letter forthcoming that all food commodity
fumigations will be conducted only by the new procedure "ETO Express"as listed in MRID
46625301. They also have stated that basil will no longer be fumigated with any formulation of
ETO (letters dated 07.07/2006, Honeywell International and 07/10/2006, ARC Specialty
Products).
Therefore, HED has reevaluated the tolerances previously proposed in the January 2006 Revised
Residue Chemistry Chapter. Thus, based on the results of HED's statistical tolerance generator
for NAFTA-harmonized tolerances, HED finds that tolerances of 7 ppm ETO and 940 ppm ECH
for spices/herbs fumigated with ETO are appropriate.
Data are not available for "vegetable, dried.". Therefore HED recommends that tolerances for
ETO and ECH be established at the same levels as herbs and spices, 7 ppm and 940 ppm,
respectively.
Tolerance Reassessments for Ethylene oxide
This was previously discussed in the Revised ETO RED (07/12/05). However, based on the
results of HED's statistical tolerance generator for NAFTA-harmonized tolerances, HED finds
that tolerances of 7 ppm ETO and 940 ppm ECH for spices/herbs fumigated with ETO are
appropriate. In addition, other tolerances previously proposed are revised as shown in the
following table.
-------
180.151
[Appendix C]
Ethylene oxide; tolerances for residues.
(a) General. (1). Tolerances are established for the residues of the antimicrobial agent and
insecticide ethylene oxide, when used as a postharvest fumigant in or on the following
food commodities:
Tablel. Tolerance Reassessment Summary for Ethylene oxide
Commodity
Current
Tolerance (ppm)
Tolerance Reassessment
(ppm)
Comment/fCorrect Commodity Definition/
Tolerances Listed Under 40 CFR §180.151 a(l)
coconut, copra
spices, whole
walnut, black
50
50
50
revoke
7
50
should be revoked, treatment not used
[herbs ana spices, group 19, d>-;al f except
basil)]
[walnut]
Tolerances Listed Under 40 CFR §180.151 a(2)
spices, ground
50
Should be revoked; ground spices included in
[herbs and spices, group 19, dried (except
basil)]
Tolerances to Be Proposed under 40 CFR 180.151 For Ethylene oxide
vegetable, dried
none
7
Remove all of Section (a)(2)
Add a new Section (a)(2):
Tolerances are established for residues of the ethylene oxide reaction product, 2-chloroethanol.
commonly referred to as ethylene chlorohydrin, when ethylene oxide is used as a post-harvest
fumigant in or on the following food commodities.
Table2. Tolerance Reassessment Summary for Ethyiene oxide
Commodity
Current
Tolerance (ppm)
Tolerance Reassessment
(ppm)
Commen.il [Correct Commodity Definition]
Tolerances to Be Proposed under 40 CFR 180.151 For Ethylene Chlorohydrin
herbs and spices,
group 19, dried
(except basil)
vegetable, dried
none
none
940
940
40
-------
[Appendix C]
Bibiliography
46625301 Wright, M. (2005) Magnitude of the Residue of Ethylene Oxide and Ethylene Chlorohydrin in/on Spices
Agency Memoranda Citations
Ethvlene Oxide. Case 2275. Revised ETO RED. DP Barcode: D313774. July 12. 2006 J. Stokes
RDI: RRB4: S Hummel (July 12, 2006)
J. Stokes:PYl:10923:(703)305-7561:7509C
Attachment 1: Tolerance/MRL Harmonization Spreadsheet
41
-------
[Appendix Cl
Attachment 1:
This attachment contains the spreadsheet output from the Tolerance/MRL Harmonization
Spreadsheet, which was developed by the NAFTA Tolerance/MRL Harmonization Workgroup
that was charged with formulating a statistically-based, scientifically defensible methodology for
establishing tolerances. The "MRL Summary1' worksheet contains the results of various
calculations performed automatically be the tolerance spreadsheet. The input to the spreadsheet
is presented first, followed by a probability plot of the data. The recommended tolerance is
highlighted on the output spreadsheet.
42
-------
[Appendix C]
Regulator:
Chemical:
Crop:
PHI:
App. Rate:
Submitter:
EPA
ETO
Spices/Herbs
1 day
Residues
2 . 530
4.090
3.500
1.260
1.180
1.280
2.360
2.000
2.820
1.340
1.230
1.180
0.839
0.900
0.774
1.650
1 .830
1.820
0.834
0.836
0.578
0.309
0.253
1.000
1.100
0.960
0.234
0.266
0.264
0.250
0.250
0.250
LN( Residues)
0.93
1.41
1.25
0.23
0.17
0.25
0.86
0.69
1.04
0.29
0.21
0.17
-0.18
-0.11
-0.26
0.50
0.60
0.60
-0.18
-0.18
-0.55
-1 .17
-1.37
0.00
0.10
-0.04
-1.45
-1.32
-1.33
-1.39
-1.39
-1.39
Z-
scores
1.21
2.07
1.64
0.36
0.12
0.44
1.07
0.94
1.40
0.53
0.28
0.20
-0.28
-0.20
-0.53
0.62
0.82
0.72
-0.44
-0.36
-0.62
-0.72
-1.07
-0.04
0.04
-0.12
-2.07
-0.82
-0. 94
-1 . 64
-1.40
-1.2 1
43
-------
[Appendix C
44
-------
[Appendix C]
Lognonual Probability Plot
EPA ETO Spices/Herbs 1 day
Percentiles
45
-------
[Appendix C]
Regulator:
Chemical:
Crop:
PHI:
App. Rate:
Submitter:
n:
min:
max:
median;
average:
EPA
ETO
Spices/Herbs
1 day
32
0.23
4.09
1.05
1.25
95th Percentile
99th Percentile
99.9th Percentile
EU Method X
Normal
(3.5)
4.0
(4.5)
4.5
EU Method I
Log Normal
4.0
7.0'
(13)
13
SU Method II
Distribution-
Free
4.0
California
Method
M + 3a
4.5
UPLMedian95th
6.0
Approximate
Shapiro-Francia
Normality Test
Statistic
0.05
0.9324
Do not reject lognormal ity assumption
46
-------
[Appendix C]
Regulator;
Chemical:
Crop:
PHI:
App. Rate:
Submitter:
EPA
ECH
Spices/Herbs
1 day
Residues
167.000
185.000
270.000
289. 000
115 .000
150.000
202.000
132.000
21.000
37 .000
53.000
31.000
79.000
70.000
132 .000
44.000
153.000
184.000
283.000
146 .000
146.000
223.000
279.000
306.000
233.000
44.000
68.000
63.000
61.000
324.000
222.000
278.000
333.000
LN( Residues)
5.12
5.22
5.60
5.67
4.74
5.01
5.31
4.88
3 .04
3.61
3.97
3.43
4.37
4.25
4 .88
3 .78
5.03
5.21
5.65
4.98
4.98
5.41
5.63
5.72
5.45
3.78
4.22
4.14
4.11
5.78
5.40
5.63
5.81
Z-
scores
0.29
0.44
0.78
1.15
-0.24
0.19
0.49
-0.19
-1.25
-1.07
-0.66
-1.15
-0.34
-0.44
-0.14
-0.91
0.24
0.39
1.07
0.09
0.14
0.66
0.99
1 .25
0.72
-0.84
-0.49
-0.54
-0.60
1.36
0.60
0.91
1 . 4 9
'f /
-------
962 .000
745.000
71.000
51 .000
135.000
142 .000
175.000
142.000
136.000
371.000
202 .000
273 .000
14.000
12.000
88.000
44.000
18.000
42.000
10.000
10.000
[Apper.di
6 . 87
6.61
4.26
3.93
4.91
4.96
5.16
4.96
4.91
5.92
5.31
5.61
2.64
2.48
4.48
3.78
2.89
3 . 7 4
2.30
2.30
xCl
" "2.27"!
1 . 87
-0.39
-0. 72
-0.09
0.00
0.34
0.05
-0.05
1.65
0.54
0.84
-1.49
-1.65
-0.29
-0.78
-1.36
-0.99
-2 .27
-1.87
48
-------
[Appendix C]
Lognormal Probability Plot
* EPA ECK Spiceo/Herbs 1 day
Percent lies
49
-------
[Appendix C]
Regulator:
Chemical:
Crop:
PHI:
App. Rate:
Submitter:
n:
min:
max:
median;
average:
EPA
ECH
Spices/Herbs
I day
53
10.00
962 .00
142.00
169 .17
95th Percentile
99th Percentile
99.9th
Percentile
EU Method
Normal
450
(520)
570
(660)
700
EU Method I
Log Normal
610
(MO)
1300
(2200)
2800
EU Method II
Distribution-
Free
460
California
Method
M + 30
UPLMedian95th
Approximate
Shapiro-Francia
Normality Test
Statistic
680
730
p-value
0.05
50
-------
[Appendix D]
Voluntary Cancellation Letter for Ethylene Oxide
Debra Edwards, Ph.D.
Director, Special Review and Reregistration Division
Office of Pesticide Programs (7508P)
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
SUBJECT: [Registrant's Request for Voluntary Termination of Basil Uses of its Ethylene
Oxide Products and Request for LabeJ Amendments
Dear Ms. Edwards:
[Registrant] ([Registrant]), consistent with FIFRA section 6(f)(l )(A), hereby irrevocably
requests voluntary termination of all basil uses of the ethylene oxide (ETO) products listed in the
table shown below. [Registrant] requests that the Administrator waive the additional 180-day
period under section 6(f)(l)(C)(ii). [Registrant] understands that the Administrator will provide
for a 30-day public comment period following publication of this request in a Federal Register
Notice. [Registrant] is including amendments to its affected registrations intended to effectuate
the voluntary use terminations and associated label changes.
(Registrant's Registrations for ETO
Registration
Number
Name
Status
Restricted Use
Product
Percent Active
Ingredient
Active
Ingredient
Ethy'ene Oxide
Ethylene Oxide
Ethylene Oxide
For the [Registration numbers] registrations listed above in the table. [Registrant] requests
voluntary termination of ETO's use on basil. Specifically, [Registrant] requests that the
following sentence be added in bold font at the end of the label use directions paragraph below,
"This product may not be used on or in any form of basil.":
[Product name] maybe safely used only to sterilize medical and laboratory items,
Pharmaceuticals, aseptic packaging, and reduce microbial load on cosmetics, and whole
and ground spices. Items to be sterilized should be thoroughly cleaned of soil before
being placed in any type of sterilizer
[Registrant] requests provisions for sale, distribution, and use of existing stocks, as EPA defined
that term at 56 Fed. Reg. 29362, as follows
The registrant may sell and distribute existing stocks for one year from the date of this
letter making the use termination request.
51
-------
[Appendix D]
Voluntary Cancellation Letter for Ethylene Oxide
The product may be sold, distributed, and used by people other than the registrant until
their stocks have been exhausted, provided that such sale, distribution, and use complies
with the EPA-approved label and labeling of the product.
If you have any questions or comments about [Registrant] 's request, please contact [Registrant
representative] at [phone number].
Sincerely,
[Registrant representative]
cc:
-------
I Appendix E]
Terms and Conditions Letter for Ethylene Oxide
[Date]
Lois Rossi
Director, Reregistration Division
Office of Pesticide Programs (7508P)
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
SUBJECT: [Registrant] - Request for Amended Registrations
Dear Ms. Rossi:
As per conversations between my company representatives and staff of the United States
Environmental Protection Agency, [Registrant], submits this request for amendment of its registrations
identified below to incorporate the below-stated terms and conditions. [Registrant] will submit all
required registration amendment forms and revised labeling incorporating the deletions and additions
set forth below by October 30, 2006.
[Registrant] 's Registrations for ETO:
Registration
Number
Name
Status
Restricted Use
Product
Percent Active
Ingredient
Active
Ingredient
Ethylene
Oxide
Ethylene
Oxide
Ethylene
Oxide
New Label Language to be Added:
For end use registrations, [list end use registration numbers] listed above in the table, [Registrant]
requests that the following label language be added in bold:
"This product may not be used on or in any form of basil."
"After August 1, 2008, this product may only be applied to or on spices, dried vegetables or
seasonings utilizing an ETO sterilization method that uses a single sterilization chamber to pre-
condition and aerate with an alternating vacuum and aeration purging procedure. If you wish
to employ an alternative method to that described below, you must contact the Environmental
Protection Agency Office of Pesticide Programs for instruction on how to receive authorization."
53
-------
"Place spices in the treatment chamber. Assure that the mixture of ethylene oxide and
air is compatible with the chamber design, then; introduce into the chamber a
concentration of Ethylene Oxide not to exceed 500 mg/L, with a dwell time not to exceed
16 hours. Then evacuate the gas from the chamber using a sequence of not less than 16
steam washes (injections and evacuations) between 1.0 PSIA (28" Hg) and 2.0 PSIA
(26"Hg) while maintaining a minimum chamber temperature of 120° F."
For technical or manufacturing-use registrations, 67470-6 and 67470-7 listed above in the table,
[Registrant] requests that the following label language be added in bold:
1. "Any product formulated from this product that is registered for use on spices, dried
vegetables, or seasonings must include the following label language:
"This product may not be used on or in any form of basil."
"After August 1, 2008, this product may only be applied to or on spices, dried vegetables or
seasonings utilizing an ETO sterilization method that uses a single sterilization chamber to pre-
condition and aerate with an alternating vacuum and aeration purging procedure. If you wish
to employ an alternative method to that described below, you must contact the registrant of this
product for an identification of any alternative methods that are acceptable to the United States
Environmental Protection Agency."
"Place spices in the treatment chamber. Assure that the mixture of ethylene oxide and
air is compatible with the chamber design, then; introduce into the chamber a
concentration of Ethylene Oxide not to exceed 500 mg/L, with a dwell time not to exceed
16 hours. Then evacuate the gas from the chamber using a sequence of not less than 16
steam washes (injections and evacuations) between 1.0 PSIA (28" Hg) and 2.0 PSIA
(26"Hg) while maintaining a minimum chamber temperature of 120° F."
2. "Any product formulated from this product that is registered as a technical or
manufacturing-use product must include the following label language:
"Any product formulated from this product that is registered for use on spices, dried vegetables,
or seasonings must include the following label language:
"This product may not be used on or in any form of basil."
"After August 1, 2008, this product may only be applied to or on spices, dried vegetables or
seasonings utilizing an ETO sterilization method that uses a single sterilization chamber to pre-
condition and aerate with an alternating vacuum and aeration purging procedure. If you wish
to employ an alternative method to that described below, you must contact the registrant of this
product for an identification of any alternative methods that are acceptable to the United States
Environmental Protection Agency."
"Place spices in the treatment chamber. Assure that the mixture of ethylene oxide and
air is compatible with the chamber design, then; introduce into the chamber a
concentration of Ethylene Oxide not to exceed 500 mg/L, with a dwell time not to exceed
16 hours. Then evacuate the gas from the chamber using a sequence of not less than 16
steam washes (injections and evacuations) between 1.0 PSIA (28" Hg) and 2.0 PSIA
(26"Hg) while maintaining a minimum chamber temperature of 120° F."
-------
[Registrant] notes that the label provision set forth above concerning basil reflects [Registrant]'s
request for use termination in its [date] letter to the Agency.
Existing Stocks Provision.
[Registrant] understands that new technology relating to the reduction in residues for ETO and
reaction products must be in use no later than August 1, 2008.
[Registrant] understands that amendments to the affected registrations and revised labels incorporating
the additions and deletions set forth above must be submitted to the Registration Division by October
30, 2006 to the following:
Marshall Swindell
USEPA Headquarters
Ariel Rios Building
1200 Pennsylvania Ave, N.W.
M/C 7505p
Washington DC, 20460
[Registrant] understands that, as of July 30, 2007, all new production of the products identified above
must bear approved revised labels incorporating the additions and deletions set forth above.
[Registrant] understands that any person other than the registrant may continue to sell, distribute, or
use its stocks of Ethylene Oxide affected products not bearing the new labeling until exhausted.
If you have any questions or comments about [Registrant]'s request, please contact [Registrant
representative] at [phone number].
Sincerely,
[Registrant representative]
------- |