Reregistration Eligibility
Decision (RED) for
Triethylene Glycol
September 2003
-------
United States Prevention, Pesticides EPA739-R-05-002
Environmental Protection and Toxic Substances September 2005
(7508C)
Reregistration Eligibility
Decision For Triethylene Glycol
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (EPA) has completed its
review of the available data on the antimicrobial triethylene glycol. The Reregistration Eligibility
Decision (RED) was approved in the form of a decision memorandum which summarized the
regulatory decision for triethylene glycol on September 30, 2003.
Based on the Agency's review, the Reregistration Eligibility Decision (RED) and risk
management decision with its associated human health and environmental risk assessments are
now being published. A Notice of Availability will be published in the Federal Register
announcing the publication of the RED.
The RED and supporting documents for triethylene glycol will be available to the public in
EPA's Pesticide Docket OPP-2005-0250 at: http://www.epa.gov/edockets.
Please note that the attached RED document pertains only to triethylene glycol and
presents the Agency's conclusions on the dietary, drinking water, occupational and ecological
risks posed by exposure to triethylene glycol alone. This document also contains product-specific
data that the Agency intends to require in Data Call-Ins (DCIs). Note that DCIs, with all
pertinent instructions, will be sent to registrants at a later date. Currently, there are no generic
data requirements. For product-specific DCIs, the first set of required responses will be due 90
days from the receipt of the DCI letter. The second set of required responses will be due eight
months from the receipt of the DCI letter.
As part of the RED, the Agency has determined that triethylene glycol is eligible for
reregistration. Sections IV and V of this RED document describe product-specific data
requirements.
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If you have questions on this document or the label changes relevant to this reregistration
decision, please contact the Chemical Review Manager, Heather Garvie, at (703) 308-0034. For
questions about product reregistration and/or the Product DCI that accompanies this document,
please contact Marshall Swindell at (703) 308-6341.
Sincerely,
Frank T. Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
Triethylene Glycol
ListC
CASE 3146
Approved By:
Frank T. Sanders
Director, Antimicrobials Division
September 26, 2005
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TABLE OF CONTENTS
Triethylene Glycol Reregistration Team i
Glossary of Terms and Abbreviations ii
Executive Summary 1
I.
Introduction
O
II. Chemical Overview 5
A. Regulatory History 5
B. Chemical Identification 5
C. Use Profile 6
III. Summary of Triethylene Glycol Assessment 8
A. Human Health Assessment 8
1. Toxicity of TEG 8
2. FQPA Safety Factor 9
3. Population Adjusted Dose (PAD) 9
4. Dietary and Residential Exposure 9
5. Aggregate Exposure 10
6. Occupational Exposure 10
7. Human Incident Data 10
B. Environmental Assessment 10
1. Environmental Fate and Transport 10
2. Ecological Risk 11
a. Toxicity (Hazard) Assessment 11
b. Risk to Listed Species 12
IV. Risk Management, Reregistration and Tolerance Reassessment Decision 13
A. Determination of Reregistration Eligibility 13
B. Comments and Responses 13
C. Regulatory Position 13
1. Food Quality Protection Act Findings 13
a. "Risk Cup" Determination 13
b. Determination of Safety to U. S. Population 14
c. Determination of Safety to Infants and Children 14
d. Endocrine Disrupter Effects 14
e. Cumulative Risks 15
2. Tolerance Summary 15
a. Codex Harmonization 16
D. Regulatory Rationale 16
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1. Listed Species Considerations 16
a. The Endangered Species Act 16
b. General Risk Mitigation 17
V. What Registrants Need to Do 18
A. Manufacturing-Use Products 19
1. Additional Generic Data Requirements 19
B. End-Use Products 19
1. Additional Product-Specific and Efficacy Data Requirements 19
VI. Appendices 20
A. Table of Use Patterns Eligible for Reregistration 21
B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 42
C. Technical Support Documents 49
D. Bibliography Citations 50
E. Generic Data Call-In 54
F. Product Specific Data Call-In 55
G. Batching of End-Use Products 56
H. List of All Registrants Sent the Data Call-In 59
I. List of Available Forms 60
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Triethylene Glycol Reregistration Team
Health Effects Risk Assessment
Michelle Centra
Tim McMahon
Najm Shamim
Timothy Leighton
Jonathan Chen
Environmental Fate and Ecological Risk Assessment
Kathryn Montague
Najm Shamim
Use and Usage Analysis
Heather Garvie
Registration Support
Marshall Swindell
Risk Management
Heather Garvie
Ben Chambliss
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARC Anticipated Residue Contribution
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e., drinking
water) lifetime exposure at which adverse, noncarcinogenic health effects are not anticipated to occur.
DWLOCDrinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLC Gas Liquid Chromatography
GLN Guideline Number
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HAFT Highest Average Field Trial
HOT Highest Dose Tested
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per
weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of
the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as
a weight of substance per unit weight of animal, e.g., mg/kg.
LEL Lowest Effect Level
LOG Level of Concern
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LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
NA Not Applicable
N/A Not Applicable
NAWQA USGS National Water Quality Assessment
NOEC No Observable Effect Concentration
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
NR Not Required
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PAD Population Adjusted Dose
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
PRZM/
EXAMS Tier II Surface Water Computer Model
Qi * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
RS Registration Standard
RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
Ill
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TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
TRR Total Radioactive Residue
UF Uncertainly Factor
g/g Micrograms Per Gram
g/L Micrograms Per Liter
USDA United States Department of Agriculture
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The Environmental Protection Agency (hereafter referred to as EPA or the Agency) has
completed its human health and environmental review for triethylene glycol and is issuing its risk
management decision. The Agency has decided that triethylene glycol is eligible for
reregistration. This Reregistration Eligibility Decision (RED) addresses the use of triethylene
glycol as a bacteriostat (against odor-causing bacteria) for air sanitization and deodorization. In
combination with other active ingredients, it is used as a fungicide, virucide and miticide for
disinfection of hard, non-porous surfaces and as an insecticide (against lice) by direct application
to caged birds and to the cage. For these uses, triethylene glycol is formulated primarily as a
pressurized liquid. This document also addresses the exposures from the use of this pesticide as
an inert ingredient. As an inert ingredient, triethylene glycol facilitates delivery of formulated
pesticide chemical products that are used as herbicides, fungicides, insecticides, growth regulators
and attractants on a wide variety of agricultural commodities. This RED reassesses the exemption
from the requirement for a tolerance for these uses. This tolerance exemption is listed in 40 CFR
180.920 (69 FR23124, Apr. 28, 2004).
In addition to the above, triethylene glycol is approved by the Food and Drug Administration
(FDA) as a preservative for food packaging adhesives as listed in 21 CFR 175.105. Currently,
however, there are no EPA registered products for this use. Triethylene glycol also has an
indirect food additive regulation [21 CFR 177.1200 (4/1/04)] for its use as a plasticizer in
cellophane. This use is regulated by the Food and Drug Administration (FDA).
Overall Risk Summary
Hazard Profile/Human Health Risk
Based on a review of the available toxicology data, the Agency has concluded that triethylene
glycol is of very low toxicity by the oral, dermal, and inhalation routes of exposure. The
toxicology database is adequate to characterize the hazard of triethylene glycol, and no data gaps
have been identified. There are no indications of special sensitivity of infants or children resulting
from exposure to triethylene glycol. Therefore, the FQPA Safety Factor has been removed (i.e.,
reduced to IX) for triethylene glycol. The Agency has not identified toxicological endpoints of
concern for the active and the inert uses of triethylene glycol. Therefore, a quantitative human
health risk assessment was not conducted for this RED document. The Agency has no risk
concerns for triethylene glycol with respect to human exposure.
Environmental Risk
The Agency has relied on open literature data that characterizes the fate properties of triethylene
glycol. The results of these studies indicate that triethylene glycol is miscible in water, mobile in
soils and stable to abiotic degradation hydrolysis and soil and aquatic photolysis. Biodegradation
is expected to proceed rapidly in surface waters.
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Ecological effects data were previously waived due to the use of triethylene glycol as an indoor
microbiocide, its high volatility, and known low toxicity (it is a preferred solvent for aquatic
organism toxicity tests). Data obtained from published studies provide additional confirmation of
the low toxicity of the compound to fish and aquatic invertebrates. The Agency has no risk
concerns for triethylene glycol with respect to non-target organisms. The Agency expects no
effects to listed species or critical habitat and therefore makes a "No Effect" determination for
TEG.
Regulatory Decision
The Agency has completed its review and has determined that the data are sufficient to support
reregistration of all supported products containing triethylene glycol.
Summary of Mitigation Measures
The Agency has determined that triethylene glycol is eligible for reregistration. Since no risks of
concern were identified, no specific mitigation measures are needed for triethylene glycol.
Data Requirements
No additional confirmatory data is required to complete the reregistration of triethylene glycol.
However, product specific data is required for all products containing triethylene glycol as
described in Section V of this document.
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I. INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1,
1984 and amended again by the Pesticide Registration Improvement Act of 2003 to set time
frames for the issuance of Reregistration Eligibility Decisions. The amended Act calls for the
development and submission of data to support the reregistration of an active ingredient, as well
as a review of all submitted data by the Agency. Reregistration involves a thorough review of the
scientific database underlying a pesticide s registration. The purpose of the Agency s review is to
reassess the potential hazards arising from the currently registered uses of the pesticide; to
determine the need for additional data on health and environmental effects; and to determine
whether the pesticide meets the no unreasonable adverse effects criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. This
Act amends FIFRA to require a tolerance reassessment. The Agency has decided that, for those
chemicals that have tolerances and are undergoing reregistration, the tolerance reassessment will
be initiated through this reregistration process. The Act also requires that by 2006, EPA must
review all tolerances in effect on the day before the date of the enactment of the FQPA. FQPA
also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a safety finding in
the tolerance reassessment based on factors including consideration of cumulative effects of
chemicals with a common mechanism of toxicity. This document presents the Agency s human
health and ecological review and the Reregistration Eligibility Decision for triethylene glycol.
Triethylene glycol is used as a bacteriostat (against odor-causing bacteria) for air sanitization and
deodorization. In combination with other active ingredients, it is used as a fungicide, virucide and
miticide for disinfection of hard, non-pourous surfaces and as an insecticide (against lice) by direct
application to caged birds and bird cages. This document also addresses the exposures and risks
from the use of this pesticide as an inert ingredient. As an inert ingredient, triethylene glycol
facilitates delivery of formulated pesticide chemical products that are used as herbicides,
fungicides, insecticides, growth regulators and attractants on a wide variety of agricultural
commodities.
The Agency has concluded that the FQPA Safety Factor for triethylene glycol should be removed
(equivalent to IX) because there is no pre- or post-natal evidence of increased susceptibility for
infants and children following exposure to triethylene glycol.
The review summarized in this document concern only potential exposures from the use of the
active ingredient triethylene glycol and its use as an inert ingredient. The Food Quality Protection
Act (FQPA) requires that the Agency consider available information concerning the cumulative
effects of a particular pesticide's residues and other substances that have a common mechanism of
toxicity. The reason for consideration of other substances is due to the possibility that low-level
exposures to multiple chemical substances that cause a common toxic effect by a common toxic
mechanism could lead to the same adverse health effect that would occur at a higher level of
exposure to any of the substances individually. Unlike other pesticides for which EPA has
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followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not
made a common mechanism of toxicity finding for triethylene glycol and any other substances.
Triethylene glycol does not appear to produce a toxic metabolite produced by other substances.
For the purposes of this action, therefore, EPA has not assumed that triethylene glycol 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 the 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
http ://www. epa. gov/pesticides/cumulative.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of triethylene glycol. In an effort to simplify the RED, the information presented
herein is summarized from more detailed information which can be found in the technical
supporting documents for triethylene glycol referenced in this RED. Related documents are
available in the Public Docket at http://www.epa.gov/edocket.
This document consists of six sections. Section I is the introduction. Section II provides a
chemical overview, a profile of the use and usage of triethylene glycol, and its regulatory history.
Section III gives an overview of the revised human health and environmental assessments based
on the data available to the Agency. Section IV presents the reregistration eligibility and risk
management decisions. Section V summarizes procedures for the product-specific data call-in
(PDCI). Finally, the Appendices contain all use patterns eligible for reregistration, bibliographic
information, generic data requirements and studies used to make the reregistration decision,
related documents and how to access them, and Data Call-In (DCI) information.
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II. CHEMICAL OVEVIEW
A. Regulatory History
Triethylene glycol was first registered in 1947 for use in hospitals as an air disinfectant. At one
point, there were approximately 105 pesticide chemical companies having active triethylene glycol
registrations. Many of these registrations were canceled over the years and more recently, the
majority of the remaining producers of triethylene glycol formulated pesticide products are being
represented by a consortium called the CSPA (Consumer Specialty Products Association) Glycols
Joint Venture. The member companies currently represented by this consortium are: Amrep, Inc.,
Chase Products Co., Medo Industries, Inc., S.C. Johnson & Son, Waterbury Companies, Inc.,
Speer Products, Inc. and Quest Chemical Corporation.
B. Chemical Identification
Triethylene Glycol:
Common Name:
Chemical Name:
Chemical family:
Case number:
CAS registry number:
OPP chemical code:
Empirical formula:
Molecular weight:
Trade and other names:
Manufacturers:
Specific Gravity:
Solubility:
Triethylene Glycol
Triethylene Glycol
None
3146
112-27-6
083501
CeHi4O4
150.20g/mol
TEG
CSPA Glycols Joint Venture companies (S.C.
Johnson & Son, Inc., Waterbury Companies, Inc,
Amrep, Inc., Speer Products, Inc., Quest Chemical
Corporation, Medo Industries, Inc.
1.1274
Highly miscible in water
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Soluble in alcohol, benzene, toluene, sparingly
soluble in ether and insoluble in petroleum ether
Boiling Point: 285 ° C, ( at 760 mm Hg) 165 ° C at 14 mm Hg.
Melting Point: -5°C(-7°C)1
Vapor Pressure: < 0.01 mm Hg at 20 ° C ( 0.00132 mm Hg at 25 °
Q1
Structure: OH-CH2-CH2-O-CH2-CH2-O-CH2-CH2-OH
C. Use Profile
The following is information on the currently registered uses of triethylene glycol products and an
overview of use sites and application methods. A detailed table of the uses of triethylene glycol
eligible for reregistration is contained in Appendix A.
Type of Pesticide: Bacteriostat
Summary of Use Sites:
Indoor Non-Food: Triethylene glycol is used on the following use sites: air treatment (eating
establishments, hospital, commercial, institutional, household, bathroom,
transportational facilities); medical premises and equipment, commercial,
institutional and industrial premises and equipment; laundry equipment;
hard non-porous surface treatments (bathroom facilities); automobiles; air
conditioning filters; bird (caged) animal treatment; pet bird cages;
environmental inanimate hard surfaces; garbage containers/storage
Target Pests: Odor-causing bacteria
Inert Uses: As an inert ingredient, triethylene glycol facilitates delivery of formulated
pesticide chemical products that are used as herbicides, fungicides,
insecticides, growth regulators and attractants on various commodities.
Formulation Types: Pressurized liquid
Method and Rates of Application
Equipment: A wall mounted dispensing unit may be needed, depending on the type of
application. Otherwise, the sanitizer is sprayed manually.
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Method and Rate: For a wall mounted unit, the number of times the product is dispensed
depends on the size of the room and should be used in accordance with the
label directions.
If the product is dispensed from a metered dose aerosol can or from a hand
held unit, as the amount dispensed will depend on the valve size utilized.
For an air sanitizer in a continuous action aerosol can, a one second spray
is used for a 9 x 9 x 7 room.
Typically, an air sanitizer that is used manually is pointed toward the center
of the room (12x 12x9) and sprayed for ten seconds.
Use Classification: General use
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III. SUMMARY OF TRIETHYLENE GLYCOL ASSESSMENT
A. Human Health Assessment
1. Toxicity of TEG
A brief overview of the toxicity of triethylene glycol is presented below. Further details on the
toxicity of triethylene glycol can be found in the supporting documentation for this RED. The
Antimicrobials Division Toxicology Endpoint Selection Committee (ADTC) memorandum, the
toxicology chapter for the RED and other supporting documentation are available on the
Agency's website in the EPA Docket at http://www.epa.gov/edockets.
The toxicological database for triethylene glycol is currently comprised of published and
unpublished studies either submitted to the Agency or obtained directly from the open literature.
Although the available studies do not meet the requirements of the Agency s OPPTS harmonized
test guidelines published in 1998, it was determined that these studies contain useful information
that is adequate for hazard characterization of triethylene glycol. These acceptable non-guideline
studies include acute, subchronic, chronic, developmental, and reproductive toxicity,
carcinogenicity, mutagenicity, metabolism/pharmacokinetics and dermal absorption studies.
Therefore, the Agency has determined that the toxicological database is complete and sufficient
for reregistration.
Major features of the toxicology profile are presented below. Triethylene glycol is shown to be of
low toxicity, with the exception of a dermal irritation study which was Toxicity Category III due
to slight irritation.
Table 1. Acute Toxicity of Triethylene Glycol Technical
Guideline No./ Study Type
870. 1 100 Acute Oral Toxicity
870. 1200 Acute Dermal Toxicity
870. 1 300 Acute Inhalation Toxicity
870.2400 Acute Eye Irritation
870.2500 Acute Dermal Irritation
870.2600 Skin Sensitization
MRID
4281 4404 &
open literature
—
OTS: 527779-
2
42814404
42814404
Open literature
Results
LD50 = 15,000 -22,000 mg/kg
Waived
LC50>5.2mg/L
Mild eye irritation
Slight irritation
Non-sensitizer
Toxicity
Category
IV
—
IV
IV
III
General Toxicity Observations
Upon reviewing the available toxicity information, the Agency has concluded that there are no
endpoints of concern for oral, dermal, or inhalation exposure to triethylene glycol. This
conclusion is based on the results of toxicity testing of triethylene glycol in which dose levels near
or above testing limits (as established in the OPPTS 870 series harmonized test guidelines) were
employed in experimental animal studies and no significant toxicity observed.
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Carcinogenicity Classification
A review of the available data has shown triethylene glycol to be negative for carcinogenicity in
studies conducted up to the testing limit doses established by the Agency; therefore, no
carcinogenic analysis is required.
Mutagenicity Potential
Triethylene glycol was tested for mutagenic or genotoxic potential and found to be negative in a
battery of studies: a bacterial gene mutation assay using Salmonella typhimurium, and in vitro
Chinese hamster ovary (CHO) mutation assay, an in vitro Chinese hamster ovary (CHO)
chromosomal aberration assay and an in vitro sister chromatid exchange assay.
2. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is intended to
provide an additional 10-fold safety factor (10X), to protect for special sensitivity in infants and
children to specific pesticide residues in food, drinking water, or residential exposures, or to
compensate for an incomplete database. The FQPA Safety Factor has been removed (i.e.,
reduced to IX) for triethylene glycol because there is no pre- or post-natal evidence for increased
susceptibility following exposure. Further, the Agency has concluded that there are no endpoints
of concern for oral, dermal, or inhalation exposure to triethylene glycol based on the low toxicity
observed in studies conducted near or above testing limit doses as established in the OPPTS 870
series harmonized test guidelines. Therefore, a quantitative risk assessment was not conducted
for triethylene glycol.
3. Population Adjusted Dose (PAD)
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which reflects the
reference dose (RfD), either acute or chronic, that has been adjusted to account for the FQPA
Safety Factor (SF). This calculation is performed for each population subgroup. A risk estimate
that is less than 100% of the acute or chronic PAD is not of concern. Since toxicological
endpoints for risk assessment were not identified based on the available data, RfD's and PAD's
have not been calculated for triethylene glycol.
4. Dietary and Residential Exposure
Dietary exposure (food and drinking water) could potentially occur from the use of triethylene
glycol as a preservative in food packaging adhesives and from its use as an inert ingredient in
agricultural pesticide formulations. Residential exposure could also potentially occur as a result
of the use of triethylene glycol in and around the home as a sanitizer, disinfectant and bird
treatment. However, risk estimates have not been calculated for potential exposures to triethylene
glycol on food, in drinking water, or as a result of use in residential settings because there are no
toxicological endpoints of concern according to a review of the available toxicity data.
5. Aggregate Exposure
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The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic Act
(FFDCA, Section 408(b)(2)(A)(ii)) require "that there is a reasonable certainty that no harm will
result from aggregate exposure to pesticide chemical residue, including all anticipated dietary
exposures and other exposures for which there are reliable information." Aggregate exposure will
typically include exposures from food, drinking water, residential uses of a pesticide and other
non-occupational sources of exposure.
Since toxicological endpoints for risk assessment were not identified based on the available data,
an aggregate risk assessment was not conducted for triethylene glycol.
6. Occupational Exposure
The occupational exposure assessment for triethylene glycol addresses potential exposures and
risks to humans who may be exposed in occupational settings". An occupational and risk
assessment is required for an active ingredient if: 1) certain toxicological criteria are triggered;
and 2) there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use or to
persons entering treated sites after application is complete. For triethylene glycol, there is
potential for exposure, however, there are no toxicological endpoints of concern, according to a
review of the available toxicity.
7. Human Incident Data
In evaluating incidents to humans, the Agency reviewed reports from the 1993-1996 National
Poison Control Centers (PCC), the Agency's Office of Pesticide Program's Incident Data System
(IDS), the California Department of Pesticide Regulation, and the National Pesticide
Telecommunications Network (NPTN). Although there are incidences that have been reported
associated with TEG in the searched database, there is no one reported incident involving TEG as
a single chemical exposure. Either no effects or minor effects are involved in these reported
incidences. The other ingredients in combination with TEG may be the reasons for the symptoms
that have been reported.
B. Environmental Assessment
A summary of the Agency's environmental review is presented below. For detailed discussions of
all aspects of the environmental review, see the Product Chemistry, Environmental Fate and
Toxicology chapters available on the Agency's website in the EPA Docket at:
http ://www/epa. gov/edockets.
1. Environmental Fate and Transport
Triethylene glycol is an aliphatic trihydroxy chemical and does not contain any hydrolyzable
hydrogen. For this reason, the Agency granted a waiver from the aquatic hydrolysis study. For
the reregistration process, however, the Agency has reviewed available open literature data and
conducted the environmental fate assessment of triethylene glycol.
Based on a review of the open literature, triethylene glycol is miscible in water, mobile in soils and
10
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stable to abiotic hydrolytic degradation as well as soil and aquatic photolysis. A number of River
Dye-away tests (complete mineralization between 7 and 11 days) have shown that triethylene
glycol degrades in soils in days (primary degradation) to weeks (complete mineralization). In
addition, sludge innoculum studies indicate that triethylene glycol undergoes ready
biodegradation. The use of sludge innoculum data as a surrogate for terrestrial soil metabolism is
subject to considerable uncertainty because sludge innoculums tend to be acclimated to the
introduction of organic substances more so than soils and the biomass on a per volume basis tends
to be greater.
2. Ecological Risk
a. Toxicity (Hazard) Assessment
As a result of the Phase IV review of triethylene glycol for reregistration under FIFRA, ecological
effects data requirements were waived due to its intended use as an indoor microbiocide, its high
volatility, and known low toxicity (it is a preferred solvent for aquatic organism toxicity tests).
Data obtained from published studies provide additional confirmation of the low toxicity of the
compound to fish and aquatic invertebrates (Table 2). As mentioned earlier in this document, no
toxicological endpoints were selected for risk assessment based on the available mammalian
database.
Table 2. Ecotoxicity of Triethylene Glycol
Species
Mysid
(Mysidopsis
bahia)
Sheepshead
minnow
(Cyprinodon
variegatus)
Bluegill sunfish
(Lepomis
macrochirus)
Menidia
beryllina
Fathead minnow
(Pimephales
promelas)
Percent
Active
Ingredient
99.9
99.9
unknown
unknown
unknown
Test Type
96-hour static
acute
96-hour static
acute
96 hour static
acute
96 hour static
96 hour flow-
through
Toxicity
LC50= 11,000
ppm
LC50 = 48,000
ppm
LC50 > 10,000
ppm
LC50 > 10,000
ppm
LC 50 59,900 -
77,400 ppm
Reference
MRID
#40228401
(Mayer, 1986)
MRID
#40228401
(Mayer, 1986)
Verschuren, 1983
Verschuren, 1983
Geiger et al,
1988
11
-------
Adverse effects to nontarget organisms are not anticipated from the indoor use of triethylene
glycol due to the low likelihood of exposure. The very low toxicity of the compound to aquatic
organisms, as indicated by the high LC50 values in the table above, further supports the
unlikelihood of adverse effects to fish and aquatic invertebrates.
b. Risk to Listed Species
Due to the low likelihood of exposure and low toxicity of triethylene glycol, the Agency expects
no effects to listed species or critical habitat and therefore makes a "No Effect" determination for
this chemical.
12
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IV. RISK MANAGEMENT, REREGISTRATION AND TOLERANCE REASSESSMENT
DECISION
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data
concerning an active ingredient, whether products containing the active ingredient are eligible for
reregistration. The Agency has previously identified and required the submission of the generic
(i.e. active ingredient-specific) data to support reregistration of products containing triethylene
glycol. The Agency has completed its review of these generic data, and has determined that the
data are sufficient to support reregistration of all supported products containing triethylene glycol.
The Agency has completed its assessment of the dietary, drinking water, residential, ecological
and occupational risks associated with the use of pesticide products containing the active
ingredient triethylene glycol. Based on a review of these data, the Agency has sufficient
information on the human health and ecological effects of triethylene glycol to make a decision as
part of the tolerance reassessment process under FFDCA and reregistration under FIFRA, as
amended by FQPA. The Agency has determined that triethylene glycol containing products are
eligible for reregistration. Appendix A summarizes the uses of triethylene glycol that are eligible
for reregistration. Appendix B identifies the generic data requirements that the Agency reviewed
as part of its determination of reregistration eligibility of triethylene glycol, and lists the submitted
studies that the Agency found acceptable.
B. Comments and Responses
Supporting documents for triethylene glycol were not issued for public comment per the Agency's
public participation process because no toxicological endpoints were identified and, as such, a
quantitative risk assessment was not conducted. To ensure that opportunity is presented to the
public to comment on the risk management decisions and supporting documents for triethylene
glycol, the Agency will implement a public comment period on this RED document.
C. Regulatory Position
1. Food Quality Protection Act Findings
a. Risk Cup Determination
Upon reviewing the available toxicity information, the Agency has concluded that there are no
endpoints of concern for oral, dermal, or inhalation exposure to triethylene glycol. This
conclusion is based on the results of toxicity testing of triethylene glycol in which dose levels near
or above testing limits (as established in the OPPTS 870 series harmonized test guidelines) were
employed in experimental animal studies and no significant toxicity observed. The Agency has
concluded that the exemption from the requirement for a tolerance is appropriate and is
considered reassessed as required by FQPA. An aggregate assessment was not conducted for
exposures through food, drinking water and residential exposure since toxicological endpoints for
13
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risk assessment were not identified based on the available data. In reaching this determination,
EPA has considered the available information on the special sensitivity of infants and children, as
well as aggregate exposure.
b. Determination of Safety to U.S. Population
As part of the FQPA tolerance reassessment process, EPA has concluded that there are no
endpoints of concern for oral, dermal, or inhalation exposure to triethylene glycol. This
conclusion is based on the results of toxicity testing of triethylene glycol in which dose levels near
or above testing limits (as established in the OPPTS 870 series harmonized test guidelines) were
employed in experimental animal studies and no significant toxicity observed. The Agency has
determined that the established exemption from the requirement for a tolerance for triethylene
glycol meets the safety standards under the FQPA amendments to section 408(b)(2)(D) of the
FFDCA, and that there is a reasonable certainty no harm will result to the general population or
any subgroup from the use of triethylene glycol. In reaching this conclusion, the Agency has
considered all available information on the toxicity, use practices and exposure scenarios, and the
environmental behavior of triethylene glycol.
Because no toxicological endpoints were identified for triethylene glycol, the Agency has
determined that exposure to it does not result in human health effects of concern. Therefore a
quantitative risk assessment was not necessary for this pesticide.
c. Determination of Safety to Infants and Children
EPA has determined that the established exemption from a requirement for a tolerance for
triethylene glycol, meet the safety standards under the FQPA amendments to section 408(b)(2)(C)
of the FFDCA, that there is a reasonable certainty of no harm for infants and children. The safety
determination for infants and children considers factors of the toxicity, use practices, and
environmental behavior noted above for the general population, but also takes into account the
possibility of increased dietary exposure due to the specific consumption patterns of infants and
children, as well as the possibility of increased susceptibility to the toxic effects of triethylene
glycol residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic effects
from triethylene glycol residues, the Agency considered the completeness of the database for
developmental and reproductive effects, the nature of the effects observed, and other information.
The FQPA Safety Factor has been removed (i.e., reduced to IX) for triethylene glycol because
there is no pre- or post-natal evidence for increased susceptibility following exposure.
d. 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 endocrine effects as the Administrator may designate." Following recommendations of its
Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined
14
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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 EPA include evaluations of potential effects in wildlife. For pesticides, 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 Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the EDSP have
been developed, triethylene glycol may be subject to additional screening and/or testing to better
characterize effects related to endocrine disruption.
e. Cumulative Risks
Any risks summarized in this document are those that result only from the use of triethylene
glycol. The Food Quality Protection Act (FQPA) requires that the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The reason for consideration of other
substances is due to the possibility that low-level exposures to multiple chemical substances that
cause a common toxic effect by a common toxic mechanism could lead to the same adverse health
effect as would a higher level of exposure to any of the substances individually. 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 for triethylene
glycol. 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 http://www.epa.gov/pesticides/cumulative/.
2. Tolerance Summary
The tolerance exemption for residues of triethylene glycol per se is established under 40 CFR
180.920 (69 FR23124, Apr.28, 2004).
Tolerance Exemptions
The following tolerance exemption for triethylene glycol is listed in 40 CFR 180.920 (7/1/04):
Triethylene glycol is exempted from the requirement of a tolerance when used as an inert (or
occasionally active) ingredient in pesticide formulations applied to growing crops only as a
deactivator.
In addition to the above, triethylene glycol is approved by the Food and Drug
Administration as a preservative for food packaging adhesives as listed in 21 CFR 175.105.
15
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Triethylene glycol also has an indirect food additive regulation (21 CFR 177.1200) for its use as a
plasticizer in cellophane. However, this use is regulated solely by the Food and Drug
Administration (FDA).
a. Codex Harmonization
Currently there are no Codex MRLs established for triethylene glycol.
D. Regulatory Rationale
The Agency has determined triethylene glycol is eligible for reregistration. Based on the available
data, the Agency has concluded that triethylene glycol exhibits low toxicity and exposures to
triethylene glycol used as both an active or inert ingredient do not present risks of concern to the
Agency. Therefore, no mitigation measures are necessary at this time.
1. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal
agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat. To
jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or
distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act subsection (a)(2)
the Environmental Protection Agency, Office of Pesticide Programs has established procedures to
evaluate whether a proposed registration action may directly or indirectly reduce appreciably the
likelihood of both the survival and recovery of a listed species in the wild by reducing the
reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After the Agency's
screening-level risk assessment is performed, if any of the Agency's Listed Species LOG Criteria
are exceeded for either direct or indirect effects, a determination is made to identify if any listed or
candidate species may co-occur in the area of the proposed pesticide use. If determined that
listed or candidate species may be present in the proposed use areas, further biological assessment
is undertaken. The extent to which listed species may be at risk then determines the need for the
development of a more comprehensive consultation package as required by the Endangered
Species Act.
For certain use categories, the Agency assumes there will be minimal environmental exposure, and
only a minimal toxicity data set is required (Overview of the Ecological Risk Assessment Process
in the Office of Pesticide Programs U.S. Environmental Protection Agency - Endangered and
16
-------
Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, pg.81).
Chemicals in these categories therefore do not undergo a full screening-level risk assessment, and
are considered to fall under a "no effect" determination. Due to the low likelihood of exposure
and low toxicity of triethylene glycol, the Agency expects no effects to listed species or critical
habitat and therefore makes a "No Effect" determination for this chemical.
b. General Risk Mitigation
Triethylene glycol end-use products (EPs) may also contain other registered pesticides. Although
the Agency is not proposing any mitigation measures for products containing triethylene glycol
specific to federally listed species, the Agency needs to address potential risks from other end-use
products. Therefore, the Agency requires that users adopt all listed species risk mitigation
measures for all active ingredients in the product. If a product contains multiple active ingredients
with conflicting listed species risk mitigation measures, the more stringent measure(s) should be
adopted.
17
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V. WHAT REGISTRANTS NEED TO DO
The Agency has determined that triethylene glycol is eligible for reregistration. No additional
generic data are required at this time to support this decision.
For end use products containing the active ingredient triethylene glycol the registrant needs to
submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. completed response forms to the PDCI (i.e., PDCI response form and requirements
status and registrant's response form); and
2. submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. two copies of the confidential statement of formula (EPA Form 8570-4);
2. a completed original application for reregistration (EPA Form 8570-1). Indicate on the
form that it is an "application for reregistration";
3. a completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
4. if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
5. the product-specific data responding to the PDCI.
Please contact Marshall Swindell at (703) 308-6341 with questions regarding product
reregistration and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail:
Document Processing Desk (PDCI/PRB)
Marshall Swindell
US EPA (75IOC)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (PDCI/PRB)
Marshall Swindell
Office of Pesticide Programs (75 IOC)
Room 266A, Crystal Mall 2
1801 South Bell Street
Arlington, VA 22202
18
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A. Manufacturing-Use Products
There are no currently registered triethylene glycol manufacturing-use products.
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of triethylene glycol for the above eligible uses
has been reviewed and determined to be substantially complete. Therefore at this time, there are
no generic data requirements.
B. End-Use Products
1. Additional Product-Specific and Efficacy Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and if
not, commit to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each product.
The Agency considers the terms "sanitizer" and "sanitization" to be public health claims,
regardless of the use site or whether the specific organisms for which the product is efficacious
against are identified or not. This policy was reiterated in the proposed Part 152/156
Antimicrobial Registration Requirements, 64 FR 50672-50730, September 17, 1999. Upon
finalization of this proposed rulemaking, efficacy data will be required to support the continued
use of the term "air sanitizer" on the product label.
Until the proposed Product Performance Guidelines for proposed Part 152/15 are finalized,
testing requirements are being deferred for products of this type. Currently, efficacy requirements
are satisfied by the chemical formula statement showing appropriate glycol content. For products
containing at least 5% glycols (triethylene, dipropylene, and/or propylene glycols), quantitative
chemical determinations must be performed, using an air sampling device, to show the
concentration of glycol vapor achieved with the product in an enclosed experimental room or
chamber when used as directed.
A product-specific data call-in, outlining specific data requirements, will be issued shortly. In the
interim, no additional public health claims can be made unless supported by the appropriate
efficacy data.
19
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VI. APPENDICES
20
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Appendix A: Use Patterns Eligible for Reregistration
Use Categories:
(1) Agricultural premises and equipment
(2) Food handling/ storage establishments premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
(12) Aquatic areas
Use Site
Formulation
Application Rate (Range)
No. of Applications
Use Limitations
1. Agricultural Premises and Equipment - no registered uses for this pattern
2. Food Handling/Storage Establishments Premises and Equipment
Air Treatment (Eating
Establishments)
1. 10807-43 -
pressurized
liquid -
automatic
dispenser
1 . 7 ounce product
contains 3400 controlled
sprays that will last for 30
days when used on a 24
hour basis or 60 days if
used 12 hours per day
when set to dispense every
1 5 minutes (room size not
specified)
1 . information not
given on label
1 . do not use in
nurseries or rooms where
infants, ill or aged
patients are confined;
food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
21
-------
2. 10807-37 &
10807-24 -
pressurized
liquid - manual
spray
2. spray the room until a
light fog forms - spray 6 to
8 seconds in an average
room (10X10)
2. spray several times
per day
2. food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
3. Commercial, Institutional and Industrial Premises and Equipment
Commercial Premises &
equipment
Shower Room Premises
Air Treatment (Unspecified)
44446-20 -
pressurized
liquid - manual
spray
44446-20 -
pressurized
liquid - manual
spray
1. 9444-136-
pressurized
liquid -
automatic
dispenser
2. 4822-293-
pressurized
liquid - manual
spray
spray surface until
completely wet and allow
to remain wet for 10
minutes; for air sanitization
spray for three seconds
spray surface until
completely wet and allow
to remain wet for 10
minutes; for air sanitization
spray for three seconds
1 . metered valve actuates
every fifteen minutes - 7
ounce product treats a
room up to 30 X 20 X 10
2. spray upward in center
of room for 10 seconds in
average room of 12 X 12
X9)
information not given
on label
information not given
on label
1 . information not
given on label
2. information not
given on label
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
1 . do not contaminate
water, food or feed by
storage or disposal
2. avoid contact with
food and food utensils
22
-------
Laundry Equipment
44446-20 -
pressurized
liquid - manual
spray
spray surface until
completely wet and allow
to remain wet for 10
minutes
information not given
on label
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
Air Treatment (Locker Room)
1. 10807-43-
pressurized
liquid -
automatic
dispenser
1. 7 ounces of product
contains 3400 controlled
sprays that will last for 30
days when used on a 24
hour basis or 60 days if
used 12 hours per day
when set to dispense every
15 minutes (room size not
specified)
1. information not
given on label
1. do not use in
nurseries or rooms where
infants, ill or aged
patients are confined;
food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
2. 9444-19-
pressurized
liquid -
automatic
intermittent
aerosol
dispenser
2.6.2 ounces treats 6,000
cubic feet of closed air
space.
2. sprayed at intervals
2. do not contaminate
water, food or feed
3. 10807-37 &
10807-24-
pressurized
liquid - manual
spray
3. spray the room until a
light fog forms - spray 6 to
8 seconds in an average
room (10X10)
3. spray several times
per day
3. food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
23
-------
Locker Room Premises
44446-20 -
pressurized
liquid - manual
spray
spray surface until
completely wet and allow
to remain wet for 10
minutes or for air
sanitization spray for three
seconds
information not given
on label
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
Air Treatment (Institutional)
1. 51838-1 -
ready to use
solution-
automatic
dispenser
operation
1. 7 ounce product for
each 6,000 cubic feet of
closed air space
1. product sprayed at
intervals
1. avoid contamination
of food
2. 51838-1-
pressurized
liquid - for
manual
operation
2. fill average size room
with mist (approximately
15 sprays)
2. repeat application
several times daily
2. avoid contamination
of food
3. 10807-37 &
10807-24-
pressurized
liquid- manual
spray
3. spray the room until a
light fog forms - spray 6 to
8 seconds in an average
room (10X10)
3. spray several times
per day
3. food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
4. 4822-293-
pressurized
liquid - manual
spray
4. spray upward in center
of room for 10 seconds in
average room of 12 X 12
X9)
4. information not
given on label
4. avoid contact with
food and food utensils
24
-------
5. 4822-531-
pressurized
liquid - wall
mounted unit in
continuous
action aerosol
can
6. 44446-20-
pressurized
liquid - manual
spray
5. one second spray for a
9.5X9X7 room
6. spray for three seconds
5. information not
given on label
6. information not
given on label
5. do not position near
heat or electrical sources;
do not spray directly
onto surfaces; in case of
contact with surfaces,
wipe immediately with
damp cloth.
6. wash hands before
eating, drinking, chew-
ing gum, using tobacco,
or using the toilet
25
-------
7. 4822-531-
wall mounted
unit in metered
dose aerosol
can or
pressurized
liquid - hand
held unit
7. using a 120 1 valve
with .22 ounces of
product:
-1 time for 2.5X2.5X7
room
-2 times for 4X3X7
room
-3 times for 4.5X4X7
room
-4 times for 5X5X7
room
using a 185 1 valve-
-1 time for 3X3X7
room
-2 times for 4.5X4X7
room
-3timesfora5.5X5X7
room
4 times for a 6 X 6 X 7
room
7. information not
given on label
7. do not position near
heat or electrical sources;
do not spray directly
onto surfaces; in case of
contact with surfaces,
wipe immediately with
damp cloth.
. 10807-43-
pressurized
liquid -
automatic
dispenser
8. 7 ounce product
contains 3400 controlled
sprays that will last for 30
days when used on a 24
hour basis or 60 days if
used 12 hours per day
when set to dispense every
15 minutes (room size not
specified)
8. information not
given on label
8. do not use in
nurseries or rooms where
infants, ill or aged
patients are confined;
food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
26
-------
Air Treatment (Commercial)
1. 51838-1-
ready to use
solution - for
automatic
dispenser
operation
2. 51838-1-
ready to use
solution - for
manual
operation
3. 10807-43
pressurized
liquid-
automatic
dispenser
4. 10807-37 &
10807-24-
pressurized
liquid - manual
spray
1. 7 ounce product for
each 6,000 cubic feet of
closed air space
2. fill average size room
with mist (approximately
15 sprays)
3. 7 ounce product
contains 3400 controlled
sprays that will last for 30
days when used on a 24
hour basis or 60 days if
used 12 hours per day
when set to dispense every
15 minutes (room size not
specified)
4. spray the room until a
light fog forms - spray 6 to
8 seconds in an average
room (10X10)
1. product sprayed at
intervals
2. repeat application
several times daily
3. information not
given on label
4. spray several times
per day
1. avoid contamination
of food
2. avoid contamination
of food
3. do not use in
nurseries or rooms where
infants, ill or aged
patients are confined;
food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
4. food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
27
-------
5. 9444-19-
Pressurized
liquid -
automatic
intermittent
aerosol
dispenser
6. 4822-293 -
pressurized
liquid - manual
spray
7. 44446-20-
pressurized
liquid - manual
spray
8. 51838-2-
pressurized
liquid -
automatic
dispenser
5. 6.2 ounces of product
treats 6,000 cubic feet of
closed air space.
6. spray upward in center
of room for 10 seconds in
average room of 12 X 12
X9)
7. spray for three seconds
8. spray for one second
toward center of average
size room (10X14X8)
5. sprayed at intervals
6. information not
given on label
7. information not
given on label
8. repeat application
several times daily
5. do not contaminate
water, food or feed
6. avoid contact with
food and food utensils
7. wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
8. spray away from
drapes, walls, plastic,
vinyl, painted or
varnished surfaces
Air Treatment (Transp Facilities)
1. 51838-1-
ready to use
solution - for
automatic
dispenser
1. 7 ounces of product for
each 6,000 cubic feet of
closed air space
1. product sprayed at
intervals
1. avoid contamination
of food
2. 4822-293-
pressurized
liquid - manual
spray
2. spray upward in center
of room for 10 seconds in
average room of 12 X 12
X9
2. information not
given on label
2. avoid contact with
food and food utensils
28
-------
3. 10807-37 &
10807-24 -
pressurized
liquid - manual
spray
4. 51838-1-
ready to use
solution - for
manual
operation
3. spray the room until a
light fog forms - spray 6 to
8 seconds in an average
room (10X10)
4. fill average size room
with mist (approximately
15 sprays)
3. spray several times
per day
4. repeat application
several times daily
3. food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
4. avoid contamination
of food
Air Treatment (Industrial)
1. 51838-1-
ready to use
solution -
automatic
dispenser
1. 7 ounces of product for
each 6, 000 cubic feet of
closed air space
1. product sprayed at
intervals
1. avoid contamination
of food
2. 51838-1-
ready to use
solution - for
manual
operation
2. fill average size room
with mist (approximately
15 sprays)
2. repeat application
several times daily
2. avoid contamination
of food
3. 10807-37 &
10807-24-
pressurized
liquid - manual
spray
3. spray the room until a
light fog forms - spray 6 to
8 seconds in an average
room (10X10)
3. spray several times
per day
3. food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
29
-------
4. 10807-43-
pressurized
liquid -
automatic
dispenser
4. 7 ounces of product
contains 3400 controlled
sprays that will last for 30
days when used on a 24
hour basis or 60 days if
used 12 hours per day
when set to dispense every
1 5 minutes (room size not
specified)
4. information not
given on label
4. do not use in
nurseries or rooms where
infants, ill or aged
patients are confined;
food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
4. Residential and Public Access Premises
Air Treatment (Unspecified)
Household (Premises & Contents)
1. 9444-136-
pressurized
liquid -
automatic
dispenser
2. 4822-293-
pressurized
liquid - manual
spray
44446-20-
pressurized
liquid - manual
spray
1 . metered valve actuates
every fifteen minutes - 7
ounce product treats a
room up to 30 X 20 X 10
2. spray upward in center
of room for 10 seconds in
average room of 12 X 12
X9)
spray surface until
completely wet and allow
to remain wet for 10
minutes or for air
sanitization spray for three
seconds
1 . information not
given on label
2. information not
given on label
information not given
on label
1 . do not contaminate
water, food or feed by
storage or disposal
2. avoid contact with
food and food utensils
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
30
-------
Air treatments
(commercial/household)
4822-531-
pressurized
liquid - wall
mounted unit in
metered dose
aerosol can or
hand held unit
using a 120 1 valve with
.22 ounces of product:
-1 time for 2.5X2.5X7
room
-2 times for 4X3X7
room
-3 times for 4.5X4X7
room
-4 times for 5X5X7
room
using a 185 1 valve-
-1 time for 3X3X7
room
-2 times for 4.5X4X7
room
-3timesfora5.5X5X7
room
4 times for a 6 X 6 X 7
room
information not given
on label
do not position near heat
or electrical sources; do
not spray directly onto
surfaces; in case of
contact with surfaces,
wipe immediately with
damp cloth.
Laundry Equipment
44446-20 -
pressurized
liquid - manual
spray
spray surface until
completely wet and allow
to remain wet for 10
minutes
information not given
on label
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toile
Automobiles
44446-20 -
pressurized
liquid - manual
spray
spray into air conditioning
system and spray for four
to six seconds
information not given
on label
shut off air conditioner
after applying the
product; wash hands
before eating, drinking,
chewing gum, using
tobacco, or using the
toilet
31
-------
Shower Room Premises
44446-20 -
pressurized
liquid - manual
spray
spray surface until
completely wet and allow
to remain wet for 10
minutes or for air
sanitization spray for three
seconds
information not given
on label
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
Hard Nonporous Surface
44446-20 -
pressurized
liquid - manual
spray
spray surface until
completely wet and allow
to remain wet for 10
minutes
information not given
on label
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
Environmental Inanimate Hard
Surfaces
44446-20 -
pressurized
liquid - manual
spray
spray surface until
completely wet and allow
to remain wet for 10
minutes
information not given
on label
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
Garbage Storage Premises &
Containers
44446-20 -
pressurized
liquid - manual
spray
spray surface until
completely wet and allow
to remain wet for 10
minutes or for air
sanitization spray for three
seconds
information not given
on label
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
Bathroom Premises
44446-20 -
pressurized
liquid - manual
spray
spray surface until
completely wet and allow
to remain wet for 10
minutes or for air
sanitization spray for three
seconds
information not given
on label
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
32
-------
Air Treatment (Bathroom)
1. 10807-43-
pressurized
liquid -
automatic
dispenser
2. 9444-19-
pressurized
liquid -
automatic
intermittent
aerosol
dispenser
3. 44446-20-
pressurized
liquid - manual
spray
4. 10807-37-
pressurized
liquid - manual
spray
1. 7 ounces of product
contains 3400 controlled
sprays that will last for 30
days when used on a 24
hour basis or 60 days if
used 12 hours per day
when set to dispense every
15 minutes (room size not
specified)
2. 6.2 ounce of product
treats 6,000 cubic feet of
closed air space.
3. spray for three seconds
4. spray the room until a
light fog forms - spray 6 to
8 seconds in an average
room (10X10)
1. information not
given on label
2. sprayed at intervals
3. information not
given on label
4. spray several times
per day
1. do not use in
nurseries or rooms where
infants, ill or aged
patients are confined;
food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
2. do not contaminate
water, food or feed
3. wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
4. food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
33
-------
5. 51838-1-
pressurized
liquid - manual
operation
5. fill average size room
with mist (approximately
15 sprays)
5. repeat application
several times daily
5. avoid contamination
of food
6. 4822-293 -
pressurized
liquid - manual
spray
6. spray upward in center
of room for 10 seconds in
average room of 12 X 12
X9
6. information not
given on label
6. avoid contact with
food and food utensils
7. 4822-531-
pressurized
liquid - wall
mounted unit in
continuous
action aerosol
can
7. one second spray for a
9.5X9X7 room
7. information not
given on label
7. information not given
on label
8. 10807-24-
pressurized
liquid- manual
spray
8. spray the room until a
light fog forms - spray 6 to
8 seconds in an average
room (10X10)
8. spray several times
per day
8. food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
34
-------
9. 4822-531-
wall mounted
unit in metered
dose aerosol
can or
pressurized
liquid - hand
held unit
9. using a 120 1 valve
with .22 ounces of
product:
-1 time for 2.5X2.5X7
room
-2 times for 4X3X7
room
-3 times for 4.5X4X7
room
-4 times for 5X5X7
room
using a 185 1 valve-
-1 time for 3X3X7
room
-2 times for 4.5X4X7
room
-3timesfora5.5X5X7
room
4 times for a 6 X 6 X 7
room
9. information not
given on label
9. information not given
on label
Locker Room Premises
44446-20 -
pressurized
liquid - manual
spray
spray surface until
completely wet and allow
to remain wet for 10
minutes or for air
sanitization spray for three
seconds
information not given
on label
wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
35
-------
Air Treatment (Locker Room)
1. 10807-43-
pressurized
liquid -
automatic
dispenser
2. 9444-19-
pressurized
liquid -
automatic
intermittent
aerosol
dispenser
3. 10807-37 &
10807-24-
pressurized
liquid - manual
spray
1. 7 ounces of product
contains 3400 controlled
sprays that will last for 30
days when used on a 24
hour basis or 60 days if
used 12 hours per day
when set to dispense every
15 minutes (room size not
specified)
2.6.2 ounces treats 6,000
cubic feet of closed air
space.
3. spray the room until a
light fog forms - spray 6 to
8 seconds in an average
room (10X10)
1. information not
given on label
2. sprayed at intervals
3. spray several times
per day
1. do not use in
nurseries or rooms where
infants, ill or aged
patients are confined;
food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
2. do not contaminate
water, food or feed
3. food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
Birds (Caged) (Animal Treatment)
11715-20-
pressurized
liquid- manual
spray
spray lightly with one burst
of 2 or 3 seconds
no more than 2 times
per week
information not given on
label
36
-------
Pet Bird Cages (Enclosed Premise
Treatment)
11715-20-
pressurized
liquid-manual
spray
thoroughly spray perches
and cage
regular intervals
information not given on
label
Air Treatment (Pet Kennels &
Enclosed Premise Treatment)
1. 4822-531-
pressurized
liquid - wall
mounted unit in
metered dose
aerosol can or
hand held unit
1. using a 120 1 valve
with .22 ounces of
product:
-1 time for 2.5X2.5X7
room
-2 times for 4X3X7
room
-3 times for 4.5X4X7
room
-4 times for 5X5X7
room
using a 185 1 valve-
-1 time for 3X3X7
room
-2 times for 4.5X4X7
room
-3timesfora5.5X5X7
room
4 times for a 6 X 6 X 7
room
1. information not
given on label
1. do not position near
heat or electrical sources;
do not spray directly
onto surfaces; in case of
contact with surfaces,
wipe immediately with
damp cloth.
37
-------
2. 4822-531-
pressurized
liquid - wall
mounted unit in
continuous
action aerosol
can
3. 4822-293-
pressurized
liquid - manual
spray
2. one second spray for a
9.5X9X7 room
3 . spray upward in center
of room for 10 seconds in
average room of 12 X 12
X9
2. information not
given on label
3 . information not
given on label
2. information not given
on label
3 . avoid contact with
food and food utensils
38
-------
5. Medical premises and equipment
Air treatments (sickroom)
1. 4822-531-
pressurized
liquid - wall
mounted unit in
metered dose
aerosol can or
hand held unit
2. 4822-531-
pressurized
liquid - wall
mounted unit in
continuous
action aerosol
can
1. using a 120 1 valve
with .22 ounces of
product:
-1 time for 2.5X2.5X7
room
-2 times for 4X3X7
room
-3 times for 4.5X4X7
room
-4 times for 5X5X7
room
using a 185 1 valve-
-1 time for 3X3X7
room
-2 times for 4.5X4X7
room
-3timesfora5.5X5X7
room
4 times for a 6 X 6 X 7
room
2. one second spray for a
9.5X9X7 room
1. information not
given on label
2. information not
given on label
1. do not position near
heat or electrical sources;
do not spray directly
onto surfaces; in case of
contact with surfaces,
wipe immediately with
damp cloth.
2. information not given
on label
39
-------
Air treatment (hospital)
1. 51838-2-
pressurized
liquid- manual
spray
2. 51838-1-
ready to use
solution -
automatic
dispenser
3. 51838-1-
ready to use
solution - for
manual
operation
4. 10807-37 &
10807-24 -
pressurized
liquid - manual
spray
5. 4822-293 -
pressurized
liquid - manual
spray
1. spray for one second
toward center of average
size room (10 X 14X8)
2. 7 ounces of product for
each 6, 000 cubic feet of
closed air space
3. fill average size room
with mist (approximately
15 sprays)
4. spray the room until a
light fog forms - spray 6 to
8 seconds in an average
room (10X10)
5. spray upward in center
of room for 10 seconds in
average room of 12 X 12
X9
1. repeat application
several times daily
2. product sprayed at
intervals
3. repeat application
several times daily
4. spray several times
per day
5. information not
given on label
1. spray away from
drapes, walls, plastic,
vinyl, painted or
varnished surfaces
2. avoid contamination
of food
3. avoid contamination
of food
4. food, food contact
surfaces and utensils
should be protected from
exposure to the spray or
rinsed with potable water
before use
5. avoid contact with
food and food utensils
6. 44446-20-
pressurized
liquid - manual
spray
6. spray for three seconds
6. information not
given on label
6. wash hands before
eating, drinking, chewing
gum, using tobacco, or
using the toilet
40
-------
7. 9444-19-
pressurized
liquid -
automatic
intermittent
aerosol
dispenser
7. 6.2 ounces of product
treats 6,000 cubic feet of
closed air space
7. sprayed at intervals
7. do not contaminate
water, food or feed
Hospital (Premises and Materials)
44446-20-
pressurized
liquid -manual
spray
decontamination against
HIV-1 of surfaces/objects
soiled with blood/body
fluids - 1800 ppm of active
quaternary water for a
contact time of 10 minutes
at room temperature - use
a 10 minute contact time
for disinfection against all
other bacteria and fungi
claimed
information not given
on label
dispose of infectious
materials according to
federal, state and local
regulations
41
-------
Appendix B: Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision
Guide To Appendix B
Appendix B lists the generic (not product specific) data requirements which support the re-registration of Triethylene Glycol (TEG).
These requirements apply to TEG in all products, including data requirements for which a technical grade active ingredient is the test
substance. The data table is organized in the following formats:
1. Data Requirement (Columns 1 and 2). The data requirements are listed by Guideline Number. The first column lists the
new Part 158 Guideline numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has
an associated test protocol set forth in the Pesticide Assessment Guidance, which are available on the EPA website.
2. Guideline Description (Column 3). Identifies the guideline type.
3. Use Pattern (Column 4). This column indicates the standard Antimicrobial Division use patterns categories for which the
generic (not product specific) data requirements apply. The number designations are used in Appendix B.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishments premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
(12) Aquatic areas
4. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this
column will identify each study by a "Master Record Identification (MRID) number. The listed studies are considered "valid"
and acceptable for satisfying the Guideline requirement. Refer to the Bibliography appendix for a complete citation of each
study.
42
-------
DATA REQUIREMENT
New
Guideline
Number
Old
Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
61-1
6 1-2 A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
42814401 and 422 11 801
42814401
42814401
42814402
42814402
42814402
42814403 and 422 11 801
42814403 and 422 11 801
42814403 and 422 11 801
not required
42814403
42814403
43
-------
DATA REQUIREMENT
New
Guideline
Number
830.7840
830.7860
830.7950
830.7370
830.7550
830.7560
830.7570
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
Old
Guideline
Number
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Study Title
Solubility
Vapor Pressure
Dissociation Constant in Water
Partition Coefficient (Octanol/Water)
PH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Use Pattern
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
CITATION(S)
MRID Number
42814403
42814403
waived
42814403
42814401; 42211801;
42814403
42814401; 42211801;
42814403
42814403
42814403
42814403
42814403
42814403
42814403
42814403
44
-------
DATA REQUIREMENT
New
Guideline
Number
830.6321
Old
Guideline
Number
63-21
Study Title
Dielectric breakdown voltage
Use Pattern
2,3,4,5
CITATION(S)
MRID Number
42814403
ECOLOGICAL EFFECTS
850.2100
850.1075
850.1075
850.1010
71-1
72-1 C
72-1 C
72-2A
Avian Acute Oral Toxicity Test - Quail/duck
Fish Acute Toxicity - Rainbow Trout
Fish Acute Toxicity - Fathead Minnow
Acute Aquatic Invertebrate Toxicity
All
All
All
All
waived due to high
volatility and low toxicity
waived due to high
volatility and low toxicity
waived due to high
volatility and low toxicity
waived due to high
volatility and low toxicity
45
-------
DATA REQUIREMENT
New
Guideline
Number
non-
guideline
Old
Guideline
Number
non-
guideline
Study Title
Other published literature/extraneous submissions:
1. Mysid (Mysidopsis bahia)- 96-hour static acute; toxicity
LC50= 1 1,000 ppm
2. Sheepshead minnow (Cyprinodon variegatus) - 96-hour
static acute; toxicity LC50 = 48,000 ppm
3 . Bluegill sunfish (Lepomis macrochirus) - 96 hour static
acute; toxicity LC50 > 10,000 ppm
4. Menidia beryllina - 96 hour static; toxicity LC50 >
10,000 ppm
5. Fathead minnow (Pimephales promelas) - 96 hour flow-
through; toxicity - LC 50 59,900 - 77,400 ppm
Use Pattern
n/a
CITATION(S)
MRID Number
The below list not required
for current uses; available
in open literature:
1.40228401
2. 40228401
3 . Open Literature
4. Open Literature
5. Open Literature
TOXICOLOGY
870.1100
870.1200
870.1300
81-1
81-2
81-3
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
2,3,4,5
2,3,4,5
2,3,4,5
4281 4404 & Open
Literature
waived
OTS 527779-2
(Nachreiner, D.J., 1991)
46
-------
DATA REQUIREMENT
New
Guideline
Number
870.2400
870.2500
870.2600
870.3100
870.3250
870.3465
870.4100
870.4100
870.4300
Old
Guideline
Number
81-4
81-5
81-6
82- la
82-3*
82-4*
83-la
83-lb
83-5
Study Title
Acute Eye Irritation - Rabbit
Acute Skin Irritation - Rabbit
Dermal Sensitization
90-Day Oral Subchronic -Rat
21 -Day Subchronic Dermal
90-Day Subchronic Inhalation
Chronic Toxicity - rat
Chronic Toxicity - non-rodent
Combined Chronic Toxicity/Carcinogenicity - rat
Use Pattern
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
CITATION(S)
MRID Number
42814404
42814404
4281 4404 & Open
Literature
Open Literature & OTS
0527779-1 (Union
Carbide, 1989 and Union
Carbide, 1990)
4281 4404 & Open
Literature
OTS 0537563-1 (Norris, J.
and W. Kintigh, 1994 &
Sun, J. and W. Kintigh,
1993)
satisfied by guideline
870.4300
4281 4404 & Open
Literature
4281 4404 & Open
Literature
47
-------
DATA REQUIREMENT
New
Guideline
Number
870.3700
870.3700
870.3800
870.5100
870.5300
870.5375
870.5900
870.7485
Old
Guideline
Number
83-3a
83-3b
83-4**
84-2
84-2
84-2
84-2
85-1
Study Title
Prenatal Developmental Toxicity - Rat
Prenatal Developmental Toxicity - Rabbit
Reproduction and fertility effects - Rat
Bacterial Reverse Mutation Test
In Vitro Mammalian Cell Gene Aberration Test
In Vitro Mammalian Chromosome Aberration Test
In Vitro Sister Chromatid Exchange
Metabolism and Pharmocokinetics
Use Pattern
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
2,3,4,5
CITATION(S)
MRID Number
428 14404 &OTS
7527779-4 (Union
Carbide, 1991)
42814404
4281 4404 & Open
Literature
OTS 50527779-1
OTS 50527779-1
OTS 50527779-1
OTS 50527779-1
42814404
*For guidelines 82-3 and 82-4, at least one is required to be fulfilled; not both (for both food and non-food uses).
**Only required for food use.
ENVIRONMENTAL FATE
835.2120
161-1
Hydrolysis of Parent and Degradates
2,3,4,5
waived
Please Note: Although the Open Literature studies do not satisfy any of the Agency's testing guideline requirements, this information is
considered adequate for characterizing the potential hazard from exposure to triethylene glycol. Therefore, no additional mammalian
toxicity data will be required at this time.
48
-------
Appendix C: Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket, located in
Room 119, Crystal Mall #2, 1801 South Bell Street, Arlington, VA 22202. It is open Monday
through Friday, excluding legal holidays, from 8:30 am to 4:00 pm.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site: http://www.epa.gov/edocket
These documents include:
• Triethylene Glycol (TEG): Antimicrobials Division's Review of the Disciplinary Sciences
for Issuance of the Reregistration Eligibility Decision (RED) Document. Reregistration
Case No.: 3146, PC Code: 083501. CAS Registry No.: 112-27-6
• Triethylene Glycol- Revised Report of the Antimicrobials Division Toxicology Endpoint
Selection Committee. PC Code 083501, Case 3146, Antimicrobials Division, 11/21/05,
Timothy F. McMahon, Ph.D., Chair, ADTC
Product Chemistry Science Chapter. PC Code 083501, Case 3146, Antimicrobials
Division, 8/13/03, A. Najm Shamim, Ph.D., Chemist
• Environmental Fate Studies and Environmental Fate Assessment. PC Code 083501, Case
3146, Antimicrobials Division, 8/13/03, A. Najm Shamim, Ph.D.
• Revised Toxicology Disciplinary Chapter. PC Code 083501, Case 3146, Antimicrobials
Division, 10/11/05, Michelle Centra
• Occupational and Residential Exposure. PC Code 083501, Case No. 3146, Antimicrobials
Division, 5/24/05, Timothy Leighton, Environmental Scientist
Ecological Hazard and Environmental Risk Characterization. PC Code 083501, Case
3146, Antimicrobials Division, 8/4/04, Kathryn Montague, M.S.
• Review of Phase IV Response Submissions in Support of FIFRA 88. Memorandum: G.
Reddy, 12/22/93
• Triethylene Glycol: Incident Report Assessment for the Reregistration Eligibility Decision
(RED) Document. PC Code: 083501. Case No. 3146 (Memorandum: J. Chen, 9/22/03).
• Triethylene Glycol Estimated Drinking Water Concentrations (Memorandum: S. Abel,
9/26/03).
Appendix D: Bibliography Citations
49
-------
MRID Number
Citation
40228401
42211801
42814404
42814401
42814402
42814403
Mayer, F.L. (1986) Acute Toxicity Handbook of Chemicals to
Estuarine Organisms. Prepared by U. S. EPA Office of Research and
Development, Environmental Research Laboratory, Gulf Breeze, FLA
EPA/600/X-3 6/231.
Reed, G. (1992) Product Chemistry Data: Ozium Glycolized Air
Sanitizer. Unpublished study prepared by Blue Coral, Inc. 10 p.
Davis, K.(1993) Compilation of Toxicology Data References for
Triethylene Glycol: Lab Project Number: TEGTOX. Unpublished
study prepared by RegWest Co. 131 p.
Davis, K. (1993) Product Chemistry Data of Triethylene Glycol: Lab
Project Number: TEG61. Unpublished study prepared by RegWest Co.
6 p.
Davis, K. (1993) Product Chemistry Data of Triethylene Glycol: Lab
Project Number: TEG62. Unpublished study prepared by RegWest Co.
13 p.
Davis, K. (1993) Physical & Chemical Characteristics of Triethylene
Glycol: Lab Project Number: TEG63. Unpublished study prepared by
RegWest Co. 91 p.
EPA ID Document Number
OTS0527779-1
OTS0527779-1
OTS0527779-1
Guzzie, P., Slesinski, F. Frank, et al. (1986a) Triethylene Glycol
Salmonella/Micro some (Ames) Bacterial Mutagenicity Assay. Bushy
Run Research Center, Export, PA. Project Report 49-58. April 29,
1986. NTIS Report No. OTS0527779-1. Unpublished.
Guzzie, P., Slesinski, F. Frank, et al. (1986b) Triethylene Glycol:/w
vitro Chromosome Aberration Study. Bushy Run Research Center,
Export, PA. Project Report 49-82. July 1, 1986. NTIS Report No.
OTS0527779-1. Unpublished.
Slensinski, R., F. Frank, and P. Guzzie (1986a) Triethylene Glycol:/w
vitro Genotoxicity Studies: CHO/HGPRT Mutation Test; Sister
Chromatid Exchange Assay. Bushy Run Research Center, Export, PA.
50
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OTS0527779-1
OTS0527779-1
OTS0527779-1
OTS0527779-1
OTS0527779-2
OTS0527779-4
OTS0537563-1
OTS0537563-1
Project Report 49-83. June 26, 1986. NTIS Report No.
OTS0527779-1. Unpublished.
Slensinski, R., F. Frank, and P. Guzzie (1986b) Triethylene Glycol: In
vitro Mammalian Cell Gene Mutation Assay in CHO Cells. Bushy Run
Research Center, Export, PA. Project Report 49-82. June 26, 1986.
NTIS Report No. OTS0527779-1. Unpublished.
Union Carbide (1989) Triethylene Glycol: Fourteen-day Dietary
Toxicity Study in Fischer 344 Rats. NTIS Report No. OTS0527779-1.
Unpublished.
Union Carbide (1990a) Triethylene Glycol: Ninety-day Dietary Toxicity
Study in Fischer 344 Rats. NTIS Report No. OTS0527779-1.
Unpublished.
Union Carbide (1990b) Developmental Toxicity Study of Triethylene
Glycol Administered by Gavage to CD-I Mice. NTIS Report No.
OTS0527779-1. Unpublished.
Nachreiner, D.J. (1991) Triethylene Glycol (TEG) Acute Aerosol
Inhalation Toxicity Test in Rats. Bushy Run Research Center; Project
Report 53-139 (BRCC No. 90-22-40272), March 4, 1991; NTIS
Report No. OTS0527779-2. Unpublished.
Union Carbide (1991) Developmental Toxicity Study of Triethylene
Glycol Administered by Gavage to CD (Sprague-Dawley) Rats. NTIS
Report No. OTS0527779-4. Unpublished.
Norris, J. and W. Kintigh (1994) Triethylene Glycol: Nine-day Aerosol
Inhalation (Nose-only Exposure) toxicity study in Rats. Bushy Run
Research Center, Union Carbide Corporation, Inc., Export, PA.
Laboratory Project ID: 93U1293, October 26, 1994. NTIS Report No.
OTS0537563-1. Unpublished.
Sun, J. and W. Kintigh (1992) Triethylene Glycol: Nine-day Aerosol
Inhalation study in Rats. Bushy Run Research Center, Union Carbide
Chemicals and Plastics Company, Inc., Export, PA. Laboratory Project
ID: 91U0027, December 14, 1992. NTIS Report No. OTS0537563-1
with cover letter dated 010693 (1992). Unpublished.
Open Literature Citations
51
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Bossert, N.L., et al. (1992) Reproductive Toxicity of Triethylene Glycol and its Diacetate
and Dimethyl ether Derivatives in a Continuous Breeding Protocol in Swiss CD-I
mice. Fund. Appl. Pharmacol. 18: 602-608.
Budavari, S., MJ. O'Neill, A. Smith, and P.E. Heckelman (eds.)1989. The Merck Index:
An Encyclopedia of Chemicals, Drugs, and Biologicals. Rahway (eleventh
edition), NJ: Merck & Co., Inc.
Clayton, G.D. and F.E. Clayton (eds.). Patty's Industrial Hygiene and Toxicology:
Volume 2A, 2B, 2C: Toxicology. 3rd ed. New York: John Wiley Sons, 1981-
1982. 3839.
Fitzhugh, O.G. and Nelson, A. A. (1946) Comparison of the Chronic Toxicity of
Triethylene Glycol with that of Diethylene Glycol. J. Ind. Hyg. Toxicol. 28(2): 40-
43.
Geiger, D.L., Call, D.J., and Brooke, L.T. (Eds). 1988. Acute Toxicities of Organic
Chemicals to Fathead Minnows (Pimephales promelas). Vol. IV. Superior
Wisconsin: University of Wisconsin-Superior. 131.
Goldstein, I, et al. (1970) Toxicity of Glycol Derivatives. Igenia, 19: 209.
Guillot, J.P., et al. (1982) Safety Evaluation of Some Humectants and Moisturizers Used
in Cosmetic Formulations. International J. Cosmetic Sci., 4: 67.
Handbook of Environmental Fate: Fate and Exposure Data For Organic Chemicals,
Volume IV, Solvents 2. Philip H. Howard, Lewis Publishers, 1989, pp 546.
Handbook of Physics and Chemistry, 64th edition (CRC Press). Product Chemistry Data
for Triethylene Glycol, 1983.
Hazard Substances Databank (HSDB), A Database of the National Library of Medicine's
TOXNET System; Product Chemistry Data for Triethylene Glycol, 2003.
Lamb, IV. et al. (1997) Triethylene Glycol. Environ. Health Perspectives, 105(Suppl 1):
235-236. Also available as an NTP Report No. PB85-137073.
Lauter, W.M. and V.L. Vria (1940) Toxicity of Triethylene Glycol and the Effect of Para-
amino-benzene Sulfonamide Upon the Toxicity of this Glycol. J. Am.
Pharmaceutical Assoc. 29: 5-8.
McKennis, Jr., et al. (1962) The Excretion and Metabolism of Triethylene Glycol. Toxic.
52
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Appl. Pharmacol, 91: 52.
Robertson, O.H., et al. (1947) Tests for the Chronic Toxicity of Propylene Glycol and
Triethylene Glycol on Monkeys and Rats by vapor inhalation and Oral
Administration. J. Pharm. Exp. Then, 91: 52.
Smyth, H.F. et al (1941) The single dose toxicity of some glycol derivatives. J. Ind. Hyg.
Toxicol. 23(6): 259-268.
Stenger, E.G., er al. (1968) Zur Toxikologie des Triathylenglkol. Arzneimittel-Forsch,
18: 1536.
Verschuren, K. 1983. Handbook of Environmental Data of Organic Chemicals. 2nd ed.
New York, NY: Van Nostrand Reinhold Co. 1153.
Supporting Documentation
NIH. 2003. NIH's Hazard Substances Databank (HSDB), A Database of the National
Library of Medicine's TOXNET System. http://www.nih.gov/TOXNET
USEPA. 1997. Pesticide Handler Exposure Database (PHED, Version 1.1), Surrogate
Exposure Guide; Estimates of Worker Exposure, May 1997.
USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial
Exposure Assessment Study. Memorandum from Siroos Mostaghimi, Ph.D., to
Julie Fairfax; dated November 4, 1999.
USEPA. 2003. Estimation of Physical/Chemical Properties Program.
http ://www. epa. gov/oppt/exposure/docs/episuitedl.htm
USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of
Pesticide Programs U.S. Environmental Protection Agency - Endangered and
Threatened Species Effects Determinations, January 24, 04, Appendix A, Section
IIB, pg.81. http://www.epa.gov/oppfead 1/endanger/consultation/ecorisk-
overview.pdf
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Appendix E: Generic Data Call-In
The Agency does not intend to issue a Generic Data Call-In at this time.
54
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Appendix F: Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date.
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Appendix G: Batching of End-Use Products
Antimicrobial Division's Batching of Products Containing Triethylene Glycol as the Active
Ingredient for Meeting Acute Toxicity Data Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity
data requirements for reregistration of products containing the active ingredient triethylene glycol,
the Agency has batched products which can be considered similar in terms of acute toxicity. (The
PC Code of triethylene glycol is 083501; the CAS Number is 112-27-6.) Factors considered in
the sorting process include each product's active and inert ingredients (identity, percent
composition and biological activity), product form (liquid, paste, solid, etc.), labeling (e.g., signal
word, precautionary labeling, etc.) and acute toxicity data.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single set of six acute toxicity studies to represent all the products within that batch. Registrants
have the option of participating with all or some other registrants of products in their product's
batch, to deal only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data
for a batch, he or she must use one of the products within the batch as the test material. If a
registrant chooses to rely upon previously submitted acute toxicity data, he or she may do so
provided that the data base is complete and valid by today's standards (see the attached
acceptance criteria), the formulation tested is considered by EPA to be similar in terms of acute
toxicity, and the formulation has not been significantly altered since submission and acceptance of
the acute toxicity data. Registrants may not support their product using data conducted on a
product from a different batch, unless this batching appendix specifically states so. The
Antimicrobials Division must approve any new or canceled formulations (that were presented to
the Agency after the publication of the RED) before data derived from them can be used to cover
other products in a batch. Regardless of whether new data is generated or existing data is
referenced, registrants must clearly identify the test material by EPA Registration Number. If
more than one confidential statement of formula (CSF) exists for a product, the registrant must
indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In (DCI) Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he or she will provide the data or depend on someone else to do so. If a registrant
supplies the data to support a batch of products, he or she must select one of the following
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options: Developing New Data (Option 1), Submitting an Existing Study (Option 4), Upgrading
an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on
another's data, he or she must choose among: Cost Sharing (Option 2), Offers to Cost Share
(Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to participate in a
batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not
to participate in a batch does not preclude other registrants in the batch from citing his or her
studies and offering to cost share (Option 3) those studies.
If a registrant would like to have the batching status of a product reconsidered, they need to
submit detailed information on their product, including a detailed rationale for the inclusion of
their product into a batch. An MSDS for each "inert" ingredient should be included where
possible. However, registrants and manufacturers should realize that the more unique their
formulation is, the less likely it is to be able to batch that product. AD/PSB notes that there were
no registered Technical Grade Active Ingredient (TGAI) products to be reviewed in this batching
chapter.
Table 1 displays the batch for the active ingredient Triethylene Glycol.
Table 1.
Batch
1
2
Registration
Number
51838-1
51838-2
4822-293
4822-531
Percent Active Ingredient
Triethylene Glycol .
Propylene Glycol .
Triethylene Glycol
Propylene Glycol
Triethylene Glycol .
Triethylene Glycol .
. 4.4%
. 4.4%
.. 4.4%
.. 4.4%
. 6.0%
. 6.0%
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Table 2 lists the products in the "No Batch" group. These products can not be batched because they
were not considered to be similar to other the products in terms of acute toxicity or because there
was insufficient information available to assist in making the decision.
Table 2. The "No Batch Group" of Products Containing Triethylene Glycol as an Active
Ingredient
Registration
Number
9444-19
9444-136
10807-24
10807-37
10807-43
11715-20
44446-20
Percent Active Ingredient
Triethylene Glycol ...6.000%
Dipropylene Glycol... 4.000%
n-Alkyl dimethyl benzyl ammonium chloride ... 0.20%
Triethylene Glycol... 9.15%
Dipropylene Glycol... 3.43%
n-Alkyl dimethyl benzyl ammonium chloride
0.17%
Triethylene Glycol... 4.5%
Propylene Glycol ...3.0%
n-Alkyl dimethyl benzyl ammonium chloride ... 0.10%
Triethylene Glycol... 3.00%
Dipropylene Glycol... 3.00%
n-Alkyl dimethyl benzyl ammonium chloride ... 0.10%
n-Alkyl dimethyl ethylbenzyl ammonium chloride ... 0.10%
Triethylene Glycol... 7.7%
Propylene Glycol ... 5.13%
n-Alkyl dimethyl benzyl ammonium chloride
0.17%
Triethylene Glycol... 0.10%
Propylene Glycol ...0.10%
Pyrethrins ... 0.09%
Piperonyl butoxide ... 0.18%
n-Octyl bicycloheptene dicarboximide ... 0.30%
Triethylene Glycol... 6.00%
n-Alkyl dimethyl ammonium chloride ... 0.10%
n-Alkyl dimethyl ethylbenzyl ammonium chloride
Isopropanol... 50.20%
0.10%
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Appendix H: List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in will be posted at a later date.
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Appendix I: List of Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /forms/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled
out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing
policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing
Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551
or by e-mail at williams.nicole@epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet at the
following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
Application for Pesticide
Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide
Product
Application for an Experimental Use
Permit
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
http ://www. epa. sov/opprdOO 1 /for
ms/8570-l.pdf
http ://www. epa. sov/opprdOO 1 /for
ms/8570-4.pdf
http ://www. epa. sov/opprdOO 1 /for
ms/8570-5.pdf
http ://www. epa. sov/opprdOO 1 /for
ms/8570-17.pdf
http ://www. epa. sov/opprdOO 1 /for
ms/8570-25.pdf
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8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Formulator's Exemption Statement
Certification of Compliance with Data
Gap Procedures
Pesticide Registration Maintenance Fee
Filing
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of
Data (PR Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical
Properties (PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR Notice
98-1)
http ://www. epa. sov/opprdOO 1 /for
ms/8570-27.pdf
http ://www. epa. sov/opprdOO 1 /for
ms/8570-28.pdf
http ://www. epa. sov/opprdOO 1 /for
ms/8570-30.pdf
http ://www. epa. sov/opprdOO 1 /for
ms/8570-32.pdf
http ://www. epa. sov/opppmsd 1 /P
R Notices/pr98-5.pdf
http ://www. epa. sov/opppmsd 1 /P
R Notices/pr98-5.pdf
http ://www. epa. sov/opppmsd 1 /P
R Notices/pr98-l.pdf
http ://www. epa. sov/opppmsd 1 /P
R Notices/pr98-l.pdf
Pesticide Registration Kit
www. epa. sov/pesticides/resistrationkit/
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Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA)
of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader).
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
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Before submitting your application for registration, you may wish to consult some additional sources
of information. These include:
1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States", PB92-221811, available through the National Technical Information Service (NTIS)
at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does charge a
fee for subscriptions and custom searches. You can contact NPIRS by telephone at (765)
494-6614 or through their website.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on
active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by
telephone at (800) 858-7378 or through their website: http://npic.orst.edu/
The Agency will return a notice of receipt of an application for registration or amended registration,
experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his
submission a stamped, self-addressed postcard. The postcard must contain the following entries to be
completed by OPP:
1. Date of receipt;
2. EPA identifying number; and
3. Product Manager assignment.
Other identifying information may be included by the applicant to link the acknowledgment of
receipt to the specific application submitted. EPA will stamp the date of receipt and provide the EPA
identifying file symbol or petition number for the new submission. The identifying number should be
used whenever you contact the Agency concerning an application for registration, experimental use
permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names, company
experimental codes, and other names which identify the chemical (including "blind" codes used when
a sample was submitted for testing by commercial or academic facilities). Please provide a chemical
abstract system (CAS) number if one has been assigned.
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