United States Prevention, Pesticides EPA-738-R-97-004

Environmental Protection And Toxic Substances April 1997

Agency (7508W)

Reregistration

EligibilityDecision(RED)

1,3,5-Triethylhexahydro-s-triazine

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

CERTIFIED MAIL

Dear Registrant:

I am pleased to announce that the Environmental Protection Agency has completed its

reregistration eligibility review and decisions on the pesticide chemical case 3147 which

contains the active ingredient 1,3,5-Triethylhexahydro-s-triazine. The enclosed Reregistration

Eligibility Decision (RED) contains the Agency's evaluation of the data base of this chemical,

its conclusions of the potential human health and environmental risks of the current product

uses, and its decisions and conditions under which these uses and products will be eligible for

reregistration. The RED includes the data and labeling requirements for products for

reregistration. It may also include requirements for additional data (generic) on the active

ingredients to confirm the risk assessments.

To assist you with a proper response, read the enclosed document entitled "Summary

of Instructions for Responding to the RED.” This summary also refers to other enclosed

documents which include further instructions. You must follow all instructions and submit

complete and timely responses. The first set of required responses is due 90 days from the

receipt of this letter. The second set of required responses is due 8 months from the

receipt of this letter. Complete and timely responses will avoid the Agency taking the

enforcement action of suspension against your products.

If you have questions on the product specific data requirements or wish to meet with

the Agency, please contact the Special Review and Reregistration Division representative Jane

Mitchell (703) 308-8061.

Sincerely yours,

Lois A. Rossi, Director

Special Review and 

 Reregistration Division

Enclosures

SUMMARY OF INSTRUCTIONS FOR RESPONDING TO

THE REREGISTRATION ELIGIBILITY DECISION (RED)

1. DATA CALL-IN (DCI) OR "90-DAY RESPONSE"--If generic data are required for

reregistration, a DCI letter will be enclosed describing such data. If product specific data

are required, a DCI letter will be enclosed listing such requirements. If both generic and

product specific data are required, a combined Generic and Product Specific DCI letter will

be enclosed describing such data. However, if you are an end-use product registrant only and

have been granted a generic data exemption (GDE) by EPA, you are being sent only the

product specific response forms (2 forms) with the RED. Registrants responsible for generic

data are being sent response forms for both generic and product specific data requirements (4

forms). You must submit the appropriate response forms (following the instructions

provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product

may be suspended.

2. TIME EXTENSIONS AND DATA WAIVER REQUESTS--No time extension requests

will be granted for the 90-day response. Time extension requests may be submitted only with

respect to actual data submissions. Requests for time extensions for product specific data

should be submitted in the 90-day response. Requests for data waivers must be submitted as

part of the 90-day response. All data waiver and time extension requests must be accompanied

by a full justification. All waivers and time extensions must be granted by EPA in order to go

into effect.

3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"--You must

submit the following items for each product within eight months of the date of this letter

(RED issuance date).

a. Application for Reregistration (EPA Form 8570-1). Use only an original

application form. Mark it "Application for Reregistration." Send your Application for

Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.

b. Five copies of draft labeling which complies with the RED and current regulations

and requirements. Only make labeling changes which are required by the RED and current

regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation

changes, or labeling changes not related to reregistration) separately. You may, but are not

required to, delete uses which the RED says are ineligible for reregistration. For further

labeling guidance, refer to the labeling section of the EPA publication "General Information

on Applying for Registration in the U.S., Second Edition, August 1992" (available from the

National Technical Information Service, publication #PB92-221811; telephone number 703-

487-4650).

c. Generic or Product Specific Data. Submit all data in a format which complies

with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA

identifier (MRID) numbers. Before citing these studies, you must make sure that they meet

the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and

each alternate formulation. The labeling and CSF which you submit for each product must

comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal

concentration. You have two options for submitting a CSF: (1) accept the standard certified

limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis

of five batches. If you choose the second option, you must submit or cite the data for the five

batches along with a certification statement as described in 40 CFR §158.175(e). A copy of

the CSF is enclosed; follow the instructions on its back.

e. Certification With Respect to Data Compensation Requirements. Complete and

sign EPA form 8570-31 for each product. 

4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE--Comments

pertaining to the content of the RED may be submitted to the address shown in the Federal

Register Notice which announces the availability of this RED.

5. WHERE TO SEND PRODUCT SPECIFIC DCI RESPONSES (90-DAY) AND

APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

By U.S. Mail:

Document Processing Desk (RED-SRRD-PRB)

Office of Pesticide Programs (7504C)

 EPA, 401 M St. S.W.

Washington, D.C. 20460-0001

By express:

Document Processing Desk (RED-SRRD-PRB)

Office of Pesticide Programs (7504C) 

Room 266A, Crystal Mall 2 

1921 Jefferson Davis Hwy. 

Arlington, VA 22202

6. EPA'S REVIEWS--EPA will screen all submissions for completeness; those which are not

complete will be returned with a request for corrections. EPA will try to respond to data

waiver and time extension requests within 60 days. EPA will also try to respond to all 8-

month submissions with a final reregistration determination within 14 months after the RED

has been issued. 
ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF PESTICIDE PROGRAMS

SPECIAL REVIEW AND REREGISTRATION DIVISION

REREGISTRATION ELIGIBILITY DECISION

1,3,5-Triethylhexahydro-s-triazine

LIST C

CASE 3147

TABLE OF CONTENTS

1,3,5-TRIETHYLHEXAHYDRO-S-TRIAZINE REREGISTRATION ELIGIBILITY

DECISION TEAM .......................................... i

ABSTRACT ................................................... v

I. INTRODUCTION .......................................... 1

II. CASE OVERVIEW ......................................... 2

A. Chemical Overview .................................... 2

B. Use Profile .......................................... 2

C. Data Requirements ..................................... 3

D. Regulatory History ..................................... 3

III. SCIENCE ASSESSMENT ..................................... 4

A. Physical Chemistry Assessment ............................. 4

B. Human Health Assessment ................................ 4

1. Toxicology Assessment .............................. 4

a. Acute Toxicity .............................. 4

b. Subchronic Toxicity ........................... 6

c. Developmental Toxicity ........................ 7

d. Mutagenicity ............................... 7

2. Toxicological Endpoints for Risk Assessment ............... 9

a. Reference Dose (RfD) .......................... 9

b. Carcinogenicity Classification .................... 9

c. Toxicology Endpoints of Concern .................. 9

3. Occupational and Residential Exposure Assessment ......... 10

a. Occupational Handler Exposure Scenarios ........... 12

b. Homeowner Handler Exposure Scenarios ........... 13

c. Post-Application Exposure Scenarios and Assumptions . . 13

d. Exposure Estimations ......................... 15

4. Occupational and Residential Risk Characterization ......... 17

a. Primary Application and Post-Application Scenarios

(Occupational Only) ......................... 17

b. Secondary Handler and Post-Application Scenarios ..... 18

5. Additional Occupational/Residential Exposure Studies ....... 20

6. Other Considerations ............................. 20

a. Potential Risks to Infants and Children ............. 21

b. Aggregate exposure .......................... 21

c. Cumulative Effects .......................... 22

C. Environmental Assessment ............................... 23

1. Ecological Toxicity Data ........................... 23

a. Toxicity to Terrestrial Animals .................. 23
b. Toxicity to Aquatic Animals .................... 24

(1) Freshwater Fish ........................ 24

(2) Freshwater Invertebrates, Acute ............. 24

2. Environmental Fate .............................. 24

3. Exposure and Risk Characterization ................... 25

a. Exposure and Risk to Nontarget Organisms .......... 25

b. Endangered Species .......................... 25

IV. RISK MANAGEMENT AND REREGISTRATION DECISION ........... 25

A. Determination of Eligibility .............................. 25

B. Determination of Eligibility Decision ....................... 26

1. Eligibility Decision ............................... 26

2. Eligible and Ineligible Uses ......................... 26

C. Regulatory Position and Labeling Rationale ................... 27

1. Potential Risks to Infants and Children/Aggregate

Exposure/Cumulative Effects ........................ 27

2. Handler Safety Requirements ........................ 28

a. Personal Protective Equipment Requirements for

Occupational Handlers ........................ 28

b. Engineering Control Requirements for Occupational

Handlers ................................. 29

c. Application and Post Application Exposure Data ...... 29

d. Additional Labeling Requirements ................ 30

V. ACTIONS REQUIRED OF REGISTRANTS ....................... 30

A. Manufacturing-Use Products ............................. 30

1. Additional Generic Data Requirements .................. 30

2. Labeling Requirements for Manufacturing-Use Products ...... 31

B. End-Use Products .................................... 31

1. Additional Product-Specific Data Requirements ............ 31

2. Labeling Requirements for End-Use Products ............. 32

a. Occupational Labeling PPE Requirements for Pesticide

Handlers ................................. 32

(1) PPE Requirements for Occupational Handlers ... 32

(2) PPE Requirements for Homeowner Handlers .... 33

b. Other Labeling Requirements - Products Intended for

Occupational Use ........................... 33

C. Existing Stocks ...................................... 34

VI. APPENDICES ........................................... 37

APPENDIX A. Table of Use Patterns Subject to Reregistration ....... 38

APPENDIX B. Table of the Generic Data Requirements and Studies Used to

Make the Reregistration Decision ................. 41

APPENDIX C. Citations Considered to be Part of the Data Base Supporting

the Reregistration of 1,3,5-Triethylhexahydro-s-triazine . . 47
APPENDIX D. Product Specific Data Call-In ................... 53

Attachment 1. Chemical Status Sheets ................... 65

Attachment 2. Product Specific Data Call-In Response Forms (Form 

A inserts) Plus Instructions ................ 66

Attachment 3. Product Specific Requirement Status and Registrant's

Response Forms (Form B inserts) and Instructions

................................... 67

Attachment 4. EPA Batching of End-Use Products for Meeting Data

Requirements for Reregistration ............. 75

Attachment 5. List of All Registrants Sent This Data Call-In (insert)

Notice .............................. 77

Attachment 6. Cost Share, Data Compensation Forms, Confidential

Statement of Formula Form and Instructions .... 79

APPENDIX E. List of Available Related Documents ............... 87

i

1,3,5-TRIETHYLHEXAHYDRO-S-TRIAZINE REREGISTRATION ELIGIBILITY

DECISION TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Assessment

Cynthia Szymanski Biological Analysis Branch

Rafael Prieto Biological Analysis Branch

Michele Cottrill Biological Analysis Branch

Frank Hernandez Economic Analysis Branch

Margaret Cogdell Biological Analysis Branch

Environmental Fate and Effects Risk Assessment

Karen Angulo Science Analysis and Coordination Staff

Mary Powell Science Analysis and Coordination Staff

Silvia C. Termes Environmental Fate and Groundwater Branch

Rick Petrie Ecological Effects Branch

Health Effects Risk Assessment

Winston Dang Occupational and Residential Exposure Branch

Raymond Locke Toxicology Branch I

Kathleen Martin Risk Characterization and Analysis Branch

Paul Lewis Risk Characterization and Analysis Branch

Registration Support

Valdis Goncarovs Antimicrobial Program Branch

Shyam B. Mathur Registration Support Branch

Risk Management

Bruce Sidwell Accelerated Reregistration Branch

Marie Boucher Accelerated Reregistration Branch
ii
GLOSSARY OF TERMS AND ABBREVIATIONS

iii

ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).

AE Acid Equivalent

a.i. Active Ingredient

ARC Anticipated Residue Contribution 

CAS Chemical Abstracts Service

CI Cation

CNS Central Nervous System

CSF Confidential Statement of Formula

DFR Dislodgeable Foliar Residue

DRES 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, non carcinogenic health effects are not

anticipated to occur.

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/WHO Food and Agriculture Organization/World Health Organization

FDA Food and Drug Administration

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA Federal Food, Drug, and Cosmetic Act

FOB Functional Observation Battery

GLC Gas Liquid Chromatography

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.

HDT Highest Dose Tested

LC Median Lethal Concentration. A statistically derived concentration of a substance that can be 50

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/l, 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.

LD Lethal Dose-low. Lowest Dose at which lethality occurs. lo

LEL Lowest Effect Level

LOC Level of Concern

LOD Limit of Detection 

LOEL Lowest Observed 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.

μg/g Micrograms Per Gram

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.

N/A Not Applicable
GLOSSARY OF TERMS AND ABBREVIATIONS

iv

NOEC No effect concentration

NPDES National Pollutant Discharge Elimination System

NOEL No Observed Effect Level

NOAEL No Observed Adverse Effect Level

OP Organophosphate

OPP Office of Pesticide Programs

PADI Provisional Acceptable Daily Intake

PAG Pesticide Assessment Guideline

PAM Pesticide Analytical Method

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

Q The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model *

1

RBC Red Blood Cell

RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose

RS Registration Standard

RUP Restricted Use Pesticide

SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)

TC Toxic Concentration. The concentration at which a substance produces a toxic effect. 

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.

ug/L Micrograms per liter

WP Wettable Powder

WPS Worker Protection Standard
v

ABSTRACT

The U. S. Environmental Protection Agency has completed its reregistration eligibility

decision for the pesticide 1,3,5-triethylhexahydro-s-triazine (Case 3147). This decision includes

a comprehensive reassessment of the required target data and the use patterns of the two currently

registered products. Additionally, the Agency has examined information concerning the exposure

and susceptibility of infants and children to 1,3,5-triethylhexahydro-s-triazine and available

information concerning aggregate exposure to 1,3,5-triethylhexahydro-s-triazine as well as the

potential for cumulative effects from 1,3,5-triethylhexahydro-s-triazine and other substances that

have a common mode/mechanism of toxicity.

1,3,5-Triethylhexahydrotriazine, or triethylhexahydrotriazine, is used as a

microbiocide/microstat in various rubber products, industrial adhesives, fuels/oil storage tank

bottom water, metalworking cutting fluids, wet-end additives/industrial processing chemicals, and

latex paints. The Agency has concluded that all uses, as prescribed in this document, will not

cause unreasonable risks to humans or the environment and therefore, all products are eligible for

reregistration. 

Triethylhexahydrotriazine is moderately acutely toxic and corrosive via the oral and

inhalation routes. Although in vitro data indicate this pesticide to be mutagenic, in vivo data

suggest that triethylhexahydrotriazine lacks in vivo mutagenic potential. EPA is concerned about

the corrosivity of triethylhexahydrotriazine and, since studies were waived due to corrosivity,

assumes that it is classified as category I for skin irritation and eye irritation potential. The

corrosivity to skin of triethylhexahydrotriazine makes dermal penetration likely, since the skin

would likely be damaged by contact with the chemical. Triethylhexahydrotriazine is classified

as toxicity category II for acute inhalation toxicity. 

For short-term (1-7 days) and intermediate-term (1 week-several months) occupational and

residential risk assessments, the Agency has chosen the 75 mg/kg/day NOEL, based on both

maternal and developmental effects, from the rat developmental toxicity study. In a sub-chronic

dermal study in rats, no systemic effects were observed at any dose level. Consistent with current

data requirements for non-food use chemicals, no chronic toxicity data have been required for

triethylhexahydrotriazine.

Because inhalation exposure data are absent and triethylhexahydrotriazine has a relatively

high vapor pressure, EPA will require data for handler and post-application inhalation exposure.

The post-application data requirement includes monitoring levels of triethylhexahydrotriazine and

its degradates in newly painted rooms where infants and children could be exposed. 

Nothing in the available toxicity data base indicates special susceptibility of infants and

children to triethylhexahydrotriazine and, therefore, the Agency has concluded that an additional

uncertainty factor for estimating risk to young organisms is not warranted at this time. 
vi

All products containing triethylhexahydrotriazine have primarily indoor, non-food uses.

Based on the available exposure information and current use patterns, EPA does not anticipate

exposure to residues of triethylhexahydrotriazine in food or drinking water. Thus, the only nonoccupational exposure to triethylhexahydrotriazine would be from uses in the home. Among

these, applying paint would yield the greatest potential exposure. Because the dermal MOE for

this worst case exposure is high (> 1600), EPA believes that aggregate exposures from other

sources of triethylhexahydrotriazine in the home are not likely to be of concern.

The Agency has not yet made a determination regarding the common mode/mechanism

of toxicity of triethylhexahydrotriazine and whether it is appropriate to consider exposure from

triethylhexahydrotriazine with other compounds in order to address potential cumulative effects.

However, based on the high dermal MOE for homeowner applicators, the lack of food uses, the

unlikelihood of residues in drinking water, and the low concentration in paint, the Agency

believes that the contribution of triethylhexahydrotriazine exposure to the risks of other chemicals

with a common mode/mechanism of toxicity is likely to be minimal. 

Before reregistering products containing triethylhexahydrotriazine, the Agency is requiring

that product specific data, revised Confidential Statements of Formula and revised labeling be

submitted within eight months of the issuance of this document. These data include product

chemistry for each registration and acute toxicity testing. After reviewing these data and any

revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the

Agency will reregister a product.
1

I. INTRODUCTION

In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended

to accelerate the reregistration of products with active ingredients registered prior to November

1, 1984. The amended Act provides a schedule for the reregistration process to be completed in

nine years. There are five phases to the reregistration process. The first four phases of the process

focus on identification of data requirements to support the reregistration of an active ingredient

and the generation and submission of data to fulfill the requirements. The fifth phase is a review

by the U.S. Environmental Protection Agency (referred to as “the Agency”) of all data submitted

to support reregistration.

FIFRA Section 4(g)(2)(A) states that in Phase 5 “the Administrator shall determine

whether pesticides containing such active ingredient are eligible for reregistration” before calling

in data on products and either reregistering products or taking “other appropriate regulatory

action.” Thus, reregistration involves a thorough review of the scientific data base 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” criterion of FIFRA.

On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.

FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA. The

FQPA amendments went into effect immediately. Among other things, FQPA amended the

FFDCA by setting a new standard for the establishment of tolerances. Because

triethylhexahydrotriazine has no food uses, and therefore no tolerances have been established, the

specific determinations outlined in FQPA are not required for the reregistration of this chemical.

Nevertheless, EPA believes that consideration of available data relating to the special sensitivity

of infants and children, as well as the potential for aggregate exposures and cumulative effects is

prudent for triethylhexahydrotriazine because children and other individuals could be exposed to

this compound in non-occupational settings.

This document presents the Agency's decision regarding the reregistration eligibility of

the registered uses of triethylhexahydrotriazine. The document consists of six sections. Section

I is the introduction. Section II describes triethylhexahydrotriazine, its uses, data requirements

and regulatory history. Section III discusses the human health and environmental assessment based

on the data available to the Agency. Section IV presents the reregistration decision for

triethylhexahydrotriazine. Section V discusses the reregistration requirements for

triethylhexahydrotriazine. Finally, Section VI is the Appendices which support this Reregistration

Eligibility Decision. Additional details concerning the Agency's review of applicable data are

available on request.
2

II. CASE OVERVIEW

A. Chemical Overview

The following active ingredient is covered by this Reregistration Eligibility

Decision:

Common Name: Triethylhexahydrotriazine

Chemical Name: 1,3,5-Triethylhexahydro-s-triazine

Chemical Family: Triazine

CAS Registry Number: 7779-27-3

OPP Chemical Code: 082901

Molecular Formula: C9H21N3

Molecular Weight: 171.29

Trade and Other Names: Vancide TH

Basic Manufacturer: R. T. Vanderbilt Company, Inc.

B. Use Profile

The following is information on the currently registered uses with an overview of

use sites and application methods. A detailed table of the uses of triethylhexahydrotriazine

is in Appendix A.

For triethylhexahydrotriazine:

Type of Pesticide: Microbiocide/Microbiostat (slime-forming bacteria)

Microbiocide/Microbiostat (slime-forming fungi)

Use Sites: Indoor Non-food

-Adhesives, Industrial

-Fuels/Oil Storage Tank Bottom Water Additive

-Metalworking Cutting Fluids

-Paints, Latex (In-can) - and aqueous slurries

-Rubber Products

-Wet-end Additives/Industrial Processing Chemicals
3

Target Pests: Slime-forming bacteria and fungi

Types/Formulations Registered:

End-use product

-Soluble concentrate/liquid

Methods of Application:

Types of Treatment - Additive treatment, Industrial preservative treatment

Equipment - Not specified (registrant must specify on label)

Timing - During manufacture, When needed, Not specified (registrant must specify on

label)

Surface Type - Not applicable

Rates of Application

Adhesives, Industrial: 95 to 475 ppm a.i. by weight;

Fuels/oil storage tank bottom water additive: 363 to 1813 ppm a.i. by weight.

Metalworking cutting fluids: 28500 ppm a.i. by weight.

Paints, latex (in-can): 475 to 1425 ppm a.i. by weight.

Rubber products: 190 to 475 ppm a.i. by weight.

Wet-end additives/industrial processing chemicals: 95 to 1425 ppm a.i. by weight.

C. Data Requirements

The Agency required registrants to supply additional data to support reregistration

in the Antimicrobial Data Call-In Notice of March 1987 and a Data Call-In Notice issued

in November of 1992 that included studies on product chemistry, ecological effects, and

toxicity. Appendix B includes all data requirements identified by the Agency for currently

registered uses to support reregistration.

D. Regulatory History

In 1967, triethylhexahydrotriazine was first registered in the United States as an

active ingredient for use as a microbiocide and bacteriostat. There are currently two

active products registered for incorporation as a preservative into adhesives, fuels, metal

working fluids, paints, slurries and latex rubber. In 1987 the Agency issued the

Antimicrobial Data Call-In Notice for toxicity data for this chemical and other

antimicrobial chemicals. Another Data Call-In Notice was issued in September 1992 for

triethylhexahydrotriazine requiring additional data in support of reregistration.
4

III. SCIENCE ASSESSMENT

A. Physical Chemistry Assessment

Color: Colorless to slightly yellow

Physical State: Liquid

Odor: Formaldehyde-like odor

Boiling Point: 205-210 C

Specific Gravity: 0.89 gm/cc

Solubility: Water: 100.000 gm/100ml

Hexane: 1.040 gm/100ml

Mineral Spirits: 0.129 gm/100ml

Vapor Pressure: 15.7 mm Hg at 25 C

Dissociation Constant: N/A

K : 0.11 (by GC) O/W

pH: 11.0 - 11.1 (5% solution in water)

Stability: Stable under basic conditions, but decomposition was

observed in acid medium.

Flammability: 150 F (Tag closed cup)

Storage Stability: Stable for more than one year when stored at room

temperature in its original container.

Viscosity: 2.80 and 2.82 Centistokes mm /s 2

Corrosion 

Characteristics: Triethylhexahydrotriazine was tested 

in solution of 4.8% for:

Brass (corrosion rate = 0.084 g/m /hr), 2

Copper (corrosion rate = 0.011 g/m /hr), 2

Low Carbon steel (corrosion rate = 0), and for 

Stainless steel (corrosion rate = 0).

B. Human Health Assessment

1. Toxicology Assessment

At present, the toxicology data base for triethylhexahydrotriazine meets the

Agency’s requirements for antimicrobials. The data are adequate and will support

a reregistration eligibility determination for currently registered non-food uses.

a. Acute Toxicity

Due to the corrosivity of triethylhexahydrotriazine (pH = 11.0-

11.1), studies of acute dermal toxicity and primary eye and skin irritation

are waived. Triethylhexahydrotriazine has been tested in an acute oral

toxicity test (MRID 41773701). In young adult male and female
5

Crl:CDBR rats, triethylhexahydrotriazine exhibited an acute oral LD50

value of 291 (193-440) mg/kg for male rats, 135 (79-231) mg/kg for

female rats, and 209 (156-280) mg/kg combined. The purity of the test

substance was 96.39% a.i..

Triethylhexahydrotriazine has been tested in an acute inhalation

toxicity test (MRID 42406101). In Crl:CDBR Sprague-Dawley rats,

triethylhexahydrotriazine demonstrated an acute inhalation LC50 of 251

(249-253) mg/M for male rats, 260 (233-290) mg/M for female rats, and 3 3

254 (212-305) mg/M combined. The LC values were calculated using 3

50

actual chamber concentrations. The purity of the test substance was

96.06% a.i.. 

Triethylhexahydrotriazine has been tested for its potential to elicit

dermal sensitization reactions in guinea pigs (MRID 42293004).

Triethylhexahydrotriazine was not a skin sensitizer in this study. The

dermal sensitization potential of triethylhexahydrotriazine was evaluated in

10 female Hartley albino guinea pigs using nine occluded dermal induction

exposures (clipped back skin; 20 mg dose), one occluded challenge

exposure (clipped right flank skin; 4 mg dose), and one occluded

rechallenge exposure (clipped left flank skin; 4 mg dose). An irritation

control group of five additional females received only the challenge dose,

and dermal reactions of the induced animals at challenge and rechallenge

were compared to those of this control group. An additional 10 females

were induced with nine dermal exposures (clipped back skin; 0.4 mg dose)

to 1-chloro-2,4-dinitrobenzene (DNCB), a known skin sensitizer, and then

challenged with this same substance (clipped right flank skin; 0.4 mg dose).

All animals in all treatment groups survived and gained weight over the test

period. After challenge with triethylhexahydrotriazine, one of the 10

animals exhibited well-defined erythema at 24 hours post-challenge. The

same animal exhibited very slight erythema at 48 hours post-challenge.

After rechallenge, four of the 10 animals exhibited very slight erythema at

24 hours post-treatment, and this slight erythema persisted in one of these

animals at 48 hours post-treatment. No edema was observed in any animal

at any time period. No dermal reactions were observed in the irritation

control group, and 9/10 animals in the positive control group (DNCBtreated) exhibited skin sensitization reactions. The purity of the test

substance was 96.39% a.i..

The acute toxicity values, along with their corresponding toxicity

categories, are summarized in Table 1.
6

Table 1. Acute Toxicity Values for Triethylhexahydrotriazine Technical

Guideline Test MRID Result Toxicity 

Category

81-1 Oral LD - Rat 41773701 LD = 291 mg/kg (M) II 50 50

LD = 135 mg/kg (F) 50

LD = 209 mg/kg (M+F) 50

81-3 Inhalation LC - Rat 42406101 LC = 251 mg/M (M) II 50 50

3

LC = 260 mg/M (F) 50

3

LC = 254 mg/M (M+F) 50

3

(LC based on actual chamber 50

concentration)

81-6 Dermal Sensitization 42293004 Triethylhexahydrotriazine was not --

Guinea Pig a sensitizer in this study.

The above studies satisfy the acute toxicity data requirements for

triethylhexahydrotriazine. Among these requirements, tests for acute

dermal toxicity, primary eye irritation in the rabbit, and primary dermal

irritation were waived due to the chemical's corrosivity. The test for acute

delayed neurotoxicity in the hen was also waived due to lack of

acetylcholinesterase inhibition and no structural similarity to compounds

known to cause delayed neurotoxicity.

b. Subchronic Toxicity

In a repeated dose, dermal toxicity study (MRID 41858301), male

and female Crl:CDBR Sprague-Dawley rats, 13/sex/group, were exposed

(intact skin) to triethylhexahydrotriazine for 13 weeks (6 hours/day, 5

days/week). The purity of the test substance was 96.6% a.i.. The dose

levels used were 0, 10, 30, or 100 mg/kg of body weight/day and were

based on the results of a preliminary acute dermal toxicity probe study. 

Parameters examined for all rats in the study included clinical signs

of toxicity, mortality, body weights, food consumption, hematology,

clinical chemistry, urinalysis, necropsy, organ weights (liver, lung,

kidneys, testes/ovaries, brain, pituitary, and heart), organ/body weight and

organ/brain weight ratios and histopathological examination of selected

organs/tissues. Severe dermal irritation occurred in both sexes at all doses

tested. However, no systemic effects were observed at any dose level. 

Based on these findings, the dermal NOEL is <10 mg

triethylhexahydrotriazine/kg body wt./day (the lowest dose tested or LDT)

and the dermal LEL is 10 mg/kg/day (LDT), based on the gross

observation of dermal irritation which was confirmed histologically.

Dermal irritation was characterized by hyperplasia, hyperkeratosis,
7

inflammation, sebaceous gland hyperplasia, and eschar formation. The

systemic NOEL is 100 mg triethylhexahydrotriazine/kg body wt./day and

the systemic LEL is >100 mg/kg/day (the highest dose tested or HDT),

based on the lack of systemic effects at any dose level tested.

c. Developmental Toxicity

A developmental toxicity study (MRID 41865701) was conducted

in which pregnant Crl:CDBR Sprague-Dawley rats (25/group) were

administered triethylhexahydrotriazine (96.6% a.i.) by gavage during

gestation days 6-15, inclusive. The dose levels used were 0, 10, 75, or 150

mg/kg body wt./day and were selected on the basis of a previous rangefinding study.

Prior to delivery, animals were sacrificed. The uterus of each

animal was examined to determine the numbers of implantation sites,

resorption, and live and dead fetuses. The fetuses were examined for

external, visceral, and skeletal alterations. 

Maternal toxicity was observed only in the high-dose (150

mg/kg/day) group and consisted of a significant (39%) decrease in body

weight gain during the dosing period (p 0.01). Therefore, the LEL for

maternal toxicity was 150 mg triethylhexahydrotriazine/kg of body wt./day

and the NOEL for maternal toxicity was 75 mg

triethylhexahydrotriazine/kg body wt./day, based on decreased body weight

gain. The LEL for developmental toxicity was 150 mg

triethylhexahydrotriazine/kg body wt./day (HDT) and the NOEL for

developmental toxicity was 75 mg/kg/day, based on the observed

significant incidences of bilateral convoluted ureters and dilated renal

pelvises in the high-dose (150 mg/kg/day) group.

These effects were statistically significant (p 0.05 for dilated renal

pelvises; p 0.01 for bilateral convoluted ureters) for the high-dose (150

mg/kg/day) group, but were within historical control values for the mid-

(75 mg/kg/day) and low-dose (10 mg/kg/day) groups. Collectively,

MRIDs 42308601, 42366200, and 42366201, and the original study (MRID

41865701), have been upgraded to acceptable.

d. Mutagenicity

Triethylhexahydrotriazine (98.0% a.i.) was evaluated in a

Salmonella typhimurium/Ames plate incorporation assay in tester strains

TA1535, TA1537, TA1538, TA98, and TA100, with and without

metabolic activation (S9), at concentrations up to those inducing
8

cytotoxicity (MRID 41343401). This study showed that, in repeat trials,

triethylhexahydrotriazine demonstrated a dose-related positive for gene

reversions in two (TA98 and TA100) of the five strains tested, but only in

the presence of metabolic activation (S9) and at elevated concentrations

(100-333 μg/plate).

Triethylhexahydrotriazine (98.0% a.i.) was positive for inducing

dose-related unscheduled DNA synthesis in primary rat hepatocyte cultures

treated at triethylhexahydrotriazine concentrations of 0.03 and 0.06

μL/mL, as determined by radioactive tracer procedures (nuclear silver

grain counts). Dose levels used were: 0, 0.001, 0.003, 0.01, 0.03, or 0.06

μL/mL (MRID 41343402).

Triethylhexahydrotriazine (98.0% a.i.) significantly increased the

numbers of thioguanine-resistant mutants in cultures of Chinese hamster

ovary (CHO) cells at a concentration of 0.02 μL/mL without exogenous

(S9) metabolic activation (MRID 41544801). Although less certain,

triethylhexahydrotriazine may also increase the numbers of mutants at

concentrations of 0.02, 0.025, 0.03, and 0.035 μL/mL with metabolic

activation (S9) and at a concentration of 0.03 μL/mL without metabolic

activation (S9). The CHO-KiBH4 (Oak Ridge National Laboratory) cell

line was used. The concentrations of triethylhexahydrotriazine tested in the

non-activated (-S9) studies were: 0, 0.03, 0.02, 0.015, 0.01, 0.007, 0.005,

and 0.003 μL/mL. With metabolic activation (+S9), the concentrations of

triethylhexahydrotriazine tested were: 0.035, 0.03, 0.025, 0.02, 0.015,

0.01, 0.007, 0.0035, 0.002, and 0.001 μL/mL. The initial test was

complemented by two confirmatory assays.

Triethylhexahydrotriazine (98.0% a.i.) did not induce micronuclei

in ICR mice in a mouse micronucleus study (MRID 41321501). Groups

of mice (15/sex/dose) were administered single doses of

triethylhexahydrotriazine in sterile distilled water orally by gavage at dose

levels of 0, 25, 125, or 225 mg/kg body weight. Negative control animals

(0 mg/kg) received distilled water only. Five females and five males were

administered an intraperitoneal dose of 0.25 mg/kg body weight of the

positive control substance, triethylenemelamine. Five per sex of the

negative control and test groups were sacrificed at 24, 48, and 72 hours

post-dosing. Positive controls were sacrificed at 24 hours post-dosing.

Both femurs were dissected out, and smears were made from each femur.

Smears were stained with May-Gruenwald-Giemsa stain and examined by

light microscopy to determine the number of micronucleated polychromatic

erythrocytes. Mortality was increased in the high-dose group (225 mg/kg),

in which 4/15 died and were therefore replaced with other mice. The

positive control substance caused a significant increase in the number of
9

micronucleated polychromatic erythrocytes, while negative control animals

and all treatment groups exhibited no such increase. Although originally

classified as Unacceptable, subsequent submission of purity data on the test

substance (MRID 41738201) upgrades this study to a classification of

Acceptable.

In summary, triethylhexahydrotriazine was shown to be mutagenic

in three of the four mutagenicity tests conducted. While the three in vitro

studies suggest a mutagenic potential for gene mutation and unscheduled

DNA synthesis, the negative in vivo micronucleus study indicates that

triethylhexahydrotriazine lacks the mutagenic potential for increased

incidence of micronucleated polychromatic erythrocytes. Based on the

available toxicity data, it is concluded that triethylhexahydrotriazine has

intrinsic mutagenicity activity which is only expressed in vitro. No further

testing is required at this time.

2. Toxicological Endpoints for Risk Assessment

a. Reference Dose (RfD)

Even though chronic occupational exposure is anticipated with the

use of triethylhexahydrotriazine, chronic testing is not required since the

NOEL from the 13-week rat dermal toxicity study is greater than 1000

times higher than human dermal exposure (i.e. assuming 100 percent

dermal exposure). In addition, since the NOEL from the 13-week rat

dermal toxicity study was greater than the highest dose tested, the Agency

does not believe that chronic exposure would indicate a risk of concern.

Finally, there are no registered food uses for triethylhexahydrotriazine.

Therefore, the Agency has decided not to establish an RfD for

triethylhexahydrotriazine. This class of chemicals (i.e., disinfectants,

microbiocides, microbiostats, sanitizers, etc.) has not been reviewed by the

FAO/WHO Joint Meeting on Pesticide Residues.

b. Carcinogenicity Classification

The cancer classification for this chemical has not been established.

Since triethylhexahydrotriazine is a non-food use pesticide, carcinogenicity

studies have not been required.

c. Toxicology Endpoints of Concern

Based on the review of the toxicology database and information on

the general use pattern for triethylhexahydrotriazine, the Agency

established toxicity endpoints to be used in the occupational and residential
10

risk characterization. They are listed in Table 2. The NOEL from the 13-

week dermal rat study was not used for short-term or intermediate-term

occupational or residential risk assessment since no systemic effects were

observed at any dose level tested. In the absence of data on dermal

absorption, 100% absorption is assumed.

Table 2. Summary of Toxicological Endpoints for Triethylhexahydrotriazine

Type of Exposure Endpoint (And Toxicological Effect)

(Duration and Route)

Acute Dietary: oral Endpoint is not required for this active ingredient as 

triethylhexahydrotriazine is a non-food use chemical.

Short-Term Occupational or Residential 75 mg/kg/day (maternal oral NOEL for decreased maternal

Exposure (one to seven days): dermal body weight gain during entire gestation period, also

developmental NOEL for increased fetal incidences of dilated

renal pelvises and bilateral convoluted ureters)

MRIDs: 41865701; 42366200; and 42308601

Intermediate-Term Occupational or

Residential Exposure (one week to

several months): dermal

3. Occupational and Residential Exposure Assessment

An occupational and/or residential exposure 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. 

EPA has determined that an exposure assessment is appropriate for

triethylhexahydrotriazine. There is a toxicological concern (i.e., maternal and

developmental effects via the oral route) and there is potential for workers and

residents to be exposed to triethylhexahydrotriazine during application and postapplication.

EPA has also determined that in and near sites where

triethylhexahydrotriazine or triethylhexahydrotriazine-containing products are

being used, individuals may be exposed to formaldehyde as this pesticide is a

possible formaldehyde generator. The registrants report in their Material Safety

Data Sheet (MSDS) that: “Simulated routine customer handling suggests that

formaldehyde off-gas is unlikely to exceed any of [the Occupational Safety and

Health Administration (OSHA) permissible exposure level (PEL) and short-term

exposure limit (STEL)] standards. Typical handling of triethylhexahydrotriazine

yielded formaldehyde off-gas levels of <0.005 to 0.01 ppm for an 8-hour

exposure (extrapolated). Because off-gas is affected by temperature, pH and plantspecific controls, plant-specific monitoring is recommended to establish compliance

with the standard.” In May 1992 OSHA published a comprehensive workplace

standard for the protection of workers in the industrial setting due to
11

formaldehyde-release in the workplace. The standard set a PEL of 0.75 ppm as

an 8-hour time-weighted average (TWA), a 15-minute STEL of 2 ppm, and

prescribes that certain actions should be taken if monitoring shows levels of 0.50

ppm as an 8-hour TWA. Further, it requires monitoring before workers enter the

premises following use of formaldehyde or when potential ambient formaldehyde

is generated from other chemicals. The standard also establishes requirements for

posting of warning signs, use of personal protective equipment, medical

surveillance, hazard communication and training.

Use Patterns

Triethylhexahydrotriazine is a microbiocide/microbiostat used against

slime-forming bacteria and fungi. Triethylhexahydrotriazine is formulated as a

soluble concentrate/liquid (ranging from 93 to 95 percent active ingredient).

Triethylhexahydrotriazine is employed in a variety of industrial uses including: 

Industrial adhesives (95 to 475 ppm a.i. by weight); 

Latex paints (in-can) (475 to 1,425 ppm a.i. by weight); 

Rubber products (190 to 475 ppm a.i. by weight); 

Fuels/oil storage tank bottom water additive (363 to 1,813 ppm a.i. by

volume); 

Metalworking cutting fluids (28,500 ppm a.i. by weight); 

Wet-end additives/industrial processing chemicals (95 to 1,425 ppm a.i. by

weight).

All triethylhexahydrotriazine products are intended for occupational use

when handled directly. Homeowners may be exposed to triethylhexahydrotriazine

while using products, such as paints, adhesives, or rubber products, to which

triethylhexahydrotriazine has been added. EPA has determined that there is a

potential for exposures to mixers, loaders, applicators, or other handlers of

triethylhexahydrotriazine, products containing triethylhexahydrotriazine, and its

break-down product formaldehyde. There are potential exposures from

applications in commercial, industrial, and residential settings. EPA has identified

two levels of handler exposures:

Primary Handlers -- persons handling end-use pesticide products containing

triethylhexahydrotriazine as an active ingredient.

Secondary Handlers -- persons handling products, such as paints,

adhesives, and metalworking/cutting fluids to which

triethylhexahydrotriazine has been added.

All handler use patterns were only assessed for dermal exposure. They

were not assessed for inhalation exposure. Although EPA believes that inhalation

exposure may be significant (the vapor pressure of triethylhexahydrotriazine is
12

15.7 mmHg @ 25 C and it is classified as category II for inhalation toxicity), no o

data are available to quantitatively assess inhalation exposure.

EPA is also aware of possible handler exposures to formaldehyde in

industrial, manufacturing, and residential settings, since formaldehyde is a possible

degradate of triethylhexahydrotriazine under certain conditions. However, no data

are available at this time upon which to assess the possible exposure and risk.

a. Occupational Handler Exposure Scenarios

Primary Occupational Handlers: Based on the use patterns, EPA

has identified two major triethylhexahydrotriazine exposure scenarios for

primary occupational handlers: (1) open-pouring the soluble concentrate

liquid formulation and (2) metering-pump applications (automatic

dispensing equipment) with the soluble concentrate liquid formulation.

Provided in Table 4 are exposure estimates for two Open-Pour Liquid

scenarios (Manufacturing of Paint and Metal-Cutting Fluid) and one

Pump-Metering System scenario. EPA assumes that mixers and loaders are

exposed more than 7 days per year (reasonable worse-case estimate). 

EPA has no data for several of the uses listed for

triethylhexahydrotriazine. However, EPA has data that may be used as a

surrogate for these uses. In this exposure and risk assessment, the

following surrogates have been used:

Data from pulp and paper mill uses is used as a surrogate for the

wet-end additives/industrial processing chemicals use, since both

use patterns use automatic dispensing equipment rather than openpour techniques; and

Data from paint manufacturing uses are used as a surrogate for the

rubber, industrial adhesives, and fuels/oil storage tank bottom water

uses, since these use patterns use open-pour techniques rather than

automatic dispensing equipment.

Secondary Occupational Handlers: Based on the use patterns,

EPA has identified several major triethylhexahydrotriazine exposure

scenarios for secondary occupational handlers of triethylhexahydrotriazine

containing products including: (1) paint, (2) adhesives, (3) rubber

products, and (4) metalworking/cutting fluids. EPA considers dermal

exposures while handling triethylhexahydrotriazine-containing paint to

represent a reasonable worse-case dermal exposure scenario for secondary

occupational handlers, other than metalworking/cutting fluid uses.

Provided in Table 4 (as Paint Application) is the exposure estimate for this

scenario.
13

With respect to secondary occupational exposure to handlers of

metalworking/cutting fluids, this exposure assessment addresses only the

potential exposures to primary occupational handlers who are adding

triethylhexahydrotriazine into metalworking fluids. Although EPA

continues to discuss with OSHA and National Institute for Occupational

Safety Health (NIOSH) the roles and responsibilities of regulating the uses

of metalworking fluids and other products in the industrial setting, OSHA

is responsible for regulating machinists' safety and exposure. Therefore,

machinists' exposures to triethylhexahydrotriazine or formaldehyde will not

be addressed in detail in this document. EPA defers to OSHA for

enforcing the formaldehyde air-level standard in industrial and

manufacturing settings.

b. Homeowner Handler Exposure Scenarios

Primary Homeowner Handlers: There are no use patterns

identified for primary homeowner handlers, since at this time all

triethylhexahydrotriazine end-use pesticide products are intended for

occupational use.

Secondary Homeowner Handlers: Based on the use patterns,

EPA has identified three major triethylhexahydrotriazine exposure

scenarios for secondary homeowner handlers of triethylhexahydrotriazine

containing products, including: (1) paint, (2) adhesives, and (3) rubber

products. (See Table 4.) EPA considers exposures while handling

triethylhexahydrotriazine-containing paint to represent a reasonable worsecase dermal exposure scenario for secondary homeowner handlers.

Provided in Table 4 (as Paint Application) is the exposure estimate for this

scenario.

c. Post-Application Exposure Scenarios and Assumptions

EPA believes there are potential exposures following applications

of triethylhexahydrotriazine in commercial, industrial, and residential

settings. EPA has identified two levels of post-application exposures as

described below.

The following post-application use patterns were only assessed for

dermal exposure. They were not assessed for inhalation exposure.

Although EPA believes that inhalation exposure may be of concern (the

vapor pressure of triethylhexahydrotriazine is 15.7 mmHg @ 25 C and it o

is classified as category II for inhalation acute toxicity), no data are

available to quantitatively assess inhalation exposure. EPA also
14

acknowledges possible post-application exposures to formaldehyde in

industrial, manufacturing, and residential settings.

Occupational and Homeowner Post-Application Exposure Scenarios

Primary Occupational Post-Application Exposures: Based on the

use patterns, EPA has identified two primary post-application

exposure scenarios in commercial and industrial settings: (1)

potential exposures following applications of

triethylhexahydrotriazine to open vats of liquids, such as adhesives,

rubbers, fuels/oil storage tank bottom water, and paints, and (2)

exposures to persons maintaining equipment, such as water systems,

and other industrial equipment, which contain products treated with

triethylhexahydrotriazine.

Secondary Occupational Post-Application Exposures: Based on

the use patterns, EPA has identified several major

triethylhexahydrotriazine exposure scenarios for secondary

occupational post-application exposures, including: (1) exposures

to persons occupying areas recently painted with

triethylhexahydrotriazine-containing paint, (2) exposures to persons

occupying areas where triethylhexahydrotriazine-containing

adhesives have recently been applied, and (3) exposures while

handling recently treated rubber.

Primary Homeowner Post-Application Exposures: EPA has

identified no major triethylhexahydrotriazine exposure scenarios for

primary homeowner post-application exposures, since at this time

all triethylhexahydrotriazine end-use pesticide products are intended

for occupational use.

Secondary Homeowner Post-Application Exposures: Based on

the use patterns, EPA has identified two major

triethylhexahydrotriazine exposure scenarios for secondary

homeowner post-application exposures: (1) exposures while

occupying areas recently painted with triethylhexahydrotriazinecontaining paint, and (2) exposures while occupying areas where

triethylhexahydrotriazine-containing adhesives have recently been

used.

EPA believes that these primary and secondary postapplication dermal exposures in industrial settings and secondary

exposures in residential settings would be lower than dermal

exposures to primary occupational handlers. Provided in Table 3
15

is a simple matrix illustrating this narrative description of these

primary and secondary exposures.

Table 3. Description of Primary and Secondary Exposures

Type of Exposure Occupational Residential

Settings -- Examples Settings -- Examples

Handler Primary Adding triethylhexahydrotriazine N/A. Triethylhexahydrotriazine is an industrial

Exposure to a vat of paint. chemical; homeowners would not handle it directly. 

Secondary Professional painter using a A homeowner using a triethylhexahydrotriazinetriethylhexahydrotriazine- containing paint.

containing paint. 

Post-Application Primary Standing near a vat where N/A. Triethylhexahydrotriazine is an industrial

Exposure triethylhexahydrotriazine was chemical; homeowners would not receive postadded. application exposures when

triethylhexahydrotriazine is handled directly

Secondary Being in a painted room. Being in a painted room. 

N/A = not applicable

d. Exposure Estimations

The Agency relied on surrogate exposure data from a study

submitted by the Chemical Manufacturers Association, the assumption of

100% dermal absorption, the use of chemical resistant gloves (except for

paint application), as well as other assumptions which are noted in Table

4 on the next two pages. Short and intermediate-term exposure estimates

were calculated for these representative use scenarios using the following

formula to estimate actual daily exposure:

unit exposure (ug/lb a.i.) x application rate (lb a.i./used)

body wt (kg)

The following exposure and risk characterization addresses both

primary and secondary exposure for occupational and residential handlers

and post-application scenarios. All of the following exposure scenarios

(both handler and post-application) were assessed for dermal exposure

only. Although EPA believes that inhalation exposure may be of concern

no data are available to assess inhalation exposure quantitatively.
16

Table 4. Daily Exposure Estimates for Triethylhexahydrotriazine Handler Scenarios

OPERATION SETTING

CALCULATION OF POUNDS A.I. CALCULATION OF

USED PER DAY WORKER EXPOSURE 1

AMOUNT OF VOLUME lb a.i. used/day UE DAILY ACTUAL DAILY

PRODUCT USED TREATED/ (μg/lb DOSE EXPOSURE 

USED PER DAY a.i.) (mg/day) (mg/kg/day) 2 3 4

Primary Exposure

Open-Pour Liquid Paint Manufacturing (also surrogate for 1.5 lb a.i. 100 gal 1.5 0.14 0.21 0.0035

industrial adhesives, rubbers, and 100 gallons paint

fuels/oil storage tank bottom water)

Open-Pour Liquid Metal-Cutting Fluid 28,500 ppm a.i. by 10 gal 2.8 (assuming 0.133 0.37 0.0062

weight for the the density of oil

concentrate oil. is 10 lbs/gal)

Pump-Metering System Pulp and Papermill Final concentration of 100 tons 285 0.0075 2.1 0.035

(surrogate for wet-end additives/ 1,425 ppm by weight

industrial processing chemicals)

Secondary Exposure

Paint Occupational Painting 1.5 lb a.i. 5 gal 0.075 182 13.6 0.225

Application 100 gallons paint

Residential 1 gal 0.015 2.72 0.046

NOTES:

 Lb a.i./used was derived from the product labels, CMA study, and the LUIS report. Where: 1

a.) For paint manufacturing, 1.5 pounds a.i. is used per 100 gallons of paint treated. Assuming that 100 gallons of paint are treated per day, the amount of a.i. handled is 1.5 lb a.i./day.

b.) For the metal worker, 28,500 ppm a.i. by weight are used for the concentrate oil for further 20-75 times dilution with water to this treated concentrated oil (400-1,500 ppm final

a.i. concentration). Since 10 gallons of oil are used per day, the lb a.i. used is 2.8 (assuming the density of oil is 10 lbs/gallon).

c.) For pulp and paper mills, 1,425 ppm a.i. by weight is used as the final concentration. Assuming 100 tons of the slurry is used per day, the lb a.i. used is 285 (where: [1,425 lbs

triethylhexahydrotriazine/1x10 lb solution]*[(100 tons of slurry)*(2000 lb/ton)]. 6

d.) For painting, 1.5 lb a.i. is added per 100 gallons of paint. It will be assumed that a homeowner (H) uses 1 gallon of paint per day, and an occupational (O) worker uses 5 gallon

of paint per day. With reference to residential versus occupational daily exposure scenarios, this table is not meant to estimate a typical daily exposure to paint, but is an estimate of

short to medium term sub-chronic (several days to several months) exposure broken down into average daily value. This is equal to 0.015 lbs a.i. used by the homeowner and 0.075

lbs a.i. used for the occupational worker. Only dermal exposure is included in this table since there are no adequate inhalation data.

UE = Unit Exposure (UE) data were derived from the Chemical Manufacturers Association study and include dermal and inhalation exposure with workers wearing gloves. Inhalation exposure 2 

data are not applicable since the CMA study does not include inhalation data for pesticides having high volatility, as is the case for triethylhexahydrotriazine. For paint application, unit dermal

exposures for workers wearing long pants, long-sleeved shirts, and no gloves were derived from the Pesticide Handlers Exposure Database (PHED) V1.1 as amended (15 replicates, grade C,

medium confidence in data). 

 DAILY DOSE (mg/day) = (UE x lb a.i. used/day x % dermal absorption); where dermal absorption = 100%. 3 

 ACTUAL DAILY EXPOSURE (mg/kg/day) = POTENTIAL DAILY EXPOSURE (mg/day)/BODY WEIGHT (kg); where BW = 60 kg. 4
17

4. Occupational and Residential Risk Characterization

Based on the above exposure estimates and underlying assumptions of the short and

intermediate-term toxicological endpoint of 75 mg/kg/day, the Agency estimated the risks

with a margin of exposure (MOE). These estimates are calculated by:

MOE = NOEL/Actual Daily Exposure

a. Primary Application and Post-Application Scenarios (Occupational

Only)

Primary application and post-application exposure scenarios are those

involving industrial uses of triethylhexahydrotriazine. 

Risk Assessment

Based on available toxicity data and exposure scenarios for

triethylhexahydrotriazine, the Agency has determined that quantitative risk

characterizations for mixer/loader/applicator and handler dermal exposures are

appropriate for short- to intermediate-term exposures. Because of the selected

toxicity endpoint for this duration of exposure to triethylhexahydrotriazine, the

Agency is characterizing the risks by MOEs. Provided in Table 5 are the MOEs for

the triethylhexahydrotriazine application scenarios.

Table 5. Worker Risk Estimates for Triethylhexahydrotriazine Handler Scenarios

OPERATION SETTING EXPOSURE MOE

ACTUAL DAILY

(mg/kg/day)

1

Primary Exposure

Open-pour Liquid Paint Manufacturing (also surrogate for industrial adhesives, 0.0035 21,429

rubbers, and fuels/oil storage tank bottom water)

Open-pour Liquid Metal-Cutting Fluid 0.0062 12,088

Pump-Metering System Pulp and Papermill (surrogate for wet-end additives/industrial 0.035 2,143

processing chemicals)

Secondary Exposure

Paint Occupational 0.225 333

Application Painting Residential 0.046 1643

NOTE: MOE = NOEL/ACTUAL DAILY EXPOSURE, where NOEL = 75 mg/kg/day. 1

EPA generally is not concerned with occupational and residential risk if

MOEs are greater than 100. For triethylhexahydrotriazine, all the primary

application exposure dermal MOEs are greater than 100; they range from

approximately 2,100 for exposure in wet-end additives/industrial processing

chemicals using a pump metering system to approximately 21,000 for open-pour

operations during paint, adhesive, and rubber manufacturing and in uses for fuels/oil

storage tank bottom water. 

As mentioned previously, triethylhexahydrotriazine is so corrosive that the

dermal acute toxicity and primary skin and eye irritation studies were waived.
18

Although no traditional risk assessment is currently available to evaluate risks posed

by corrosivity, the Agency has determined that triethylhexahydrotriazine products

may pose significant handler risk due to its corrosivity. The Agency is addressing

these risks through the establishment of PPE requirements that are to be included on

all end-use product labeling that are classified as toxicity category I or II for skin or

eye irritation potential.

In addition, the Agency did not conduct a quantitative risk characterization

for chronic exposure (several months to one-year) due to the lack of a chronic

toxicological endpoint. However, based on the NOEL being greater than the highest

dose tested for subchronic toxicity (13-week dermal study), and the high MOE for

primary handlers, the Agency does not believe that a chronic exposure MOE would

indicate a risk of concern. As previously discussed, the Agency does not have data

to assess directly any post-application exposure to triethylhexahydrotriazine.

However, EPA believes that dermal exposures incurred during handling tasks are

likely to be higher than dermal exposures incurred during post-application. Because

all the dermal MOEs for handlers are greater than 100, EPA believes that the postapplication dermal MOEs would also be greater than 100. 

Risk Concerns

EPA is concerned about potential inhalation exposures to

triethylhexahydrotriazine for primary handler and primary post-application

situations, since it is classified as category II for acute inhalation toxicity and the

vapor pressure is high (i.e., 15.7 mmHg at 25 C). At this time, EPA has no data o

upon which to conduct an exposure or risk assessment for inhalation concerns. Due

to the Agency's concerns about potential inhalation exposure and the lack of

inhalation exposure data, the Agency is requiring primary handler and primary postapplication inhalation exposure data. Even though the Agency has concerns about

these exposure scenarios, the Agency believes that primary handler and primary

post-application inhalation exposures are not likely to be a risk of concern based on

recommendations noted in the pesticide's MSDS. The MSDS states “Effective

exhaust [must be maintained] to draw fumes and vapors away from workers to

prevent routine inhalation. If local exhaust ventilation is applied, a capture velocity

of 100 to 150 feet per minute should be maintained. Local exhaust is recommended

during product mixing.” Thus, the Agency is requiring primary handler and postapplication dermal and inhalation exposure data to confirm that the risks associated

with these exposure scenarios would not indicate a risk of concern.

In addition to inhalation concerns about triethylhexahydrotriazine itself in

primary occupational settings, EPA is concerned about potential inhalation

exposures to formaldehyde (a potential triethylhexahydrotriazine degradate) in these

situations. However, since OSHA has established Permissible Exposure Level

(PEL) and Short-Term Exposure Limit (STEL) standards for formaldehyde in

industrial and manufacturing settings, EPA defers to OSHA in enforcing

formaldehyde air levels in these settings. 

b. Secondary Handler and Post-Application Scenarios
19

Exposures to products containing triethylhexahydrotriazine as an additive

(such as paints, rubber, or adhesives) may occur in industrial, manufacturing, and

residential settings.

Risk Assessment

Secondary occupational/residential exposures are expected to be short-term

and intermediate-term. Chronic exposure is expected only for occupational

workers. Based on available toxicity data and exposure scenarios for

triethylhexahydrotriazine, the Agency has determined that a quantitative risk

characterization for painters (occupational and residential) is appropriate. Because

of the selected toxicity endpoint for short- to intermediate-term exposure to

triethylhexahydrotriazine, the Agency is characterizing the risks by MOE. Provided

in Table 5 are the MOEs for the triethylhexahydrotriazine dermal secondary handler

scenarios. The Agency did not conduct a quantitative risk characterization for

chronic exposure (several months to one-year) due to the lack of a chronic

toxicological endpoint. However, based on the NOEL being greater than the highest

dose tested (13-week dermal study), and the high MOE for painters, the Agency

does not believe that a chronic exposure MOE would indicate a risk of concern.

The Agency does not have data to assess directly post-application

(occupational or residential) dermal exposure to triethylhexahydrotriazine.

However, EPA believes that dermal exposures incurred during application are likely

to be higher than exposures incurred during post-application. Because the painter

exposure dermal MOEs are greater than 100, EPA believes that the post-application

dermal MOEs would also be greater than 100. Thus, a quantitative assessment of

the dermal post-application exposure risks is not necessary.

Risk Concerns

EPA is also concerned about potential inhalation exposures to

triethylhexahydrotriazine for secondary handler and secondary post-application

situations, particularly when triethylhexahydrotriazine-containing paint is used, since

triethylhexahydrotriazine is classified as category II for acute inhalation toxicity and

the vapor pressure is high (i.e., 15.7 mmHg at 25 C). At this time, EPA has no

o

data upon which to conduct an exposure or risk assessment for inhalation concerns.

Thus, the Agency is requiring secondary handler and secondary post-application

inhalation, as well as dermal, exposure data. Even though the Agency has concerns

about potential inhalation exposures to triethylhexahydrotriazine for these exposure

scenarios, the Agency believes that secondary handler and secondary postapplication inhalation exposure are not likely to be of concern since

triethylhexahydrotriazine concentrations in paint or adhesives would be relatively

low (usually less than 1% a.i.). The Agency is requiring these exposure data to

confirm that risks associated with these exposure scenarios are acceptable.

In addition to inhalation concerns for triethylhexahydrotriazine in secondary

occupational and residential settings, EPA also is concerned about potential

inhalation exposures to formaldehyde (a potential triethylhexahydrotriazine
20

degradate) in these situations. In industrial and manufacturing settings, such as

metalworking shops, EPA defers to OSHA enforcement of OSHA's formaldehyde

air-level standards. Since potential inhalation exposures may also occur in

residential settings where OSHA does not traditionally have jurisdiction, EPA is

unable to defer these concerns to OSHA enforcement. Therefore the Agency is

requiring secondary applicator and post application inhalation exposure data to

confirm that risks associated with these formaldehyde exposure scenarios are

acceptable. These inhalation exposure studies will monitor for

triethylhexahydrotriazine as well as its degradates (formaldehyde).

5. Additional Occupational/Residential Exposure Studies

Handler Studies

EPA is requiring the following confirmatory data for handler exposures: 

For painting with a brush;

For painting with a roller;

For painting with a sprayer.

For each of these handler exposure scenarios, studies should be conducted using

guideline numbers: 231, 232, 233, and 234 for the estimation of both inhalation and dermal

exposures in indoor and outdoor sites. The air monitoring study must include monitoring

for potential degradates (formaldehyde) as well as monitoring for triethylhexahydrotriazine

itself.

Post-Application Studies

EPA is requiring confirmatory data for post-application exposures in painted areas where

paint is applied by brush, roller, and sprayer. For these exposure scenarios, studies should

be conducted using guideline numbers: 133-3 for dermal passive dosimetry exposure and

133-4 for inhalation passive dosimetry exposure. The air monitoring studies for paint uses

must include monitoring for the potential degradate (formaldehyde) as well as monitoring

for triethylhexahydrotriazine itself.

6. Other Considerations 

The Food Quality Protection Act of 1996 amends both FFDCA and FIFRA by

setting a new safety standard for the establishment of tolerances. In determining whether

or not a tolerance meets the new safety standard, FQPA directs EPA to consider

information concerning: the susceptibility of infants and children to residues of the

pesticide in food; the potential for aggregate exposures from dietary as well as nonoccupational sources, such as pesticides used in and around the home; and the potential for

cumulative effects from a pesticide and other substances that have a common mechanism

of toxicity.

Because triethylhexahydrotriazine has no food uses, and therefore no tolerances have

been established, the specific determinations outlined in FQPA are not required for this
21

chemical. Nevertheless, EPA believes that consideration of available data relating to the

special sensitivity of infants and children, as well as the potential for aggregate exposures

and cumulative effects is prudent for triethylhexahydrotriazine because children and other

individuals could be exposed to this compound in non-occupational settings.

a. Potential Risks to Infants and Children

In determining whether or not an additional uncertainty (safety) factor is

appropriate for assessing risks to infants and children, EPA takes into account the

completeness and reliability of the toxicity data base, the nature of the effects

observed in pre-and post-natal studies, and other information such as

epidemiological data.

Based on current data requirements, only one developmental study is usually

required, and reproduction studies are not routinely required for non-food use

chemicals. A reproduction study has not been required for

triethylhexahydrotriazine.

The effects observed in the triethylhexahydrotriazine developmental study

can be summarized as follows:

Results from a rat developmental toxicity study (triethylhexahydrotriazine

was administered by gavage during gestation days 6-15, inclusive) indicated both

developmental and maternal toxicity. Developmental toxicity was observed at 150

mg/kg/day (highest dose tested) and consisted of increased fetal incidences of dilated

renal pelvises and bilateral convoluted ureters. Therefore, the LEL was 150

mg/kg/day and the NOEL was 75 mg/kg/day. In terms of maternal toxicity,

decreased body weight gains were observed during the entire dosing period at 150

mg/kg/day (highest dose tested). Thus the maternal LEL was 150 mg/kg/day and

the NOEL was 75 mg/kg/day.

In the triethylhexahydrotriazine study, developmental effects occurred at the

same dose level as maternal effects. The Agency would generally be concerned

when developmental effects are seen at doses lower than those which cause maternal

effects.

Nothing in the available data suggests special sensitivity of young organisms

to triethylhexahydrotriazine. Therefore, the Agency concludes that an additional

uncertainty factor need not be applied to the short and intermediate term NOELs

selected for the triethylhexahydrotriazine risk assessments at this time.

b. Aggregate exposure

In examining aggregate exposures, EPA takes into account available

information concerning exposures from pesticide residue in food and other

exposures for which there is reliable information. These other sources of exposure

can include drinking water, and non-occupational exposures, e.g., to pesticides used

in and around the home.
22

There are no food uses of triethylhexahydrotriazine, therefore exposure to

triethylhexahydrotriazine residues in the diet are not expected. Because the uses of

triethylhexahydrotriazine are primarily indoors, EPA does not anticipate any

significant residues in drinking water. Thus, the only likely non-occupational

exposure to triethylhexahydrotriazine would be from uses in the home. These

include applying paints and adhesives containing triethylhexahydrotriazine, handling

rubber products which contain it as a preservative, and occupying the same room or

area where triethylhexahydrotriazine-containing products are being applied or have

been used. 

Based on available surrogate exposure information, applying

triethylhexahydrotriazine-containing paints would result in the reasonable worst case

exposure scenario, i.e., the highest exposure, for homeowners. The dermal MOE

for this scenario is > 1600. No data are available to estimate inhalation exposure,

which could be significant given the volatility of triethylhexahydrotriazine.

Therefore, the Agency is requiring inhalation exposure data for both applicators and

post-application exposure, including measurements of air concentrations in newly

painted rooms where infants and children could be exposed. Pending receipt and

review of this inhalation exposure data, EPA believes that it is reasonable to assume

that aggregate exposures to triethylhexahydrotriazine in the home are not likely to

be of concern based on the high MOE for dermal exposure.

c. Cumulative Effects

The Agency has not yet made a determination regarding the common

mode/mechanism of toxicity of triethylhexahydrotriazine and whether it is

appropriate to consider exposure to triethylhexahydrotriazine with other compounds

in order to address potential cumulative effects. There are significant structural

differences between triethylhexahydrotriazine and other more commonly known

triazine pesticides such as atrazine, simazine, and propazine. Unlike these other

triazines, triethylhexahydrotriazine has no aromatic ring, no double bonds, and is

not chlorinated. Because of these structural dissimilarities, the Agency would not

expect a common mechanism of toxicity between triethylhexahydrotriazine and the

other triazine pesticides.

Furthermore, based on the high dermal MOE for homeowner applicators, the

lack of food uses, the unlikelihood of residues in drinking water, and the low

concentration in paint, the Agency believes that the contribution of

triethylhexahydrotriazine exposure to the risks of any other compounds with a

common mode/mechanism of toxicity is likely to be minimal considering the

currently registered triethylhexahydrotriazine uses. 
23

C. Environmental Assessment

1. Ecological Toxicity Data 

a. Toxicity to Terrestrial Animals

Birds, Acute and Subacute: An acute oral toxicity study using the technical grade

of the active ingredient is required to establish the toxicity of a pesticide to birds.

The preferred test species is either mallard duck or bobwhite quail. Results of this

test are tabulated below.

Table 6 : Avian Acute Oral Toxicity

Species % A.I. LD50 a.i. Toxicity MRID No. Study

Mg/Kg/Day Category Classification

Northern Bobwhite Quail 96 311 Moderately toxic 42223201 Acceptable

(Colinus virginianus)

Northern Bobwhite Quail 96 394 Moderately toxic 00164390 Supplemental

(Colinus virginianus)

Mallard duck 96 595 Slightly toxic 00164390 Supplemental

(Anas platyrhyncus)

These results indicate that triethylhexahydrotriazine is slightly to

moderately toxic to avian species on an acute oral basis. The guideline

requirement (71-1) for a biocide is fulfilled (MRID 42223201).

Two subacute dietary studies using the technical grade of the active

ingredient are required to establish the toxicity of a pesticide to birds;

however, the Agency has determined that one avian subacute dietary toxicity

study is sufficient for a biocide such as triethylhexahydrotriazine that has

only indoor use patterns. The tested species is the bobwhite quail (an upland

gamebird). Results of this test are tabulated below.

Table 7: Avian Subacute Dietary Toxicity

Species % A.I. LC50 (ppm) Toxicity MRID No. Study

Category Classification

Northern Bobwhite Quail 96 > 5000 Practically non-toxic 42317001 Acceptable

(Colinus virginianus)

These results indicate that triethylhexahydrotriazine is practically

non-toxic to avian species on a subacute dietary basis. The guideline

requirement (71-2) is fulfilled (MRID 42317001).
24

b. Toxicity to Aquatic Animals

(1) Freshwater Fish

One freshwater fish toxicity study is typically required for

microbiocides; however, tests with two species are available. The tests are

conducted with the technical grade of the active ingredient in order to

establish the toxicity of a pesticide to fish. The preferred test species are

rainbow trout (a cold-water fish) and bluegill sunfish (a warm water fish).

Results of these tests are tabulated below.

Table 8 : Freshwater Fish Acute Toxicity 

Species % A.I. LC50 Toxicity Category MRID No. Study

(ppm) Classification

Rainbow trout 96 35 Slightly Toxic 42209701 Acceptable

(Oncorhynchus mykiss)

Rainbow trout 96 23 Slightly Toxic ACC128718 Acceptable

(Oncorhynchus mykiss)

Bluegill sunfish 95 31 Slightly Toxic ACC128718 Acceptable

(Lepomis macrochirus)

The results indicate that triethylhexahydrotriazine is slightly toxic to

freshwater fish on an acute basis. The guideline requirement (72-1)

is fulfilled (MRIDs 42209701, ACC128718).

(2) Freshwater Invertebrates, Acute

A freshwater aquatic invertebrate toxicity test using the technical

grade of the active ingredient is required to assess its toxicity to

invertebrates. The preferred test species is Daphnia magna. Results of this

test are tabulated below.

Table 9 : Freshwater Invertebrate Toxicity 

Species % A.I. LC50/ Toxicity Category MRID No. Study

EC50 (ppm) Classification

Waterflea (Daphnia magna) 96 26 Slightly Toxic 42557301 Acceptable

The results indicate that triethylhexahydrotriazine is slightly toxic to

aquatic invertebrates on an acute basis. The guideline requirement (72-2) is

fulfilled (MRID 42557301).

2. Environmental Fate

Environmental Fate Assessment

The current policy for microbiocides requires a hydrolysis study. The

Agency does not have a hydrolysis study for this active ingredient, but, based on the
25

behavior of structurally related chemicals, the expected reaction products may be

formaldehyde and ethylamine. However, the effect of different pHs on the rate of

hydrolytic degradation is not known. The data requirement is not fulfilled. Data

are needed on the rate of hydrolysis of triethylhexahydrotriazine at pH 5, 7 and 9,

and the reaction products must be identified.

3. Exposure and Risk Characterization

a. Exposure and Risk to Nontarget Organisms

The Agency requires only a limited number of ecotoxicology and

environmental fate studies for microbiocides with indoor use patterns. The available

data classify triethylhexahydrotriazine as moderately toxic to birds on an acute oral

basis, practically non-toxic to birds on a subacute dietary basis, and slightly toxic

to freshwater fish and aquatic invertebrates on an acute basis. While the hazard to

aquatic organisms from triethylhexahydrotriazine has been characterized, a

quantitative risk assessment has not been conducted. The risks to aquatic

environments are regulated under the NPDES permitting program of the Agency's

Office of Water. Labels for all triethylhexahydrotriazine products must require that

discharges to aquatic environments comply with an NPDES permit.

The fuel additive use of triethylhexahydrotriazine may be associated with

periodic releases into the environment from the purging of storage tanks. This

terrestrial use is expected to result in minimal to no exposure.

b. Endangered Species

The Agency does not anticipate any exposure of concern to fish and wildlife,

providing that triethylhexahydrotriazine products are discharged into the

environment in accordance with all disposal laws or a NPDES permit.

IV. RISK MANAGEMENT AND REREGISTRATION DECISION

A. Determination of 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 required to support reregistration of products containing

triethylhexahydrotriazine. The Agency has completed its review of these generic data, and has

determined that the data are sufficient to support reregistration of all products containing

triethylhexahydrotriazine under the conditions specified in this RED. Appendix B identifies the

generic data requirements that the Agency reviewed as part of its determination of reregistration

eligibility of triethylhexahydrotriazine, and lists the submitted studies that the Agency found

acceptable.
26

The data identified in Appendix B were sufficient to allow the Agency to assess the

registered uses of triethylhexahydrotriazine and to determine that triethylhexahydrotriazine can be

used under the conditions specified in this RED without resulting in unreasonable adverse effects

to humans and the environment. The Agency therefore finds that all products containing

triethylhexahydrotriazine as the active ingredient are eligible for reregistration. The reregistration

of particular products is addressed in Section V of this document. 

The Agency made its reregistration eligibility determination based upon the target data base

required for reregistration, the current guidelines for conducting acceptable studies to generate such

data, published scientific literature, etc. and the data identified in Appendix B. Although the

Agency has found that all uses of triethylhexahydrotriazine are eligible for reregistration, it should

be understood that the Agency may take appropriate regulatory action, and/or require the

submission of additional data to support the registration of products containing

triethylhexahydrotriazine, if new information comes to the Agency's attention or if the data

requirements for registration (or the guidelines for generating such data) change. 

Under section 5 of the Occupational Safety and Health Act, 29 U.S.C. 651 et sec, every

employer has a general duty to furnish a place of employment which is free from recognized

hazards that are causing, or are likely to cause, serious physical harm. Every employer is also

required to comply with occupational safety and health standards promulgated by OSHA.

Operations such as blending and formulating using 1,3,5-Triethylhexahydrotriazine in general

industry (i.e., Standard Industrial Codes 20 - 39) may be subject to other OSHA requirements.

There is no OSHA PEL for triethylhexahydrotriazine. 

Because triethylhexahydrotriazine currently has no food uses and no tolerances have been

established, the specific determinations outlined in the Food Quality Protection Act of 1996 are not

required for the reregistration of this chemical. Nevertheless, EPA has considered available data

relating to the sensitivity of infants and children, the potential for aggregate exposures and

cumulative effects in its risk management decision for triethylhexahydrotriazine because children

and other individuals could be exposed to this compound in non-occupational settings.

B. Determination of Eligibility Decision 

1. Eligibility Decision

Based on the reviews of the generic data for the active ingredient

triethylhexahydrotriazine, the Agency has sufficient information on the health effects of

triethylhexahydrotriazine and on its potential for causing adverse effects in fish and wildlife

and the environment. The Agency has determined that triethylhexahydrotriazine products,

labeled and used as specified in this Reregistration Eligibility Decision, will not pose

unreasonable risks or adverse effects to humans or the environment. Therefore, the Agency

concludes that products containing triethylhexahydrotriazine for all uses are eligible for

reregistration.

2. Eligible and Ineligible Uses 

The Agency has determined that all current uses of triethylhexahydrotriazine are

eligible for reregistration.
27

C. Regulatory Position and Labeling Rationale 

The following is a summary of the regulatory positions and rationales for

triethylhexahydrotriazine. Where labeling revisions are imposed, specific language is set forth in

Section V of this document.

Labeling Rationale/Risk Mitigation Measures

1. Potential Risks to Infants and Children/Aggregate Exposure/Cumulative Effects

In determining whether infants and children are particularly susceptible to the toxic

effects of triethylhexahydrotriazine, EPA considered the completeness and reliability of the

toxicity data base, the nature of the effects observed in toxicity studies, and other

information. 

Based on current data requirements, only one developmental study is usually

required for non-food use chemicals. In the developmental study for

triethylhexahydrotriazine, effects on the fetuses were seen at the same dose as effects on the

mothers. Nothing in the available toxicity data base suggests special susceptibility of young

organisms to triethylhexahydrotriazine. Therefore, the Agency has concluded that an

additional uncertainty factor need not be applied to the short-term and intermediate-term

NOELs selected for the triethylhexahydrotriazine risk assessments at this time. 

In examining aggregate exposure, EPA takes into account available information

concerning exposures from the pesticide residue in food and other exposures for which there

is reliable information. These other sources of exposure can include drinking water, and

other non-occupational exposures to pesticides used in and around the home.

No dietary exposure is expected since there are no food-uses of

triethylhexahydrotriazine. Because there are no outdoor uses, residues in drinking water

are unlikely. Thus, residential uses are the only potential sources of exposure that could

be aggregated. EPA assumes that applying paint containing triethylhexahydrotriazine would

be the reasonable worst case exposure scenario for homeowners. Because the dermal MOE

for this scenario is high (> 1600), EPA believes that aggregate exposures to other sources

of triethylhexahydrotriazine in the home are not likely to be of concern. To confirm this

assumption, EPA is requiring dermal and inhalation exposure data for applicators and for

post application-exposures including monitoring air concentrations in newly painted rooms

where infants and children could be exposed. 

The Agency has not yet made a determination regarding the common

mode/mechanism of toxicity of triethylhexahydrotriazine and whether it is appropriate to

consider exposure from triethylhexahydrotriazine with other compounds in order to address

potential cumulative effects.

However, based on the high dermal MOE for homeowner applicators, the lack of

food uses, the unlikelihood of residues in drinking water, and the low concentration in

paint, the Agency believes that the contribution of triethylhexahydrotriazine exposures to
28

the risks of other compounds with a common mode/mechanism of toxicity is likely to be

minimal considering the currently registered triethylhexahydrotriazine uses.

2. Handler Safety Requirements

During reregistration, the Agency considers handler safety requirements for

occupational and residential uses.

a. Personal Protective Equipment Requirements for Occupational Handlers

The Agency establishes handler safety requirements when risk assessments

or general concerns suggest such requirements are appropriate. If EPA determines

that no specific handler requirements are warranted based on the potential acute or

other adverse effects of the active ingredient, the handler safety requirements will

be based on the acute toxicity characteristics of the end-use product. 

The Agency is developing standardized requirements for occupational

handlers of industrial biocides, based on the acute toxicity characteristics of each

end-use product. In addition, OSHA has established requirements for hazard

communication and use of personal protective equipment for protection of workers

potentially exposed to chemical or other types of hazards in the workplace. OSHA’s

hazard communication standard (29 CFR 1910.1200) establishes requirements for

labeling, preparation and dissemination of Material Safety Data Sheets (MSDSs),

training, etc., for workers potentially exposed to hazardous chemicals. OSHA

requirements for the selection and use of personal protective equipment (29 CFR

1910, Subpart I) include an assessment of the workplace to determine if hazards

potentially requiring the use of head, eye, face or foot protection are present or are

likely to be present. If hazards are identified, employers must select and have

employees use appropriate personal protective equipment (PPE) which has been

properly fitted and selected based on the potential hazard present. Employers are

required to provide training on the proper use of personal protective equipment,

when it is required, what equipment is necessary, how to properly don, doff, adjust,

and wear the PPE, the limitations of the equipment, proper care and maintenance,

useful life, and disposal of the PPE.

For triethylhexahydrotriazine, the MSDS recommends the use of rubber

gloves, goggles, a NIOSH cartridge respirator if respiratory irritation or excessive

off-gassing occurs (respiratory protection is typically not required), and effective

exhaust or local exhaust ventilation. If these measures are appropriately selected,

maintained, and used, worker exposures during operations where

triethylhexahydrotriazine is used in paint, adhesives, rubber products, and

metalworking/cutting fluids are expected to be reduced. 

In general for occupational-use products, the Agency requires that handlers

(mixers, loaders, applicators, etc.) of all industrial biocides wear long-sleeve shirts,

long pants, shoes, and socks as minimum work attire. For industrial biocide end-use

products that are classified as toxicity category I or II for acute dermal or skin

irritation potential, handlers are required to wear chemical-resistant gloves and a
29

chemical-resistant apron in addition to the minimum work attire. For industrial

biocide end-use products classified as toxicity category I or II for eye irritation

potential, handlers are required to wear protective eyewear. For industrial biocide

end-use products classified as toxicity category I or II for acute inhalation toxicity,

handlers are required to wear a respirator. The type of respirator must be based on

the acute toxicity category and the vapor pressure and must be specified on the enduse product labeling. Table 10 summarizes the personal protective equipment

requirements for industrial biocides based on acute toxicity and corresponding

toxicity categories. EPA will assist registrants in determining the appropriate type

of respirator during the end-use product stage of reregistration.

Table 10. Personal Protective Equipment Requirements for Industrial Biocides Based on Acute

Toxicity and Corresponding Toxicity Categories

Route of Concern Toxicity Toxicity Toxicity Toxicity

Category I Category II Category III Category IV

Acute Dermal Long sleeve shirt, Long sleeve shirt, long Long sleeve shirt, Long sleeve shirt,

Toxicity or Skin long pants, shoes, socks, pants, shoes, socks, & long pants, shoes,& long pants,

Irritation Potential & chemical- resistant chemical- resistant gloves, socks shoes,& socks

gloves & apron & apron

Eye Irritant Protective Eyewear Protective Eyewear No minimum No minimum

Acute Inhalation Respirator Respirator No minimum No minimum

Toxicity

At this time for all handler tasks, safety requirements for products containing

triethylhexahydrotriazine must be determined based on the acute toxicity

characteristics of the end-use product. It should be noted that in the case of

triethylhexahydrotriazine, there are currently no products registered solely as

manufacturing use products (MPs).

b. Engineering Control Requirements for Occupational Handlers

EPA is prohibiting open pouring and requiring the use of meter pumps or

other automatic dispensing equipment for triethylhexahydrotriazine use in wet-end

additives and industrial processing chemicals. For use in paint, rubber products,

industrial adhesives, or fuel/oil storage tank bottoms, EPA is requiring that the vats

to which the triethylhexahydrotriazine is added must be closed and equipped with

mechanical vents to the outdoors.

c. Application and Post Application Exposure Data

EPA is requiring worker exposure data for triethylhexahydrotriazine

containing paint applied by brush, roller, and spray. Additionally, the Agency is

requiring post application monitoring data to determine exposure to residents or

occupants of areas that have been painted with triethylhexahydrotriazine-containing

paints. These post application data will include monitoring for the potential

degradate (formaldehyde) as well as for triethylhexahydrotriazine itself. 
30

These data are being required because the Agency currently has no

appropriate data available to estimate inhalation exposure to

triethylhexahydrotriazine and because this compound is volatile. These data are

considered confirmatory because the MOEs for triethylhexahydrotriazine for dermal

exposure alone are high, greater than 300 for occupational painters and greater than

1600 for homeowners.

However, if the results of these required studies indicate higher than

anticipated exposures to workers or homeowners applying paint or to persons

occupying newly painted areas, EPA may require additional inhalation toxicity data

and/or further restrictions on use.

d. Additional Labeling Requirements

The Agency is also requiring specific label language addressing application

restrictions, effluent discharge requirements, and user safety requirements and

recommendations. Label language is found in Part V.

V. ACTIONS REQUIRED OF REGISTRANTS

This section specifies the data requirements and responses necessary for the reregistration of both

manufacturing-use and end-use products.

A. Manufacturing-Use Products

As noted previously, there are currently no triethylhexahydrotriazine products registered

solely as manufacturing use products (MPs). Whenever possible, EPA strongly encourages

registrants to separate manufacturing use registrations from end use registrations in order to make

clear for the registrants and the Agency which specific data needs and labeling requirements apply

to each category of product. However, when one product is used for both manufacturing and end

use purposes, as is the case with triethylhexahydrotriazine, that product is subject to both sets of

labeling and data requirements.

1. Additional Generic Data Requirements

The generic data base supporting the reregistration of triethylhexahydrotriazine for

the above eligible uses has been reviewed and determined to be substantially complete. The

Agency is requiring confirmatory data for hydrolysis and for post-application dermal and

inhalation exposures in painted areas where paint is applied by brush, roller, and sprayer.

For these exposure scenarios, studies should be conducted using guideline numbers:

161-1 Hydrolysis

133-3 Dermal Passive Dosimetry Exposure

133-4 Inhalation Passive Dosimetry Exposure

231 Estimation of Dermal Exposure (Outdoor)

232 Estimation of Inhalation Exposure (Outdoor)

233 Estimation of Dermal Exposure (Indoor)

234 Estimation of Inhalation Exposure (Indoor) 
31

The air monitoring studies for paint uses must include monitoring for the potential

degradate (formaldehyde) as well as monitoring for triethylhexahydrotriazine itself. 

The Agency is issuing a DCI concurrent with this RED to triethylhexahydrotriazine

registrants for the hydrolysis data. However, because much of the exposure data needed

for triethylhexahydrotriazine is generic in nature and will also be required for other

antimicrobial chemicals with similar characteristics and uses, EPA is developing a generic

exposure DCI. Triethylhexahydrotriazine registrants will receive the generic exposure DCI

at the same time as registrants of other antimicrobial chemicals with similar uses. 

2. Labeling Requirements for Manufacturing-Use Products

To remain in compliance with FIFRA, manufacturing use product (MP) labeling

must be revised to comply with all current EPA regulations, PR Notices and applicable

policies. The MP labeling must bear the following statement under Directions for Use:

“Only for formulation into a [list type of pesticide, i.e.

microbicide/microbiostat/bacteriostat] for use as an additive for [list uses that are

being supported by MP registrant, i.e., industrial adhesives, metalworking cutting

fluid, latex paints and aqueous slurries, synthetic rubber latex, and marine fuels].”

A MP registrant may, at his/her discretion, add one of the following statements to a MP

label under “Directions for Use” to permit the reformulation of the product for a specific

use or all additional uses supported by a formulator or user group:

(a) “This product may be used to formulate products for specific use(s)

not listed on the MP label if the formulator, user group, or grower

has complied with U.S. EPA submission requirements regarding

support of such use(s).”

(b) “This product may be used to formulate products for any additional

use(s) not listed on the MP label if the formulator, user group, or

grower has complied with U.S. EPA submission requirements

regarding support of such use(s).”

B. End-Use Products

1. Additional Product-Specific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed productspecific data regarding the pesticide after a determination of eligibility has been made. The

product specific data requirements are listed in Appendix D, the Product Specific Data CallIn Notice.

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 study MRID numbers
32

should be cited according to the instructions in the Requirement Status and Registrants

Response Form provided for each product.

2. Labeling Requirements for End-Use Products

a. Occupational Labeling PPE Requirements for Pesticide Handlers

Sole-active ingredient end-use products that contain triethylhexahydrotriazine

must be revised to adopt the handler personal protective equipment requirements set

forth in this section. Any conflicting PPE requirements on current labeling must be

removed.

(1) PPE Requirements for Occupational Handlers

Any necessary PPE for each triethylhexahydrotriazine occupational

end-use product will be established on the basis of the end-use product's

acute toxicity category as specified in Section V of this document. All enduse products will be required to specify the minimum work attire for all

handlers. 

The minimum handler labeling requirements for occupational uses of

triethylhexahydrotriazine end-use products is:

“Mixers, loaders, applicators and other handlers must wear:

-- Long-sleeve shirt and long pants,

-- Shoes plus socks.”

If the end-use product is classified as toxicity category I or II for eye

irritation potential or if data for this route of concern are waived due to

corrosivity, add:

-- Protective eyewear.

If the end-use product is classified as toxicity category I or II for

acute dermal toxicity or skin irritation potential or data for either of these

routes of concern are waived due to corrosivity, add:

-- Chemical-resistant apron, and

-- Chemical-resistant gloves .

*

For the glove statement, use the statement established for triethylhexahydrotriazine through *

the instructions in Supplement Three of PR Notice 93-7. In addition, for concentrated

triethylhexahydrotriazine products, the corrosiveness and penetration of

triethylhexahydrotriazine must be considered. Appropriate chemical-resistant materials must

be listed on the product labeling. 

If the end-use product is classified as toxicity category I or II for

acute inhalation toxicity, a respirator requirement must be added. The type
33

of respirator must be specified in the statement and is based on the acute

toxicity category and the vapor pressure. EPA will assist registrants in

determining the appropriate type of respirator during the end-use product

phase of reregistration.

In addition to the minimum PPE specified above, the following

specific PPE and engineering-control requirements must be added to labels

containing the following uses.

When labeling contains uses for wet-end additives/industrial processing

chemicals, add the following:

“For use in wet-end additives/industrial processing chemicals, meter

pumps or other automatic dispensing equipment is required. Open

pouring is prohibited.”

When labeling contains uses for paint, rubber products, or industrial

adhesives, or fuels/oil storage tank bottom water, add the following:

“For use in paint, rubber products, industrial adhesives, or fuels/oil

storage tank bottom water, the vats to which

triethylhexahydrotriazine is being added must be closed and equipped

with mechanical vents to the outdoors.” 

Placement in Labeling

The personal protective equipment requirements must be placed on

the end-use product labeling in the format and language specified above and

must be placed in the “Hazards to Humans” section of the pesticide labeling.

(2) PPE Requirements for Homeowner Handlers

EPA's regulatory authority does not encompass requiring label

statements for paints or other homeowner products that have had

triethylhexahydrotriazine added as part of the manufacturing process.

However, based on EPA's assessment of potential homeowner risks, no

additional PPE is needed. 

b. Other Labeling Requirements - Products Intended for Occupational Use

The Agency is requiring the following labeling statements to be located on

all end-use products containing triethylhexahydrotriazine that are intended for

occupational use. Additional handler safety requirements will be determined based

on the acute toxicity characteristics of each end-use product.

Application Restrictions
34

“Do not use this product in a way that will contact workers or other

persons.”

“Do not apply this product as a spray.”

Timing of Applications

Labels must specify when and how often in the manufacturing process the

product is added or applied.

Effluent Discharge Restriction

“This product is toxic to fish. Do not discharge effluent containing this

product into lakes, streams, ponds, estuaries, oceans or other water unless

in accord with the requirements of a National Pollution Discharge

Elimination System (NPDES) permit and permitting authority has been

notified in writing prior to discharge. Do not discharge this product to

sewer systems without previously notifying the local sewage treatment plant

authority. For guidance contact your State Water Board or Regional Office

of the EPA.”

User Safety Requirements

If gloves or protective eyewear are required PPE on the end-use product,

add:

“Follow manufacturer’s instructions for cleaning/maintaining PPE. If no

such instructions are available for washables, use detergent and hot water.

Keep and wash PPE separately from other laundry.”

User Safety Recommendations

- “Users should wash hands before eating, drinking, chewing gum, using

tobacco, or using the toilet.”

- “Users should remove clothing immediately if pesticide gets inside. Then

wash thoroughly and put on clean clothing.”

Registrant: add the following statements only if gloves are required PPE on

the end-use product:

- “Users should remove PPE immediately after handling this product. Wash

the outside of gloves before removing. As soon as possible wash

thoroughly.”

C. Existing Stocks
35

Registrants may generally distribute and sell products bearing old labels/labeling for 26

months from the date of the issuance of this Reregistration Eligibility Decision (RED). Persons

other than the registrant may generally distribute or sell such products for 50 months from the date

of the issuance of this RED. However, existing stocks time frames will be established case-by-case,

depending on the number of products involved, the number of label changes, and other factors.

Refer to “Existing Stocks of Pesticide Products; Statement of Policy”; Federal Register, Volume

56, No. 123, June 26, 1991.

The Agency has determined that registrants may distribute and sell triethylhexahydrotriazine

products bearing old labels/labeling for 26 months from the date of issuance of this RED. Persons

other than the registrant may distribute or sell such products for 50 months from the date of the

issuance of this RED. Registrants and persons other than registrants remain obligated to meet preexisting Agency imposed label changes and existing stocks requirements applicable to products they

sell or distribute.
36
37

VI. APPENDICES
38

APPENDIX A. Table of Use Patterns Subject to Reregistration
39

Report Run Date: 07/13/95 ) Time 09:59 APPENDIX A ) CASE 3147, [Triethylhexahydrotriazine] Chemical 082901 [1,3,5-Triethylhexahydro-s-t LUIS 2.1 ) Page1

PRD Report Date: 06/16/95 

44444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444

SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use

 Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations

 Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes

 cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]

 cycle

USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED

)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))

ADHESIVES, INDUSTRIAL Use Group: INDOOR NON-FOOD

Industrial preservative treatment., SC/L W 95 W 475 * NS NS NS NS NS NS C18, C24

During manufacture., Not on label., Not

Applicable., Not applicable for this use.

FUELS/OIL STORAGE TANK BOTTOM WATER ADDITIVE Use Group: INDOOR NON-FOOD

Additive treatment., Not on label., Not SC/L V 372 V 465 * NS NS NS NS NS NS

on label., Not Applicable., Not

applicable for this use.

Additive treatment., When needed., Not on SC/L V 363 V 1813 * NS NS NS NS NS NS A08

label., Not Applicable., Not applicable

for this use.

METALWORKING CUTTING FLUIDS Use Group: INDOOR NON-FOOD

Industrial preservative treatment., SC/L V 28500 V 28500 * NS NS NS NS NS NS C18, C24

During manufacture., Not on label., Not

Applicable., Not applicable for this use.

PAINTS, LATEX (IN-CAN) Use Group: INDOOR NON-FOOD

Industrial preservative treatment., SC/L W 475 W 1425 * NS NS NS NS NS NS C18, C24

During manufacture., Not on label., Not

Applicable., Not applicable for this use.

RUBBER PRODUCTS Use Group: INDOOR NON-FOOD

Industrial preservative treatment., SC/L W 190 W 475 * NS NS NS NS NS NS C18, C24

During manufacture., Not on label., Not

Applicable., Not applicable for this use.

WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS Use Group: INDOOR NON-FOOD

Industrial preservative treatment., SC/L W 95 W 95 * NS NS NS NS NS NS C18, C24

During manufacture., Not on label., Not

Applicable., Not applicable for this use.

 SC/L W 475 W 1425 * NS NS NS NS NS NS C18, C24
40

Report Run Date: 07/13/95 ) Time 09:59 APPENDIX A ) CASE 3147, [Triethylhexahydrotriazine] Chemical 082901 [1,3,5-Triethylhexahydro-s-tr LUIS 2.1 ) Page 2

PRD Report Date: 06/16/95 

444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444

LEGEND

444444

 HEADER ABBREVIATIONS

 Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.

 noted otherwise)

 Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.

 noted otherwise)

 Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).

 Max. # Apps @ Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: “4 applications per year” is expressed as “4/1 yr”; “4 applications per 3 

 years” is expressed as “4/3 yr” 

 Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.

 noted otherwise)/A]

 Min. Interv (days) : Minimum Interval between Applications (days)

 Restr. Entry Interv (days) : Restricted Entry Interval (days)

 PRD Report Date : LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products

 registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have

 data that has been captured.

 SOIL TEXTURE FOR MAX APP. RATE

 * : Non-specific

 C : Coarse

 M : Medium

 F : Fine

 O : Others

 FORMULATION CODES

 SC/L : SOLUBLE CONCENTRATE/LIQUID

 ABBREVIATIONS 

 AN : As Needed

 NA : Not Applicable

 NS : Not Specified (on label)

 UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet, 

 briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part, 

 parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, -- 

 APPLICATION RATE

 DCNC : Dosage Can Not be Calculated

 No Calc : No Calculation can be made

 W : PPM calculated by weight

 V : PPM Calculated by volume

 U : Unknown whether PPM is given by weight or by volume

 cwt : Hundred Weight

 nnE-xx : nn times (10 power -xx); for instance, “1.234E-04" is equivalent to “.0001234"

 USE LIMITATIONS CODES

 A08 : Preclean claim.

 C18 : Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority.

 C24 : Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water. (NPDES license restriction)

 * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
41

APPENDIX B. Table of the Generic Data Requirements and Studies Used to Make the Reregistration Decision

GUIDE TO APPENDIX B

Appendix B contains listings of data requirements which support the reregistration for

active ingredients within the case 1,3,5-Triethylhexahydro-s-triazine covered by this

Reregistration Eligibility Decision Document. It contains generic data requirements that apply

to 1,3,5-Triethylhexahydro-s-triazine in all products, including data requirements for which a

“typical formulation” is the test substance.

The data table is organized in the following format:

1. Data Requirement (Column 1). The data requirements are listed in the order in

which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer

to the test protocols set in the Pesticide Assessment Guidelines, which are available from the

National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)

487-4650.

2. Use Pattern (Column 2). This column indicates the use patterns for which the data

requirements apply. The following letter designations are used for the given use patterns:

A Terrestrial food

B Terrestrial feed

C Terrestrial non-food

D Aquatic food

E Aquatic non-food outdoor

F Aquatic non-food industrial

G Aquatic non-food residential

H Greenhouse food

I Greenhouse non-food

J Forestry

K Residential

L Indoor food

M Indoor non-food

N Indoor medical

O Indoor residential

3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,

this column lists the identifying number of each study. This normally is the Master Record

Identification (MRID) number, but may be a “GS” number if no MRID number has been

assigned. Refer to the Bibliography appendix for a complete citation of the study.
42
43

APPENDIX B

Data Supporting Guideline Requirements for the Reregistration of Triethylhexahydrotriazine

REQUIREMENT USE PATTERN CITATION(S)

PRODUCT CHEMISTRY

61-1 Chemical Identity ALL 41677801

61-2A Start. Mat. & Mnfg. Process ALL 41677801

61-2B Formation of Impurities ALL 41677801

62-1 Preliminary Analysis ALL 41677802

62-2 Certification of limits ALL 41677802

62-3 Analytical Method ALL 41677802

63-2 Color ALL 41677803

63-3 Physical State ALL 41677803

63-4 Odor ALL 41677803

63-5 Melting Point ALL 41677803

63-6 Boiling Point ALL 41677803

63-7 Density ALL 41677803

63-8 Solubility ALL 41677803

63-9 Vapor Pressure ALL 41677803

63-11 Octanol/Water Partition ALL 41677803

63-12 pH ALL 41677803, 44139701

63-13 Stability ALL 41677803
Data Supporting Guideline Requirements for the Reregistration of Triethylhexahydrotriazine

REQUIREMENT USE PATTERN CITATION(S)

44

ECOLOGICAL EFFECTS

71-1A Acute Avian Oral - Quail/Duck ALL 42223201, 164390, 164390

71-2A Avian Dietary - Quail ALL 42317001

71-2B Avian Dietary - Duck ALL 42317001

72-1A Fish Toxicity Bluegill ALL 42209701, ACC128718

72-1C Fish Toxicity Rainbow Trout ALL ACC128718

72-2A Invertebrate Toxicity ALL 42557301

TOXICOLOGY

81-1 Acute Oral Toxicity - Rat ALL 41773701

81-2 Acute Dermal Toxicity - ALL Waived

Rabbit/Rat

81-3 Acute Inhalation Toxicity - Rat ALL 4406101

81-4 Primary Eye Irritation - Rabbit ALL Waived

81-5 Primary Dermal Irritation - Rabbit ALL Waived

81-6 Dermal Sensitization - Guinea Pig ALL 41620501

82-3 90-Day Dermal - Rodent ALL 41858301

83-3A Developmental Toxicity - Rat ALL 41865701, 42308601, 42366200, 42366201

83-3B Developmental Toxicity - Rabbit ALL Waived

84-2A Gene Mutation (Ames Test) ALL 41343401, 41343402, 41544801

84-2B Structural Chromosomal ALL 41738201, 41321501

Aberration

84-4 Other Genotoxic Effects ALL 41544801, 41343402
Data Supporting Guideline Requirements for the Reregistration of Triethylhexahydrotriazine

REQUIREMENT USE PATTERN CITATION(S)

45

OCCUPATIONAL/RESIDENTIAL EXPOSURE

133-3 Dermal Passive Dosimetry M,O Confirmatory Data Required*

Exposure

133-4 Inhalation Passive Dosimetry M,O Confirmatory Data Required*

Exposure

231 Estimation of Dermal Exposure at K,M,O Confirmatory Data Required*

Outdoor Sites

232 Estimation of Inhalation Exposure K,M,O Confirmatory Data Required*

at Outdoor Sites

233 Estimation of Dermal Exposure at M,O Confirmatory Data Required*

Indoor Sites

234 Estimation of Inhalation Exposure M,O Confirmatory Data Required*

at Indoor Sites

ENVIRONMENTAL FATE

161-1 Hydrolysis ALL Confirmatory Data Required

* See page 31
46
47

APPENDIX C. Citations Considered to be Part of the Data Base Supporting the Reregistration of 1,3,5-Triethylhexahydro-s-triazine

GUIDE TO APPENDIX C

1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies

considered relevant by EPA in arriving at the positions and conclusions stated

elsewhere in the Reregistration Eligibility Document. Primary sources for studies in

this bibliography have been the body of data submitted to EPA and its predecessor

agencies in support of past regulatory decisions. Selections from other sources

including the published literature, in those instances where they have been considered,

are included.

2. UNITS OF ENTRY. The unit of entry in this bibliography is called a “study”. In the

case of published materials, this corresponds closely to an article. In the case of

unpublished materials submitted to the Agency, the Agency has sought to identify

documents at a level parallel to the published article from within the typically larger

volumes in which they were submitted. The resulting “studies” generally have a

distinct title (or at least a single subject), can stand alone for purposes of review and

can be described with a conventional bibliographic citation. The Agency has also

attempted to unite basic documents and commentaries upon them, treating them as a

single study.

3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted

numerically by Master Record Identifier, or “MRID number”. This number is unique

to the citation, and should be used whenever a specific reference is required. It is not

related to the six-digit “Accession Number” which has been used to identify volumes

of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few

cases, entries added to the bibliography late in the review may be preceded by a nine

character temporary identifier. These entries are listed after all MRID entries. This

temporary identifying number is also to be used whenever specific reference is needed.

4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry

consists of a citation containing standard elements followed, in the case of material

submitted to EPA, by a description of the earliest known submission. Bibliographic

conventions used reflect the standard of the American National Standards Institute

(ANSI), expanded to provide for certain special needs.

a Author. Whenever the author could confidently be identified, the Agency has

chosen to show a personal author. When no individual was identified, the

Agency has shown an identifiable laboratory or testing facility as the author. 

When no author or laboratory could be identified, the Agency has shown the

first submitter as the author.

b. Document date. The date of the study is taken directly from the document. 

When the date is followed by a question mark, the bibliographer has deduced

the date from the evidence contained in the document. When the date appears

as (19??), the Agency was unable to determine or estimate the date of the

document.
48

c. Title. In some cases, it has been necessary for the Agency bibliographers to

create or enhance a document title. Any such editorial insertions are contained

between square brackets.

d. Trailing parentheses. For studies submitted to the Agency in the past, the

trailing parentheses include (in addition to any self-explanatory text) the

following elements describing the earliest known submission:

(1) Submission date. The date of the earliest known submission appears

immediately following the word “received.”

(2) Administrative number. The next element immediately following the

word “under” is the registration number, experimental use permit

number, petition number, or other administrative number associated

with the earliest known submission.

(3) Submitter. The third element is the submitter. When authorship is

defaulted to the submitter, this element is omitted.

(4) Volume Identification (Accession Numbers). The final element in the

trailing parentheses identifies the EPA accession number of the volume

in which the original submission of the study appears. The six-digit

accession number follows the symbol “CDL,” which stands for

“Company Data Library.” This accession number is in turn followed by

an alphabetic suffix which shows the relative position of the study within

the volume.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

49

00164390 Shellenberger, T. (1971) Letter sent to R. Sawyer dated Sept 17, 1971: Acute

toxicological evaluations of Vancide TH with wildlife: GSRI Proj. No.

NC-475. Prepared by Gulf South Research Institute. 11 p.

41321501 Putman, D.; Melhorn, J. (1989) Structural Chromosome Aberration: Mouse

Micronucleus: Vancide TH: Lab Project Number: T8796/ 122010. 

Unpublished study prepared by Microbiological Associates, Inc. 28 p.

41343401 San, R.; Kruel, C. (1989) Mutagenicity Salmonella/Mammalian Microsome

Plate Incorporated Assay Ames Test with Confirmation: Lab Project Number:

T8796/501014. Unpublished study prepared by Microbiological Associates,

Inc. 71 p.

41343402 Curren, R. (1989) Other Genotoxic Effects: Unscheduled DNA Synthesis in Rat

Primary Hepatocytes: Lab Project Number: T8796/380010. Unpublished study

prepared by Microbiological Associates, Inc. 30 p.

41620501 Trimmer, G. (1990) Dermal Sensitization Test in the Guinea Pig (Buehler

Method): Lab Project Number: 240822. Unpublished study prepared by Exxon

Biomedical Sciences, Inc. 44 p.

41677801 Flynn, F. (1990) Product Identity and Composition of Hexahydro-1,3,

5-triethyl-s-triazine. Unpublished study prepared by R. T. Vanderbilt Co., Inc. 

25 p.

41677802 Flynn, F. (1990) Analysis and Certification of Product Ingredients of

Hexahydro-1,3,5-triethyl-s-triazine. Unpublished study prepared by R. T.

Vanderbilt Co., Inc. 10 p.

41677803 Flynn, F.; Agahigian, H. (1990) Physical and Chemical Characteristics of

Hexahydro-1,3,5-triethyl-s-triazine. Unpublished study prepared by R. T.

Vanderbilt Co., Inc. in assoc. with Baron Consulting Co. 5 p.

41738201 Flynn, F. (1989) Identification, Assay and Stability of Test Substance

Hexahydro-1,3,5-triethyl-s-triazine (VANCIDE TH): Supplement. 

Unpublished study prepared by R.T. Vanderbilt Co., Inc. 7 p.

41738202 Flynn, F. (1989) Identification, Assay and Stability of Test Substance

Hexahydro-1,3,5-triethyl-s-triazine (VANCIDE TH): Supplement. 

Unpublished study prepared by R. T. Vanderbilt Co., Inc. 7 p.

41738203 Flynn, F. (1989) Identification, Assay and Stability of Test Substance

Hexahydro-1,3,5-triethyl-s-triazine (VANCIDE TH): Supplement. 

Unpublished study prepared by R. T. Vanderbilt Co., Inc. 7 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

50

41773701 Trimmer, G. (1991) Acute Oral Toxicity Test with LD50 Estimation in the Rat

with Vancide TH: Lab Project Number: 140802. Unpublished study prepared

by Exxon Biomedical Sciences, Inc. 44 p.

41858301 Trimmer, G. (1991) Vancide TH: 90 Day Subchronic Dermal Toxicity Study in

Rats: Lab Project Number: 240810-MRD-89-408. Unpublished study prepared

by Exxon Biomedical Sciences, Inc. 429 p.

41865701 Beyer, B. (1991) “Development Toxicity Study in Rats with Vancide TH”: Lab

Project Number: MRD-89-408: 240834. Unpublished study prepared by Exxon

Biomedical Sciences, Inc. 274 p.

42209701 Marchado, M. (1992) Vancide TH: Acute Toxicity to Rainbow Trout

(Oncorhynchus mykiss) Under Flow-Through Conditions. Unpublished study

prepared by Springborn Labs., Inc. 56 p.

42223201 Pederson, C.; Helsten, B. (1992) Hexahydro-1,3,5-triethyl-striazine

(VANCIDE TH): 21 Day Acute Oral LD50 Study in Bobwhite Quail: Lab

Project Number: 121-003-03. Unpublished study prepared by Bio-Life

Associates, Ltd. 66 p.

42308601 Beyer, B. (1992) Supplemental Information to MRID 41865701 Developmental

Toxicity Study in Rats with Vancide TH: Unpublished study prepared by Exxon

Biomedical Sciences, Inc. 6 p.

42317001 Pederson, C. (1992) Hexahydro-1,3,5-Triethyl-s-triazine (Vancide TH) 8-Day

Acute Dietary LC50 Study in Bobwhite Quail: Lab Project Number:

121-002-01. Unpublished study prepared by Bio-Life Associates, Ltd. 60 p.

42366200 R.T. Vanderbilt Co., Inc. (1992) Submission of Data in Response to

Antimicrobial Data Call-in for VANCIDE TH: Toxicology Study. Transmittal

of 1 study.

42366201 Beyer, B. (1992) Supplemental Information to MRID 41865701 and MRID

42308601--Developmental Toxicity Study in Rats with VANCIDE TH: Lab

Project Number: 20309. Unpublished study prepared by Exxon Biomedical

Sciences, Inc. 7 p.

42406101 Whitman, F. (1992) Vancide TH: Acute Inhalation Toxicity Study in Rats: Lab

Project Number: MRD-89-408: 140816. Unpublished study prepared by Exxon

Biomedical Sciences, Inc. 112 p.
BIBLIOGRAPHY

MRID CITATION

______________________________________________________

51

42557301 Putt, A. (1992) Vancide TH--Acute Toxicity to Daphnids (Daphnia magna)

under Flow-through Conditions: Lab Project Number: 92-10-4468. 

Unpublished study prepared by Springborn Labs, Inc. 58 p.

44139701 R.T. Vanderbilt Co., Inc. (1996) pH of a 5% Aqueous Solution of hexahydro1,3,5-triethyl-s-triazine: Unpublished study prepared by R.T. Vanderbilt Co.,

Inc. 9 p.
52
53

APPENDIX D. Product Specific Data Call-In

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

DATA CALL-IN NOTICE

CERTIFIED MAIL

Dear Sir or Madam:

This Notice requires you and other registrants of pesticide products containing the

active ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status

Sheet, to submit certain product specific data as noted herein to the U.S. Environmental

Protection Agency (EPA, the Agency). These data are necessary to maintain the continued

registration of your product(s) containing this active ingredient. Within 90 days after you

receive this Notice you must respond as set forth in Section III below. Your response must

state: 

1. How you will comply with the requirements set forth in this Notice and its

Attachments 1 through 6; or

2. Why you believe you are exempt from the requirements listed in this Notice and

in Attachment 3, Requirements Status and Registrant's Response Form, (see

section III-B); or

3. Why you believe EPA should not require your submission of product specific

data in the manner specified by this Notice (see section III-D).
54

If you do not respond to this Notice, or if you do not satisfy EPA that you will comply

with its requirements or should be exempt or excused from doing so, then the registration of

your product(s) subject to this Notice will be subject to suspension. We have provided a list

of all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as

well as a list of all registrants who were sent this Notice (Attachment 5).

The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide

and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this

information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-

0107 and 2070-0057 (expiration date 03-31-99).

This Notice is divided into six sections and six Attachments. The Notice itself contains

information and instructions applicable to all Data Call-In Notices. The Attachments contain

specific chemical information and instructions. The six sections of the Notice are:

Section I - Why You Are Receiving This Notice

Section II - Data Required By This Notice

Section III - Compliance With Requirements Of This Notice

Section IV - Consequences Of Failure To Comply With This Notice

Section V - Registrants' Obligation To Report Possible Unreasonable

Adverse Effects

Section VI - Inquiries And Responses To This Notice

The Attachments to this Notice are:

1 - Data Call-In Chemical Status Sheet

2 - Product-Specific Data Call-In Response Form 

3 - Requirements Status and Registrant's Response Form

4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data

Requirements for Reregistration

5 - List of Registrants Receiving This Notice

6 - Cost Share and Data Compensation Forms

SECTION I. WHY YOU ARE RECEIVING THIS NOTICE

The Agency has reviewed existing data for this active ingredient and reevaluated the

data needed to support continued registration of the subject active ingredient. The Agency has

concluded that the only additional data necessary are product specific data. No additional

generic data requirements are being imposed. You have been sent this Notice because you

have product(s) containing the subject active ingredient.

SECTION II. DATA REQUIRED BY THIS NOTICE

II-A. DATA REQUIRED

The product specific data required by this Notice are specified in Attachment 3,

Requirements Status and Registrant's Response Form. Depending on the results of the studies

required in this Notice, additional testing may be required.
55

II-B. SCHEDULE FOR SUBMISSION OF DATA

 You are required to submit the data or otherwise satisfy the data requirements specified in

Attachment 3, Requirements Status and Registrant's Response Form, within the time frames

provided. 

II-C. TESTING PROTOCOL

 All studies required under this Notice must be conducted in accordance with test standards

outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been

established. 

These EPA Guidelines are available from the National Technical Information Service

(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650). 

Protocols approved by the Organization for Economic Cooperation and Development

(OECD) are also acceptable if the OECD-recommended test standards conform to those specified

in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD

protocols, they should be modified as appropriate so that the data generated by the study will

satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for

complying with data requirements when the studies were not conducted in accordance with

acceptable standards. The OECD protocols are available from OECD, 2001 L Street, N.W.,

Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-

0350).

All new studies and proposed protocols submitted in response to this Data Call-In Notice

must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].

II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES

 ISSUED BY THE AGENCY

 Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the

requirements of any previous Data Call-In(s), or any other agreements entered into with the

Agency pertaining to such prior Notice. Registrants must comply with the requirements of all

Notices to avoid issuance of a Notice of Intent to Suspend their affected products. 

SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

III-A. SCHEDULE FOR RESPONDING TO THE AGENCY

 The appropriate responses initially required by this Notice for product specific data must

be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately

respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent

to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to

failure to comply with this Notice are presented in Section IV-A and IV-B.
56

III-B. OPTIONS FOR RESPONDING TO THE AGENCY

The options for responding to this Notice for product specific data are: (a) voluntary

cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or

(c) request a data waiver(s).

A discussion of how to respond if you chose the Voluntary Cancellation option is

presented below. A discussion of the various options available for satisfying the product specific

data requirements of this Notice is contained in Section III-C. A discussion of options relating to

requests for data waivers is contained in Section III-D. 

There are two forms that accompany this Notice of which, depending upon your response,

one or both must be used in your response to the Agency. These forms are the Data-Call-In

Response Form, and the Requirements Status and Registrant's Response Form, Attachment 2 and

Attachment 3. The Data Call-In Response Form must be submitted as part of every response to

this Notice. In addition, one copy of the Requirements Status and Registrant's Response Form

must be submitted for each product listed on the Data Call-In Response Form unless the voluntary

cancellation option is selected or unless the product is identical to another (refer to the instructions

for completing the Data Call-In Response Form in Attachment 2). Please note that the company's

authorized representative is required to sign the first page of the Data Call-In Response Form and

Requirements Status and Registrant's Response Form (if this form is required) and initial any

subsequent pages. The forms contain separate detailed instructions on the response options. Do

not alter the printed material. If you have questions or need assistance in preparing your

response, call or write the contact person(s) identified in Attachment 1.

1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting

voluntary cancellation of your product(s) containing the active ingredient that is the subject of this

Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In

Response Form, indicating your election of this option. Voluntary cancellation is item number 5

on the Data Call-In Response Form. If you choose this option, this is the only form that you are

required to complete.

If you chose to voluntarily cancel your product, further sale and distribution of your

product after the effective date of cancellation must be in accordance with the Existing Stocks

provisions of this Notice which are contained in Section IV-C.

2. Satisfying the Product Specific Data Requirements of this Notice There are various

options available to satisfy the product specific data requirements of this Notice. These options

are discussed in Section III-C of this Notice and comprise options 1 through 6 on the

Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data

Call-In Response Form. Deletion of a use(s) and the low volume/minor use option are not valid

options for fulfilling product specific data requirements.

3. Request for Product Specific Data Waivers. Waivers for product specific data are

discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status

and Registrant's Response Form. If you choose one of these options, you must submit both forms

as well as any other information/data pertaining to the option chosen to address the data

requirement.
57

III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

If you acknowledge on the Data Call-In Response Form that you agree to satisfy the

product specific data requirements (i.e. you select item number 7a or 7b), then you must select

one of the six options on the Requirements Status and Registrant's Response Form related to data

production for each data requirement. Your option selection should be entered under item

number 9, “Registrant Response.” The six options related to data production are the first six

options discussed under item 9 in the instructions for completing the Requirements Status and

Registrant's Response Form. These six options are listed immediately below with information in

parentheses to guide registrants to additional instructions provided in this Section. The options

are:

(1) I will generate and submit data within the specified time frame (Developing Data)

(2) I have entered into an agreement with one or more registrants to develop data

jointly (Cost Sharing)

(3) I have made offers to cost-share (Offers to Cost Share)

(4) I am submitting an existing study that has not been submitted previously to the

Agency by anyone (Submitting an Existing Study)

(5) I am submitting or citing data to upgrade a study classified by EPA as partially

acceptable and upgradeable (Upgrading a Study)

(6) I am citing an existing study that EPA has classified as acceptable or an existing

study that has been submitted but not reviewed by the Agency (Citing an Existing

Study)

Option 1, Developing Data -- If you choose to develop the required data it must be in

conformance with Agency deadlines and with other Agency requirements as referenced herein and

in the attachments. All data generated and submitted must comply with the Good Laboratory

Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment

Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5. 

The time frames in the Requirements Status and Registrant's Response Form are the time

frames that the Agency is allowing for the submission of completed study reports. The noted

deadlines run from the date of the receipt of this Notice by the registrant. If the data are not

submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the

affected registration(s).

If you cannot submit the data/reports to the Agency in the time required by this Notice and

intend to seek additional time to meet the requirements(s), you must submit a request to the

Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed

schedule including alternative dates for meeting such requirements on a step-by-step basis. You

must explain any technical or laboratory difficulties and provide documentation from the

laboratory performing the testing. While EPA is considering your request, the original deadline

remains. The Agency will respond to your request in writing. If EPA does not grant your

request, the original deadline remains. Normally, extensions can be requested only in cases of

extraordinary testing problems beyond the expectation or control of the registrant. Extensions

will not be given in submitting the 90-day responses. Extensions will not be considered if the

request for extension is not made in a timely fashion; in no event shall an extension request be

considered if it is submitted at or after the lapse of the subject deadline.
58

Option 2, Agreement to Share in Cost to Develop Data -- Registrants may only choose

this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the

attached data tables that your product and at least one other product are similar for purposes of

depending on the same data. If this is the case, data may be generated for just one of the products

in the group. The registration number of the product for which data will be submitted must be

noted in the agreement to cost share by the registrant selecting this option. If you choose to enter

into an agreement to share in the cost of producing the required data but will not be submitting

the data yourself, you must provide the name of the registrant who will be submitting the data. 

You must also provide EPA with documentary evidence that an agreement has been formed. Such

evidence may be your letter offering to join in an agreement and the other registrant's acceptance

of your offer, or a written statement by the parties that an agreement exists. The agreement to

produce the data need not specify all of the terms of the final arrangement between the parties or

the mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve

the terms of the agreement they may resolve their differences through binding arbitration.

Option 3, Offer to Share in the Cost of Data Development -- This option only applies to

acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer

to pay in an attempt to enter into an agreement or amend an existing agreement to meet the

requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this

option) to exercise its discretion not to suspend your registration(s), although you do not comply

with the data submission requirements of this Notice. EPA has determined that as a general

policy, absent other relevant considerations, it will not suspend the registration of a product of a

registrant who has in good faith sought and continues to seek to enter into a joint data

development/cost sharing program, but the other registrant(s) developing the data has refused to

accept your offer. To qualify for this option, you must submit documentation to the Agency

proving that you have made an offer to another registrant (who has an obligation to submit data)

to share in the burden of developing that data. You must also submit to the Agency a completed

EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data, Attachment

7. In addition, you must demonstrate that the other registrant to whom the offer was made has

not accepted your offer to enter into a cost sharing agreement by including a copy of your offer

and proof of the other registrant's receipt of that offer (such as a certified mail receipt). Your

offer must, in addition to anything else, offer to share in the burden of producing the data upon

terms to be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA

section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA

of its election of an option to develop and submit the data required by this Notice by submitting a

Data Call-In Response Form and a Requirements Status and Registrant's Response Form

committing to develop and submit the data required by this Notice.

In order for you to avoid suspension under this option, you may not withdraw your offer

to share in the burdens of developing the data. In addition, the other registrant must fulfill its

commitment to develop and submit the data as required by this Notice. If the other registrant fails

to develop the data or for some other reason is subject to suspension, your registration as well as

that of the other registrant will normally be subject to initiation of suspension proceedings, unless

you commit to submit, and do submit the required data in the specified time frame. In such cases,

the Agency generally will not grant a time extension for submitting the data.

Option 4, Submitting an Existing Study -- If you choose to submit an existing study in

response to this Notice, you must determine that the study satisfies the requirements imposed by

this Notice. You may only submit a study that has not been previously submitted to the Agency
59

or previously cited by anyone. Existing studies are studies which predate issuance of this Notice. 

Do not use this option if you are submitting data to upgrade a study. (See Option 5).

You should be aware that if the Agency determines that the study is not acceptable, the

Agency will require you to comply with this Notice, normally without an extension of the

required date of submission. The Agency may determine at any time that a study is not valid and

needs to be repeated.

To meet the requirements of the DCI Notice for submitting an existing study, all of the

following three criteria must be clearly met:

a. You must certify at the time that the existing study is submitted that the raw data

and specimens from the study are available for audit and review and you must

identify where they are available. This must be done in accordance with the

requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.

As stated in 40 CFR 160.3(j) “ 'raw data' means any laboratory worksheets,

records, memoranda, notes, or exact copies thereof, that are the result of original

observations and activities of a study and are necessary for the reconstruction and

evaluation of the report of that study. In the event that exact transcripts of raw

data have been prepared (e.g., tapes which have been transcribed verbatim, dated,

and verified accurate by signature), the exact copy or exact transcript may be

substituted for the original source as raw data. 'Raw data' may include

photographs, microfilm or microfiche copies, computer printouts, magnetic media,

including dictated observations, and recorded data from automated instruments.” 

The term “specimens”, according to 40 CFR 160.3(k), means “any material

derived from a test system for examination or analysis.”

b. Health and safety studies completed after May 1984 must also contain all GLPrequired quality assurance and quality control information, pursuant to the

requirements of 40 CFR Part 160. Registrants must also certify at the time of

submitting the existing study that such GLP information is available for post-May

1984 studies by including an appropriate statement on or attached to the study

signed by an authorized official or representative of the registrant.

c. You must certify that each study fulfills the acceptance criteria for the Guideline

relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3

Technical Guidance and that the study has been conducted according to the

Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both

available from NTIS). A study not conducted according to the PAG may be

submitted to the Agency for consideration if the registrant believes that the study

clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70

which states the Agency's policy regarding acceptable protocols. If you wish to

submit the study, you must, in addition to certifying that the purposes of the PAG

are met by the study, clearly articulate the rationale why you believe the study

meets the purpose of the PAG, including copies of any supporting information or

data. It has been the Agency's experience that studies completed prior to January

1970 rarely satisfied the purpose of the PAG and that necessary raw data are

usually not available for such studies.
60

If you submit an existing study, you must certify that the study meets all requirements of

the criteria outlined above.

If you know of a study pertaining to any requirement in this Notice which does not meet

the criteria outlined above but does contain factual information regarding unreasonable adverse

effects, you must notify the Agency of such a study. If such study is in the Agency's files, you

need only cite it along with the notification. If not in the Agency's files, you must submit a

summary and copies as required by PR Notice 86-5.

Option 5, Upgrading a Study -- If a study has been classified as partially acceptable and

upgradeable, you may submit data to upgrade that study. The Agency will review the data

submitted and determine if the requirement is satisfied. If the Agency decides the requirement is

not satisfied, you may still be required to submit new data normally without any time extension. 

Deficient, but upgradeable studies will normally be classified as supplemental. However, it is

important to note that not all studies classified as supplemental are upgradeable. If you have

questions regarding the classification of a study or whether a study may be upgraded, call or write

the contact person listed in Attachment 1. If you submit data to upgrade an existing study you

must satisfy or supply information to correct all deficiencies in the study identified by EPA. You

must provide a clearly articulated rationale of how the deficiencies have been remedied or

corrected and why the study should be rated as acceptable to EPA. Your submission must also

specify the MRID number(s) of the study which you are attempting to upgrade and must be in

conformance with PR Notice 86-5.

Do not submit additional data for the purpose of upgrading a study classified as

unacceptable and determined by the Agency as not capable of being upgraded.

This option should also be used to cite data that has been previously submitted to upgrade

a study, but has not yet been reviewed by the Agency. You must provide the MRID number of

the data submission as well as the MRID number of the study being upgraded.

The criteria for submitting an existing study, as specified in Option 4 above, apply to all

data submissions intended to upgrade studies. Additionally your submission of data intended to

upgrade studies must be accompanied by a certification that you comply with each of those

criteria as well as a certification regarding protocol compliance with Agency requirements.

Option 6, Citing Existing Studies -- If you choose to cite a study that has been previously

submitted to EPA, that study must have been previously classified by EPA as acceptable or it

must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies

generally will have been classified as “core-guideline” or “core minimum.” For all other

disciplines the classification would be “acceptable.” With respect to any studies for which you

wish to select this option you must provide the MRID number of the study you are citing and, if

the study has been reviewed by the Agency, you must provide the Agency's classification of the

study.

If you are citing a study of which you are not the original data submitter, you must submit

a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation

Requirements.
61

Registrants who select one of the above 6 options must meet all of the requirements

described in the instructions for completing the Data Call-In Response Form and the Requirements

Status and Registrant's Response Form, as appropriate.

III-D REQUESTS FOR DATA WAIVERS

If you request a waiver for product specific data because you believe it is

inappropriate, you must attach a complete justification for the request, including technical

reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any

supplemental data must be submitted in the format required by PR Notice 86-5). This will be the

only opportunity to state the reasons or provide information in support of your request. If the

Agency approves your waiver request, you will not be required to supply the data pursuant to

section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an

option for meeting the data requirements of this Notice within 30 days of the receipt of the

Agency's decision. You must indicate and submit the option chosen on the Requirements Status

and Registrant's Response Form. Product specific data requirements for product chemistry, acute

toxicity and efficacy (where appropriate) are required for all products and the Agency would grant

a waiver only under extraordinary circumstances. You should also be aware that submitting a

waiver request will not automatically extend the due date for the study in question. Waiver

requests submitted without adequate supporting rationale will be denied and the original due date

will remain in force.

IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

IV-A NOTICE OF INTENT TO SUSPEND

The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to

failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to

FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to

Suspend include, but are not limited to, the following:

1. Failure to respond as required by this Notice within 90 days of your receipt of this

Notice.

2. Failure to submit on the required schedule an acceptable proposed or final protocol

when such is required to be submitted to the Agency for review.

3. Failure to submit on the required schedule an adequate progress report on a study

as required by this Notice.

4. Failure to submit on the required schedule acceptable data as required by this

Notice.

5. Failure to take a required action or submit adequate information pertaining to any

option chosen to address the data requirements (e.g., any required action or

information pertaining to submission or citation of existing studies or offers,

arrangements, or arbitration on the sharing of costs or the formation of Task

Forces, failure to comply with the terms of an agreement or arbitration concerning

joint data development or failure to comply with any terms of a data waiver).
62

6. Failure to submit supportable certifications as to the conditions of submitted

studies, as required by Section III-C of this Notice.

7. Withdrawal of an offer to share in the cost of developing required data.

8. Failure of the registrant to whom you have tendered an offer to share in the cost of

developing data and provided proof of the registrant's receipt of such offer or

failure of a registrant on whom you rely for a generic data exemption either to:

a. inform EPA of intent to develop and submit the data required by this Notice

on a Data Call-In Response Form and a Requirements Status and

Registrant's Response Form;

b. fulfill the commitment to develop and submit the data as required by this

Notice; or

c. otherwise take appropriate steps to meet the requirements stated in this

Notice, unless you commit to submit and do submit the required data in the

specified time frame.

9. Failure to take any required or appropriate steps, not mentioned above, at any time

following the issuance of this Notice.

IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS 

UNACCEPTABLE

The Agency may determine that a study (even if submitted within the required time) is

unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds

for suspension include, but are not limited to, failure to meet any of the following:

1. EPA requirements specified in the Data Call-In Notice or other documents incorporated

by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data

Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,

conduct, and reporting of required studies. Such requirements include, but are not limited

to, those relating to test material, test procedures, selection of species, number of animals,

sex and distribution of animals, dose and effect levels to be tested or attained, duration of

test, and, as applicable, Good Laboratory Practices.

2. EPA requirements regarding the submission of protocols, including the incorporation

of any changes required by the Agency following review.

3. EPA requirements regarding the reporting of data, including the manner of reporting,

the completeness of results, and the adequacy of any required supporting (or raw) data,

including, but not limited to, requirements referenced or included in this Notice or

contained in PR 86-5. All studies must be submitted in the form of a final report; a

preliminary report will not be considered to fulfill the submission requirement.

IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
63

EPA has statutory authority to permit continued sale, distribution and use of existing

stocks of a pesticide product which has been suspended or cancelled if doing so would be

consistent with the purposes of the Act. 

The Agency has determined that such disposition by registrants of existing stocks for a

suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not

be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants

permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional

circumstances. If you believe such disposition of existing stocks of your product(s) which may be

suspended for failure to comply with this Notice should be permitted, you have the burden of

clearly demonstrating to EPA that granting such permission would be consistent with the Act. You

must also explain why an “existing stocks” provision is necessary, including a statement of the

quantity of existing stocks and your estimate of the time required for their sale, distribution, and

use. Unless you meet this burden the Agency will not consider any request pertaining to the

continued sale, distribution, or use of your existing stocks after suspension.

If you request a voluntary cancellation of your product(s) as a response to this Notice and

your product is in full compliance with all Agency requirements, you will have, under most

circumstances, one year from the date your 90 day response to this Notice is due, to sell,

distribute, or use existing stocks. Normally, the Agency will allow persons other than the

registrant such as independent distributors, retailers and end users to sell, distribute or use such

existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of

voluntarily cancelled products containing an active ingredient for which the Agency has particular

risk concerns will be determined on case-by-case basis.

Requests for voluntary cancellation received after the 90 day response period required by

this Notice will not result in the Agency granting any additional time to sell, distribute, or use

existing stocks beyond a year from the date the 90 day response was due unless you demonstrate

to the Agency that you are in full compliance with all Agency requirements, including the

requirements of this Notice. For example, if you decide to voluntarily cancel your registration six

months before a 3 year study is scheduled to be submitted, all progress reports and other

information necessary to establish that you have been conducting the study in an acceptable and

good faith manner must have been submitted to the Agency, before EPA will consider granting an

existing stocks provision.

SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE 

UNREASONABLE ADVERSE EFFECTS

Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a

pesticide is registered a registrant has additional factual information regarding unreasonable

adverse effects on the environment by the pesticide, the registrant shall submit the information to

the Agency. Registrants must notify the Agency of any factual information they have, from

whatever source, including but not limited to interim or preliminary results of studies, regarding

unreasonable adverse effects on man or the environment. This requirement continues as long as

the products are registered by the Agency.

SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
64

If you have any questions regarding the requirements and procedures established by this

Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.

All responses to this Notice (other than voluntary cancellation requests and generic data

exemption claims) must include a completed Data Call-In Response Form and a completed

Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product

specific data) and any other documents required by this Notice, and should be submitted to the

contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data

exemption option is chosen, only the Data Call-In Response Form need be submitted.

The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic

Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.

 

Sincerely yours,

Lois A. Rossi, Director

Special Review and

 Reregistration Division

Attachments

1 - Data Call-In Chemical Status Sheet

2 - Product-Specific Data Call-In Response Form 

3 - Requirements Status and Registrant's Response Form

4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data

Requirements for Reregistration

5 - List of Registrants Receiving This Notice

6 - Cost Share and Data Compensation Forms and the Confidential Statement of

Formula Form
65

Attachment 1. Chemical Status Sheets

1,3,5-TRIETHYLHEXAHYDRO-S-TRIAZINE DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

You have been sent this Product Specific Data Call-In Notice because you have product(s)

containing 1,3,5-triethylhexahydro-s-triazine.

This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data

required by this notice, and point of contact for inquiries pertaining to the reregistration of 1,3,5-

triethylhexahydro-s-triazine. This attachment is to be used in conjunction with (1) the Product

Specific Data Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2),

(3) the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use

Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance

Criteria, (6) a list of registrants receiving this DCI (Attachment 5) and (7) the Cost Share and Data

Compensation Forms in replying to this 1,3,5-triethylhexahydro-s-triazine Product Specific Data

Call-In (Attachment 6). Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

The additional data requirements needed to complete the database for 1,3,5-triethylhexahydros-triazine are contained in the Requirements Status and Registrant's Response, Attachment 3. The

Agency has concluded that additional data on 1,3,5-triethylhexahydro-s-triazine are needed for

specific products. These data are required to be submitted to the Agency within the time frame listed.

These data are needed to fully complete the reregistration of all eligible 1,3,5-triethylhexahydro-striazine products.

INQUIRIES AND RESPONSES TO THIS NOTICE

If you have any questions regarding this product specific data requirements and procedures

established by this Notice, please contact Jane Mitchell at (703) 308-8061.

All responses to this Notice for the Product Specific data requirements should be submitted

to:

Jane Mitchell

Chemical Review Manager Team 81

Product Reregistration Branch

Special Review and Reregistration Branch 7508W

Office of Pesticide Programs

U.S. Environmental Protection Agency

Washington, D.C. 20460

RE: 1,3,5-Triethylhexahydro-s-triazine
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Attachment 2. Product Specific Data Call-In Response Forms (Form A inserts) Plus Instructions

INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR 

PRODUCT SPECIFIC DATA

Item 1-4. Already completed by EPA. 

Item 5. If you wish to voluntarily cancel your product, answer “yes.” If you choose this

option, you will not have to provide the data required by the Data Call-In Notice and

you will not have to complete any other forms. Further sale and distribution of your

product after the effective date of cancellation must be in accordance with the Existing

Stocks provision of the Data Call-In Notice (Section IV-C).

Item 6. Not applicable since this form calls in product specific data only. However, if your

product is identical to another product and you qualify for a data exemption, you

must respond with “yes” to Item 7a (MUP) or 7B (EUP) on this form, provide the

EPA registration numbers of your source(s); you would not complete the

“Requirements Status and Registrant's Response” form. Examples of such products

include repackaged products and Special Local Needs (Section 24c) products which

are identical to federally registered products.

Item 7a. For each manufacturing use product (MUP) for which you wish to maintain

registration, you must agree to satisfy the data requirements by responding “yes.”

Item 7b. For each end use product (EUP) for which you wish to maintain registration, you

must agree to satisfy the data requirements by responding “yes.” If you are

requesting a data waiver, answer “yes” here; in addition, on the “Requirements

Status and Registrant's Response” form under Item 9, you must respond with Option

7 (Waiver Request) for each study for which you are requesting a waiver. See Item

6 with regard to identical products and data exemptions.

Items 8-11. Self-explanatory.

NOTE: You may provide additional information that does not fit on this form in a signed

letter that accompanies this form. For example, you may wish to report that your

product has already been transferred to another company or that you have already

voluntarily canceled this product. For these cases, please supply all relevant details

so that EPA can ensure that its records are correct.
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Attachment 3. Product Specific Requirement Status and Registrant's Response Forms (Form B inserts) and Instructions

INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND

 REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA

Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item

3. This number must be used in the transmittal document for any data

submissions in response to this Data Call-In Notice.

Item 4. The guideline reference numbers of studies required to support the product's

continued registration are identified. These guidelines, in addition to the

requirements specified in the Notice, govern the conduct of the required studies. 

Note that series 61 and 62 in product chemistry are now listed under 40 CFR

158.155 through 158.180, Subpart C.

Item 5. The study title associated with the guideline reference number is identified. 

Item 6. The use pattern(s) of the pesticide associated with the product specific

requirements is (are) identified. For most product specific data requirements, all

use patterns are covered by the data requirements. In the case of efficacy data, the

required studies only pertain to products which have the use sites and/or pests

indicated.

Item 7. The substance to be tested is identified by EPA. For product specific data, the

product as formulated for sale and distribution is the test substance, except in rare

cases.

Item 8. The due date for submission of each study is identified. It is normally based on 8

months after issuance of the Reregistration Eligibility Document unless EPA

determines that a longer time period is necessary.

Item 9. Enter only one of the following response codes for each data requirement to

show how you intend to comply with the data requirements listed in this table.

Fuller descriptions of each option are contained in the Data Call-In Notice.

1. I will generate and submit data by the specified due date (Developing Data). By

indicating that I have chosen this option, I certify that I will comply with all the

requirements pertaining to the conditions for submittal of this study as outlined in

the Data Call-In Notice. By the specified due date, I will also submit: (1) a

completed “Certification With Respect To Data Compensation Requirements”

form (EPA Form 8570-29) and (2) two completed and signed copies of the

Confidential Statement of Formula (EPA Form 8570-4).

2. I have entered into an agreement with one or more registrants to develop data

jointly (Cost Sharing). I am submitting a copy of this agreement. I understand

that this option is available only for acute toxicity or certain efficacy data and only

if EPA indicates in an attachment to this Notice that my product is similar enough
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to another product to qualify for this option. I certify that another party in the

agreement is committing to submit or provide the required data; if the required

study is not submitted on time, my product may be subject to suspension. By the

specified due date, I will also submit: (1) a completed “Certification With

Respect To Data Compensation Requirements” form (EPA Form 8570-29) and

(2) two completed and signed copies of the Confidential Statement of Formula

(EPA Form 8570-4).

3. I have made offers to share in the cost to develop data (Offers to Cost Share). I

understand that this option is available only for acute toxicity or certain efficacy

data and only if EPA indicates in an attachment to this Data Call-In Notice that my

product is similar enough to another product to qualify for this option. I am

submitting evidence that I have made an offer to another registrant (who has an

obligation to submit data) to share in the cost of that data. I am also submitting a

completed “Certification of Offer to Cost Share in the Development Data”

form. I am including a copy of my offer and proof of the other registrant's

receipt of that offer. I am identifying the party which is committing to submit or

provide the required data; if the required study is not submitted on time, my

product may be subject to suspension. I understand that other terms under Option

3 in the Data Call-In Notice (Section III-C.1.) apply as well. By the specified due

date, I will also submit: (1) a completed “Certification With Respect To Data

Compensation Requirements” form (EPA Form 8570-29) and (2) two

completed and signed copies of the Confidential Statement of Formula (EPA

Form 8570-4).

4. By the specified due date, I will submit an existing study that has not been

submitted previously to the Agency by anyone (Submitting an Existing Study). I

certify that this study will meet all the requirements for submittal of existing data

outlined in Option 4 in the Data Call-In Notice (Section III-C.1.) and will meet the

attached acceptance criteria (for acute toxicity and product chemistry data). I will

attach the needed supporting information along with this response. I also certify

that I have determined that this study will fill the data requirement for which I

have indicated this choice. By the specified due date, I will also submit a

completed “Certification With Respect To Data Compensation Requirements”

form (EPA Form 8570-29) to show what data compensation option I have chosen. 

By the specified due date, I will also submit: (1) a completed “Certification With

Respect To Data Compensation Requirements” form (EPA Form 8570-29) and

(2) two completed and signed copies of the Confidential Statement of Formula

(EPA Form 8570-4).

5. By the specified due date, I will submit or cite data to upgrade a study classified by

the Agency as partially acceptable and upgradable (Upgrading a Study). I will

submit evidence of the Agency's review indicating that the study may be upgraded

and what information is required to do so. I will provide the MRID or Accession

number of the study at the due date. I understand that the conditions for this
69

option outlined Option 5 in the Data Call-In Notice (Section III-C.1.) apply. By

the specified due date, I will also submit: (1) a completed “Certification With

Respect To Data Compensation Requirements” form (EPA Form 8570-29) and

(2) two completed and signed copies of the Confidential Statement of Formula

(EPA Form 8570-4).

6. By the specified due date, I will cite an existing study that the Agency has

classified as acceptable or an existing study that has been submitted but not

reviewed by the Agency (Citing an Existing Study). If I am citing another

registrant's study, I understand that this option is available only for acute toxicity

or certain efficacy data and only if the cited study was conducted on my product,

an identical product or a product which EPA has “grouped” with one or more

other products for purposes of depending on the same data. I may also choose this

option if I am citing my own data. In either case, I will provide the MRID or

Accession number(s) for the cited data on a “Product Specific Data Report” form

or in a similar format. By the specified due date, I will also submit: (1) a

completed “Certification With Respect To Data Compensation Requirements”

form (EPA Form 8570-29) and (2) two completed and signed copies of the

Confidential Statement of Formula (EPA Form 8570-4).

7. I request a waiver for this study because it is inappropriate for my product

(Waiver Request). I am attaching a complete justification for this request,

including technical reasons, data and references to relevant EPA regulations,

guidelines or policies. [Note: any supplemental data must be submitted in the

format required by P.R. Notice 86-5]. I understand that this is my only

opportunity to state the reasons or provide information in support of my request. 

If the Agency approves my waiver request, I will not be required to supply the

data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies my waiver

request, I must choose a method of meeting the data requirements of this Notice

by the due date stated by this Notice. In this case, I must, within 30 days of my

receipt of the Agency's written decision, submit a revised “Requirements Status

and Registrant's Response” Form indicating the option chosen. I also understand

that the deadline for submission of data as specified by the original data call-in

notice will not change. By the specified due date, I will also submit: (1) a

completed “Certification With Respect To Data Compensation Requirements”

form (EPA Form 8570-29) and (2) two completed and signed copies of the

Confidential Statement of Formula (EPA Form 8570-4).

Items 10-13. Self-explanatory.

NOTE: You may provide additional information that does not fit on this form in a signed

letter that accompanies this form. For example, you may wish to report that your

product has already been transferred to another company or that you have already

voluntarily canceled this product. For these cases, please supply all relevant

details so that EPA can ensure that its records are correct.
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Attachment 4. EPA Batching of End-Use Products for Meeting Data Requirements for Reregistration

Attachment 4.

There is no tox batching for this RED because there are only two end use products

containing triethylhexahydrotriazine.
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Attachment 5. List of All Registrants Sent This Data Call-In (insert) Notice
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Attachment 6. Cost Share, Data Compensation Forms, Confidential Statement of Formula Form and Instructions

Instructions for Completing the Confidential Statement of Formula 

The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed

copies of the form are required. Following are basic instructions:

a. All the blocks on the form must be filled in and answered completely. 

b. If any block is not applicable, mark it N/A. 

c. The CSF must be signed, dated and the telephone number of the responsible party

must be provided.

d. All applicable information which is on the product specific data submission must

also be reported on the CSF. 

e. All weights reported under item 7 must be in pounds per gallon for liquids and

pounds per cubic feet for solids.

f. Flashpoint must be in degrees Fahrenheit and flame extension in inches. 

g. For all active ingredients, the EPA Registration Numbers for the currently

registered source products must be reported under column 12. 

h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all

common names for the trade names must be reported.

i. For the active ingredients, the percent purity of the source products must be

reported under column 10 and must be exactly the same as on the source product's

label. 

j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or

grams. In no case will volumes be accepted. Do not mix English and metric

system units (i.e., pounds and kilograms). 

k. All the items under column 13.b. must total 100 percent. 

1. All items under columns 14.a. and 14.b. for the active ingredients must represent

pure active form. 

m. The upper and lower certified limits for ail active and inert ingredients must follow

the 40 CFR 158.175 instructions. An explanation must be provided if the proposed

limits are different than standard certified limits. 

n. When new CSFs are submitted and approved, all previously submitted CSFs

become obsolete for that specific formulation. 
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United States Environmental Protection Agency

Washington, D.C. 20460

Certification of Offer to Cost 

Share in the Development of Data

Form Approved

OMB No. 2070-0106,

2070-0057

Approval Expires

3-31-99

Public reporting burden for this collection of information is estimated to average 15 minutes per response, including 

time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and 

completing and reviewing the collection of information. Send comments regarding the burden estimate or any other

aspect of this collection of information, including suggestions for reducing this burden to, Chief Information Policy

Branch, PM-233, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of

Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

Please fill in blanks below:

Company Name Company Number

Product Name EPA Reg. No.

I Certify that:

My company is willing to develop and submit the data required by EPA under the authority of the Federal

Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However my company would prefer to enter

into an agreement with one or more registrants to develop jointly or share in the cost of developing data.

My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an

offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all terms

could not be reached otherwise. This offer was made to the following firms on the following date(s):

Name of Firm(s) Date of Offer

Certification:

I certify that I am duly authorized to represent the company named above, and that the statements that I have made on

this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or

misleading statement may be punishable by fine or imprisonment or both under applicable law.

Signature of Company’s Authorized Representative Date

Name and Title (Please Type or Print)

EPA Form 8570-32 (5/91) Replaces EPA form 8580 which is obselete
84
85

United States Environmental Protection Agency Form Approved

Washington, DC 20460 OMB No. 2070-0107,

CERTIFICATION WITH RESPECT TO

DATA COMPENSATION REQUIREMENTS

2070-0057

Approval Expires

3-31-99

Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for 

reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the

collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, 

including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection 

Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project 

(2070-0106), Washington, DC 20503.

Please fill in blanks below.

Company Name Company Number

Product Name EPA Reg. No.

I Certify that:

1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act 

(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original 

data submitter to cite that study.

2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the 

original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the 

company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections 

3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation 

requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)

 [ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached

“Requirements Status and Registrants' Response Form,”

3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or

reregistration under FIFRA.

Signature Date

Name and Title (Please Type or Print)

GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or

reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).

Signature Date

Name and Title (Please Type or Print)

EPA Form 8570-31 (4-96)
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APPENDIX E. List of Available Related Documents

The following is a list of available documents for 1,3,5-Triethylhexahydro-s-triazine that

my further assist you in responding to this Reregistration Eligibility Decision document. 

These documents may be obtained by the following methods:

Electronic

File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible

reader. Electronic copies can be downloaded from the Pesticide Special

Review and Reregistration Information System at 703-308-7224. They also are

available using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on

WWW.EPA.GOV., or contact Nancy Tompkins at (703)-308-8013.

1. PR Notice 86-5.

2. PR Notice 91-2 (pertains to the Label Ingredient Statement).

3. A full copy of this RED document.

4. A copy of the fact sheet for 1,3,5-Triethylhexahydro-s-triazine.

The following documents are part of the Administrative Record for 1,3,5-

Triethylhexahydro-s-triazine and may included in the EPA's Office of Pesticide Programs

Public Docket. Copies of these documents are not available electronically, but may be

obtained by contacting the person listed on the Chemical Status Sheet.

1. Health and Environmental Effects Science Chapters.

2. Detailed Label Usage Information System (LUIS) Report.

The following Agency reference documents are not available electronically, but may be

obtained by contacting the person listed on the Chemical Status Sheet of this RED document.

1. The Label Review Manual.

2. EPA Acceptance Criteria