United States           Prevention, Pesticides       EPA739-R-05-008
Environmental Protection     and Toxic Substances       September 2005
Agency              (751OC)


Reregistration Eligibility Decision


for Trichloromelamine

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           UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                             WASHINGTON, D.C.  20460
                                                                   OFFICE OF
                                                           PREVENTION, PESTICIDES
                                                           AND TOXIC SUBSTANCES
CERTIFIED MAIL

Dear Registrant:

       This is to inform you that the Environmental Protection Agency (EPA) has completed its
review of the available data on the antimicrobial trichloromelamine. The enclosed Reregistration
Eligibility Decision (RED) document was approved on September 23, 2005.

       Based on its review, EPA is now publishing its Reregistration Eligibility Decision (RED)
and risk management decision for trichloromelamine and its associated human health and
environmental risks. A Notice of Availability will be published in the Federal Register
announcing the publication of the RED.

       The RED and supporting risk assessment for trichloromelamine  are available to the
public in EPA's Pesticide Docket OPP-2005-0262 at: http://www.epa.gov/edockets.

       Please note that the trichloromelamine risk assessment and the attached RED document
concern only this particular pesticide. This RED presents the Agency's conclusions on the
dietary, drinking water, occupational and ecological risks posed by exposure to
trichloromelamine alone. This document also contains both generic and product-specific data
that the Agency intends to require in Data Call-Ins (DCIs).  Note that DCIs, with all pertinent
instructions, will be sent to registrants at a later date.  Additionally, for product-specific DCIs,
the first set of required responses will be due 90 days from the receipt of the DCI letter. The
second set of required responses will be due eight months from the receipt of the DCI letter.

       As part of the RED, the Agency has determined that trichloromelamine will be eligible
for reregistration provided that all the conditions identified in this document are satisfied.
Sections IV and V of this RED document describe data requirements and necessary label
amendments.  Instructions for registrants on submitting the revised labeling can be found in the
set of instructions for product-specific data that accompanies this document.

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       If you have questions on this document or the label changes relevant to this reregistration
decision, please contact the Chemical Review Manager, Jennifer Slotnick, at (703) 305-0601.
For questions about product reregistration and/or the Product DCI that accompanies this
document, please contact Adam Heyward at (703) 308-6422.
                                         Sincerely,
                                        Frank T. Sanders
                                        Director, Antimicrobials Division

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                       REREGISTRATION ELIGIBILITY
                                  DECISION
                                      for
                           TRICHLOROMELAMINE
                                     ListC
                                  CASE 3144
                                                Approved By:
                                                Frank T. Sanders
                                                Director, Antimicrobials Division
                                                September 23, 2005
Attachment

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Table of Contents

Trichloromelamine Reregistration Team	   i
Glossary of Terms and Abbreviations	   ii
Executive Summary	    iv

I. Introduction	   1
II. Chemical Overview	   3
      A. Regulatory History	   3
      B. Chemical Identification 	   3
      C. Use Profile	    4
III. Summary of Trichloromelamine Risk Assessments	    5
      A. Human Health Risk Assessment	    5
             1. Toxicity of Trichloromelamine	   5
             2. FQPA Safety Factor	    8
             3. Population Adjusted Dose (PAD)	   9
                   a. Acute PAD	   9
                   b. Chronic PAD	   9
             4. Exposure Assumptions	   9
             5. Dietary Risk Assessment	   9
                   a. Dietary Risk from Food	    9
                   b. Dietary Risk from Drinking Water	    11
             6. Residential Risk Assessment	   11
             7. Aggregate Risk	   11
             8. Occupational Risk	    12
                   a. Occupational Toxicity	    12
                   b. Occupational Handler Exposure	   13
                   c. Occupational Handler Risk Summary	   13
      B. Environmental Risk Assessment	    15
             1. Environmental Fate and Transport	   15
             2. Ecological Risk	   15
                   a. Toxicity (Hazard) Assessment	   16
                   b. Exposure and Risk	    16
                   c. Risk to Listed Species	   16

IV. Risk Management, Reregistration, and Tolerance Reassessment Decision...    17
      A. Determination of Reregistration Eligibility	    17
      B. Public Comments and Responses	    17
      C. Regulatory Position	    17
             1. Food Quality Protection Act Findings	   17
                   a. "Risk Cup" Determination	   17
                   b. Determination of Safety to U. S.  Population	    18
                   c. Determination  of Safety to Infants and Children	    18
                   d. Endocrine Disrupter Effects	    18
                   e. Cumulative Risks	   19
             2. Tolerance Summary	    19

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                   a. Tolerance Exemption Currently Listed and Tolerance
                         Reassessment	  20
                   b. Codex Harmonization	   20
      D. Regulatory Rationale	  20
             1. Human Health Risk Management	  20
             2. Environmental Risk Management	      21
             3. Other Labeling Requirements	  21
             4. Listed Species Considerations	  21
                   a. The Endangered Species Act	  21
                   b. General Risk Mitigation	  22

V. What Registrants Need to Do	  23
      A. Manufacturing-Use Products	  25
             1. Additional Generic Data Requirements	  25
             2. Labeling for Technical and Manufacturing-Use Products	  25
      B. End-Use Products	  25
             1. Additional Product-Specific Data Requirements	  25
             2. Labeling for End-Use Products	  26
                   a. Label Changes Summary Table	  27

VI. Appendices	  28
      A. Table of Use Patterns for Trichloromelamine	    29
      B. Table of Generic Data Requirements and Studies Used to Make the
                   Reregistration Decision	    32
      C. Technical Support Documents	     37
      D. Bibliography Citations	    38
      E. Generic Data Call-In	    43
      F. Product Specific Data Call-In	    44
      G. Batching of End-Use Products	    45
      H. List of All Registrants Sent the Data Call-In	    48
      I. List of Available Forms	    49

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                       Trichloromelamine Reregistration Team
Health Effects Risk Assessment
Laura Bailey
Timothy Leighton
Timothy McMahon
Najm Shamim

Ecological Risk Assessment
Genevieve Angle

Registration Support
Adam Heyward

Risk Management
Jennifer Slotnick
Ben Chambliss

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GLOSSARY OF TERMS AND ABBREVIATIONS

a.i.             Active Ingredient
aPAD          Acute Population Adjusted Dose
APHIS         Animal and Plant Health Inspection Service
ARTF          Agricultural Re-entry Task Force
BCF           Bioconcentration Factor
CDC           Centers for Disease Control
CDPR          California Department of Pesticide Regulation
CFR           Code of Federal Regulations
ChEI           Cholinesterase Inhibition
CMBS          Carbamate Market Basket  Survey
cPAD          Chronic Population Adjusted Dose
CSFII          USDA Continuing Surveys for Food Intake by Individuals
CWS           Community Water System
DCI           Data Call-In
DEEM         Dietary Exposure Evaluation Model
DL            Double layer clothing {i.e., coveralls over SL}
DWLOC       Drinking Water Level of Comparison
EC            Emulsifiable Concentrate Formulation
EDSP          Endocrine Disrupter Screening Program
ED STAC       Endocrine Disrupter Screening and Testing Advisory Committee
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
EXAMS       Tier II Surface Water Computer Model
FDA           Food and Drug Administration
FFDCA        Federal Food, Drug, and Cosmetic Act
FIFRA         Federal Insecticide, Fungicide, and Rodenticide Act
FOB           Functional Observation Battery
FQPA          Food Quality Protection Act
FR            Federal Register
GL            With gloves
GPS           Global Positioning System
HIARC        Hazard Identification Assessment Review Committee
IDFS           Incident Data System
IGR           Insect Growth Regulator
IPM           Integrated Pest Management
RED           Reregistration Eligibility Decision
LADD          Lifetime Average Daily Dose
LC50           Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
               death in 50% of test animals, usually expressed as the weight of substance per weight or volume
               of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO           Lawn Care Operator
LD50           Median Lethal Dose.  Statistically derived single dose causing death in 50% of the test animals
               when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
               substance per unit weight of animal, e.g., mg/kg.
LOAEC        Lowest Observed Adverse Effect Concentration
LOAEL        Lowest Observed Adverse Effect Level
LOG           Level of Concern
LOEC          Lowest Observed Effect Concentration
mg/kg/day      Milligram Per Kilogram Per Day
MOE           Margin of Exposure
MP            Manufacturing-Use Product
MRID          Master Record Identification (number). EPA's system of recording and tracking studies
               submitted.
MRL           Maximum Residue Level
                                                 ii

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N/A           Not Applicable
NASS          National Agricultural Statistical Service
NAWQA       USGS National Water Quality Assessment
NG            No Gloves
NMFS         National Marine Fisheries Service
NOAEC        No Observed Adverse Effect Concentration
NOAEL        No Observed Adverse Effect Level
NPIC          National Pesticide Information Center
NR            No respirator
OP            Organophosphorus
OPP           EPA Office of Pesticide Programs
ORETF        Outdoor Residential Exposure Task Force
PAD           Population Adjusted Dose
PCA           Percent Crop Area
PDCI          Product Specific Data Call-In
PDF           USDA Pesticide Data Program
PF10           Protections factor 10 respirator
PF5            Protection factor  5 respirator
PHED          Pesticide Handler's Exposure Data
PHI            Pre-harvest Interval
ppb            Parts Per Billion
PPE           Personal Protective Equipment
PRZM         Pesticide Root Zone Model
RBC           Red Blood Cell
RED           Reregistration Eligibility Decision
REI            Restricted Entry Interval
RID           Reference Dose
RPA           Reasonable and Prudent Alternatives
RPM           Reasonable and Prudent Measures
RQ            Risk Quotient
RTU           (Ready-to-use)
RUP           Restricted Use Pesticide
SCI-GROW     Tier I Ground Water Computer Model
SF             Safety Factor
SL             Single layer clothing
SLN           Special Local Need (Registrations Under Section 24C of FIFRA)
STORET       Storage and Retrieval
TEP           Typical End-Use Product
TGAI          Technical Grade Active Ingredient
TRAC         Tolerance Reassessment Advisory Committee
TTRS          Transferable Turf Residues
UF            Uncertainty Factor
USDA         United States Department of Agriculture
USFWS        United States Fish and Wildlife Service
USGS          United States Geological  Survey
WPS           Worker Protection Standard
                                                 ill

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EXECUTIVE SUMMARY

       The Environmental Protection Agency (hereafter referred to as EPA or the Agency) has
completed its human health and environmental review for trichloromelamine and is issuing its
risk management decision. The Agency has decided trichloromelamine is eligible for
reregistration provided all measures outlined in this document are implemented.
Trichloromelamine is a sanitizer and disinfectant with direct and indirect food uses, as well as
non-food uses. It is used on hard surfaces and as a fruit and vegetable wash. End-use products
are formulated as a soluble concentrate (in powder form). Trichloromelamine currently has a
tolerance exemption as an antimicrobial pesticide when, ready for use, the end-use concentration
does not exceed 200 ppm (40 CFR 180.940(c)) when applied to food processing equipment and
utensils.

Overall Risk Summary

       The Agency's human heath risk assessment indicates  no risks of concern. Acute and
chronic dietary risk estimates were completed for the general U.S. population and all population
subgroups.  All dietary risk estimates are below the Agency's level of concern. As none of the
uses associated with trichloromelamine are expected to impact either surface or ground water
resources, no drinking water assessment was performed.  When considering aggregate risk from
dietary and residential exposures, risk estimates are below the Agency's level of concern.

       To address occupational exposure, combined dermal and inhalation risks for handlers
were assessed. All margins of exposures (MOE) are below the Agency's level of concern when
workers are wearing baseline PPE (long-sleeved shirt and pants, no gloves).  In cases such as
this, where  an oral endpoint is used to evaluate inhalation exposures, an additional lOx route-to-
route extrapolation is used to determine if a confirmatory inhalation toxicity study is warranted.
The inhalation MOE for either washing mess kits or fruits and vegetables in military mess halls
falls below the MOE of 1,000.  Therefore, an inhalation study will be required to confirm these
findings.

       Due to limited potential for environmental exposure, environmental risks are below the
Agency's level of concern.

Dietary Risk

       Acute and chronic dietary (food) risks are below EPA's level of concern for the general
U.S. population and all population subgroups.  A screening-level acute dietary risk assessment
(assumes 100% of fruits/vegetables consumed are treated with trichloromelamine and 100%
transfer of residues from treated food-contact surfaces) was conducted. Risk estimates for the
most highly exposed population subgroup, children, are 31.6% of the aPAD and, therefore, were
not of concern.

       Chronic dietary risk estimates were also made using the same assumptions.  This
assessment concludes that the chronic risk estimates are below the Agency's level of concern for
the general  U.S. population (<10% of the cPAD) and  all population subgroups (<54% of the
cPAD for children). Risks, therefore, are not of concern, and no mitigation measures are
necessary.

                                           iv

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Drinking Water Risk

       None of the uses associated with trichloromelamine are expected to impact either surface
or ground water resources. Therefore, no drinking water assessment was performed.

Residential Risk

       A separate residential risk assessment was not performed, as the assessment for
occupational handlers in restaurants is considered to be a conservative and protective surrogate
for residential uses. Since a higher application rate is found on the label used to calculate
occupational risks, these values are used to represent residential risks in the aggregate assessment
and are an overestimate of the residential exposures and risks. These values are not being
refined because the assessment shows no risks of concern.

Aggregate Risk

       The aggregate risk assessment integrates the assessments conducted for dietary and
residential exposure. Using the Aggregate Risk Index (ARI) method, aggregate calculations
were performed for adults only, as no residential exposure scenario exists  for children. The
ARIs are greater than 1.8 for males and females and below the Agency's level of concern
(ARI<1).  No mitigation measures are necessary to reduce risks from aggregate exposures.

Occupational Risk

       To address occupational exposure, combined dermal and inhalation risks for handlers
were assessed.  All margins of exposures (MOE) are below the Agency's level of concern when
workers are wearing baseline PPE (long-sleeved shirt and pants; no gloves). However, since the
inhalation MOE for either washing mess kits or fruits and vegetables  in military mess halls falls
below the MOE of 1,000, when the additional route-to-route extrapolation uncertainty factor is
applied, an inhalation study will be required to confirm these findings.

Environmental and Ecological Risk

       The Agency conducted an environmental risk assessment to determine the potential
impact of trichloromelamine use  on non-target terrestrial and aquatic  organisms. Environmental
exposure modeling was not conducted for trichloromelamine because its limited use as a food
surface disinfectant in restaurants and similar establishments is not likely to result in significant
outdoor exposure.  The uses of trichloromelamine considered in this RED make it unlikely that
any appreciable exposure to terrestrial or aquatic organisms would occur.  The Agency expects
no effects to listed species or critical habitat and therefore makes a "No Effect" determination for
trichloromelamine. However, the high toxicity of trichloromelamine  to freshwater organisms is
of concern in the event of a spill or misuse of the product.

Regulatory Decision

       The Agency has completed  its review and has determined that the  data are sufficient to
support reregistration of all supported products containing trichloromelamine. The Agency is
issuing this RED for trichloromelamine, as announced in a Notice of Availability published in
                                            v

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the Federal Register.  The RED and supporting risk assessment for trichloromelamine are
available to the public in EPA's Pesticide Docket OPP-2005-0262 at
http://www.epa.gov/edockets.  This RED document includes guidance and time frames for
making any necessary label changes for products containing trichloromelamine.

Summary of Mitigation Measures

       The Agency has determined that trichloromelamine is eligible for reregistration provided
the label changes included in Table 12 in Section V of the RED are implemented.  As there are
no risks of concern, no mitigation measures are necessary.

Data Requirements

       Additional confirmatory data are required to complete the reregistration of
trichloromelamine. A complete list of data gaps is presented Section V and Appendix B (Table
of Generic Data Requirements).  In addition, product-specific data is required for all products
containing trichloromelamine as described in Section V of this document.
                                          VI

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I.      Introduction

       The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984 and amended again by the Pesticide Registration Improvement Act of 2003 to set time
frames for the issuance of Reregistration Eligibility Decisions.  The amended Act calls for the
development  and submission of data to support the reregistration of an active ingredient, as well
as a review of all submitted data by the U.S. Environmental Protection Agency (EPA or the
Agency). Reregistration involves a thorough review of the scientific database underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.

       On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law.  This Act amends FIFRA to require tolerance reassessment. The Agency has decided that,
for those chemicals that have tolerances and are undergoing reregistration, the tolerance
reassessment  will be initiated through this reregistration process.  The Act also requires that by
2006, EPA must review all tolerances in effect on the day before the date of the enactment of the
FQPA. FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safety finding in tolerance  reassessment based on factors including consideration of cumulative
effects of chemicals with a common mechanism of toxicity. This document presents the
Agency's human health and ecological risk assessments and the Reregistration Eligibility
Decision (RED) for trichloromelamine.

       Trichloromelamine is used as an indirect food-contact sanitizer and disinfectant in or on:
mess gear; food processing plants; eating establishments; industrial and institutional food service
areas; food marketing, storage, and  distribution equipment  and utensils; food dispensing
equipment; soft custard equipment;  and  household/domestic dwellings. Trichloromelamine is
also used as a direct food-contact sanitizer in one product as a fresh fruit and vegetable wash.
Trichloromelamine is used as a sanitizer on non-food contact premises and equipment in
hospitals and  nursing homes (non-critical areas) and institutional, commercial,  and industrial
settings.

       The Agency has concluded that the FQPA Safety Factor for trichloromelamine should be
removed (equivalent to IX) based on: (1) the developmental toxicity studies both showed a lack
of effects in offspring up to and including the highest doses tested in both studies; (2) the
LOAELs for both studies were based on general systemic effects that were not considered
severe; (3) both studies were well-designed and provided an adequate dose-response for
trichloromelamine; and (4) the risk  assessment does not underestimate the potential risk for
infants and children.

       Risks  summarized in this document are those that result only from the use of the active
ingredients trichloromelamine.  The Food Quality Protection Act (FQPA) requires that the
Agency consider available information concerning the cumulative effects of a particular
pesticide's residues and other substances that have a common mechanism of toxicity.  The
reason for consideration of other substances is due to the possibility that low-level exposures to
multiple chemical substances that cause a common toxic effect by a common toxic mechanism

                                           1

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could lead to the same adverse health effect that would occur at a higher level of exposure to any
of the substances individually. Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made a common
mechanism of toxicity finding for trichloromelamine and any other substances.
Trichloromelamine does not appear to produce a toxic metabolite produced by other substances.
For the purposes of this action, therefore, EPA has not assumed that trichloromelamine has a
common mechanism of toxicity with other substances.  For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative.

       This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of trichloromelamine.  In an effort to simplify the RED, the information
presented herein is  summarized from more detailed information which can be found in the
technical supporting document for trichloromelamine referenced in this RED.  The risk
assessments and related addenda are not included in this document, but are available in the
Public Docket OPP-2005-0262 at http://www.epa.gov/edocket.

       This document consists of six sections.  Section I is the introduction. Section II provides
a chemical overview, a profile of the use and usage of trichloromelamine, and its regulatory
history.  Section III, Summary of Trichloromelamine Risk Assessments, gives an overview of the
human health and environmental assessments, based on the data available to the Agency.
Section IV, Risk Management, Reregistration, and Tolerance Reassessment Decision, presents
the reregistration eligibility and risk management decisions.  Section V, What Registrants Need
to Do, summarizes  the necessary label changes based on the risk mitigation measures outlined in
Section IV. Finally, the Appendices list all use patterns eligible for reregistration, bibliographic
information, related documents and how to access them, and Data Call-In (DCI) information.

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II.     Chemical Overview

       A.    Regulatory History

       Trichloromelamine was first registered in the United States in 1959 as an active
ingredient.  Currently eight products (six end-use products and two technical-grade products) are
registered under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
for use as a disinfectant and sanitizer (primarily on food-contact surfaces).
       B.
Chemical Identification
                              ci
                                           N
                                          CI
                                       N
                                  N
                                           N
                                      CI
                  Figure 1.  Molecular Structure of Trichloromelamine
       Common name:

       Chemical name:

       Chemical family:

       Empirical formula:

       CAS Registry No.:

       Case number:

       OPP Chemical Code:

       Molecular weight:

       Other names:
       Basic manufacturer:
               Trichloromelamine

               1,3,5-Triazine, N,N',N"-trichloro-2,4,6-triamino-

               Triazine

               C3H3Cl3N6

               7673-09-8

               3144

               077101

               229.42

               Decco Salt No. 5; l,3,5-Triazine-2,4,6-triamine, N,N',N"-
               trichloro-; 2,4,6-Tris(chloroamine)triazine; Chloromelamine;
               Melamine, N2,N4,N6-trichloro-; Melamine, trichloro-; N,N',N"-
               Trichloro-2,4,6-triamine-l,3,5-triazine; TCM

               JohnsonDiversey, Inc.; H & S Chemical Co., Inc.; DBK, Inc.
                             3

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       Chemical properties:  Trichloromelamine is in the form of a powder and is cream in
                             color. It has a melting point above 300°C. The water solubility
                             of trichloromelamine is 0.064 g/100 mL at 20°C.
                             Trichloromelamine has a vapor pressure of 7.1 x 10"5 mm Hg at
                             25°C.
       C.
              Use Profile
       The following is information on the currently registered uses of products that contain
trichloromelamine as an active ingredient and an overview of use sites and application methods.
A detailed table of the uses of trichloromelamine eligible for reregistration is contained in
Appendix A.

Type of Pesticide:   Algicide, Disinfectant, Microbiocide/Microbiostat (slime-forming
                    bacteria), Bacteriocide/Bacteriostat, Sanitizer
Summary of Use:
Food:
Non-Food:
                    Trichloromelamine is used as an indirect food-contact sanitizer and
                    disinfectant in or on: mess gear (used at oversees military bases); food
                    processing plants; eating establishments (on equipment, utensils, dishware,
                    glasses, surfaces, tabletops, countertops, floors, walls, sinks, and
                    splashbacks); industrial and institutional food service areas (premises and
                    equipment); food marketing, storage, and distribution equipment and
                    utensils; food dispensing equipment; soft  custard equipment; and
                    household/domestic dwellings (food-contact surfaces).
                    Trichloromelamine is also used as a direct food-contact sanitizer in one
                    product as a fresh fruit and vegetable wash.

                    Trichloromelamine is used as a sanitizer on non-food contact premises and
                    equipment in hospitals and nursing homes (non-critical areas) and
                    institutional, commercial, and industrial settings.
                     Slime-Forming Bacteria, Animal Pathogenic Bacteria (g- and g+
                     vegetative), Bacteria (causing rot or decay), Algae
Target Pests:


Formulation Types: All end-use products are powders and are soluble concentrates.
Method and Rates of Application:
Equipment:

Application Rates:
                    Applied to surfaces by immersion, wiping/swabbing, or spraying

                    The maximum labeled application rate for the direct food use (fruit and
                    vegetable wash) is 0.0345% a.i. in solution (0.115 Ibs. used daily). For
                    indirect and non-food uses, the maximum labeled application rates are
                    0.0276% a.i. in solution and 0.115 Ibs. used daily.
Use Classification:   General use

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III.    Summary of Trichloromelamine Risk Assessments
       The purpose of this summary is to assist the reader by identifying the key features and
findings of these risk assessments and to help the reader better understand the conclusions
reached in the assessments.  The human health and ecological risk assessment document listed in
Appendix C was used to formulate the safety finding and regulatory decision for
trichloromelamine.  While the risk assessment is not included in this document, it is available
from the OPP Public Docket and may also be accessed on the Agency's website at
http ://epa. gov/dockets.  Hard copies of these documents may be found in the OPP public docket
under docket number OPP-2005-0262. The OPP public docket is located in Room 119, Crystal
Mall II, 1801 Bell Street, Arlington, VA, and is open Monday through Friday, excluding Federal
holidays, from 8:30 a.m. to 4:00 p.m.

       A.     Human Health Risk Assessment

              1.     Toxicity of Trichloromelamine

       A brief overview of the acute toxicity studies and those used for determining endpoints in
the risk assessment are outlined below in Tables 1-3. Further details on the toxicity of
trichloromelamine can be found in the "Trichloromelamine Risk Assessment for the
Reregistration Eligibility Decision," dated September 15, 2005. This document is available on
Agency's website in the EPA Docket at http://www/epa.gov/edockets.

       The Agency has reviewed all toxicity studies submitted for trichloromelamine and has
determined that the toxicological database is sufficient for reregistration. The studies have been
submitted to support guideline requirements. Major features of the toxicology profile are
presented below.

Table 1.  Summary of Acute Toxicity Data for Trichloromelamine
Guideline
No.
Study Type
MRID #(s)
Results
Toxicity
Category
Acute Toxicity
81-1
81-2
81-3
81-4
81-5
81-6
Acute Oral
Acute Dermal
Acute Inhalation
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
43165701
43159901
43368501
43159902
43159903
43159904
LD50 = 398 mg/kg
LD50 > 2000 mg/kg
LC50= 0.4 mg/L, males and 0.780
mg/L, females
Severe conjunctival irritation
Severe irritant
No sensitization reactions for group
treated with 0.1% [w/v] solution
II
III
II
I
II
NA
Notes: LC = Lethal Concentration; LD = Lethal Dose; NA = Not Applicable

       The doses and toxicological endpoints selected for various exposure scenarios are
summarized in Table 2 below. For the chronic dietary endpoint, the uncertainty factor (UF) of
300 includes a lOx interspecies extrapolation, lOx intraspecies variation, and 3x extrapolation
                                           5

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from a subchronic study to a chronic endpoint. The Agency chose the NOAEL of 30 mg/kg/day
from the subchronic study in rats as a conservative endpoint for all exposure scenarios.  Residues
of trichloromelamine are likely to disappear quickly based on the chemistry of
trichloromelamine, and subchronic and chronic exposures are likely to be very low.

Table 2.  Doses and Toxicological Endpoints Used in Exposure Scenarios
Exposure
Scenario
Acute Dietary
(General
Population
including infants
and children)
Acute Dietary
(Females 13+
years of age)
Chronic Dietary
(All populations)
Short-Term
Incidental Oral
(1-30 days)
Intermediate-
Term
Incidental Oral
(1-6 months)
Dose Used in Risk
Assessment, UF
NOAEL = 30 mg/kg/day
UF=100
Acute RfD = 0.3
mg/kg/day
Special FQPA SF
and Level of
Concern for Risk
Assessment
FQPA SF = 1
aPAD = acute RfD
FQPA SF
= 0.3 mg/kg/day
Study and Toxicological Effects
90-Day Oral Rodent Study
(MRID 43064301)
LOAEL =150 mg/kg/day
A NOAEL of 30 mg/kg/day was
determined, based on histological lesions
(engorgement of small blood vessels of
the adrenal gland, brain, kidneys, liver,
lung, and pituitary gland) observed at the
next highest dose of 150 mg/kg/day.
An appropriate endpoint for this sub-population was not identified in the hazard database
NOAEL = 30 mg/kg/day
UF = 300
Chronic RfD = 0.1
mg/kg/day
NOAEL=30 mg/kg/day
UF=100
NOAEL=30 mg/kg/day
UF=100
FQPA SF = 1
cPAD = chronic RfD
FQPA SF
= 0.1 mg/kg/day
Target MOE = 100
Occupational = NA
Target MOE = 100
Occupational = NA
90-Day Oral Rodent Study
(MRID 43064301)
LOAEL =150 mg/kg/day
A NOAEL of 30 mg/kg/day was
determined, based on histological lesions
(engorgement of small blood vessels of
the adrenal gland, brain, kidneys, liver,
lung, and pituitary gland) observed at the
next highest dose of 150 mg/kg/day.
See Chronic Dietary Endpoint
See Chronic Dietary Endpoint

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Exposure
Scenario
Short-Term and
Intermediate-
Term Dermal
Exposure
Short-Term and
Intermediate-
Term Inhalation
Exposure
Dose Used in Risk
Assessment, UF
Oral Study
NOAEL= 30 mg/kg/day
UF=100
Dermal
Absorption=100%
Special FQPA SF
and Level of
Concern for Risk
Assessment
Target MOE = 100
Study and Toxicological Effects
See Chronic Dietary Endpoint
No appropriate route-specific study was available. The oral endpoint of 30 mg/kg with a
Margin of Exposure of 100 (1 Ox inter-species extrapolation, lOx intra-species variation) is
used. An additional lOx route-to-route extrapolation is used to determine if a confirmatory
inhalation toxicity study is warranted.
Notes: UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RiD = reference dose (NOAEL/UF),
MOE = margin of exposure


General Toxicity Observations
Table 3. Summary of General Toxicity Data for Trichloromelamine
Guideline
No.
Study Type
MRID #(s)
Results
Subchronic Toxicity
82-1 (a)
90-day Oral Study
(Rodent)
43064301
NOAEL = 30 mg/kg/day
LOAEL =150 mg/kg/day, based on the observation
of histological lesions (engorgement of small blood
vessels of the adrenal gland, brain, kidneys, liver,
lung, and pituitary gland).
Developmental Toxicity
83-3
Developmental Toxicity
43614301
(Rabbit)
43614302
(Rat)
Systemic Toxicity NOAEL < 30 mg/kg/day and
LOAEL < 30 mg/kg/day, based on depressions in
mean maternal body weights and decreased mean
feed consumption values.
Developmental toxicity NOAEL 120 mg/kg/day
Maternal NOAEL < 62.5 mg/kg/day and LOAEL <
62.5 mg/kg/day, based on clinical signs at several or
all dose levels (alopecia, gasping, altered respiration,
salivation, lethargy, chromodacryorrhea), reduction
in body weight gains, and statistically significant
trends for decreased food consumption at all dose
levels.
Developmental toxicity NOAEL = 500 mg/kg/day

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Guideline
No.
Study Type
MRID #(s)
Results
Mutagenicity Studies
84-2(a)
84-2(b)
84-2(c)
Gene Mutation
42148801,
42021801,
42021701
Positive result at 25 jig/plate for TA98 and at 50
(ig/plate in Chinese hamster ovary cells, both with
and without metabolic activation. Negative result in
primary rat hepatocytes.
Notes: NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level

Melamine Toxicity
       Trichloromelamine is expected to rapidly break down into hypochlorous acid and
melamine (EPA, 1994).  A number of toxicity studies have been performed to characterize the
hazard of melamine.  The Agency has concluded that it is unlikely that melamine is a
carcinogenic hazard to humans from the pesticidal usage of a pesticide product (EPA, 1988).
They noted that "humans are not likely to be exposed to the high doses of melamine that produce
the urinary tract toxicity that precedes and seems to lead to the carcinogenic response in rats"
(EPA,  1993). This conclusion is based on the review of a number of studies, including a mouse
carcinogenicity study in which no evidence of tumors were found due to exposure to melamine
at the highest dose tested. In addition, the weight-of-evidence is not sufficient to reasonably
anticipate that melamine will cause serious or irreversible chronic health effects (EPA, 1983).

Endocrine Disruption Potential
       EPA is required under the Federal Food Drug and Cosmetic Act (FFDCA), as amended
by FQPA, to develop a screening program to determine whether certain substances (including all
pesticide active and other ingredients) "may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator
may designate." When the appropriate screening and/or testing protocols being considered under
the Agency's Endocrine Disrupting Screening Program (EDSP) have been developed,
trichloromelamine may be subjected to additional screening and/or testing to better characterize
effects related to endocrine disruption.

              2.      FQPA Safety Factor

       The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is
intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in
infants and children to specific pesticide residues in food, drinking water, or residential
exposures, or to compensate for an incomplete database.  The FQPA Safety Factor has been
removed (i.e., reduced to IX) for trichloromelamine based on: (1) the developmental toxicity
studies both showed a lack of effects in offspring up to and including the highest doses tested in
both studies; (2) the LOAELs for both studies were based on general systemic effects that were
not considered severe; (3) both studies were well-designed and provided an adequate dose-
response for trichloromelamine; and (4) the risk assessment does not underestimate the potential
risk for infants and children. Based on the analysis of submitted developmental toxicity studies,
the Agency determined that no special FQPA Safety Factor was  needed since there were no
residual uncertainties for pre- and/or postnatal toxicity.

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             3.     Population Adjusted Dose (PAD)

       Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which
reflects the reference dose (RfD), either acute or chronic, that has been adjusted to account for
the FQPA Safety Factor (SF). This calculation is performed for each population subgroup. A
risk estimate that is less than 100% of the acute or chronic PAD is not of concern.

                    a.     Acute PAD

       Acute dietary risk for trichloromelamine is assessed by comparing acute dietary exposure
estimates (in mg/kg/day) to the acute Population Adjusted Dose (aPAD).  Acute dietary risk is
expressed as a percent of the aPAD.  The aPAD is the acute reference dose (0.3 mg/kg/day)
modified by the FQPA safety factor.  The acute reference dose was derived from a 90-day
subchronic oral toxicity study in rats in which both the NOAEL (30 mg/kg/day) and the LOAEL
(150 mg/kg/day) were determined.  The trichloromelamine aPAD is 0.3 mg/kg/day based on a
reference dose of 0.3 mg/kg/day, and incorporating the FQPA safety factor of IX.

                    b.     Chronic PAD

       Chronic dietary risk for trichloromelamine is assessed by comparing chronic dietary
exposure estimates (in mg/kg/day) to the chronic Population Adjusted Dose (cPAD). Chronic
dietary risk is expressed as a percent of the cPAD. The cPAD is the chronic reference dose (0.1
mg/kg/day) modified by the FQPA safety factor (IX).  The cPAD was derived from a 90-day
subchronic oral toxicity study in rats in which both the NOAEL (30 mg/kg/day) and the LOAEL
(150 mg/kg/day) were determined based on histopathological lesions. The trichloromelamine
cPAD is 0.1 mg/kg/day based on a reference dose of 0.1 mg/kg/day, which includes the
incorporation of the FQPA safety factor (IX) for the overall U.S. population or any population
subgroups.

             4.     Exposure Assumptions

       Acute and chronic  dietary exposure assessments were conducted using FDA assumptions
for the residues, migration, and surface area of exposure from indirect food-contact surfaces.
The assessment for the fruit and vegetable rinse was conducted using food consumption data
from the USDA's Continuing Surveys of Food Intakes by Individuals (CSFII) from  1994-1996
and 1998. The CSFII data are based on the reported food consumption by more than 20,000
individuals over two non-consecutive survey days. For exposure estimates,  mean consumption
data are used for adult male and female populations. It is assumed that children are not eating in
military mess halls overseas.

             5.     Dietary Risk Assessment

                    a.     Dietary Risk from Food

       Generally, a dietary risk estimate that is less than 100% of the acute or chronic PAD does
not exceed the Agency's risk concerns.  A summary of acute and chronic risk estimates are
shown in Table 4.

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       Screening-level dietary risk assessments were conducted for the direct and indirect food
uses of trichloromelamine.  The estimates dietary intake (EDI) for consumption of fruits and
vegetables was based on a mean consumption estimate for males and females ages 20 and older
in military mess halls from the CSFII data for both acute and chronic exposures. The dietary
intake for fruits and vegetables is limited to subset of the general population, specifically
members of the military; since this subpopulation is not representative of the general population,
the 90th percentile was not used to calculate dietary risk.  For disinfecting mess kits, FDA worst-
case assumptions were used.  The results of the assessment for military mess hall patrons showed
risks to be 6.2% (males) and 7.1% (females) of the aPAD and 18.6% (males) and 21.3%
(females)  of the cPAD and, therefore, are not of concern.

       The indirect food uses in eating establishments, disinfecting utensils and countertops,
were also  assessed using FDA worst-case assumptions.  For both assessments, the product with
highest percent of the active ingredient in solution (as diluted per label instructions) was used to
estimate the worst  case scenario. However, two labels state that additional quantities should be
used if the diluted  solution falls below 100 ppm available chlorine and list the amount of product
required to achieve 200 ppm available chlorine.  Although the Agency does not believe that these
higher concentrations will be used often, as a conservative measure, they are assessed as an acute
exposure.  The results of the assessment for bar and restaurant patrons showed risks to be <32%
of the aPAD and 53.7% of the cPAD for children,  the most highly exposed population subgroup.
Therefore, all risks are below the Agency's level of concern.

Table 4. Summary of Dietary Exposure and Risk
Population
EDI"
(mg/kg/day)
%PAD"
Military

Adult Males
Adult Females
Fruits/Vegetables
0.00282
0.00290
Mess Kits
0.0158
0.0184
Total
0.0186
0.0213
Acute
6.20%
7.10%
Restaurant/Bar (Acute)

Adult Males
Adult Females
Children
Food Utensil
0.0135
0.0158
0.0632
Countertop
0.00677
0.0079
0.0316
Total
0.0203
0.0237
0.0948
Chronic
18.6%
21.3%

Acute
6.77%
7.90%
31.6%
Restaurant/Bar (Chronic)

Adult Males
Adult Females
Children
Food Utensil
0.00669
0.00780
0.0312
Countertop
0.00483
0.00563
0.0225
Total
0.0115
0.0134
0.0537
Chronic
11.5%
13.4%
53.7%
EDI=Estimated Daily Intake; PAD=Population Adjusted Dose (acute or chronic)
a EDI=Intake (mg/person/day)/BW (adult male=70kg, adult female=60kg, and child=15kg)
b %PAD = EDI/aPAD or cPAD * 100, where aPAD=0.3 mg/kg/day and cPAD=0.1 mg/kg/day
                                            10

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                    b.     Dietary Risk from Drinking Water

       None of the uses associated with trichloromelamine are expected to impact either surface
or ground water resources. Therefore, no drinking water assessment was performed.

              6.     Residential Risk Assessment

       A separate residential risk assessment was not performed, as the assessment for
occupational handlers in restaurants is considered to be a conservative and protective surrogate
for residential uses.  Since a higher application rate is found on the label used to calculate
occupational risks, these values are used to represent residential risks in the aggregate assessment
and are an overestimate of the residential exposures and risks. These values are not being
refined because the assessment shows no risks of concern.

              7.     Aggregate Risk

       The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic
Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there  is a reasonable certainty that no harm
will result from aggregate exposure to pesticide chemical residue, including all anticipated
dietary exposures and other exposures for which there are reliable information."  Aggregate
exposure will typically include exposures from food, drinking water, residential uses  of a
pesticide, and other non-occupational sources of exposure. A short-/intermediate-term aggregate
assessment was performed for adults exposed to trichloromelamine based on the following
exposure scenarios: dietary exposure from eating food that has come into contact with treated
surfaces, utensils, and glassware; dermal and inhalation exposure from opening and pouring of
the trichloromelamine product in residential  settings; and dermal and inhalation exposure from
wiping the countertop in residential settings. No aggregate assessment was performed for
children as they are not likely to have non-dietary exposures. Further, a long-term aggregate
assessment is not necessary, as the residential exposure scenarios associated with
trichloromelamine uses involve only short- and  intermediate-term exposures.

       Aggregate MOE calculations were performed using the Aggregate Risk Index (ARI)
method (EPA, 2001). Generally, an ARI that is greater than 1 does not  exceed the Agency's risk
concerns. As shown in Table 5, no aggregate risks of concern were identified for either males or
females, as the ARI value is above 1 for both. Further details on the aggregate risk assessment of
trichloromelamine can be found in the "Trichloromelamine Risk Assessment  for the
Reregistration Eligibility Decision," dated September 15, 2005.  This document is available on
Agency's website in the EPA Docket at http://www/epa.gov/edockets.
                                           11

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Table 5. Summary of Short- and Intermediate-Term (ST/IT) Aggregate Exposure and
Risk Calculations
Population
Adult Males
Adult Females
Chronic Food
Exposure
mg/kg/day
(MOE)
0.0115(2610)
0.0134 (2240)
Opening and
Pouring
Inhalation
Exposure
mg/kg/day
(MOE)
1.72X10"6
(1.7xl07)
1.72X10'6
(1.7xl07)
Opening and
Pouring
Dermal
Exposure
mg/kg/day
(MOE)
3.18xlO'3
(9400)
3.18xlO'3
(9400)
Wiping
Inhalation
Exposure
mg/kg/day
(MOE)
1.16xlO'3
(26,000)
1.16xlO'3
(26,000)
Wiping
Dermal
Exposure
mg/kg/day
(MOE)
1.20x10-'
(250)
1.20x10-'
(250)
Aggregate
Risk Index
1.89
1.83
ARI = I/ ((UFi/MOEi) + (UF2/MOE2) + (LrF3/MOE3) + ...), where the UF = 300 for chronic dietary exposure and 100 for
inhalation and dermal exposures. ARIs greater than 1 are not of concern.

              8.      Occupational Risk

       Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide.  Occupational handlers of trichloromelamine include workers in military mess halls;
restaurants and bars; food processing plants; institutional, commercial, and industrial sites; and
hospitals and nursing homes.  In this assessment, it is assumed that workers in military mess
halls and restaurants represent the high-end exposure scenario for all workers exposed to
trichloromelamine.  Occupational risk for all of these potentially exposed populations is
measured by a Margin of Exposure (MOE) which determines how close the occupational
exposure comes to a No Observed Adverse Effect Level (NOAEL) from toxicological studies.
In the case of trichloromelamine, MOEs greater than 100 are not of concern to the Agency. This
MOE includes the standard safety factors of 10X for intraspecies variability (i.e. differences
among humans) and 10X for interspecies extrapolation (differences between humans and
animals).

       Occupational risk is assessed for exposure at the time of application (termed "handler"
exposure).  Application parameters are generally defined by the physical nature of the
formulation (e.g., formula and packaging), by the equipment required to deliver the chemical to
the  use site, and by the application rate required to achieve an efficacious dose. Occupational
risks were assessed for exposures from powder formulations, as all products are in this form.  For
more information on the assumptions and calculations of potential risk of trichloromelamine to
workers, see the Occupational Exposure Assessment (Section 5.1) in the "Trichloromelamine
Risk Assessment for the Reregistration Eligibility Decision," dated September 15, 2005.

                     a.      Occupational Toxicity

       The toxicological  endpoints used in the assessment can be found in Table 2 above.
                                            12

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                    b.     Occupational Handler Exposure

       Occupational handler risk estimates have been assessed for trichloromelamine using
surrogate unit exposure data from the Chemical Manufacturers Association (CMA) database,
application rates from labels, and EPA estimates of daily amount handled (MRID 42587501).

       The Agency has determined that there are potential exposures to individuals who mix,
load, apply, and otherwise handle trichloromelamine during the usual use patterns associated
with the pesticide's use.  Based on the use patterns, the following exposure scenarios were
assessed:

(1)    mixing/loading powder formulations (opening and pouring packets into water);
(2)    applying by dipping mess kits into diluted solution;
(3)    applying by dipping fruits and vegetables into diluted solution;

(4)    applying by dipping food utensils into diluted solution; and
(5)    applying by wiping countertops with diluted solution.

                    c.     Occupational Handler Risk Summary

       Occupational Handler Exposure Assumptions
       Exposure analyses were performed using the surrogate data from the Chemical
Manufacturers Association (MRID 42587501) and the DERMAL model (U.S. EPA, 1997).  A
description of these and the calculations used  are included in the Occupational Exposure
Assessment (Section 5.1) in the "Trichloromelamine Risk Assessment for the Reregistration
Eligibility Decision," dated September 15, 2005. Both inhalation and dermal exposures were
assessed, and these exposures were combined because the endpoints were based on the same
study.  The target MOE is 100. Scenarios with an MOE less than 100 indicate a risk of concern.

       The following assumptions and factors were used in order to complete the exposure and
risk assessments for occupational handlers:

•      It is assumed, for this assessment, that two 4.77 oz. packets are sufficient for the needs of
       an individual worker in a mess hall kitchen per day, either washing mess kits or washing
       fruits and vegetables;

•      Labels for restaurant and bar use state that additional quantities should be used if the
       diluted solution falls below 100 ppm available chlorine. It is assumed, for this
       occupational assessment, that the available chlorine does not fall over the course of a day,
       and that the standard label rate is sufficient for the needs of one worker in a restaurant per
       day.  The maximum typical rate from any label for this use was the basis for this
       assessment;

•      The surrogate data from the Chemical  Manufacturers Association (MRID 42587501) for
       'solid pour' scenarios are representative to model dermal and inhalation exposure from

                                           13

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       opening the packet and pouring the contents, as well as for 'wiping' scenarios are
       representative of inhalation exposure from standing over the containers with solution
       while washing mess kits, fruits and vegetables, countertops, and utensils;

•      To calculate the dermal exposure for a worker treating mess kits, fruits, and vegetables,
       the DERMAL model was used (U.S. EPA, 1997);

•      A body weight of 70 kg was assumed because the endpoint is not gender specific;

•      The inhalation and dermal absorption rates are 100%;

•      Baseline PPE includes long sleeve shirts, long pants and no gloves or respirator; and

•      All trichloromelamine products are powders that are mixed with water per labeled
       instructions to form a diluted solution.

Summary of Risk Estimates for Handlers
        All of the inhalation and dermal MOEs are above the target MOE of 100 with baseline
PPE and, therefore, not of concern.  No respiratory or dermal PPE is required.  As a conservative
measure, it is assumed that, because this is potentially a small-scale process, one person could
mix the solution and use it immediately after. The combined risks from these exposures are
below the Agency's level of concern.  However, as the inhalation MOE for either washing mess
kits or fruits and vegetables in military mess halls falls below the MOE of 1,000, when the
additional route-to-route extrapolation uncertainty factor is applied, an inhalation study would be
required to confirm these findings. The MOEs for handlers are summarized in Tables 6 and 7.

Table 6. Occupational Handler Risk Summary
Exposure Scenario
Mix/Load (Opening and
Pouring) Powder

Washing


Wiping
Use site
Mess Kits & Fruits/Vegetables
(Military Mess Halls)
Food Utensils & Hard Surfaces
(Commercial/Institutional)
Mess Kits
Fruits/Vegetables
Food Utensils (Comm/Inst)
Commercial/Institutional Hard
Surfaces
Label Application Rate
(Ib a.i./day)a
0.115
0.00292
0.1 15 (0.0276% a.i.)
0.1 15 (0.0345% a.i.)
0.00292 (0.01 17% a.i.)
0.00292
Baseline
Dermal
MOE
240
9400
5200
4200
6100
250
Baseline
Inhalation
MOE
440,000
1.7 xlO7
660
660
26,000
26,000
aFor dermal calculations for washing mess kits; fruits and vegetables; and food utensils, the weight fraction of active
ingredient in the product (after dilution) is used rather than the pounds of a.i. used daily.
                                            14

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Table 7. Combined Occupational Handler Risk Summary
Exposure Scenario
Mix/Load (Opening and
Pouring) Powder +
Washing

Mix/Load (Opening and
Pouring) Powder + Wiping
Crop
Mess Kits
Fruits/Vegetables
Food Utensils
Commercial/Institutional
Hard Surfaces
Dermal
MOE
230
230
3700
240
Inhalation
MOE
660
660
26,000
26,000
Aggregate
MOE
170
170
3200
240
       B.
Environmental Risk Assessment
       A summary of the Agency's environmental risk assessment is presented below.
Trichloromelamine has several registered use sites: fruits and vegetables, eating establishment
utensils and glassware, and food and non-food contact surfaces. The following risk
characterization is intended to describe the magnitude of the estimated environmental risks for
trichloromelamine use sites and any associated uncertainties.

       For detailed discussions of all aspects of the environmental risk assessment, see the
Ecotoxicology and Environmental Risk Assessment (Section 8.0) in the "Trichloromelamine
Risk Assessment for the Reregistration Eligibility Decision," dated September 15, 2005.

              1.     Environmental Fate and Transport

       According to EPA's EPI Suite  database used by OPPTS, a linear model on
biodegradability predicts that trichlormelamine has a high probability of biodegrading in water
within hours.  The half-life in air for trichloromelamine, as determined through mediation of the
hydroxy radical in the atmosphere, is about 16 days (based on a 12-hour day), and it appears to
be moderately persistent in the atmosphere (EPA, 2005).

       The half-life of trichloromelamine in  soils has been estimated to be about 38 days and
150 days in sediments. With an estimated Koc of 150, it is likely to be immobile and  persistent in
soils and sediments and may not pose  a concern for groundwater contamination.  However,  as
trichloromelamine is immobile, it may pose a concern for surface water contamination due to
soil erosion. Because use of trichloromelamine is limited to use as a food and food-contact
surface sanitizer in restaurants and similar establishments, and in military mess halls,
trichloromelamine is not expected to enter the environment and exposure to soil and water
should be minimal.

              2.     Ecological Risk

       The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimated environmental concentrations based on environmental fate
characteristics and pesticide use data.
                                           15

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                    a.     Toxicity (Hazard) Assessment

       Information regarding the potential ecotoxicity of trichloromelamine is shown in Table 8.
In addition, although the information currently available regarding melamine, a degradate of
trichloromelamine, toxicity is insufficient for a hazard assessment, the Agency believes that there
is sufficient evidence to conclude that melamine may be chronically toxic to fish and
invertebrates, causing adverse effects on reproduction and embryonic development.  It was noted
that melamine may be more toxic, chronically, than the data reviewed indicate (EPA, 1983).
Based on the structure-activity-relationship (SAR) of melamine to meta-phenylenediamine, the
96-hour ECso for melamine for green algae is expected to be 2.4 mg/L. The LCso for daphnids is
expected to be 5.9 mg/L, and the MATC is expected to range between 0.05 and 0.09 mg/L.

Table 8. Summary of Ecotoxicity Data (Trichloromelamine)
Endpoint Type
Acute Avian Oral
Acute Avain Diet
Acute Avain Diet
Acute Fish Toxicity
Acute Fish Toxicity
Acute Aquatic Invertebrate
Toxicity
Species
Bobwhite quail
(Colimts virginianus)
Bobwhite quail
(Colinus virginianus)
Mallard duck
(Anas platyrhynchos)
Bluegill sunfish
(Lepomis macrochirus)
Rainbow Trout
Daphnia
Results
LD50 > 5,000 mg/kg
NOEC = 5,000 mg/kg
LD50>2,150mg/kg
LC50>5,OOOmg/kg
NOEC = 2,500 mg/kg
LC50 = 4.5 mg/L
NOEC =1.0 mg/L
LC50 = 4.0 mg a.i./L
NOEC = 0.56 mg a.i./L
EC50 = 0.80mgai/L
NOEC = 0.32 mg ai/L
Reference/MRID#
42250801
42280801
42247401
41934901
42010601
42020801
                    b.     Exposure and Risk

       Environmental exposure modeling was not conducted for trichloromelamine.  Because
the use of trichloromelamine is limited to use as a food surface disinfectant in restaurants and
similar establishments, significant outdoor exposure is not likely to result. The uses of
trichloromelamine considered in this RED  make it unlikely that any appreciable exposure to
terrestrial or aquatic organisms would occur. However, the high toxicity of trichloromelamine to
freshwater organisms is of concern in the event of a spill or misuse of the product.

                    c.     Risk to Listed Species

       Due to the low likelihood of exposure and low toxicity of trichloromelamine, the Agency
expects no effects to listed species or critical habitat and therefore makes a "No Effect"
determination for this chemical.
                                           16

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IV.    Risk Management, Reregistration, and Tolerance Reassessment Decision

       A.    Determination of Reregistration Eligibility

       Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not 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 trichloromelamine as an active ingredient.  The Agency has completed its
review of these generic data and has determined that the data are sufficient to support
reregistration of all supported products containing trichloromelamine.

       The Agency has completed its assessment of the dietary, occupational, drinking water,
and ecological risks associated with the use of pesticide products containing the active ingredient
trichloromelamine. Based on a review of these data, the Agency has sufficient information on
the human health and ecological effects of trichloromelamine to make decisions as part of the
tolerance reassessment process under FFDCA and reregistration process under FIFRA, as
amended by FQPA. The Agency has determined that trichloromelamine-containing products are
eligible for reregistration provided that: (i) current data gaps and confirmatory data needs are
addressed and (ii) necessary label amendments are made. Label changes are described in Section
V. Appendix A summarizes the uses of trichloromelamine that are eligible for reregistration.
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of trichloromelamine and lists the submitted studies
that the Agency found acceptable.  Data gaps are identified as generic data requirements that
have not been satisfied with acceptable data.

       B.    Public Comments and Responses

       Risk assessments for trichloromelamine were not issued for public comment per the
Agency's public participation process because no risks of concern were identified.  To ensure that
an opportunity is presented to the public to comment on the risk assessments and risk
management decisions for trichloromelamine, the Agency will implement a public comment
period on this RED document.

       C.    Regulatory Position

             1.     Food Quality Protection Act Findings

                    a.     "Risk Cup" Determination

       As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with trichloromelamine. The Agency has concluded that the exemption from the requirement of
a tolerance for trichloromelamine meets the FQPA safety standards and that the risk from dietary
exposure is within the "risk cup." An aggregate assessment was conducted for exposures
through food and other residential uses. The Agency has determined that the human health risks

                                           17

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from these combined exposures are within acceptable levels.  In reaching this determination,
EPA has considered the available information on the special sensitivity of infants and children,
as well as aggregate exposure from food and residential uses.

                    b.     Determination of Safety to U.S. Population

       As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with trichloromelamine.  The Agency has determined that the established tolerance exemption
for trichloromelamine meets the safety standards under the FQPA amendments to section
408(b)(2)(D) of the FFDCA,  and that there is a reasonable certainty no harm will result to the
general population or any subgroup from the use of trichloromelamine. In reaching this
conclusion, the Agency has considered all  available information on the toxicity, use practices
and exposure scenarios, and the environmental behavior of trichloromelamine.

       Dietary risk assessments were conducted for adults and children, with the highest risk
(31.6% aPAD and 53.7%cPAD for children) being below the Agency's level of concern.
Aggregate assessments were only conducted for adults, as no residential non-dietary exposure
scenarios existed for children. The Aggregate Risk Index was above  1.8 for both adult males and
females, which is above the Agency's level of concern (ARK1).

                    c.     Determination of Safety to Infants and Children

       EPA has determined that the established tolerance exemption  for trichloromelamine, with
amendments and changes as specified in this document, meets the safety standards under the
FQPA amendments to section 408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of
no harm for infants and children. The safety determination for infants and  children considers
factors of the toxicity, use practices, and environmental behavior noted above for the general
population, but also takes into account the  possibility  of increased susceptibility to the toxic
effects of trichloromelamine residues in this population subgroup.

       No Special FQPA Safety Factor is necessary to protect the safety of infants and children.
In determining whether or not infants and children are particularly susceptible to toxic effects
from trichloromelamine residues, the Agency considered the completeness of the database for
developmental and reproductive effects,  the nature of the effects observed, and other
information. The FQPA Safety Factor has been removed (i.e., reduced to IX) for
trichloromelamine based on: (1) the developmental toxicity studies both showed a lack of effects
in offspring up to and including the highest doses tested in both studies; (2) the LOAELs for both
studies were based on general systemic effects that were not considered severe; (3) both studies
were well-designed and provided an adequate dose-response for trichloromelamine; and (4) the
risk assessment does not underestimate the potential risk for infants and children.

                    d.     Endocrine Disrupter Effects

       EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including  all pesticide active and other

                                           18

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ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system.  EPA also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP).

       When the appropriate screening and/or testing protocols being considered under the
EDSP have been developed, trichloromelamine may be subject to additional screening and/or
testing to better characterize effects related to endocrine disruption.

                    e.      Cumulative Risks

       Risks summarized in this document are those that result only from the use of
trichloromelamine. The Food Quality Protection Act (FQPA) requires that the Agency consider
"available  information" concerning the cumulative effects of a particular pesticide's residues and
"other substances that have a common mechanism of toxicity." The reason for consideration of
other substances is due to the possibility that low-level exposures to multiple chemical
substances that cause a common toxic effect by a common toxic mechanism could lead to the
same adverse health effect  as would a higher level of exposure to any of the substances
individually.  Unlike other  pesticides for which EPA has followed a cumulative risk approach
based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding for trichloromelamine.  For information regarding EPA's efforts to determine which
chemicals  have a common  mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's website at
http ://www. epa. gov/pesticides/cumulative/.

             2.     Tolerance Summary

       A tolerance exemption is currently established for trichloromelamine in the 40CFR §
180.940(c) when used in accordance with good manufacturing practice as an ingredient in an
antimicrobial pesticide formulation,  provided that the substance is applied on a semi-permanent
or permanent food-contact  surface (other than being applied on food packaging) with adequate
draining before contact with food. Trichloromelamine is currently exempted from the
requirement of a tolerance when applied to food processing equipment and utensils, provided
that, when ready for use, the end-use concentration does not exceed 200 ppm as total available
chlorine.
                                           19

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       Although there is a use for dairy processing on one of the labels (Reg. No. 6198-3), no
tolerance exemption for this use has been established and this registrant has expressed its
intention to remove this use from the label (Landman, 2005). Any registrant wishing to maintain
this use site for trichloromelamine must petition the Agency for an exemption from the
requirement of a tolerance under the 40CFR § 180.940(b).  If no  such petition is received by the
Agency, any reference on a label to dairy processing facilities or dairies must be removed during
product reregistration.
                    a.     Tolerance Exemption Currently Listed Under 40 CFR
                           §180.940 and Tolerance Reassessment

Table 9.  Tolerance Reassessment Summary for Trichloromelamine
Tolerance Exemption Listed Under 40 CFR § 180.940 (c)
Use Site


Food
processing
equipment and
utensils






Current
Limit (ppm)

200 (as
available
chlorine)







Tolerance
Reassessment
(ppm)
200 (as
available
chlorine)







Correct Definition/Comment


Trichloromelamine is exempted from the requirement of a
tolerance as an antimicrobial pesticide, provided that the
substance is applied on a semi-permanent or permanent food-
contact surface (other than being applied on food packaging)
with adequate draining before contact with food, when
applied to food processing equipment and utensils, as long
as, when ready for use, the end-use concentration does not
exceed 200 ppm as total available chlorine. Based on the
evaluation of available data, the current tolerance of 200 ppm
should remain.
                    b.
Codex Harmonization
       Currently there are no Codex MRLs established for trichloromelamine.

       D.    Regulatory Rationale

       The Agency has determined that trichloromelamine is eligible for reregistration provided
that additional required data confirm this decision and the necessary label amendments are made.
Where labeling revisions are warranted, specific language is set forth in the summary table of
Section V of this document.

             1.     Human Health Risk Management

       As the risk estimates resulting from dietary, residential, and occupational exposures are
all below the Agency's level of concern, no risk mitigation measures are required to address
human exposure to trichloromelamine.
                                          20

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              2.      Environmental Risk Management

       As the uses of trichloromelamine considered in this RED make it unlikely that any
appreciable exposure to terrestrial or aquatic organisms would occur, no risk mitigation measures
are required to address environmental exposure to trichloromelamine.

              3.      Other Labeling Requirements

       In order to be eligible for reregistration, various use and safety information will be
included in the labeling of all end-use products containing trichloromelamine. As there are no
mitigation measures being required, the only specific labeling statements (in Section V) are
precautionary (in case of a spill) based on acute ecotoxicity data.

              4.      Listed Species Considerations

                     a.     The Endangered Species Act

       Section 7 of the Endangered Species Act,  16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize,  fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. § 402.02.

       To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects,  a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed  or candidate species may be present in the proposed use areas, further
biological assessment  is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.

       For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency -

                                            21

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Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB,
pg.81).  Chemicals in these categories therefore do not undergo a full screening-level risk
assessment, and are considered to fall under a "no effect" determination. Due to the low
likelihood of exposure and low toxicity of trichloromelamine, the Agency expects no effects to
listed species or critical habitat and therefore makes a "No Effect" determination for this
chemical.

                     b.      General Risk Mitigation

       Trichloromelamine end-use products (EPs) may also contain other registered pesticides.
Although the Agency is not proposing any mitigation measures for products containing
trichloromelamine specific to federally listed species, the Agency needs to address potential risks
from other end-use products. Therefore, the Agency requires that users adopt all listed species
risk mitigation measures for all active ingredients in the product.  If a product contains multiple
active ingredients with conflicting listed species risk mitigation measures, the more stringent
measure(s) should be adopted.
                                            22

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V.     What Registrants Need to Do

       The Agency has determined that trichloromelamine is eligible for reregistration provided
that: (i) additional data that the Agency intends to require confirm this decision and (ii) necessary
label amendments, set forth in the Label Changes Summary Table in Section B below (Table
12), are made. The additional data requirements that the Agency intends to obtain will include,
among other things, submission of the following:

       For trichloromelamine technical grade active ingredient products, the registrant needs to
submit the following items:

Within 90 days from receipt of the generic data call in (GDCI):

       1. completed response forms to the GDCI (i.e., DCI response form and requirements
       status and registrant's response form); and

       2. submit any time extension and/or waiver requests with a full written justification.

Within the time limit specified in the GDCI:

       1. cite any existing generic data which address data requirements or submit new generic
       data responding to the GDCI.

Please contact Jennifer Slotnick at (703) 305-0601 with questions regarding generic
reregistration.

By US mail:                                   By express or courier service:
Document Processing Desk (GDCI/AD)          Document Processing Desk (GDCI/AD)
Jennifer Slotnick                               Jennifer Slotnick
Office of Pesticide Programs (75 IOC)             Office of Pesticide Programs (75 IOC)
US EPA                                       US EPA
1200 Pennsylvania Ave., NW                    Room 266A, Crystal Mall 2
Washington, DC 20460                          1801 S. Bell Street
                                              Arlington, VA 22202
                                          23

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For end-use products containing the active ingredient trichloromelamine, the registrant needs to
submit the following items for each product.

Within 90 days from the receipt of the product-specific data call-in (PDCI):

       1. completed response forms to the PDCI (i.e., PDCI response form and requirements
       status and registrant's response form); and

      2. submit any time extension or waiver requests with a full written justification.

Within eight months from the receipt  of the PDCI:

       1. two copies of the confidential statement of formula (EPA Form 8570-4);

      2. a completed original application for reregistration (EPA Form 8570-1).  Indicate on
      the form that it is an "application for reregistration";

      3. five copies of the draft label incorporating all label  amendments outlined in Table 12
      of this document;

      4. a completed form certifying compliance with data compensation requirements (EPA
      Form 8570-34);

       5. if applicable, a completed form certifying compliance with cost share offer
      requirements (EPA Form 8570-32); and

      6. the product-specific data responding to the PDCI.

      Please contact Adam Heyward at (703) 308-6422 with questions regarding product
reregistration and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail:
Document Processing Desk (PDCI/AD)
Adam Heyward
Office of Pesticide Programs (75 IOC)
US EPA
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (PDCI/AD)
Adam Heyward
Office of Pesticide Programs (75 IOC)
US EPA
Room 266A, Crystal Mall 2
1801 South Bell Street
Arlington, VA 22202
                                          24

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       A.     Manufacturing-Use Products

              1.     Additional Generic Data Requirements

       The generic database supporting the reregistration of trichloromelamine has been
reviewed and determined to be substantially complete. However, the following additional data
requirements have been identified by the Agency as confirmatory and included in the generic
DCI for this RED.

       The Agency has established an interim two-tiered system for toxicology testing
requirements.  Tier I toxicology data requirements would apply to all indirect food additives that
result in residue concentrations ranging from 0-200ppb which applies to trichloromelamine.  The
requirements would consist of an acute toxicity testing battery, subchronic toxicity study in the
rodent, a developmental toxicity study in the rat, and a mutagenicity testing battery. Each of
these data requirements has been fulfilled for trichloromelamine.

       The risk assessment noted deficiencies in the surrogate dermal and inhalation exposure
data available from the Chemical Manufacturers Association (CMA) data base. Therefore, the
Agency is requiring confirmatory data to support the uses assessed with the CMA exposure data
within this risk assessment. The risk assessment also noted that many of the use parameters
(e.g., amount handled and duration of use) were based on professional judgments.  Therefore,
descriptions of human activities associated with the uses assessed are required as confirmatory.
Table 10. Confirmatory Data Req
Guideline Study Name
28-Day Inhalation Toxicity Study-Rata
Dermal Indoor Exposure
Inhalation Indoor Exposure
Descriptions of Human Activity
uirements for Reregistration
New OPPTS Guideline No.
870.3465
875.1200,875.1600
875.1400,875.1600
875.2800
Old Guideline No.
82-4
233
234
133-1
'Study duration must be at least 28 days.

              2.     Labeling for Technical and Manufacturing-Use Products

       To ensure compliance with FIFRA, technical and manufacturing-use product (MP)
labeling should be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The Technical and MP labeling should bear the labeling contained in Table
12, Label Changes Summary Table.

       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 product-specific
data regarding the pesticide after a determination of eligibility has been made. The Registrant
                                           25

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must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies.  If a registrant believes that previously submitted data
meet current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product.

       A product-specific data call-in, outlining specific data requirements, will be sent to
registrants at a later date. The efficacy studies the Agency intends to call-in are listed in Table
11 below.

Table 11. Efficacy Data Requirements for Reregistration
Claim




Disinfectant



Disinfectant
Sanitizer


Sanitizer

Use Pattern




Hard inanimate
surfaces



vegetables
Non-food contact
surfaces (non-
residual)

Previously cleaned
food-contact
surfaces (non-
residual)
EPA Reg.
Nos.



40510-1
65169-1



40510-1
65169-1
70627-28

6198-3
8160-1
65169-1
70627-26
70627-28
Guideline Study Name


AOAC Use Dilution Test (Hard
water and organic soil) or
AOAC Germicidal Spray Test or
AOAC Hard Surface Carrier Test
(Distilled water only)

Special Study3
Sanitizer Test for Hard Inanimate
Non-Food Contact Surfaces


AOAC Germicidal
and Detergent Sanitizers Method

New OPPTS
Guideline
No.


810.2100
(c), (d), (e)



NA
810.2100(1)


810.2100

Old
Guideline
No.


91-2 (b),
(c), (d)



NA
91-2 (j)


91-2 (1)(2)

NA=Not Applicable
a The registrant for this use will need to work with the Agency to establish an acceptable protocol for this study.

              2.     Labeling for End-Use Products

       Labeling changes are necessary to protect the environment in case of a spill.  Specific
language to incorporate these changes is specified in Table 12.

       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 document.
Persons other than the registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the labeling changes described in 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.
                                            26

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                            a.     Label Changes Summary Table




      In order to be eligible for reregistration, amend all product labels to incorporate the language in the following table.




Table 12.  Labeling Changes Summary Table
Summary of Labeling Changes for Trichloromelamine
Description
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
Environmental Hazards
Amended Labeling Language
If more than 50 pounds or 5 gallons of product is sold in one package:
"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries,
oceans, or other waters unless in accordance with the requirements of a National Pollution
Discharge Elimination System (NPDES) permit and the permitting authority has been
notified in writing prior to discharge. Do not discharge effluent containing 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."
"This chemical is toxic to aquatic organisms."
Placement on Label
Precautionary
Statements
Precautionary
Statements
immediately following
the User Safety
Recommendations
                                                         27

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VI. APPENDICES
       28

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Appendix A. Table of Use Patterns for Trichloromelamine
Use Site
Formulation
Method of
Application
Application Rate
(Range)1
Use Limitations
Food handling/storage establishments premises and equipment
Eating/Drinking
Establishments (Premises
and Equipment: Hard
Surfaces)
Eating/Drinking
Establishments (Utensils,
Dishes, and Glassware)
Dairy Processing Plants
Food Processing Plants
Powder (Soluble
Concentrate)
Powder (Soluble
Concentrate)
(Reg. 6198-3;
65 169-1; 70627-
26)
Powder (Soluble
Concentrate)
(Reg. 6198-3)
Powder (Soluble
Concentrate)
(Reg. 6198-3;
70627-28)
Immerse
Surfaces (Reg.
6198-3)
Wipe/Swab
Surfaces (Reg.
8160-1; 65169-1;
70627-28)
Spray Surfaces
(Reg. 8160-1)
Immerse
Surfaces
Immerse
Surfaces
Immerse
Surfaces; Wipe
or Swap Surfaces
0.012%-0.024%
0.0117%-0.0169%
0.0169%
0.0114%-0.024%
0.012%-0.024%
0.012%-0.024%
Never use soap when prewashing. Never towel
dry sanitized items.
Never use soap when prewashing. Never towel
dry sanitized items. Do not reuse solution the next
day.
Never towel dry sanitized items. Do not reuse
solution the next day.
Never use soap when prewashing. Never towel
dry sanitized items.
Never use soap when prewashing. Never towel
dry sanitized items.
Never use soap when prewashing. Never towel
dry sanitized items. Do not reuse solution the next
day.
1 Application rate is given in terms of percent of active ingredient in diluted solution following label directions for dilution.
                                                            29

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Use Site
Foodservice Equipment
(including soft-serve,
yogurt, shake, and slush)
Mess Gear
Fresh Fruits and Vegetables
Formulation
Powder (Soluble
Concentrate)
(Reg. 70627-26)
Powder (Soluble
Concentrate)
(Reg. 40510-1)
Powder (Soluble
Concentrate)
(Reg. 40510-1)
Method of
Application
Immerse
Surfaces
Immerse
Surfaces
Wash and
Completely
Immerse
Application Rate
(Range)1
0.0114%-0.0227%
0.0276%
0.0345%
Use Limitations
Never use soap when prewashing. Never towel
dry sanitized items. Do not reuse solution the next
day.
Use only when hot water rinse is not available.
Allow mess gear to air dry. Do not reuse solution
after disinfecting 100 mess kits.
Do not cut or peel fruits or vegetables before
disinfecting. After immersion, rinse with potable
water. Solutions are not to be reused.
Commercial, institutional and industrial premises and equipment
Commercial Premises
Schools
Institutional/Industrial Food
Service Areas
Powder (Soluble
Concentrate)
(Reg. 8160-1)
Powder (Soluble
Concentrate)
(Reg. 8160-1;
70627-28)
Powder (Soluble
Concentrate)
(Reg. 70627-28)
Wipe Surfaces
Spray Surfaces
Wipe Surfaces
Spray Surfaces
Wipe Surfaces
0.0169%
0.0169%
0.0136-0.0169%
0.0169%
0.0136%
Never towel dry sanitized items. Do not reuse
solution the next day.
Never towel dry sanitized items. Do not reuse
solution the next day.
Never towel dry sanitized items. Do not reuse
solution the next day.
Never towel dry sanitized items. Do not reuse
solution the next day.
Never towel dry sanitized items. Do not reuse
solution the next day.
30

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Use Site
Formulation
Method of
Application
Application Rate
(Range)3
Use Limitations
Residential and public access premises
Residential Premises
Powder (Soluble
Concentrate)
(Reg. 8160-1)
Wipe Surfaces
Spray Surfaces
0.0169%
0.0169%
Never towel dry sanitized items. Do not reuse
solution the next day.
Never towel dry sanitized items. Do not reuse
solution the next day.
Medical premises and equipment
Nursing homes and
hospitals (non-critical areas)
Powder (Soluble
Concentrate)
(Reg. 70627-28)
Wipe Surfaces
0.0136%
Never towel dry sanitized items. Do not reuse
solution the next day.
31

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Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision

Guide to Appendix B
      Appendix B contains listing of data requirements which support the reregistration for active ingredients within case #3144
(trichloromelamine) covered by this RED.  It contains generic data requirements that apply to trichloromelamine in all products,
including data requirements for which a "typical formulation" is the test substance.

The data table is organized in the following formats:

       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 Guidance, which are
available from the National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.

      2.     Use Pattern (Column 4). This column indicates the use patterns for which the data requirements apply. The following
letter designations are used for the given use patterns.
      (1) Agricultural premises and equipment
      (2) Food handling/ storage establishments premises and equipment
      (3) Commercial, institutional and industrial premises and equipment
      (4) Residential and public access premises
      (5) Medical premises and equipment
      (6) Human water systems
      (7) Materials preservatives
      (8) Industrial processes and water systems
      (9) Antifouling coatings
      (10) Wood preservatives
      (11) Swimming pools
      (12) Aquatic areas

      3.     Bibliographic Citation (Column 5). If the Agency has acceptable data in its files, this column list the identify 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.

                                                           32

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DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
61-1
61-2a
61-2b
62-1
62-2
62-3
63-2
63-3
63-4
None
63-5
63-6
63-7
63-8
63-9
63-10
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
UV/Visible Absorption
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant in Water
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
42385101, 42283401, 421311012
42385101, 42283401, 42131101
43350301,42131101
43350302,42131101
43350302,42131101
43350302,42131101
42385101,42131101
42385101,42131101
42131101
Waived3
42385101,42131101
Not Applicable
42385101,42131101
42385101,42131101
Not Applicable
43350303
2 MRID 42131101 was also submitted to fulfill old guideline 160-5, Chemical Identity.
3 The study is waived because, based on the chemical structure, it is not likely to provide useful information in the UV region.
                                                                         33

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DATA REQUIREMENT
New Guideline
Number
830.7550
830.7560
830.7570
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
830.6321
Old Guideline
Number
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Study Title
Partition Coefficient (Octanol/Water)
PH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
Use Pattern
All
All
All
All
All
All
All
All
All
All
All
CITATION(S)
MRID Number
Not Applicable
42385101,42131101
43395401,42131101
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
ECOLOGICAL EFFECTS
850.2100
850.2200
850.1075
850.1010
71-1
71-2
72-1
72-2
Avian Acute Oral Toxicity Test
Avian Dietary Toxicity
Fish Acute Toxicity - Freshwater
Acute Aquatic Invertebrate Toxicity
All
All
All
All
42250801
42280801 (quail), 42247401 (duck)
41934901 (bluegill), 42010601
(rainbow trout)
42020801
TOXICOLOGY
870.1100
870.1200
870.1300
81-1
81-2
81-3
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
All
All
All
43165701
43159901
43368501
34

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DATA REQUIREMENT
New Guideline
Number
870.2400
870.2500
870.2600
870.3100
870.3100
870.3200
870.3250
870.3465
870.3700
870.3800
870.4100
870.4200
870.4200
870.4300
870.5265
870.5385
Old Guideline
Number
81-4
81-5
81-6
82-la
82-lb
82-2
82-3
82-4
83-3
83-4
83-la
83-lb
83 -2a
83 -2b
83-5
84-2
84-2
Study Title
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization
90-Day Feeding-Rodent
90-Day Feeding-Non-Rodent
21/28-Day Dermal Toxicity - Rat
90-day Dermal Toxicity - Rodent
90-Day Inhalation - Rat
Developmental Toxicity
Reproduction and Fertility Effects - 2 Generation Repro
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent (dog)
Oncogenicity - Rat
Oncogenicity - Mouse
Combined Chronic Toxicity/Carcinogenicity
Bacterial Reverse Mutation Assay
Micronucleus Assay
Use Pattern
All
All
All
All
All
All


All
All





All
All
CITATION(S)
MRID Number
43159902
43159903
43159904
43064301
Waived4
Waived5
Waived6
Data gap
43614302 (rat), 43614301 (rabbit)
Waived7
Waived8
Waived7
Waived7
Waived7
Waived7
42148801 (Structural Chromosomal
Aberration)
Not Required9
4 The 90-feeding study in the rodent is sufficient to cover this guideline.
5 This study is waived because the risks are below the Agency's level of concern using the conservative 100% dermal absorption factor and an oral endpoint.
6 This requirement was waived because the registrants committed to submitting a 90-day feeding study in its place.
7 This study is waived because risk levels are acceptable using conservative assumptions.
8 These studies are waived because melamine, a degradate of trichloromelamine, is the chemical of concern for any potential chronic effects, as
trichloromelamine rapidly breaks down into hypochlorous acid and melamine.
9 Only one of the 2 studies, 870.5385 or 870.5375, is necessary. MRID 42021801 satisfies this requirement under guideline 870.5375.
                                                                        35

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DATA REQUIREMENT
New Guideline
Number
870.5375
870.5550
870.7485
870.7600
Old Guideline
Number
84-2
84-2
85-1
85-2
Study Title
Cytogenic assay with human lymphocytes
UDS Assay
General Metabolism
Dermal Absorption
Use Pattern
All
All


CITATION(S)
MRID Number
42021801
42021701
Waived10
Waived11
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2400
875.2900
875.2500
875.2900
875.1200
875.1600
875.1400
875.1600
133-3
133-4
233
234
Dermal Passive Dosimetry
Inhalation Passive Dosimetry
Dermal Indoor Exposure
Inhalation Indoor Exposure
All
All
All
All
Waived12
Waived11
Data Gap
Data Gap
ENVIRONMENTAL FATE
835.2120
161-1
Hydrolysis

Not Applicable
10 Metabolism data are not required for the registered uses of trichloromelamine. In addition, trichloromelamine rapidly degrades to hypochlorous acid and
melamine.  Melamine is rapidly eliminated in urine after oral dosing and has been found to be not of toxicological concern.
11 The risks are below the Agency's level of concern assuming 100% dermal absorption. This study is waived as no refinements are needed to the assessment.
12 As trichloromelamine breaks down rapidly into melamine, the post-application exposure studies are waived.
                                                                       36

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Appendix C. Technical Support Documents

       Additional documentation in support of this RED is maintained in the OPP docket,
located in room 119, Crystal Mall #2, 1801 Bell St., Arlington, VA 22202.  It is open Monday
through Friday, excluding legal holidays, from 8:30 AM to 4:00 PM.

       The RED and supporting document, in hard copy form, may be viewed in the OPP docket
room or downloaded or viewed via the Internet at the following sites:

http://www.epa.gov/pesticides/antimicrobials
http ://www. epa. gov/edockets

The RED technical support document is the risk assessment:

•      Trichloromelamine Risk Assessment for the Reregistration Eligibility Decision, PC Code
       077101, Case 3144, Antimicrobials Division, 9/15/05.
                                          37

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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)

1.  MRID Studies
MRID#      Citation

41934901     Bowman, J. (1986) Acute Toxicity of Trichloromelamine to Bluegill Sunfish
             (Lepomis macrochirus): Lab Project Number: 34811. Unpublished study prepared
             by ABC Labs, Inc. 17 p.

42010601     Bowman, J. (1986) Acute Oral Toxicity Trichloromelamine to Rainbow Trout
             (Salmo gairdneri): Lab Project Number: 34812. Unpublished study prepared by
             Analytical Bio-chemistry Laboratories, Inc. 17 p.

42020801     Burgess, D.; Frazier, S.; Schoen, L. (1991) Acute Toxicity Trichloromelamine to
             Daphnia magna: Lab Project Number: 34813. Unpublished study prepared by
             ABC Laboratories, Inc. 15 p.

42021701     Cifone, M. (1986) Evaluation  of Trichloromelamine in the Rat Hepatocyte
             Unscheduled DNA Synthesis Assay: Lab Project Number: 20991 Unpublished
             study prepared by Hazleton Laboratories America, Inc. 25 p.

42021801     Ivett, J. (1986) Clastogenic Evaluation of Trichloromelamine in an In Vitro
             Cytogenic Assay Measuring Chromosomal Aberration Freq- uencies in Chinese
             Hamster Ovary (CHO) Cells: Lab Project Number: 20990. Unpublished study
             prepared by Hazelton Laboratories America, Inc. 33 p.

42131101     Leifheit, B. (1990) Product Chemistry for Trichloromelamine,  Technical Grade.
             Unpublished study prepared by Drackett Co. 8 p.

42148801     Jagannath, D. (1987) Evaluation of Trichloromelamine, (...) in Ames Salmonella/
             Microsome Reverse Mutation Assay: Lab Project Number: 20988. Unpublished
             study prepared by Hazleton Labs., America, Inc. 26 p.

42247401     Fletcher, D.; Pedersen, C. (1988) Trichloromelamine: 8-Day Acute Dietary LC50
             Study in Mallard Ducklings: Lab Project Number: 88 DC 109. Unpublished study
             prepared by Bio-Life Associates, Ltd. 26 p.

42250801     Fletcher, D.; Pedersen, C. (1988) Trichloromelamine: 21-Day Acute Dietary
             LD50 Study in Bobwhite Quail: Lab Project Number: BLAL 88 QD 109.
             Unpublished study prepared by Bio-Life Assocs. 31 p.

42280801     Fletcher, D.; Pedersen, C. (1988) Trichloromelamine: 8-Day Acute Dietary LC50
             Study in Bobwhite Quail: Lab Project Number: BLAL 88 QC 110. Unpublished

                                         38

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             study prepared by Bio-Life Associates, Ltd. 25 p.

42283401     DBK Incorporated (1992) Trichloromelamine & DBK Food Contact Sanitizer:
             Product Chemistry Data. Unpublished study. 35 p.

42385101     Schneder, D. (1992) Trichloromelamine--Efficacy Data "Replacement Study":
             Lab Project Number: TCM-EFF. Unpublished study prepared by H & S Chemical
             Co. Inc. 25 p.

42587501     Popendorf, W.; Selim, M.; Kross, B. (1992) Chemical Manufacturers Association
             Antimicrobial Exposure Assessment Study: Second Replacement to MRID
             41761201: Lab Project Number: Q626. Unpublished study prepared by The
             University of Iowa. 316 p.

43064301     Michie, M. (1989) Trichloromelamine-90-Day Subchronic Study in Rats: Lab
             Project Number: 75-51-0743-88: 40-0743-88. Unpublished study prepared by
             U.S. Army Environmental Hygiene Agency. 1177 p.

43159901     Glaza, S. (1994) Acute Dermal Toxicity Study in Trichloromelamine (TCM),
             #14468W46 in Rabbits: Final Report: Lab Project Number: HWI 31102386:
             TP3016. Unpublished study prepared by Hazleton Wisconsin, Inc. 31 p.

43159902     Glaza, S. (1994) Primary Eye Irritation Study of Trichloromelamine (TCM),
             #14468W46 in Rabbits: Final Report: Lab Project Number: HWI 31102388:
             TP3015. Unpublished study prepared by Hazleton Wisconsin, Inc. 26 p.

43159903     Glaza, S. (1994) Primary Dermal Irritation Study of Trichloromelamine (TCM),
             #14468W46 in Rabbits: Final Report: Lab Project Number: HWI 31102387:
             TP3014. Unpublished study prepared by Hazleton Wisconsin, Inc. 24 p.

43159904     Glaza, S. (1994) Dermal Sensitization Study of Trichloromelamine (TCM),
             #14468W46 in Guinea Pigs—Closed Patch Technique: Final Report: Lab Project
             Number: HWI 31102389: TP2008. Unpublished study prepared by Hazleton
             Wisconsin, Inc. 38 p.

43165701     Glaza, S. (1994) Acute Oral Toxicity Study of Trichloromelamine (TCM),
             #14468W46 in Rats: Final Report: Lab Project Number: HWI/31102385.
             Unpublished study prepared by Hazleton Wisconsin, Inc. 44 p.

43350301     Schneider, D. (1994) Trichloromelamine-Series 61-3: Product Chemistry: Lab
             Project Number: TCM-61-3. Unpublished study prepared by H&S Chemical Co.,
             Inc. 5 p.

43350302     Schneider, D. (1994) Trichloromelamine-Series 62-1,2: Product Chemistry: Lab
             Project Number: TCM-62-1,2. Unpublished study prepared by H&S Chemical

                                         39

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43350303
43368501
43395401
43614301
43614302
45012316
Co., Inc. 6 p.

Schneider, D. (1994) Trichloromelamine—Series 63-9, 10, 11: Product Chemistry:
Lab Project Number: TCM-63-9, 10, 11. Unpublished study prepared by H&S
Chemical Co., Inc. 8 p.

Viau, A. (1994) An Evaluation of the Acute Toxicity of Inhaled
Trichloromelamine Dry Powder Formulation in the Albino Rat: Lab Project
Number: 90906. Unpublished study prepared by Bio- Research Lab., Ltd. 190 p.

Lee, H. (1994) Physical and Chemical Characteristics of Trichloromelamine: Lab
Project Number: 7673/09/08/A1: 233 Al. Unpublished study prepared by S.C.
Johnson & Son, Inc.  17 p.

Tyl, R.; Marr, M.; Myers, C. (1995) Developmental Toxicity Evaluation of
Trichloromelamine Administered by Gavage to New Zealand White Rabbits:
Final Report: Lab Project Number: 65C-5742-300/400. Unpublished study
prepared by Research Triangle Institute. 215 p.

Tyl, R.; Marr, M.; Myers, C. (1995) Developmental Toxicity Evaluation of
Trichloromelamine Administered by Gavage to CD (Sprague-Dawley) Rats: Final
Report: Lab Project Number: 65C-5742-100/200. Unpublished study prepared by
Research Triangle Institute. 246 p.

Walls, C.; Walters, J. (1999) Exposure and Risk Assessments for Sodium Lauryl
Sulfate: Lab Project Number: 99-02: 99-01. Unpublished study prepared by
Novigen Sciences, Inc. 153 p.
2.  Website References

EPA, 2001. "General Principles for Performing Aggregate Exposure and Risk Assessments."
       US Environmental Protection Agency, Office of Pesticide Programs.  November 28,
       2001.  http://www.epa.gov/pesticides/trac/science/aggregate.pdf

EPA, 2004a. Overview of the Ecological Risk Assessment Process in the Office of Pesticide
       Programs U.S. Environmental Protection Agency - Endangered and Threatened Species
       Effects Determinations, Appendix A, Section IIB, pg.81. US Environmental Protection
       Agency.  January 24, 2004.
       http://www.epa.gov/oppfeadl/endanger/consultation/ecorisk-overview.pdf

EPA, 2004b.  USEPA/OPP Pesticide Products Database Query - Updated Weekly. US
       Environmental Protection Agency,  http://www.cdpr.ca.gov/docs/epa/m2.htm.  Accessed
       July, 2004.

EPA, 2005. Estimation Program Interface (EPI) Suite. US Environmental Protection Agency.

                                          40

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       http://www.epa.gov/oppt/exposure/docs/episuite.htm. Accessed 2005.

European Chemicals Bureau, 2004. European Inventory of Existing Commercial Substances.
       http://ecb.jrc.it/ EINECS# 231-648-4. Accessed 2004.

FDA, 2003. "Sanitizing Solutions:  Chemistry Guidelines for Food Additive Petitions." US
       Food and Drug Administration. January, 1993.  http://www.cfsan.fda.gov/~dms/opa-
       cg3a.html.  Last accessed June 9, 2003.

H&S Chemical Co., Inc, 2004. Material Safety Data Sheet.
       http://www.hschem.com/tccmmsds.html. Accessed 2004.

USD A, Agricultural Resarch Service,  1999. "Food and Nutrient Intakes by Children 1994-96,
       1998." ARS Food Surveys Research Group, US Department of Agriculture, available
       under "Products" at http://www.barc.usda.gov/bhnrc/foodsurvey/home.htm.  Last
       accessed July 28, 2004.

Wilson JW, CW Enns, JD Goldman, KS Tippett, JH Mickle, LE Cleveland, and PS Chahil,
       1997. "Data tables: Combined results fromUSDA's 1994 and 1995 Continuing Survey
       of Food Intakes by Individuals and 1994 and 1995 Diet and Health Knowledge Survey."
       ARS Food Surveys Research Group, available under "Releases" at
       http://www.barc.usda.gov/bhnrc/foodsurvey/home.htm.  Last accessed July 28, 2004.

4. Supporting Documents

Environmental Protection Agency, 1983.  Meeting with FDA Toxicology Department
       concerning their evaluation of pituitary tumor incidence in male Fischer 344 rats and
       bone marrow leukemia incidence in female F 344 rats in the 30-month melamine study
       submitted by American Cyanamin (1983).  Memorandum from Stephanie April,
       Toxicology Branch, to Tim Gardner, Registration Division. December 14, 1983.

Environmental Protection Agency, 1984.  Melamine Studies. Memorandum from Stephanie
       April, Toxicology Branch, to James Davis,  Pesticide and Toxic Substances. May 2,
       1984.

Environmental Protection Agency, 1988.  Data waiver request for Trichloromelamine; EPA ID.
       No. 8029-5; Proj. No. 8-0169A; Caswell No. 877. Memorandum from James Rowe,
       Toxicology Branch, HED, to Quang Bui, Section Head of Section V, Toxicology Branch,
       HED. July 6, 1988.

Environmental Protection Agency, 1993.  Carcinogenicity Peer Review of Melamine.
       Memorandum from Stephen C. Dapson, Senior Pharmacologist, HED, and Esther Rinde,
       Manager of Carcinogenicity Peer Review Committee, HED, to Phil Hutton, Insecticide-
       Rodenticide Branch, Registration Division. July 21, 1993.
                                         41

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Environmental Protection Agency, 1994.  Trichloromelamine: Review of Acute Toxicity Studies
       Submitted in Response to DCI.  Memorandum from Jess Rowland, Toxicologist, HED, to
       K. Davis and B. Alder, Product Managers, Reregistration Division.  July 21, 1994.

Environmental Protection Agency, 1997.  Standard Operating Procedures (SOPs) for Residential
       Exposure Assessments. Prepared for the Office of Pesticide Programs, Health Effects
       Division. Contract No. 68

Environmental Protection Agency, 2000.  Review of the Proctor & Gamble Submission for
       Registration of the Product, FIT, to Wash Fruits and Vegetables. Memorandum from
       Robert Quick,  Chemist, RASSB, to Velma Noble, Product Manager Team, RMB I. DP
       Barcode D262976.

Environmental Protection Agency, 2004.  Residue Chemistry Comments on the
       Trichloromelamine Preliminary  Risk Assessment. Electronic Correspondence from
       Robert Quick,  Chemist, RASSB, to L. Bailey, Senior Environmental Scientist,
       Antimicrobial Division, Immediate Office.  August 24, 2004.

Landman, LC, 2005. "Reference to use in Dairies, B-T-F Chloromelamine Sanitizer, EPA Reg.
       No. 6198-3." Correspondence from Dr. L. Charles Landman, National Chemicals, Inc. to
       Adam Heyward, Antimicrobials Division.  September 22, 2005.
                                         42

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Appendix E. Generic Data Call-In

The Agency intends to issue a Generic Data Call-In at a later date. See Chapter V of the
trichloromelamine RED for a list of studies that the Agency plans to require.
                                          43

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Appendix F. Product Specific Data Call-In




The Agency intends to issue a Product Specific Data Call-In at a later date.
                                          44

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Appendix G.  Batching of Trichloromelamine Products for Meeting Acute Toxicity Data
Requirements for Reregistration

       In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing trichloromelamine as an
active ingredient, the Agency has batched products which can be considered similar for purposes
of acute toxicity.  Factors considered in the sorting process include each product's active and
inert ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular), and labeling (e.g.,  signal word, use
classification, precautionary labeling). Note that the Agency is not describing batched products
as "substantially similar," since they may not have similar use patterns.

       Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.

       Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch.  It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material.  If a registrant chooses to rely upon previously submitted acute toxicity  data, he/she
may do so provided that the data base is complete  and valid by today's standards  (see partial list
of acceptance criteria attached), the formulation tested  is considered by EPA to be similar for
acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the acute toxicity data. The Agency must approve any new or canceled
formulations (that were presented to the Agency after the completion of the RED) before data
derived from them can be used to cover other products in a batch. Regardless of whether new
data is  generated or existing data is referenced, registrants must clearly identify the test material
by EPA Registration Number.  If more than one confidential statement of formula (CSF) exists
for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.

       In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within  90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product.  The  second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who  wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so.  If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's

                                            45

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data, he/she must choose among:  Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6).  If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.

       If a registrant would like to have the batching status of a product reconsidered, he/she
must submit detailed information on the product, including a detailed rationale for the inclusion
of the product into a batch. An MSDS for each "inert" ingredient should be included where
possible. A current version of the Confidential Statement of Formula (CSF) is to be included in
the submission.  However, registrants and manufacturers should realize that the more unusual
their formulation is, the less likely it is to be able to batch that product.

Table 1.
Batches for Products Containing The Active Ingredient Trichloromelamine
Batch
1
Registration
Number
8160-1
65169-1
70327-26
Percent Active Ingredient
Trichloromelamine
Trichloromelamine
Trichloromelamine
18.0%
18.7%
18.2%
No Batch Group: The following products were not considered similar enough to any of the other
products to be placed in a batch.  These products are not batched.
No Batch Group
Registration
Number
6198-3
40510-1
65146-1
70627-27
70627-28
Percent Active Ingredient
Trichloromelamine
Trichloromelamine
Potassium Iodide
Trichloromelamine
Trichloromelamine
Trichloromelamine
9.5%
19.3%
28.6%
98.0%
91.0%
18.2%
Please note that while products may have the same percent active ingredient as another product,
the composition of their inert ingredients may vary greatly.
                                            46

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                MINIMUM ACUTE TOXICITY ACCEPTANCE CRITERIA
               Does the study report clearly identify the test material? That is, is the
               test material identified by EPA Registration Number,  product name,
               or, is the product listed as technical grade?

               Does the report state that the study was conducted in concurrence with
               the (1984) 40 CFR §160.12?
 3             Is the test species identified?

 4             Are the test animals the proper weight?  (Rats approximately 200-300
               grams, rabbits approximately 2.0 - 3.0 kg.)

 5             Acute oral, dermal and inhalation toxicity: Did the observation period
               last for 14 days, or, until the test subjects appeared normal?
               Primary eye irritation: Did the observation period continue for 21 days,
               or, until all irritation subsided?  Studies displaying excessive irritation
               (toxicity category I) may be stopped before 21 days.

               Primary skin irritation: Did the observation period continue for 14 days,
               or, until all irritation subsided?  Studies displaying excessive irritation
               (toxicity category I) may be stopped before 14 days.

               Acute inhalation toxicity: Were the test subjects exposed to the material
               for at least 4 hours (if there was no mortality during the exposure)?

               Acute inhalation toxicity: Was particle size determined at least twice
               during the exposure?  Was the MMAD between 1 and 4 microns
               (micrometers)?
 10            Acute inhalation toxicity: Was the particle concentration
               determined at least twice during the study?
Studies that do not meet each (1-10) of the criteria listed above will be rejected. Please be
informed that EPA's guidelines change from year to year. A study that was accepted 25 or more
years ago may not be currently acceptable.

Please refer to the following documents for more information.
1.      Health Effects Test Guidelines. Series 870. EPA 712-C-98-189, August 1998.
2.      Conduct of Acute Toxicitv Studies. EPA 737-R-97-002, September 1997.
                                           47

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Appendix H. List of All Registrants Sent the Data Call-In




A list of registrants sent the data call-in will be posted at a later date.
                                            48

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Appendix I.  List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /forms/.

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)

Instructions

       1.     Print out and complete the forms. (Note: Form numbers that are bolded can be
             filled out on your computer then printed.)

       2.     The completed form(s) should be submitted in hardcopy in accord with the
             existing policy.

       3.     Mail the forms,  along with any additional documents necessary to comply with
             EPA regulations covering your request, to the address below for the Document
             Processing Desk.

       DO NOT fax or e-mail  any form containing 'Confidential Business Information'  or
'Sensitive  Information.'

If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail at williams.nicole@epamail.epa.gov.

       The following Agency Pesticide Registration Forms  are currently available via the
internet at  the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of
a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR
Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR
Notice 98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.gov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf

http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf

http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf

http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf

http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
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Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/

Dear Registrant:

       For your convenience, we have assembled an online registration kit that contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):

       1.     The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
             Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
             Protection Act (FQPA) of 1996.

       2.     Pesticide Registration (PR) Notices

             a.      83-3 Label Improvement Program—Storage and Disposal Statements

             b.      84-1 Clarification of Label Improvement Program

             c.      86-5 Standard Format for Data Submitted under FIFRA

             d.      87-1 Label Improvement Program for Pesticides Applied through
                    Irrigation Systems (Chemigation)

             e.      87-6 Inert Ingredients in Pesticide Products Policy Statement

             f      90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement

             g.      95-2 Notifications, Non-notifications, and Minor Formulation
                    Amendments

             h.      98-1 Self Certification of Product Chemistry Data with Attachments (This
                    document is in PDF format and requires the Acrobat reader.)

       Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.

       3.     Pesticide Product Registration Application Forms (These forms are in PDF format
             and will require the Acrobat reader.)

             a.      EPA Form No. 8570-1,  Application for Pesticide
Regi stration/Amendment

             b.      EPA Form No. 8570-4,  Confidential Statement of Formula

             c.      EPA Form No. 8570-27, Formulator's Exemption Statement

             d.      EPA Form No. 8570-34, Certification with Respect to Citations of Data

             e.      EPA Form No. 8570-35, Data Matrix
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       4.     General Pesticide Information (Some of these forms are in PDF format and will
             require the Acrobat reader.)

             a.     Registration Division Personnel Contact List

             b.     Biopesticides and Pollution Prevention Division (BPPD) Contacts

             c.     Antimicrobials Division Organizational Structure/Contact List

             d.     53 F.R.  15952, Pesticide Registration Procedures; Pesticide Data
                    Requirements (PDF format)

             e.     40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
                    format)

             f     40 CFR Part 158, Data Requirements for Registration (PDF format)

             g.     50 F.R.  48833, Disclosure of Reviews of Pesticide Data (November 27,
                    1985)

       Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:

       1.     The Office of Pesticide Programs' Web Site

       2.     The booklet "General Information on Applying for Registration of Pesticides in
             the United States", PB92-221811, available through the National Technical
             Information Service (NTIS) at the following address:

                    National Technical Information Service (NTIS)
                    5285 Port Royal Road
                    Springfield, VA 22161

       The telephone number  for NTIS is (703)  605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication  will become available during the Fall of 1998.

       3.     The National Pesticide Information Retrieval System (NPIRS) of Purdue
             University's Center for Environmental and Regulatory Information Systems. This
             service does charge a fee for subscriptions and custom searches. You can contact
             NPIRS by telephone at (765) 494-6614 or through their Web site.

       4.     The National Pesticide Telecommunications Network (NPTN) can provide
             information on  active ingredients, uses, toxicology, and chemistry of pesticides.
             You can contact NPTN by telephone at (800) 858-7378  or through their Web site:
             ace. orst. edu/info/nptn.

       The Agency will return a notice of receipt of an application for  registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner

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encloses, with his submission, a stamped, self-addressed postcard.  The postcard must contain
the following entries to be completed by OPP:

                    Date of receipt
                    EPA identifying number
                    Product Manager assignment

       Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date of
receipt and provide the EPA identifying File Symbol or petition number for the new submission.
The identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms,  common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities).
Please provide a CAS number if one has been assigned.
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